Elite Pharmaceuticals Q4 2025 Earnings Report

Elite Pharmaceuticals EPS Results

• Actual EPS: $0.01
• Consensus EPS: N/A
• Beat/Miss: N/A
• One Year Ago EPS: N/A

Elite Pharmaceuticals Revenue Results

• Actual Revenue: $32.00 million
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Elite Pharmaceuticals Announcement Details

• Quarter: Q4 2025
• Date: 6/30/2025
• Time: After Market Closes
• Conference Call Date: Tuesday, July 1, 2025
• Conference Call Time: 11:30AM ET

Elite Pharmaceuticals (OTCMKTS:ELTP) (OTCMKTS:ELTP) is a specialty pharmaceutical company focused on the development, manufacturing and commercialization of high‐quality generic and proprietary drug products. The company’s operations encompass formulation development, analytical testing, regulatory support and commercial launch activities. Elite Pharmaceuticals places particular emphasis on niche therapeutic areas where it can leverage its expertise in dosage form design and controlled‐substance handling.

Elite’s product portfolio includes oral solids, semi‐solids, liquids and specialized controlled‐release formulations. Key therapeutic segments served by the company include pain management, respiratory therapy, hormone replacement and central nervous system indications. Through both in‐house development and strategic licensing arrangements, Elite Pharmaceuticals has built a diversified pipeline of abbreviated new drug applications (ANDAs) targeting complex generics and limited competition markets.

Headquartered in Newtown, Pennsylvania, Elite Pharmaceuticals serves customers across the United States through relationships with national wholesalers, specialty pharmacies and healthcare institutions. The company also maintains international partnerships to distribute select products in regions such as Latin America and the Asia‐Pacific, leveraging its regulatory and manufacturing capabilities to meet varying market requirements.

Founded in 2005, Elite Pharmaceuticals is led by a management team with deep experience in pharmaceutical development, regulatory affairs and manufacturing operations. Under the leadership of CEO Thomas M. Droll and a seasoned executive team, the company continues to expand its product offerings and strengthen its presence in targeted therapeutic niches, while adhering to stringent quality and compliance standards.

Elite Pharmaceuticals Q4 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Revenues grew 52% YoY to $84 million and operating income surged 82% to $19.6 million, marking record financial performance.
• Positive Sentiment: The launch of Lisdexamfetamine in Q4 captured ~8–10% share of a $3.5 billion market, driving significant new revenue despite high competition.
• Negative Sentiment: An $18.9 million noncash fair value adjustment on derivatives led to a GAAP pretax loss and zero EPS for FY2025, though it does not affect cash flow.
• Positive Sentiment: Working capital rose 41% to $45.9 million, debt decreased, and operating cash flow swung from a $3.2 million burn to a $7.5 million surplus, strengthening the balance sheet.
• Neutral Sentiment: Elite is engaging a financial advisor to explore mergers and acquisitions or a Nasdaq uplisting, with a decision expected in the coming months.

Presentation

[Operator]

Good morning, ladies and gentlemen, and welcome to the Elite Pharmaceuticals conference call. At this time, all lines have been placed on a listen only mode. Before management begins speaking, the conference has the following statement. Elite would like to remind the 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.

[Operator]

Actual results may differ materially. Elite disclaims any obligation to update or revise its forward looking statements except as required by law. More complete information regarding forward looking statements, risks, and uncertainties can be found in the reports Elite files with the SEC, which is available on Elite 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, mister Nadrat Hakim, president and chief executive officer of Elite Pharmaceuticals. Sir, the floor is yours.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Thank you, Jenny, and good morning, ladies and gentlemen, and thank you for joining us today. My name is Nusraq Hakim. I am Elite's chairman and CEO. This is our earnings call. Our CFO, Carter Ward, will give us a summary of the company's financials, after which I'll give you an update and answer some of the questions that you submitted to Diane. Mister Ward, you have the floor.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

Thank you, Nasrat, and thanks to everybody for calling in. We had to wait a few extra minutes to have such a big crowd calling in, so really appreciate your interest. Thank you again for calling in. Yesterday, we filed our 10 k.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

That's the annual report. We're on a fiscal year a March fiscal year. So it's for the fiscal year ending 03/31/2025. That's our twenty twenty five fiscal year. The report's available at our website, elitepharma.com, under the investor relations section.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

If you haven't seen it yet, please get a copy and take a look. As always, I'm gonna provide some context and a little color to the financial statements and also answer finance questions that we received overnight as well. I'll answer that throughout my my presentation. Let's start with the p and l. Total revenues for the twenty twenty five fiscal year were $84,000,000.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

You compare that to 56,600,000.0 for the prior year, March 2024 fiscal year, That is a $27,900,000 increase or 52%. There's two main factors that contributed to the increase. First, the elite label has become well established in our niche markets. The twenty twenty four fiscal year is when we launched our elite label. That was the first year.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

We were an unknown net. We did well in 2024 and throughout 2025. We've now solidified our place in the market. We've expanded our market share, and we're no longer unknown. We are a known entity in the market.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

We've and we have distinguished ourselves as a reliable supplier of quality products, and and that equals increased revenues. The second main factor is the launch of our Lisexamfetamine product line during the last quarter of this fiscal year, so January to March. Lissectamphetamine is is the generic for Vyvanse. It's a very large market with high demand. On the flip side, there's also quite a bit of competition in that market, more than 10 suppliers currently in the market.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

And we've done a really good job. We've grabbed a decent share of the market as reflected in the p and l statement. One thing to keep in mind though, the Liddex market remains highly competitive. Our good name in the industry goes far, but it only goes so far. So we're doing very well with this product, but this is generic pharma pharmaceuticals.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

It's an industry which is defined by tough competition. And Luzdex is a typical generic product when it comes to those characteristics. More than 10 suppliers in the market that equals price pressure. There's quota pressure because this is a class two product. All of the factors that are typical to the generic market.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

Kirko is doing he's our chief commercial officer. Kirko is doing a great job, but this is generic. And that's saying without past performance not guarantee future results is a part of the fabric of this industry. That being said, we are doing excellent with Lisdex and Sentiment. Moving down to p and l.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

Our operating income was $19,600,000. That's our that's our income, our profit. Compare that to 10,800,000.0 for the 2024 fiscal year. That's an 8,800,000.0 increase or 82%, almost doubling, profits. Now I got a question that I received pretty much every quarter, and that's regarding there's an item on our p and l below the line.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

It's called change in fair value of derivatives. Now this is related to the valuation of warrants that were issued in 2017. It's a noncash technical entry required by GAP. It has to do with the valuation of the warrant. If the valuation of the warrant goes up, we record an expense and we increase liability.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

On the flip side, if the valuation goes down, we record income and we decrease the liability. How do we value it? We value it using the Black Scholes model, which essentially means that if our stock price increases, the valuation will also increase, and therefore, we book an expense. If the stock price goes down, the opposite happens. We book income.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

During the fiscal twenty twenty five year, this year, our stock price almost tripled. We went from 15¢ to 44¢, and we're very grateful for that. It's a good thing. But when you run that through the black chose model, the result is an increase in valuation of approximately $18,900,000, and that's the expense we show on the p and l. The most important thing to take away here is that we will never pay cash for any expense shown.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

And the flip side is we also will never receive cash if the stock price goes down and we report income. So it's a noncash expense and a noncash income item. There's no cash ever associated with this. This is a technical gap book entry. Please also note that our stock price today is much higher than it was even three months ago.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

On March 31, it was 44¢. So the next ten q, the one for the quarter just ended June 2025, we're gonna show another expense for change in fair value of derivatives as a result of the further increase in the stock price. Another thing to note that with the 18,900,000.0 change in derivative value, it resulted in Elite having a pretax loss of $52,000. Despite showing a pretax loss, we still booked income tax expense of $4,300,000. And I got a question on that.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

How do we have an income tax expense if we show a pretax loss? Well, the answer is that the 18,900,000.0 expense is not deductible for tax purposes. The IRS and the state tax authority, they don't recognize this as an expense when it comes to taxes. So I'll also add that this item is also not considered in any enterprise valuation models either. It's something you have to do for GAAP.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

Got a question on earnings per share. Wanted to know what is our earnings per share. Well, that's listed right on our our p and l statements towards the bottom of the EPS for for this year, 2025, was zero. And last year, it was 2¢. Now the EPS includes all of those below the line items.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

So this year, we have that $18,900,000 change in valuation, which is a negative as far as EPS. That's why the EPS went down to zero. Last year, we had the release of a deferred tax valuation allowance, the asset valuation allowance, and that was approximately 19,000,000 in income. Again, a noncash item, but that increases EPS. That's a positive to EPS.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

So that's keep those things in mind when you're looking at the EPS. Take a look at the below the line items and know that they are. And now for the cash flow statement, our operating cash flow this year was positive 7,500,000.0. That's compared to a cash burn last year of $3,200,000. So that's a $10,700,000 swing to the positive.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

Now 2024, last year, we just launched the elite label, and that that means we have investments in inventory, receivables, so increases in inventory, increases in receivables, and those are drags on cash flow. And those in in last year, those totaled $20,000,000. So that's the reason for the burn in 2024. This year, we've continued to expand this market share. We launched the list deck, and the inventory and receivables continue to rise, which is a good thing because that portends to future revenues, but it is a a drag on cash flow.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

Those increases were 13,200,000.0. That's 6,800,000.0 less than the 20,000,000 in in the prior year, but it's also less than the 10,700,000.0 positive trend in cash flow. Meaning that this doesn't fully explain how we went from 3,000,000 burn to 7,000,000 positive. The factor that bridges these two is the profits. Remember, operating profits were up 8,800,000.0.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

Profits are a major driver of cash flows, and profits are the reasons that we are in business. So we buy we buy inventory, we sell, we increase our receivables, we collect every time. If they call out a rotation, everything is to the positive, and eventually, it's gonna result in cash flow, and it has. So now to the balance sheet. This is a good segue because the balance sheet continues to strengthen.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

And I looked over some of my prior presentations, and I've been saying that for quite quite a while now. So our balance sheet continues to strengthen, which is a great thing. Our working capital as of 03/31/2025 was $45,900,000. Now you can compare that to 27,000,000 as of March 2024. That's a $19,000,000 increase of 41%.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

Go down further into working capital. Remember, working capital is current assets minus current liabilities. Our current assets increased from 40,000,000 in 2024 to 58,000,000 this year. And then but the current liabilities, they it decreased from 13,000,000 in '24 to 12,000,000 this year. So you don't see that too often.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

Current assets increasing by 18,000,000 with current liabilities actually decreasing. You can expand that analysis even further. When you look at the noncurrent liability, you're gonna see a similar trend. Our noncurrent liability, excluding the derivative, the noncash, was 5,800,000 this year compared to 6,700,000.0 in 2024. So that's a decrease of $900,000.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

The takeaway here is that Elite has low debt, and it continues to decrease. Our debt continues to decrease. We have low debt, decreasing debt combined with increasing working capital. Both things you wanna see and both are hallmarks of a strong balance sheet. So this is what I mean when I say our balance sheet continues to shrink.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

That's what I look at. Also received a question on when we are paying the loans, which are owed to Najra and one of our directors, Davis Kasky. If look at our financial statements, there's a subsequent event section. I think it's note 17. And it says that we have paid those loans to Nasrat and to Davis Caskey.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

They've been repaid after March 31. So as of March 31, we still owe the money. It's on our financial statement, but it's no longer owed. And going forward, you'll no longer see those liabilities on our balance sheet. That loan gave us working capital.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

That was about two years ago when we were just starting with the the of launching the elite label. So that loan gave us the working capital that kick started the elite label, and you see how well that's worked out. And that working capital was crucial in this success. So Nasrat and Davis provided that money just when we needed it at the the perfect time, and it worked out extremely well. And that's one of the good things about working here, one of the things I enjoy, working with Nasrat and having such support from him and and our entire board of directors.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

It's really great working with them. I have a few more questions that I received before I wrap it up here. Will Elite be an accelerated filer in fiscal twenty twenty six, the year fiscal year that we're currently in? To be an accelerated filer, the main criteria that we would have to meet is that we haven't already met is we need more than a $100,000,000 in annual revenue to be an accelerated file. So let's see how that plays out.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

Just something that we're we're monitoring. Does the leak plan to change to calendar year reporting? We get that question a lot, and the answer to that is no. We are focusing on other areas that provide greater shareholder value than changing the reporting period. We're not gonna extend the resources and the time and the focus on on that.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

We'll provide we're we're doing that elsewhere. So some of these financials are record rev we had record revenues this year, above the record revenues from last year. This year, we crossed $18,000,000 for the first time. We had record profits, just under $20,000,000 in profits. It's clear that the elite label is establishing itself in the market.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

The Lusdex launch was extremely successful and continues. Our balance sheet is strengthening. Our cash flow is solid. Working capital is increasing. Debt is decreasing.

[Carter Ward, Chief Financial Officer at Elite Pharmaceuticals Inc]

So put that all together, I'd say it was a it was a good year. It was a really good year. Our next quarterly report is due in August, and we'll have more to say that. Now I'd like to introduce our chairman and CEO, mister Nazrat Hakim.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Thank you, Carter, for this wonderful news.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Just to recap couple of things that Carter said and take it up a notch. It is continued on a strong growth trajectory. Our revenues for fiscal year twenty twenty five were $84,000,000 like you heard, 52% growth over the year before. Operating income from 2025 was 19.6, and that's an increase of 82 percent over the year before. Another record year for Elite.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

I've been saying that for five years now. Operating profit grew from 2,100,000.0 in 2021 to 10.8 last year and 19.6 this year. 2.1 in '21 to 19.6 this year. Revenues grew from 25,000,000 in '21 to 57 last year and 84,000,000 this year. Not too long ago, Elite's revenues were 7,500,000.0 for the entire year, not the quarter, for the entire year.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

And the stock was lingering between 3 to 5¢, about 4 on the average. A $100,000 investment in the lease back then would have generated 1 and a half million dollars today. That's nice. $100,000, you would have bought a nice car. 1 and a half million dollars, you'll buy a house and couple of nice cars.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Now just to reiterate what I've said before in previous calls, I'm not saying this. I'm not asking anybody to buy or sell any stock. That decision to invest or not to invest is between you and your financial adviser. I'm not crazy about people that invest in the stock and when it goes down, they come and find it to me, and when it goes up, you know, they think they're brilliant. This is between you and your financial adviser.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Whether you invest the relief or not, it's your decision. Our job is to report the numbers that we've generated by our team's hard work. Anyway, you look at it, it's an outstanding growth, and our stock price reflects it. The recent growth comes from our launch of Lisdexamtetamine and strong results from our existing commercial products, including the Lisdexamtetamine IR NEON. Don't wanna lose sight of that.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Lisdexamtetamine is a new kid on the block, but our foundation has been the legacy products both in IR and ER up till now. Think of Elite as revenues as coming from three sources, the old legacy products, and premium IR, ER, and Litex. Litex was launched in January. It's a central nervous system stimulus used for attention deficit disorder. The brand is Vyvanse, and the IQVIA reported annual sales of over 3,500,000,000.0 based on NXT for this product.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

The market volume for Listex is growing still due to continuing brand to generic conversion, and I'll explain that in a second. Overall, market growth due to increased scripts because anytime a product becomes generic, more doctors write it up and because more insurance companies allow it. Pitchenerics have about 68% of the market year to date in 2025. That's up from 53% in 2024. Both numbers are impressive that the brand is still holding on to that much, and that's because of the quota and other issues.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

But what you can see is that further market penetration by the generics is expected. Usually, when a product becomes generic, it drops by 90% in sales from the brand and becomes all generic, and then it expands more more doctors like chips. In this case, it has not happened because of quota and the fact that the brand received a huge quota last fall. As the market generalizes, the price competition is increasing so that the margins will go down. But the margins continue to be very attractive.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

We have 13 companies that are active competitors in the market right now. Elite currently has about eight to 10% of the market according to IQVIA. When you have 13 companies that are fighting for this huge product and little Elite gets eight to 10, that's a that's an excellent solid start. In addition to the next, our existing products are doing very well, starting with generic Adderall IR. The IQVIA reported annual sales for Adderall IR of $400,000,000 based on NFT, and they reported a weak market share year to date of the IR to be about 20%.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Again, that's an old military entity. This product's been around for a long time, and the market is stable, and we're doing that well in it. This is a strong product for us. Another of the least important product is generic Adderall XR. The IQVIA report annual sales for this is 800,000,000 based on NFT, and we command 16% of the market according to IQVIA, 11% on Elite's label, and five under the Borel pharma label, which is Presto.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Now note that Pressco is not exclusive license for Amphetamine ER ended in March 31, but they are selling out their remaining inventory. It ended in March, but they still have a lot of material that they are still selling to today. Going forward, once they are depleted, Elite will sell this product exclusively under our label. The next step is the legacy product, isradipine, trimethramine, pantomethrazine. They are small market size, but Elite has a strong market share with attractive margins for these small products.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Example for isradipine and somethromine, even though they are small, the margins are not bad, and we command about 50% of the market. This is in those license for generic naltrexone and and centermine tablets and capsules ends in September. At that time, Elite will begin selling these products exclusively under our label. But nevertheless, as of today, that is still a part of our legacy products, the very average and all that's shown that study and precision zone have been selling for a while. Other than these three categories, we also have what we've launched recently and they're still working on.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

We've launched generic methotrexate. It's a small product for a million dollar of NSP according to IQVIA. We have a minor share of the market in that. Generic oxy aPAP, that's the brand for Percocet. The IQVIA report annual sales of 300,000,000 per year for this product.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

And for HydroAPAD, the brand is Norco, IQVIA reports 325,000,000 in sales. Elite is beginning to build market shares in these products. These products are large lots, easily accessible, lots of players, and small profit margins. And that's why we have not been as aggressive with them. K?

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

They're they're gonna take up a lot of lap time, a lot of equipment, and we will get around to them, but we have bigger fish to fry. We have the list of this world and then to put me in IR and ER. Generic protein and acetaminophen, generic protein and a tab, which will launch in October, has a growing market share, which is currently this dollar share of 5%. K? It's a $50,000,000 product according to NFT.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

We are at about 5%, and we will continue to grow that market. In the near future, sometime this year, we have methadone to get through validation on launch, And we have not given it a priority because, again, once list access to market, that begins the number one priority, but that will be coming sometime this year. The IQVIA data for that is about $20,000,000 of according to NSP. Our partner, Decel, which received last October for an estimate on our approval from the Israeli government, they have received, meaning they picked up, the first order from Elite. We don't know if they shipped it to Israel or when it's gonna get there.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

But when it gets there, the product will be launched. They have also put in for a second order for later this year. Dextel provides the sales and marketing and distribution for Elite's product, and put me in IR, which we will manufacture and package for them. They pay a constant price for the product, and Elite will share them the profit when the sales prices exceed certain amount. We have a three year agreement with Bexel, and it says renewable for two additional years, and everything after that is negotiable.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

In our development pipeline, we have two ANDA files and under review by FDA. The generic oxy ER, whose brand is OxyContin. It's a paragraph four filing, and the patent lawsuit is on the way by multiple companies against Purdue. We're waiting to see what happens in court. And from our side, we have been extremely smart.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Doctor Tim Smith handled this brilliantly. We have tried to avoid being a part of the lawsuit and let everybody book it out while we don't spend any money on on lawsuits. And so far, we've been successful. But now it's time to face the music. So last week, we filed a motion to dismiss against for due.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Most likely, the judge will reject it and will have to go to discovery sometime in two, three months. But we are trying to delay the process from having to spend money on this and let other companies look it out for as far and as long as we can. The second is a dopamine agonist ANDA for the treatment of Parkinson's. We are due to respond to FDA inquiries very soon by August, I believe. And then the FDA will make a decision whether they have more questions that we can move forward.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

We will update you and update everyone on these products as they receive approval. We recently announced the successful BE study for undisclosed anticoagulant, I e, blood thinner. That is the brand, has not done generic yet. The annual sales are 27,000,000,000 according to IQVIA, and the market has not been generalized yet. There is no generic in the market by anybody.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

The brand brand has unexpired patent listed in in the old book. And, of course, everybody has to wait till these patents are overcome, they're unexpired, or somebody has to challenge them and and try to invalidate them. We expect to submit the ANDA probably in q one of twenty twenty six. We have stability work to do. We're working hard on r and d.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Elite has other generic products expected to enter the studies, but we gotta make sure we have finalized formulation for these other products before we enter the study. We need to make sure that testing is robust. The clinical batches withstand stability and no unexpected issues come up. These studies are not cheap, and we need to make sure before we start one I will not start the pilot, but start the DE study. We need to make sure that all of our docs are enrolled.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

We continue to make R and D a priority, and we will update everyone on these products upon the successful completion of the DE study like we did with the blood thinner. And as far as our facilities are concerned, and there'll be a q and a about that, our 34,000 square foot state of the art inventory and packaging expansion is operational. With this expansion, Elite has the capacity for all of our products coming to Elite to be able to be packaged here for the next five years. Right right now, running only one shift, we have more capacity in that facility to be able to package everything that we have. That's on one shift.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Just to summarize, Elite's five year terms of growth continues. Elite is executing its strategy of developing and filing new ANDAs and growing sales while supporting our working capital growth and pipeline development. The increase in the ELTP stock price reflects this growth. Listex is expected to continue to be a key product for Elite with attractive margins over the next year as this market continues, it's converting to generics. Antipamine IR and ER is a mature market, and we expect to successfully defend our strong market shares.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

And and and, certainly, ER is expected to grow after Prasvil is phased out. Elite is positioned as an attractive mid sized genetic pharmaceutical company with consistent profits, steady growth, and low debt. Our stock price has been strong, and we continue to evaluate mergers and acquisition acquisition options and alternatives including of listing to to Nasdaq. And we will report that when we have material events to report. Let's go to q and a.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

We have lots of questions, and and many of them was really good because they were redundant. So a lot of people are investing the same thing. We have lots of questions, but they come in different categories. So we've divided them up for you for general. The of course, a lot of questions about the anticoagulant, partnership which is Excel, potential sale of the company.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

So that's how I'm gonna go through them in in the form that I just listed. We'll start first with the general stuff and go down the list till we ever finally the potentially merger and acquisition. Question is from a gentleman who's asking when is Elite planning to apply with the FDA for a greater expansion of the manufacturing capacity of other drug states besides tablets and capsules? And the reason behind this and few other people ask about the same subject is the gentleman is a vet who used the ketamine in his practice and recommends that we explore it. Ketamine is an injectable product and it's also available as inhaler.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

It's not established as a capsule that's approved by FDA, but I know that people compound it into a lavish or a solid dosage for the animals or for humans. This will be an original NDA, Drug Application, or at the very least, a five zero five b two NDA. So this is gonna be a long term project to to explore. And and thank you for that. Another gentleman sent us a list of the top 10 blockbuster drugs with the patent expiring in 2025.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

I do appreciate the positive ideas and interaction with our stockholders. Thank you both, and please keep them coming. This is the kind of feedback that I really appreciate. People are thinking positively and giving us positive feedback. Can you provide an update on the old packaging line moving to the new facility and any updates regarding the new manufacturing suite that are to take their place at the old facility?

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Yes. So let's take it on to two. The first one, we have moved the old packaging line into the new facility. After we made sure that the new packaging line is working. So first, we set up the new package online.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

We don't put that in there, but we left the old package online in its place just in case if something goes wrong. And sure enough, after two, three months, because of serialization, all the issues, we start noticing anomalies. We needed to stop and reverted back to the old line, got all the engineers to service all the equipment to come in, troubleshoot. They fixed the whole thing, tested it again. It's been running great.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

So we went ahead and transferred the old package of line to the new facility. So now in the new facility, we have two package of lines, which freed up the space where it used to be. We have not purchased any equipment or done anything in that space yet. We better just strip it. It takes a little bit of time, but that's what we spent.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

What can you say about the API shortage reported to FDA and DEA? Well, we are required to report to the FDA on product shortage, whether it is controlled substance or not. For example, naltrexone is not a controlled substance. Yes. We were notified by our suppliers a few months ago that they're not gonna have anything, like, from January, February till June, July due to API shortage on their part.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

The API that goes into making our API. K? So we have to report that to the FDA. Other shortages happen because of quota issues. When you sell all of your quota and then you can't sell anymore, people will call in and they wanna buy a product and you have to sell the okay.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

I only have limited amount for people that are committed to, and and that's about it. So that's what what I believe you're referring to. We have to report that on monthly basis, and we're very honest and upfront about it. Latest pharma and China turf impact, do we have any impact from this turf? As of today, the active pharmaceutical ingredients we have imported are exempt from the Trump tariffs.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Also, our imported APIs were and continue to be duty free. K? We have not focused on the API. There were other little issues where I some price increases are here and there, but overall, it has not been really that material. Prefiction for the 2026 and 2027 annual review annual revenues of current and other approved genetics, we're not gonna do projections down the line because we don't know.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Okay. The blood thinner and anticoagulant. Lots of questions about this. I will read some of them just to to show you the trend and so you can understand that we brought you to your question. And and then I'll answer all of them as a package.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Lots of questions about that. Please tell us more about the $27,000,000,000 debt. K. Will this be the strategy moving forward? I need us to go after unexpired patent blockbuster drugs ahead of our competitors to be forced to file and get the 180 exclusivity.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

How does Elite intend to address the unexpired patent? Does Elite anticipate any potential litigation? Has Elite communicated with the patent holder and NDA holder? What are the patent challenges noted in the press release? What percentage of the market for twenty twenty seven generic generic anticoagulant can elute realistically capture.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Realistically, I can't answer that. We haven't even filed the application. But let me go through the others. By and large, it's an outstanding product. It's the best anticoagulant out there, period.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

It does have a a patent. We are not I would love to become a Paragraph IV company, but we are not set and built for that. We can do once we can do this, but we're not have our activists. The unexpired patent and the litigation and all of those stuff you're asking about are patent issues that will be settled after we file, we have to notify the and and the holder that we filed, and we are or are not infringing on your patents. If we are not infringing, they're gonna come and look and see that you're not.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

If we are infringing, I'm a nice guy. We're not gonna launch till the patent expires or it caused to lose otherwise. You know? We're not gonna go fight in a battle we are gonna lose. So if they have a follow-up patent, you leave it alone.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

If it is obvious or something that can be challenged, you challenge it. We will deal with that, though, in couple of years when we get the approval. K? So the 27,000,000,000 new anticoagulants just announced, Is the branded drug or does the branded drug have foreign patent expiring before US patent? Would Elite pursue foreign partnerships to sell our generic in foreign market prior to being able to enter The US market?

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

I left this question separately from the others because this was something I was exploring before we got this question. And, unfortunately, the answer is no. If it was approved in The US, if our application was already approved in The US, then I could do that. I will find somebody, and we will file with the doctor in Europe, and it should be a lot less paperwork to get an approval. But since we only passed the BE that has not been reviewed by the FDA, and they have not approved the application, I cannot do any of that.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

I'll have to go to Europe, make everything from scratch, file with the I I told you the GP, study there, and do the whole process, which will take a a very long time. I don't mind if we can partner with somebody to do that, but that's that's not something I'm pursuing at this time. A very, very, very good question, though. Alright. Next question is I noticed that under the tab of pipeline and generic drugs, the list is empty.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Is this because it is done on purpose to protect our frequency from our competitors? Yes. We don't list the name because people go shopping and to see what you're doing, and then they start making the same product. How many potential drugs are actually in our current pipeline? And, approximately, what's the IQVIA amount?

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

We have several products in the pipeline, and we'll issue the IQVIA amount once we pass the fee or when we file the application. Any good news with r and d in India or elsewhere to expand our pipeline? Another question in the r and d, is it happening soon? The answer is yes. This is happening.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

But like a lot of things that happened in the industry with the thirst and people getting gun shy, people from India are not being able to get a visa to The US as easily as where they were in the old days. And a part of our strategy with the Indians that they'll develop everything there, and then they'll transfer it over here. And even though we've been successful at doing one where a guy who came in, the top scientists came in and and we worked on a product, The next step, the two scientists were not able to get a visa, so we're working with that. So the answer is yes. It's not going as fast as I would like it to, but it is happening.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Any good news with the sale launch on timeline? Yes. As I stated earlier, the sale said they are ready to receive the the materials so they cannot pick up the inventory. We don't know if it's gonna ship or when it's gonna get there or going by plane. But when they launch it and they let us know, and they are ready to obtain an order for the next shipment in few months.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Potential sale of the company. That's the last group of questions, and we'll start covering those again. I'm gonna read some of them because they're redundant, and then I'll address all of them combined. Do we know what what course we are taking? Buyout or Nasdaq?

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Our top priority is merchant acquisition, a buyout. If that does not work, then Nasdaq is an option. I am following up on Nasdaq's message on the most recent quarterly call where he anticipated transforming transferring to being listed on the Nasdaq sooner rather than later, possibly during the current quarter. Could you please provide me with an update on where we are in the process? I made a point during the last conference call of saying merger and acquisition first, then Nasdaq for a reason.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

And if we even if we wanted to, we couldn't go to Nasdaq in a quarter. There's a lot that goes into being uplifted on Nasdaq. It's a lot of work. How does not feel about getting acquired with a premium added to the acquisition price per share with a potential 25% per on European emissions? I like signing up.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

The fact is once we put Elite out for a bit and a serious offer is made, then at the end of the day, you, the proposal, will decide whether you sell the company, not me, if I like it or not, really. At the end of the day, it's your vote that will decide. Wouldn't every big pharma pharma company want to acquire a company like Elite to avoid the theft if drugs are manufactured in The US versus waiting five to ten years for a newly built facility to be approved by the FDA to operate and manufacture drugs. Absolutely. You will think so.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

And we are a very nice fit for many companies. The fact is most companies have their own problems and internal poll politics and policies and internal agendas. So not too many people will make the initiative, and this is why you need an intermediary, a a I mean, a firm to go and reach out to these people. A lot of people know something is a good deal, but they don't take a chance because they like their job. And I'm out of the fear if it goes solid, then they'll be named.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

But I agree with you. We are a good fit for a lot of companies, and we will see what happens next. It's he is actively reaching out to all big pharma companies and informing them that we are for sale and ready to be acquired or merged to avoid the turf as well as drugs are manufactured outside The US. I have any potential suitable approach at least to discuss a buyout. Was there any activities around the buyout?

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Did we hire an m and a firm? Does Elite have a target sale twice a month? Have any suitors come close to this price? Okay. That's not how it works.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

We don't set the price of mine, and we don't tell people come on down and and buy us. We have a firm identified that we are heavily engaged with and have been for a while, but we have not hired them officially yet for the purpose of m and a. Once we do, we are locked in with them for a certain period of time. So we wanna make sure we're a 100% sure before we move to phase two. There are steps that must be taken before we make it to that point.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

K? This is where you start. You start with valuation. Elite does not do that. We don't pay how much will work.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

We provide paperwork and somebody else does that. An independent firm performs the evaluation, and they issue an opinion that cost a lot of money if you ask for it. Because that makes them liable that what they are telling is the truth, and other companies would rely on that, including the stockholders that it has been done properly. Okay? So to summarize everything that that everybody's talking about or asking for these 15 questions or so that we got on on this subject, our primary objective is m and a.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

To do so, we need to contract an independent firm, m and a firm, to conduct the evaluation of the company. We've done that. This is not an easy task task for a growing company like Elite. When you accept an income, it's a lot easier to come up with a value of what you're worth. But when we are growing, it requires different, more complicated models.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

We have our legacy products that are easy, israzepine and and and the bariatrics. That's an easy assessment. We have amphetamine IR and ER. That's not that difficult to evaluate either because we have a good history on them, and they are mature market with solid history of sales. K?

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

But you have list decks, which we just started. And pending products are a lot harder to evaluate. At the end of the day, we'll get a range representing But when they grow models, they're gonna come up with a single number. They have to say, well, under these conditions, this is what we'll do.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Under these conditions, that's what we'll do, and you have to be arranged. K? The process is complicated, and the the the it it it involves a lot and it involves everybody. So just let me walk you very quickly to high level through this. Our departments in house, they go through audit themselves, internal audits by implementing GMP and checks and balances.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

The department has had to monitor the employees and make sure that we're doing everything perfectly. Carlson and his team audit all departments internally to make sure he's ready for the external auditors. Auditors like Medalles will come in with their team on-site and by requesting their return documents and audit Carter and his team. The auditors are responsible to their management and the SEC for the queues and case that we filed. And they could be audited by the SEC, or they could be put out to be informed on us with lawyers from a separate firm overseeing the whole process.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

Now on top of all of this, we need an independent MMA firm that we hire who will audit everybody and then come up with their own projections and model for the valuation. That becomes phase one. Next step is phase two. If the numbers they come up with are available, then we'll give the m and a firm a green light to move forward and find the super. Then the acquiring firm, the ones that's super who's interested in us, will do their own valuation and make an offer.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

They are not gonna take anybody's worth for it. So it doesn't matter how many sets and balances you have. If the offer is reasonable, it will be presented to the board of directors for the vote. And then upon their approval, you guys are the final say in this process. You make the final decision.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

You, the stockholders. K? We will decide if we will enact phase two within the coming three to four months. By then, we'll have a couple of quarters of list tax sales under our belt and a better idea on the valuation. If these options do not look attractive, then and only then, we'll add Nasdaq uplisting to the mix.

[Nasrat Hakim, President and Chief Executive Officer at Elite Pharmaceuticals Inc]

I hope that was a nice summary. And if anybody have any questions, we are meeting together in six weeks, and we hope to talk to you then. Thank you, ladies and gentlemen, and we'll talk to you in six weeks. Thank you, operator.

[Operator]

Thank you very much. This does conclude today's conference call. You may disconnect your phone lines at this time, and have a wonderful rest of the day. We thank you for your participation.

Participants

Executives

• Nasrat Hakim, President and Chief Executive Officer
• Carter Ward, Chief Financial Officer