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Well 1% market share is 51 million dollars in revenue. Lol.
If they match the percentage of the market they have with Adderrall IR (at least for April that they told us about), that’s $340,680,000 in revenues.
1 of 3 needle movers.
Yeah it’s in the CNS stimulant category.
Which drug has a market of 5.1 BILLION ??
Elite Pharmaceuticals Reports Positive Results from a Pivotal Bioequivalence Study
NORTHVALE, NJ / ACCESSWIRE / August 28, 2023 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company")(OTCQB:ELTP), a specialty pharmaceutical company engaged in the development, manufacture, and distribution of niche generic products, today reported positive results from pivotal fed and fasted bioequivalence studies for an undisclosed generic drug product in a class of medications called CNS stimulants. IQVIA reported annual sales for the twelve months ending June 2023 of $5.1 billion for the brand and generic market for this product.
The studies were open-label, randomized, balanced, single oral dose, two-treatment, two-period, two sequence, two-way crossover comparative bioavailability studies in healthy, adult, human subjects under fed and fasting conditions. The results indicate that the generic product is bioequivalent to the branded product. Elite is compiling the data for this product to file an Abbreviated New Drug Application with the US Food and Drug Administration. ...
Guess I was right, delayed results. Lol
Still has to cover so he/she/it has no choice.
I’m interested to see how much extra manufacturing space Nasrat is aiming for when it’s time to expand. Currently in a GMP building of 55,000 square feet.
Epic was acquired with nearly 215 employees and a GMP building of 110,000 square feet.
Congrats?
I take that as he will sell off just enough to get his initial investment out and let the rest ride.
I would assume so. He mentioned the 3 NMs in clinical stages but could there also be other large generics like those, maybe further back like formulation development or entering PKs? Sure.
If this plays out how we expect, there will be many big winners here.
Vegas trip still on the table?
Don’t think either of the other two needle movers could be any on that list except Vyvanse. Nasrat said they were in the opioid or stimulant categories.
I hope so. Much rather underestimate and be surprised to the upside.
“A few minutes ago, I got a call from Kirko the IMS or IQVIA data came out for the month of May, we just launched in April and we didn't have that much material to launch, because we were making everything for Lannett. And for the month of April, for the [Adderrall] IR, were on command with 6.68% of the market. I definitely expect that number to improve.”
IF this is an accurate annualized number, that means Elite pulls in around $22,378,000 on the Adderrall IRs alone.
Per the intro, Adderrall IR is a $335M market. Although we don’t know exact numbers because Elite doesn’t break down financials by each drug, we know the lion’s share of Elite’s revenues are from the Adderrall IR/ER products. Nasrat also expects the Adderrall ER revenues to increase by 1.5 - 2x next year, likely a combination of Prasco/Burel + Kirko’s efforts.
Now let’s think about the biggest upcoming products - Oxy, NM #2, and NM #3.
Theoretically:
Capturing the same amount of Oxycontin market share (6.68% of $517M) = +$34,535,600/yr.
Capturing the same amount of Concerta market share (6.68% of $1.15B) = +$76,820,000/yr.
Capturing the same amount of Vyvanse market share (6.68% of $2.53B) = +$169,004,000/yr.
^ This completely discounts any market share we will gain from the dopamine agonist and the antimetabolite products that are likely to be approved in late Oct 2023 and late Dec/Jan 2024, respectively.
Even if these above estimates are wildly high, think about this. If Elite gets just 25% of the above numbers + existing revenues, that puts us north of $100M in revenues per year. 2 of the 3 NM products *should* be approved by or before EOY 2024.
Accumulated experience and this guy to also assist with making sure FDA filings are done correctly:
WILLIAM SCOTT GRONER Quality & Regulatory Affairs Consultant
Scott Groner is Vice President of Quality & Regulatory Affairs at Elite. Scott brings more than 30 years of regulatory and quality experience in both the pharmaceutical brand and generic industry and includes extensive knowledge in regulations, quality systems, assessments, FDA submissions, compliance, and product applications for both oral solid dosages and sterile and non-sterile liquid products. In addition to six years of consulting in the pharmaceutical industry, Scott’s experience includes positions at Duramed, Pfizer, Schering-Plough and Warner Lambert. Scott received a Bachelor of Science in Chemistry from Western New England College.
This is a good point.
Did we assume this trial he referred to was a BE trial because he also stated we would file another needle mover (not Oxy) before EOY?
But, they have also announced PK results related to SequestOx when they typically don’t PR those types of studies at all.
So, me personally?
Either they withheld them for competitive reasons - want to keep competition in the dark for as long as possible (if only ~2 months, so be it) until filing. We do know this could be one of the largest generics Elite has ever filed for, maybe THE biggest?
OR
Could there have been a delay of some kind, maybe Nasrat didn’t get the results the next day like he thought he would? Could they still be announced next week or so? Who knows.
We should hear about the filing relatively soon in any case, assuming things went well.
Unless you think they were negative. I just highly doubt it.
They *usually* don’t announce PK trials and they clearly never formally PR’d the human insufflation study that we now know was positive. They withheld those results for competitive reasons.
YES I KNOW BE TRIALS ARE A DIFFERENT KIND OF CLINICAL TRIAL.
Point is, they clearly decide to announce some results and not others.
Either that (withheld them for competitive reasons) or maybe there was a delay of some kind and they still do plan to release them? No idea.
Could potentially get both these PRs in October:
Oxy filing acceptance news + FDA approval of a smaller drug filed last December, $12M market
https://elite.irpass.com/Elite-Pharmaceuticals-Files-ANDA-with-US-FDA-to-Market-Dopamine-Agonist-12-22-2022
Not half the interest rate but half the total dollar amount paid in interest because the loan balance is much less.
Because we have an idea but we don’t know for sure which generic is being trialed (and neither does the competition).
As much as I’d like to hear about it now, I can understand the decision not to announce because that also typically comes with IQVIA numbers, which gives us and the competition a pretty clear indication of which product it is.
As far as self serving decisions, there have been some. But there is also paying off loans to save what, 50%+ in interest costs? Does it really matter if Elite pays Nasrat or Wells Fargo if Elite is now paying half the amount of interest they otherwise would’ve?
Who do you think is more invested in Elite succeeding - a random bank or the largest Elite shareholder?
Doing a great job with the standard earnings filings and calls and not even announcing likely positive trial results that he could have announced this week…?
Yeah, what a P&D… /sarcasm
Who are these amateur clowns
News flash - I don’t memorize every post you make and clearly no one else does either as the question of exclusivity came up.
Same, much prefer it this way. The scumbags will always be here. At least now they don’t go totally unchecked on their garbage.
FDA update the timeframes or something? Link the sauce
Looks like Hikma has the first approval and 180 days Vyvanse generic exclusivity starting tomorrow, actually. 8/24/23
The OG Poorme is back in the call center and Jammy is on light desk duty after a particularly difficult goat.
Lol right? Stock has doubled or even tripled depending on which low point you look at earlier this year.
Run of the mill FUD and not even particularly good at it.
Lol I would take that bet.
You would agree though that strategically, if it helps us get a better market position for these larger drugs, even if withholding trial results to do so, that’s ultimately a net positive for Elite, right?
No reason to assume they failed. Similar to how they didn’t PR the insufflation results, they may be holding the cards on this close to the chest while they prepare the filing. Nasrat did mention on the last call - “we’ll announce filings and approvals.” Something like that.
I hoped they would release the results but if these CNS ANDAs are what we think they are, that means these are billion or multi-billion dollar drug markets. If them keeping a low profile is to establish a better market position at and after launch, I’m fine with that. More revenues should drive the price higher down the road than announcing trial results now, honestly.
Talking to yourself again? Weird
Low energy
Short cat is admittedly outta the bag now lol
Might as well cover, hang it up and move on
“All I have to do is figure out how to cover 16m share short”
Hopefully you go absolutely broke covering too.
No chance.
Almost 4 million volume in the first 30 minutes.
Sure beats the hell out of 10k shares traded for the whole day, 90k shares the whole day… :)
Sounds like that might’ve been the case with multiple partners. Nasrat specifically called out ones like TAGI, made it sound like they pull their weight and maybe we want to keep some of those arrangements in place.
Good to have a lot of our drugs being sold on our label by Kirko, sounds like he’s able to squeeze out more $ on both our larger and smaller generics.
Whew that’s a juicy one. We’ll hear about it upon filing at the very least.
Haha desperate