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spk00: 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 statement. Elite would like to remind their listeners that remarks made during this call may contain forward-looking statements that involve risks and uncertainties that 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 report's 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.
spk03: Thank you, Matthew, and good morning, ladies and gentlemen. 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 CEO, Robert Chen, 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 have submitted to Diane. Robert, you are on.
spk01: Thank you, Nesret, and thank you to everyone who's joining our third quarter conference call today. Yesterday, we filed our 10-Q for our third quarter ended December 31st. ELE is on a March fiscal year. A copy of 10-Q is announced by the announcer earlier, is available in the investor section of our website at elefarm.com. It is also on SEC, GOF, and many other websites that provide link to our filings. Now I would like to give an overview of the financial and some commentary as well. I will start with the income statement. We had a strong sales of about $9.3 million for this quarter, up by 3% as compared to the same quarter last year. Our sales on amphetamine IR tablets and amphetamine ER capsules remain steady and strong. Moving down to cost of goods sold, Our cost of goods sold was about 4.3 million as compared to 5 million for the same period in the prior fiscal year. The decrease was due in large part to an improved margin on products sold during the three-month end date of December 31st, 2022. The company posted a gross profit of about 4.9 million for this quarter versus 4 million for the prior quarter. The increase in gross profit was due to a combination of increased sales and improved product margin. Our operating expense spent is about $3 million for this quarter and $2.2 million for the prior quarter. The increase in operating expense was largely due to the increased spending in product development. As a result, our operating income was about $2 million versus $1.8 million prior quarter last year. Our net income was about $3 million as compared to $2.3 million for the prior quarter. The main driver contributing to the increase in net income was the recognition of other income of $3 million, partially offset by the increased spending in interest payment. For the nine months ended December 31st, 2022, we had a strong sales of about 25.5 million versus 24.6 million for the same period last year, up about 0.9 million, or 4%. This is primarily due to the strong sales of amphetamine IR tablets and amphetamine ER capsules. I just want to give you information about this sales figure. Our company has been on an upward trend in sales, including $8 million in the fiscal year 2019, $18 million for 2020, $25 million for 2021, and $32 million for last year. Now, we're judging by the trends of sales so far. The company's sales number this year is expected to exceed the sales number of last year at $32 million. And we hold the momentum. We'll go on. For the first three quarters, the cost of Corsair was about $12.4 million versus $13.2 million for last year. The gross profit was about $13.2 million, a $1.8 million over last year, due to strong revenue and improved product margin. Our operating expenses stand at about $9.1 million versus $7.2 million for both periods. The increase in operating expense was mostly attributable to the increase of spending in product development, in payroll and professional expenses. Our operating income was about 4.1 million versus 4.2 for the same period last year. Our net income for the nine months ended December 31st, 2022, was about 4.8 million as compared to 6.5 for the prior period. The main driver contributing to the decrease in net income including the following four factors. $1 million lower from derivative liability due to outstanding stock warrants, $0.9 million for NOL sales, which the company does not have during this period, and a $7.7 million spending increase in interest payment and a partial offset by other income of $1 million recognized in this period. So I'll give a little bit update about the derivative liability. The change in the fair value of derivative instrument is determined in large part by the change in the closing price of company's common stock with an inverse relationship. In other words, the higher the common stock price, the larger liability. Also for your information, this transaction does not have any impact on the company's cash flow. Now let me move down to a balance sheet. Our working capital remains solid at about $27 million, up about $14.3 million as compared to March 31, 2022. The increase in working capital reflects the company's ability to control its spending and to a greater degree due to the $12 million loan we have obtained from the East West Bank in April last year. The loan will be used for general working capital purpose. Our total cash on hand is about 18 million on December 31st, 2022. With that, I now will turn the floor back to Nazareth for an overview of the company.
spk03: Thank you, Robert. Today's updates will cover elite financials, R&D pipeline, manufacturing facility, and sales and distribution, and commercial strategies. Then we'll go to Q&A. I'll start with a few words about elite financials. Good fundamentals start with a sound balance sheet. That leads to a strong R&D pipeline, manufacturing systems, and sales and distribution organization. So I'll start with the first one. Elite has solid numbers for revenues, profits, and cash flow for both the quarter and year to year. I am very pleased with the direction the sales are going and looking forward to Elite taking on that task. This is our fourth year of growth and profitability. Not long ago, we did not have enough money to pay for working capital. Today, we are self-sufficient and profitable. We have followed revenues for this quarter and year to date, and we are on target to surpass last year's performance and exceed annual revenues for the fourth year in a row. That is not common, nor it's an easy task for an OTC company. It is unfortunate that our increase in revenues by more than 450% over the past four years was met with a 50% decline in our share price. It is frustrating. To me, the board of directors, the employees, and elite stockholders. On a positive note, the increase in revenues and profitability gave us the opportunity to have a strong R&D pipeline. Elite continues to invest in product development. Our goal is to commercialize new competitive products to continue to grow and diversify our portfolio. It takes years to build a solid R&D system and pipeline. First, you need product selection, not an easy task. It involves a lot of uncertainty because you never know who's going to be in the market several years from now and who's going to own the API plant and whether they're going to manufacture in India or China where they are more competitive in pricing than us. Then you move on to the pre-formulation selection to analyze how many of these products selected can be made at your facility without a major capital investment, such as CapEx to remodify your facility. This could be an area where Elite has an advantage. with difficult to make formulations that involve fluid bed technology or those that involve controlled substances. Because for example, you cannot make the governed products overseas. So you eliminate at least that part of the competition. Then going through the formulation optimization, you have to do in vitro stability, impurity profiles, a challenge in comparison to the brand, pilot clinical trials, which also cost a lot of time and money, optimization of the formulations, pivotal clinical trials, again, lots of money, long-term stability, ANDA filing, FDA inspections, approval, and finally, large-scale manufacturing and sales and distributions. I mentioned each and every one of these steps because this is what it takes to create an entire R&D system so you can have an R&D pipeline. First, product selection. Several products have been evaluated and selected, and now with the input of sales and marketing, we have a better chance at picking the products that have the best opportunity of making money in the future. Second step is other products entered into the formulation development stage. So now the first part of the pipeline is getting filled with the help of Kirchhoff and the team, and analysis is being done as to what's viable and what's not. And second, we have in the second analysis products that are being screened for potential formulation to go into the clinical trials. Several products are undergoing in vitro evaluation and brand comparison. And ELITE has had two additional products that have moved from the formulation development phase into the clinical study phase this year or this quarter. ELITE recently completed successful BE studies for two generics with issued press releases on both. has been filed, an ANT has been filed, and the other will be filed in Q2. And there's a third product that we haven't made an announcement about that I've updated you on before. It's a generic opioid extended release that we are working on and doing an infatuation study, and that is expected to be filed this year as well. So if you look at all the stages of product development, we have populated each and every one of them for us to have a true pipeline that will be continuing from now to several years to come. We will update you on other development products when we reach a specific milestone such as a BE study, filing, or approval. Now, a healthy balance sheet also enables us to support R&D, but also manufacturing and sales and distribution. We continue to improve our manufacturing facilities by adding new equipment and personnel. We are able to maintain the current business with one enhanced shift except for packaging where we have two shifts. Again, this is the third pillar that I look for. First, we have a sound balance sheet. Then we have an R&D pipeline that is populated throughout every stage. Now the manufacturing facility, do we have capacity? We're running at one shift. Granted, it's enhanced, but we can go to two shifts and potentially three or even weekends. And to do that, you have to make sure that the equipment, you have some redundant equipment, and the personnel are capable to do that, to expand with the demand as it comes. As of today, running at one shift, we are capable of supporting the business as it is and as it was under our partner, Lynette. Next is the sales and distribution organization. This is a division that we did not have before, and I've talked to you about this for about a year now. Ever since we learned that Lynette had their own products that got approved by FDA, we started working on bringing in a sales and marketing professional and getting licenses and all of that stuff. So this is what we sell right now. We have been preparing for and are now ready to launch our own label with our own sales and distribution organization. Direct sales are an important strategic step that allows us to retain a large share of the product's revenues and profits and give us more direct control of product sales and pricing strategies. Since our last discussion, Elite has in place logistics, warehousing, sales, and financial reporting for both controlled and uncontrolled substances and products. Elite has wholesale manufacturing licenses for all 50 states and the District of Columbia. ELITE's products are listed in the Compendia. Contracts are in place with certain key distributors with others to follow. Starting in April, ELITE will have the following products in the market under our ELITE Labs Amphetamine IR and ER. These products are in a competitive market. The management of DEA quotas can be and has been challenging. Amphetamine IR remains on the FDA shortage list, and customers remain very interested in quality supplier for both of the IR and ER products. Elite expects those products to continue to do very well under Elite's label. We're going to continue supplying Lynette until April, and after that, we'll take over, and I expect them to do very well under Elite's label. Isradipine and Trimipramine will be sold under Elite's label as well as of April. Although modest in size, both products have only one or two competitors. Therefore, the margins can be attractive. We believe that being directly involved in pricing will help Elite to increase the value of these products. Loxapine and Dentaline will also be offered as of April 1st under Elite's label. Loxapine has recently been on the FDA's product shortage list. Densely in pricing has been challenging with the competitors like MNIL and PAR. We are expecting though to capture a modest market share with good margins as we enter under our own label. In addition, we continue to sell select products through licensees. Our long term partners TADI is an example of that. International opportunities moving very slowly, but Elite has a couple of opportunities for sales of our products outside of the U.S., which we continue to work and develop with partners. Elite will provide updates going forward upon reaching milestones or material levels of sales. VigabTrend is a specialty product in a competitive market. The market became more challenging because at the time when Elite filed and the time we got an approval, so many other companies got in. And the product, because it is so specific and it requires rims, was very difficult to sell. So we decided to divest it to a partner who is more suited for this job that knows how to handle this kind of product. And in addition to money received, we also have three-year contract. contract manufacturing with this buyer, with buyers. To wrap up, Elite is executing on its growth plans and launching our own sales and distribution department. We look forward to another good quarter and an exciting year. Let me go to Q&A. And a little comment about Q&A before we start with the questions you submitted to Diane. Some of the questions are always pre-intelligent. Others this time were a little more on the emotional outbursts and some are predictions and comments or advice. So what I'll do is we'll group them and answer really what is relevant to the business. And I'll give a couple of examples on the things that I usually get. So the first group, a couple of people ask about the stock buyback. Lots of advice on that. Isn't it a perfect time to declare a stock buyback? The stock is depressed and this could be a decent strategy if the priorities are were there. We did not have the money we have committed for other things. When you have extra money to spare after supporting new products and worrying about the loan and developing your own R&D and sales and marketing, you have extra money. This wouldn't be a bad thing to do. We are not in a position to do that right now Time to buy back half the outstanding shares. Borrow money for it if the company has to. Again, same answer. Thank you for your advice, but these are things we don't think about all the time. What plans does Elite have to produce a non-generic product? Again, we've never talked about making a non-generic product. We have the ARC technology, and everybody knows what status of SQL ARC is. And all the other products are generic. So where did this question come from? I'm not sure. Update of pending trials of potential generics. Very smart question. And future revenues for those new drugs. We do not comment on future revenues for products. We can tell you what the IMS data is. And that's simply because by the time we get an approval, we don't know how many people have gotten in. So to tell you now this is how much we're going to make before we know even we have approval or how many people are there is impossible. But as to the first part of the question, as I said earlier, we have one product that's already filed. Two that test DE will be filed soon. One right now and the other is the opioid I spoke about. and three other products that will go into clinical trials within the coming two quarters. Several questions about Sequest OX. The first is, is Sequest OX still on life support or will you finally pull the plug and allow it to rest in peace? That's funny. It's a pending application and If we decided to move on with the final clinical trials, we'll let you know as of now who we are not. How does Sequest Arc stack up against its competitors, Remoxy and Roxybond? That's a smart question, actually. You know, Moxie is abused with certain technology that's considered to be physical abuse, and they really struggled with that. They rejected them three times. They took three filings with the FDA. Their NDA was rejected three times, and they did not give up, which is really good. And the second is Roxibond, which the company has been struggling to. They got a good technology that makes multiple opioids, And one of the ones they made before was Morphobond, which is morphine sulfate. This one is OxyCodone. And both products have not done very well. They are branded products, so they have to be detailed, cost tens of millions of dollars, and the revenues were less than the cost of these products. So they have been sold from one company to the next. I know they ended up now because a few years ago, these products were offered to us. The fact is, Elite's technology is the best of all of them, but we would still encounter the same challenges that they are encountering with cost. All of these products have genetics. With respect to our Sequest Ox, once and if we get there, we need to figure out what to do at the time for the IR because the IR products for OxiIR are in the market and they're extremely inexpensive. And even the VA and the government and everybody that talks about the crisis in the U.S. with opioids, they don't buy these products. They are not buying them now. They are still buying the generic because their dollar goes further in covering more of their VA people, for example, or the insurance insists on it. So even though it sounds sexy, that is not really the product for us right now. The more lucrative product would be if the question was about Sequestox ER because ERs always have a better market for multiple reasons. But that to me is the one I think about and I haven't found a way to penetrate the market because Pfizer have the same technology we have except ours is better in that we don't leak like they used to. They got approval for truck second, but they did not launch. And our entire revenues for Elite are a rounding error in Pfizer's balance sheet, and yet they saw a risk, and they did not launch. So that would be the product I would think about for the future, and I figured out what to do with it, not the other two. Operations, can you please provide an update on the net situation? That's a good question. Our contract with Lynette is almost done. April 1st is the date. We are in the process of transitioning to our own sales and marketing team. It is my expectation that we have done well the last quarter. As you saw from the numbers, we're going to do well this quarter. The quarter after we split from Lynette, we may have a dip, and the dip would be because all of the products we're making, they have taken it and selling it. So April, May, June, We need time in order for us to build our own inventory in order to be able to launch. But for the DAA quota, we would be doing that concurrently in the past quarter. But the DAA will not give you extra material so it can launch for you and make product for somebody else. We have not been successful at letting them do that. So we may have a little bit of a dip. But after that, we are going to do very well. My prediction is that... This coming year is going to be bigger than the current year. I am hoping we'll hit the $40 million and beyond, frankly, for next year. Just a little bit more pressure on Kirko. Does Elite have a second shift? Only for packaging. We only run one shift Monday through Friday. It's enhanced in that some people come in a little early and stay a little late, as needed. Except for packaging, as of end of January, we started the second shift. Lots of questions about Kirko. At what point do you see a third shift being employed to handle the current and new opportunities being provided by Kirko and his team? Update on Mr. Kirko's first six months of activities. Do you see any results from hiring a new VP of sales or is he mainly working on building a new sales and distribution infrastructure? Well, that's what a new VP of sales would be doing. He's doing all of the above. I will not go through a ton of details. I've already updated you on all the contracts and the states and all of that that he's working on. I will summarize by saying this. Kirko is an outstanding addition to our team. He is exceptional at what he does, and he is delivering on all of my expectations. Kirko and I have been together to many of these sales meetings and will be for an entire week on the road at a sales meeting in Dallas. Uplisting. Is the NASDAQ still on the dark burner as the stock has not moved upward in any meaningful fashion? NASDAQ is always on the top of my agenda. Let me repeat. NASDAQ is always on top of my agenda. Uplisting will happen when the time is right. I'm not going to get anxious and have reverse splits when we're running so low in stock price or anything else. We need to do things right. Emotions have no place in making business decisions. We have to be patient. I may be frustrated like heck because of the stock price with the achievements that I just mentioned. All of the four divisions I mentioned that we're doing very well in and the stock being still so low is very frustrating. I'll acknowledge that. But that's not going to make me rush through things and get us all into a situation that we wish we're not in. Poison pill. Will Elite renew the poison pill in November 2023? No. Short selling. There is a lawsuit and people are inquiring about it. We're not going to be a part of it. We'll watch and keep our options open, but right now it's all guesses and innuendo. I haven't read anything concrete yet or seen anything concrete as it pertains to elite. I think we get more damage from stockholders, not stockholders, people who hang around our chat rooms and for the past 15 years just that not elite. or from some of our stockholders that are not happy with the stock price. Then we get damage from the naked shorts. Last question about stock promotion. Can Elite do more marketing telling the story of Elite? And the gentleman goes on to say that he runs a company and he can help us do that. What can Elite Marketing do besides what I proposed to attract more investors? I appreciate your question and offer to help. What we can do is what we've been doing, okay? Stick to our principles, stay focused on the job, nourish the fundamentals, improve the revenues and profits and balance sheet like we have, develop the R&D system and pipeline like we have, enhance manufacturing and create self-marketing organization like we did. This is what made us profitable. Now, then move to NASDAQ, and when we move to NASDAQ or before we move to NASDAQ, that is when your idea will be seriously considered. This concludes our today's conference call. Thank you all for joining us, and thank you, Matthew. Have a wonderful day.
spk00: Thank you, everyone. This concludes today's event. You may disconnect at this time and have a wonderful day. Thank you for your participation.
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