Elite Pharmaceuticals, Inc. (ELTP) Earnings Call Transcript & Summary

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 contain forward-looking statements that involve risks and uncertainties and are subject to changes at any time, including, but not limited to, statements about Elite's expectations regarding future operating results. Forward-looking statements are made pursuant to the safe harbor provisions of the federal securities laws and represent management's current expectation. Actual results may differ materially. Elite disclaims any obligation to update or revise its forward-looking statements, except as required by law. More complete information regarding forward-looking statements, risks and uncertainties can be found in the reports Elite files with the SEC, which are available on Elite's website at elitepharma.com under the Investor Relations section. Elite encourages you to review these documents 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 of Elite Pharmaceuticals. Sir, the floor is yours.

Thank you, Kate. Good morning, ladies and gentlemen, and thank you for joining us today. My name is Nasrat Hakim. I am Elite's President and CEO. This is our earnings call, and our CFO, Mr. Carter Ward, will give us a summary of the company's financials, after which I'll come back with a corporate update and answer some of the questions that you submitted to Dianne. Mr. Ward, you have the floor.

Thank you, Nasrat, and thanks to everyone, as always, for calling in today. Last Friday, August 14, 2020, we filed our 10-Q for the quarter ended June 30, 2020. So we're on a March fiscal year. That means the June quarter is the first quarter of our 2021 fiscal year. The Q is available on the Investors section of our website, which is elitepharma.com as well as sec.gov and other websites that provide links to our filings. If you haven't gone through the Q yet, please get a copy from elitepharma.com or any of the other sites. 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've received questions and comments from shareholders and Elite followers. I'll do my best to address those questions that are related to the financials. Let's start with the P&L, where we reported our highest to date quarterly revenues. Revenues for the quarter ended June 2020 were $7.5 million, and that's compared to $3.4 million for the June 2019 quarter. That's a $4.2 million increase, or 124% as compared to the last -- same quarter of last year. The increase was driven by revenues from generic extended release Adderall, which was launched on March 30 this year, and we also saw strong growth as compared to last year for the generic immediate release Adderall, Isradipine and Phentermine as well. And also, our naltrexone product has been a steady performer, contributing consistent numbers to revenues. The June 2020 quarter was clearly a very strong one for Elite. It's also the fifth consecutive quarter of double- or triple-digit revenue growth compared to the comparable quarter of the prior year. Over the last 5 quarters, encompassing the 4 quarters of the 2020 fiscal year plus the first quarter of this 2021 fiscal year, we have averaged quarterly revenue growth of 155% as compared to the comparable quarter of the prior year. Over this same 5-quarter period, when looking on a quarter-to-quarter basis, we have increased our revenues in 4 of the 5 quarters with an average revenue increase of almost 50%. That's quarter-to-quarter. All of our product lines are contributing to this growth, but there's 3 product lines that particularly stand out, based not just on the numbers, which are retrospective, but also on the prospective factors as well. Those 3 products are generic immediate release Adderall, generic extended release Adderall and Isradipine. All 3 have significantly contributed to our growing revenues, and all 3 also show future upside potential. Generic extended release Adderall has been in the market for slightly more than 1 quarter, having been launched on March 30 of this year. Generic immediate release Adderall was launched during the June 2019 quarter, so that product has been in the market for just over 1 year. Both products still have future upside as our alliance partner, Lannett, continues its penetration of the market. Lannett, to date, has done an excellent job establishing these products and should -- we expect should continue expanding the market share. Isradipine is a product with a relatively small market size but competitive factors predict future upside in Isradipine that would provide contributions to Elite's results above their current levels. The takeaway from our revenues is that we not only achieved record revenues, more than doubling the prior year and our fifth consecutive quarterly increase, but the products responsible for most of the growth have the potential for even more future upside. Much of the credit for Elite's strong performance is due to its manufacturing lab and quality personnel as well as marketing and supply chain partners. They have all done a phenomenal job ensuring we continue to run on all cylinders, producing record volumes, record revenues and all during the COVID-19 pandemic. Moving down the P&L to the operating income line, you'll see we had an operating profit of $830,000 for the quarter, and that's as opposed to a loss of $1.1 million in the prior year. So that's just under a $2 million improvement in profitability on a year-to-year basis. The balance sheet, specifically receivables, payables and inventories, provide some context and visibility into how this turnaround is reflected in our financials. Since March 2020, our receivables have increased by $300,000, and our inventories were up $1.4 million. Both are indicative of growing revenues. We need to buy and stock more inventory to meet the growing demand, and our receivables are naturally higher due to increased billings to customers. On the payables and accrual side, those are also up by approximately $240,000. It's natural to expect those to increase with operations and revenues, but note that the increase in these items is less than the increase in inventories and receivables. This shows the strengthening of our working capital position that results from operating profits on our P&L statement as well as the positive operating cash flow, which is reported on our cash flow statement. Finally, on our balance sheet, our overall equity increased by $1.1 million since March 31. Almost all of this was due to our net income, which includes the operating income of $800,000 combined with other income and expense items such as derivatives and sales of our state NOLs. So however you look at it, the financial metrics and ratios, they're all moving in a positive direction. Finally, there were a couple of questions which I received, and I figured I'd address them now instead of waiting until Nasrat does the Q&A section. The first question had to do with whether or not there is a ratchet applicable to the Series J preferred stocks and warrants for transactions done with Lincoln Park Capital. And the answer to that is there is no ratchet to the Series J preferred stocks or the warrants for Lincoln Park transactions. No ratchet was given in relation to any sales of shares to Lincoln Park under the equity line that was in effect from 2017 to July 1, 2020, and no ratchet will be given to any sales of shares for Lincoln Park under the most recent Lincoln Park agreement. The Series J preferred shares and warrants specifically exclude any ratchet from sales of shares to Lincoln Park Capital. To further ensure no ambiguity as to the issue of ratchets, Nasrat Hakim has specifically raised -- waived any ratchets from the Series J preferred shares and the warrants relating to the Lincoln Park transaction. And that waiver is attached to the Q, the 10-Q. It's Exhibit 10.57. So it's a public document. The second question relates to the sale of SunGen rights to half of the profit earned from sales of the generic Adderall products, which were negotiated with SunGen as part of the co-development agreement between SunGen and Elite. That co-development agreement is just one facet of SunGen's overall business. SunGen was entitled to sell its rights in the co-development agreement, and they offered these rights to Elite for a cash price equal to 3x estimated earnings earlier this year. That translates to several million dollars, 3x the earnings of the profits from Adderall. Elite did not have the cash available to consummate the deal at the time of SunGen's offer and accordingly, our Board declined SunGen's offering. Subsequently, Mikah Pharma, which is owned by Nasrat Hakim, offered to buy the rights for the same cash terms offered to Elite. This transaction was consummated between SunGen and Mikah. Elite's position remains the same as prior to SunGen's sale of this asset. Elite will receive the same amount of profit as when SunGen was its partner. SunGen was determined to sell this asset regardless of Elite's position, and they could have chosen any partner they desired to sell to. Rather than SunGen selling to a third party, which may have complicated the relationship with Elite, they decided to sell to Mikah. Certainly, from a relationship standpoint, this sale by SunGen to Mikah is a much better situation for Elite than if the assets were sold to a third party. I've also received comments about Elite acquiring full rights of these products, and that's something we still hope to achieve in the future. But at this point, Elite is not in a position to pay cash for these assets. I can say that in the future, if we are in a position to acquire these rights, it is to Elite's benefit that they are held by our largest shareholder with a demonstrated resolve in Elite's success as opposed to being held by a company that may have other priorities. So now our Chairman and CEO and President, Mr. Nasrat Hakim, would like to give an update and his comments.

Thank you, Carter, and thank you for the fantastic financials. Regarding revenues and profits, let me highlight a couple of things that Carter articulated very nicely. In 2019, our revenues for the entire year were $7.5 million. In 2020, our revenues went up to $18 million. $7.5 million to $18 million, that's a substantial increase in revenues year-to-year. In 2021, the first quarter revenues are $7.5 million. That's equivalent to the revenues for the entire year for 2018 and 2019. And compared quarter-to-quarter between 2020 Q1 and 2021 Q1, going from $4.4 million to $7.5 million is substantial increase as well. And finally, this is the fifth quarter in a row that our revenues increased comparable to the equivalent quarter in the previous year, 5x in a row. And I expect this trend to continue throughout Elite's fiscal year of 2021. We are finally profitable, and this is the beginning of sustained profitability. I'll start with the safety update because COVID-19 is a pandemic that's affecting us all, not only at Elite but all of our suppliers and sales and marketing and so on. We had to adjust to doing business to fit today's environment. We've implemented new rules and policies to ensure that our employees and associates are safe and they are protected and protecting each other. We are following local and federal guidelines and the CDC recommendations. We feel an obligation to our employees, stockholders and patients to do our part to ensure that there are no drug shortages, especially for our top products, Amphetamine IR and ER, which are used for attention deficit disorder for children at this time when everybody is going back to school. We created and implemented employee protection plan that entails employee training. That includes the standards: temperature monitoring, social distancing whenever possible, wearing masks, appropriate attire, washing hands and proper hygiene. But we also staggered the shifts when possible to give people more space and less proximity. We limited the number of associates in the manufacturing suites to 2 and increased the airflow in the rooms and air circulation per hour and in addition to monitoring of the HEPA filtration. All nonessential employees have been given the option to work from home. So regulatory affairs, when you can do your work from home, we are advising to do that, medical affairs, accounting, except for Carter. His wife petitions that we keep him aboard, and we decided to accommodate her. We do have -- I do have some concerns. And that is, any employee could get sick outside of work. And we don't have lots of redundancies. We are a small company. So employees with critical role can affect the business. Carter is the CFO. He has 2 people helping him. And if anything happens to him, they will carry us through, but the institutional knowledge lies with him. So if anything happened to any of our senior staff, we will suffer. We will get by, but there will be definitely consequences. Our raw material and API suppliers, okay, they could become affected with COVID-19. It doesn't have to be at Elite. Somebody else's work somewhere else could be affected. And then the productivity gets affected, and we may not be able to receive the API or raw material. Sales and marketing by Lannett could slow down because of this, okay? Now to be fair and balanced, all of the things that I mentioned could happen to our competitor, and we could be the beneficiaries of it. I do not wish it upon anybody and would like us to take all precautions to make sure that our employees are protected, and I hope our partners are, too. Speaking of API suppliers, as I updated you before, and we had questions on this, we have secured enough API quota from the DEA to support Lannett's sales projections throughout the end of this year. We will be submitting another proposal to the DEA for next year, sometime in October. Now due to the limited working capital, we placed the orders with the API supplier that will be staggered and delivered to us on monthly basis. Our facility is in a very good shape. We have a very nice facility that we are very proud of. We will be spending hundreds of thousands of dollars this year on expanding the facility, improvements and upgrades to increase capacity. We purchased a 30 cubic foot V blender, a new higher speed tablet press and upgraded our packaging line, so now it has 25% more capacity. We are utilizing SAP more and more, and we hired a full time employee, an expert in SAP and material management, to help us streamline our systems. On the commercial front, Amphetamine ER was launched just in December. That's 8 months ago. It was -- sorry, this was approved in December. It was launched in March. That is record speed. By the time we got the approval, it was around Christmastime. Not much work was happening. But also in January, if you remember, we did not get the quota from the DEA. So we really started scrambling to get the product out by February. And our staff did an excellent job in supplying Lannett with what they need by March. And that's where now April through June is our first quarter of launching it. 8 months ago was not a very long time ago. A lot of work was done and people deserve credit for that. Lannett has done an excellent job in sales and marketing for Amphetamine ER and IR. Amphetamine IR has 11 players, and yet Lannett was able to benefit the market and bring us actually not only revenues but profits, increasing year-over-year. Today, they are working on multiple contracts. And as of today, Walgreens is our largest customer. Last time I updated you on Loxapine, where we got an approval for site transfer and we had an issue with the API supplier. I am happy to say that we have signed a contract with the API supplier, and they will continue -- they'll start supplying us with Loxapine. We placed our first order, and it should be here. It's made in India so it should be here within about 3 months. As soon as we receive it, we already have identified a sales and marketing partner, and we will be launching that product. The IQVIA is about $5 million for Loxapine. And there are 4 approved, and that's including ours. FYI, Loxapine is and has been for a while on FDA's product shortage list. Antibiotics tablets, ANDA, this product was developed and filed with our partner, SunGen. As per the agreement, 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 actually. SunGen has not filed the response with the FDA yet. They plan to do that in September or October. We will keep you updated as to the progress of the antibiotic ANDA. Elite is executing on its growth plan, getting product approvals and launching new products. And our sales and marketing partner, Lannett is doing great job, and TAGI and Glenmark are doing as well. In development, we are working on central nervous system product that we have discussed previously. Let me pause here and make this very clear because I got some questions on that. This product, Elite has the know-how and can move forward by itself to optimize the formulation, conduct clinical trials and file the product with no obligation to anybody else. We resolved the issues with SunGen, and this product now is with Elite. You've sent quite a few questions to Dianne that we grouped into a few categories. Already, Carter addressed the Mikah questions and the ratchet. I will try and address the rest.

The second set of questions were about Lincoln Park Capital. Why is Elite using Lincoln Park Capital to raise money? Please explain the Elite's lower-than-expected price of $0.03 in the contract. Why not use a nondilutive method, such as borrowing money? The answer is really simple. Lincoln Park Capital is the best and cheapest way to raise money. Banks and institutes, in general, cost us a lot of money. We met with many of them, and they all follow a similar formula. So in way of an example, if we were going to raise $20 million for R&D and buying new products and assume that the stock price is $0.10, the financial institutes want a premium discount on these products. So they're going to ask you to sell it to them for $0.075. And they also demand warrants that are equal to the stock price. So now if we want to raise $20 million at $0.075, we'll have to give up 266 million shares -- in shares and also another 266 million shares in warrants. That's more than 0.5 billion shares in order to raise $20 million. And actually, it's not $20 million; it's $18 million because the bank also charges you 10% fee for facilitating the transaction. So for $18 million raised, it will cost us more than 0.5 billion shares if we go with these institutes. That's untenable. Now let me give you an analysis that Carter made for me earlier today. Over the past 7 years, we have sold 246 million shares through Lincoln Park. This is starting 7 years ago before I even joined the company. The 246 million raised $42 million. So why wouldn't you want to go with Lincoln Capital when you can raise $42 million with 246 million shares versus $0.5 billion for 18 million shares (sic) [ 0.5 billion shares for $18 million ]? So why not use a nondilutive means such as borrowing money? Multiple reasons: Because that requires someone to lend it you, and people are not lining up just to give you free money. By way of an example, Carter was trying to get money from our bank for working capital. And they said, no, unless I, Nasrat Hakim, cosigned for Elite. I do have an account at that bank, too, and they want me to cosign for the company. That's what every single institute does when you try to borrow money when you're Elite, where you're going to have a ton of assets for them to leverage against. Second, if we default on these payments, we would lose the company. At a minimum, we have to file for some form of bankruptcy, Chapter 7 or Chapter 11. Akorn Pharmaceutical was trading at $20 per share, and they had 100 million shares outstanding. So instead of doing what we're doing and selling shares and diluting themselves, as it's called, to raise money, they decided to borrow money to buy high-tech and other companies. Today, they cannot pay the $1 billion that they borrowed. And on the 20th, this Thursday, a judge will award the company basically to the debtors. The stock went from $20 to $0.12, okay? Now the stockholders, I'm sure they are wishing that the company diluted them and the stock would have maybe been $10, and they'll have 200 million shares outstanding. The Lincoln Park deal was a very good deal and is a very good deal for Elite. Our former CEO, Carter and Dianne deserve all the credit. I was not here when they signed the first -- where they signed the first deal, but I maintained it because it is the best thing for Elite. The third set of questions had to do with our stock, stock price, R&D and stock future. Why is our stock so low? What are you going to do about it? How do we compare to the rest of the industry? What does Elite's R&D pipeline look like? I am painfully aware of what our stock is trading at. And for every person that sends Dianne an email complaining that they own 1 million shares or 2 million shares and they are under, I own 100x more than that. So it's killing me 200x more. And I wish -- and we are doing a lot of things to get it up, but I wish there was a magic wand that could waive and get it to go up. So the first thing I want to do for stockholders' sake is put things in perspective for you, define what happened, what is happening now, and maybe where are we going to go in the future. So let's look at the industry and see what's going on in the industry, generic industry. We're not talking about brands, Pfizers and others. We're talking about the generic industry. Looking at the generic industry for the past 5 years and naming just about any company you can think of, starting with the largest company in the world. Teva Pharmaceutical, which acquired Actavis and Watson, the other 2 largest companies in the world, was $65, 5 years ago. Today, it's $12. They have a negative P/E ratio in that they have no earnings per share. Actually, they do lose [ $0.78 ] per share. The company's market cap is about $12 billion to $13 billion, and they owe about $26 billion. This is a little bit like a person who owns a house that's worth $100,000, and they have a mortgage on it for $200,000, $300,000. The best company of all these, almost dozen I'm going to go through is Dr. Reddy. Dr Reddy was $65, 5 years ago, and they are about $60 today. Not a lot of loss over 5 years, and most of it really gained in the last year. And they have a P/E ratio. Actually, they have earnings per share of [ 40 ]. At Sandoz, they dissolved their generic decision. They were at one time the biggest and they became the second biggest, and they dissolved the generic business. Mylan $54, 5 years ago; $16 today. They also have a P/E ratio. Purdue, bankrupt. Amneal, they purchased Impax and $350 million worth of products from Watson and they were $45, 5 years ago. They are $4 today, and they operate at a loss, negative P/E ratio. Valeant $250, down to $17, operating at a negative P/E ratio. Perrigo, $200, down to $50. Endo Pharmaceuticals $80, that's 8-0, down to $3. Lannett, I think the world have met. They are doing an outstanding job for us. They were $50, 5 years ago. They are $6 today. Again, negative earnings. Akorn $20, 5 years ago; $0.12 today. InflaRx Pharmaceuticals 5 years ago, $0.04 today. The consolidation in the pharmaceutical industry and the time we have gone through have been very rough. Everybody wants to hear that our stock is going through the roof and making money, and that is the best news for me that I could ever share with you and with my family. But this sector as a sector has been suffering. And little Elite not only did not go bankrupt, we survived. We have our lights on. We pay our employees. We comply with FDA requirements, DEA requirements, OSHA requirements. As I said, we meet payroll, and we're thriving. We have shifted to becoming profitable. We still found companies to make deals with, such as SunGen and others, in order for us to survive and now would reach profitability. And the outlook looks really positive, considering that ER is in its infancy with respect to the product life cycle. Hopefully, we will max out maybe in 2 to 3 years and start to see where it's going to settle then. But as of now, everything looks good for us. So are we worse off than the generic industry? I would say no. Are we worse off if we diluted the company, the borrowing -- or borrowing money from a lender that comes after us? No. We would not exist today if we did that. With all of that, we're a small company and we're on the LPC. Obviously, our stock gets manipulated. We have low volumes. When you have 500,000 shares changing hands at $0.06 a share or $0.07 a share, that's $30,000, $35,000. Anybody who had a grant can manipulate the heck out of the company. That's why I keep talking about creating fundamentals and getting the heck off the bulletin board and the LPC and moving on to a place where we have institutional investors coming in. As I mentioned, a solid quarter. We've had 5 quarters in a row where we have done very well, and yet the stock did not move. That pressure is building up, and I do believe sooner or later, we are going to take off. Let me say in conclusion that we are in the best financial shape ever, and we are doing better than most in the industry. We've stabilized the company. We have solid manufacturing facility with excellent GMP compliance and history and financial sources through our profitability and Lincoln Park Capital. We have an avenue to buy products, work with partners or go at it by ourselves for R&D. We are profitable and targeting sustained profitability. We have $75 million in federal tax credit, meaning that the first $75 million that we earn, we don't pay taxes on. We have very little debt. If you look at our debt to market cap, we're running at about 7%. If you look at Teva, they're running at 200%. Our profitability and Lincoln Park deal are critical factors in our investing in R&D. The list I just went through is our vehicle to NASDAQ. It makes us very appealing for somebody to buy us out or for us to merge with another company, sales and marketing or of the sort and continue. The news has been fantastic, in spite of the stock has not moved in the past. I have no remedy for that. I do not have a magic wand for me to get the stock up. All I have is our hard work, continuing to get the best deals for Elite to ensure that we will get to where we're going. This concludes our meeting. Thank you, and be safe.

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.