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.
Thank you, Nasrat, and thank you to everyone for calling in today. As you heard in Nasrat’s introduction, I am Marc Bregman, Elite’s new CFO. To give you a brief background about myself. I have over 27 years of financial and operational experience, including positions as Controller at Langan Engineering and Controller at Chemtrade Logistics. I also help corporate financial positions at Chemetall and National Starch & Chemical and early in my career I spent several years as an auditor. I have a deep understanding and wealth of experience in financial accounting, financial planning and analysis, governance and compliance, and financial auditing, Sarbanes Oxley, and cost accounting. I must say, I’m excited to be part of Elite and to help the company continue to grow and move to the next level. Yesterday we filed our 10-K for the year ended March 31, 2021. We’re on a March fiscal year. So the fourth quarter is our year end. Copy of the 10-K is available in the Investors section of our website, elitepharma.com. Today I’d like to give an overview of the financials and add a bit of commentary as well. As always, we received questions and comments from shareholders and Elite followers, and we will do our best to make sure we address those comments in our presentation. Let me begin with the income statement. We had record sales of $25.4 million this fiscal year, up 41% from last year. While we enjoyed organic growth a key driver is the generic version of Adderall for which we have a strong partner in Lannett. We had a gross profit of $11.9 million, which at 40% -- 47% margin is a few points higher than last year. We did a great job as well controlling costs while maintaining our R&D spend resulting in savings of $0.5 million. This gave us an operating profit of $2.1 million, compared to a loss last year of $2.3 million. We posted a net income of $5.1 million, which included help from a PPP loan, a positive fair value adjustment on our derivatives and the sale of past tax benefits. However, if you adjust for these items, our net income would have been $1.9 million for the year. This truly is a remarkable increase over prior years and is consistent with continuing an upward trend for both revenue and income. What’s really key to note here is that this increasing revenue supports our product pipeline development. Now let me turn over to our balance sheet. Our working capital is strong at $6.4 million, that’s nearly 300% higher than last year. Our cash from operating activities brought in $3.2 million, of which we use some of the cash to pay down some loans. And lastly, our debt-to-equity ratio is less than 0.5 to 1. To reiterate, we have revenue growth in our organic base, but it’s the generic Adderall that stands out as our main growth driver. Again, our alliance partner with this product is Lannett, who continues to penetrate the market. The bottomline here is Elite is profitable and has a stable outlook. And with that, I’d like to turn it over back to Nasrat to give an overview on the company. Thank you.
Thank you, Marc. In today’s update I’m going to talk about safety. Elite’s goals for the next two, two and a half years as they pertain mostly to R&D and commercial products, a couple of thoughts about financials and then we’ll take some Q&A. Regarding safety, we are operating in a once in a century pandemic. COVID-19 is a pandemic that is affecting us all. It is affecting the Elite, our suppliers, service providers, and sales and marketing partners. We are following local and federal guidelines, and the CDC recommendations. Among the many things that we have done to protect our employees and business is to increase the airflow and circulation 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 system, 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. At Elite, we invested in our employees and it paid off. We protected them and they protected our business. Now the majority of our employees are vaccinated. But that is not the case globally. For example, in India, the ratio of vaccinated people is less than 4%. Why is that important, because that is where we conduct our clinical trials and also by API, raw materials and components. Therefore, the situation in India is directly impacting our R&D program and interrupting at least right now one of the clinical trials that we are conducting. Now that we are profitable, Elite’s goal for the next two and a half years is to continue profitability, cash flow be -- being cash flow positive and maintain adequate working capital. One of the ways we can do that is by growing our current commercial pipeline and investing in R&D. So I’ll spend a few minutes talking about the R&D process. First is the product selection or selecting the product that fits into our portfolio and that can be made at our facility. For example, recently I was approached and Elite was approached with an opportunity to make an injectable and a medical device. Well, that’s not helpful. Elite facility is not configured for that. Our product can be controlled substances or non-controlled substances. We have a DEA license. They can be tablets or capsules, instant release, late release or extended release technology. Once we identify the product that fits our technology, we need to reverse engineer the brand’s formulation. We do that by creating DOE, Design of Experiment that produces multiple formulations, covering most possibilities for the brand formulation. Then we test each formulation and compare it to the brand to narrow it down. To do that, we have to develop proper analytical methods, invest money today or a few years ago in API and raw materials, dedicate a portion of our manufacturing facility and employees to R&D work, add a portion and dedicate a portion of the lab for developing analytical methods and for testing and placing the samples on stability. Once we feel confident that our formulation is similar to a brand that is we are getting a similar solution profile at multiple PhDs, et cetera. And the two formulations act in a similar manner on stability with respect to content assay and degradation profile then we manufacture a clinical lot and conduct a pilot clinical trial. A pilot clinical study will either fail or needs to be repeated and needs to be repeated or it will give you enough data to run an IV, IVC. IV, IVC means in vivo in vitro correlation. That’s what you need to create a formulation fit for and go to a pivotal clinical trial. This process that I very quickly described takes years and many formulations do not mature into a successful clinical trial or a filing and none of the events that I just described, we PR or report, because they are non-material till we get a successful pivotal clinical trial that becomes material or have a filing, so this is why we do a lot of work behind the scenes and all of a sudden, you will hear about results. Conducting a pivotal clinical trial cost a lot of money. To get to that point cost a ton of money and time. But once you get there, it cost a lot of money surrounding. The formulations that pass the vigorous testing and make it successfully through clinical trials then after that requires the manufacturing of all of the lots, placing them on six-month accelerated and room temperature stability, before compiling ANDA and then filing with FDA that will take 10 months for review if they’re going to have any questions. Why am I walking you through all of this, to share with you all the things we do that we do not announce? It takes years before we get to a pivotal clinical trial. We are and has been actively working on multiple formulations for Elite and for Elite with the partner, two groups. I can tell you today that our goal is to execute four clinical trials and have four filings in 2022. Let me repeat that, our goal is to conduct four pivotal clinical trials and file four ANDAs in 2022. Financials permitting, we intend to do this the following year, after that, that is conduct four more clinical trial and file four new ANDAs. Hopefully, the following year with a received approval for the four we filed before, so that’s how you create a pipeline where things are going in and you have continuity in case if there is depreciation of the sales in the market. And that’s really will be a critical point for us to get to NASDAQ. Product development is Elite’s number one focus. Our pipeline is our lifeline and we can see that when we can afford to, but when you don’t have money, you slow things down. Right now we’re profitable, so we are going to move forward with all the things that we’ve been working on internally that are the foundations for getting to the pivotal clinical trials. Why because we need to diversify. Amphetamine IR and ER are great products for Elite and we have other good products such as Isradipine and Loxapine and Dantrolene and Naltrexone, and Bariatrics. Our objective is to grow our commercial pipeline and we can only do that with investments in R&D. We are also pragmatic about how to add a new product. We look at all alternatives buying products or the rights to a product, in licensing, co-development with the partner, contract manufacturing or developing products on our own. Not too long ago, Elite had limited capital for development. As our pipeline investment exceeded our profits, we didn’t have money to invest in R&D at that level. So we partnered with companies like SunGen and Mikah. We’ve partners helped to fund this development or block formulation or have their own. We continue to benefit from this products and we will continue to evaluate opportunities where we might buy products or rights to product. Our focus is on oral solid dosage products that are difficult to formulate, such as extended releases and possibly extended releases that also happen to be a controlled substance. As a public company, we will report key material events, which typically are a successful pivotal DE [ph] a study, FDA approval or a product launch, many product opportunities are being pursued and progressing nicely, you will eventually hear about them. Marc covered all the relevant financials. I just want to add that going from $7.5 million to $18 million to $25.4 million is a major achievement, even if we did not have once in a lifetime pandemic. The revenues would have been even higher, but for a one-time inventory adjustment at our major sales and marketing partner had due to their financial situation. On the commercial front, this quarter we launched Loxapine Capsules in June with our partner Prasco under the Burel Pharmaceutical label. Loxapine continues to be on the FDA product shortage list. We expect this product launch to go well. We have a new partner for Isradipine and Phentermine, which is actually an old partner, it’s Epic Pharma. These two products, Isradipine and Phentermine are interesting products because they have limited competition. 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 these products. We have continued to see growth from Amphetamine IR and ER in recent months. Amphetamine IR and ER are the reason for our profitability. Elite is executing on its growth plans, obtaining product approvals and launching new products and our sales and marketing partners are performing well. We look forward to another successful year. A - Nasrat Hakim: The question is our press release no longer refers to a pipeline of proprietary pharmaceutical abuse deterrent opioid products or drug products which have high barrier to entry. Does that mean those aspects of the business plan are gone for good? No, it doesn’t. Not at all. There is an entire section about our ADTC technology on our website. We still believe this is a valuable asset for Elite. We are currently focused on -- we are currently not focusing on opioids, because of the current environment around opioids in the U.S. That’s the only reason. Regarding products of our barrier to entry, this is our primary focus. Second question is on antibiotics. What happened to the second and the lag between Elite and SunGen, positive topline results were reported back in October 2018, but it was never filed with FDA? That’s correct. Good things and bad things happen when you have a partner. SunGen due to their circumstances decided not to move forward. We discuss both antibiotics, the one that we filed and then we didn’t periodically, but we are going to have a resolution yet. NASDAQ, when will Elite go to NASDAQ, please disclose the current plan? We have always said that we will make the move once we have strong fundamentals to support the listing. I don’t want us to go to the NASDAQ and then we don’t have the fundamentals and gravitate back to things stock. We are protecting the company by insisting we get there when we have fundamentals, because that’s how you’re measure the NASDAQ. People cannot manipulate the stock on NASDAQ because fundamental stock. If you don’t perform, the stock goes down, if you perform, it goes up. Unlike most what happened to us, every time we announce good news, the stock goes down. I would like to see more approvals. I would like to see higher revenues and also higher profits before we proceed. Frankly, uplisting to NASDAQ is key objective for Elite, when the time is right. I will continue to monitor our growth and fundamentals and we’ll update you on uplisting when the time is right. Question on capital structure? Is there any plan to reduce the number of outstanding shares? If you mean by reducing the number of outstanding shares by a buyback, then the answer is no. Elite’s money is better spent on R&D than on stock buyback. We have gone through the analysis multiple times. It is in our best interest to stick with the present course and continue working with R&D till we get the right products that will give us the right revenues and profits and that will get us to NASDAQ. Profitability, another question, when did -- when do you expect to make a profit? We’re already profitable, right? And the last question, when will you -- when will we acquire markers right to half of the Amphetamine IR and ER ANDAs? When we have or can raise sufficient cash to do so. We know exactly how much we need. When we have it, the product is available. My personal guess it will probably happen in mid-2022.