Elite Pharmaceuticals, Inc. (ELTP) Earnings Call Transcript & Summary
June 30, 2026
Earnings Call Speaker Segments
Operator
operatorGood morning, ladies and gentlemen, and welcome to the Elite Pharmaceuticals Year-End Fiscal Year 2026 Conference Call. [Operator Instructions]. 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 and can be found in the reports Elite files with the SEC, which are available on Elite's website at elitepharma.com under the Investor Relations section. Elite encourages you to review these documents carefully. With that covered, it is now my pleasure to turn the floor over to your host, Mr. Nasrat Hakim, President and Chief Executive Officer of Elite Pharmaceuticals. Sir, the floor is yours.
Nasrat Hakim
executiveThank you, Matthew. And good morning, ladies and gentlemen, and thank you for joining us today. My name is Nasrat Hakim. I am Elite's Chairman and CEO. This is our earnings call. 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 Diane. Mr. Ward, you have the floor. .
Carter Ward
executiveThank you, Nasrat, and good morning, everybody. Yesterday, we filed our 10-K. That's our annual report for the fiscal year ended March 31, 2026, were in the March fiscal year. 10-K, if you haven't seen it yet, it's available at our website, elitepharma.com under the Investor Relations section. Today, as usual, I'm 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 time to ask them. Let me start with the P&L first. Total revenues for the year were $149 million, $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. Elite Label was launched in fiscal 2024. So 2026 is our third year. And let's look at how we've done since we've launched the Elite label. In the first year, '24 -- 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&Ls solid, sustained growth strategy? How do we do it? It's typical generics. The strategy is straightforward, deliver quality product on time and 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 is always done. And most importantly, continued pipeline development. We need to develop, produce, develop new products and launch new products. So further to this, Elite Label started 3 years ago with generic Adderall, isradipine, tendimetrosine and a few other products. And in the last 2 years, just to illustrate pipeline development. Last 2 years, we've launched generic Vyvance, generic Tylenol coating, generic Norco, generic Percocet, generic Otrexup, generic Revia. And we also brought in-house the old products, naltrexone and Fentamine. 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 in never end. Cycle never ends. So people have followed. We know they'll notice that since March 31 of this year, 3 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 the 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 profit since we've launched the Elite Label have more than quadruples went from $11 million to $49 million. Some of this is due to product mix yielding better margins, but most is due to product line growth and expansion. We're selling more of the products we started with. We're adding more products, and we're selling more of those as well. Been getting this question all the 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 record revenues and profits every year. Well what 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. I can't really promise on percentages. Let's just see what happens. But while the fundamentals are in place for growth. So to sum up the P&L before moving on, it was quite a year, record year, great job by the sales teams, the production teams. These are 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, we'll answer some of these questions going forward. It's in Note 1 to our financials is a large note and there's a section disaggregation of revenues. And that shows our direct versus indirect revenues. So you see -- you look at that table this year, our direct sales were 44% of revenues and our indirect were 56%. Last year, they flip flop. Last year, direct was 59% and this year is $1 million indirect or last year it was 41% indirect. Direct sales, they generally have lower volumes. They have higher margins, indirect with the opposite, they have higher volumes and lower margins, but the thing to keep in mind, remember that distribution channel, whether it's direct versus indirect, is just 1 of several factors affecting the margins. 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 our distribution channels. In the market, you have demand, supply competition quota availability. You have all of those dynamics going on 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 results. 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 and 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's 219% increase. Pretty simple, there's 1 word that can explain this and that where it is profits. -- profits drive your cash flow. If 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'll 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 debt. 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 1 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 loss as well as NOLs? Just so 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 31, 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. So we expect that we're going to have to start making payments of federal taxes this year. We're going to use up our NOLs, 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 1 in our earnings per share section 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 reported derivative expects -- and if we record -- if the stock price goes down, so it went up in 2025, we had expects. It went down in 2026, we had any revenue kind of counterintuitive, but that's how it goes. So you want more details. Just look at Note 1 non financial statements, that will enter and answer your questions, hopefully, on earnings per share calculations. We've got the usual questions on derivative income expense. I already covered that stock price up as 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. First, the warrants they have been outstanding for 9 years. They're 10-year warrants. They've been out for 9 years already. and every cap chart that I have prepared since then over the last 9 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 9 years ago, and it has not changed. Secondly, the warrants, their 10-year warrants already 9 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 are done next year, 1 way or the other. There's a cash exercise option, which we're discussing with Mr. Kim, who is the holder of the warrants. And that would obviously be positive cash effect for the company because we'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 9 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 have been calculating over the 9 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 9 years. Another question. Are we considered an accelerated or not 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 1 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 31, 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 30, 2026, 3 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 30 and on basis of that, it will affect the next year. And obviously, when we know that, when everything is finalized, it will be disclosed. And then 1 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 you take a look at it, actually does an excellent job explaining what a chargeback is. It's the difference between the price to wholesale 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 delivered 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 31, but that relate to the shipments that we delivered on or before March 31. 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 adding 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 audit procedures and performed on something that's very, very common to all generic companies like ours. So to sum up these financials. Yes, 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. I 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. 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 10-Q is for the first quarter of our fiscal 2027 -- fiscal year and today, June 30 is the end of that quarter. And that -- our next 10-Q 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.
Nasrat Hakim
executiveThank you, Carter for these outstanding numbers. You should have downplayed it a little. Every time we have good news, the stock price goes down. So let's hope this is an exception. It's been amazing. I'm going to just slide 3 fewer numbers and go on because it's really impressive. And this cycle we've been on has been outstanding. -- the revenues for this fiscal year is $149 million, well, 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 5 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 rule. This has been established time and time again every quarter, 4 quarters a year for 5 years now or more actually, more like 7. Operating income for this fiscal year, $49 million, again, $150 million, $151 million increase over previous year. Looking back at 5 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 1 is most intriguing. The working capital is at $94.7 million for this year. About 3 years ago, Elite didn't have enough money needed help with working capital to launch our products. And Dave is 1 of our Board of members and myself have to loan the company -- we're happy to own 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 that owns as the first quarter. Over this time, over the past 5 years, we have transitioned into a solid, a midsized 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, 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 on buses that take over the company and they go out and buy a whole bunch of products, and they license this and that and borrow $1 billion and then 2, 3, 4 years later, you cannot pay it and in that 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 once something like that come 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 5 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 and profitability, all while maintaining a strong balance sheet as 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 operations team have effectively defended and/or grew the market shares of our key products, while maintaining good margins. Again, anyone competition, some companies but 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. LifeTec and the generic survives 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 LifeTec's overall market grew about 20% during each of the last 2 years. Now it's mostly generic last year. 35% of the volume was with the brand. This year, it's about 15. So the generic -- a brand to general 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. About what I'm reporting to you now that we are at 10% of the market, our sales. And similiar, the generic aero is another pillar for Elite before we lead. IQVIA shows Elite's current market share about 14%. And -- and tatami 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 are still a part of that growth and going with it -- is another 1 of our pillars. IQVIA reports that we have about 12% market share -- 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, Naltrexone is 1 of them, okay? We launched it recently. We've had it for years, but the Tegean precision dosing we're selling it now that we're selling it. We are at 12% market share according to IQVIA, and it's growing. Isradipine and trimepramine are small markets, each 1 of these products have only 1 competitor. So it's rather been our competitor is Teva -- so remember I mean, it's a broken. Even though they are small products, the margins are healthy because there's only 1 competitor. And we have a strong market share in that. Trimepramine has been with us for years. And there is only 1 primary competitor. We hold about 30% of the market share with good margins. And Fentemine is another 1 of our old products that have been with us for a very, very long time. We have recently launched Codeine with acetaminophen, coding Oxy-APAP, a Hydro-APAP, methadone and methotrexate. Next month, we will be launching rubenro 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 Lytx or enfitamine IR and ER. Our partner, is doing well in selling patina 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 2 ANDAs that are pending with FDA. We have an ANDA for OxyContin AR okay? -- oxycodone generic is Oxycontin. And from a patent perspective, we are in a good shape. We did actually a brilliant job on that. The team did an excellent job. We went into litigation, what we're due for under $100,000 of spending will reach a favorable conclusion where we can launch pending FDA issues in August of next year. Other companies like Accord, have spent millions of tens of millions. And they still are sample at us, they can launch yet. So the team did an excellent job at handling the litigation for OxyContin. There's an ongoing lab issue status. When you create the ANDA for Oxy ER, there are 3 different versions to it. That is the BE study you got a pass and be equivalent to brand, perfect, then the FDA asked for insuflation you go into humans and have them small cure products and north OxyContin perfect. Then we ask you to do lab anti-abuse studies. -- where you have to dissolve your product and there's in any household common item there is octane because the cigarette litter has it. Orange juice because it's in the fridge. Coca-Cola -- and you got to do this in this process to get about a year and smoke ability to see if somebody could fire it up to a pipe or something. One of the tests, the FDA asked his question about recently, and we need to resolve that issue before we move forward, okay? 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 patterns. 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 I'll talk about it more later, including Oxy. But there are certain things we cannot do. You got to go with whatever the FDA sets and whatever the court set whenever you have patent pending and you have litigation. We also recently announced the passing of a BE study for seizure medication or anticonvulsion medication. We will issue a press release when the NDA is filed with FDA. We do have several other products in development stage, and we will make announcement on each once we reach a material event, most likely a 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 Sea, 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 5 years plus, easy. It also allowed for additional manufacturing suites by freeing up the space where the packaging line was, now we created 3 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 and 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 3/4 billion unit total on 1 shift. We can double that easily triple that by going to 2 shifts. And if you work on the weekends, it's even more. And this is without adding another active 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 wrap up. 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 similar of our stock. We all know the positives and the tremendous negative that goes with being on 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 company that taught us to watch 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 collaboration to that effect, and we said no. And other companies that looked at Elite wanted to buy our products, the location facility, whatever, but they won't buy our products, we said no, okay? 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 we were asking for was too much, so we said no. However, we have not been presented with what I would consider or with the Board of Directors and the seniors staff team will consider it 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 until we get the appropriate offer for us to take it to the stockholder. Still 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, okay? We will accommodate them. And we will see what happens, okay. If a positive outcome results from that. We will update you on it. If not, we will continue looking. Now in the meantime, has been working on this, my directive team for over 2 years, we prepare to go to NASDAQ because that's our first option. OTC is not an option anymore, we've overgrown that merger acquisitions, combined 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 all as 1 of the options that I mentioned, we could merge with another company and the 2 companies got to NASDAQ or we collaborate with another company and the 2 companies together could go to NASDAQ or we can buy somebody and then go to NASDAQ or we just go to NASDAQ as Elite our solid financials, okay, and solid fundamentals. The most important thing for ever to understand is that at all times, -- we continue to operate the company with our long-term value of mine. That includes growing our product line and growing our pipeline. These 2 do not get compromised regardless of what else were the structures are working on. As you can see from our financials this year, this quarter, last quarter, the quarter before and the quarter for dating back to 5 years. As I've 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 ANDAs 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 midsized generic 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. Right, let's go to Q&A and look at the questions submitted.
Nasrat Hakim
executiveThere were a lot of questions and many of them are redundant, but all of them were grouped into certain groups and they address the same thing asking about the Purdue case, asking about the anticoagulant, asking about the seizure anticonvulsion medication, asking about M&A and some general questions, but all of them were pretty much the same mindset for the stockholders. So if I don't read your question specifically, it's because somebody else thought about the same thing, and I don't want to waste all your time reading 50 questions that means the same thing. Okay? So first, we have got positive bioequivalency results for an anticonvulsant. I recall the FDA has been trying to fast track certain generic ANDAs, have you heard any updates on that effort? Is it already in place? And so what kind of approval time line should we expect. Also, there's another question from 2 or 3 other people. When do -- 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 and no fast tracking is available for this product. And yes, we did announce the successful BE 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 a new asset, okay. In general, it takes about a few months to put the ANDA together 6 months for stability. FDA takes about 10 months to review it. And then the FDA may choose to pause and then ask you a question with for you to answer before they kick in the 10 months again. And there could be certain issues. So there is 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 a single shift on 2 lines, okay? -- and that takes care of our needs. So as I said before, a 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 1 more package in line. You recently mentioned that potential partnership could require additional manufacturing space are we actively looking at more space now? So does this mean we are accelerating faster than roughly 6 years of loan guidance from a couple of years ago. That is correct. Not only we're looking, we've identified facility. We're not going to pull the plug until 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 they 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. Congratulations on the stipulation agreement and settlement with Purdue Pharma. I see this is a smart necessary move. -- especially the way you let Accor take the lead and only for the remaining thesis for -- 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 is not -- Elite is not treated as a new filer. One, a court may not get the 6 months even though they want all the cases, who gets the 6-month exclusivity is the person who filed first or the group that filed first, that's first of. Who wins the core battle is not relevant to the FDA, whoever 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? I 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 actives, we sold some product just delays from filing even though there were no generics, they gave us $120 million just to the layers 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. That's because of the uncertainty. When will we get a 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 the 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 we 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 months day for the anticoagulant -- and regarding our critical June 1, 2026 ANDA submission for the generic anticoagulant but management believes 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 3-month stake? Has the FDA issued a formal acknowledgment of receipt for the June 1 anticoagulant submission based on the standard PDUFA action date, what is management's internal time line 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 a first to file. There are quite a few companies in the market that filed before us. It's an excellent opportunity. It's a superior opportunity is line first to point. There is no such information from other companies that could help us truncate the 6-month date. We know certain things to do but has nothing to do with other companies. There's Paragraph III or Paragraph IV filings. And based on what our technology is infringing or not inflation, that's how you find, okay? -- the anticoagulant product has been filed with the FDA. The FDA acknowledged the receipt. It usually takes them about 10 months of review and they never take them on. They always pause and ask you questions and extend it, okay? But when we get approval, we will definitely know. Please provide the current status of the antigen and the main reason for the delay. That's true. I did say I rated before. You mentioned you were assessing options for the ANDA. What factors are being considered? And when do you expect to reach a decision, okay? Well, I reached a decision on went ahead and file, but toast we're not doing the work in order to translate the date from 2032. And the reason I delayed it is because every something with patents. And the patents are not on 1 thing. Some patents will be on the API particle size of composition. Others will be on the distro or the impurities. Some have to do with the formulation. So you look at them and you line them up and see which 1 is the longest and which 1 is in the middle and try to go after some of the patents either by circumventing them, okay, or by challenging them. So we're in the process of trying to circumvent a couple of patents to reduce the time line. And it took too long side ahead and proceed with the filing, but we are continuing to work on overcoming the patents as possible. Is it likely that Elite announces another positive BE trial resolved before the end of the year? Yes, it is. And when it happens, we will issue a press release. Does Elite have any plans to pursue NDAs whether abuse deterrent or not, now that the financials are more stable. ANDAs cost a lot of money and our finances, even though they are stable, they are ANDA stable, we already have spot 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'm not sure that invest our money in ANDAs or if there is an ANDA that could be a partner that finance it, and we will do the work. So no, we're not considering any ANDAs at this time, that doesn't mean 1 that has the right circumstances came to us, we would not consider it. All right. On cost optimization and price compression defense, histamine, given the Elite current and current recommend a 17% market share in the generic Biovance 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 profile. And furthermore, has the company secured APQ aggregate production quotas from the DA to ensure volume stable. Elite has 10% of the market share for Lista7. Market prices did fall from what they started at, which is normally 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, 1 of the distributors. Somebody else offered them a lower price. They came to us and said, "Did you meet it." And we said, no, go ahead and go with them. and they decided not to even though it was higher by a lot -- lower by a lot, they said, you guys are a reliable supplier, we're staying with you. So this is not a slogan. We defend it by doing the right things, and this is 1 of them. And the DEA has provided sufficient code for us to invent our shares, our market share. A question on Redland. We don't even make the products on in very round numbers, what were unit sales of our Adderall and Vyvanse this quarter and previous to 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. But we are definitely going to have the soft launch and good to maturity in time -- but there are bigger fish to fry. I mean you are even a huge product like an Altroxone now is more viable than that. It is a good product, and it will pay the electric bill 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 produce limited product availability and increase sales of Vyvance and at role. The answer is, yes, we source a minimum of two API suppliers, and we do all the analytical work and we filed with FDA and get them approved for every 1 of our products. And as I said, a minimum of because some products we do even more. Relationships other than potential expansion of the Dexcel 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 1 recently. But for now, Dexcel is the primary international opportunity. And Dexcel has interest in adding more Elite products to their portfolio in Israel. Is Elite pursuing the purchasing Doxycyline from Praxigenfanen? -- for another near-term product launch? Or is this no longer a worthwhile market? We're not considering purchasing it. And it's not worthwhile market. 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 is not a priority. Is the anti-counterfeit has led been sued by the BMS yet. We find it as a paragraph 3 for now okay? Can you tell me the pharmaceutical turfs are having any impact on M&A offer or negotiations. Honestly, they are not, because all of our APIs that we receive whether it was before the Trump administration or during the Trump administration. There have been exempt from first. We have not had any impact in there, so not disease that when they look at our books. Is Elite approaching the largest tier of more than 19 approved ANDAs, which will mean higher FDA 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 ANDA for another year or 2. Yes. Does Elite market generic opioids such as Oxy-App in New York? Or do you have -- 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. All right. I see that the European patent for ebaxiban expired on May 19, 2026. I wonder if Elite could be filed with the EMA, the European Medical Agency to sell a generic version of ELIQUIS in Europe. If not, -- could they partner with another drug manufacturers such as Teva to perfect the application? We have not disclosed or discussed the product mention with anybody in Europe. But this general question really applies to all Elite 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 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 as 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 the key milestones investments should -- what key milestone investments should investors watch for? What looks most likely at this point, merger, acquisition, uplifting 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 OTC, 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, okay? All of them are in play, okay? The first 1 -- it's in place that we agreed we are not going to do it. Second one, we have hired 1 of the best in the world to try and find the right tutor 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 of into NASDAQ. At all times, I would like to emphasize all of this merger acquisition and going to NASDAQ, does not effect from the business. We continue to operate the company with our long-term values of mind that includes growing our product line and growing our pipeline, okay? This concludes our meeting today. Thank you, ladies and gentlemen, and thank you, Matthew. Looking forward to speaking to you in August. .
Operator
operatorThank 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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