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

Good morning, ladies and gentlemen, and welcome to the Elite Pharmaceuticals First Quarter of Fiscal Year 2027 Conference Call. [Operator Instructions] Before management begins speaking, the conference has the following statement. Elite would like to remind listeners that remarks made during this call may contain forward-looking statements that involve risks and uncertainties that are subject to change at any time including, but not limited to, statements about Elite's expectations regarding forward operating results. Forward-looking statements are made pursuant to the safe harbor provisions of the federal securities laws and represent management's current expectations. Actual results may differ materially. Elite disclaims any obligation to update or revise its forward-looking statements, except as required by law. More complete information regarding forward-looking statements, risks and uncertainties can be found on the reports Elite files with the SEC, which is available on the 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. This is Elite's 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 that you've submitted to Dianne. Mr. Ward, you have the floor.

Thank you, Nasrat. Good morning, everybody. Thank you for calling in. Yesterday, we filed our 10-Q that's our quarterly report. It's for the quarter ended June 30, 2026. We're on a March 31 fiscal year, so the June quarter is our first quarter of the fiscal 2027. It's available at our website at elitepharma.com, under the Investor Relations section. If you haven't seen it yet, please go there. Take a copy. As always, I'm going to provide some context, some color to the financial statements and answer any finance questions we received. We received a lot of questions this time. Thank you very, very much. I really appreciate everybody taking the time to ask the questions and paying attention. Nice to know people are out there. Let me start with the area. I'm going to start with the area that I received the most questions are. Many questions on revenues and operating profit. I'm not going to go to a specific question because they're all pretty much similar. Revenues for the quarter with $32.4 million and operating profits were $7.5 million, both in line with the previous 3 quarters, both solid and steady. The questions I received, however, they're not related to this solid performance, but rather the change as compared to the June 2025 quarter, which is our 10-Q presents some comparison the quarter-on-quarter changes. The June 2025 quarter was Elite's best quarter ever so far. Got a lot of questions on the top line revenue decrease and what we're doing to increase the top line in the future, got questions on COGS and margins, and I'll address all of them. Let's start by looking at the June 2025 quarter and how it compares to all of the quarters that followed. It's really a textbook example of how the generic market works. First, keep in mind, it takes several years to commercialize the product. That's the pipeline we always talk about. Pipeline is the lifeblood of any generic company say that every time, every call many times, I'm sure. So you have to identify opportunities well in advance and then you spend a few years getting an ANDA approved so that you're ready when the generic market does come online. And that's what we did with generic Vyvanse, Listdex, Amphetamine. We launched that in early 2025, we captured a decent market share and at attractive prices. Most importantly, the Listdex market was a generic market in its initial stage, and that is the key. Also key is that the generic market is defined by competition. We were the only company launching into the Listdex market. There were more than 10 companies doing the same as Elite at that time, maybe even more than 15. So you put that in the mix, that type of competition, and you have a fluid market at that point in time with competition increasing. As competition increases, prices decrease. Over time, the weaker, more inefficient companies can't make it at the lower prices, they drop out. And eventually, the market stabilizes and an equilibrium is reached. And that's what happened during June July 2025 time period. Elite came out of that correction with an intact market share actually trending up with stable prices volumes and stable operations. Prices were lower than the initial market phase, but still solid. And Elite is now established as a reliable supplier of choice for generic Vyvanse. Just as we are the same for generic Adderall and have been for years. So count Vyvanse in that category as well now. So you need to keep all this in mind when asking about when the question is asked about comparing June 2026 to June 2025. In June 2025, the market was higher, hadn't reached the equilibrium that it has now. June 2026, we're at the steady state. In fact, we've been in a steady market state for the last 4 quarters now, approximately Q2 through Q4 of last year and this year, Q1. So the results over that time period, those 4 quarters, they've been pretty steady and solid. Prices are lower than the initial market phase, but the volumes they're trending up. Talking about volumes. Volumes are a main driver of COGS of cost of goods sold. Got a lot of questions overnight on cost of goods sold. Then just so you know, there's a positive correlation between the 2, more volume, more costs. But also with respect to COGS, there's also a different mix this year as compared to last year. It's not just Listdex in the COGS. Most notable would be Naltrexone, which we weren't selling last year, but we are selling this year and selling quite a bit of it. Naltrexone expensive ingredient, active ingredients, so that drives up COGS. I hope that answers the questions on 2026 versus 2025. But there's more going on here than just how a product launch works and what happens. In that regard, I got some questions on what's the next steps? What are we doing to grow revenues in the future. To answer that, let's look back over the past few years because I always like to say that looking at the past can give you some insight into the future. So let's go back to the beginning of this decade, early 2020s. There was no Elite label and back then, we sold private label phentermine, Naltrexone, few other products. Then we launched the private label generic Adderall that took us to another level. Revenues were around in the low $30 million or so for -- this is annual revenues. If you noticed, we were above that for quarterly revenue now. But we launched a generic private label Adderall, revenues reached $30 million. Then we launched the Elite label in 2023, and that brought us up several levels and the revenues crossed the $80 million mark annually and growing. Then last year, we launched generic Vyvanse and again, cranked it up a few more levels and the revenues were above $140 million last year, almost $150 million actually. So that's how we got to where we are today. But the question is, well, what's next? Well, that's the pipeline. We always talk about the pipeline. You have to remember, all of our products were once in the pipeline, Adderall, Vyvanse, all these products were pipeline products at one time. It's a pipeline that brought us to where we are today. It's also the pipeline that will continue to grow Elite's revenues and our profits. As always, Nasrat is going to talk more about the pipeline. But from a finance perspective, we continue to fund product development and our business model remains the same as it was for the past product launches. We've grown Elite from -- by using a robust pipeline that we keep filled and we keep it moving. There's velocity through our pipeline. We're going to continue to doing that. And that will grow revenues and profits in the future. I hope that answers those questions. Before moving on, one last question I received on revenues and it comes from the revenue concentration footnote. Question was Elite's biggest customer now accounts for 60% of revenues versus 51% last year. Our overall revenue is down because this customer is requiring price concessions do they control so much of the market that Elite cannot diversify away from them? The generic market is highly concentrated in a few large wholesalers. That's true for everybody, not just for Elite, we all have to deal with them. But the reductions in price, the stabilization of the correction in prices especially in the Listdex. It's not a result of customer concentration, but rather it's the overall interaction of supply, demand, competition, the traditional market concepts, the economics that drive prices in the generic market and in pretty much any market. So that's the real explanation for price fluctuations, not really customer concentration. Moving down the P&L. We have research and development. R&D expense was $2 million this year for the quarter compared to $1.7 million last year's June 2025 quarter, that's the pipeline development I just spoke of. We did have quite an eventful quarter for R&D. During this quarter, we launched Methadone during this quarter. And just after the quarter, we launched Ropinirole. We filed an NDA and ANDA during this quarter. We had a successful pivotal vial study, which is quite a big deal. So all of that in this quarter itself. Once again, pipeline is the lifeblood and we're very healthy when it comes to that area of the company. Moving on to the cash flow statement. Cash provided by operations was $10.1 million this year compared to $14.8 million last year, again, very solid $10.1 million, while it's less than last year's extraordinary quarter the cash flow this quarter was better than the last 3 -- the subsequent quarters to last year. So the last 3 quarters, we had better cash flow in the June 2020 sixth quarter than we did Qs 2, 3 and 4 of last year. to the balance sheet, which continues to strengthen. Cash is $38.9 million, up from $298 million at the beginning of the year, did receive a question noting this cash accumulation and asking what plans do we have as far as deploying and utilizing that level of liquidity. As always, we say all the time, new products, they're a top priority for us. As is ensuring we're able to make the products, operational capacity. So we're always evaluating options in those areas and having this type of liquidity definitely helps us as to options that are feasible for us to achieve. So to answer the question, plans for utilization of cash resources are focused on new products, growing our product line and facility improvements enabling us to make the new products and to increase our volumes on our existing products. Working capital was $84.1 million as of June 30 of this year, 2026. That's actually down from the beginning of the year where working capital was $94.7 million. So I got a question on that. They wanted to know why the decrease since we had such profits, such positive cash flow, how could working capital go down? Logical question, good question. Well, remember, working capital are assets minus current liabilities. And if you look at the line item, in the liability section for warrant derivatives. You'll see at the beginning of the year, the warrants were classified as long-term liabilities, meaning not part of working capital. But at June 30, they were classified as current liability, meaning part of working capital, bringing working capital down. Current liability come due in less than a year and the warrants expire in April 2027. So April 2027 is less than a year from June 2026, so they are current, more than a year from March 2026, so they were not current. The result is we have $17 million noncash. That's the key noncash liability, which was previously not included as a reduction in working capital, and it's now included as a reduction in working capital. So that's how working capital can go down even if you have profits and strong cash flow. Working capital decreased overall by $10 million, but we moved $17 million in noncash liabilities from long term to current during this quarter. So it's easy to do the math, and you can see there's effectively a strengthening of our working capital position, which you should have when you have this type of profits and this type of cash flow. And finally, since we're on the subject of warrant derivatives, I got the usual questions on what's going on with the warrants. Well, like I said, they expire in April 2027. So there's 3 profitable outcomes with these warrants, all of which will happen on or before April 2027. The first outcome that's possible as the warrants will be exercised for cash. That would be nice. Elite would get around $12 million in cash for the warrant exercise. Second outcome the warrants provide for our cash was exercised. So the number of shares will be in a cashless exercise less than $79 million, and it's really based upon the stock price at the time of the exercise. The higher the price at the time, the more shares of the $79 million that get issued, the lower price, the last shares that get issued. But in all cases, it will be less than 79 million shares. That's just how the math works. And the third outcome is probably not going to happen, but that the warrants expire without exercise on their expiration date. So they just end in accordance with contracts without anything happening. We're discussing these options with Nasrat Hakim, the warrant holder, and we expect resolution before April 2027 of these. To sum up the financials, we had strong performance, revenues, profits, cash flow, all steady and strong and they're all in line with the last 3 quarters. If you're comparing this year to last year, remember the June 2025 quarter was an extraordinary quarter. really due to the natural price adjustment cycle that defines how generic markets work. We launched Listdex into fluid initial state markets, which had higher prices, which eventually corrected and has since reached a steady state. And that's where we are today. Product development, most important product development continues. It's on schedule for future product line expansion and the same growth through the generic life cycle that brought us to where we are today. Now I'd like to introduce our Chairman and CEO, Mr. Nasrat Hakim.

Thank you, Carter. And thanks for the analysis. It's not -- the best way to look at financials is to compare today's quarter with a year ago, because of seasonal changes and because of so many other factors. So you compare apples to apples. For example, most of the sales of perfume happen around the Christmas, so you cannot say that the following quarter, we didn't do very well or the prices crashed, you have to wait in a higher year and compare that our business is no different. So we do that. However, there are exceptions, okay? I've been in this business for 40 years, and I've seen this many times. Whenever a company gets exclusivity because they are the first to file, they get 180 days to sell the products along with the brand, that's 2 quarters. And during these quarters, they make a lot of money. They make a killing because they're selling at brand prices, which is hundreds of times higher than generics. Well, that expires into quarters. And then a year later, when you are comparing that quarter to a quarter a year later, the revenues and profits will go down. And statistically, it looks bad in comparison. However, it's a very good problem to have. In our case, we were really lucky we came in at detail end of the higher prices and end up having a very good quarter. That's not a bad thing. It looks bad when you compare it to today's quarter. However, our sales study, our profits are excellent, and the company is doing great. So saying the revenues from 2027 first fiscal quarter are lower than the same period of the prior fiscal quarter revenues and income, not because we did not do very well this quarter, but because this specific quarter was very good due to Listdex launch and higher prices. For the last 4 quarters, our market shares have been increasing for all of our major products. Listdex, Amphetamine IR, Amphetamine ER and Naltrexone. I'll give you a couple of high-level numbers. The difference between the quarter last year and this quarter, the volume went up 14.75% overall, 10% for Listdex. Again, even though the price tightened a year ago, have been steadily selling and expanding our market. We've expanded it by 10.2%, which is an excellent achievement. The reason we made money a year ago is again because the prices were a lot higher than it just came out as generic. So for our 4 largest products, Listdex, generic Vyvanse, mix Amphetamine IR, Amphetamine ER and Naltrexone, we have increased the market share and now maintaining prices. Our legacy products, Isradipine, Trimipramine, Phendimetrazine and phentermine. Sales and marketing shares were also in line with previous years. Our recently launched combo products, APAP with Codeine, Oxy/APAP, hydro APAP and methadone were in line with historical sales and improving. In the long term, all of these products are expected to continue to grow new product launches. We've had also 2 of them. We've had methadone in April and Ropinirole ER in July. Both products will contribute to our future growth. We had a good quarter for our pipeline, at least reported a successful BE study for an undisclosed anticonvulsant product, a seizure medication. The brand product has annual sales of $840 million according to IQVIA. We are currently putting together the FDA filing for this product. Elite filed an undisclosed entity coagulant product in June. It is a substantial product that is not yet of patent and IQVIA report $26 billion in sales. We are in negotiation with the brand about the pattern and filing for market entry. Elite's Oxy ER, generic for OxyContin ER, which we have reported on previous calls, continue to be under review by the FDA. Regarding merger and acquisition, as discussed in our last call, we continue to evaluate buyout and uplisting, and I will be speaking about that more in Q&A, which is coming up next. We are looking for the alternative that provides the most value for our shareholders, and we'll talk about that in a second. As we proceed with these alternatives, we will update you when a material event occurs. So let me go to Q&A and speak about -- see of the different sorts of questions you've asked in sequence, the turfs and their effect on M&A. M&A and the NASDAQ before I get into the rest of the questions. And I list a couple of questions just to honor the people who've been sending questions, and I'm not going to read them all because many of you sent similar questions about the same subject.

A couple of the questions. You said all API have been a turf exempt and tariffs aren't affecting M&A negotiations any of the parties that approach you new companies specifically pressured by the strong term environment looking to acquire domestic manufacturing and does that change the profile of who likely to make an adequate offer. Can you please clarify if the upcoming third of deadlines can affect or not affect the acquisition of Elite by foreign drug company? All right. I'm not going to read that -- these questions. These 2 will give you enough flavor of what's on people's mind. Right now, there are no turfs currently, okay. There are plans to have 100% turfs imposed on generics. It could start in August of 2028 and it could go up to 200% a year later. This is very big and part of news for Elite. Any way you look at it, if they put turfs even on the API, it will be like everybody else, and that would disadvantage us. But if they put the tariffs like the Trump administration is proposing on the finished product, then that will give us a huge advantage over many manufacturers in India, China and Eastern Europe who will have to pay these surfs. So a company like that who is in India or China now is going to have to pay 100% or 200%, that gives us advantage in 2 ways: one, okay, our pricing will be more competitive and hopefully will command more of the market. Two, these companies would want a presence in the U.S. and Elite would look like a very attractive company to either acquire or merge with. So yes, the turfs will happen. The issue is that they have not happened yet. And a lot of companies are waiting to see that the administration is going to force the issue or back down. In fact, the reason stated by Trump for the turf strategy is to reward companies that manufacture here in the United States, whether the Indian or Chinese. And if they move their manufacturing facility or acquire somebody in the U.S., they'll give them the reward [indiscernible] of these turfs. So this is a great news for us. It just hasn't happened yet. It is in the plans and everybody is watching it. And if it materializes, it's very welcome for us on both avenues. That leads us to what we're going to do in [indiscernible] and NASDAQ. We're still working on finding a suite and we're renewing the contract or extending the contact by 6 months with the gun company we're working with, so we can finalize a couple of things. But regardless, NASDAQ is a motion, and I'll talk about that in a moment. So let me lead you at least one of the questions about NASDAQ, and then I'll elaborate on that. Mr. Carter said, you are ready for NASDAQ and Mr. Hakim called OTC an option anymore. Given the September 30, 2026 float assess that determines accelerated filer status. Is there a target date for uplifting? Yes. And would you uplift as standalone or only in combination with M&A transaction? No, definitely, we will go at NASDAQ alone or we may purchase another company and then go or if somebody acquired us. It's not only, okay? So we are open to all options, but regardless of what happens, we're going to be at NASDAQ. My -- as to the question is what's your target date, It is not going to happen by the time we talk again, which is in November. But my best guess is that by the time we talk after that in February, it will be -- I just happened or about to be finalized. An interesting question on operations, is Elite is only currently running a single shift? What is the need for an additional facility expansion? Are you anticipating a large increase in product manufacturing or packaging needs? Our packaging needs are taken care of. We've resolved that issue, and we're good for years to come, but we'll talk about manufacturing in a second other some ask about -- you've said the last time you're assessing the new facility and you may pull the product soon. When are you going to do that? It is true that we're running only one shift right now. However, you set up your facility for the future. Currently, we are doing great, and our greatest asset is the attention that is the older C2 products. That is a great pillar, but it's only one. The second one is a collection of a whole bunch of products. So the vision is to ensure that we have multiple pillars. The blood center anticoagulant will be one. That one is already filed. We're already in negotiations to try and get it in 2028. Second one is in R&D. And between the 2 of them, that will be a substantial part of the market for blood thinners. And hopefully, the second one will get to clinical trial and be in the market also by around the same time. Other products that are perpetual. We have 50 million diabetics in America. There are excellent diabetic products that are coming off patent. Our head is in the ring, and we are very close to 3 of the formulations, so having that as a product that is ongoing, this is not something that's seasonal. This is not something you take on for a while. These are products that you need all the time and the huge population happen. That will be another pillar for us to focus on. In order for us to have a viable manufacturing facility, we need to take over a warehouse of one of the next to us revamp it and make it for pharmaceuticals and then put equipment in it and then qualify the equipment. And that process takes about 2 years. So we need to start now in order for us to have a house for all these products that we have on R&D that's going to meet the company what it is in the future. Okay. Hopefully, that answers your question. Last question is of 3 parts, about 3 products in R&D. First about Oxy ER, you have launch plans for August 2027 or approval by FDA for over 2027, which we don't. We have authorization with Purdue to launch by August 2027. But there is unresolved issue in [indiscernible]. I have a question, what is the realistic time line for resolving the FDA question. And thus, August 2027 still hold if it slips. If the filing with FDA slips, there is no way you [indiscernible] product. So August 2027, wouldn't mean anything. The first thing is that we need to fix this one issue that the FDA pointed out to and give us a year to study and get back to them. And we were working with a consultant and the team in house to try and resolve the issue and we will keep you updated. As of now, we just started working on it. I will have more information in the future. But we need to resolve that issue and then we can launch in August 2027. You flagged ASP an undisclosed anticoagulant and filed and 2 ANDAs already pending and said another BE result is likely before year's end. Which near-term catalysts, you view as most material to sustain a 40% 5-year revenue compound annual growth rate. And when should the investors expect the anticonvulsant and filed the anticonvulsant and the seizure medication, will probably be filed before we go to NASDAQ. I would assume it's going to be in the beginning of the first quarter of this calendar year, okay? As to the rest of it, a 40% increase over 5 years really is not that high. It is doable, but I'm not going to prioritize because I don't know that we pass the clinical trials or get approval. Anticoagulant, you filed [indiscernible] which implies a 2032 linked time line tied to patent expiry. But said you are still working on circumvent or challenge specific patterns to truncate it. That is true. What is the probability and time line of converting any of those back ends into a near year launch? It is -- the probability is high. We are in negotiations, and my gut feeling as of now, we just started the negotiations is that we're going to be able to file this -- to launch this product in 2028. All right. That concludes our conference call today. We look forward to talking to you in November. Thank you, Matthew.

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