Elite Pharmaceuticals - Earnings Call - Q3 2025

Executive Summary

• Q3 FY2025 revenue was $14.4M (−8% YoY; −24% QoQ) with operating income of $1.1M (−69% YoY) as holiday timing delayed late-December shipments into early January; January was “best ever” for shipments and revenue according to management, implying a meaningful Q4 rebound.
• Net loss of $(10.9)M (−$0.01 EPS) was driven by a non-cash mark-to-market increase in warrant derivative liabilities as ELTP’s share price rose; operating performance (gross profit $6.1M; 43% GM) remained positive.
• Strategic launches: generic Vyvanse (Dec 26), Hydrocodone/APAP (Dec 2), Codeine/APAP (Oct 7), and Methotrexate (Aug 27). Vyvanse revenue recognition largely missed Q3 due to delivery timing, but January sales were strong; DEA quotas are a gating factor for ADHD products.
• Packaging expansion milestone: new 144 Ludlow packaging facility approval (Feb 9, 2025) removes a bottleneck and should aid throughput and margins mix over time; management reiterated FY25 revenue outlook to “skip the 60s and comfortably hit the 70s” (i.e., $70M+), aided by Vyvanse ramp and pipeline.
• Potential stock catalysts: January/February run-rate strength flowing into Q4, Oxy/APAP launch by/before April, and M&A/NASDAQ path “very near” (management acknowledges a reverse split would be required for uplisting).

What Went Well and What Went Wrong

• What Went Well

  • January run-rate strength after shipment timing issues: “January 2025 was our best ever with regards to shipments, revenues, contribution margin,” nearly matching the entire Q3 quarter; February tracking similarly.
  • ADHD portfolio expansion: full commercial launch of Vyvanse (generic Lisdexamfetamine) with volumes “well in excess of all…other products combined,” and continued leadership in Adderall IR (~17% share) and ER (~16% incl. Prasco).
  • Capacity unlock: FDA approval of the new packaging facility removes a bottleneck and doubles packaging capacity; CFO notes costs shift from G&A to COGS, aiding matching to revenue as volumes scale.

• What Went Wrong

  • Revenue dip from shipment timing: Q3 revenue fell to $14.4M (−8% YoY; −24% QoQ) as late-December shipments moved to early January due to holidays and customer receiving schedules.
  • Margin pressure vs prior year: gross margin at 43% (vs 45% LY) and higher G&A (+59% YoY) from regulatory/compliance costs and pre-approval overhead for the new facility.
  • Non-cash warrant revaluation drove bottom-line loss: derivative liability rose to $33.6M (from $6.3M at 3/31/24), creating a large P&L hit despite positive operating profit.

Transcript

Moderator (participant)

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 statements. 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 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.

Nasrat Hakim (President, Director and CEO)

Thank you, Matthew. And happy Valentine's Day, everybody. 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 us a summary of the company's financials, after which I'll give you an update and answer some of the questions that you've submitted to Diane. Mr. Ward, you have the floor.

Carter Ward (CFO)

Thank you, Nasrat. Yesterday, we filed our 10-Q. It's for the Q3 of our fiscal year ending March 31st, 2025. So our Q3 ends December 31st, 2024. It's available on our website, elitepharma.com, under the investor relations sections. If you haven't seen it yet, please get a copy.

As I always do, I'm going to provide some context, give you some color to the financial statements. And throughout my presentation, I received a lot of questions overnight, and I'll weave in answers to those questions as best I can into my presentation as well. Let's start with the P&L. Total revenues for the quarter were $14.4 million that compares to $15.5 million for the December 2023 quarter. It's a $1.1 million decrease or 8% decrease.

There was a delay in shipments, among other factors, at the end of December due to the Christmas/New Year's holidays, if you guys remember, happened on a Wednesday in the middle of the week, and that impacted revenues for the quarter.

Many customers, they delayed shipments into January since a lot of people took most of those two weeks off. Our customers, they didn't want shipments sitting in trucks waiting to be received and processed so instead, we just had to hold on to them till everyone was back at full strength a few days later in January. Now, when I say shipments were delayed until early January, I'm not just talking about the product lines which we had been selling the past two years, which were substantial, especially the generic Adderalls.

Those had delays. What's also included in this delay is the full commercial launch of the lisdexamfetamine, which is our generic to Vyvanse. These volumes were well in excess of all of our other products combined. And they were delayed as well, same reason. It would have been nice to have some of that shipped before December 31st instead of a few days later.

But the most important thing is that they were shipped they're on the market we're gaining share. I did get a question on, was the Vyvanse launch, were the revenues included in this quarter, December quarter? Just so you know, when we shipped, we shipped in December we shipped to our distribution center in Ohio. And that's not revenue to the company our revenue is recorded when it's earned and when it's earned is, with regards to most of our products, when we deliver to the customer.

I had other questions on revenue recognitions. Those volumes were not included in the December financials because they were delivered in the first week of January. If you look at our balance sheet, you'll see that our inventory increased more than $6 million during this quarter. From $14 million in September to $20 million in December, December 31st.

That should give you a good visual of the shipments that went a few days after the quarter end. They were there they were sitting in our warehouse, orders received, pallet stage, ready to ship. They were. In fact, January 2025 was our best ever with regards to shipments, revenues, contribution margin, and February's tracking in a similar fashion. The month of January was almost as much as the entire quarter that we just reported. As I said, January is also tracking in a similar fashion.

So I did get some questions asking about what would the revenue be like without a delay. Well, this will give you some idea of what it would have been like. On a year-to-date basis, the nine-month revenues are $52 million. That's compared to $38.7 million last year so that's a 35% increase, $13.4 million on year-to-date this year as compared to last year.

Last year, for the whole year, all 12 months, we did $56 million. This year, we're already above $52 million. Still have a quarter to go. So note that another thing, the nine-month numbers this year, they do not include a contribution from Lisdex, which has taken our January and February revenues to the highest levels so far. So it's safe to say that last year's record revenue number has already been eclipsed.

Moving down the P&L statement, there's R&D expense of $1.8 million and G&A expense of $2.7 million for the December 2024 quarter both of them are up compared to the December 2023 quarter. R&D is up 28%, and G&A is up 59%.

I'll address each one as far as R&D is concerned. As I said, probably every presentation I've ever made, R&D is the lifeblood of any generic pharmaceutical company. We just had a successful Lisdexamfetamine launch, which was two years in the making.

You don't just launch the product overnight. It doesn't just happen overnight. It's two years of developing, formulating, testing, submitting, getting approval. It takes quite a while. That's what we're doing now for future products we're spending money now to ensure that in the future, there's a continuous flow of follow-on products in the next one to two years, just as we did with the Lisdex, which we began several years ago. Nasrat will discuss product development in more detail.

Just from a finance perspective, accounting rules, GAAP, requires we expense these costs when we incur them. The expectations are obviously that what we're doing now will be successful in the future, result in more products, future products, future revenues, and future profits. With regards to the increase in G&A costs, there's a couple of factors at play. First, regulatory costs have been increasing. The fees are up. Costs more to comply compliance is more expensive. The consultants and everything we need to do for compliance with FDA, DEA, SEC, all of the alphabet agencies, everything costs more.

And we also have a few more headcounts that we had to hire for compliance. The second factor in the G&A increase, and that's a temporary the second one is a temporary one. And that factor has just ended. And that's the facility at 144 Ludlow that was constructed and validated in 2024.

But it was only approved last week, a couple of days ago, actually. Now that the packaging facility in 144 is approved, it becomes part of our manufacturing assets, and it's not an overhead asset thanks to this approval. This is a big deal from both operational as well as a financial perspective. I got some questions on clarifying what is this new facility, what is it going to do. It's going to more than double our packaging capacity, which was our bottleneck up until now.

Plus, we're adding a lot of new warehouse space that we can now use. We were running out of space before. The business is increasing so fast. We need this extra space, and we especially needed this tremendous increase in packaging facility and capacity. So operational, that's a big deal.

From a finance standpoint, these costs, I can now match them with our revenues. It's part of our product costs it's part of our COGS. And it's no longer part of our G&A overheads. So the increase in G&A overheads, at least that portion of it, was temporary and that will go away as of a few days ago when we got the approval. Looking at the balance sheet, we're continuing to strengthen.

The two-week delay in shipment doesn't affect the balance sheet as much as it does the P&L since the inventories are there they're ready to go they're sitting in working capital. Our working capital, which is current assets minus current liabilities, our working capital continues to increase. It was $27 million at the beginning of the year, the fiscal year, and it's now $33 million as of December 31st, 2024. So that's a $6.4 million or 24% increase over the nine-month period.

It's also up almost a million dollars since September as well. So in addition to strong and growing working capital, our long-term debt is low, and it continues to decrease. Our non-derivative long-term cash liabilities were $6.7 million at the beginning of the year, the fiscal year. And on December 31st, they were less than $6.1 million. The takeaway here is that our increase in working capital is resulting from profits and efficient operations and not from long-term debt.

I did get a question asking, did we have to borrow money to fund the new launches, the Lisdex launch? And the answer is no. The investment in working capital for Lisdex alone is in excess of $6 million. It's actually a little over $7 million we funded that from our own cash flow, our own working capital.

So some companies do get working capital from long-term debt. We do not. At Elite, we fund our own working capital. We're paying down long-term debt, and we're increasing working capital at the same time. So those are two things you want to see.

Had a couple of other questions that I'll answer. What are our plans to clean up our capital structure? Our capital structure is actually very solid and very clean. We have almost everything in common stock. We have no preferreds. We do have some warrants. We have no onerous covenants, so this capital structure is almost as clean as anything can possibly be, so we're really looking good as far as that's concerned.

Got a question on, will the Hakim and Khaski promissory notes be paid at the end of the fiscal year? Remember, the fiscal year ends March 31st those aren't due on March 31st they're actually due in the first quarter of the next fiscal year, and our plans are that we will pay those amounts, which total $4 million when they come due, which will be in Q1 of the 2026 fiscal year. So to sum things up, one other question. Is a new lease in Florida signed? Will this benefit Elite in future from a tax perspective? Not really first of all, Florida has a corporate income tax.

But our income taxes are based really upon our operations and where we ship. The state income taxes, we have multiple states that we have to file in. So it's quite complex. But having an office in Florida doesn't really have much of an impact on our taxable situation. It really is depending upon where we ship. And there's all of these concepts of state nexus that apply based upon our shipments.

So to sum things up, our financials have never been stronger. And they are one of the reasons that Elite is positioned extremely well for the next phase of our strategic plan, which I'm sure Nasrat will go into a little more in detail. So now I'd like to introduce him, our CEO and President, Mr. Nasrat Hakim.

Nasrat Hakim (President, Director and CEO)

Thank you, Carter. In January, Elite's unallocated revenues, as Carter stated, were about $12.5 million That's almost as much as the entire Q3. The profits made in the month of January were more than the profits made in the entire Q3.

Why is this important? It's important because the revenues were lower in a single quarter. It does not mean that that is a trend or that's going to continue. And the reverse is true. Just because the revenues in January are very high, that doesn't mean that trend will continue. I'm not saying it will or it will not. I'm just saying one point in space and time does not set a trend. And everybody was jumping on one event in a quarter out of context that the sales are going down our sales are not going down.

Elite is still leaders in the industry in academia, IR, and we will be as well in Lisdex. The second thing I want to caution is that don't pull out your calculators and take what we just said about the Q4 about January and multiply it by three and then say, "Oh, Nasrat said we're going to make $37.5 million." I'm not saying that.

We're giving you a flavor of January to put your hearts at ease that what is happening or what has happened in Q3 is not a trend. It's a point in space and time that is still, when you look at the totality of the three quarters, advantageous to Elite. Elite continues to grow, and Elite is in its best financial position ever. Let's look at the last three quarters of our fiscal year. The quarter-over-quarter comparison includes certain time effects and uncertainties.

It is better to compare fiscal year to date and the revenues rising from that. Revenues for the last three quarters grew to $52.4 million, which is a 35% growth over the same period last year. Operating income for the last three quarters was $8.4 million, which is 19% growth over the same period last year.

Elite is on target for another record year when our fiscal year ends in March. As a reminder, our annual revenue trend started in fiscal 2021, starting in fiscal 2021 i don't want to go past that, for $25 million in 2021. They were even $7.5 a couple of years before. Went up to $32, went up to $34, and $57 last year. Now, for fiscal year 2025, we are already at $52 million over three quarters, and we still have a quarter of sales remaining to be booked.

Elite is heading for another record year. I am certain that we will skip the 60s and comfortably hit the 70s range in revenues. I'm not going to be too bold and say we're going to hit 80 we're going to stop over here, and we'll see what happens. But there is no way our projection from last year is not going to come true.

I do expect this trend to continue throughout this year with the launch of Lisdexamfetamine and other new products. Enough about financials. It's everything what Carter said and making sure that our faithful and true stockholders understand the big picture. You can buy stocks you can sell stocks you can do whatever you want. My job is just to outline for you where we stand, and the rest of it is up to you.

In sales and distribution, Elite's most recent launches included generic Lisdexamfetamine. The brand name, as you know, is Vyvanse. It's a central nervous system stimulant used to treat attention deficit disorder. The IQVIA reported annual sales of over $4 billion for this product. The product was launched on December 26. That's when we moved everything to the distribution center.

The actual revenue started being booked in January because that's when the movement of goods went to the customers. We have seen a higher level of interest from consumers in Vyvanse. Now, it's a matter of COVID and other complicated things, but we're in very good shape in there. And launching this product is now the primary focus of our sales. We expect Lisdexamfetamine to do well and be a key contributor to Elite's growth going forward.

Next, we launched generic hydrocodone with APAP. The brand name is Norco. We launched it in December. IQVIA data for that product is $300 million. I will say a few more words during the Q&A about opioids and the sale of opioids and the status of opioids.

Generic codeine with APAP launched in October. The brand name is Tylenol with codeine. The IQVIA reported annual sales of over $40 million. Generic Methotrexate launched in August. This product used to be in shortage. It's no longer readily available now. The IQVIA report is about $60 million of annual sales.

Additional products that will be coming in the next few months: Oxy-APAP, the generic for Percocet, and Methadone. For everyone to understand, we had a schedule of getting a product to the market every six to eight weeks till we got to the prize, which is Vyvanse. That's when that is consuming all of our time. So now we focused on what is important: amphetamine IR, amphetamine and Vyvanse. And the launches for the other two products took a backseat.

These two products will be rescheduled and are being worked on they just are not top priority. And I will address the dates, at least for Oxy, in my comments later. The most important product up to date for Elite has been Adderall IR, which has IQVIA annual sales of $400 million, and the generic Adderall XR, which has IQVIA reported annual sales of over $800 million.

We continue to see strong market demand for these products, and we are in a very good shape for these products. IQVIA lists Elite market share for the past year for the IR, amphetamine IR, at 17%. You understand how many players are out there and how big they are some of them are 100 times bigger than Elite. Yet Elite is one of the top leaders in sales of the IR. And for we command 13% through our sales and 3% through Prasco, 16% of the market for the amphetamine.

For a small little company, that is an unbelievable achievement. And it is not a single event in space and time. We have proven it time and time again for the past two years. Azathioprine, Trimipramine, and Phendimetrazine are smaller products, but Elite also has a strong market share that we maintain in all three of them.

We also have our partner Dexcel that we contracted with to sell amphetamine IR in Israel. They got approval last October from the Israeli Minister of Health. They will launch the product as soon as they finish going through the technicalities. They will provide the sales, marketing, and distribution for this product, and we will manufacture them, package it.

They'll pay us transfer price and we'll have profit sharing. They have not launched the product yet because they are still going through labeling in Israel, they have to go through complicated labeling in Hebrew, English, and Arabic. Okay? And we're working with them on that my guess is that we'll probably launch it toward the end of Q2. Elite will be selling all of our products exclusively under our own label by later this year, except overseas. Okay? Dexcel will continue to sell with Dexcel under their name.

Currently, though, we do have two licensees. Okay? Prasco, who has a non-exclusive license for amphetamine and that ends on March 31, 2025. Prasco has been selling amphetamine under their Prasco and Burel Pharmaceuticals label. After March 31, however, Elite will sell amphetamine exclusively under our name and our label.

At Precision Dose, who has a license for generic naltrexone and phentermine, they sell under their TAGI and Precision Dose labels. Their license will expire in September, and Elite will sell these products exclusively under our label as well.

Under development, we have two ANDAs right now. Generic oxycodone whose brand name, of course, is OxyContin. This is a Paragraph IV filing, and so we need both product approval and the settlement of the remaining Purdue product patents prior to commercialization. The Paragraph IV patent lawsuits remain, as we discussed in the last phone call or in the last conference call, and it depends on the stay and Purdue's next move and the court's decision.

Purdue most likely will appeal to the Supreme Court by the end of March. They will ask for something called the writ of certiorari. It is highly likely the Supreme Court will reject it. If they do, it'll take about six weeks to do that. But regardless, we don't know if Purdue is going to come up with another patent that they claim everybody's infringing on and start the cycle over again.

We wait to see, and we're trying to minimize the cost and not to be too involved in the lawsuits. Let somebody else handle the dirty work and all the money, and hopefully, we will all share in the results later on. We have a generic dopamine agonist, ANDA, for treatment of Parkinson's under review by FDA. It is still under active review by FDA, FDA keeps asking questions, and we keep answering so we will let you know and update you once we get approval for either of these two products. Elite continues to make R&D a priority. We're spending a lot of money on R&D.

Also, reality is we're a small company that has a lot going on. Between the sales of amphetamine IR and all of the other products that we have and bariatrics and azathioprine and now the launching of the Golden Goose, which is Vyvanse.

The pressure on the lab and other departments to make small lots of R&D and stop the equipment flipover, make something there, clean the equipment, the process delays us by weeks. So R&D has not been moving as fast as I would like to. It's moving at lightning speed, but at Elite, lightning speed is not fast enough for us.

So I have been looking and contracting with companies to see if we can do some of the R&D work outside. In fact, I just returned from India, where I explored several companies that could help us in a financially meaningful fashion of doing some of the work that we could do at Elite, but we don't have the time to because commercialization is very important to us, and see how we balance that out. If this materialized and we get something going in there, we will update you hopefully by the next conference call. But it is really one of our best options to accelerate our R&D program.

Regarding the infrastructure, our 34,000 sq ft state-of-the-art inventory and packaging expansion is nearly ready, and I'm saying nearly for a reason. Our filing strategy was well received by FDA. We filed a CBE30 for a tablet and a capsule to show them that we can make both at this new facility after we obtained the approval for everything possible: DEA, OSHA, municipality.

And the FDA looked at the application and looked at all of our work, and it was undeniable. They performed an audit that's virtual and gave us approval between them and the center to proceed with the facility. And the reason I said nearly is because once they approve a tablet and a capsule, it means you can make either in there and all we have at Elite, we don't have injectables and what have you on liquids. We have tablets and capsules. Now we file a blanket CBE0 or a gratuitous amendment or just annual reportable and start doing everything.

Over the next two, three weeks, we will set the strategy, file it with FDA, and proceed forward. But the approval is done. It's valid. It's just a matter of now how to dot your I's and cross your T's and make sure you're ready if the FDA comes in for a full inspection. Beautiful facility one of these days, we'll have a meeting there and show it off to our stockholders.

This expansion not only took care of all the products we have now and we will have in the future for the next at least five years from the standpoint of packaging, but the fact that we moved packaging from the manufacturing facility will allow us to put manufacturing suites instead of the packaging lines, which are usually long, and help also our capacity in manufacturing as well.

Okay. To wrap up before we go to Q&A, growth is expected to continue in the future for recently launched products, including Lisdex and upcoming product launches, including Oxy-APAP and methadone. Elite is positioned as an attractive generic pharmaceutical company with consistent profits, steady stream, and low debt. Our fundamentals are strong. We are in the best financial position that we have ever been.

We have always targeted merger and acquisition and/or Nasdaq as our endpoint, and you all know I've been talking about this for years, and I refuse to reverse split the stock and go to Nasdaq before we have fundamentals because we did not have the fundamentals, meaning that I am certain if we did that prematurely, we will end up gravitating back to the OTC or worse, we'll go bankrupt. We will lose tremendous value. I have resisted that for years, even though it was the sexy thing to do. Everybody advised me to do it.

We were not going to do it now that we have strong fundamentals. It is time. We believe now is the right time for merger and acquisition or uplifting to Nasdaq. We have been quietly working very hard on this issue, and you should expect a PR about that sometime soon.

Let me go to Q&A. We had a ton of questions a lot of them were not germane to what's going on, so I took them out maybe we'll address them in the next quarter or not. I love people's curiosity and asking things about generalities, but some of them are way off base, and I took Diane's questions and consolidated them but reduced them also as well.

I'm still addressing quite a bit that is okayish and no problem we'll have a conversation about that, That's not going to impact us. Okay? The first question the person asks about a new product that is non-opioid pain medication.

It's called JOURNAVX, and the question is, what effect will recent approval of the non-opioid pain medication JOURNAVX have on Elite's plans to launch their Oxy pain medication, and there were three or four other questions about the same thing, including, are you working on non-opioid pain medication? We're not. Okay?

The effect of this new product, okay, remains to be seen, but I don't think it'll have an effect on us, and I'll explain why that's my opinion. JOURNAVX, by the way, is a sodium V channel inhibitor that selectively blocks peripheral pain-sensing neurons, so it doesn't work on the brain pain receptors. It's new.

Because it's new, it will take some time for it to become mainstream. It has to be tested, and we got to look at the side effects once you test it among a large population, which is going to take years. Second, it's a brand, and it's extremely expensive. So you think if you go to a doctor and take out your wisdom teeth, the insurance companies allow you to take this versus a Norco, a Percocet, or an APAP with codeine? I do not see that happening anytime soon.

Again, that's my personal opinion. Drugs like that, the insurance companies will not approve them very easily, and it's going to take a very long time for them to be tested so for the foreseeable future, my opinion is we're fine. Next question at the last conference call, Nasrat was speaking about one of the medications. I don't remember which, but he mentioned that they sold the total amount of their quota or of their allotment that they were allowed to sell in general.

Can you provide some additional color to the concept at this next meeting? My general question is, who is setting quota on how much we can sell and what? We're not allowed to sell as much as we want to sell for any given drug. The question is yes and no. It's yes for non-opioids for non-opioids, you can, as long as you're approved by FDA, you can sell whatever you want, as much as you want, to anybody that will buy it. But the answer is absolutely no for opioids. The DEA determines how much quota you get and therefore how much we can sell.

We are suffering through that right now, frankly. We have a lot more orders and sales than we have quota. It takes a while to get through the DEA and go through the process to try and get them to up the quota if they choose to. But the answer sometimes is no, you're getting nothing. Okay? A bunch of questions about approved procedures. Not sure what that is.

Update on the pending launch of imminent products, I believe. Update on the pending launches of approved generic Percocet, Oxy with acetaminophen. It's safe to say that we would launch it before April, by or before April. Okay? Can you please provide more color as to the opioid regulations and how it affects the whole supply chain?

The opioid regulations are insane, starting with the Quota and the process you get Quota and filing it with the UN and going through the DEA and the things you have to prove before you get it. After you do all of that, you have the states to deal with. It is said that we are one nation under God. It is true, but we're not one nation among ourselves. Each state acts and treats us differently.

One state lets us sell Oxy-APAP or Hydro-APAP or APAP with codeine on the same license that we have for selling drugs because it is drug. Other states bill us $50,000 a year in a fee. Every year we have to pay that. If you reach a certain number of tablets or capsules, then they penalize you $250,000. So you got to work out the details of all of that before you launch because you could end up launching at a loss from all of the fees that some of the states charge you. It is really insane. Turco is very careful with that. We're all very careful with that.

We're trying to manage it the best we can and make sure that we end up at the end of the day in the green. I have not had a chance. It's been very busy of figuring out from a legal standpoint if I can sell in some states and not others. I think I probably could come up with something, but it'll take a lot of thinking and a lot of court proceedings to get there. As of now, we're managing, Everything is good, but it definitely is arduous, and it's a very hard task to achieve.

Questions about Vyvanse? A whole bunch of questions about Vyvanse. Can you please provide more color around the Vyvanse launch? The DEA gave 24% more quota to Takeda in September, shortage of Vyvanse. Did they move some of this quota to Elite upon approval, or are we satisfied with the DEA quota for Vyvanse?

Does Elite have enough Vyvanse quota and access to reliable API, or are we experiencing or expecting to run out similar to most of our generic companies? The DEA gave Takeda a massive amount of quota, and some of the responses to us is that, yeah, we wanted to make sure that we deal with the shortage. That's their call. I will make no comment about that, I sell Vyvanse at a heck of a lot lower price than they do, maybe 10% on the dollar. But nevertheless, the DEA is in charge, and they decide how to allocate this.

They gave us quota, and the quota they gave us, we went out and solicited business, and I'm happy with that. Then we solicited enough business, and we don't want to sign contracts with everybody and have failure to supply. So before we started the process, we asked for more quota to just get a sense of security that it's coming.

Well, eventually, they gave us a little more quota, but they didn't give it to the API manufacturer. So even if I had quota, I couldn't buy it. So this is why we slow things down a little to make sure that we distribute what we have over our vendors and clients and do not get into trouble with failure to supply. It's a very tough thing to manage, and that's one of the reasons we just didn't dump it in the market on December 26th.

We need to make sure when the DEA gives you 12 bottles of quota, you plan to sell one bottle per month, and that's how you distribute. If you sell it all in three months and ask for quota again and they don't give you, you get hit with failure to supply and lose. So it has to be managed, and that's what we're doing and so far, with amphetamine IR, and Vyvanse, we have managed it extremely well.

Will Percocet be launched within six to eight weeks? As I said, no. Vyvanse changed all of that. We will launch that probably by April, no later than April. Partnerships. A lot of questions about Dexel. They are our partner. Are they going to get Vyvanse? Are we going to go global? Are they going to have more sales in two years? So let me summarize all of that with this.

Dexcel is our partner. We've been working with them for three years and accommodating them in any way we can so they can get the approval in Israel, and they did. Now they are working to get their labeling and marketing set, and we're working with them on that.

Along the way, they've mentioned that they're interested in amphetamine, and Vyvanse and other things. But one thing at a time. Let's go through one process successfully, then step and repeat. We can repeat it again and again but as of now, they haven't sold a single bottle, and I've invested three years in them. I want to make sure we get through this, we see some benefit, and then we'll talk.

But the opportunity is there, The market is there, We're dealing with them the best we can and accommodating them any way we can. New facility. Lots of questions about that, I already addressed that. Upon the final approval of the facility, it was already approved for expansion. When will that happen? Was the new facility approved? Yes, it was. Is it functional? Yes, it is.

Is the new equipment producing 120 bottles a minute operational, totally operational? Could you also follow up on what capacity and manufacturing we should expect from this facility? I will give you the generality of this for packaging. We do not have to think about it for years to come because the packaging line that we have and the one we're moving from the current facility, and we already plumbed it for a third one that we can install in a heartbeat. We are set for a very, very, very long time. Okay?

And it's good that it relieved us in the other building so we can change some of the packaging line space to suite. In addition, the new facility had a huge vault. We're keeping the old vault, of course, in Building 135, and we have another vault in the old warehouse so we're also covered very nicely for vault space for controlled substances.

All right. What else? Trump administration. Oh my God. Okay. What effect do you think RFK Jr. coming on board will have on our overseas sales with his health reform, wellness reform for mental health approach? Less drugs? Is it a potential issue on volume? I don't think anything is going to come out of this, honestly. There is a lot more than one thing to policy.

I'm not sure why the person who's asking the question mentioned if it's going to be an issue of volume. I do not see him asking us to give him a bottle of opioid for every bottle we sell. If he does, we'll have to discuss the price, But I do not see any effect in that. We don't make injectables, and he seems to be anti-vax.

Everything else we make is generic that helps the public, and he's in support of that, So I'm not concerned about that. The second seven, eight questions are all intelligent, important, and talk about the same thing, How would the tariff that Trump is setting hurt Elite, or would they hurt Elite? Do they affect the API? Do they affect the supply chain? Are we going to pass on the cost to the consumers, or are we going to eat it? So let me address that in a minute.

The API for opioids has to be made in the U.S., so there are no tariffs there. You cannot make opioids overseas and bring them here. Having said that, when I thought about this and I'm trying to protect us, there is a way it could affect us because the people who are making the opioids may have a raw material that makes opioids that could come from overseas. Okay?

So to date, all of my suppliers have said they don't see an impact yet because most of this material is coming from European countries that are not subject to tariffs, Italy, Spain, and what have you, and not from India and China. We will see when the tariffs become, what's going to happen.

Second, my gut feeling is I don't think that President Trump is going to put tariffs on medical products. That is not a popular thing to do, and it doesn't serve any purpose. Okay? We're trying to lower the price of drugs in America, not increase it. Okay? So it's highly unlikely that that's going to happen.

If for some reason certain products, the bariatrics or Isradipine or Trimipramine, Venlafaxine, products that we buy from overseas got affected, of course, we're going to have to increase the price. I sold it to everybody in the industry. Okay? All of our competitors, everybody is going to be impacted, so we'll increase that. So I do not see an impact on Elite in the short term under all of the tariffs that have been discussed to date.

If things change later and we start some kind of a turf war that has to do with medical equipment and medical products, then I will update you then as of now, I think we're safe. The last set of questions, the general questions, are about merger and acquisition and Nasdaq. Did you receive any M&A offers for Elite? Think of it this way if you have your house up for sale, people make you an offer, If you don't have it up for sale, nobody's going to come make you an offer. Okay?

So we have not offered Elite for merger acquisition yet, and therefore nobody's come and talked to us about it. Are there currently any companies interested in merging or acquiring Elite? Again, same answer. Is the plan to uplift to Nasdaq without any reverse stock split still intact?

This is a tricky question, and I'll address that in a minute. Is the timeline for uplifting to Nasdaq or acquisition merger still on track to be around August 2026? No. All right? So let me take a minute and talk about Nasdaq and merger and acquisition. We have been setting that as a goal for years now. And the first few months I joined the company, our previous chairman, who is extremely knowledgeable and well-connected in the industry, took me to a New York entity that wanted us to go to Nasdaq and have a reverse split and even have us on the Israeli exchange.

And I said no because I believe then, as I believe till recently, that rushing to do something like this is extremely detrimental to the stockholders. Now things are different. We have turned Elite around. We went from a company that almost went bankrupt because the FDA got turned down on the art technology, and we turned things around and now we're a viable company that has profits and revenues, and we are a leader in the industry on some of these products.

Our fundamentals are strong, and this is the time for us to seek out mergers and acquisition or Nasdaq. What would be the first step if we were going to do that? The first step would be you will sign up with a world-renowned company, the top companies in the country, Jefferies, J.P. Morgan, Wells Fargo, Bank of America, among others. And believe me, I've talked to them all. Then if you sign up with one of them, they will bring you suitors.

Then when the management, first-line management, my senior staff and I listen to these people and see that the offer is viable, it goes to the, or we have offers to entertain, it goes to the next level, which is the board of directors. Board of directors approve it. It'll go to you, the stockholders. The stockholders approve the purchase, the sale, the acquisition.

Then it'll go to the SEC, and that will be it. If we go through this process and we either don't get the right offer or we reject the offer, then the next step is Nasdaq. We have the fundamentals, We have everything that we need to go to Nasdaq. We cannot go to Nasdaq without a reverse split. Okay?

Now, I am not as concerned because we do have fundamentals before any hit, any little blip, and we would have gravitated back to the board and board but now we are a strong company with current products that will last for a long time to come and future products that are in the pipeline. So we have a business continuity, and I do think we can withstand Nasdaq right now.

So whatever happens, it's going to go exactly in these two points that I outlined. And the reason I said no to the last question is the timeline for uplifting to Nasdaq or acquisition merger is August 26th. It's not. The time is very near, We need to work on it now. Thank you, Matthew. And thank you, ladies and gentlemen. We look forward to talking to you again next quarter.

Moderator (participant)

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