Elite Pharmaceuticals, Inc. (ELTP) Earnings Call Transcript & Summary

Good morning, ladies and gentlemen, and welcome to the Elite Pharmaceuticals First Quarter of Fiscal Year 2026 Conference Call. [Operator Instructions]. 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. 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's website at elitepharma.com under the Investor Relations section. Elite encourages you to review these documents carefully. With that covered, it is now my pleasure to turn the floor over to your host, Mr. Nasrat Hakim, President and Chief Executive Officer of Elite Pharmaceuticals. Sir, the floor is yours.

Thank you, Matthew, and good morning, ladies and gentlemen, and thank you for joining us today. My name is Nasrat Hakim. I am Elite's Chairman and CEO. This is our earnings call. Our CFO, Carter Ward, will give you a summary of the company's financials, after which I'll give you an update and answer some of the questions you've submitted to Dianne. Mr. Ward, you are on.

Thank you, Nasrat, and thanks to everybody for calling in today. Yesterday, we filed our 10-Q. That's the quarterly report. It was for the quarter ended June 30, 2025. We are on a March 31 fiscal year. So this is the first quarter of the fiscal year ending March 31, 2026. 10-Q is available at elitepharma.com under the Investor Relations section. If you haven't seen it already, please get a copy from our website. I'm going to provide some context and color to the financial statements and answer the questions we've been receiving, receiving overnight. And as always, thanks so much for the questions. Really appreciate your interest in Elite. I'm going to start with the P&L. Total revenues for the quarter were $40.2 million. Compare that to $18.8 million for the June 2024 quarter, it is more than double, $21.4 million increase, which is 114%. So our revenues more than doubled as compared to last year. Also note that our revenues for the entire year last year were $84 million. This quarter alone, we had almost half of last year's revenue. This increase is attributed to 2 main factors. First, the Elite label is doing really well. It has become well established in our niche markets. We launched the Elite label during the 2024 fiscal year. We were unknown then. Elite label was not in the market until 2024. Actually, April 1, 2023, was when we launched it. That initial product launch included a few products, including our generic Adderall, which is our -- which was our leading product at the time. Now it's 2 years later. We've been in the market for 2 years. We're a known entity. The product lines from that initial launch, they have secured a nice place in the market. We have a growing market share and growing revenue streams for those initial products. We -- Elite continues to distinguish ourselves as a reliable supplier of quality products, and that translates into a nice P&L and good financials. The second main factor is the contribution received from the Lisdexamfetamine product line. Lisdexamfetamine, we call it Lisdex, it's the generic of Vyvanse. This has a large market with high demand. It was not part of the initial launch from 2 years ago. As a matter of fact, this quarter, this June 2025 quarter was only the second quarter of substantial commercial operations for Lisdex. It really got launched in a big way the end of January of 2025. So less than 6 months in the market. And so keep that in mind when comparing June 2025 with June 2024. 2025 has Lisdex, 2024 does not, and that is a big difference. So moving down to the P&L. We had gross profit of $27.2 million. Compare that to $8.5 million for the June 2024 quarter more than tripled. It's an $18.7 million increase or 220%. We went from $8.5 million last year in profit -- gross profit to $27 million this year. And the gross profit percentage, if you look at the gross profit percentage, which is the gross profit divided by revenue, it was quite a bit higher this year as well as compared to last year. Gross profit percentage this year, the June 2025 quarter was 68%. Compare that to last year's gross profit percentage, which was 45% for the quarter of June 2024. Much higher gross profit percentage. Again, it's mostly due to Lisdexamfetamine, which had a higher margin, but there's some important factors to keep in mind regarding this. I mentioned this during our last call, the Lisdex market is highly competitive. There are more than 10 suppliers currently in the market, Elite being one of them. Elite has grabbed a decent share of the market. It's reflected in our P&L. You can all see it, but the competition is strong. In a competitive market, it creates a downward price pressure, very typical for generic markets. When you're in such a competitive market, maintaining and increasing market share usually results in increased distribution through the large national wholesalers as opposed to direct-to-customer sales. We had a nice high proportion of direct customer sales, and we're getting more and more into the distribution through the national wholesalers. The wholesalers, they provide a breadth of market access that's multiples of what we're able to achieve via direct sales alone. This results in increased volumes, but it comes at the price of lower margins. Again, typical. This is how generic marketplace works. This is the phase that Elite is in right now. And -- we're operating in that market. The takeaway here with regards to the gross profit margin percentage, the percentage is that it will be difficult to maintain the level of the percentage achieved during this June 2025 quarter. And we are seeing decreased margins with regards to the Lisdex as expected. The Lisdex, this is a product that's relatively new in the generic market and this type of settling in price and margins is common. Eventually, competition evens things out an equilibrium is reached and the market becomes more stable. That's what happened in the Adderall, the generic Adderall market, which is a much more mature market, and it will surely happen with Lisdex one day as well. Circo and his team are continually doing well in establishing Elite's Lisdex. But with regards to the gross profit percentage and the margins, that all saying about past performance not being indicative of future results holds true for us as well. We're a generic pharma manufacturer, and that's just part of the fabric of our industry. Got some questions on the operating expense section of the P&L. First was R&D expense, which was lower this year as compared to last year. This year or this quarter, the June 2025 quarter was -- we had R&D expense of $1.7 million versus $2.2 million last year, June 2024 quarter. A couple of things. First, we're doing product development now in India this year, and it's less expensive than product development not in India. Also, our lab was proportionately more involved in commercial operations during the 2025 quarter as compared to being involved in R&D. Remember, last year, this time, for this quarter, we were involved in the last phase of the Lisdex approval. We've all seen how well that has gone. And this year, the same lab is tasked with supporting the commercialized Lisdex. So we've kind of allocated some of the resources that went into product development of Lisdex.'s now supporting the commercialized products. I also got a question on the increase in professional and legal expense. This year or for this quarter, it was $600,000 and the June 2024 quarter, it was $55,000. So first of all, this data is in one of the footnotes. I believe it's footnote 5 to the financials. Very impressive. Thank you for reading such -- giving such a detailed read to the financial statements. Don't usually get a question on a footnote, so excellent job there. But the large increase this year is from consulting costs this quarter relating to, I guess, you call it the M&A project and our evaluation of options in that area. I am now going to have more to say on this subject. But as far as the financials are concerned, as you see from our footnotes, we accrue quite a bit of expenses for this project. So moving down our P&L. our operating income, so that's gross profit minus cost of goods sold. Our operating income was $21.7 million for the June 2025 quarter. Compare that to $3.9 million for last year's June 2024 quarter. So that's a $17.8 million or a 456% increase. Actually, I should say operating income is gross profit minus operating expenses, G&A, R&D, those expenses. So we had $21.7 million this quarter compared to $3.9 million for the June '24 quarter. One thing I want to point out, the operating income for all of last year, the 12 months ended March 31, 2025, was $19.6 million. So we had higher operating income in these 3 months than we did all of last fiscal year, $21.7 million 3 months versus $19.6 million for 12 months ended March 31. In the below-the-line section of the P&L, I got the usual question that we've been getting a lot is why is our net income so much lower than the operating income? Operating income was $20 million, yet we're showing a net loss -- net loss of $5.4 million. Take a look at the below-the-line section of the P&L, and you'll find your answer. Number one, change in fair value of derivative financial instruments was an expense of $22 million, and we also had $5 million in income tax expense. So I'm going to address each one separately. First, go through this again, the change in value of derivatives. This is related to the valuation of warrants issued in 2017. It's noncash. It's a technical entry required by GAAP. GAAP is generally accepted accounting principles, GAAP. If the valuation of the warrants goes up, we record an expense, and we record an increased liability. If the valuation goes down, we record income and a decreased liabilities. The warrants are valued using the Black Scholes model, which 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. Valuation goes down and we book income. So stock price up expense, stock price down income. During the June 2025 quarter, our stock price rose by almost 67%. We went from $0.44 to $0.73 as of June 30, 2025. When you run that through the Black Scholes model, the result is an increase in valuation of approximately $22 million, and that's the expense we're showing on the P&L. The most important thing here with regards to this, and I stress this a lot, is we will never pay cash for any expense shown here for these derivatives. And we will also never receive cash if the stock price goes down and we report income. There is no cash ever. This is just technical GAAP book entries that we are required to make. Also, please note that our stock price today is much lower than $0.73, the closing price from June 30. So the price at September 30 is below $0.73, the next 10-Q that we file for the September quarter will show revenue for change in fair value of derivatives as a result of this. Let's just see what happens. We still have about 6 weeks to go before September 30. One other thing regarding the change in derivative values and people listening to these calls, I get this question a lot. But I remember many, many, many years ago, we had operating losses on our P&L and our stock price was dropping, and that resulted in change in derivative value that would result in income. because the stock price was dropping. Sometimes the amount of income that we recorded would be more than our loss. So we would have -- we would show a net income even though we had an operating loss. Here, we're showing a net loss while we have an operating income. But back then, we had an operating loss and a net income because of these derivatives, and I really don't remember getting too many questions about this back then. But I'm very happy to answer these questions today as our financials are so much better today than they were all those years ago. Now with regards to the income tax expense, the other component of the below-the-line expenses. It should be noted that the IRS and the tax authorities, they don't recognize income or expenses from change in derivative value. This is what's known as a permanent difference between generally accepted accounting principles and the tax code. So they don't -- they just ignore that as well. And also note that change in derivative values is not considered in any enterprise valuation models, anybody looking to value our company, they adjust these derivative entries out. So with the tax code not recognizing the derivative item, our tax expense is really based on the $20 million plus of operating income. And based on that, we booked a tax expense of $5.3 million. So you put the derivatives and the taxes together, and that's how you end up with a net income that's so much lower than the operating income. So now to the cash flow statement. Our operating cash flow for the 3 months ended June 2025 was positive $14.8 million, compare that to a positive cash flow of $3.1 million for the June 2024 quarter. So we improved our cash flow by $17.9 million compared to last year. That's 577% increase in operating cash flows. Not much to say really here, strong earnings, drive cash flow. It's as simple as that, and it's true for us. Now to the balance sheet, which continues to strengthen. I've been saying that for some time. Our working capital as of June 30, 2025, was $67 million. That's one of my favorite metrics. Working capital. You compare that to $46 million 3 months earlier. As of March 2025, the $21 million increase in working capital over the 3-month period, 46% increase as well. I always like to drill a little further into working capital, which is current assets minus current liabilities. Current assets increased from $58 million to $78 million, a $20 million increase, while current liabilities total decreased from $12 million to $11 million. I mentioned this has happened in our last financials, and I said that you don't see that happen too often, but it happens again. Our current assets increased by $20 million with current liabilities decreasing by $1 million. Usually, you're going to see the ratio, you see them both increase at different ratios, and that's how you end up with larger working capital. But for this case, our assets went up and our liabilities went down. If you look at the noncurrent liabilities, you're going to see the -- you're going to see a similar trend. Noncurrent liabilities, which are not part of working capital, excluding the derivatives, were $5.6 million at June 30, 2025, compare that to $5.8 million at March 31, 2025, 3 months earlier. So those went down as well from $5.8 million to $5.6 million. Takeaway here is that Elite has low debt, and we have low debt that continues to decrease and working capital that continues to increase. So these are hallmarks of a strong balance sheet. And I did get one question overnight on the balance sheet, and that was on the -- was on the real estate. Here it is. It was on the real estate that we own. We own our factory. We own a couple of properties that we operate under. And it has to do with the market value of our real estate versus the book value shown on our financials. And person asking the question, you used the real property as a hidden asset, wants to know, can we adjust the financial statements to reflect the real value of the real estate. And the answer is according to GAAP, no, we cannot. You -- we can decrease and we -- if the value of the of the real estate wherever to be less than our cost, then we are required to decrease, let's call it an impairment of an asset. We can decrease it. We can only decrease it, we can never increase it. So you're right about it being a hidden asset. So the value -- whatever the market value is, we are not allowed to increase our cost to reflect that. So thank you for that question. Excellent, excellent question. Some of these financials, we had record revenues, more than $40 million for the quarter. We had record profits, almost $22 million for the quarter, which were more than the profits than for all of last year. The Elite label continues to perform well in the market. Lisdex is doing excellent. The margins, however, are difficult to maintain in the future due to generic market competition. Our balance sheet is strengthening. Our cash flow is solid. Our working capital is increasing. Our debt, which is already low, continues to decrease. All in all, I'd just say the 2022 fiscal year has started off extremely well, probably the best start to a fiscal year that I've certainly seen. Our next quarterly report is due in November, and I look forward to speaking to everyone then. Now I'd like to introduce our Chairman and CEO, Mr. Nasrat Hakim.

Thank you, Carter. And for this wonderful news and great numbers. It's only been 6 weeks since we spoke last. Our positive trend continues. Revenues for Elite's first fiscal quarter were $40.2 million and $21.7 million in profit. That is impressive. Elite's new product launches, especially Lisdex, have allowed Elite to continue to grow rapidly. Elite's generic Lisdex, a central nervous system product used to treat ADHD with the brand name Vyvanse was launched in January. Elite has roughly 8% of market share according to IQVIA and an opportunity for more volume growth. The market volume for this generic product is growing and the conversion from brand to generic continues. Last quarter, the generic portion was 63%. Now it's 73%. So the market keeps on expanding, and it will probably end up reaching 90% within 3, 4 quarters. Additional market penetration by the generic companies is definitely expected. This is not out of the ordinary. That's what happens with every product that goes generic. But the second factor that is very positive is that the market itself for Lisdex is expanding -- expanded by 2% this last quarter alone over the quarter before because now doctors write more scripts because the insurance companies encourage it because now it's generic. So there are 2 factors that are continuing to make the market bigger. One is the insurance companies and doctors are going to write more scripts and two, it's the fact that the brand is losing part of their share. So this is why we expect our share of the market to grow. Now you heard what Carter said, it's a highly competitive market. Therefore, the price per bottle may go down, but that would be compensated for to some extent with the fact that the market is getting bigger. Adderall IR is our second best product. And as per IQVIA numbers, we continue to hold 18% to 20% market share. There's like about 12 competitors out there, and Elite is one of the smaller companies. And yet we hold almost 1/5 of the market. We are in a very good position to defend our shares, doing is -- doing a -- Circo is doing an outstanding job. And that is really not because our prices are cheap, but because we are considered a reliable supplier. the margins for IR are very attractive, and this is a key product for Elite. Another key product for Elite is the amphetamine ER, and we hold 11% of the market on that. Prasco, which we terminated the agreement with on March 31, still have a product that they're selling, and they have about 3% of the market, and we will end up converting that sooner or later. As of today, between our share that we sell to Prasco and our share that we sold to the market, we are about 14% to 15%. Isradipine, Trimipramine are smaller products we don't talk about a lot, but they have attractive margins. because each one of them has only one competitor in the market. So when the market is only a couple of million or $5 million and you are 1 of 2, that's not a bad place to be. Phendimetrazine, our bariatric product, we hold about 30% of the market. Precision dose license for the generic naltrexone and phentermine in September, and Elite will start selling these under our label. Naltrexone API supply has been limited this year due to shortage. We expect naltrexone to be one of our better products for next year and going forward. We have recently launched 3 products, generic Percocet which is Oxy/APAP, that we launched in April, generic Norco, which we launched in December and APAP with Codeine, which we launched last October. We are building market shares for each of these products. Generic methotrexate launch was in August, and the pricing is very competitive for this one, and we have a minor market share for this product. I get a lot of questions about methadone. We will launch methadone as soon as our resources allow it. There are more important products to work on such as Lisdex, Lisdexamfetamine IR and ER. And we do have limited capacity in manufacturing. In packaging, it's unlimited. In manufacturing, it's still limited. So when the time is right, we will go ahead and launch methadone. Our partner, Dexcel received approval in Israel for Amphetamine IR, and we shipped product to them recently for their launch. There's only one other competitor in Israel that sells Amphetamine IR. At this time, we've shipped the first shipment. And as soon as we did that, they turned around and put in an order for a second one that we will be sending to them later this year. We have 2 ANDAs in our pipeline that I've updated you on a few months ago or 6 weeks ago. generic Oxy ER, that's a generic for Oxycontin. This is a Paragraph IV filing and the patent lawsuits are ongoing. We, from our end, are awaiting Purdue and the courts to make a decision. And the other is the generic dopamine agonist, an NDA for the treatment of Parkinson's. In addition to that, we've recently announced a successful BE study for the undisclosed anticoagulant generic. The brand has an unexpired patent listed in the Orange Book. So commercialization of this product will require addressing the unexpired patent. We will determine our approach for this product closer to the filing time. We also have other generic products in advanced development stages. that we will update you on when the time comes. Elite continues to make R&D a priority, and we will update everyone on these products once we have a material event, passing a PE or filing. We have been pretty busy here in addition to making all of the stuff, hosting the FDA. FDA just completed an inspection of the facility, a general GMP. And they issued observations that were minor. We are in the process of correcting and responding to them. Our response should go out a week from Friday or a week from today. We are proud of our facility, including our new expansion. There were no comments whatsoever on the packaging facility and the new building and new expansion and are pleased that we have completed this FDA inspection. Mergers and acquisitions. Okay. Since the last time we spoke 6 weeks ago, we've had strategy meetings with the M&A partner. As discussed in our last call, we continue to focus on M&A. I am giving the M&A team until the end of the year to see what materializes. If we don't see a serious progress and/or desired outcome, then we will start thinking about NASDAQ in Q1 calendar year of 2026. However, as of now, we are moving forward full swing with the merger and acquisition. There is a lot that goes into either alternative, whether you want to go through NASDAQ or you want to go for M&A. And we continue to look for the alternative that provides the most value for our shareholders. We are not married to the M&A. It is the preferred idea. But if we feel that, that is not going to be as good for the stockholders as NASDAQ, then we have no problem switching policies. But as of now, that's our focus. And we definitely will update you in case if there is any material event. Just to summarize all of this, our trend of growth continues. Elite is executing its strategy of developing and filing new ANDAs and growing sales while supporting working capital, we have a record working capital now, pipeline development costs and maintaining a strong cash position, the strongest ever in our history. Our stock price reflects that growth. Lisdex is expected to continue to be a key product for Elite with attractive but reduced margins over the next year. Higher volumes, I expect as market continues to convert to generics. Amphetamine IR and ER, they are in a mature market, and we expect to successfully defend our strong market shares as we have done for the past couple of years. We are positioned as an attractive midsized generic pharmaceutical company with consistent profits, steady growth and low debt. Our stock price has been strong, and we continue to evaluate M&A and uplisting options. We are looking for the alternative that is best for our shareholders. Let's go to Q&A. We did not get a ton of questions this time as we usually do. And actually, I am very pleased to say the questions were intelligent and to the point, nondistractive and wanting to own the narrative. So I appreciate the questions this time.

The first one is about the Trump administration and Trump recently instructed the top pharmaceutical manufacturers to lower the cost of prescription drugs. What impact will this have on the pricing profitability of Elite products? The administration actions should affect the branded products. The purpose of what the Trump administration is trying to do is to get the brand companies to lower their products. For example, Lisdex before it became generic, the price was at least 10 to 100x more than it is today. So I do not anticipate that, that's going to impact us because the generic companies are the cheap drugs, and these are the ones that save the patients and the country billions of dollars per year. So I do not see any impact on us yet, and we are watching this very carefully. With broader and more sweeping tariffs going into effect in the first part of August, what impact will this have on Elite, high ingredient costs, so on and so forth, okay? As I stated the last time, the API import has been exempt from turfs. So all of our APIs that we received from overseas, many of them we get from the U.S. because we deal a lot with controlled substances and you don't make them overseas. They are made in the U.S. But for the products that are made overseas, we have not impacted yet because they're exempt. However, if the prices go up, we -- and not only for the APIs, it could be for bottles and other IPIs, inactive pharmaceutical excipients. We and the rest of the industry will adjust our prices to compensate, okay? Now keep in mind, sometimes the contract has a lag time before you can do that. But in general, even if that happen, Elite will survive and we will go ahead and adjust our prices because everybody else in the industry is going to go up with us. Next question was on product pipeline R&D in India. Does this happen soon? It is happening. Our first product should go to clinical trials in the first half of 2026 if everything goes well. And maybe sooner if everything goes well because any time you're transferring products like this, you got to do quite a few things in addition to transferring it and pilot studies and so on before you get to the BE. So there's a lot of work that goes on before you finally get the BE and see a few pass. Partnerships, Dexcel launch. Did this happen? Or are we still waiting? As indicated before, yes, it happened. What is occurring with Dexcel delivery? It seems as if they should have accounted for it by now. Is there any revenue recognition? Are we still waiting to confirm shipment, okay? Well, Dexcel took possession of their product in the U.S. And the day they did that, that became their product, and they paid us for it, okay? After that, it is their game. They need to get it through customs and get it to Israel and get it through the Israeli Ministry of Health and sell it. That part is on them, but they did receive it from us and they paid us for it. As a matter of fact, they are so optimistic about the market that they put in for a second order that they want us to deliver before the end of this year. Do we have any new partnerships cooking? Any new partnerships cooking? I don't know Chef Ramsay was an investor in Elite. Well, thank you, Chef Ramsay. We are -- as I've been reporting to you guys, we are concluding all the partnerships that we have whenever we have the opportunity to do so. For example, Prasco and Tagi Precision Dosing, for an example. And we want to convert everything to Elite owned and Elite operated. Now having said that, we are always extremely open-minded at Elite. We will explore any partnership that is advantageous to the company. But as of now, we're trying to consolidate and be on our own. But if some partnership comes up that is advantageous to us, we'll absolutely consider it. potential sale of the company. Was there any activities around the buyout? Did we hire an M&A firm? I am asking because Mr. Hakim said it would happen before August 2026, and it may take up to 6 months to sell the company. As the first part, was there any activities around the buyout? The answer is absolutely yes. We've been updating you on this for several months now. There was and there are a lot of activities around the buyout. There are a lot of things you have to do before you get to a place where you find the suitor where you have meeting of the minds. We started this process in the fall of 2024. Back then, we had our legacy business, the bariatric product. isradipine, naltrexone, and we had our new products, Amphetamine IR and ER. This part of the business was very easy to evaluate by our M&A company. The wildcard is the valuation of Lisdex and a couple of other political factors, what's happening with the turfs and the fear of other countries and investing in the U.S. and all of that. But that was all done before Lisdex was the wildcard. At the time, we have not launched this Lisdex and any assessment would have been just an estimate. And of course, our estimate of what we believe we can do and somebody else's estimate are going to be profoundly different. Our M&A partner is working on finding us a suitor. If an acceptable offer is presented today, we'll be more than happy to consider it. But if not, we will wait another quarter or 2 to show realistic revenues and profits that include Lisdex and show the trending for the sales of Lisdex, which would take the guesswork out of how much is the company is really worth, okay? The timetable for M&A is flexible. We will likely continue through the end of this year. Options continue to be acquisition, which is our #1 focus. if it does not happen by Q1 of calendar year 2026, then we will start doing the prep work for option #2, which is uplisting. And while we're doing that, we'll continue looking for an acquisition as well. This concludes this update. Thank you all, and looking forward to talking to you in November. Thank you, Matthews, and have a wonderful weekend.

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