Q4 2026 Elite Pharmaceuticals Inc Earnings Call

June 30, 2026

Speaker #4: Thank you for holding. We look forward to talking with you soon. Please hold the line, and we'll be right back with you.

Operator: Thank you for holding. We look forward to talking with you soon. Please hold the line, we'll be right back with you.

Speaker #5: Good morning, ladies and gentlemen, and thank you for your patience. Your conference will begin shortly. Once again, thank you for your patience; your conference will begin shortly.

Operator: Good morning, ladies and gentlemen, thank you for your patience. Your conference will begin shortly. Once again, thank you for your patience. Your conference will begin shortly.

Speaker #3: Thank you for holding. We appreciate your time and patience. Please stay on the line, and we’ll be back in just a moment.

Operator: Thanks for holding. We appreciate your time and patience. Please stay on the line, and we'll be back in just a moment.

Speaker #4: Thank you for holding. We sincerely appreciate your patience. Please stay on the line, and we'll be back in a moment.

Operator: Thank you for holding. We sincerely appreciate your patience. Please stay on the line, and we'll be back in a moment.

Speaker #3: Thank you for holding. We look forward to talking with you soon. Please hold the line, and we'll be right back with you.

Operator: Thank you for holding. We look forward to talking with you soon. Please hold the line, and we'll be right back with you.

Speaker #4: Thank you for holding. We look forward to talking with you soon. Please hold the line, and we'll be right back with you.

Operator: Thank you for holding. We look forward to talking with you soon. Please hold the line, and we'll be right back with you.

Speaker #5: Good morning, ladies and gentlemen, and welcome to the Elite Pharmaceuticals year-end fiscal year 2026 conference call. At this time, all lines are placed on listen-only mode.

Operator: 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.

Speaker #5: 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.

Speaker #5: 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.

Speaker #5: ELITE disclaims any obligation to update or revise its forward-looking statements except as required by law. More complete information regarding forward-looking statements, risks, and uncertainties can be found in the reports ELITE files with the SEC, which are available on ELITE's website at elitepharma.com/investorrelations section.

Operator: More complete information regarding forward-looking statements, risks, and uncertainties can be found in the reports Elite files with the SEC, which are available on Elite's website at elitepharma.com under the investor relations section. Elite encourages you to review these documents carefully. With that covered, it is now my pleasure to turn the floor over to your host, Mr. Nasrat Hakim, President and Chief Executive Officer of Elite Pharmaceuticals. Sir, the floor is yours.

Speaker #5: 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.

Speaker #5: Sir, the floor is yours.

Speaker #6: Thank you, Matthew. Good morning, ladies and gentlemen, and thank you for joining us today. My name is Nasrat Hakim. I am ELITE's Chairman and CEO.

Nasrat Hakim: Thank you, Matthew. 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 Dianne. Mr. Ward, you have the floor.

Speaker #6: 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.

Speaker #6: Mr. Ward, you have the floor.

Speaker #7: Thank you, Nazrat. And good morning, everybody. Yesterday, we filed our 10-K. That's our annual report for the fiscal year ended March 31, 2026. We're on a March fiscal year.

Carter Ward: Thank you, Nasrat. Good morning, everybody. Yesterday, we filed our 10-K. That's our annual report for the fiscal year ended March 31, 2026. We're on a 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, we're going to provide some context and some color to the financial statements, also answer the finance questions I received overnight and questions we got over the weekend even. 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, 149. 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, very impressive growth this year.

Speaker #7: The 10-K, if you haven't seen it yet, is available on our website, elitepharma.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.

Speaker #7: 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.

Speaker #7: $149 million. And that's compared to $84 million for the March 2025 fiscal year, last year. That is a $65 million increase—a 77% increase. Another year, another revenue record.

Speaker #7: 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.

Carter Ward: 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. 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. We went from $57 million. Second year, we were $84 million. That was last year. 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. Not only did we increase the actual dollars, but the percentage increase was also higher than it was last year. That's pretty tough to do.

Speaker #7: And let's look at how we've done since we launched the ELITE label. In the first year, 2024, revenues were $57 million, which was a 66% increase over the year prior to launching.

Speaker #7: So we went from $57 million the second year; we were at $84 million—that was last year. And this year, $149 million, with a 77% increase.

Speaker #7: 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.

Speaker #7: 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.

Carter Ward: When the numbers get as big as they are now, when you're dealing in percentages, it's hard to increase the percentage. P&L is clear, solid, sustained growth. The 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 we've always done. Most importantly, continue pipeline development. We need to develop new products and launch new products. Further to this, the Elite label started three years ago with generic Adderall, isotretinoin, bendamustine, a few other products.

Speaker #7: So, this 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.

Speaker #7: We need to develop, produce, develop new products, and launch new products. So, further to this, the ELITE label started three years ago with generic Adderall, isradipine, phendimetrazine, and a few other products.

Speaker #7: And in the last two years, just to illustrate the pipeline development—in the last two years, we've launched generic Vyvanse, generic Tylenol with codeine, generic Norco, generic Percocet, generic Otrexup, and generic Revia. We also brought in-house the old products naltrexone and phentermine.

Carter Ward: In the last two years, just to illustrate pipeline development, last two years, we've launched generic Vyvanse, generic Tylenol with codeine, generic Norco, generic Percocet, generic TREXIMET, generic ReVia, and we also brought in-house the old products, naltrexone and phentermine. We brought those back in-house, and now we're selling them exclusively on the Elite label. 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. To sustain the growth, this requires continued product development. It never ends. The cycle never ends. People that follow Elite, we know they'll notice that since 31 March 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 bioequivalence study.

Speaker #7: 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.

Speaker #7: It's pipeline development, product launches—that's where the growth comes from. But to sustain the growth, this requires continued product development. The cycle never ends.

Speaker #7: So, people who have followed Elite know that, since March 31 of this year, three months ago, we've launched methadone, we've filed an ANDA for a generic coagulant, we reported positive results for a pivotal bioequivalence study, and there was a lawsuit relating to oxycodone which was dismissed, so that's gone now.

Carter Ward: There was a lawsuit relating to oxycodone which was dismissed. 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. Increase is 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. The profits since we've launched the Elite label have more than quadrupled. Went from $11 to $49 million. Some of this is due to product mix yielding better margins, but most is due to product line growth and expansion.

Speaker #7: 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 and maintain growth.

Speaker #7: 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. The increase is more than $29 million, a 151% increase in operating income, profits.

Speaker #7: 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 quadrupled.

Speaker #7: 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.

Speaker #7: 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—it's called the usual question now.

Carter Ward: 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, I call it the usual question now. I've received it many times in the last few quarters. 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, all I can say is the infrastructure's 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. Do the math. Percentage math gets tougher as the numbers get bigger. 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.

Speaker #7: 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.

Speaker #7: 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, and all the components are in place for growth.

Speaker #7: 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.

Speaker #7: Let's just see what happens. But all the fundamentals are in place for growth. So, to sum up the P&L before moving on, it was quite a year.

Carter Ward: 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 one to our financials. It's a large note, and there's a section, "Disaggregation of Revenues," that shows our direct versus indirect revenues. 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-flopped. Last year, direct was 59%, and this year is 41% indirect, or last year was 41% indirect. Direct sales, they generally have lower volumes. They have higher margins.

Speaker #7: Record year—great job by the sales teams and the production teams. These were truly stellar MVP numbers that they put up this year. I’ve got some questions on direct versus indirect sales and the effect on margins.

Speaker #7: 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.

Speaker #7: It's a large note, and there's a section: Disaggregation of Revenues. That shows our direct versus indirect revenues, so you'll see if you look at that table.

Speaker #7: This year, our direct sales were 44% of revenues, and our indirect were 56. Last year, they flip-flopped. Last year, direct was 59, and this year is 41% indirect, or last year was 41% indirect.

Speaker #7: Direct sales generally have lower volumes and higher margins. Indirect sales are the opposite; they have higher volumes and lower margins. But the thing to keep in mind is that the distribution channel—whether it's direct versus indirect—is just one of several factors affecting the margins.

Carter Ward: Indirect is the opposite. They have higher volumes and lower margins. The thing to keep in mind, remember that distribution channel, whether it's direct versus indirect, is just one 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 in the market, that generally has more of an effect on margins than do the distribution channels. When you put everything together, the volume, the margin, the direct versus indirect channels, you look at the result. What was that result? The result was record revenues, record gross profits, and higher gross margin percentage as well.

Speaker #7: The distribution channel is really more of a driver of volumes, as compared to the others, which I'll call margin drivers. Product mix and real-time market conditions are generally more relevant to margins than our distribution channels.

Speaker #7: In the market, you have demand, supply, competition, and quota availability. You have all of those dynamics going on in the market, and that generally has more of an effect on margins.

Speaker #7: Then do the distribution channels. But when you put everything together—the volume, the margin, the direct versus indirect channels—you look at the result.

Speaker #7: 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.

Carter Ward: Triple Crown right there. We hit all of the numbers this year as compared to last year. Next, we'll look at the cash flow statement. Operating cash flow this year was +$23.7 million. We can compare that to $7.5 million last year. Our cash flow increased by more than $16 million this year. It's 219% increase. Pretty simple. There's one word that can explain this, that word is profits. Profits drive your cash flow. You go down the cash flow statement. Don't talk about this too much, but there's cash flows from financing activities. You look there, it says bond and loan principal paid was $4.6 million this year. Last year, we paid back bonds and loans, $845,000. We always talk about how we're committed to reducing long-term debt, this is pretty obvious there.

Speaker #7: 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.

Speaker #7: So we can compare that to $7.5 million last year. So our cash flow increased by more than $16 million this year, which is a 219% increase.

Speaker #7: 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.

Speaker #7: Don't talk about this too much, but there's cash flows from financing activities, and if you look there, it says bond and loan principal paid.

Speaker #7: It 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 that's pretty obvious here.

Speaker #7: 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 an $18.5 million increase in cash, or 163%.

Carter Ward: 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, 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. 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.

Speaker #7: Working capital, my favorite one this year, was $95 million. Last year, it was $46 million. Almost a $49 million increase, or 106%. Long-term debt was down.

Speaker #7: We were at $4.7 million this year versus $5.8 million last year, so debt went down by $1.2 million. That's a 20% reduction. To sum up the balance sheet:

Speaker #7: 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.

Speaker #7: 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?

Carter Ward: 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 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. 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. We used up $10.6 million in NOLs this year. Whenever you have profits, you owe taxes, and you 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.

Speaker #7: NOLs, just so you know, are the tax losses from past years—years and years ago. And they carry forward. We can use them to apply against current income taxes, which we do.

Speaker #7: There is a line item on the balance sheet called deferred tax asset, which gives the deductions. And as of March 31st, those were valued at $7.8 million.

Speaker #7: 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.

Speaker #7: We never have profits. You owe taxes, and you used 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.

Speaker #7: We're going to use up our NOL—everything that's available to us. We always record the expense; the 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.

Carter Ward: 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, 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 dilutive effect of the warrants and the options were excluded because they are considered anti-dilutive.

Speaker #7: 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, it really has to do with the income attributable to shareholders.

Speaker #7: Last year was actually a loss. We had $19 million in derivative expense, which put us into a loss. Therefore, the dilutive effect of the warrants and the options was excluded because they are considered anti-dilutive.

Speaker #7: So, that's just an accounting thing. This year, we had derivative income, and we had a net profit. So, these dilutive instruments—warrants and options—were not considered anti-dilutive, so they were put in.

Carter Ward: This year, we had derivative income, and we had a net profit. 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. 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. If you want more details, just look at note one 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.

Speaker #7: 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.

Speaker #7: And if we record if the stock price goes down—so, it went up in 2025, we had expense. It went down in 2026, we had a revenue.

Speaker #7: Kind of counterintuitive, but that's how it goes. So you want more details—just look at Note 1 on the financial statements. That will answer your questions, hopefully, on earnings per share calculations.

Speaker #7: I've got the usual questions on derivative income and 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.

Carter Ward: 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 nine years. They're 10-year warrants. They've been out for nine years already. 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. They're going to either be exercised or they're going to expire next year. They are done next year one way or the other.

Speaker #7: And a concern about dilution and an impact on the cash flows of these warrants. First, the warrants have been outstanding for nine years.

Speaker #7: They're 10-year warrants. They've been out for nine years already. 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.

Speaker #7: Potential dilution from these warrants was recognized nine years ago, and it has not changed. Secondly, the warrants are 10-year warrants and are already nine years in.

Speaker #7: 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.

Speaker #7: There's a cash exercise option, which we're discussing with Mr. Hakeem, who's the holder of the warrants. That would obviously have a positive cash effect.

Carter Ward: 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. 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 an excellent question.

Speaker #7: For the company, because it would 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.

Speaker #7: 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.

Speaker #7: 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.

Speaker #7: Another question: Are we considered an accelerated or non-accelerated filer? And are we still a smaller reporting company? That is the question. That's an excellent question.

Speaker #7: 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.

Carter Ward: It's highly technical, and it's one that I asked quite a while ago of our SEC council because I had the same question. 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, 31 March 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 30 September 2026, three months from now. Any changes resulting from that assessment will take effect during the year-ended March 2028. No changes for this year. Let's see what happens on 30 September. On the basis of that, it will affect the next year.

Speaker #7: 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.

Speaker #7: The next assessment, the next test we have to go through—and that will relate to our market float on September 30, 2026—is three months from now.

Speaker #7: And any changes resulting from that assessment will take effect during the year ending March 2028. So, no changes for this year. Let's see what happens on September 30th.

Speaker #7: And based on that, it will affect the next year. And obviously, when we know that, when everything is finalized, it will be disclosed. And then, one more final question we got pretty late last night.

Carter Ward: Obviously, when we know that, when everything is finalized, it will be disclosed. One more final question we got pretty late last night. Can I speak to the critical audit matter related to the chargeback reserve? In our opinion, our auditors mention the chargeback reserve as a critical audit matter. Chargebacks are related to indirect sales. The audit opinion, you should take a look at it. 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.

Speaker #7: Can I speak to the critical audit matter related to the chargeback reserve? In our opinion, our auditors mentioned the chargeback reserve as a critical audit matter.

Speaker #7: So, chargebacks are related to indirect sales. The audit opinion should take a look at it. It actually does an excellent job explaining what a chargeback is.

Speaker #7: 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.

Speaker #7: Since chargebacks occur after we ship and after we deliver to the wholesaler, gap 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.

Carter Ward: 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 31 March but that relate to the shipments that we delivered on or before 31 March. One thing with accounting, most of accounting, there are estimates involved. With regards to chargebacks, the amounts can be large. The auditors, because of that, the materiality, they consider a critical matter, and they spend a lot of time, I mean a lot of time, thoroughly vetting all aspects of the underlying, the source documents, the assumptions, the data. Very thorough on that, just because of the materiality. It's pretty standard audit procedures and performed on something that's very common to all generic companies like ours.

Speaker #7: 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 it a critical matter.

Speaker #7: And they spend a lot of time—and I mean a lot of time—thoroughly vetting all aspects of the underlying source documents, the assumptions, the data. Very, very thorough on that.

Speaker #7: 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.

Carter Ward: 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. Can't say enough good things. The pipeline is strong, and continued growth potential is out there. 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. That option is definitely on the table as well and being considered among all the other options. That concludes my presentation.

Speaker #7: Another year, another record: record revenues, record profits. Revenues are up 77%. Profits are up 151%. Operating cash flows more than tripled from last year. The balance sheet continues to strengthen.

Speaker #7: 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.

Speaker #7: So the writing on the wall is clear. The company is stronger than ever. We're an attractive investment. Nazareth will talk a lot about that, I'm sure, from an M&A standpoint.

Speaker #7: 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.

Speaker #7: So, that option is definitely on the table as well and is being considered among all the other options. That concludes my presentation. Our next scheduled report is the 10-Q.

Carter Ward: Our next scheduled report is the 10-Q. It's for the Q1 of our fiscal 2027 fiscal year. Today, 30 June, is the end of that quarter. Our next 10-Q is a short turnaround. It's due in August. I look forward to speaking with everyone then. Now I'd like to introduce our Chairman and CEO, Mr. Nasrat Hakim.

Speaker #7: It's for the first quarter of our fiscal 2027 year, and today, June 30th, is the end of that quarter. Our next 10-Q has a short turnaround.

Speaker #7: 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. Nazareth Hakeem.

Speaker #1: All right. Thank you, Carter. For this outstanding numbers. You should have downplayed it a little. You know, every time we have good news, the stock price goes down.

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. Let's hope this is an exception. It's been amazing.

Speaker #1: So, let's hope this is an exception. It's been amazing.

Speaker #2: I did downplay it a little.

Carter Ward: I did downplay it a little.

Speaker #1: I'm going to just recite three of your numbers and go on, because it's really impressive. And this cycle we've been on has been outstanding.

Nasrat Hakim: Yeah. I'm going to just recite three of your numbers and then 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. Wow, 77% increase over last year. Any other company on Nasdaq and anywhere else hits these numbers, and the stock will explode. If you look at the last 5 years, we've increased revenues on 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 and for 5 years now or more, actually. More like seven. Operating income for this fiscal year, $49 million. Again, 150%, 151% increase over the previous year. Looking back at 5 years, that's an increase of about 80% each year.

Speaker #1: The revenues for this fiscal year are $149 million. Wow, a 77% increase over last year. Any other company on NASDAQ or anywhere else hits these numbers, and the stock will explode.

Speaker #1: And if you look at the last five years, we've increased revenues on average by 40% per year. This is not the only year we're doing it.

Speaker #1: This is not an exception to the rule. This has been established time and time again—every quarter, four quarters a year, and for five years now or more, actually.

Speaker #1: More like seven. Operating income for this fiscal year: $49 million. Again, that's a $150–151 million increase over the previous year. Looking back at five years, that's an increase of about 80% each year.

Speaker #1: 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.

Nasrat Hakim: 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 3 years ago, Elite didn't have enough money, needed help with working capital to launch our products. Dave is one of our board members, and myself had to loan the company, or 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 5 years, we have transitioned into a solid mid-size generic company with all the facets of pharmaceutical company, including our own sales and marketing. We did that with internal growth, not with acquisitions.

Speaker #1: About three years ago, ELITE didn't have enough money and needed help with working capital to launch our products. Dave, one of our board members, and myself had to loan the company—we were happy to loan the company—$3 million to get it through launching new products.

Speaker #1: 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 a pharmaceutical company, including our own sales and marketing.

Speaker #1: 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.

Nasrat Hakim: 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 $1 billion. Then, 2, 3, 4 years later, you cannot pay it, and you end up bankrupt. 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 arise and it is advantageous to Elite. Many opportunities have arise, but we did not want to take on the headache because it was not really worth it.

Speaker #1: 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. Then two, three, four years later, you cannot pay it, and you end up bankrupt and the stock goes to zero.

Speaker #1: 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.

Speaker #1: And many opportunities have arisen, 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.

Nasrat Hakim: It's something that we will consider further in the future. When 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 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. 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.

Speaker #1: But when something like that comes up, we will look at it. Why? Because we are an established pharmaceutical company with strong fundamentals and very low debt.

Speaker #1: 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 have expanded our manufacturing and packaging capacity, and I'll talk about that a little more in a minute.

Speaker #1: 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.

Speaker #1: Our product mix is the key to our success. Our sales and operations team have effectively defended and/or grown the market shares of our key products.

Nasrat Hakim: 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. Even though we enjoy a healthy share of a lot of the big products that we have for a tiny company like us. Lisdex, the generic Vyvanse 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.

Speaker #1: While maintaining good margins. Again, anytime there's competition, some companies start to dump the prices so they can get more share, and they don't care about bringing the whole market down.

Speaker #1: 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, LIFTEX—the generic Survance—was launched about a year ago.

Speaker #1: And now we have roughly a 10% market share. ELITE was able to effectively penetrate the market and defend our market share with minimal disruption to the overall market.

Speaker #1: And that is really key. That's how a lot of prices go down—when people don't do that. The LIFTEX overall market grew about 20% during each of the last two years.

Nasrat Hakim: The Lisdex 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%. The brand to 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. 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.

Speaker #1: Now it's mostly generic. Last year, 35% of the volume was with the brand. This year, it's about 15%. So the brand to generic conversion is almost fully matured now.

Speaker #1: A little note for everybody. IQVIA does not really reflect ELITE's 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.

Speaker #1: 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.

Speaker #1: This is an old molecular entity. It's been around for a decade, and it's still growing. We're still a part of that growth and going with it.

Speaker #1: Amphetamine is another one 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.

Nasrat Hakim: amphetamine ER is another one 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 one of them. Okay. We launched it recently. We've had it for years, but TAGI and Precision Dose were selling it. Now that we're selling it, we are about 12% market share according to IQVIA, and it's growing. isradipine and trimipramine are small markets. Each one of these products have only one competitor. isradipine, our competitor is Teva. trimipramine, it's Breckenridge. Even though they are small products, the margins are healthy because there's only one competitor. We have a strong market share in that.

Speaker #1: The second part of what is contributing to our revenues are our legacy products. Naltrexone is one of them. We launched it recently—we've had it for years, but TAGI and Precision Dosing were selling it.

Speaker #1: Now that we're selling it, we have about a 12% market share, according to IQVIA, and it's growing. Isradipine and trimipramine are small markets. Each one of these products has only one competitor.

Speaker #1: So, for Isradipine, our competitor is Teva. For Trimipramine, it's Brookridge. Even though they are small products, the margins are healthy because there's only one competitor.

Speaker #1: And we have a strong market share in that. Phendimetrazine has been with us for years, and there's only one primary competitor. We hold about 30% of the market share with good margins.

Nasrat Hakim: Phentermine has been with us for years, and there is only one primary competitor. We hold about 30% of the market share with good margins. Phentermine is another one of our old products that have been with us for a very long time. We have recently launched codeine with acetaminophen, APAP with codeine, oxycodone/APAP, hydrocodone/acetaminophen, methadone, and methotrexate. Next month, we will be launching ropinirole 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 lisdexamfetamine or amphetamine IR/ER. Our partner, Dexcel, is doing well in selling amphetamine IR, speaking of which, in Israel. They are talking to us about potentially having other products there, transferring other products from Elite over there.

Speaker #1: And Phentermine is another one of our old products that has been with us for a very, very long time. We've recently launched codeine with acetaminophen.

Speaker #1: APAP with Codeine, Oxy APAP, Hydro APAP, Methadone, and Methotrexate. Next month, we will be launching Ropinirole. The market cap for this is about $12 million.

Speaker #1: And we always target 5% to 10% of the market. And we usually exceed that on products that are really good, such as LIFTEX or Amphetamine IR. Our partners that sell are doing well in selling Amphetamine IR, speaking of which, in Israel.

Speaker #1: 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 the FDA.

Nasrat Hakim: 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 oxycodone ER. Okay? Oxycodone ER, the generic is oxycodone. 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 millions, if not tens of millions, and they still are in the same boat as us. They cannot launch yet. So the team did an excellent job at handling the litigation for oxycodone. There is an ongoing lab issue to address.

Speaker #1: We have an ANDA for OxyContin. OxyContin—the generic is OxyContin. And from a patent perspective, we are in good shape. We did actually a brilliant job on that.

Speaker #1: 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.

Speaker #1: In August of next year. Other companies like Accord have spent millions, if not tens of millions, and they still are in the same boat as us.

Speaker #1: They can't launch yet. So the team did an excellent job handling the litigation for OxyContin. There's an address. When you create the end for Oxy, there are three different versions of it.

Nasrat Hakim: When you create the ANDA for oxycodone ER, there are three different versions to it. There is the BE study. You got to pass and be equivalent to the brand. Perfect. The FDA asked for insufflation study, where you go into humans and have them snort your product and snort oxycodone. Perfect. 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 is in the fridge. Coca-Cola. You got to do this, and this process took 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. Okay?

Speaker #1: There is the BE study. You have to pass and be equivalent to the brand. Perfect. Then the FDA asked for an insufflation study, where you go into humans and have them snort your product and snort OxyContin.

Speaker #1: 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.

Speaker #1: Heptane, because the cigarette lighter has it. Orange juice, because it's in the fridge. Coca-Cola. And you've got to do this and this process together for about a year.

Speaker #1: And smokeability, to see if somebody could fire it up through a pipe or something. One of the tests the FDA asked us questions about recently, and we need to resolve that issue.

Speaker #1: 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.

Nasrat Hakim: 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 I will talk about it more later, including oxycodone. There are certain things we cannot do. You got to 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 anti-convulsion medication. We will issue a press release when the ANDA is filed with FDA.

Speaker #1: 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.

Speaker #1: 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’ve got to go with whatever the FTA sets and whatever the courts set whenever you have patents pending and you have litigation.

Speaker #1: We also recently announced the passing of a BE study for a seizure medication, or anticonvulsant medication. We will issue a press release when the ANDA is filed with the FDA.

Speaker #1: We do have several other products in the development stage, and we will make announcements on each once we reach a material event—most likely when a BE is completed.

Nasrat Hakim: We do have several other products in development stage, and we will make announcement on each once we reach a material event, most likely if the BE is completed. R&D continues to be a priority. 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 Northvale, New Jersey, which has a 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.

Speaker #1: R&D continues to be a priority. In addition to our in-house development, we also continue to evaluate product opportunities from the outside. We will update everyone on the pipeline when material events occur.

Speaker #1: Another important accomplishment in the last couple of years is really the improvement in our facility. With the expansion of our campus, we have a new facility located at 144 Ludlow Avenue in Northfield.

Speaker #1: 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.

Speaker #1: And this is very important for a company that manufactures a lot of controlled substances. It drastically improved our packaging capabilities to cover all of our product needs and allow for potential growth for the next five-plus years.

Nasrat Hakim: It improved drastically our packaging capabilities to cover all of our product needs and allow for potential growth for the next 5 years plus. It also allowed for additional manufacturing suites. By freeing up the space where the packaging line was, now we have 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. 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.

Speaker #1: Easy. It also allowed for additional manufacturing suites. By freeing up the space where the packaging line was, we created three suites in that space alone.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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.

Nasrat Hakim: We can double that easily, triple that by going to 2 shifts, and if you work on the weekends, it's even more. This is without adding another packaging line. 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 stability of our stock. We all know the positives and the tremendous negatives that goes with being on the OTC.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: I'll cover M&A before we 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.

Speaker #1: 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 go with being on the OTC.

Speaker #1: 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.

Nasrat Hakim: 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 thought we 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. The location, facility, whatever, but they want to buy our products. We said no. Okay. We have another pharmaceutical company that offered us to buy their pharmaceutical company.

Speaker #1: We have had companies look at us and find us too large for their balance sheet. The same company that thought we're too large for their balance sheet expressed interest in a collaboration—of us becoming the R&D and manufacturing part for them and coming up with some kind of collaboration to that effect—and we said no.

Speaker #1: Another company that looked at ELITE wanted to buy our products—the location, facility, whatever. But they want to buy our products. We said no.

Speaker #1: 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.

Nasrat Hakim: 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're not going to rush into this. We're not going to discuss and debate any substandard pricing. 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. Okay? We will accommodate them, and we will see what happens.

Speaker #1: 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.

Speaker #1: 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 stockholders.

Speaker #1: Till then, we'll keep the show open and let people come and look—look at our financials and study it, and decide if they want to buy us for the appropriate price.

Speaker #1: 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.

Nasrat Hakim: Okay? If a positive outcome results from that, we will update you on it. If not, we will continue looking. Now, in the meantime, Carter Ward's been working on this, my directive team, for over two years. We prepared to go to Nasdaq because that's our third option. OTC is not an option anymore. We've outgrown 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, we can go to Nasdaq as we are, or with one of the options that I mentioned.

Speaker #1: If not, we will continue looking. Now, in the meantime—and Carter has been working on this, my directive team for over two years—we're prepared to go to NASDAQ because that's our third option.

Speaker #1: OTC is not an option anymore. We've outgrown 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.

Speaker #1: Going to NASDAQ, and we can go to NASDAQ, as we are always one of the options that I mentioned. We could merge with another company, and the two companies go to NASDAQ.

Nasrat Hakim: 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, okay, 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.

Speaker #1: Or we could collaborate with another company, and the two companies together could go to NASDAQ. Or we could buy somebody and then go to NASDAQ.

Speaker #1: 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.

Speaker #1: That includes growing our product line and growing our pipeline. These two do not get compromised, regardless of what else we're distracted by or working on.

Speaker #1: As you can see from our financials—this year, this quarter, last quarter, the quarter before, and the quarter before that—dating back to five years.

Speaker #1: 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.

Nasrat Hakim: We will continue to assess opportunities in M&A, but in parallel, we are taking necessary steps for us to uplist 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 cost 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-size 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. All right. Let's go to Q&A and look at the questions you submitted.

Speaker #1: Just to summarize, ELITE is executing its strategy of developing and filing new ANDAs and growing sales, while supporting working capital growth, pipeline development costs, and maintaining a strong cash position.

Speaker #1: 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.

Speaker #1: ELITE is positioned as an attractive, mid-sized 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.

Speaker #1: 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 categories and they address the same things.

Nasrat Hakim: There were a lot of questions, many of them were redundant, 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 anticonvulsant medication, asking about M&A, and some general questions. 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. Okay. First, we just got positive bioequivalence 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 if so, what kind of approval timeline should we expect?

Speaker #1: Asking about the Purdue case, asking about the anticoagulant, asking about the seizure anticonvulsant medication, asking about M&A, and some general questions. But all of them were pretty much the same mindset for the stockholders.

Speaker #1: So, if I don't read your question specifically, it's because someone 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.

Speaker #1: So first, we just got positive value equivalency results for an anticonvulsant. I recall the FDA has been trying to fast track certain generic ANDAs.

Speaker #1: 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 or three other people.

Nasrat Hakim: 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. A lot of questions about the same thing, I'll also read some more questions later on, 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. Yes, we did announce a 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 new asset. Okay.

Speaker #1: When do we plan to file the ANDA for this product? What is the drug? How many companies are there, etc.? So a lot of questions about the same thing, and I'll also read some more questions later on.

Speaker #1: But these are about ten 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.

Speaker #1: And yes, we did announce a 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.

Speaker #1: This is for competitive reasons. This is to protect our stockholders and to protect our company and your asset. In general, it takes a few months to put the NDA together.

Nasrat Hakim: In general, it takes about few months to put the ANDA together. 6 months is for stability. FDA takes about 10 months to review it, 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. There could be patent issues. 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 single shift on 2 lines. Okay. That takes care of our needs.

Speaker #1: Six months is for stability. The FDA takes about 10 months to review it. Then the FDA may choose to pause and ask you a question, and wait for you to answer before they start the 10 months again.

Speaker #1: And there could be that in issues. So there is a lot of uncertainty on when we will go to the market. I cannot tell you that, because I do not know myself.

Speaker #1: 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?

Speaker #1: Or are we still able to meet the current pipeline on a single shift? We do actually run only a single shift on two lines, and that takes care of our needs.

Speaker #1: So as I said before, there's a huge opportunity for growth. If we double or triple our manufacturing capacity, packaging can handle it. And if they go beyond tripling it, then we'll add one more packaging line.

Nasrat Hakim: As I said before, huge opportunity for growth. If we double, triple our manufacturing capacity, the packaging can handle it. If they go beyond the tripling it, 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 6 years of room, 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 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.

Speaker #1: You recently mentioned that a potential partnership could require additional manufacturing space. Are we actively looking at more space now? If so, does this mean we are accelerating faster than the roughly six years of room guidance from a couple of years ago?

Speaker #1: That is correct. Not only are we looking, we've identified a 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, and how much it's going to cost us to retrofit it.

Speaker #1: 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 a beautiful facility that we may be interested in.

Nasrat Hakim: 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 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, Accord may not get the 6 months, even though they won all the cases. Who gets the 6-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.

Speaker #1: Congratulations on the stipulation agreement and settlement with Purdue Pharma. I see this as a smart, necessary move, especially the way you let a court take the lead and only fought the remaining pieces to protect our capital outlays.

Speaker #1: My understanding is that while we don't get exclusivity or first-to-file rights, those go to a court. The settlement means that ELITE is not treated as a new filer.

Speaker #1: One ANDA filer may not get the six-month exclusivity 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.

Speaker #1: That's first to file. Who wins the court battles is not relevant to the FDA. Whoever files with the FDA is the first. All right. So, ELITE is not treated as a new filer.

Nasrat Hakim: Elite is not treated as a new filer. This should allow us to sell during Accord'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 Actavis, we sold some Purdue product just to delay us from filing. Even though there were no generics, they gave us $120 million just to delay us. Okay? 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 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.

Speaker #1: This should allow us to sell during a court's exclusivity period while others can't. Is that accurate? I'm not sure if that's really accurate. There are times when you settle with a company like Purdue, you can sell your product.

Speaker #1: At Activus, we sold some Purdue product just to delay us from filing. Even though there were no generics, they gave us $120 million just to delay us.

Speaker #1: 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.

Speaker #1: 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 a tentative approval?

Speaker #1: 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.

Nasrat Hakim: 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. 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-to-file positioning and truncated 30-month stay for the anticoagulant ANDA regarding our critical 1 June 2026 ANDA submission for the generic anticoagulant.

Speaker #1: We're working with the FDA. We're hoping we will do things to their satisfaction, and everything will come together so we will be able to launch our product.

Speaker #1: 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?

Speaker #1: 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.

Speaker #1: Whether it'll be in person or virtual remains to be seen. Our first-to-file positioning and truncated 30-month stay for the anticoagulant enter regarding our critical June 1, 2026 ANDA submission for the generic anticoagulant.

Speaker #1: Buzz 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 30-month stay?

Nasrat Hakim: 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 acknowledgment of receipt for the 1 June anticoagulant submission based on the standard go-do-for action date? What is management's internal timeline for tracking toward the tentative approval? Okay. 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. It's not first-to-file. There is no such information from other companies that could help us truncate the 36-month stay.

Speaker #1: Has the FDA issued a formal acknowledgement of receipt for the June 1st anti-coagulant submission, based on the standard GADUFA action date? What is management's internal timeline for tracking toward the tentative approval?

Speaker #1: Okay. And there were about ten other questions, but all of them are about the same thing. The anti-coagulant product that was recently filed is not a first to file.

Speaker #1: There are quite a few companies in the market that filed before us. It's an excellent opportunity. It's a superior opportunity. It's not a first-to-file.

Speaker #1: There is no such information from other companies that could help us truncate the 36-month stay. We know certain things to do that have nothing to do with other companies.

Nasrat Hakim: We know certain things to do that 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 infringing, that's how you file. Okay? The anticoagulant 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. Okay? But when we get approval first, we will definitely let you know. Please provide the current status of the anticoagulant ANDA and the main reason for the delay. Okay. 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? Okay.

Speaker #1: There are 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 the FDA.

Speaker #1: The FDA acknowledged the receipt. It usually takes them about 10 months of review, and they never take just 10 months. They always pause and ask you questions and extend it.

Speaker #1: But when we get approval, we will definitely let you know. Please provide the current status of the anti-coagulant ANDA and the main reason for the delay.

Speaker #1: That's true. I did say I delayed it before.

Speaker #2: You mentioned you were assessing options for the ender. What factors are being considered, and when do you expect to reach a decision?

Speaker #1: 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.

Nasrat Hakim: Well, I reached a decision and went ahead and filed. That doesn't mean we're not doing the work in order to truncate the date from 2032. The reason I delayed it is because every ANDA comes in with patents, and the patents are not on one thing. Some patents will be on the API particle size of composition, others will be on the dissolution or on the impurities. Some have to do with the formulation. 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 patents, either by circumventing them, okay, or by challenging them.

Speaker #1: And the reason I delayed it is because every ender comes in with patents and the patents are not on one thing. Some patents will be on the API particle size of composition.

Speaker #1: Others will be on the disso or on the impurities. Some have to do with the 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 patents either by circumventing them or by challenging them.

Speaker #1: So we were in the process of trying to circumvent a couple of the patents 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 patents if possible.

Nasrat Hakim: We were in the process of trying to circumvent a couple of the patents to reduce the timeline. It took too long, so I decided to go ahead and proceed with the filing. But we are continuing to work on overcoming the patents if possible. Is it likely that Elite announces another positive BE trial result before the end of the year? Yes, it is. 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? NDAs cost a lot of money. Our finances, even though they're stable, they are not NDA stable. We already have Cequa stocks that's already still active. I don't know for how long. But it's still active. We're not investing any money on it.

Speaker #2: Is it likely that ELITE announces another positive BE trial result before the end of the year?

Speaker #1: Yes, it is. And when it happens, we will issue a press release.

Speaker #2: Does Elite have any plans to pursue NDAs, whether or not they abuse the terms?

Speaker #1: Now that the financials are more stable—NDAs cost a lot of money. And our finances, even though they're stable, they're not NDA-stable. We already have Sequest Ox that's still active.

Speaker #1: I don't know for how long, but it's still active. And we're not investing any money in it. I'd much rather invest our money in ANDAs, or if there is an NDA, that would mean a partner finances it and we do the work.

Nasrat Hakim: I much rather invest our money in ANDAs, or if there is an NDA, that would be a partner that finance it, and we will do the work. 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. All right. On cost optimization and price compression defense, lisdexamfetamine, given the Elite current command, currently command a 17% market share in the generic Vyvanse space. It's 10%, really. 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 profile? Furthermore, has the company secured APQ, aggregate production quotas, from the DEA to ensure volume stability? Elite has 10% of the market share for Lisdex, not 17%.

Speaker #1: 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.

Speaker #2: Right.

Speaker #1: On cost optimization and price compression defense, list techs and vitamin. Given that ELITE's current command is 17% market share in the generic Vyvanse space—it's really 10%.

Speaker #1: And that pricing compression for this molecule can historically reach 90%. What specific operational or supply chain cost optimization measures is management deploying to protect our current margin profile?

Speaker #1: And furthermore, has the company secured APQ—aggregate production quotas—from the DEA to ensure volume stability?

Speaker #2: ELITE has 10% of the market share for list techs, not 17%.

Speaker #1: 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.

Nasrat Hakim: Market prices did fall from where they started at, which is normal. You start very high and then they tighten up. The increase in volume compensated for that. The conversion from brand to generic compensated for that. 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?" We said, "No. Go ahead and go with them." 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." This is not a slogan.

Speaker #1: 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.

Speaker #1: 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?

Speaker #1: 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.

Speaker #1: 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 one of them.

Nasrat Hakim: We defend it by doing the right things, and this is one of them. The DEA has provided sufficient quota for us to maintain 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. 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. The prices, the profit margins are low.

Speaker #1: And the DEA has provided sufficient quota for us to maintain our share—our market share.

Speaker #2: A question on Ritalin. We don't even make the product, so I will not read that. In very round numbers, what were unit sales of our Adderall and Vyvanse this quarter and previous too?

Speaker #2: Not dollars, just units.

Speaker #1: 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.

Speaker #2: Can you share methadone soft launch results to date, including volumes or other helpful proxy? And how do they compare with your expectations?

Speaker #1: 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.

Nasrat Hakim: We're not going to focus a lot on it at this time. We are definitely going to have the soft launch and go to maturity in time. There are bigger fish to fry. Lisdex, 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, we do all the analytical work, we file it with FDA and get them approved for every one of our products.

Speaker #1: We are definitely going to have the soft launch and get to maturity in time. But there are bigger fish to fry. List techs, amphetamine IR, amphetamine—even a huge product like naltrexone now is more viable than that.

Speaker #1: It is a good product. It'll pay the electric bills, and it'll help out with a lot of things. But it doesn't deserve a lot more attention than that.

Speaker #2: Are there other API suppliers for ELITE?

Speaker #1: 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 file to the FDA and get them approved for every one of our products.

Speaker #1: And as I said, a minimum of, because for some products we do even more.

Nasrat Hakim: 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 one recently. For now, Dexcel is the primary international opportunity. Dexcel has interest in adding more Elite products to their portfolio in Israel. Is Elite pursuing purchasing doxycycline from Praxgen for another near-term product launch, or is this no longer a worthwhile market? We're not considering purchasing 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, maybe when we get the new facility, we can do something with it. Right now, it's not a priority.

Speaker #2: Aside from the potential expansion of the Dexcel partnership, does Elite have any additional plans for international expansion?

Speaker #1: New international opportunities do come in from time to time, and are evaluated—we just did one recently. But for now, Dexcel is the primary international opportunity.

Speaker #1: And Dexcel has interest in adding more Elite products to their portfolio in Israel.

Speaker #2: Is ELITE pursuing purchasing doxycycline from Prexogen Fungin for another near-term product launch, or is this no longer a worthwhile market?

Speaker #1: We're not considering purchasing it, and it's not a not worthwhile market. It's just too much of a headache to be able to do it right now.

Speaker #1: 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.

Nasrat Hakim: Is the anticoagulant ANDA filed as a Paragraph III or IV? If IV, has BMS been sued by the BMS yet? We filed it as a Paragraph III for now. Okay. Can you tell me if the pharmaceutical tariffs 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, they have been exempt from tariffs. 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 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 under for another year or two. Yeah.

Speaker #2: Is the anticoagulant filed as a paragraph three or four? If it's four, has ELITE been sued by the BMS yet?

Speaker #1: We filed it as a paragraph three for now.

Speaker #2: Can you tell me if the pharmaceutical terms are having any impact on M&A offers or negotiations?

Speaker #1: Honestly, they're not, because all of our ANDAs that we receive, whether it was before the Trump administration or during the Trump administration, they have been exempt from terms.

Speaker #1: We have not had any impact in there, so nobody sees that when they look at our books.

Speaker #2: Is Elite approaching the largest tier of more than 19 approved ANDAs, which will mean higher FDA fees?

Speaker #1: 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.

Speaker #2: Does Elite market generic opioids such as Oxy-APAP in New York, or have you made the business decision to avoid marketing these products in New York because of the excess tax?

Nasrat Hakim: Does Elite market generic opioids such as oxycodone, oxy APAP 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 apixaban expired on 19 May 2026. I wonder if Elite could file with the EMA, the European Medicines Agency, to sell a generic version of Eliquis 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 Elite products.

Speaker #1: We market today in all states, but that may change—not only for New York, but for several states—because of the treatment and the fees.

Speaker #2: All right. I see that the European patent for Apixaban expired on May 19, 2026. I wonder if ELITE could file with the EMA, the European Medicines Agency, to sell a generic version of Eliquis in Europe?

Speaker #2: If not, could they partner with another drug manufacturer, such as Teva, to perfect the application?

Speaker #1: We have not disclosed or discussed the product mentioned with anybody in Europe. But this general question really applies to all ELITE products. There will be a time.

Speaker #1: 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.

Nasrat Hakim: There will be a time, it is not now because we are 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 is 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 milestone investments should investors watch for?" "What looks most likely at this point? Merger, acquisition, uplisting and so on?" Okay, several questions are all about the same thing. The options, as I stated earlier, I answered this question pretty much.

Speaker #1: But as of today, it's not on the agenda.

Speaker #2: M&A questions. Would the Jefferies M&A and strategic mandate be 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.

Speaker #2: Could you please share an update on the process and the key milestones? What key milestone investments should investors watch for? What looks most likely at this point?

Speaker #2: Merger, acquisition, uplisting, and so on.

Speaker #1: Okay. Several questions are all about the same thing. The options, as I stated earlier—I answered this question pretty much—are to leave things as they are and stay on the OTC, which is really not something we're going to do.

Nasrat Hakim: To leave things as they are and stay on the OTC, which is really not something we are going to do. To sell the company, merge, acquire, or be acquired with another company. That is what we have hired a bank to help us do. Or to go to Nasdaq. Okay? All of them are in play. Okay? The first one, it is in play. As we all agree, we are not going to do it. Second one, we have hired one of the best in the world to try and find the right suitor for us. The third is something we can do also with the help of an agency, but we pretty much can do by ourselves of going to Nasdaq. Okay. At all times, I would like to emphasize all of this merger, acquisition, and going to Nasdaq does not distract from the business.

Speaker #1: To sell the company, merge, acquire, or be acquired by another company. That is what we've hired a bank to help us do. Or to go to NASDAQ.

Speaker #1: All of them are in play. The first one, it's in play that we're not going to do it. The second one, we have hired one of the best in the world to try and find the right suitor for us.

Speaker #1: And the third is something we can also do with the help of an agency, but we pretty much can do it ourselves—to go to NASDAQ.

Speaker #1: At all times, I would like to emphasize that all of this merger, acquisition, and going to NASDAQ 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.

Nasrat Hakim: We continue to operate the company with our long-term values in mind. That includes growing our product line and growing our pipeline. Okay? This concludes our meeting today. Thank you, ladies and gentlemen. Thank you, Matthew. Looking forward to speaking to you in August.

Speaker #2: This concludes our meeting today. Thank you, ladies and gentlemen, and thank you, Matthew. We look forward to speaking with you in August.

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

Q4 2026 Elite Pharmaceuticals Inc Earnings Call

Request TrialDemo

Elite Pharmaceuticals

Earnings