Elite Pharmaceuticals, Inc. (OTCQB:ELTP) Q4 2020 Earnings Conference Call June 30, 2020 11:30 AM ET
Nasrat Hakim – President and Chief Executive Officer
Carter Ward – Chief Financial Officer
Conference Call Participants
Good morning, ladies and gentlemen, and welcome to the Elite Pharmaceuticals Conference Call. [Operator Instructions] Before management begins speaking, the company has the following statements. Elite would like to remind their listeners that remarks made during this call may contains forward-looking statements that involves risk and uncertainties are subject to changes at any time including but not limited to statements about Elite’s expectation regarding future operation results. Forward-looking statements are made pursuant in the safe harbor’s provision of the Federal Securities and Law represents management’s current expectations. Actual results may differ materially. Elite disclaims any obligation to update or revise its forward looking statements except as required by law.
For more complete information regarding the forward looking statements, risks and uncertainties can be found on the reports that will be filed with the SEC, which are available on Elite’s website @elitepharma.com under the Investor Relations section. Elite encourages you to review this document carefully.
With that covered, it is now my pleasure to turn the floor over to your host, Mr. Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals. Sir, the floor is yours.
Thank you, Catherine. And good morning, ladies and gentlemen, and thank you for joining us today. My name is Nasrat Hakim; I am Elite’ President and CEO. This is our earnings call and our CFO Mr. Carter Ward will give us a summary of our company’s fantastic financials. After which I’ll come back with the corporate update and answer a few of the questions that you have submitted to Dianne. Ward, floor is yours.
Thank you, Nasrat, and thanks as always everyone calling in today. Yesterday, we filed our 10-K for the fiscal year ended March 31st, 2020. K is available on the Investor Section of our website which is elitepharma.com. It’s also on sec.gov and the many other websites that provide links to our filings. If you haven’t gone through the K yet please get a copy from elitepharma.com or any of the other usual sites. So today, I’d like to review some of the key parts of the financials, providing analysis context and insight into the numbers. As always, we have received questions and comments from shareholders and Elite followers. And I’ll do my best to address those that are financials related as part of my comments.
First, I want to point out that as a result of recent changes in SEC regulations, Elite is now classified as a smaller reporting company as opposed to an accelerated filer, which we were prior to the change. It’s a technical item but one of the more notable effects of this technical change in the regulations is filing deadlines. So annual reports are now due 90 days from the year-end date. June 29th is 90 days from March 31st as opposed to 75 days for accelerated filers. Quarterly reports are due 45 days after the quarter end as opposed to 40 days under the old regulations or the regulations for accelerated filers. So we got a few messages from shareholders wondering why it seemed that the K was filed later than in prior years and it was and that’s the reason there’s new regulations with a new reporting schedule that we follow.
Also the SEC had some issue with their website last night. So the filing actually went a little later than usual. But that was due to some technical issues with the SEC that have been sorted out obviously. So let’s start with the P&L. Revenues for the year ended March 2020, the 2020 fiscal year were $18 million and that compares to $7.6 million for the 2019 fiscal year. So that’s a $10.6 million or 137% % increase as compared to the last year. So clearly without a doubt these are our highest revenues, as well as the largest dollar increase in our revenues in Elite’s history. No year has come close to that. The increase in revenues can be attributed to the three products that we launched during fiscal 2020. Those are generic Adderall, immediate-release Adderall, generic Dantrolene and to a lesser extent for fiscal 2020 at least generic extended-release Adderall. The extended-release Adderall was launched at the very end of 2020 fiscal year.
So remember, our revenues consist of two distinct streams. There’s manufacturing revenues and there’s profit splits. The manufacturing revenues, those are earned when we make and we ship the product. So those increased from $5.4 million in 2019 to $14.5 million in 2020. It’s a $9.1 million increase or a 166%. The main drivers here are the three generic products launched this year, ones I just mentioned immediate release Adderall; extended release Adderall and Dantrolene and our existing products prior to those from the prior years. They’ve also had very strong years especially Isradipine and Naltrexone. You also have to give it a lot of credit to our manufacturing lab and quality personnel, as well as our supply chain partners. All have done a phenomenal job ensuring that we continue to run on all cylinders producing record volumes, shipping record volumes and all of this during the current Covid pandemic.
So that’s quite an achievement, really remarkable what everybody has done. The other parts of our revenues are profits splits and those we earn as our marketing partners sell into the market. These depend on the timing of their in market sales so there’s a natural lag of a few quarters up to even four or could even be six quarters from when we manufacture to when those in market sales are achieved. And when we earn those profit split revenues. So profit splits, they’re up from $2.2 million in 2019 to $3.5 million this year. So that’s a $1.3 million increase or 59%. So you notice there’s a lower rate of increase in profit splits as compared to manufacturing revenues. And this is due to the timing lag I just mentioned between the two types of revenues especially since the extended-release Adderall was launched during the last month of the year. So we ship launched quantities during March 2020, but other than a $375,000 milestone earned when we launched the product, will be earning the profit split revenues as our marketing partner which is Lannett as they sell it into the market. So it takes a few quarters after the product launch for the profit splits to start coming online.
So immediate release Adderall and Dantrolene were launched earlier in the fiscal year, fiscal 2020. So they’ve already started to positively impact on profit split revenues. And amphetamine, the Adderall extended release has not yet impacted profit split revenues because they were launched right at the end of the year. But we do expect additional contribution from the extended release Adderall as those profit splits start to come online over the next few quarters. So you put the increases in both manufacturing revenues and profits put together, you get total revenues going up from $7.6 million to $18 million in a single year. So before moving on, I think it’s important to keep in mind that extended release Adderall has just been launched and the immediate release version of Adderall as well as Dantrolene. They’re both relatively new in the market.
Our marketing partner has done a great job with all of these products, but there’s still room for growth in the future. So moving down the P&L, we come to research and development expenses, which went down from $7.6 million last year 2019 to $5.5 million this year fiscal 2020. That’s a $2.1 million decrease or 28%. As I’ve always said there are two things to always keep in mind when it comes to R&D expenses. First is that R&D is the lifeblood of any pharmaceutical company. A large part of the $7.6 million that we spend in 2019, they went to the products that were launched in early 2020 and part of the $5.5 million spent this year in 2020 also went to the product that we launched at the very end of fiscal 2020.
So we need to spend money anywhere from two to three years before we get the revenues. That’s what happens with everybody and our financials clearly show this. The other thing to keep in mind with regards to R&D expenses is that what you spend it on is just as important as the amount spent just because R&D spend has decreased, it doesn’t mean that our efforts and R&D activities have also decreased. Certain product development activities such as clinical trials, they cost more than others; changes in amounts spent are often a result of the nature and the specific cost of the activities engaged in during a particular period. And that’s the case with us. Our R&D efforts continue at the usual levels and we expect costs to fluctuate going forward based upon the nature of the specific activities conducted.
So in summary, fiscal 2020 was a milestone year for Elite. We launched three important products during the year. We achieved record revenues that greatly exceeded any prior year and most importantly, the revenues have been earned from growth in existing products and from the introduction of new products. All of which are showing signs of continued consistency and further growth. We achieved a significant improvement in our financial, our condition during fiscal 2020. We, last year in fiscal 2019, we had a growing concern opinion which we don’t have this year, but there’s still significant competitive and regular regulatory challenges faced by us and everyone in our industry and those remain. We’ll always have our work cut out for us in meeting these challenges. But we did make major strides this year towards achieving the underlying fundamentals in our financials that we seek for improved shareholder value.
So now our Chairman and CEO Mr. Nasrat Hakim would like to give an update in his comments.
Thank you, Carter. What a difference a year makes. An increase in revenue from $7.6 million to $18 million is a solid step in the right direction, becoming profitable enough to support an R&D pipeline would get us to the right destination. That is where we want to be. An essential part of growth is to also hold on to what you have. We are working with our partner Lannett to protect our current shares of the market and ensure that we grow it. Lannett is in charge of sales and marketing and they have done a very good job with the market shares for the IR in spite of the fact that it’s a saturated market with 11 players. We trust they’ll do the same thing with amphetamine ER. From our side, Elite is protecting and improving the business by ensuring that our GMP facility has the right capacity, equipment, material and personnel to support Lannett and our other sales and marketing partners.
We secured enough API quota from the DEA to support Lannett’s sales projections through the end of this year. That is fantastic news. We struggled with that in the first quarter and a little bit in the second and finally the DEA came around and gave us enough quota to support the sales and marketing projections through the end of the year. In March, Elite was inspected by the FDA again for Pharmacovigilance and REMS. After eight day inspection the FDA issued a minor observation on a Form 483. The observation was for our website not having a link to REMS for [Indiscernible]. We explained to the FDA that the product is not and has never been marketed or commercialized. Further the link on the website to the REMS was corrected three days before. They issued the observation that did not help. We still got a minor observation but the FDA was kind enough to annotate that it was corrected before they left.
Regardless, this is a great outcome and outstanding news. That makes five inspections, four of which we got zero observations and one that we got this Mickey Mouse observation quote. Elite has also successfully pivoted away from opioids during the opioid crisis and the negative environment and lawsuits that came with it and we are extremely lucky that we have never been a part of that. Elite is executing on its growth plan, getting product approvals and launching new products. And our sales and marketing partners Glenmark, TAGI and Lannett are all performing well. Regarding amphetamine ER capsules, the product was approved last December. We successfully launched it by March. Lannett, our sales and marketing partner has done a very good job with this product and we expect this product to continue to grow and contribute to our profit and revenues. Amphetamine ER is also marketed by Lannett and they have done an excellent job considering that this product has 11 players, most of which are very big pharma companies.
They obtained enough shares for us to enjoy the revenues that Carter just cited a few minutes ago. Luxepine, the transfer of Luxopine capsules and several of you had questions about that. Our facility was approved last quarter and we have a sales and marketing partner identified. The delay has been from the API supplier. As soon as we launched this product, we will let you know. We were hoping to launch it two three months ago, but as i said the API supplier had an issue and we are working with our partner and the API supplier to resolve that. This is a product that has an IMS data of $5 million. And there are four AMDAS approved including ours. Loxapine is on the FDA’s product shortage list. The antibiotic tablets ANDA, this product was developed and filed with our partner Sanjin as per the agreement the ANDA will be in SunGen’s name. We received a complete response letter with a minor designation. The work on the minor amendment was completed by Elite a while back. Sanjin has not filed the response with FDA. They plan to do so sometime in September or October.
I will discuss that further in a couple of minutes. On the development pipeline, Elite is working on the central nervous system product discussed previously. We continue to work on other differentiating genetics for our future growth, and we will update you on those development projects upon achieving key milestones. Covid-19 has impacted our business like they impacted everybody else in the industry. We created an employee protection plan where those who are what we call non-essential, non-essential means that they can perform their job from home, working from home. Lab personnel went on two shifts in order to create more space between personnel. And we require them to wear masks and clean the place regularly. Manufacturing, we have rules on having no more than two operators in the room with frequent air changes and gowning and masks in order to secure their safety. This is a serious issue that’s affecting everybody in the industry. So far the impact has been minimal on us, but it’s always in the back of my mind in case if we have resurgence or we have a second wave in the fall. That could be a serious issue not only to Elite and here but also to our API suppliers and others in the pharmaceutical industry.
We held a special shareholder meeting last week for the proposals for additional authorized shares passed by a large majority. The election results are provided in our June 24 filing on the shareholder meeting. Thank you all for voting and thanks for all those who voted for or against.
I will take a minute and address the SunGen products that I just cited. We have several products with SunGen. The two antibiotics, central nervous system and also amphetamine ER and IR. The SunGen is a good company and they have a solid R&D group. Today’s landscape has had financial impact on SunGen and I have discussed that in previous meetings. We know what’s happening in China. Long before Covid-19, the turf war, the issues that were having with the Chinese, the devaluing of the currency, people unable to get money out of the country. SunGen depends on financing from China. They have spent a lot of money on R&D with very little money coming in, as many stopped or slowed down and coming in they needed to rediscover themselves or come up with an exit strategy. That impacted us on the antibiotic drug that I just mentioned. And also on the central nervous system drug.
In addition, we were very concerned about amphetamine IR and ER who are they can divest to and what’s going to happen. Their CEO and I entered into negotiations to acquire SunGen at least the R&D solid doses line. SunGen have also an injectable division. We reached an agreement and decided to approach our boards with it. The offer was 100% in stock, the CEO accepted it. He saw it as a very good thing for the company. He thought that they’ll be an upside when they get our stocks is then that it’s going to go up with all these new products we’ll be getting. But their board rejected it because they do not understand the — stock and restrictions that comes with it. In the meantime, SunGen was also negotiating with other Chinese firms to acquire them. We had the first shot at it and the board did not accept a 100% stock offer.
They offered Elite to buy amphetamine IR and ER but insisted also on 100% in cash. I called the Board meeting. Mr. Ward informed us that we cannot afford to spend that kind of money on new products. We do not have it and we cannot raise it. After Elite rejected the offer that’s how Mika ended up with the enders by stepping in. It is my hope that eventually Elite will end up with these two products. Okay. A question from the stockholders as why there was no 8-K and the answer is simple; this transaction was between two privately held companies after Elite was given the right of first refusal and rejected the offer. Further, there is no impact on Elite. The impact on Elite really for this transaction is zero. All Mika is step into SunGen’s shoes, that’s it. That had no impact on Elite whatsoever. As a matter of fact there are positive impacts on Elite that I will not go through in here today. That did not require an 8-K but we did publish this event as a part of our 10-K. We included it in detail in our 10-K.
There were several questions about this subject and I hope I covered them all. So I’ll move on to others and I’ll circle back to this. The questions really were coming in after just few minutes ago from Dianne because of the delay in the SEC. Yesterday they had some technical issues and they could not get the 10-K out so every question Dianne gave me up till the last second, I have try to add it to my presentation, group it with others or addressed separately. The first question is please explain the following timeline and Carter just went through that. The accelerated filing and the status on all of this. There is no need for me to repeat all of that.
Can you provide guidance for Q1, 2021 which is this quarter? Please provide some type of forecast for the next few quarters as we haven’t had much information in the last five months.
I will share with you what I know and that is the quarter ending today we will hit the $7 million in revenues and that quarter would not have any profit splits from the ER, is that right, Carter? We don’t see any profit splits this quarter.
No. There should be some.
Yes, very minimal because of the launch, okay. So the quarter will end today. We will hit the $7 million. The last quarter was almost $5 million.
Just under $5 million.
Okay. I expect the same funds for next quarter, but as I just told you we are going through a pandemic. I cannot make you promises that I cannot keep. And we don’t run sales or marketing therefore I can’t give you projections. All I can do is when Lannett gives me a solid projection for what they want us to make for three months, I would have a good sense what am I going to make during these months. But beyond that the schedule keeps changing, okay.
How is the company progressing on the needed update for internal control measures? What will still be needed to take place?
Nothing as Carted stated, goal concern is removed and we are under control.
Yes. Well, first of all, the growing concern — there is no going concern opinion that’s been removed and I mean the business and the financials demonstrate just why that was the case. We don’t have that issue and on the internal controls, there were material weaknesses in internal controls in the 2019 10-K, all of which have been remediated. What we did to do that is listed in item 9a of the 10-K. But we spent the money. We hire the people. We updated the documentation and implemented the controls and to such an extent that we feel that we’ve achieved — we remediated the material weaknesses and have an effective internal control environment and that’s the assertion made by management in this 10-K.
No. The auditors this year because we’re a smaller reporting company. We’re not required to have a separate audit done. Management is required to make the assertion that they always make which we made, but we’re not required to go and have a separate audit done of our internal controls.
Okay. Thank you, Carter. Next question is on increased and authorized, was the increase in shares issued related to CEO holding and how can you guarantee investors that further dilution will not happen?
A part of it was due to the Series J. But the other parts were for us to have the ability to have to conclude business opportunities similar to the one I just explained to with SunGen. If these shares were available and they were presented and we could actually catch them out we would have had a very good deal with a company, which had a lot of product in that pipeline including some that are first to file and [paragraph] for filings. You always need the ability to maneuver otherwise we continue producing very little and taking that very little first getting to the point of breaking even and then maybe a little bit profitable and that little im-profitability will take us forever to get one product through the market. And maybe one of these days we should have a Board with the stockholders if that’s the rate that we need to go on that’s the rate we have to go on. But for us, to go after new products and get the companies next level and increase revenues and all the things that people ask me to do, and do it with nothing that’s asking a little too much. So, yes, there is a potential that we may be using some of these shares but anything we use is for Elite benefit and for the stockholders benefit, okay. Nothing extravagant. It’s all R&D related that we hope the return on the investment will be several folds once the R&D succeeds.
The impact of Covid-19. I covered that. Has Covid-19 — has any material impact on Elite? It is under control. Is Elite planning on or already involved in any Covid research or related production?
No. We’re not. Our facility is not set up to handle that. Usually, this is a vaccine and vaccines are usually injectables. An injectable product has been done in a facility that has lemon air and has water standards that are a lot higher than ours. Just to give you a very simple example from the facilities that I ran for vaccines, if I give you a bottle of water and has bacteria in it and you boil it you can drink it there is no issue whatsoever. But if you inject it in your bloodstream you will die immediately from pyrogens. Even the parts of the bacteria that have been dead will kill a human being. So the controls on injectables are very high standard and our facility is made to run solid dosage forms things that are ingestible. So when you take something through the stomach even if it has some form of bacteria and it’s not going to hurt you just like eating food. But if you inject it in bloodstream, it’s a problem and this requires; the Covid-19 vaccine requires that level of facility. It would be very exciting to be part of that actually, okay.
Amphetamine ER, how many existing suppliers are there for Adderall XR? And has that number been recently reduced i.e. Teva or anyone else it?
Teva did not exit. It might did anyone else as a matter of fact one more entered the market and that’s Mylan. Mylan entered about a week ago or few days ago.
Okay. I trust in Lannett. They have done a sensational job with amphetamine IR in spite of the fact that there are 11 players there and we came in late, okay. The product — our product was approved recently. People have been in the market for the IR for years. And yet Lannett was able to penetrate that market and do a very good job. I trust they will do the same thing with the ER and that was a great part of having the IR first because now they established the customer base, they have the relationship with everybody with Walgreens and so on that are buying from them and they can easily add on the ER to that.
Since Adderall XR has launched, has the DEA quota issue been worked out or normalized?
Yes, it has. The DEA was kind enough to give us quota through the end of the year. Now that doesn’t mean I have product. I need you to understand that quota means they allow me to buy it. Now I have to work with the API supplier whom they all want upfront cash and the product is extremely expensive and by that bring it in-house test it and then make a product from it. Then sent it to Lannett and that’s transfer price 30 days later they pay us. So there is a lot of money that is tied up in working capital when you do something like this. The step one which is a very, very good step is to have approval from the government to do it. Step two now you got to have the money to do it and such thing you got to wait till you get money back so the cycle starts over again, okay.
Following the approval of some [Indiscernible] there was discussion about the DEA quota issues that we just addressed that, okay, there’s no issue here.
SunGen Elite Adderall AR, what is going on with transferring the end from SunGen’s name to Elite, okay. We did that because Mika took over and as SunGen requested that before actually, it was in the works but when Mika took over we told [Duleep] go ahead and do that, okay. Mainly because of the transfer of the product, okay.
The two antibiotics. Can you please provide an update on the co development of antibiotics?
SunGen suppose to have them the name, we’re working very closely with them in order to find a resolution to these. They don’t invest any more money and they don’t even invest money in even trying to launch a product. So we got to come up with something that’s a win-win for both parties. We are working on that.
CNS, ANDA, what is the status of SunGen partnership CNS, ANDA with the potential of $1.5 billion market?
As it would require a bio equivalency trial before submitting and we were led to believe this effort was on the front burner. Why the delay? Well, the delay is because SunGen is not putting in any money. So I reached an agreement with SunGen that we will take over this product. We have no further obligation to them. We are going to develop it to a point where we can run a clinical trial. And it will be 100% Elite’s product. We are separating ourselves from SunGen. This product will be going forward all they know how will be ours. We are exploring its viability right now and once we get to a point where there is a milestone will notify you of that.
Luxopine, update on Luxopine launch. We just did that.
Last question. In September 2019, the FDA issued a notice seeking input on the development and evaluation of abuse deterrent formulation of central nervous system stimulus. Can Elite R technology be applied to its CNS product?
That’s a very good question and the answer is yes. Our technology works on all the products that affect the brain function especially the pleasure area even works on alcohol, okay. But this would require a rich partner. It’s not an easy project. It cost a lot of money. How much money we spent on SequestOx and on development of the R technology. We do have the technology. We can do it. We just need the resources. We raise the money internally or we find the partner to does that.
This was the last question and that concludes this meeting. We will meet again in six weeks.
Yes. I think August 14th is the next filing date. So I got to see what days it works out.
Right. So in about six weeks we will meet again. Have a wonderful day everybody.
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.