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This is why Vyvance has a much larger potential market. With what Elite might be able to do to develop a Vyvanse ANDA puts it in great position to capture market share early. As for the reason to engage PFE in some discussion? Not sure. Still, in the link you shared there is this highlight that indicates Elite might be able to create its own ANDA...
But because Vyvanse requires a rate-limited step of enzymatic conversion to become active amphetamine, it may be harder for users to achieve the desired surge of euphoria, even if they snort or inject it.3 In fact, a study in the Journal of Psychopharmacology found that when Vyvanse was administered via injection in doses as high as 50mg, it did not produce significant euphoric effects. On a “drug likability” scale, subjects felt a much greater drug-like “rush” from d-amphetamine than from Vyvanse. The study also noted that it was very difficult to extract the active amphetamine from the product through crushing.4
This could, therefore, discourage people from abusing it. The journal Pharmacy and Therapeutics noted that Vyvanse’s structure as a prodrug may offer a lower potential for abuse and reduces the risk of food or drug interactions. It is also the only stimulant with FDA-approved abuse-deterrent labeling.
AS I stated in four words there is no negotiation
To use a medical term, this is in contraindication of business facts...and fails to grasp how things are done in business, the process for communication, or how a CEO (in this case Nasrat) would want to be perceived. We are talking about one of the biggest pharma companies (PFE) being approached by a very small company (ELTP). In fact, the egos of CEOs (of big or small companies) cannot tolerate personal rejection. That is why this particular matter was done through an emissary.
In whatever the manner the process may have been done is not the question. The salient question is - What was the basis for the approach? A small company emissary cold-calling a big company does not get beyond the gate keeper who protects the decision-makers. Due to this, we can surmise it was not a cold-call without predicate and, as it was out of the blue for investors, Nasrat had no reason to mention it. This means there must have been an initial interaction that induced the outreach for which there are, were, or will be some additional discussion.
Still, we may hear nothing more at the next CC. Not because no one would have asked (I intend on doing so), but because nothing came of it. In that case, I can only say to Nasrat - that was an unforced tactical blunder. But he should know that, which means this is an interesting point of contemplation for investors. However, moderation is warranted. These are not negotiations. Based on what we heard on the CC, they can be classified as inquiries. Always a good start.
I have long made a living by parsing words, which is not splitting hairs nor cutting them...so, let's look at the key phrase offered by Nasrat...
We contacted Pfizer as recently as couple of weeks ago via our business development, and intermediary.
No, Nasrat did not...
He mentioned that Elite Business Development met with Pfizer - not us...
What I'm trying to tell you here in simple terms is that anti-abuse technology is constantly on my mind. Frankly, someone asked about us contacting Pfizer to make COVID-19 tablets or capsules. We contacted Pfizer as recently as couple of weeks ago via our business development, and intermediary. But it wasn't about COVID. It's about our technology, because that is one thing that I do not talk about, because we have not gotten anything that we can report to you guys on. But it is definitely always on my mind.
What news?
WTF!!!!!!!!!????????
Which is it?
takes time for revenues to flow in. Expect a modest increase over last Q.
It is my expectation that the next quarter will be within the ballpark of this quarter revenue wise. We are on target to surpass last year's performance.
Excellent information...
Lisdex is the API for Vyvanse®, the leading branded pharmaceutical product for the treatment of attention deficit hyperactivity disorder (ADHD), with FY 2019 annual sales surpassing $2.5 billion (now ~ $3.7B). Patient demand for the generic version is expected to be strong after the patent expires.
Although I mentioned this to Dianne in one of my more recent pre-CC questions/observations, a generic Vyvanse has to be one of the drugs on the list Elite is developing, as it will be coming off patent in 2023 and fits the two-year window you have discussed. Not lost on the learned, you well know it has a global market greater than Adderall and Concerta combined and by a factor of more than 2X.
Still, Elite will not be the only company seeking to enter the generic market for Vyvanse. Others are already set to compete. Having lost in court to overturn the patent, the following companies have submitted ANDAs with the FDA for a generic version of Vyvanse and are likely waiting for 2023 patent expiration:
• Amneal Pharmaceuticals
• Roxane Laboratories
• Sandoz, a subsidiary of Novartis
• Mylan Pharmaceuticals
• Actavis, which is now part of ABBVIE
You didn't mention the Pompano Beach, Florida Office Lease that ends on October 31, 2023.
Nasrat said 4 ANDA's for calendar year 2022 and 4 more for calendar year 2023.
Q4 2021 call: I can tell you today that our goal is to execute four clinical trials and have four filings in 2022. Let me repeat that, our goal is to conduct four pivotal clinical trials and file four ANDAs in 2022.
Q1 2022 call: Our goal is to pass and/or file 4 ANDAs before December 2022. You can do the math and determine how many ANDAs we must be working on or have worked on to get 4 viable ANDAs in 2022.
Q2 2022 call: And the last one (question) is Elite still on track for filing four ANDAs in 2022? The answer is yes, we are doing well and on target.
So you think we wait another 2 years
Can't remember if you posted yet on Nasrat trying to DUMP his Mikah Pharma address just 3 days after the August CC
While the PFE story is intriguing, it is speculative. Reasonable? Perhaps. But investors need to make sure they correctly frame the story. Nasrat has become most careful about what he says and, to be crystal clear, he never said he met with representatives from Pfizer. From the CC transcript...https://seekingalpha.com/article/4470089-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-on-q2-2022-results-earnings-call-transcript
here is what he said...
What I'm trying to tell you here in simple terms is that anti-abuse technology is constantly on my mind. Frankly, someone asked about us contacting Pfizer to make COVID-19 tablets or capsules. We contacted Pfizer as recently as couple of weeks ago via our business development, and intermediary. But it wasn't about COVID. It's about our technology, because that is one thing that I do not talk about, because we have not gotten anything that we can report to you guys on. But it is definitely always on my mind.
So insurance is a major problem for us. They insure us on everything else, but they will not insure us on opioids. They call it opioid exclusion. So they give us product liability, we're insured right now for Elite. But if we do opioids, then that section is not accepted. Okay. And we will have to fend for ourselves and pay for that ourselves. So that's the second thing. And the third is finding a sales and marketing partner who's willing to sell these products and risk themselves also for lawsuits and insurance issues. That's been our issue
So by the way, for example, if we were working on Oxy ER anti-abuse, if Pfizer did not. The profits from such a product will be high enough that I would be willing to take the risk. And I would launch at risk. And there are a few other things that I have already thought of that we do to mitigate that risk. But I definitely would be willing to take a chance if there was enough money coming in to hire the best lawyers, I know that we can pay them and at the end of the day, we'll end up prevailing because in my mind, I know which steps we need to go through to prevail during these lawsuits.
The answer is yes, we are doing well and on target. We have a product that's filed and we expect approval in Q1, Q2 of next year. We have multiple products at different stages of development, couple of that will be ready for clinical trials within the first half of next year and a couple will do them probably during the second half, part of it be the formulations will be more ready and part of it also financial. We also have other development products at the formulation and stability stage.
Let's talk about this...
Plus, the track record of return on R&D is quite questionable.
Return on research capital is a component of productivity and growth since research and development is one of the ways companies develop new products and services for sale. This metric is commonly used in industries that rely heavily on R&D, such as the pharmaceutical industry.
Return on research capital (RORC) measures a firm's revenues generated from R&D activities.
Return on research capital (RORC) is calculated by dividing current gross profits by the prior year's R&D expenditures. It usually takes more than one year to realize the return on R&D; sometimes, it may be realized over more than one year.
The following is from a WSJ story from 12.21.21…
Since early November, the most speculative stocks have been crushed, even as the wider market reached new highs. Among those losing 20% or more: The “meme” stocks of GameStop and AMC Entertainment, electric-car maker Tesla, hydrogen darling Plug Power, bitcoin and a host of tiny unprofitable stocks. The businesses have little in common, but all have high valuations that rely on buyers willing to bet on a story—and have benefited from the surge in individuals trading stocks. No one buys GameStop, let alone bitcoin, because of a discounted cash flow model. Still, the value of speculative stocks and crypto depend on stories, not on reported earnings. It is about what is possible, even if not probable.
Thanks for the comment and my response is - Perhaps. However, the reality is that a reverse at these prices puts a ceiling on the return. Having failed to bankrupt Elite by preventing their access to LPC capital, the manipulation of the share price remains as an attempt to limit success. This leaves a single question - Cui Bono?
Suggesting Elite buyback shares is a misapplication of the process that makes sense for large companies but not for Elite.
A buyback done by big companies is done over a specific period of time and can often amount to 10-40% of the O/S shares...again, over a set period of time (usually 1-3 years). OBTW: Often the companies make these announcements but actually do not end up buying all the shares they say they will. After all, what retail investor is actually paying attention to that? And you might be surprised that the analysts care more about financial performance over time. Which brings us back to the reality of Elite.
So, if Elite decided to buyback just 10% of its shares at today's share price, they would be paying about $3.4 Million. That would be fiscally irresponsible for two reasons: 1) poor use of its limited capital and 2) a 10% reduction in O/S would be unlikely to have a material impact on the price.
The reported logic behind why big companies buyback shares is that they view their shares as underpriced and argue that the best investment they could make is to buyback shares rather than investing in its business development. Most of the time that argument is debatable. However, that argument cannot be made for Elite. The best use of its cash is business development.
Still, when looking at big company buybacks, what is often missing from the calculation by the retail investor - but not the company - is the company no longer has to pay dividends on the repurchased shares (because it owns them). For smaller companies not paying a dividend, there is no similar benefit. In fact, they can find a precipitous drop in the share price post buyback because they use up precious few financial resources on what is considered "financial engineering" as opposed to investing in fundamental growth. This can also raise questions of ill-conceived decisions that can diminish the credibility of management.
With the manipulation that Elite's share price already faces and the concerns expressed about Elite's management on this board, why would they take such a set of risks?
We investors do not want Elite to buyback shares. We want Elite to accumulate enough cash to buy the half of the SunGen portfolio held by Mikah. Now that would have a material impact on revenues. And that could happen in the next 4-6 quarters.
Im not gonna stand for what the CEO & Mikah are getting away with anymore. You might! But I'm not!!
Its time to take action!!
Elite Pharmaceuticals Inc. (“Elite”) signed a License and Distribution Agreement with Dexcel Ltd. (Or Akiva, Israel) to be the exclusive distributor
Actually...this is a mistaken application of the facts...
The deal was for one country and one country only
pproval by EMA takes place by using a centralized procedure that leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway.
Elite would have to get an euro approval to sell in Europe
Question: Do Dexcel's total revenues matter for Elite's purposes of commercialization? This is a company that distributes 69 unique products in 39 different countries. Is it not the commercial reach that matters to Elite?
Now that you mentioned it, that is correct! It is Dexcel's commercialization capability in EUROPE that matters to Elite.
Like the shell game, got to keep the eyes on the prize.
Good idea, still...
I emailed yesterday and pointed out Elite had PR'd their agreement with LCI on Adderall commercialization and, correspondingly, should PR the agreement with Dexcel. I went on to explain the other good opportunities for PR's that were missed (e.g., extension of the LCI agreement). I further explained that it needed to be news on the ELTP website rather than an SEC filing that is just part of the wallpaper. I also added the following...
While there are many shareholders who think the CEO should PR what he had for breakfast, I am more realistic and my realism understands that no small part of being on the OTC renders having the share price manipulated, which is due to a range of factors not the least of which is the lack of relevant news to capture interest. It is my hope that tomorrow I see a PR and I will be pleased.
Your point is that words matter and that is what I have been saying about looking carefully at what Nasrat says on the CCs.
Of course, understanding the language of business helps!
It all sounds reasonable...the point is Elite's CEO will have the company focusing on a generic Vyvanse because it makes business sense.
Trust me, Nasrat knows...
Why ask the board? Why not ask Elite?
As noted, this is a 53 year old firm with a good brand reputation and extensive commercial reach. The reach into new ex-US markets matters because...
The US ADHD (Attention-Deficit Hyperactivity Disorder) market size stood at $4.61 billion USD in 2019 and is projected to reach $7.15 billion USD by 2025. While the global ADHD market is expected to move from $29.56 billion USD in 2021 to reach $45.68 billion USD by 2025.
Let me add something to the mix...at open Elite was 3.2 cents and then a $570 transaction (~19,000 shares) dropped it to 2.8 cents. Anyone have an algorithm that makes sense of that?
Really? I thought the realm of sub-penny was for those companies that were near BK, had a broken business model, and/or were lacking recurring revenues. I guess AMC & GME have made it clear that closing locations and losing money no longer matters, it is emotions and a stock (not a company) that matters.
So...at its current share price Elite's annual revenues will be greater than its marketcap. And I thought that was such an important issue. Funny how the parameters for what matters to Elite investors keep shifting.
I have to ask if anyone can find a company that is and has been profitable for more than a year, selling on the OTC, with a marketcap lower than its annual revenues? I am a pretty good researcher but I cannot seem to find one. And I think if we throw sub-penny into mix the algorithm will break!
Retail bolder is bailing.
DD, glad you are still hanging around Elite...
Buy back shares? NOOOOO...that is a waste of money that should be better spent on R&D, business development, or acquiring the Mikah share of the SunGen portfolio, which is the goal and requires capital they are saving for that purpose.
What buyers of ELTP shares want to do has no impact on the longer term value of the business. I thought it is logically understood that the p/s has nothing...zero...zip...nada...to do with Elite's business valuation. As for holding shares, it has always been about the nexus between knowledge and courage.
OBTW: Should I be surprised there are no comments on the alleged year-end tax loss sales? No, because one thing I can count on is when some allegation is shot down, there is always something else to deflect to. Funny how that is...the effort to offer some explanation that seems good enough, until it is not because the facts are in opposition.
Right, tax loss selling in 15 minutes 1.5 M shares sold. Any retail investor would not be selling that number of shares in that short of time. At what point is it not clear Elite's shares are being manipulated?
I actually did a tax loss selling post three years ago and the answer was...
Once again, if we can agree that “tax loss” season is from November 1 – December 31, we can look at the p/s movement in that time since 2011 and what do we find?
2011: Nov 1-Dec 31, the share price move UP 20%...NO TAX LOSS SELLING
2012: Nov 1-Dec 31, the share price move UP 12%...NO TAX LOSS SELLING
2013: Nov 1-Dec 31, the share price move UP 33%...NO TAX LOSS SELLING
2014: (the year of the 97 cent pinnacle and 22 nadir) Nov 1-Dec 31, the share price moved UP 23% Twenty-three percent in a year when the swing was huge. Go figure!
2015: Nov 1-Dec 31, the share price moved DOWN 8% Which marks the ONLY decrease and it was single digits
2016: (the infamous CRL and what do we find?) Nov 1-Dec 31, the share price move was FLAT…zero. NO TAX LOSS SELLING
2017: A modest increase in the p/s…NO TAX LOSS SELLING
2018: So far, this month offers nothing but the same…NO TAX LOSS SELLING.
The price was bumping up a bit and it has been, but in less than a couple of minutes the volume goes from 745k to 2.065m and the p/s drops with no news. And we are supposed to believe there is no manipulation. Right!
I could not agree more. And in case there is any question about Elite's p/s being manipulated, I offer this again for reading pleasure...
https://www.griproom.com/fun/10-signs-your-stock-is-being-manipulated
Question: Why is it that there are efforts to obscure the reality that Elite is profitable?
Answer: Because to derail the conversation is to make it about anything other than Elite's success. The longer that reality gets denied or derailed the longer the effort to manipulate the stock is viable.
It is important to understand what is meant when I say Elite's EARNINGS BEFORE INTEREST, TAXES, DEPRECIATION, AND AMORTIZATION. So, let's look at the numbers and perhaps it will become clear...
The insert below is from Elite' Q2 2022. Please note the line that says income BEFORE TAXES is larger than the number of the line that says net income. That its the point...EBITDA is higher because it is BEFORE EXPENSES ARE DEDUCTED...However, when they are the BOTTOM LINE THE NUMBER IS SMALLER BECAUSE NET INCOME is the profits of a company that are left over AFTER ALL EXPENSES HAVE BEEN PAID...NOT BEFORE! https://www.myaccountingcourse.com/accounting-dictionary/net-income#:~:text=In%20other%20words%2C%20net%20income%20is%20the%20profits,have%20a%20net%20loss%20instead%20of%20net%20income.
AND HERE IS THE SLICE OF ELITE MORE RECENT 10Q FOR ILLUSTRATIVE PURPOSES. If there is continued confusion, it is not that I cannot help further, it is that...I will not!
I write when I have something to say that is strategy related, and I have the time.
That is correct.