Elite Pharmaceuticals, Inc.

Elite Pharmaceuticals, Inc.

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Drug Manufacturers - Specialty & Generic

Elite Pharmaceuticals, Inc. (ELTP) Q3 2021 Earnings Call Transcript

Published at 2021-02-17 15:27:07
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. 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.
Nasrat Hakim
Thank you, Paul. Good morning, ladies and gentlemen, and thank you for joining us today. My name is Nasrat Hakim, I am Elite's, Chairman 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 the corporate update and answer some of the questions that you've submitted to Dianne. Mr. Ward, you have the floor.
Carter Ward
Thank you, Nasrat. And thanks everyone as always for calling in today. Yesterday, we filed our 10-Q for the quarter and the nine months ended December 31, 2020. We're on a March fiscal year, so the December quarter is the third quarter of our 2021 fiscal year. The Q is available on the Investor section of our website, which is elitepharma.com, as well as sec.gov and the other websites that provide links to our filings. If you haven't gotten 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, and I'll do my best to address those questions that are related to the financials. So let's start with the P&L, where we reported another double digit growth in revenues that makes seven quarters in a row now, where we have achieved double or triple digit revenue growth on a year-on-year basis. Revenues for the quarter ended December 2020 were $6.05 million as compared to $5.05 million with the December 2019 quarter, so that’s $1 million increase or 20% as compared to the same quarter last year. The increase was driven by revenues from generic extended release Adderall, which was launched on March 30th of this year. We also saw strong growth as compared to last year for generic immediate release Adderall and generic Dantrolene capsules. Our other products Isradipine, Phentermine, Phendimetrazine and Naltrexone also continued their consistent performance, with continuing solid contributions to revenues. While Phentermine, Naltrexone and Phendimetrazine do provide a stable revenue as they've done for many years now. It's the generic Adderall, and Isradipine products that continue to stand out as the growth driver, both retrospectively as evidenced by revenues reported and prospectively, with certain factors seeming to indicate additional future upside for these products. Remember, our generic Adderall products are still relatively new in the market. We launched the immediate release product just a little over a year ago. And we launched the extended release product less than a year ago, only nine months or so. And our alliance partner with these products Lannett, they continue to do an excellent job penetrating the market, and they should continue expanding market share. So these factors were mentioned in previous calls, and the results are clearly evidenced on our P&L statements. The takeaway here is that the factors that have driven the substantial year-on-year growth over the past seven quarters remain and they should continue their positive contributions prospectively. Moving down to P&L statement, we achieved an operating profit of $1 million for the quarter. That's compared to an operating profit of $600,000 during the December 2020, 2019 quarter, that's a 67% improvement in profitability, and the third consecutive quarter with operating profits and that's the first four Elite. On a fiscal year-to-date basis to nine months from April to December, the – our operating profit was $3.2 million, that's compared to an operating loss of $900,000 for the same nine month period in 2019. That's a 4.1 million turnaround in profits since last year. And this has led to a significant strengthening of our financials. Our balance sheet working capital has more than quadrupled from $1.6 million to $7.3 million during the last nine months. And our operations have generated a positive cash flow of more than $3.9 million this year. And that's compared to an operating burn of $600,000 last year. That's a $4.5 million improvement in cash flow. And, obviously a stronger balance sheet that goes with it. So that's the impact of the increased revenues and profits, a positive cash flows and the strengthening balance sheet. Now, one last thing before turning things over to Nasrat. And that's a question I received, which might as well answer now. That's okay with Nasrat and the question is, what is the status? And are you still planning on a NASDAQ uplisting? That's a good question. I get that a lot. Thanks for asking it. And yes, and uplisting is still very much in our plans. As we said, in the past, Elite's fundamentals have to be in order for us to uplift to the NASDAQ, and from the financial side, that means increasing revenues, profits, positive cash flows, and the financial means to continue developing more products, so most of the attention given to our financials is on these factors. And as you can see from our financials, there's been great improvement over the past 12 to 18 months. And those fundamentals are shaping up nicely. But there's other financial fundamentals that I focus on, which are just as important, front and center from my standpoint is controlling Elite's level of debt, growing revenues at double and triple-digit rates require us to continually develop and commercialize new products. Oftentimes, this requires incurring substantial debt, which acts as a drag on future growth, a detriment to further product development, and in some cases, results in companies going under. And there have been a few notable examples of this recently. Elite on the other hand, we've been developing products, we've been commercializing products, but without incurring anywhere near the level of debt incurred by so many others in the industry. Our growth has been financed at first, through equity financing, and for most of this fiscal year from internal cash flows alone, no debt. I repeat that. No debt. So when we talk about fundamentals being in place, there is three debt-related ratios that I focus on. And all three demonstrate just how relatively debt free we are in comparison to some of our peers in the generic market. First is the ratio of long-term debt to current market cap. Now Elite’s long-term debt is less than 5% of our market cap. That compares to Teva, which is 190%, Amneal 340%, and Endo, which is 400%. So these companies, they each have loans that are two, three and four times their market caps and Elite is just the opposite. It's our market cap that's larger, and it's more than 20 times that of our long-term loans. Second ratio, our focus on a lot is the ratio between long-term debt and equity. So Elite’s long-term debt is approximately 21% of its equity. And that compares with Teva, which is 202%, Amneal 973% and Endo, which has negative equity and more than $8 billion in long-term debt. So Elite’s debt is a fraction of its equity, while others have debts that are multiples of their equity. The third ratio that really sticks out is the times interest earned ratio and that measures EBIT -- Earnings Before Interest and Taxes in relation to interest expense. So this is a ratio where the higher number indicates stronger financials due to revenues being greater than underlying debt and interest expense. So Elite’s times interest ratio is 18 that’s compared to three for Teva and one for Amneal, and one for Endo. So this means that thanks to our low level of debt, we have a much greater percentage of earnings available for product development as compared to other companies, which have debt and interest expense that consume large portions of their earnings, leaving less available for product development. So one of the reasons why we're able this year to fund product development internally – from internal cash flows. So if you ask me about the status of an uplisting, I would say that everything we need to do and need to see from a financial standpoint is coming together. The fundamentals on the P&L statement, the cash flow statement and the balance sheet they've improved substantially, and are actually in some cases among the strongest in our sector. This is on the critical path to achieving the uplisting and we're doing well in meeting this. So to sum things up from a finance perspective, our financials continue to strengthen, revenues are up, cash flow is positive, debt is low -- very low, and the ratios and fundamentals are coming together on target. You know, things don't always go as planned, but this is going as planned and it's nice to see so much being on track. Now our Chairman and CEO, Mr. Nasrat Hakim, like to give an update and his comments.
Nasrat Hakim
Thank you, Carter. I’m going to cover a five points. The first is a safety update. Second is research and development. Third, commercial and current products; fourth, recapping financials, and fifth Q&A. Regarding safety, we operate in a pandemic. COVID-19 is a pandemic that is affecting us all. It is affecting Elite. It's affecting our suppliers, service providers and sales and marketing partners. We are following local and Federal guidelines and the CDC recommendations. We created an implemented employee protection plan that includes employee training, daily temperature monitoring, social distancing, wearing masks, appropriate attire, washing hands, proper hygiene, et cetera. We also staggered the shifts when possible to give people more space and less exposure. We limited the number of associates in the manufacturing suites to two and increased the airflow in the manufacturing rooms. In addition to hyperfiltration, we installed UV lamps to ensure that if viruses and bacteria reach an air conditioning or a heating ventilation or duct, then they'll be killed before they end up in someone else's office. All non-essential employees have been given the option to work-from-home, because safety measures are very high at Elite. Why I update you on safety every quarter? Because these safety measures protect the employees, which protect the business continuity of this company and that protects the shareholders and the patients. Regarding research and development. Now that we are cash positive, our first priority was to secure enough cash to cover working capital and facility maintenance. We have achieved that. The second priority is research and development. The partnership with SunGen was an important partnership to both companies. They had the R&D niche, and we had the GMP facility that is approved by FDA and DEA. We have manufacturing equipment and systems capable of multiple technologies, tablets and capsules is center release, delayed release or sustained release and extended release, utilizing either aqueous or organic non-aqueous coating technology. SunGen had good formulators, our regulatory team strategy. SunGen for the most part, utilized Elite facility and Elite staff to manufacture and test the GMP part of their ideas and formulations. Now that SunGen could not continue, we supplemented our R&D capabilities by hiring Dr. Jason LePree. Dr. LePree is a no stranger to Elite. He is a registered pharmacist and a PhD in Pharmaceutics. Dr. LePree’s priorities are number one; the central nervous system product that we have discussed before. Number two, evaluate and prioritize the R&D ideas, formulations and products that Elite has. And number three; establish a pipeline for the company. We also hired a Vice President of Regulatory Affairs to further improve our regulatory strategy that we'll be working with Dr. LePree. It is Elite vision and the creation of the three basket approach that led us despite all that happened to profitability. Our in-house research and development is key to the next steps in our growth. Elite continues to work on differentiated generics for future growth. Elite's focus is on solid overall dose production -- products that are difficult to formulate that creates a barrier to entry to some companies and make us more competitive. A final note on R&D, we are not going to use the Lincoln Park Capital to buy and does or run clinical trials at current prices. We have not tapped into Lincoln Park Capital for more than a year now. And we have no intention of doing so at today's share prices. That could change if the share price is right. And the return on investment for Elite is worthy. The third point I would like to discuss is all commercial products. Mixed Amphetamine IR and ER have been the backbone of this company as of late. So, regarding the API supply and DEA controls which you have had questions on that. We do not have any issues currently. We have not encountered any issues with the API supplier or with the DEA. The DEA has been for about a year now excellent at granting our requests for more quota and our API supplier had been happy to supply it with upfront payments. Amphetamine IR and ER are distributed by Lannett, our sales and marketing partner. They are doing a good job and we expect amphetamine IR and ER to continue to add to our profits and revenue growth. Loxapine, we have a sales and marketing partner for Loxapine that is eager to sell this product. Loxapine is currently on the FDA product shortage list. The API supplier has been the cause of the delay. They promised API this month. When they deliver, we'll be ready to move on and move fast. As soon as we receive the API, it will get priority to be made so we can launch. We will update you upon the launch date, once the launch takes place we will update you via a press release. The IQVIA is about $5 million for this product and currently there are four ANDAs approved including ours. Recapping financials, Elite profitability growth continues, And that is fueled by Amphetamine IR, ER and other products such as Isradipine. Revenues this quarter was $6 million and the fiscal year-to-date revenues for nine months only, are $21 million. Compare this for with $7.5 million two years ago and $80 million last year. In nine months, we have generated more revenues than we did the entire year last year and almost three times the year before. And we still have a quarter to go. We've had seven consecutive quarters of year-on-year revenue growth and three consecutive quarters of profitability. Income from operations were $1 million this quarter and a $3 million for year-to-date. Working capital is under control and cash at hand is enough to cover working capital, and an investment in research and development and clinical trials. We will start running clinical trials very soon, within weeks. To make sure everybody understands, we will issue a press release when there is a material event. We do not do that when we start clinical trial or we run the pilot or what have you, only when there is a material event, you'll hear about it. A - Nasrat Hakim: You've sent quite a few questions to Dianne. And we group them as always, because many of them are duplicates or address the same issue. The first focus on the new hire, Dr. LePree, discuss the addition of Dr. LePree to Elite's team and reason for hiring? What he will do for the company? What he will do in his new position? Another question, last month Elite announces hiring of Dr. Jason LePree to bolster Elite to develop a new products and facility improvement. Can you provide additional insight to a layperson about the type of work Dr. LePree will be doing for the company? Is Dr. LePree in-charge of starting new projects or continuing other projects? Is the hiring/rehiring of the new employee related to renewal or continuation of cluster stocks? I've addressed most of the issue about Dr. LePree. Dr. LePree’s hiring was 100% to boost our R&D pipeline. As I stated before, the partnership with SunGen was wonderful for both of us. But when we parted ways, all we had to do is bring in an R&D formulator. What they had to do is create an empire new company. All they had really is R&D. We had everything else, except for which we did before. But we tapered that down, because they took on that role. So Dr. LePree will be filling that role. He will be evaluating the products that we already have, such as the central nervous system product. And as I said, we will be moving in few weeks and running a clinical trial to evaluate that product. So Dr. LePree will decide if you need to run an IV, IVC in vivo, in vitro coloration, change the formulation or find it to be successful and move forward. His responsibilities also include, looking at all the things we have done at Elite, when we worked on projects, but never took them to clinical trials, because we didn't have any money, okay? Less than a year ago, as Carter has updated everybody, we barely have money for working capital. Now that we have money, we will start working on testing these things that we've done before. And third, he will outline and new ideas and new products from scratch and start testing them, and see if they are viable as well. So his role is everything that you've outlined here he encompasses all of it. Even though Dr. LePree was with us before when we worked on SequestOx and he is very knowledgeable in ART technology. That's not his function here. And that's what we're going to be doing, and I'll talk about that a little later some more. Next sets of questions are about the share buyback and mergers and what have you. So can you please come up with a plan that would stop dilution or reverse dilution like pay the CEO in cash not in shares, as much as I would love that, that would help the lead because if a lead pays me in cash, they will not have that cash both in clinical trials and R&D. Okay. Paying me in share does not hurt their cash flow and then they can invest more on R&D, which brings better value for the stockholders. Have the CEO buy shares in the open market? Okay. I'm getting the shares from Elite. And this way, Elite will keep the cash. But if Elite gives me money and I go ahead and buy shares on the open market that would hurt Elite, because they don't have any money. And I'm at the same point having the same shares. So it's really is in Elite’s best interest, not mine, for them to pay me in shares. And a proposal on buying back shares every quarter, same thing that is really a very smart idea. However, we don't have a ton of money. If we invest this money in something that will bring a return on investment, such as Amphetamine IR and ER, we made a big investment in that and look what's happening right now. If we invest in new products and we hit the right product, we’ll do very well. If we buy back shares that does not affect the company much, it may increase the share price a little bit. But that does not generate revenues, or profits. An email from a long time shareholder EH, I chose to answer this question. I usually don't do that, because I really want to make a point beyond the question. The question is about rumors of possible merger, and also selling shares in private deals. Can you promise me to abandon it? Don't believe all the rumors here. I've been with this company for seven, eight years now and not getting paid except in shares that I don't see because Carter keeps them actually.
Carter Ward
We haven’t issued the shares for many years.
Nasrat Hakim
If obviously, I want to sell my shares in a private deal, I would have done that long time ago. I have a commitment to this company. We have gone through a lot with the FDA and the ART technology and the chain environment and what's happening in China, what happened in SunGen, and we still prevailed. We are now at the point where I would like us to be. But we definitely are, as costs are articulated in a million times better place than most companies, at least we kept the lights on even though Elite was never profitable till recently. And we have enough money to continue with R&D without having to worry about that. Because, if we had the – the same thing that happened to a company like Acorn, that borrowed a billion dollars to buy new products and when they did not materialize, ended up bankrupt. And the low-end the stockholders lost everything. Okay. That – the same thing would have happened to us. We diluted the shares, yes, we brought in more partners. But today, the company is safe. And nobody can say, we're going to go to bankrupt and lose everything, okay. Development products, somehow this central nervous system product disappeared from the pipeline, please provide more detailed information as to the pipeline of the company, or this will be a blow to the morale of the investors? As emphasized earlier, this is a very important product for us. And it's the first of block of lobbyists taken on. Now what you saw is Dianne is trying to update our website. So we have the pain products, which we needed to remove, because we don't want to be a part of the lawsuits. And second, this was a part of the co-development products with SunGen. And we’ve removed those as well, okay. We will state something different on the website soon as soon as we're finished upgrading it. New partnerships, can you disclose any new partnerships? When it's relevant, and when it's time I can. I can just do that because somebody asked me. However, we have a partner that we signed with for sales and marketing, but since we have not gone to the markets with the product, we haven't disclosed them. We will do that when we launch the product. Adderall and Mikah, could you address that?
Carter Ward
Okay. There was a question about, right about the Adderall and the Mikah, and the question was, let me see, does Mr. Hakim have a plan to allow Elite to acquire the profit split portion of the Adderall product that Mikah acquired from SunGen? So, first, let's take a – take a step back. SunGen, when we were developing the product, SunGen invested a few million dollars along with the Elite to develop the products. I mean, that's what it costs to develop these products. So, in return for that, we each get a share of – an equal share of the profit splits that are earned. So SunGen then offered their rights to their portion of the profit split to Elite. Now, at the time, we were not able to fund such an acquisition, so we had to decline their offer. And then Mikah bought the rights from SunGen, the same rights on the same terms that were offered to Elite. So, which was a good thing for us, because it's better that Mikah holds it than somebody else that doesn't really have our best interests in mind. So we hope in the future that Elite will be able to acquire these rights, when we're able to do it. And it's just better for us that the rights are held by Mikah. It's easier to deal with Mikah, obviously, as opposed to some other party because Mikah does have Elite’s best interest in mind, and a true third-party would not. So that's where we stand on that.
Nasrat Hakim
Thank you, Carter. The last question is on the ART technology and SequestOx. I'm going to – not going to read all of them. I'll just go ahead and jump straight to the answer. We are not and we will not be working on the ART technology in conjunction with opioids. Let me repeat that. We're not going to do that in conjunction with opioids. I'll give you a simple example. You probably read already last week, McKinsey, a consulting firm. All they do is give advice. Just about every company I've worked for, they bring in McKinsey to give them advice on how to run their company. And these guys do absolutely nothing except give verbal advice. They have never made a pill, a pain pill or any pill in their life. They just got fined $500 million or settled $570 million with a couple of states, because they alleged that they contributed to the opioid pandemic by giving advice to Purdue. Purdue an ethics advice, but because they hired them, and these guys give them advice, they got $570 million in settlement. There is a second settlement that's going on right now also against McKinsey for another $600 million. And that barrier will cover like four of the states. That's over $1 billion for giving advice. So this is why I asked them to remove any reference to opioids. I don't want to get frustrated into this. Even though, anybody that would sue would know we're going to win, because we never sold opioids, but they go through the motions, so they can drain you out, the insurance company settled with them. And I don't want to be there.
Carter Ward
Won’t give any advice either?
Nasrat Hakim
Exactly. Okay. Now, our anti-abuse technology can be utilized for the agonist, antagonist products and approach. Okay? For example, it doesn't have to be opioids. It can be an agonist, antagonist, such as methylphenidate, or even amphetamines. Now, I'm not saying we're working on that or not. We're not going to discuss this. All I'm telling you is, if the product shows potential, then we will work on it. When we worked on it with the opioids, and it shows tremendous potential and we knew that we can contribute to solving the opioid pandemic, we learn from the FDA and the government that they had no interest in buying a branded product, so they can get the generic quote for their VA and other people. So that was really disheartening. So we're not going to jump in and start spending millions of dollars on utilizing the excellence of our technology on non-opioids yet, still we study the market. We're not going to hire McKinsey. We'll hire somebody like McKinsey. Tell us if there is potential, if there is, we'll invest in it. If not, it's a great technology. We have great patents on it. And it's there in our back pocket, but not for opioids now. Now, where do the opioids come in? With other foreign markets, such as China. For example, before all of this happened, I was in the middle of negotiations with a parent company for PuraCap on making the Naltrexone bid here at Elite and shipping it to China, because it's a non-control. Actually, it's antagonists. And there, they will do the opioid part, okay. And things change, and they couldn't get any money out of China after that. And whatever happens, things died out. But that would be something we'll be interested in. If you find a company in China or in Europe or India where you don't get sued, and our technology is really viable and proven, then we'll go ahead and invest in it.
Carter Ward
That was the last question. And thank you all for coming today. Have a wonderful day. And thank you for your participation.
Operator
Thank you, ladies and gentlemen. This does conclude today's conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.