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"Patience you must have," Sprot.
As usual, well thought out and insightful post Fabius... chock-full-of-wisdom... Please allow me to embellish it some.
I believe someone here is putting too much enphasis on the filing date:
3- to me Partnership is the word for the company's historical change; entity of the change depending on several different apsects of contract agreement
4- IPCI has some pending catalysts other than Rexista filing
I believe point 3 and 4 above could trigger a price jump that you'll never catch up with if you stay out of the stock.
unprecedented" epidemic of opioid painkiller overdose deaths.
http://www.aol.com/article/2016/08/26/the-surgeon-general-just-sent-a-worrisome-letter-to-every-doctor/21459520/
overdosing on prescription painkillers like oxycodone, fentanyl, and morphine.
Maybe Par Pharma would like to also sell a branded oxycodone.
Though a $12 buy out would be very nice right now
Special to The Life Sciences Report (5/11/16)
The key for us over the next three months is to file the NDA for Rexista™. We anticipate an FDA PDUFA action date within a six-month period, or by early 2017. We believe achieving this important milestone would open up other doors for the Intellipharmaceutics, particularly when it comes to securing credible partnering opportunities leading to the commercialization of Rexista™ on terms that are favorable or acceptable to us.
You would not say "on terms that are favorable or acceptable to us" unless you had already had offers that were NOT favorable or acceptable to them.
IPCI "may," "will," "should," "expects," "plans," "plans to," "anticipates," "intends," to develop certain products which Angelo "believes," "estimates," "predicts," 20K shares today "could," "potentially," "make," you a Millionaire in 3 to 5 years!!!
I've made a number of assumptions in the preparation of my forward-looking statements. You should not place undue reliance on my forward-looking statements, which are subject to a multitude of known and unknown risks and uncertainties that could cause actual results, future circumstances or events to differ materially from those stated in or implied by my forward-looking statements."
Boy this waiting for Godot is painful... kinda wish I could fall asleep and wake up in 3 to 5 years to see if my "beliefs," "estimates," "predictions," come to fruition.
Excellent post numbers - chock full of researched information and logical thinking.
Can/would you give us your assessment on Rexista's potential and what is your gut feeling re: the partnership structure.
but I still need to eat sometimes.
Remember the two approved now are the most common
I'm not surprised that they have not yet partnered Keppra... it is the least valuable one in their pipeline with at most a 25% potential of each of the rest of the indications... and as you can see by the delay in the Rexista NDA filing... TIME is at a premium as well as money.
I would not be surprised to see a total package done where one up-and-coming Generic Wholesaler/Distributor takes on the whole portfolio.
I think the key right now is a partnership on Rexista and or Regabatin... that... will totally change the landscape.
Effexor XR has low value. I think it costs less than $1 per pill. A months supply costs around $11 to $55, according to goodrx.com
WAY WAY WAY OFF!
There is no such thing as a $15M milestone payment or $40M minimum sales requirement.
There was a rumor several years ago about a $15 million milestone payment for IPCI on FDA approval - but it was only a rumor.
I believe IPCI did get a $3 million milestone payment on approval... I think, but they never disclosed milestone figures, royalty %ages or minimum sales requirements.
I did some figuring before Focalin approval and my guesstimate was that they would get a low of $10 million a year and a high of $20 million a year, for ALL 6 strengths - the 15mg is a popular strengths and accounted for about 25% of the total - since the 2 doses (15mg and 30mg) bring in about $4.5 million... I think it's safe to assume that when all 6 doses are approved they should get around $14.5 million... not bad...
Seroquel and Effexor may do as well for them, and the others should be at least half as profitable for them... so figure on $12 million each for those main 3 ($12M x 3 = $36 M) and $6 million each for the other 6 ($6M x 6 = $36M) that adds up to $72 Million in "Bottom Line Revenue" on just the ANDAs... and it should all happen within the next 2 years.
Everytime I do some figuring on what this company has, I become full of nervous energy regarding what it's potential is.
And I've always said it's not about the ANDAs - it's about Rexista and Regabatin - although the ANDAs aren't bad even just by themselves.
20K shares today makes you a MILLIONAIRE in 3 to 5 years.
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Doog....I'll take two of those ! LOL
Frugal... you're taking a risk on losing your shares... cheap.
I have often seen that a stock will take a quick and violent drop that can/will last no more than an hour before they turn it up never to look back.
MM are required to keep an orderly trading environment and they are given a heads up before news that would cause heavy trading - they see your stop loss, and all other stop losses out there - they'll bring it down to trip it and cause an avalanche of shares which they buy on the drop so they are loaded to fill demand... I've seen it often - if you believe in the science... I would suggest removing the stop loss.
Abuse-Deterrent Drugs: A New Investment Opportunity
http://seekingalpha.com/article/3999753-abuse-deterrent-drugs-growing-field#alt1
Not a mention of IPCI - which is why we are $2 instead of $6.00 - $8.00
I don't have time... but perhaps someone can raise awareness of IPCI in their comment section.
That was a buying spree at ~ 2:30 for about 85K shares in lots of 10K to 22.5K, and a second spree at ~ 4:45 for 75K shares in lots of 5K to 15K.
Maybe a fund finally taking a position.
Hell... you could get all you want for under $2.00 if you come across the border... no wall there right???
LOL
Geezzz... only a few years ago our dollar was worth .75 of yours - now it's the other way around.
A very insightful post from the past which I think is well worth repeating.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=119987128
JJAAMMAANN Member Profile JJAAMMAANN Thursday, January 21, 2016 12:27:00 PM
Re: AngeloFoca post# 14447 Post # of 17000
I've been dabbling in the Pharma world for a few years now...some good investments, and some not so good. This one looks pretty promising with low share count, and lots of promising irons in the fire. It seems with all the "Behind the scenes" work being done here that any number of catalysts could take the Share Price to well over $10 in a matter of hours. If any big IP comes in and buys up shares, the float will be severely limited and this will really take off.
I'm still reading up on the company, but have take a small stake of $5,000 for now. If I like what I see/read, I will buy more. With a lows near $1.75, and Highs near $4.00 the opportunity to get in and get out quick and make a descent profit along the way are apparent too...but take your chances because if you pull out too early you may miss the train leaving the station when a partner is named with one of the products in the pipeline...
Seems Very Exciting here....
Best Of Luck!
In My Own Personal Opinion Of Course!
Got this from the CPXX MB - note date, stock was selling at under $2 bucks
port077ver • Feb 23, 2016 10:58 AM
be patient , you can buy at 1.20-.50 next week
i sold all
couple weeks later it was selling at over $30.00
How do you suppose he feels now???
A buyout offer for 20X the market cap
If we (IPCI) had a signed contract with a pharmaceutical OR we had an FDA approval, my best guess is this statement would be changed to "more likely than not that its loss carry-forwards WILL be realized. But, I'm not a CPA.
Seems like the carry forward LOSS is somewhat less than my $60 million guesstimate.
http://quote.morningstar.com/stock-filing/Quarterly-Report/2016/5/31/t.aspx?t=:IPCI&ft=&d=29462cc0418ed017e87044b46827bc7d
page 17... 9. Income taxes
The Company has had no taxable income under the Federal and Provincial tax laws of Canada for the three and six months ended May 31, 2016 and May 31, 2015. The Company has non-capital loss carry-forwards at May 31, 2016, totaling $26,549,423 in Canada and $50,605 in United States federal income tax losses that must be offset against future taxable income. If not utilized, the loss carry-forwards will expire between 2016 and 2032. - The Company has provided a full valuation allowance on the Company’s loss carry-forwards as it is more likely than not that its loss carry-forwards will not be realized.???? Anyone understand this???
For the six months ended May 31, 2016, the Company had a cumulative carry-forward pool of Canadian Federal Scientific Research & Experimental Development expenditures in the amount of $12,408,000 which can be carried forward indefinitely. this one I understand
At May 31, 2016, the Company had approximately $2,710,000 of unclaimed Investment Tax Credits which expire from 2025 to 2035. These credits are subject to a full valuation allowance as they are not more likely than not to be realized. Boy... I find the language confusing!!!
On January 10, 2013, the Company completed a private placement financing of an unsecured convertible debenture in the principal amount of $1.5 million (the “Debenture”), which had an original maturity date of January 1, 2015. The Debenture bears interest at a rate of 12% per annum, payable monthly, is pre-payable at any time at the option of the Company, and is convertible at any time into 500,000 common shares at a conversion price of $3.00 per common share at the option of the holder.
Dr. Isa Odidi and Dr. Amina Odidi, principal shareholders, directors and executive officers of the Company purchased the Debenture and provided the Company with the $1.5 million of the proceeds for the Debenture.
Effective May 26, 2016, the July 1, 2016 maturity date of the Debenture was extended to December 1, 2016.
Hopefully a nice up front payment comes in for the Rexista partnership by Dec 1, so this debenture can finally be put to bed.
http://ir.collegiumpharma.com/phoenix.zhtml?p=irol-eventDetails&c=253995&eventID=5233422
Here is the Collegium Conference call - 1/2 hour well spent - gives insight into what marketing Rexista (by it's partner) will entail and some related details.
21% of scripts are currently ADF formulations
20 million scripts a year are now NON ADF immediate release formulations.
3 additional ADF formulation FDA approvals are expected this year. I know 1. Egalet, 2. Pfizer... the other ???? IPCI ???? I don't think they are insinuating Remoxy???
This is my understanding regarding the Pain Medications out there, and would like to hear if someone has a better or different understanding.
When numbers like $2.5 Billion market are tossed around for Rexista... those numbers specifically speak to the Oxycontin market share of the Pain drugs out there... as you can see from the chart for sales up to end of 2013. 4th Qtr 2013 = $585 Million = ~2.34 Billion yearly.
https://www.drugs.com/stats/oxycontin
There were additional sales of immediate release Hydrocodone as you can see from the chart for sales up to end of 2013. ~4th Qtr 2013 = $264 Million = ~1.05 Billion yearly.
https://www.drugs.com/stats/acetaminophen-hydrocodone
So Rexista's #s often expressed here on this MB are for it's potential against Oxycontin only - the other immediate release Hydrocodone players can continue as they are whithout it being a concern for us.
However... I think that those immediate release indications will be taken off the market within a couple of years... so if by that time, say Rexista has captured 25% of the Oxycontin pie... then it will get an additional boost by getting 25% of the additional $1 Billion becoming available... or an additional $250 Million.
Now, there are complexities such as the $1 Billion of generic Oxycodone products would translate to probably $5 or $6 Billion in branded product - but I believe that as a condition for taking the generics off the market, the ADF formulation manufacturers will need to come down in price, where the insurance companies will agree to, or be required to cover them... so in short, the "Pain Meds Pie" will stay the same size, approx $4 to $5 Billion, and it will initially at least, be divided amongst 5 or 6 players, and I think that eventually Rexista will get the lion's share of the pie.
So... eventually... This part is for "numbersarefun" - $1.0 to $1.5 Billion market share x 25% to 30% royalties = $250 to $450 Million PURE PROFIT to IPCI divided by 40 to 50 million shares (what I think IPCI will have by then) = a low of $5.00 to a high of $11.25 in earnings x 15 to 25 PE = $75.00 to $281.25 per share... on Rexista alone.
There you go Doog!
p.s. - for the conservatives on the board - OK - cut all that in half - $37.50 to $140.62 per share... on Rexista alone.
20K shares today makes you a millionaire in 3-5 years!!!
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The NDA route also provides IPCI with exclusivity for 5 years as I recall.
Sale of other Oxy products will certainly continue.
I like sitting silent and reading others posts
https://www.quora.com/What-is-the-profit-margin-on-drugs-sold-by-pharmaceutical-companies
What is the profit margin on drugs sold by pharmaceutical companies? just the profit margin on physically producing the drug at a "drug manufacturing plant"?
It can vary very widely. Say starting from 5% to may be 95%. It depends on the demand and competition. Some medicines are very profitable and can fetch the manufacturer about more than 70%- 90%.
Based on examples that I have first hand knowledge of as well as colleagues of mine in the industry it is often 80-90% but can be much less for mature products that have more competition.
Hey numbers... you're good with the numbers.
Thanxs for providing us with a comparable "real life" case to give us a realistic picture of what can be expected for Rexista in say 2 to 3 years down the road.
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then of course if say 40 million in profits is seen its then split.
However that $20 million in royalties ..... IF PROFIT TO BOTTOMLINE, requires taxes to be paid
How will new development and clinical trials of other candidates be paid for ???
nPODDDS™
The nPODDDS™ technology platform is designed to provide for certain unique drug delivery features in a product. These include the release of the active substance to show a divergence in a dissolution and/or bioavailability profile. The divergence represents a point or a segment in a release timeline where the release rate, represented by the slope of the curve, changes from an initial rate or set of rates to another rate or set of rates, the former representing the usually higher rate of release shortly after ingesting a dose of the drug, and the latter representing the rate of release over a later and longer period of time, being more in the nature of a controlled-release or sustained action. It is applicable for the delivery of opioid analgesics in which it is desired to discourage common methods of tampering associated with misuse and abuse of a drug, and also dose dumping in the presence of alcohol. It can potentially retard tampering without interfering with the bioavailability of the product.
If controlled release lasts 12 hours... I'll agree with Doog... $100 a share within a few years LOL.
10K shares now makes you a millionaire in 3 to 5 years, LOL.
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http://www.intellipharmaceutics.com/technology_portfolio.cfm
We are so wrapped up in Rexista... and rightly so... that we forget about the plethora of other drug delivery platforms IPCI has.
We need to get a healthy partner for Rexista and Regabatin... decent up front money so we're cash rich and can start hiring some product developers... dreamers that can think up of what products on the market today can be enhanced by which of IPCI's extended release platforms... and some scientists that can see it to fruition... under the Odidi's tutelage.
IPCI can become HUGE
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http://www.intellipharmaceutics.com/hypermatrix.cfm
Hypermatrix™ is a novel concept based on hyper-dimensionality in which a drug matrix assembly is defined as five dimensional in nature: length, height, width, space, and time. The understanding and controlling of properties associated with these dimensions facilitates time-release delivery of a wide range of pharmaceuticals.
Our Hypermatrix™ technology works within the human body, responding to the multivariate external environment of the Gastro-Intestinal Tract (GIT), releasing active drug at the desired time and according to the desired profile. This is achieved with:
Spatial Recognition and Control of the optimum GIT site for drug release
Defensive Control over adverse factors such as food effects or excess acidity
Temporal Control over the time when drug release commences or ends
Structural Control over the physical characteristics of the solid dosage form from ingestion to full release
Rate Control over the entire release profile to deliver true intelligent extended-release
I think the rate control is what is going to make this a "best in class" drug... besides the fed/fasting advantage.
I still believe the FDA is very interested in seeing if Rexista, once it gets the initial pop of drug and then turns into a steady state release... if that steady state is maintained for a full 12 hours
If so... Goodby Oxycontin.
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Whoever it is... I hope they are negotiating with at least 2 potential partners... that would pretty much guarantee that they are getting appropriate value.
Their cash reserve, or lack of, does not put them at a strong negotiating position... but the fear that the "other guy" might get it, is a an extremely strong motivator.
Ever been to an auction where 2 people want the same "used" product and the winner winds up paying more than what it would have cost him to buy it new LOL.
I think a healthy partnership will really put this small biotech on the map.
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IPCI is developing a technological Platform, which should attract some Big Pharma
Not sure when their PDUFA date is.
Negotiating Partnerships on a product is rather common and basically follow well established practices.
First an assessment is made on... what the market potential is... what are the likelyhood of that product achieving that potential... when might that potential be achieved, and how much will it cost in $ to assure it achieves that potential.
One of the factors in a partnership is the royalty percentage - I once gave what expectations are on those, based on how far along the product is towards commercialization. At the stage Rexista is at... NDA submitted FDA approval not yet received... I would say the royalty % will be 20%-25% for up to $1 billion aggregate sales 25%-30% northwards of $1 billion aggregate sale if/when that figure is achieved.
If Partnership is AFTER FDA approval I would bump those % figures up by 5%
There will be milestone payments along the way - my guess is $40 to $50 million up front, plus an additional $50 million on FDA approval, + $100 million on achieving $1 billion aggregate sales and perhaps an extra $25 million if those sales goals are achieved before a certain date. I would guess another $100 million on achieving $3 billion aggregate sales.
As you see such a contract protects the sales partner if Rexista proves to be a dud, but also rewards IPCI if Rexista achieves great success... and of course there will be minimal sales clause or loss of contract with a return of sales rights along with a severance payment of say perhaps $50 million to IPCI.
So all of the above is standard practice and common occurrance... BUT... we do have a problem which will, or has, murkied up the waters, and I have no idea as to how it's going to be handled.
Supposing everything goes according to plan and 3 years down the road Rexista PODDS has sold over a billion $ worth, and is selling $750 million a year and well on it's way to that $3 billion aggregate sales milestone... another word, a great success... BUT... over the hill comes Rexista PODDS + PODRAS... WHAT THE HELL HAPPENS THEN!!!
I have no idea how they would handle that - of course you can build into the contract that the current partner gets "rights of first refusal" but who decides what that new partnership is worth - supposing a new entity makes a "wild bid" for Rexista PODDS + PODRAS, what happens then???
These things will all have to be ironed out BEFORE Rexista PODDS is partnered and you can't pull out template A and just change the #s a bit... although I imagine similar circumstances have been resolved before, so that there is some precedence.
Mostly what I'm saying is that IPCI's Rexista PODDS partnership is not such a cookie cutter format... and can become, or is, quite complex.
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“Some men see things as they are and say, why; I dream things that never were and say, why not.”
20K shares today makes you a millionaire in 3 to 5 years!
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they holding something back wath we don't see and therefore institutionals aren't coming in.