Elite Pharmaceuticals, Inc.

Elite Pharmaceuticals, Inc.

$0.48
-0 (-0.62%)
Other OTC
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Drug Manufacturers - Specialty & Generic

Elite Pharmaceuticals, Inc. (ELTP) Q1 2022 Earnings Call Transcript

Published at 2021-08-17 15:28:08
Operator
Thank you for holding. We sincerely appreciate your patience. Please stay on the line and we'll be back in a moment.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 expectations. 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 Cate, and 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 new CFO, Marc Bregman, 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. Marc, you have the floor.
Marc Bregman
Thank you, Nasrat, and thanks to everyone for calling in today. Yesterday, we filed our 10-Q for the quarter ended June 30th, 2021. We're on a March fiscal year, so the June quarter is our first quarter of fiscal 2022. A copy of the 10-K is available in the Investor section of our website at elitepharma.com. Today I'll give an overview of the financials and some commentary as well. As always, we receive questions and comments from shareholders and Elite followers, and we will do our best to address those questions today. Starting with the income statement. We posted sales of 7.1 million this fiscal Quarter, down 6% compared to the same time last year. Manufacturing revenue was down due to the timing of shipments as Lannett was building inventory last year. Although this was slightly offset by better sales of our other products and stronger licensing fees. Again, our largest product remains the generic version of Adderall for which we have a strong partner in Lannett. Despite lower sales, however, we posted an operating profit of 1 million, which is 100,000 higher than last year. This is due to a stronger margin of 14% compared to 11% last year. We posted a net income of 2.4 million for the Quarter. This included a positive fair value adjustment on our derivatives and a sale of past tax benefits. Debt income after adjusting for these one-time or non-cash benefits on both years was 919,000 for the Quarter, 130,000 higher than last year. Now turning over to our balance sheet, our working capital continues to grow to 8.5 million up 2.1 million from year-end. This is directly due to cash flow from operations combined with low debt. So to reiterate, although sales were lower simply due to timing, a strong margin resulted in income growth versus last year. As I mentioned in the last call, we continue to have revenue growth in an organic base, but it is the generic Adderall that continues to stand out as our main growth driver. Elite is strong and growing. With that, I'd like to turn it over to Nasrat to give an overview of the Company. A - Nasrat Hakim: Thank you, Marc. Our last conference call was only 8 weeks ago. During that call, I outlined Elite's goals for the next two, two-and-a-half years. In today's update, I'll make a few comments about Elite's financials, then I'll update you on safety, manufacturing facility and commercial products, our R&D pipeline, and then we'll go to Q&A. As Marc stated, our revenues for this quarter were $7.1 million. If you recall, last quarter we were in the $4 million range, the last quarter ending in March of 2021. That wasn't because sales declined, that was because Lannett sold what they had in inventory, and did not replace it all. Why do I think that? Because the profit split we got from the quarter before, where the sales were in the $6 million and $7 million range, was about the same. So that team determines how much the sales are. Depleting the inventory is a standard practice in the pharmaceutical industry, sometimes they build it and you see the effect Marc talked about, and sometimes they deplete it when they reach equilibrium and they have money. Depleting it is a standard practice in the pharmaceutical industry and a fast way to raise money for the Company too, but it does have its downside as well. The bottom line from all of this is the following, the sales, and profit from Amphetamine IR and ER are solid and getting better. As you know, revenues from the last 3 years went up from $7.5 million to $18 million to $25 million dollars. Two years ago, 18 million in revenues was the best year ever for Elite. Last year when we earned 25 million in revenues, that became our best year ever. I believe that the current year is shaping up to be our best year ever yet in revenues and profit split. You would think that higher revenues and profits would lead to higher stock prices, I understand a lot of things about this business, but I do not understand the rationale for Elite's stock movement. It seems to be inversely proportional to our performance; the better we do, the worst the stock gets. The stock was higher when we were broke and had to sell shares to survive than it is now when we are profitable, self-sufficient, and self-sustaining. As I updated you before, if you look at the genetic sector as a whole, you'll find that the stock price of the majority -- not all, the majority of the companies have been depressed over the past 5 years. I looked at and compared 5 stocks this morning: Teva, of the 5 stocks; DAVA, Perrigo, Lannett, and Aimil declined between 60% and 85% in value over the past 5 years. While only one, Dr. Reddy increased by 30% over the past 5 years, and just to be accurate, Dr. Reddy increased over the past year-and-a-half or so because they changed their business model, and there we're following the same pattern as everybody else, but they recovered and to their credit got ahead. The more interesting part is their P/E ratios. 3 of the 5 have a negative P/E ratio; their earnings per share are negative, they're losing money. That's Perrigo, Lannett, and Teva. Dr. Reddy and Amneal have a positive P/E ratio. Dr. Reddy's P/E ratio is 45, Amneal 's is 87. Elite, like most companies in the industry, has declined from $0.17 to $4.5 or $0.05 over the past 5 years. Our P/E ratio is 6. If we are treated like Dr. Reddy and Amneal, not like the other three that are losing money. Just like Dr. Reddy and Amneal, our stock price would be $0.33 or $0.65 today, just based on substituting their P/E ratio for ours. This is not the only metric to assess a Company's value, there are other metrics that are used for Company valuation, and we fair very well under those metrics as well, an example will be, we have very low debt. The tide will turn, in due time the stock should go up, in the meantime, we need to stay focused and stay the course, and take care of our business, starting with our employees and employee safety. Regarding safety, we are operating in a once-in-a-lifetime pandemic. COVID-19 is a pandemic that is affecting all of us, it is affecting Elite, our supplier, service providers, and sales and marketing partners, not only in our business, it's affecting every business. We are following local and federal guidelines and the CDC recommendations. Most of our employees are vaccinated, we are still asking everyone to social distance as much as possible, we are holding meetings via Microsoft Team and conference calls for employees that must be in the same manufacturing suite with increased airflow and circulation, And in addition to hyperfiltration, we've installed UV lamps to ensure that if viruses and bacteria reach an air conditioning or a heating ventilation system, they would get killed before they enter someone else's office. All non-essential employees have been given the option to work from home. At Elite, we have invested in our employees, and it paid off. We protected them, and they are protecting our business. The elite business has not been materially affected by COVID yet, because we do have multiple sources for many of our materials. We have been able to manage the problem well, and -- I hope that we continue. This pandemic is going to be around for generations, and it is most likely to move from an epidemic to an endemic. An endemic is when a disease continues to flourish up in certain parts, it's going to be very hard to get rid of this virus, and therefore, we need to manage our business accordingly and that is why I update you on safety every single time we talk. I have my eye on the ball because even with API s that we make in the U.S. and Elite buys from a U.S. source, it still scares me because some of the components that could go into that API could be coming from India and China, or a country that's infected with a severe case of COVID-19, even Latin America. On the R&D front, of course, our objective is to grow our commercial pipeline. And we can only do that by investing in R&D and /or purchase new products. Protecting and improving our current commercial product line is key to continuing profitability. The protection part is a joint effort with our sales and marketing partner. We provide them a product with a reasonable [Indiscernable] so they can compete. That's our part of it. And they need to penetrate the market and compete with that product. Now, expanding the product line is a function of R&D. I shared Elite's goal with you 8 years -- 8 weeks ago, so let me recap. Our goal over the next 2.5 years is to continue profitability, continue to upgrade our manufacturing facility, stay cash flow-positive, maintain adequate working capital, and the rest of the money will be invested in R&D or new product purchases. I get advice from our stakeholders telling me to go into the vaccine business because it's lucrative and that's literally what's happening lately. We cannot do that. In R&D we have to select the right product that fits our portfolio, and can be made at our facilities. For example, we're not configured to make injectables, creams, or ointments. That requires a totally different technology of laminar air, and bacterial control, and purified water of high injectable standard. We do not have that. We would pass on that opportunity unless somebody is offering us the product plan and the facility. Opportunities that include controlled or non-controlled substances that are orally administrated, either tablet or capsule that are instant release, delayed-release, or extended-release, would fit within our portfolio. These are the things we keep looking for. Once we identify the product and begin reverse engineering, it takes years. and a lot of time and money before we run a pivotal clinical trial, and I'm telling you this because you'll understand that the fact I'm promising, we're going to take care of before the end of the year. We have been working for a long time on these products. Many formulations do not materialize into clinical trials or filing, because of multiple things you encounter throughout the life of the development process, you may fail the first, second, and third time before you finally confirm a clinical trial, or get successful clinical trial and file. SunGen, which had great scientists, the success rate was about 25% on the products they worked with us on. We do a lot of work behind the scenes that the public does not know about or hear. Our goal is to pass and/or file 4 ANDAs before December 2022. You can do the math and determine how many ANDAs we must be working on or have worked on to get 4 viable ANDAs in 2022. Now, let me be clear. The formulations that do not work the first, second time are not a waste. They can be reworked. You learn from the errors and you learn what not to do, and you can come back and try again. But that costs delays, time, and money. Financially permitting, we intend to do this next year as well, conduct four more clinical trials and file more ANDAs, and hopefully, by then we will four labels while the first four we filed, will be in the process of getting approvals for. This plan is a critical part of getting to and thriving on NASDAQ. On the commercial front, we are profitable and our commercial products and sales and marketing partners are key to continuing profitability, we cannot do this alone. Amphetamine IR and ER continue to be the highest contributors to revenues and profit, Lannett is doing well at market penetration. This quarter's profit split was the highest we have had to date, and I expect that trend to continue. Isradipine and Trimipramine are with our partner, Epic. These 2 products are interesting because they have limited competition. Each one has only one competitor in the market. Glenmark, our previous partner, was not able to give them the attention we believe they deserve. We expect Epic to be more effective in the marketing of Isradipine and Trimipramine. And let me make a comment here. It is about market penetration when you have 16, 20 players. But when you're the only one in the market or there's 2, it's about the price adjustment. And when Actavis were selling these products, we were making millions. Glenmark was selling them at a small little margin above cost, and that is not the way to handle it. That's why we reverted to Epic, hoping that they know how to sell these products. Tagi is doing well with the Naltrexone and the Bariatrics. They are running second in sales of the Bariatrics compared to KVK, which has 85% of the market, we have about 16. But we hope that Tagi will capture a larger share of the market, as KVK solve their problems with the FDA and the Federal Government. KVK got in trouble with the FDA, their owner and their head of the quality were indicted, because apparently instead of using the supplier that ANDA approved by FDA, they bought products from Mexico, which was not approved, and a lot cheaper, and were competing with that for Hydroxyzine. So the FDA and the Federal Government indicted them and they are under investigation, and that could materialize to business for Elite. Loxitane, Prasco is our partner there, we've launched Loxapine capsules in June with Prasco under the label Burel Pharmaceutical. Does Loxapine continue to be on the FDA product [Indiscernable] list, and we hope that Prasco does well with that. Elite is executing monetary growth plans, obtaining product approvals, and launching new products. Our sales and marketing partners are performing well. We look forward to another successful year. We received a lot of questions that Dianne, as always, was kind enough to group and put into several categories. I'll go ahead and start with the first on the pipeline. Is Elite considering buying additional assets/drugs or is the plan to develop them in-house? Actually, it's both. Elite evaluates all types of opportunities, whether it is buying AMVAs, contract manufacturing, developing, or go developing our own ANDAs, we find generally that developing our own and is the most attractive. In the last CC, Nasrat stated that there would be 4 ANDAs filed in each of the next 2 years. Was he referring to the calendar or fiscal year? Getting picky here, calendar year. Can you please provide more color as to the 4 ANDAs that will be submitted in 2022; market size, type of drug, use of biotechnology, or not? I wish I could. First, for competitive reasons, I can't, but second, as I explained a few minutes ago, we run a dozen projects, and let's say four ends up for this year. So I don't know which four are going to end up really being the ones, but I can promise you this, we will disclose that information when it's appropriate. And there will be instant release, delayed-release, or extended-release tablets or capsules, and they may or may not contain a controlled substance, it will fit into our portfolio. COVID impact. The question is last conference call, Mr. Hakim mentioned that API might be a concern since the problems with COVID in India, is Elite still having these concerns or is the Company able to source API to manufacture their medications? Our API and other raw materials are sourced from many different companies spread all over Europe and also Asia. We have not experienced supply chain interruption as a result of COVID, and whatever interruption we've encountered, really is not material. We did have one part of a clinical trial that was paused, put on hold, and then continued in India because of COVID-19. That part of the CT was completed and the results were provided. As I stated before, my concern is not for today, because today we have absolutely no material impact on Elite. My concern is as this pandemic lingers on, is there going to be a concern in the future? And I'm trying to be ready now to address that issue before it becomes a bigger problem than it already is. We had several questions about Adderall. I'll read 3 of them because they are from different flavors, and then I'll answer that. As the generic Adderall IR has been great market penetration -- showed great market penetration, the ER product which has been in the market for about 16 months now is hardly showing any significant sales. Not true, but let's go on. Can you shed some light as to why this may be and what Lannett is doing to start moving the product as this is the drug that really should have pushed us to the next level? That is correct. Our expectation for Adderall ER? Well, multiple of what we are seeing are sales what you were expecting. If not, what is holding us back and what is its potential contribution to revenues in 2022? May I have insight or guidance as to the relative flat earnings from Adderall as generic products? Is it the limitation of the DEA quota or Lannett not penetrating the market? Okay. I don't want us to blame Lannett, or be tough on Lannett because I do believe they are doing a decent job from the standpoint of sales and marketing. So let me frame this in the right form. Amphetamine IR has 11 competitors. Each and everyone is trying to outbid the other and get into the top companies, CVS, and Walgreen, and Walmart, and Cardinal Health, and McKesson. And there are 8 competitors in ER. The first problem we encountered if you recall, was the delayed entry. President Trump shut down the government, the FDA did not have resources, and they actually delayed our application by a year. We were supposed to be number four. When you give somebody a product that there are three other competitors and you're number four, it's a little bit of a fight, when you give them eight competitors, it's a much bigger fight. We don't want to blame Lannett, we got to where we got, and by that time we were one of eight. There was rationing of control services at the time. That had minimal impact, not really much. But the last portion is the market penetration. So let me explain that. In my days at Actavis, whenever we have market penetration, we waited when the bids came on. Let's say, for example, CVS. CVS does not call people every single day to see if they can buy drugs from them cheaper. They have you bid on certain products or products once a year. For the rest of the year, you got that contract till they come in late and say, what have you done for me lately and try to negotiate a lower price with you or they put it forbid with others. So when a product is only a little more than a year old, it tells you that Lannett has only had 1 or 2 shops getting in, and every single time you bid, you learn from that and see how you need to go lower or higher, or how to adjust the pricing. Now, they have penetrated very well into the IR market, way beyond my expectations because frankly, the first approval was maybe in 2012, and we didn't get into the game until much, much later. I expect them to do the same with ER, it's just a matter of time, and I expect, as I said earlier, the revenues and profit split from the IR and ER will grow. Another question about Lannett, with Lannett cutting in the low profitable drug marketing, have we been impacted? Let me explain the question. Every Company has products that really do not bring in any profit, but they use them as a basket so they can get their foot into the door, and they sell it to a Costco or to Walgreen's or wherever, and then that will give them an in to sell other products there. Lannett re-evaluated their product line and cut down several products that they don't believe are profitable, or that are really not worth their time. There's absolutely no impact on Elite's products whatsoever, we are not in that category. The next question is about the payment of salary and stocks. Will HN consider taking his salary and bonus in all-cash, then purchase Elite share on the open market? This is funny. The first part is valid, the second one is funny. I used to get 100% of my compensation in stocks, which meant at the end of the year, I had to pay 50% of my salary, equivalent to 50% of my salary to work at Elite. A while back, the board changed that to half and half, so now I just work for free. They -- half goes to the government, and half is issued in a piece of paper that Marc now and all the starter used to store somewhere. I hope and I would love to see the Board pay me 100% in cash next year. Now, the reason I've never pushed for that, is because we need the money, even now when we're profitable at the end of the day, you saw Marc's numbers, we make a million dollars. That's not a heck of a lot of money for R&D, and that's why we're partnering with Mikah and doing other things in order to increase that number. So for me to tap into that, I don't have the heart to do it. When we are much more profitable, nothing would please me, than be making cash and actually taking it to the bank. All right. Another question. Again, every single quarter, everybody asks about the purchase of the SunGen ownership in Adderall and Mikah. I have answered that question every single quarter for the past 5 quarters. If you wish to hear the answer, go back and read all transcripts. I am not going to address this issue again because right now, the question is just being asked to be asked. We have addressed this, Carter has addressed this, the board's addressed this. We're done with that. We've purchased -- Mikah's purchased SunGen's share in Amphetamine IR and ER, and that is so much better for us than another Company doing it. Please comment on the development agreement with Mikah that's included [Indiscernable] thank you. Marc, could you take that, please?
Marc Bregman
Sure Nasrat. Well, Elite continues to carefully allocate our development capital, to use it wisely, however, we have done for example, on agreement with SunGen when developing new products. The deal with Mikah is modeled after that agreement. It allows Elite to execute a greater number of development projects, with the support of another party. Although we give out part of the profit through profit splits, it allows us to do a greater number of projects and diversify our risk. In a difficult and highly competitive generic industry, diversifying risk is very important, and this is why we do this.
Nasrat Hakim
Thank you, Marc. The next question says it's financial in nature. And this is an interesting question, I'm not going to read the whole thing, I'll read a part of it. A number of shareholders are now worried that your strategy has now pivoted from your original goal to list Elite on NASDAQ to taking Elite private. Perhaps this is crazy speculation? Yes, it is. That said, shareholder discussion centers around your controlling interest of both Elite and Mikah and that by taking Elite private you could then merge both companies and sell both companies as one entity, leaving shareholders with nothing. If this is a crazy question Marc, please tell us on Tuesday's conference call. This is not crazy, this past crazy a few miles ago and got into the insane sort of fire proportion. I enjoy as much as the next guy reading about conspiracy theories and fake news and all of that, but this is silly. So let me officially and unequivocally state. Taking Elite private has not been discussed at all, ever, by me, by the Board of Directors, by Dianne, by Marc, by Chris, by anybody at Elite. As a Public Company, Elite would be required to go through an extensive process to go private. I lived through that at Actavis one time. And again, this has not been discussed. And why hasn't it been discussed? Because nobody brought that to my attention that, "If we do this, it benefits Elite shareholders." None. Elite stock is subject to the volatility of being on the OTC. The price is down right now. Our strategy to get it up is to develop, file, and launch new products to increase our revenues and profits, and shareholders s' value. All this conspiracy stuff you hear about taking Elite private and depriving the stakeholders or having majority control, is not true. Our focus on Elite is to make Elite profitable, and get us to a place where the stock price is less volatile and less subject to manipulation. And manipulation doesn't mean somebody is doing something illegal, a lot of people do manipulate the stock legally. One form of manipulation is with the folks from Robinhood. You can buy a stock or 2 or 5 stocks, you can spend $5 of Elite's money, or of your money to buy Elite share, and try to feel how people want to sell it and start taking it down. We are always open to evaluating opportunities that make financial sense for Elite. And we do have a ton of partners right now. We have Prasco, and Lannett, and Mikah, and TAGI, and Epic. We have a lot of partners, we need products. Are you still on track for a NASDAQ move in 2022? Let me say this, moving to NASDAQ continues to be an objective as discussed in past calls.