Good morning, ladies and gentlemen, and welcome to the Elite Pharmaceuticals First Quarter of Fiscal Year 2024 Conference Call. [Operator Instructions] 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 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.

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. I will give you a summary of the company's financials, an update on Elite's R&D, manufacturing, sales and distribution and answer some of the questions that you submitted to Dianne. Yesterday, we filed our 10-Q for the quarter ending June 30, 2023. We are on March fiscal year and the June quarter is the first quarter of our 2024 fiscal year. A copy of the 10-Q is available in the Investor Relations section of elitepharma.com as well as on the sec.gov and many other websites that provide links to filings of public companies. If you haven't done so already, please get a copy of the Q and read it. As I said, you can obtain that from elitepharma.com or many of the other websites that I mentioned. Today, I'll review with you some of the key points of the financials, starting with the P&L statement. We just had another solid quarterly revenues, achieving $9 million during the June 2023 quarter, a $1.3 million increase from June 2022 or approximately 17% increase. Increased revenues have been driven by the successful launch of the Elite label product line during this quarter. This is our first quarter we go with the Elite label. The Elite label is now being sold to more than 25 of the largest wholesalers and retailer pharmacy distributors in the country. During our products to market our own label, we have encountered some difficulties. But overall, the financials show the success that we've had during our first quarter. Over the years, Elite has made a name for itself as a reliable manufacturer of quality niche generic products, which other licensees have enjoyed the partnering with us. We have now achieved the critical mass that allows us to offer our products under our own label, and Elite has begun establishing a name for itself with most of the companies serving the United States wholesale and retail market. As with any new business segment, there have been learning curves, but overall, the launch has been a success with record revenues achieved. Moving down the P&L. R&D costs are up by almost 20% from last year. Pipeline development is the most critical aspect of a generic company. Our pipeline is our blood line. All growth is related to the pipeline. We continue to invest in our future as demonstrated by the R&D expenses in our P&L statement. Finally, our operating income was $1.6 million this year, a 60% increase as compared to the June 2022 quarter. Moving to the balance sheet. Biggest takeaway on the balance sheet is the increase in working capital. Working capital was up $1.7 million or 12% since the beginning of the fiscal year. Profitable businesses create working capital, and our balance sheet reflects that as well. We see a loss increase in inventory and accounts receivable, approximately $4.7 million overall. That is all in line with growth achieved from the Elite label launch. Typical indicators of a growing business is the continued growth of working capital as our receivables and inventory turnover. To summarize the financial statement for you, for P&L statement shows record revenues, increased profits, increased R&D investment and decrease in the G&A cost. And our balance sheet indicates an increase in working capital, low debt and a clean capital structure. All are matrices that we want to see. It's only been 6 weeks since our last investor call, so a lot of the things that have to do with the site have not changed. So let me start with R&D first. Elite recently filed 2 ANDAs a generic antimetabolite ANDA and a generic dopamine agonist ANDA. These products are under review by FDA. The company also submitted partial ANDA for pain management for FDA review. The partial application contained the recently concluded insufflation study. Elite received correspondence from FDA requesting certain information. The information has been gathered and the response will be out to FDA this week. This is 1 of the 3 needle mover products that I spoke of 6 weeks ago. Elite has another product that is undergoing a pivotal BE clinical trial. If we pass, then we expect to file this ANDA this year, just to make sure that everybody understands me. Two of the 3 needle mover ANDA as I spoke of, will be filed this year. Elite continues to invest in product development. Our goal is to commercialize a new competitive products as we grow and diversify our portfolio. We will update you on other developing products when we reach certain milestones such as filing or approval. Regarding the facility manufacturing on products, not much has changed since 6 weeks ago. The products that bring in the revenues are, by far, first, the [ Dextroamphetamine ] IR and ER. These are Elite's largest products. We expect them to continue to be our largest products this year under the Elite label. We have contracts in place, and we expect to maintain our double-digit market shares. Management of the DEA quota is always a challenge. However, Elite has been able to manage through this challenge to date. Amphetamine IR remains on the FDA shortage list and both products are in demand. Isradipine and Trimipramine are being sold under the Elite label as of April 1. Although these products are modest on volume, they only have one other competitor. Isradipine, is in particularly -- a particular interest to us. It's a great opportunity for us. And hopefully, under Kirko, we will capitalize on that. We had Isradipine being sold by another company, first, Glenmark and [indiscernible]. The revenues from Isradipine for the entire year, last year when the product was under another company are less than what we got in 1 month under Kirko. When you have your own product and you care, then you invest more time and effort into selling your products and in their profitability. Loxapine and Dantrolene are also interest to us. These 2 products have each 2 competitors in the market. Pricing has been challenged though, despite a few competitors. We expect that we will capture a modest part of the market, and hopefully, they will do also better under us than they did under our licenses. We will continue to sell selective products under licenses as well. For example, our long-term partner, TAGI, continues to sell Phentermine and Naltrexone. Elite owns multiple generic products, some of which are licensed to Prasco and TAGI, and others that we are selling ourselves. Elite has developed a new customer relationship with at least 27 companies, including Cardinal Health, CVS, Walgreens, Myers, Publix and McKesson. Product shipments started on April 1 without a hedge. We grew revenues from direct sales each month this quarter. Revenues grew by 17% over last year's first quarter. We maintained a strong cash position. Working capital increased as expected. Further growth potential will come from new sales, increased margins and the Prasco license. Prasco has been given a nonexclusive license for 2 years to sell Dextroamphetamine ER, under their Burel label, and those sales are expected to begin in January 2024. In addition, the TAGI license continues through 2025, and they will continue to sell Phentermine and Naltrexone. As to wrap up, Elite is executing its growth plans by filing new ANDAs, obtaining product approvals and creating our own sales and distribution organization. We look forward to reporting on our second quarter of direct sales when we talk again in November.

Now we'll go to some questions-and-answers. Some of the questions that you sent to Dianne, we did what we always do we grouped them all together and try to address each segment by itself. The first set of questions are about the opioid we filed. Once Elite gains generic Oxy approval can we launch as soon as the finished plots are made? If we get approval, then yes, you can launch. Usually, that's how it happens, okay, with a product that's a brand that's being transferred to generic. But the premise is, if we get approval on the launch, the answer is yes, you can launch a day, you get approval. Now, if you get tentative approval or approve a goal, you'll have to wait until certain things are certified. Do any other company have generic exclusivity rights? We have to wait out first? We don't know that yet. If there's somebody else that are filed and they're going to beat us to the market. If the FDA gives somebody exclusivity, then they will have 180 days head spot on all of us. But as of now, we do not know that anybody has done all the testing required by FDA and filed as well. We know a lot of people are filed to do they're all certified FDA requirements. Does Elite expect any lawsuits from Purdue over this product? It would be difficult to imagine Purdue not suing anybody over this quarter. And they'll always find the pace it's their biggest product. Of course, they're going to find -- they try and find something to sue for. That's not to be unexpected. That doesn't hinder us from launching them. You got to assess the risk and see if they have a valid point. Does in test challenging the OxyContin patent and winning effect Elite? It does in a positive manner. When somebody has a patent and somebody else is validated, they don't evaluate it only for themselves, they validate it for everybody in the industry. So in test challenges [ for due and validated ] some of their patents, these patents are no longer valid on us either, and we can go ahead and file without the restrictions on these attributes. So in test challenge did have an effect on Elite and [ OxyContin ] as they did on everybody else in the industry. Does ANDAs get 180-day head spot? Only if they are the first to file or satisfy all of our peer requirements. The fact that they won a case in court is relevant. So you could sue somebody on relative over the patent. But if you don't have a pending application and you're first to file, you're not going to get anything out of it, okay? So are they going to get the 180 days only if they are the first to file and to the best of my knowledge I haven't heard that they filed an application yet. General pipeline. What are the expected IMS numbers market size for the needle movers ANDAs in the pipeline that are the closest to being filed with the FDA? The IMS or IQVIA numbers will be announced when we make a press release about these products when the time comes. Are any of these already pending with FDA? We will definitely make statement about that when the time comes. Of the needle movers recently discussed in what category of undisclosed and does Elite foresee the largest opportunity, opioid, stimulus or cardiovascular? Well, we are in the stimulus and opioid category. We don't have the cardiovascular 1 yet, but the products are in the other 2 categories. Does Elite anticipate any of these outperforming our Adderall IR and ER? The answer is yes. But we really don't know because we don't know how many other players are there. And now we can have an Indian company that makes the [ API achieve on the cost ] everybody. But all evidence right now shows that these products will be as big, if not bigger than Adderall IR and ER, at least 2 of the 3. Or any new BE studies expected to be completed this calendar year? We've done quite a few BE and insufflation and pilot studies this year. One, we will get the results for tomorrow. And I expect it to be possible, then it's one of the needle movers. What are we going to do anything, let's say, in Q4 of this year remains a question mark after the meeting with the CRO and the scientists tomorrow regarding a few products, will determine if we are going to run a pilot or a BE, and whether we're running it in the fall or next year, depending on several factors, including availability of debt at the clinical sites. Had any products been submitted to FDA that haven't already been disclosed to shareholders? I like that question, okay? If we did not disclose it, obviously, I'm not telling you about it. So hopefully, the question is I'm not going to open up that door. It's hard to tell you when the time comes, we will update you, and I will speak to that in a couple of minutes. We always issue press releases when we submit an ANDA with the FDA. DEA and Adderall, has Elite's had any future conversations with the FDA DEA on additional API quota for Adderall, given the recent FDA letter about unused product and shortages? We have conversations with the DEA, not the FDA, with the DEA, regularly, because they do give us quota, but they do give us quota hand to mouth. We do have current quota that they just approved, but it's only for a couple of months. And we go back immediately and submit and show them all the sales and show them all the contracts and ask that we get more quota in order to give us some time to order the API, bring it in, process it, test it, make the finished product and so on. Does Elite anticipate being granted any additional quota for this year and the next year? Of course, if they do not give us quota, number one, they'll put us out of business. And number two, and more importantly, then I have a huge shortage. We command a respectable portion of the market as a small company. So the DEA thus cooperate with us, thus work with us. But as I said, they are not super liberal in issuing a quota, they granted a little at a time. There have been different pressures, I guess, the press release that the FDA and DEA are also drug makers to boost output to address the overall shortage. Not quite -- okay. Can you comment on how this will impact Elite, and the company's overall products? Will the DEA make it easier to increase the company's quota to increase output? The DEA and FDA, it's a combined statement that we received [ copies of ] before they made it public. And the gist of it were really like that asking you if you have an extra quota that you ask for 100 kilos and you only need 50 kilos and that if, they do not say, hey, you have 50, but you need 100, would you like us to give you the other 50. It was an volunteering quota, it was actually asking everybody that has extra quotas to give it back. If you haven’t read it, please read it. And if you read it, read it carefully. The FDA got in because the shortage does impact the FDA and the DEA starting to work with the FDA to try and manage the situation. We've done a great job at managing the debate, but it has not been easy. It's not really an easy process. It requires a lot for us to get a couple of months’ worth of coding. Partnership was controlled during the [ CC and also mentioned in new Prasco/Burel ] agreement to distribute Israeli are beginning January 1. Or the date of the first commercial sales. Can you respond on that? I thought Elite was going 100% alone after we ended our agreement with Lannett. I never grow 100% in everything. My motto is very simple. If anything makes lead money, we will do it, and we are open-minded to it. The deal with Burel with Prasco is excellent. It will materialize and going to January 1. For you who do not know, Prasco/Burel are the sales force for the authorized generic. And they ask us if you would supply them instead of the authorized generic as of January 1, 2024, and we said, yes. Once that materialize and see the amount of sales would become a material event, then we'll discuss it more, but I am ecstatic about the contract and about Prasco and Burel doing this on their own label, because that helps us also and other financial points in that there are no chargebacks and rebates and very complicated financial. This is an easier transaction. And it's always nice to protect the company by having multiple sources of income and not consuming all the working capital into chargebacks and rebates. Corporate operation has really decided to operate with the temporary CFO from [ Mazars ], the new auditor, I don't know where this came from. How is the permanency of search going? Are you using accounting contracts and consultants in the interim? We frankly have the necessary qualified personnel in place while we identify a permanent CFO. In Norway, has this business activity has been hampered by adding a CFO, and the fact is we do have 2 consultants working as CFOs that have helped us put the entire 10-K the last time, before and the Q and helping us with internal controls of finances. So when we find a permanent CFO will make an announcement. In the meantime, we have a lot of help, and we're doing very well. In addition to the fact that last time, I did this presentation without the CFO, the stock actually went up, so I may not hire one for a while. We'll see how that goes. All right. About what point in time in production, it's expected to [ max out ] the current facility? When the sales are enough that we cannot make any more and go to the second and third shift. We still have capacity in there, but it's really difficult to run a plant at 24/7. So before we get to that point where we're having to go to second shift in all departments and first shift on weekends, I definitely as I mentioned the last time, thinking about the solution for that. Are we nearing the need for any new shifts to be created at our facility? Any time we do, we go ahead and [ accommodate ]. For example, in packaging, that got to be a way too much for people to come in earlier in the morning and stay low to running extended shift. So we run 2 shifts still we cut off, okay? Same thing in the lab. We [ staggered ] people in the morning and then in the afternoon to do the same thing as well as manufacturing. Couple of questions that Dianne has not commented, I address got it from the message board, but I'll entertain them because they were entertaining, all right? So the first, who can say, gentlemen, I apologize, the first person, it could be [ LAD ], I don't know, says some new sales constantly allege that must -- intentionally over the years have been to purposefully put out their minimum press releases and continue accumulating enough shares at the low price via salary and dilution to ultimately take over the company. Serious conspiracy theories. Take it private at a very low price. To be clear, I do not personally believe this. I think it is a smear designed to harm the stock. Please consider refuting the property. First, I addressed this before and I've stated before that I had no interest in taking Elite private. If I always speak over the company, I was a better a long time ago. We are selling the assets I have for shares or something else or would not have done what I’ve done to get the company to be profitable and value so much more, okay? So I already sorted this issue, but when people don't want to listen, they don't listen and they keep repeating the same lies over and over again until somebody believes it. But let's take what you said step-by-step. First, regarding the press releases that we purposefully issued their minimum press releases, take a moment and think about that. When we issue a profound press releases about great achievements of the company's financials and moving to profitability and contracts with other companies, all the great stuff that we have done in the past 5 years when we've been every year, creating more revenues and more profit than the year before. When we do all of that and the stuff doesn't even move. Do you think making a stupid superficial statement like, oh, we're thinking about finding this product or it's going to move anything? No, it will make us into a joke. When somebody wants to invest in Elite and look at all the press releases and the press releases are all Mickey Mouse press releases, they can see through that. So yes, we only issue press releases that are relevant. We do this at least 4x a year for our financials. And any time there is a material event, other than that, we're not going to change our clarification, okay. I have already addressed the issue with taken over the company. I have no interest in doing that personally. Now if a company like my old [ active company, wanted to buy Elite ], they have project, that's fine. It's a human well, which bought for Epic, wanted to buy Elite, I'm fine with it. But for me, personally, if you take the company private, I have, and I've stated before, a few months back and a few months before that, I have 0 interest in doing that. Second question is really long. So I'm not going to [ call thing, but I will read just of it ]. With many investors are very frustrated with the stock price, the business fundamentals have greatly improved over the year, but that has not [ onset into a tough ] price success. The person goes on and on about analyzing the company and says, I honestly do want the company and the stock to both do well. The gist of the full page commentary is 2 things. One is, I am asking that Elite consider paying all salaries in cash, ASAP, and that's the first one. And second, and consider even a $500,000 to $1 million stock buyback plan, $1 million would currently be anywhere from 23 million to 25 million to 33 million shares, okay. We will talk about buybacks and all of that at the future date, investing $1 million to get 25 million shares when you have 1-plus billion shares outstanding is not going to do anything to the company or the stockholders. And it's going to take away $1 million that can be spent on multiple clinical prices that could bring us Amphetamine IR and ER and have a huge impact on the company. So this is to the second one. But as to your first inquiry that asked that Elite considered paying all salaries and cash ASAP, hereby you should be decreased [ subsequently ], we're going to do that, for 2 reasons. Number one, because you asked and number two because really the Board have already voted that we do that last week. So the Board actually about a year ago approved on doing that. But it approved it to the caveat as the company can afford it. Well, we couldn't afford it, because it is hypocritical for me, for example, I'm the Board to take money in cash and then turn around and loan the company money. So that's why we can do it. Even though the Board has been thinking along with the same line, you're thinking, hey, let's start paying everybody in cash, but [ also there is out of stock ]. If we tell you in cash, then we have less money to do clinical trials. And we're paying less in cash and then asking me to loan us money, it didn't make any sense. So in the last meeting, last annual meeting, the one before this one, we talked about that. And this one, they said the same thing. You still have a green light to consider doing this and that's just what we're going to work on. So both the ideas are viable. One we're going to work on paying everybody in cash; and the second is stock buyback is on the table, but there is a matter of whether you can afford it or not, okay? And there'll be a time, and it would be profitable enough for us to split the money into a buyback program and supporting the clinical trials. But that will be after we pay our loans, as you all know, have loaned the company money, one of our great Board of Director members loaned the company money as well. When that is paid, an Elite can live within its means. Then it will make a lot of sense for us to spend money on R&D and spend it also on buying back stocks, right? With that being said, looking forward to talking to you in November and reporting on the second quarter's results. Thank you, Matthew, and everybody have a great day.

Thank you, everyone. This concludes today's event. You may disconnect at this time, and have a wonderful day. Thank you for your participation.