Elite Pharms Inc

Good morning, ladies and gentlemen, and welcome to the Elite Pharmaceuticals year-end of fiscal year 2026 conference call. At this time, all lines are placed on a listen-only mode. Before management begins speaking, the conference has the following statement. Elite would like to remind listeners that remarks made during this call may contain forward-looking statements that involve risks and uncertainties that are subject to change at any time. including, but not limited to, statements about ELITE's expectations regarding forward 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, Thank you, Matthew. Thank you.

Good morning, ladies and gentlemen, and thank you for joining us today. My name is Nasrat Hakim. I am a lead chairman and CEO. This is our earnings call. Our CFO, Carter Ward, will give us the financial update, after which I'll come back with a brief update and answer some of the questions you've submitted to Dianne. Mr. Ward, you have the floor.

Thank you, Nasrat, and good morning, everybody. Yesterday, we filed our 10-K. That's our annual report for the fiscal year ended March 31st, 2026. We're in the March fiscal year. 10-K, if you haven't seen it yet, it's available at our website, EliteFarmer.com, under the Investor Relations section. Today, as usual, we're going to provide some context and some color to the financial statements. and also answer the finance questions I received overnight and questions we got over the weekend even. And as always, thank you so much for those questions. We really appreciate you taking the time to ask them. Let me start with the P&L first. Total revenues for the year were $149 million. and that's compared to 84 million for the March 2025 fiscal year, last year. That is a $65 million increase, 77% increase. Another year, another revenue record. So very impressive growth this year. The Elite Label, we're in our third year of the Elite Label. The Elite Label was launched in fiscal 2024. So 2026 is our third year. and let's look how we've done since we've launched the Elite Label. In the first year, 2024, the revenues were $57 million and that was a 66% increase over the year prior to launching. So we went from $57 million, second year we were $84 million, that was last year, and this year $149 million with a 77% increase. Just to put some of this into perspective, we started this year from a baseline of Record Revenues. Last year was Record Revenues. And not only did we increase the actual dollars, but the percentage increase was also higher than it was last year. So that's pretty tough to do. When the numbers get as big as they are now, when you're dealing in percentages, it's hard to increase the percentage. So P&L is clear, solid, sustained growth strategy. How do we do it? It's typical generics. The strategy is straightforward. Deliver quality product on time as promised to become the go-to supplier of choice in the market, which we are for our products. Achieve a critical mass, which we've done. Run efficiently, which we've always done. And most importantly, continue pipeline development. We need to develop, produce, develop, develop new products and launch new products. So further to this, the Elite Label started three years ago with generic Adderall, Isratapine, Dendimetricine, a few other products. And in the last two years, just to illustrate pipeline development, last two years, we've launched generic Vyvanse, generic Tylenol with coating, generic Norco, generic Percocet, generic Atrexap, generic Revia, and we also brought in-house the old products, Naltrexone and Fentanyl. We brought those back in-house and now we're selling them exclusively on the Elite label. So it's clear that this is what explains what we reported on our financials this year, the 10 Ks, the 10 Qs and over the past few years. It's pipeline development, product launches. That's where the growth comes from. But to sustain the growth, This requires continued product development. It never ends. Cycle never ends. So people that follow Elite, we know they'll notice that since March 31st of this year, three months ago, we've launched methadone. We filed an ANDA for a generic coagulant. We reported positive results for a pivotal bioequivalent study. There was a lawsuit relating to oxycodone, which was dismissed. So that's gone now. That's not standing in our way. The products, we continue to develop. The pipeline development, the efforts never stop, and we are on schedule. That's the critical factor to sustain, maintain growth. Let me move down to P&L. We'll look at operating income. 2026, this year, operating income was $49 million. Compare that to $20 million Last year, 2025, increases more than $29 million, 151% increase in operating income, profits. First year of the elite label, we had an operating income of $11 million. Last year, $20 million. This year, $49 million. So the profits since we've launched the elite label have more than quadruples, went from $11 to $49 million. Some of this is due to product mix. We're selling more of the products we started with, we're adding more products, and we're selling more of those as well. I've been getting this question, I call it a usual question now, I've received it many times in the last few quarters, and the question that I've got is whether we will continue to increase the percentage rate of growth as well as setting records. Revenues and Profits Every Year. Well, all I can say is the infrastructure is in place. The critical mass is there for the elite label. The product development is on schedule for new products in the pipeline. All the components are in place for growth. But do the math. Percentage math gets tougher as the numbers get bigger. So we did it this year. Percentage-wise, we increased. Can't really promise on percentages. Let's just see what happens. all the fundamentals are in place for growth. So to sum up the P&L before moving on, it was quite a year, a record year, great job by the sales teams, the production teams. These were truly stellar MVP numbers that they put up this year. Got some questions on direct versus indirect sales and the effect on margins. There's a new table in our financial statements, which hopefully will answer some of these questions going forward. It's in Note 1 to our financials. It's a large note, and there's a section, Disaggregation of Revenues. And that shows our direct versus indirect revenues. So you see, if you look at that table, this year our direct sales were 44% of revenues, and our indirect were 56%. Last year, it's a flip-flop. Last year, direct was 59%, and this year it's 41%. The distribution channel is really more of a driver of volumes as compared to the other, which I'll call margin drivers. Product mix and real-time market conditions is generally more relevant to margins than are distribution channels. In the market, you have demand, supply, competition, quota availability. You have all of those dynamics going on in the market, and that generally has more of an effect on margins than do the distribution channels. But when you put everything together, the volume, the margin, the direct versus indirect channels, you look at the result. And what was that result? The result was record revenues, record gross profits, and higher gross margin percentage as well. So triple crown right there. We hit all of the numbers this year as compared to last year. So next, we'll look at the cash flow statement. Operating cash flow this year was positive $23.7 million. So we can compare that to $7.5 million last year. So our cash flow increased by more than $16 million this year, 219% increase. Pretty simple. There's one word that can explain this, and that word is profits. Profits drive your cash flow. We go down the cash flow statement. Don't talk about this too much, but there's cash flows from financing activities. And you look there and it says bond and loan principal paid was $4.6 million this year. Last year, we paid back bonds and loans $845,000. So we always talk about how we're committed to reducing long-term debt. And this is pretty obvious there. It shows right up on our cash flow statement. We are paying down our debts. Now to the balance sheet. Cash was $29.8 million compared to $11.3 million last year, so it's $18.5 million increase in cash, 163%. Working capital, my favorite one, is this year was $95 million. Last year was $46 million, almost a $49 million increase, 106%. Long-term debt was down. We were $4.7 million this year versus $5.8 million last year. So debt went down by $1.2 million, a 20% reduction. Sum up the balance sheet. You will not see a better balance sheet anywhere, really. Cash is up, working capital is up, long-term debt is down. This is the textbook definition of a strengthening balance sheet. Every year we get stronger and stronger, this year included. I have a few more questions. Might as well go through those now. One question, do we have any more NOLs, net operating losses? Well, NOLs, just so you know, those are the tax losses from the past years, years and years ago, and they carry forward. We can use them to apply them against current income taxes, which we do. There is a line item on the balance sheet called deferred tax asset, which gives the value of those tax deductions. and as of March 31st, those were valued at $7.8 million and last year at the beginning of the year or the end of last year was $18.4 million. So we used up $10.6 million in NOLs this year. Whenever you have profits, you owe taxes and use up the NOL deductions if you have them. We expect that we're going to have to start making payments of federal taxes this year. We're going to use up our NOL, everything that's available to us. We always record the expense. Expense gets recorded no matter what, but because of the NOL, we haven't actually had to make payments to the federal government because of these deductions, but those days are coming to an end. Another question is, why is there a 70 million increase in fully diluted shares outstanding? It's a little getting in the weeds, but if you look at note one in our earnings per share section, it really has to do with the income attributable to shareholders. Last year was actually a loss. We had $19 million in derivative expense, which put us into a loss, and therefore the The dilutive effect of the warrants and the options were excluded because they are considered anti-dilutive. So that's just an accounting thing. This year we had derivative income and we had a net profit. And so these dilutive instruments, warrants and options were not considered anti-dilutive. So they were put in. It's the same warrants. It's the same options. It's just different accounting treatments depending upon really how the derivative expense goes. Just so you know, the derivatives, if our stock price goes up over the year, we record a derivative expense. And if the stock price goes down, so it went up in 2025, we had expense. It went down in 2026, we had a revenue. Kind of counterintuitive, but that's how it goes. So if you want more details, just look at Note 1 on financial statements. That will answer your questions, hopefully, on earnings per share calculations. I've got the usual questions on derivative income expense. I already covered that. Stock price up is expense. Stock price down is income. I did get a first-time question on the outstanding warrants and a concern about dilution and an impact on the cash flows of these warrants. The warrants, they have been outstanding for nine years. They're 10-year warrants. They've been out for nine years already. And every cap chart that I have prepared since then, over the last nine years, and every discussion with investment bankers and other parties with serious interest in Elite have included them as part of Elite's capital structure. Potential dilution from these warrants, that was recognized nine years ago, and it has not changed. Secondly, The warrants, they're 10-year warrants already nine years in. That means they expire next year. So they're going to either be exercised or they're going to expire next year. They're done next year one way or the other. There's a cash exercise option, which we're discussing with Mr. Hakim, who's the holder of the warrants. And that would obviously be positive cash effect for the company because he'd be buying the shares, giving the money to the company. and with no effect on dilution. The dilution would be the same that has been in place for the last nine years. There's a cashless exercise option in the warrants and that obviously has no effect on cash and it results in lower dilution than we had been calculating over the nine years. So in all cases, there's no strain on cash flow and there's no additional dilution in play. Everything is as it's been for the last nine years. Another question, are we considered an accelerated or non-accelerated filer and are we still a smaller reporting company? That is a question, that's an excellent question. It's highly technical and it's one that I asked quite a while ago of our SEC counsel because I had the same question. So the direct answer is that We will continue to report, as we're doing now, we will continue as a non-accelerated filer and a smaller reporting company through the end of this fiscal year, March 31st, 2027. No changes, no change in how we file our 10-K for this year. The next assessment, the next test we have to go through, and that will relate to our market float on September 30th, 2026, three months from now, and any changes resulting from that assessment will take effect during the year ended March, 2028. So no changes for this year. Let's see what happens on September 30th and basis of that, it will affect the next year. And obviously when we know that, when everything is finalized, it will be discussed. And then one more final question we got Pretty late last night. Can I speak to the critical audit matter related to the chargeback reserve? So in our opinion, our auditors mentioned the chargeback reserve as a critical audit matter. So chargebacks are related to indirect sales. The audit opinion, as you take a look at it, actually does an excellent job explaining what a chargeback is. It's the difference between the price the wholesaler pays and the price the end customer pays. It's a standard thing that happens in the generic business. Since chargebacks occur after we ship and after we deliver to the wholesaler, GAAP accounting, generally accepted accounting principles, they require that we estimate the amount of chargebacks that we're going to receive after March 31st, but that relate to the shipments that we delivered on or before March 31st. One thing with accounting, most of accounting, there's estimates involved. and with regards to chargebacks the amounts can be large so the auditors because of that the materiality they consider a critical matter and they spend a lot of time and I mean a lot of time thoroughly vetting all aspects of the underlying the source documents the assumptions the data very very thorough on that just because of the materiality it's pretty standard order procedures and performed on something that's very, very common to all generic companies like ours. So to sum up these financials, I guess you could say the record-breaking streak continues. Another year, another record. Record revenues, record profits, revenues up 77%, profits up 151%, operating cash flows more than tripled from last year. The balance sheet continues to strengthen. We had record high working capital. Long-term debt continues to drop. Can't say enough good things. The pipeline is strong and continued growth potential is out there. So the writing on the wall is clear. The company is stronger than ever. We're an attractive investment. Nasrat will talk a lot about that, I'm sure. From an M&A standpoint, we get more and more attractive as an investment because of the performance of the company. Also, we're ready for the NASDAQ. This company is a NASDAQ company. So that option is definitely on the table as well and being considered among all the other options. That concludes my presentation. Our next scheduled report is the 10Q. It's for the first quarter of our fiscal 2027 fiscal year. And today, June 30th, is the end of that quarter. And our next 10Q is a short turnaround. It's due in August. So I look forward to speaking with everyone then. And now I'd like to introduce our chairman and CEO, Mr. Nasrat Hakim.

Thank you, Carter, for these outstanding numbers.

You should have downplayed it a little. You know, every time we have good news, the stock price goes down. So let's hope this is an exception. It's been amazing.

I did downplay it a little.

I'm going to just recite three of your numbers and go on because it's really impressive. Thank you. This cycle we've been on has been outstanding. The revenues for this fiscal year is 149. Wow, 77% increase over last year. Any other company on NASDAQ and anywhere else hits these numbers and the stock will explode. And if you look at the last five years, we've increased revenues on the average by 40% per year. This is not the only year we're doing it. This is not an exception to the rules. This has been established time and time again, every quarter, four quarters a year, and for five years now, or more actually, more like seven. Operating income for this fiscal year, 49 million, again, 150, 151 increase over previous year. Looking back at five years, that's an increase of about 80% each year. I will not go through all the numbers Carter went through. You already have them. But this one is most intriguing. The working capital is at $94.7 million for this year. About three years ago, Elite didn't have enough money needed help with working capital to launch our products. And Dave is one of our board of members and myself had to loan the company, we're happy to loan the company $3 million to get it through launching new products. Today, Elite doesn't need anybody's money. They almost have $100 million in Working Capital, they're almost as rich as Carter. Over this time, over the past five years, we have transitioned into a solid, mid-sized generic company with all the facets of pharmaceutical company, including our own sales and marketing.

We did that with internal growth, not with acquisitions.

We did that by developing and manufacturing our own products, not licensing products. This way we have maximized profitability for the stockholders. I know of a lot of companies and a lot of my former CEO colleagues and bosses that take over a company and they go out and buy a whole bunch of products and they license this and that and borrow a billion dollars and then Two, three, four years later, you cannot pay it and you end up bankrupt and the stock goes to zero. We have done everything in a conservative way to protect the stockholders and maximize profitability. We still have the option of licensing and acquiring products from other companies if the opportunity arises and it is advantageous to elite. And many opportunities have arised, but we did not want to take on the headache because it was not really worth it. It's something that we will consider further in the future. But when something like that comes up, we will look at it. Why? Because we are an established pharmaceutical company that has strong fundamentals and very low debt. Over the past five years, we have introduced our sales and distribution force that has done an exceptional job. We've added new products. We expanded our manufacturing and packaging capacity, and I'll talk about that a little more in a minute. And we enhanced our revenues on profitability, all while maintaining a strong balance sheet that you just heard from Carter and an efficient workforce. I haven't done the math, but on average, we generate more than $2 million in revenue per employee.

Our product mix is the key to our success.

Our sales and operation team have effectively defended and or grew the market shares of our key products while maintaining good margins. Again, anytime there's competition, some companies start to dump the prices so they can get more shares and they don't care about bringing the whole market down Elite is a very responsible company. We have not had that impact on anybody, and even though we enjoy a healthy share of a lot of the big products that we have for a tiny company like us. Lyftex, the generic Survivance was launched about a year ago, and now we have about roughly 10% market share. Elite was able to effectively penetrate the market and defend our market share with minimal disruption to the overall market. And that is really key. That's how a lot of prices go down when people don't do that. The list tax overall market grew about 20% during each of the last two years. Now, it's mostly generic. Last year, 35% of the volume was with the brand. This year, it's about 15%. So the brand's generic conversion is almost fully matured now. A little note for everybody, IQVIA does not really reflect elite sales for what they are, for reasons that we don't fully understand. But what I'm reporting to you now, that we are at 10% of the market, our sales. Amphetamine IR, the generic Adderall, is another pillar for elite. IQVIA shows Elite's current market share about 14%. Amphetamine IR market has grown 6 to 12% per year in the past few years. This is an old molecular entity. It's been around for a decade, and it's still growing, and we're still a part of that growth and going with it. Amphetamine ER is another one of our pillars. IQVIA reports that we have about 12%. MarketShare, and this also has been growing, and it has grown about 8% to 12% per year in the last few years. The second part of what has been contributing to our revenues are our legacy products. Neltrexone is one of them. We launched it recently. We've had it for years, but Taggy and Precision Dosing were selling it now that we're selling it. We are about 12% market share according to IQVIA. And it's growing. Izradapine and Trimipramine are small markets. Each one of these products have only one competitor. So Izradapine, our competitor is Teva. Trimipramine, it's a Brooklyn Ridge. Even though they're small products, the margins are healthy because there's only one competitor. And we have a strong market share in that. Fendiametrazine has been with us for years, and there's only one primary competitor. We hold about 30% of the market share with good margins, and Fentermine is another one of our old products that have been with us for a very, very long time.

We've recently launched Codeine with acetaminophen, ABAP with Codeine, OxyABAP, Hydro APAP, Methadone, and Mesotrexate.

Next month, we will be launching Repenrol, Repenrol ER. The market cap for this is about $12 million, and we always target 5% to 10% of the market, and we usually exceed that on products that are really good, such as Listex or amphetamine IR and ER. Our partner, Dexcel, is doing well in selling amphetamine IR, speaking of which, in Israel. and they are talking to us about potentially having other products there, transferring other products from Elite over there. In the pipeline today, which needs to keep on feeding the sales and marketing team, we have two ANDAs that are pending with FDA. We have an ANDA for Oxycontin ER. Oxycontin ER is generic as Oxycontin. and from a patent perspective, we are in good shape. We did actually a brilliant job on that. The team did an excellent job. We went into litigation with Purdue for under $100,000 of spending. We reached a favorable conclusion. where we can launch pending FDA issues in August of next year. Other companies like Accord have spent tens of millions and they still aren't seeing both of us, they can't launch yet. So the team did an excellent job at handling the litigation for OxyContin. There's an ongoing lab issues to address. When you create the ANDA for Oxy-ER, there are three different versions to it. There is the BE study, you get a pass and be equivalent to the brand, perfect. Then they ask for insufflation study where you go into humans and have them snort your product and snort OxyContin, perfect. Then they ask you to do lab anti-abuse studies where you have to dissolve your product and theirs in any household common item there is. Heptane because the cigarette lighter has it. Orange juice because it's in the fridge. Coca-Cola. And you got to do this in this process of about a year. And smokeability to see if somebody could fire it up through a pipe or something. One of the tests the FDA asked this question about recently, and we need to resolve that issue before we move forward. Other than that, the patent issue looks promising, and the application barring the in vitro study, which means a study in the lab, they have no other issues as of now. We have submitted an ANDA for an undisclosed anticoagulant generic. The brand has unexpired patents, therefore timing of approval and launch of this product will depend on FDA approval and the disposition of the patents on the Orange Book. There are some questions about that and we'll talk about it more later, including Oxy, but There are certain things we cannot do. You gotta go with whatever the FDA sets and whatever the courts set whenever you have patents pending and you have litigation. We also recently announced the passing of a BE study for seizure medication or anticonvulsant medication. We will issue a press release when the ANDA is filed with FDA. We do have several other products in development stage. and we will make announcements on each once we reach a material event, most likely if the BE is completed. R&D continues to be a priority. And in addition to our in-house development, we also continue to evaluate the product opportunities from the outside. We will update everyone on the pipeline when material events occur. Another important accomplishment in the last couple of years is really the improvement in our facility. The expansion of our campus, we have a new facility located at 144 Ludlow Avenue in North Sale, New Jersey, which has packaging, inventory, and warehouse space. This new expansion is critical because it allowed us to triple our DEA storage vault space. and this is very important for a company that manufactures a lot of controlled substances. It improved drastically our packaging capabilities to cover all of our product needs and allow for potential growth for the next five years plus. Easy. It also allowed for additional manufacturing suites. By freeing up the space where the packaging line was, now we created three suites in that space alone. Our old warehouse was maxed out on space because of all of the packaging components. The cartons and cardboards and empty bottles and caps and so on. And now it looks great. It has tremendously improved. because we moved all of that across the street with the packaging operation. With this expansion, we have positioned the company to meet significant future growth, especially for packaging. For packaging, we are making about three quarters of a billion units total on one shift. we can double that easily triple that by going to two shifts and if you work on the weekends it's even more and this is without adding another packaging line so the opportunity for expansion especially for packaging and the vault space was outstanding manufacturing is good but if we're going to bring in more products then I need to think about the next step or we all need to think about the next step I'll cover M&A before we go to All right. We're always considering ways to bring value to our shareholders. The options obviously have been to leave things as they are and stay on OTC. That's not a good idea for the stability of our stock price or for the stability of our stock. We all know the positives and the tremendous negatives that goes with being on the OTC. Second is to sell the company, merge, acquire, or be acquired by another company. To that end, we have been using a bank to assist us in assessing M&A opportunities. We have had companies look at us and find us too large for their balance sheet. The same companies that thought were too large for their balance sheet expressed interest in collaboration of us becoming the R&D and manufacturing parts for them and coming up with some kind of a collaboration to that effect and we said no. Another company that looked at elite wanted to buy our products, location, facility, whatever, but they won't buy our products. We said no. We have another pharmaceutical company that offered us to buy their pharmaceutical company. and it would have been a good opportunity but the fact that what they were asking for was too much so we said no. However, we have not been presented with what I would consider or what the board of directors and the senior staff team would consider to be an adequate opportunity to move forward. We are not going to rush into this. We're not going to discuss and debate any substandard pricing. And we will wait till we get the appropriate offer for us to take it to the stockholders. Till then, we'll keep the show open and let people come and look and look at our financials and study it and decide if they want to buy us for the appropriate price. Our M&A agent tells us there is another large company that's interested right now. We will accommodate them, and we will see what happens. If a positive outcome results from that, we will update you on it. If not, we will continue looking. Now, in the meantime, and Carter's been working on this, my directive's been for over two years, we prepare to go to NASDAQ because that's our third option. OTC is not an option anymore. We've overgrown that. Merger acquisitions combining with another company is definitely an option. That's really complicated, especially in today's market and with the way our stock is moving up and down. Going to NASDAQ, and we can go to NASDAQ as we are, or it was one of the options that I mentioned. We could merge with another company and the two companies go to NASDAQ, or we collaborate with another company and the two companies together could go to NASDAQ, or we can buy somebody and then go to NASDAQ. or we just go to Nasdaq as elite with our solid financials and solid fundamentals. The most important thing for everyone to understand is that at all times, we continue to operate the company with our long-term value in mind. That includes growing our product line and growing our pipeline. These two do not get compromised regardless of what else we're distracted or working on. as you can see from our financials this year, this quarter, last quarter, the quarter before, and the quarter before dating back to five years. As I stated in the past, we will only pursue opportunities that bring value to our shareholders. We will continue to assess opportunities in M&A, but in parallel, we are taking necessary steps for us to uplift at Nasdaq. Just to summarize, Elite is executing its strategy of development and filing new enders and growing sales while supporting working capital growth and pipeline development costs and a strong cash position. Elite maintains a strong reputation as a dependable supplier or a supplier of choice, and we will build on that strength to grow our recently approved and recently launched products. Elite is positioned as an attractive mid-sized genetic pharmaceutical company with consistent profits, steady growth, and low debt. We will continue to evaluate and pursue alternatives if they bring value to our shareholders. All right, let's go to Q&A and look at the questions you submitted. There were a lot of questions and many of them were redundant, but all of them were grouped into certain groups and they addressed the same thing. Asking about the Purdue case, asking about the anticoagulant, asking about the seizure anticonvulsion medication, asking about MNA, and some general questions. But all of them were pretty much the same mindset for the stockholders. If I don't read your question specifically, it's because somebody else wrote about the same things and I don't want to waste all of your time reading 50 questions that mean the same thing. So first, we just got positive bioequivalency results for an anti-convulsant. I recall the FDA has been trying to fast track certain genetic enders. Have you heard any updates on that effort? Is it already in place? And if so, what kind of approval timeline should we expect? Also, there's another question from two, three other people. When do we plan to file the ANDA for this product? What is the drug? How many companies are there, et cetera? Okay, so a lot of questions about the same thing, and I'll also read some more questions later on. But these are about 10 questions that were summarized into what you just heard. First, as far as fast tracking, to the best of my knowledge, no fast tracking is available for this product. And yes, we did announce a successful DE study at this time. We will issue a press release when the ANDA is filed. We do not release product names for those studies until the products are approved. This is for competitive reasons. This is to protect our stockholders and to protect our company and your asset. In general, it takes about a few months to put the ANDA together.

Six months is for stability.

FDA takes about 10 months to review it. and then the FDA may choose to pause and then ask you a question, wait for you to answer before they kick in the 10 months again. And there could be patent issues. So there's a lot of uncertainty on when will we go to the market. I cannot tell you that because I do not know myself. I have to go through the process and hope that we do our best to get there as fast and as soon as possible. Have we started running a second production shift yet? or are we still able to meet the current pipeline on a single shift? We do actually run only single shift on two lines. And that takes care of our needs. So as I said before, huge opportunity for growth. If we double, triple our manufacturing capacity, packaging can handle it. And if they go beyond the tripling it, then we'll add one more packaging line. You recently mentioned that potential partnership could require additional manufacturing space. Are we actively looking at more space now? If so, does this mean we are accelerated faster than roughly six years of room guidance from a couple of years ago?

That is correct.

Not only we're looking with identified facility, we're not going to pull the plug till we Do the study, figure out which products could go there, how much it's going to cost us to lease it, how much it's going to cost us to retrofit it, how much are the products going to be making, and how fast we'll get the return on our investment. Once we finish that, we may pull the plug on it, but we've identified the beautiful facility that we may be interested in.

Okay.

Congratulations on the stipulation agreement and settlement with Purdue Pharma. I see this is a smart, necessary move, especially the way you let Accord take the lead and only fought the remaining pieces to protect our capital outlays. My understanding is that while we don't get exclusivity first to file rights, those go to Accord, The settlement means that Elite is not treated as a new filer. One, a court may not get the six-month even though they won all the cases. Who gets the six-month exclusivity is the person who filed first or the group that filed first. That's first to file. Who wins the court battles is not relevant to the FDA. Whomever files with FDA is the first. All right, so Elite is not treated as a new filer. This should allow us to sell during a court's exclusivity period while others can't. Is that accurate? Don't know if it's really accurate. There are times when you settle with a company like Purdue, you can sell your product. At Activus, we sold some Purdue product just to delay us from filing, even though there were no genetics. They gave us $120 million just to delay us, okay? So there are certain cases where you can sell and you can't. I'll have to take a closer look and discuss it more with our patent attorneys. Why didn't Elite issue a press release? I'll explain that in a second. It's because of the uncertainty. When will we get the tentative approval? I don't know. What's your new strategy? We don't have a new strategy. Our old strategy is doing great. We worked with Purdue and we got a settlement from them. We're working with the FDA. We're hoping we will do things to their satisfaction and everything will come together and we will be able to launch our product. And if anything complicates it, we will figure out a way to resolve it. That's how you do business. Any plans to hold an in-person shareholder meeting again in the future? whether we go to Nasdaq or we sell the company either way we're going to have to have a shareholder meeting in order to vote on that soon enough whether it will be in person or virtual remains to be seen our first file positioning and truncated 30-month stay for the anticoagulant and regarding our critical June 1st, 2026 ANDA submission for the generic anticoagulant, does management believe that our strategic timing has successfully secured the first-to-file or shared exclusivity position? What specific litigation pathway or legal framework are we modeling to potentially truncate the standard 30-month stay? Has the FDA issued a formal acknowledgement of receipt for the June 1st anticoagulant submission based on the standard GDUFA action date? What is management's internal timeline for tracking toward the tentative approval?

Okay, and there were about 10 other questions, but all of them are about the same thing.

The anticoagulant product that was recently filed is not There is no such information from other companies that could help us truncate the 36-month stay. We know certain things to do that has nothing to do with other companies. There's paragraph three or paragraph four filings. and based on what our technology is infringing or not infringing, that's how you file. The anti-coagulant product has been filed with FDA. The FDA acknowledged the receipt. It usually takes them about 10 months of review and they never take 10 months. They always pause and ask you questions and extend it. But when we get approval, we will definitely let you know.

Please provide the current status of the anticoagulant and the main reason for the delay. That's true, I did say I delayed it before.

You mentioned you were assessing options for the ANDA. What factors are being considered and when do you expect to reach a decision? Well, I reached a decision and went ahead and filed, but that doesn't mean we're not doing the work in order to truncate the date from 2032. and the reason I delayed it is because every end comes in with patterns and the patterns are not on one thing. Some patterns will be on the API particle size of composition. Others will be on the DISO or on the impurities. Some have to do with formulation. So you look at them and you line them up and see which one is the longest and which one is in the middle and try to go after some of the patterns either by circumventing them, okay, or by challenging them. So we were in the process of trying to circumvent a couple of the patterns to reduce the timeline and it took too long so I decided to go ahead and proceed with the filing but we are continuing to work on overcoming the patterns if possible. Is it likely that ELITE announces another positive BE trial result before the end of the year? Yes it is. And when it happens, We will issue a press release. Does the elite have any plans to pursue NDAs, whether abuse deterrent or not, now that the finances are more stable? You know, NDAs cost a lot of money. And our finances, even though they're stable, they're not NDA stable. We already have Seacoast Ox that's already still active. I don't know for how long, but it's still active. And we're not investing any money on it. I much rather invest our money in ANDAs or if there is an NDA that could be a partner that financed it and we will do the work. So no, we're not considering any NDAs at this time. That doesn't mean if one that has the right circumstances came to us, we would not consider it. On cost optimization and price compression defense, Lisdex amphetamine, given the elite current command, currently command is 17% market share in the generic Vyvanse space. It's 10% really. And that pricing compression for this molecule can historically reach 90%. What specific Operational or supply chain cost optimization measurement is management deploying to protect our current margin profiles. Furthermore, has the company secured APQ aggregate production quotas from the DEA to ensure volume stability? Elite has 10% of the market share for LISTEX, not 17%. Market prices did fall from where they started at, which is normal. You start very high and then they tighten up. But the increase in volume compensated for that. The conversion from brand to generic compensated for that. So we're doing extremely well. We look to defend our margin shares through good relationships. High reliability, and frankly, this is not a guess or a slogan. There was a company that was buying a product from us, one of the distributors. Somebody else offered them a lower price. They came to us and said, would you meet it? And we said, no, go ahead and go with them. And they decided not to, even though it was lower by a lot. They said, you guys are a reliable supplier. We're staying with you. So this is my slogan, we defend it by doing the right things and this is one of them. And the DEA has provided sufficient quota for us to maintain our shares, our market share. A question on Ritalin, we don't even make that product so I will not read that. In very round numbers, what were unit sales of our Adderall and Vyvanse this quarter? and previous two, not dollars, just units. We don't release unit sales for competitive reasons. But if you really want to know, you can extrapolate from our percentages, go to IQVIA and maybe you can take a good guess. Okay. Can you share methadone soft launch results to date, including volumes or other helpful proxy? and how they compare with your expectations. Methadone is a competitive market. It's really a modest product and the prices, the profit margins are low. So we're not going to focus a lot on it at this time. We are definitely going to have the soft launch and good to maturity in time. There are bigger fish to fry, less tax, amphetamine IR, amphetamine ER, even a huge product like naltrexone now is more viable than that. It is a good product. It will pay the electric bills and it will help out with a lot of things, but it doesn't deserve a lot more attention than that. Are there other API suppliers for Elite that can help reduce limited product availability and increase sales of Vyvanse and Adderall? The answer is yes. We source a minimum of two API suppliers, and we do all the analytical work, and we file it with FDA and get them approved for every one of our products. And as I said, a minimum of, because some products we do even more. Relationships other than potential expansion of the Dexel partnership, does Elite have any additional plans for international expansion? New international opportunities do come in from time to time and are evaluated. We just did one recently. But for now, Dexel is the primary international opportunity. And Dexel has interest in adding more Elite products to their portfolio in Israel. Is Elite pursuing purchasing Doxycycline from Praxigen Fungin for another near-term product launch or is this no longer a worthwhile market? We're not considering purchasing it and it's not a not worthwhile market. It's just too much headache to be able to do it right now. It's a high volume, low profit molecule. And maybe when we get the new facility, we can do something with it. But right now, it's not a priority.

Is the anticoagulant filed as a paragraph 304?

If four has been sued by the BMS yet. We filed it as a paragraph three for now. Can you tell me if the pharmaceutical TERFs are having any impact on M&A offer or negotiations? Honestly, they are not because all of our APIs that we received, whether it was before the Trump administration or during the Trump administration, they have been exempt from TERFs. We have not had any impact in there, so nobody sees that when they look at our books. Is ELITE approaching the largest tier of more than 19 approved anders, which will mean higher FTA fees? Yes, and we do have a couple of discontinued applications, duplicate applications that we will do something with when the time comes to stay under for another year or two.

Yeah.

Does Elite market generic opioids such as OxyCop, OxyAPAP in New York, or have you made the business decision to avoid marketing these products in New York because of the excess tax? We market today in all states, but that may change not only for New York, for several states because of the treatment and the fees.

Yeah.

All right, I see that the European patent for Apexaban expired on May 19th, 2026. I wonder if Elite could file with the EMA, the European Medical Agency, to sell a generic version of Aliquist in Europe. If not, could they partner with another drug manufacturer such as Teva to perfect the application? We have not disclosed or discussed the product mentioned with anybody in Europe. But this general question really applies to all Philippe products. There will be a time, it's not now because we're extremely busy with a lot of other things, improving the company, increasing the size of the company, where we could consider marketing our products in Europe. But as of today, it's not on the agenda. M&A questions. With the Jefferies M&A and strategic mandate concluding this June, can management provide a definitive update on the status of project M&A? Another question is management has previously noted possible strategic alternatives including a sale, merger, or uplisting to NASDAQ. Could you please share an update on the process and what key milestones investments should investors watch for? What looks most likely at this point? Merger, acquisition, uplisting and so on. Several questions are all about the same thing. The options, as I stated earlier, I answered this question pretty much. to leave things as they are and stay on the EOTC, which is really not something we're going to do. To sell the company, merge, acquire, or be acquired with another company. And that is what we've hired a bank to help us do. Or to go to Nasdaq. All of them are in play. The first one, it's in play, but we're not going to do it. Second one, We have hired one of the best in the world to try and find the right shooter for us. And the third is something we can do also with the help of an agency, but we pretty much can do by ourselves at Golden Finansdeck. At all times, I would like to emphasize all of this merger acquisition and Golden Finansdeck does not distract from the business. We continue to operate the company with our long-term values in mind. That includes growing our product line and growing our pipeline. This concludes our meeting today. Thank you, ladies and gentlemen, and thank you, Matthew. Looking forward to speaking to you in August.

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