Elite Pharmaceuticals Q4 2026 Earnings Call Transcript

Quartr
Provided by Quartr
June 30, 2026

Key Takeaways

  • Positive Sentiment: Elite reported record fiscal 2026 revenue of $149 million, up 77% year over year, and operating income rose 151% to $49 million. Management said growth was driven by continued product launches, better product mix, and stronger execution across sales and manufacturing.
  • Positive Sentiment: Cash flow and the balance sheet improved meaningfully, with operating cash flow rising to $23.7 million from $7.5 million last year. Cash, working capital, and debt all moved in the right direction, and long-term debt fell to $4.7 million.
  • Positive Sentiment: Management highlighted a deepening pipeline, including a launched methadone product, a filed generic anticoagulant ANDA, and a positive bioequivalence study for another product. They also said additional BE results and ANDA filings are expected over time, supporting future growth.
  • Neutral Sentiment: The company emphasized that its growth is being built through internal development rather than acquisitions, while still leaving M&A and a potential Nasdaq uplist as options. Leadership said they are actively evaluating strategic alternatives but will only pursue deals that create value for shareholders.
  • Positive Sentiment: Elite said its recent facility expansion in Northvale, New Jersey significantly increases packaging, warehouse, and DEA vault capacity. Management believes the added space positions the company for several years of future manufacturing and packaging growth.
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Earnings Conference Call
Elite Pharmaceuticals Q4 2026
00:00 / 00:00

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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.

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. Nusrat Hakim, President and Chief Executive Officer of Elite Pharmaceuticals. Sir, the floor is yours.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

Thank you, Matthew. Good morning, ladies and gentlemen. Thank you for joining us today. My name is Nusrat Hakim. I am Elite's Chairman and CEO. This is our earnings call. Our CFO, Carter Ward, will give us the financial update. After which, I'll come back with a brief update and answer some of the questions you've submitted to Diane. Mr. Ward, you have the floor.

Carter Ward
Carter Ward
CFO at Elite Pharmaceuticals

Thank you, Nusrat. Good morning, everybody. Yesterday, we filed our 10-K. That's our annual report for the fiscal year ended March 31st, 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 and 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, and that's compared to $84 million for the March 2025 fiscal year, last year. That is a $65 million increase, 77% increase. Another year, another revenue record. Very impressive growth this year.

Carter Ward
Carter Ward
CFO at Elite Pharmaceuticals

The Elite label, we are in our third year of the Elite label. The Elite label was launched in fiscal 2024. 2026 is our third year. Let's look how we have done since we have 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 is pretty tough to do.

Carter Ward
Carter Ward
CFO at Elite Pharmaceuticals

When the numbers get as big as they are now, when you are dealing in percentages, it is hard to increase the percentage. P&L is clear, solid, sustained growth. The strategy, how do we do it? It is 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 have done. Run efficiently, which we have always done, and 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, Is tretinoin, bendamustine, a few other products.

Carter Ward
Carter Ward
CFO at Elite Pharmaceuticals

In the last two years, just to illustrate pipeline development, last two years, we have 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 are selling them exclusively on the Elite label. It is 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 is pipeline development, product launches. That is where the growth comes from. To sustain the growth, this requires continued product development. It never ends. Cycle never ends. People that follow Elite, we know they will notice that since March 31st of this year, three months ago, we have launched methadone. We filed an ANDA for a generic anticoagulant. We reported positive results for a pivotal bioequivalence study.

Carter Ward
Carter Ward
CFO at Elite Pharmaceuticals

There was a lawsuit relating to oxycodone, which was dismissed. That is gone now. That is not standing in our way. The products we continue to develop, the pipeline development, the efforts never stop, and we are on schedule. That is the critical factor to sustain, maintain growth. Let me move down to P&L. We will 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 have launched the Elite label have more than quadrupled. 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.

Carter Ward
Carter Ward
CFO at Elite Pharmaceuticals

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. 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.

Carter Ward
Carter Ward
CFO at Elite Pharmaceuticals

To sum up the P&L before moving on, it was quite a year. A record year. Great job by the sales teams, the production teams. These were truly stellar MVP numbers that they put up this year. Got some questions on direct versus indirect sales and the effect on margins. There's a new table in our financial statements which hopefully will answer some of these questions going forward. It's in note 1 to our financials. It's a large note, 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 our indirect were 56%. Last year, they flip-flopped. Last year, direct was 59%, this year is 41% indirect. Last year was 41% indirect. Direct sales, they generally have lower volumes. They have higher margins.

Carter Ward
Carter Ward
CFO at Elite Pharmaceuticals

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 1 of several factors affecting the margins. The distribution channel is really more of a driver of volumes, as compared to the other, which I'll call margin drivers. Product mix, 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, higher gross margin % as well.

Carter Ward
Carter Ward
CFO at Elite Pharmaceuticals

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 positive $23.7 million. We can compare that to $7.5 million last year. Our cash flow increased by more than $16 million this year, 219% increase. Pretty simple. There's 1 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, there's cash flows from financing activities. You look there, it says bond loan principal paid was $4.6 million this year. Last year, we paid back bonds loans, $845,000. We always talk about how we're committed to reducing long-term debt, this is pretty obvious there.

Carter Ward
Carter Ward
CFO at Elite Pharmaceuticals

It shows right up on our cash flow statement. We are paying down our debts. Now to the balance sheet. Cash was $29.8 million compared to $11.3 million last year, so it's $18.5 million increase in cash, 163%. Working capital, my favorite one, is this year was $95 million. Last year was $46 million. Almost a $49 million increase, 106%. Long-term debt was down. We were $4.7 million this year versus $5.8 million last year, so debt went down by $1.2 million, a 20% reduction. Sum up the balance sheet, you will not see a better balance sheet anywhere, really. Cash is up, working capital is up, long-term debt is down. This is the textbook definition of a strengthening balance sheet. Every year we get stronger and stronger, this year included. Have a few more questions. Might as well go through those now.

Carter Ward
Carter Ward
CFO at Elite Pharmaceuticals

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.

Carter Ward
Carter Ward
CFO at Elite Pharmaceuticals

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, 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, 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, therefore the dilutive effect of the warrants and the options were excluded because they are considered anti-dilutive. That's just an accounting thing.

Carter Ward
Carter Ward
CFO at Elite Pharmaceuticals

This year we had derivative income, we had a net profit, these dilutive instruments, warrants, and options were not considered anti-dilutive, 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, it went up in 2025, we had expense. It went down in 2026, we had a revenue. Kind of counterintuitive, 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.

Carter Ward
Carter Ward
CFO at Elite Pharmaceuticals

Stock price up is expense, stock price down is income. I did get a first-time question on the outstanding warrants and a concern about dilution and an impact on the cash flows of these warrants. First, the warrants, they have been outstanding for nine years. They're 10-year warrants. They've been out for nine years already, and every cap table 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.

Carter Ward
Carter Ward
CFO at Elite Pharmaceuticals

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's an excellent question.

Carter Ward
Carter Ward
CFO at Elite Pharmaceuticals

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. The direct answer is that we will continue to report as we're doing now. We will continue as a non-accelerated filer and a smaller reporting company through the end of this fiscal year, March 31st, 2027. No changes. No change in how we file our 10-K for this year. The next assessment, the next test we have to go through, that will relate to our market slope on September 30th, 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 September 30th. Basis of that, it will affect the next year.

Carter Ward
Carter Ward
CFO at Elite Pharmaceuticals

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, 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.

Carter Ward
Carter Ward
CFO at Elite Pharmaceuticals

Since chargebacks occur after we ship and after we deliver to the wholesaler, GAAP accounting, generally accepted accounting principles, require that we estimate the amount of chargebacks that we're going to receive after March 31st, but that relate to the shipments that we delivered on or before March 31st. One thing with accounting, most of accounting, there's estimates involved. With regards to chargebacks, the amounts can be large. The auditors, because of that, the materiality, 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, very thorough on that, just because of the materiality. It's pretty standard audit procedures, and performed on something that's very, very common to all generic companies like ours.

Carter Ward
Carter Ward
CFO at Elite Pharmaceuticals

To sum up these financials, yes, you could say the record-breaking streak continues. Another year, another record. Record revenues, record profits. Revenue's up 77%, profits up 151%. Operating cash flow is 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.

Carter Ward
Carter Ward
CFO at Elite Pharmaceuticals

That concludes my presentation. Our next scheduled report is the 10-Q. It's for the first quarter of our fiscal 2027 fiscal year. Today, June 30th, 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.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

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.

Carter Ward
Carter Ward
CFO at Elite Pharmaceuticals

I did downplay it a little.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

I'm going to just recite three of your numbers and then go on because it's really impressive and the 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 five years, we've increased revenues on the average by 40% per year. This is not the only year we're doing it. This is not an exception to the rule. This has been established time and time again every quarter, four quarters a year, and for five years now or more actually. More like seven. Operating income for this fiscal year, $49 million. Again, 150%-151% increase over previous year. Looking back at five years, that's an increase of about 80% each year.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

I will not go through all the numbers Carter went through. You already have them. This one is most intriguing. The working capital is at $94.7 million for this year. About three years ago, Elite didn't have enough money, needed help with working capital to launch our products. Dave is one of our board members, and myself had to loan the company, well, happy to loan the company $3 million to get it through launching new products. Today, Elite doesn't need anybody's money. They almost have $100 million in working capital. They're almost as rich as Carter. Over this time, over the past five years, we have transitioned into a solid mid-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.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

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 two, three, four years later, you cannot pay it, and you end up bankrupt, and the stock goes to zero. We have done everything in a conservative way to protect the stockholders and maximize profitability. We still have the option of licensing and acquiring products from other companies if the opportunity 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.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

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 5 years, we have introduced our sales and distribution force that has done an exceptional job. We've added new products. We expanded our manufacturing and packaging capacity, and I'll talk about that a little more in a minute. We enhanced our revenues and profitability, all while maintaining a strong balance sheet that you just heard from Carter and an efficient workforce. I haven't done the math, but on average, we generate more than $2 million in revenue per employee. Our product mix is the key to our success.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

Our sales and operation team have effectively defended and/or grew the market shares of our key products while maintaining good margins. 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 for 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.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

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%-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.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

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%-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. 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, and we have a strong market share in that.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

phentermine has been with us for years, and there's 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, very long time. We have recently launched codeine with acetaminophen, APAP with codeine, oxycodone acetaminophen, hydrocodone/acetaminophen, methadone and methotrexate. Next month, we will be launching Ropinirole ER. The market cap for this is about $12 million. We always target 5%-10% of the market, and we usually exceed that on products that are really good, such as Lisdex or Amphetamine IR and IR. 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.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

In the pipeline today, which needs to keep on feeding the sales and marketing team, we have two ANDAs that are pending with FDA. We have an ANDA for OxyContin ER. Okay? oxycodone ER's generic is OxyContin. 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 can't launch yet. So the team did an excellent job at handling the litigation for OxyContin. There is an ongoing lab issue to address.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

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 OxyContin. 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's in the fridge. Coca-Cola. You got to do this, and this process took about a year. 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?

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

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'll talk about it more later, including Oxy. 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 anticonvulsion medication. We will issue a press release when the ANDA is filed with FDA.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

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 a 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. This is very important for a company that manufactures a lot of controlled substances.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

It improved drastically our packaging capabilities to cover all of our product needs and allow for potential growth for the next five years plus. Easy. It also allowed for additional manufacturing suites. By freeing up the space where the packaging line was, now we created three suites in that space alone. Our old warehouse was maxed out on space because of all of the packaging components, the cartons and cardboards and empty bottles and caps and so on. Now it looks great. It has tremendously improved because we moved all of that across the street with the packaging operation. With this expansion, we have positioned the company to meet significant future growth, especially for packaging. For packaging, we are making about three-quarters of a billion units total on one shift. We can double that easily, triple that by going to two shifts.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

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, if we're going to bring in more products, 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. Second is to sell the company, merge, acquire, or be acquired by another company.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

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're 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, we said no. Other companies that looked at Elite wanted to buy our products. Location, facility, whatever, they want to buy our products. We said no. Okay. We have another pharmaceutical company that offered us to buy their pharmaceutical company, it would have been a good opportunity, the fact that what they were asking for was too much, we said no.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

We have not been presented with what I would consider or what the board of directors and the senior staff team will 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. Okay? If a positive outcome results from that, we will update you on it. If not, we will continue looking.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

In the meantime, Carter's been working on this, my directive team, for over two years. We prepare to go to Nasdaq because that's our third option. OTC is not an option anymore. We've outgrown that. Merger acquisitions combined with another company is definitely an option. That's really complicated, especially in today's market and with the way our stock is moving up and down. Going to Nasdaq, we can go to Nasdaq as we are, or with one of the options that I mentioned. We could merge with another company and the two companies go to Nasdaq, or we collaborate with another company and the two companies together could go to Nasdaq, or we can buy somebody and then go to Nasdaq, or we just go to Nasdaq as Elite with our solid financials, okay, and solid fundamentals.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

The most important thing for everyone to understand is that at all times, we continue to operate the company with our long-term value in mind. That includes growing our product line and growing our pipeline. These two do not get compromised regardless of what else we're distracted or working on. As you can see from our financials this year, this quarter, last quarter, the quarter before, and the quarter before, dating back to five years. As I stated in the past, we will only pursue opportunities that bring value to our shareholders. We will continue to assess opportunities in M&A, 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.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

Elite maintains a strong reputation as a dependable supplier or a supplier of choice, 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. There were a lot of questions, many of them were redundant, all of them were grouped into certain groups, they address the same thing. Asking about the Purdue case, asking about the anticoagulant, asking about the seizure anticonvulsion medication, asking about M&A, and some general questions. All of them were pretty much the same mindset for the stockholders.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

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?" Also, there's another question from two, three other people. "When do we plan to file the ANDA for this product? What is the drug? How many companies are there?" Et cetera. Okay? A lot of questions about the same thing, and I'll also read some more questions later on, but these are about 10 questions that were summarized into what you just heard.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

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 your asset. Okay? In general, it takes about few months to put the ANDA together. Six months is for stability. FDA takes about 10 months to review it, and then the FDA may choose to pause and then ask you a question, wait for you to answer before they kick in the 10 months again. There could be patent issues. There is a lot of uncertainty on when will we go to the market.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

I cannot tell you that because I do not know myself. I have to go through the process and hope that we do our best to get there as fast and as soon as possible. "Have we started running a second production shift yet, or are we still able to meet the current pipeline on a single shift?" We do actually run only single shift on two lines. Okay? That takes care of our needs. As I said before, huge opportunity for growth. If we double, triple our manufacturing capacity, the packaging can handle it, and if they go beyond the tripling it, then we'll add one more packaging line. "You recently mentioned that potential partnership could require additional manufacturing space. Are we actively looking at more space now?

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

If so, does this mean we are accelerating faster than roughly six 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. Once we finish that, we may pull the plug on it, but we've identified the beautiful facility that we may be interested in. Mm-hmm. "Congratulations on the stipulation agreement and settlement with Purdue Pharma.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

I see this is 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. 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. 1, 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. 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.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

There are times when you settle with a company like Purdue Pharma, you can sell your product. At Actavis, we sold some Purdue Pharma product just to delay us from filing, even though there were no generics. They gave us $120 million just to delay us. 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 tentative approval? I don't know. What's your new strategy? We don't have a new strategy. Our old strategy is doing great. We worked with Purdue Pharma, we got a settlement from them. We're working with the FDA.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

We're hoping we will do things to their satisfaction, everything will come together, 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 June 1st, 2026, ANDA submission for the generic anticoagulant. Does management believe that our strategic timing has successfully secured the first-to-file or shared exclusivity position?

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

What specific litigation pathway or legal framework are we modeling to potentially truncate the standard 30-month stay? Has the FDA issued a formal acknowledgement of receipt for the June 1st anticoagulant submission based on the standard go-do for action date? What is management's internal timeline for tracking toward the tentative approval? 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. We know certain things to do that has nothing to do with other companies.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

There's Paragraph III or Paragraph IV filings. Based on what our technology is infringing or not infringing, that's how you file. Okay. The generic anticoagulant product has been filed with FDA. The FDA acknowledged the receipt. It usually takes them about 10 months of review. They never take 10 months. They always pause and ask you questions and extend it. Okay. When we get approval first, we will definitely let you know. Please provide the current status of the generic 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.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

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. The reason I delayed it is because every ANDA comes in with patents. 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. We were in the process of trying to circumvent a couple of the patents to reduce the timeline, and it took too long.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

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 stock 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. I much rather invest our money in ANDAs, or if there is an NDA, there could be a partner that finances it, and we will do the work.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

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 Elite currently commands 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. 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.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

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. 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. 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.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

We don't even make that product, 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, 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. 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.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

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, it will help out with a lot of things, 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. 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.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

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 Prasco 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. Is the anticoagulant ANDA filed as Paragraph III or IV? If IV, has Elite been sued by 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?

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

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. Nobody feels that when they look at our books. Yeah. Is Elite approaching the largest tier of more than 19 approved ANDAs, which will mean higher FDA fees? Yes, we do have a couple of discontinued applications, duplicate applications that we will do something with when the time comes to stay under for another year or two. Yeah. Does Elite market generic opioids such as oxycodone, OxyAPAP 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
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

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 May 19th, 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. This general question really applies to all Elite products. There will be a time, it's not now because we're extremely busy with a lot of other things, improving the company, increasing size of the company, where we could consider marketing our products in Europe. As of today, it's not on the agenda. M&A questions.

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

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. To leave things as they are and stay on the OTC, which is really not something we're going to do. To sell the company, merge, acquire, or be acquired with another company. That is what we've hired a bank to help us do. To go to Nasdaq. Okay? All of them are in play. Okay?

Nasrat Hakim
Nasrat Hakim
President and CEO at Elite Pharmaceuticals

The first one, it's in play, we already agreed we're not going to do it. Second one, we have hired one of the best in the world to try and find the right 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. 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, and thank you, Matthew. Looking forward to speaking to you in August.

Operator

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

Executives
    • Carter Ward
      Carter Ward
      CFO
    • Nasrat Hakim
      Nasrat Hakim
      President and CEO
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