Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
For the first time after 3yrs of being invested I feel stuck.
their fiscal Q3...which begins Monday right!
Kind of sad... not to ever know what it feels like to have "a full glass"... NO???
Wouldn't that be nice ! ! !
Angelo- You yourself said PAR has about 34% of the 15 and 30mg Focalin market. That market is $200M annually. 34% of $200M is $68M. IPCI is getting $2M or 3% of that $68M. 1% of the total $200M. I highly doubt they will get a 30-50% royalty on the Seroquel sales. Use common sense here. The deal is better on Seroquel but not by a factor of 10. Once again, $1M per month and maybe $1.25M and I will be jumping for joy with $1.5M per month.
But my estimates for Seroquel are coming in at $3M per quarter.
My numbers assumed double for margins .. yours is 3 to 4 times
Zoom- I am coming up with same as you- $3M per quarter on Seroquel
There is one major omitted calculator in your figuring... we'll use your figures and apply that calculator to see what really happens using your figures.
IPCI's royalty %age on Focalin is around 5% to 10%.
IPCI's royalty %age on Seroquel is probably around 30% to 40%.
So... on the minimum... if Focalin royalty now 10% versus Seroquel 30% then that calculating factor would be your $1.5 million per quarter X 3 or $4.5 million per quarter.
And... on the maximum... if Focalin royalty now 5% versus Seroquel 40% then that calculating factor would be your $1.5 million per quarter X 8 or $12 million per quarter.
Suddenly looks quite different than your figuring... but it's your figures with the one element you oversaw... and I certainly expect Seroquel royalty %age to be a minimum 30% to possibly 50%.
I think the biggest unknown in all this figuring is whether MNK is as adapt at capturing market share as PAR has been.
ps - I would cut these figures in half as PAR has I believe 34% market share on Focalin... the best I would hope for MNK with Seroquel is 16%, which is the fair share since there are going to be 6 distributors... so far.
I would imagine they would give them a "heads up" and pre-notify them that in fact they can begin shipping on May 1st... and not wait until May 1st to say OK you can ship now.
IPCI may already have been notified... and hopefully will PR it possibly next week... possibly Monday.
Has anyone ever experienced this kind of situation???
They notify the first filer before they are approved as to when exactly they can start selling... I would guess the same for all others.
There are 1,840 April 2017 PUT option contracts that are open - representing 184,000 shares which will change hands by end of day tomorrow.
Some of those shares will of course be from stock the PUT buyers have in their portfolios, and probably some of the PUTS themselves will be bought by the sellers... (16 have so far traded today) but I think several thousands of shares will have to be acquired on the open market... in order to deliver them on monday.
Not predicting anything, other than that many thousands of shares will change hands by end of day tomorrow.
3525 Call contracts representing 352,300 shares will all expire worthless.
The uptick in ANDA approvals and rejections for the latest fiscal year is thanks to almost 1,000 new employees that FDA was able to hire because of the Generic Drug User Fee Amendments (GDUFA), which is meant to help reduce the ANDA backlog.
And those reviews and approvals may pick up even more moving forward as, according to the GDUFA I performance goals (GDUFA II negotiations have recently concluded and FDA may push to eight-month and 10-month reviews of ANDAs between 2018 and 2022), FDA this fiscal year will begin to “review and act on 90 percent of complete electronic ANDAs within 10 months after the date of submission.”
What I see in IPCI that I do not see in some of these other hot stocks is many potential revenue streams plus some technology that could be a blockbuster. So I see less risk in IPCI.
Thanxs Mike... so I guess everything is a go for May 1st launch as long as MNK Seroquel gets final approval which is I think a given... in fact we should be hearing any day now, as they are not going to wait till last minute to say it's a go.
I'm guessing 20% for the PLUS in cost-PLUS so that's 80K added to the balance sheet next quarter.
I noticed this in their balance sheet
Change in non-cash operating assets & liabilities
Inventory
2017............... 2016
(402,974)........ -
Inventory $402,974 now and had nothing last year??/
Is it possibly $474K worth of Seroquel XR that they have manufactured for MNK ??? sitting waiting for May 1st distribution???
Only thing that makes sense to me... can anybody more adapt at reading balance sheets help with that???
I'm sure Naloxone (used to reverse the effects of narcotic drugs) will be within reach if blood test shows abnormally high concentration in bloodstream.
Someday soon... everyone will be saying remember when you could have bought it for $2.27???
(2) The Company entered into a separate acknowledgement and agreement with Drs. Isa and Amina Odidi dated October 22, 2009 to be bound by the performance-based stock option agreement dated September 10, 2004 pursuant to which Drs. Isa and Amina Odidi are entitled to purchase up to 2,763,940 of the Company’s common shares upon payment of U.S. $3.62 per share, subject to satisfaction of the performance vesting conditions. The value of the option-based awards are determined using the Black-Scholes pricing model calculated as at the award date
according to the stock option plan they owe a bonus on the first 5 to be approved
we are paying around 1 million on each of these approvals
for oxycodone hydrochloride immediate-release oral tablets
274,500 shares at the $2.56 ask.
My guess it's BS. Probably set at All Or None as protection.
If I had $800K I would take the whole thing.
We need an institution here to take one big gulp.
We've debated here as to what we can expect Rexista to capture in sales... and that it would be a slow process and heavily dependent on marketing etc.
I propose that "possibly" it will not be at all the case... and that capturing 20% of the market can happen easily and within a year.
Unlike Pfizer's Troxyca, Collegium's Extampa, Egalet's Arymo... IPCI's Rexista is BIOEQUIVALENT to OxyContin... that's right... it can market itself as a OxyContin GENERIC...
I was looking for a post from last week that stated the stats on sales of Seroquel XR by the 180 day exclusivity holder - ???Accord, PAR, Handel??? - but I can't find it so I'm going by memory.
I believe it stated that it had captured over 50% of the market share from Astra Zeneca... and market size came down to perhaps 70% ?
We also know that PAR with it's 180 day exclusivity on the 15mg and 30 mg Focalin XR captured 43% of the market from Novartis... and market size decreased to ~ 70% ?
Using those stats which are true to life... I think we can comfortably assume that Rexista XR should be able to capture - relatively quickly - at least 20% of the $2 billion OxyContin market - although it will likely do it at 70% the cost of OxyContin... so market will likely come down to ~ 1.4 Billion $.
Of course it sounds like a "pie in the sky" post... but WHY would the Focalin XR and Seroquel XR generics be able to capture half of the branded market and why would Rexista XR... essentially a generic OxyContin not be able to capture the same share or at least 20% right out of the gate.
20% of $1.4 Billion = $280 million to IPCI and partner - a fair share 30% to IPCI would = $84 million... ALL WITHIN A YEAR ! ! !
Wow... Collegium has really gotten beat up the last 10 days or so.
http://finance.yahoo.com/chart/IPCI#eyJjb21wYXJpc29ucyI6IkNPTEwsRUdMVCIsImNvbXBhcmlzb25zQ29sb3JzIjoiIzFhYzU2NywjZjAxMjZmIiwiY29tcGFyaXNvbnNHaG9zdGluZyI6IjAsMCIsImNvbXBhcmlzb25zV2lkdGhzIjoiMSwxIiwibXVsdGlDb2xvckxpbmUiOmZhbHNlLCJib2xsaW5nZXJVcHBlckNvbG9yIjoiI2UyMDA4MSIsImJvbGxpbmdlckxvd2VyQ29sb3IiOiIjOTU1MmZmIiwibWZpTGluZUNvbG9yIjoiIzQ1ZTNmZiIsIm1hY2REaXZlcmdlbmNlQ29sb3IiOiIjZmY3YjEyIiwibWFjZE1hY2RDb2xvciI6IiM3ODdkODIiLCJtYWNkU2lnbmFsQ29sb3IiOiIjMDAwMDAwIiwicnNpTGluZUNvbG9yIjoiI2ZmYjcwMCIsInN0b2NoS0xpbmVDb2xvciI6IiNmZmI3MDAiLCJzdG9jaERMaW5lQ29sb3IiOiIjNDVlM2ZmIiwicmFuZ2UiOiIxeSJ9
Note a comparison between IPCI, COLL, and EGLT - Click the different time frames - note that IPCI has done better than the others throughout the year and at least as well even further out.
Guess the others also don't keep their shareholders informed.
Timeline:
February 2nd - FDA accepts IPCI's NDA filing for Rexista.
By: February 22nd - Within 20 days of FDA acceptance... IPCI notifies Purdue of their Paragraph 4 challenge.
By: April 8th - Within the 45 day allowance... Purdue must file lawsuit against IPCI's Rexista for patent infringement... or forever hold their peace.
That of course... is the latest possible scenario.
If IPCI submitted the challenge on same day they received FDA acceptance (February 2nd) then the 45 day period Purdue had, to mount a lawsuit, would have expired last Monday March 20th.
Opening day trout fishing is Saturday April 9th - so if no news by April 8th, I will have a good time fishing.
1st quarter report should make for some very interesting reading.
IF... IPCI recognizes in the 1st Qtr filing, royalties from PAR's January and February's sales of the 25mg and 35mg...
THEN... we will probably show a profitable 1st quarter... my guess, 4 cent profit
There was some guessing on my part... but I believe that IPCI receives a 10% royalty cut during the 6 months exclusivity period... which then drops to 2.5% or 5% thereafter.
Angelo- If you look at the latest presentation on page 30 they say:
I think as long as we see a good 1QE showing strong Focalin sales
otherwise Rexista goes the way of Keppra and Glucophage
you are saying its OK to pay around 1 million per approval and then it not be commercialized?
Thanks cysonic... well put.
If you set goals and agree on a bonus for the achievement, you have to pay.
It is our first approved product developed in house at Intellipharmaceutics without the support or regulatory input of a development partner.
if they get approval, we owe millions in bonuses. what good are they if they can't get commercialized other than costing us more money?
clearly they were collecting ANDA fees in 2015 for prior ANDA's filed in 2012 as stated above. so I believe its reoccurring
just abandon save the annual ??? filing fee
Opana ER brought in $158 million in sales last year for Endo,
“Do the benefits of reformulated Opana ER continue to outweigh its risks.” That would be a big loss for Endo, as Opana ER is the company’s most profitable pain management drug. Poor Endo... maybe there's still a chance to nab Rexista???
William Blair analyst Tim Lugo believes that the likelihood of Opana ER being pulled off the market has increased
We believe that gross margins for Opana ER are in the range of branded products (>80%) I put that in there for those who insist on posting that margin on Rexista is in the 20% range.
Still doesn't make sense why Odidi canceled the conference on March 9.
I've been riding Genfit, on Paris stock Exchange.
it's head to head with Intercept to be first in the market for NASH.
phase3, pure development stage biotech, cash likely to last until final approval,
potential market it's huge, but company currently has no revenue, no earnings, just cash burn; if approved will be hitting the market in 2019 and the market cap is....
...980Mln euro, 31mln shares !!!
rumor of a potential ascquisition sent the shares from 20 to 35 Yesterday...
more than one here would say it was corretly priced at 10, where it was last october, beacause it has just uncertainties on its future, nothing sure.
Means they have placed a PO for launch
Yesterday, someone who works in a state institution for Drug Addiction told me the drug of choice that they prescribe now is Mallinckrodt's Roxycodone
http://www2.mallinckrodt.com/Brands/Opioid_Products/
http://www.rxlist.com/roxicodone-15-30-mg-drug.htm
https://www.google.com/search?q=roxycodone&ie=utf-8&oe=utf-8
Maybe MNK would make a good partner for Rexista XR.