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.
Mackie's estimates are $0.24 in 2017 and $0.78 in 2018. So there seems to be some disagreement among the analysts. Also, it is highly likely there will be more shares outstanding due to an offering at some point unless the upfront payment on any Rexista, Poddras and/or Regbatin partnership deal is quite large, which they could be.
Here is what the Mackie analyst said about Seroquel sales:
According to Symphony Health Solution, sales in the U.S. for 12 month ended August 2015 for brand Seroquel XR were approx.
US$1.2BN. We are assuming market size would decrease by 35% to US$780M per year after its genericization. We estimate IPCI’s
generic Seroquel XR would take max. 9% of the market and after that the market share would drop by 20% on yearly basis. We are
assuming a gross margin of 80% and that IPCI and Mallinckrodt would evenly split the gross profit. Our estimates of IPCI’s share
from its generic Seroquel XR sales in the U.S. from 2017 to 2020 are US$13.5M, US$21.2M, US$17.0M, and US$13.6M, respectively.
Maxim has a new report out with $0.39 in EPS in 2017 and $2.43 in 2018. Obviously, if the 2018 number is accurate, the stock will be in the $30's sometime in late 2017 or early 2018. Obviously, a lot depends on Rexista approval.
A research house called Aegis put a buy rating on IPCI yesterday with an $8 price target.
That would likely be a waste of corporate resources since there are so many players already selling Keppera. They just can't really add any value there at this point.
If Keppera was a true moneymaker, it would have been partnered as quickly as Seroquel. I suggest we just stop talking about it as it is irrelevant at this point. We have much, much bigger fish to fry and once some of that is in the boiler, you will never mention Keppera ever again.
There was no reason to mention MallinKrocdt's opioid franchise in this presentation unless there are signaling there is something more there. PErhaps the rumor that they are 97% done on a Rexista partnership deal is less fictional than we thought.
That buyout rumor from the other board is likely fiction, but it still sounds about right, in terms of the upfront and milestone payments. Something like that is probably on the horizon, even if the timing and specific dollar figures are not exactly right.
IMHO, it has nothing to do with MM's and everything to do with computerized trading. The huge volume you have seen these last few days reflects computers trading the same shares over and over again among themselves based on their algorithms which generate tiny profits for them on every trade but significant profits when considering how many trades they make in a day. Unfortunately, it does distort the market but most of the computers will go away before too long and the price will eventually end up where it is supposed to be, which is higher.
Very good news - Seroquel partnered quickly and a very needed $3 million upfront cash payment. That should mean the risk of a dilutive offering has been greatly reduced in the short term. The stock should pop nicely on this.
So, IPCI will trade about one-third of its 22.8 million float today. I can't imagine that one-third of the owners sold today, so quite a bit of the shares traded likely changed hands many times today. Which means it likely was a bunch of computers doing most of the trading and those computers likely know very little about the company or its long term prospects. Which also indicates our financial markets are operating sub-optimally. Nothing new, with any of that but I just wanted to complain about the current state of the financial markets and how they don't do as good a job as they could in promoting capitalism any longer because of mindless computer traders using hyper-short-term indicators to trade with one another to make pennies per trade. In the end, it is not a huge problem as the price discovery function of the markets is likely not overly distorted by it in most cases, but we would likely be better off as a nation without the algorithms causing so much trading over so little of a corporate event. I recommend taxing capital gains made in less than 1 second at a 99% rate and in less than one minute at a 95% rate. We need capital to be focused on the longer term if we are going to get good long run allocation of capital decisions.
Meanwhile, it was a very good day for IPCI and I strongly suspect there will be much better days ahead. I don't know if computers can have remorse but if they can, they will likely regret they had hold of IPCI shares on several occasions today only to trade them away before the really big news of Rexista filing, the grant of the PODRAS patent and a meaningful partnership deal or deals.
Total shares outstanding - 29. Total float - 22.8. Total short - 1.2 or 5.2%. Source: Bloomberg
They cannot use the ATM this close to the quarter's financial report.
Nice! This will send the stock higher and then there is still all of the other potential developments as well. BTW, we should have known that it might be an FDA approval as these typically do happen late on Fridays.
I am sure that given the stock's movement higher, the exchange may have been pressuring them to announce something. It could be positive or negative. If the company has negative news, it would likely want to get it out before too many people get hurt buying on unfounded speculation. If it has positive news, then the fact that the stock has been rising is an indication it has leaked into the public sphere and some were trading on inside info, thus pressuring the company to get the info out. I have no idea which way this could go so I believe we will just have to wait until some announcement is made. But the stock price rising is likely the best hint we have as to what we are going to hear. It is hard to keep deals secret.
Brean Capital out with a new report assuming coverage of IPCI with a Buy rating and an $8 price target. Not much of a report (1 pager with earnings model) but I suppose something is better than nothing. Nothing new in it that you do not already know.
The opposite is also true - what positive points have you brought up?
Why would the FDA give IPCI the ability to proceed without a phase III test if the concerns you raise are legit? Why would they wave the application fee? It seems pretty unreasonable to believe the FDA would lead the company down the path it has if the concerns you raise are so obvious. The overwhelming need for something to help on the terrible opioid abuse front is certainly causing the FDA to prioritize such drugs. Do you really think Rexista has no value in deterring abuse? Really?
Has anyone else raised this concern about Rexista or is this your own pet beef? And if it is only you, doesn't that seem a bit odd? Given the seriousness of the issue (people dying is pretty serious), you would think you would not be the only person in the world to raise this concern.
Since you are well informed of these matters, why don't you give us a quick review of each situation and how it applies to IPCI? Aso, you avoided some of the other questions I asked.
So if what you say is true, why would the FDA allow this drug to get this far without deep sixing it already? Are they that stupid? Why would they allow the trials to proceed in the first place if this is such a risk? And, if indeed they are aware of that risk, might they have determined that their was a greater risk from dying from an overdose than dying from the blue dye?
If you go to Briefingwire.com, you will see that anyone can post a release on anything and it will get distributed across the internet for free. In this case, the author is identified as "Doug B.". So, I would say that the possibility that Doub B. is intentionally manipulating the share price might be meaningfully greater than zero. If so, I hope the SEC catches up with him (should be pretty easy for them to do - just get his info from Briefingwire.com) and punishes him appropriately.
One thing is for sure from my perspective, Doug B. is almost certainly not a legitimate source.
That being said, there are many things that actually could happen that would be very positive for the stock, an acquisition being one of them. In fact, an acquisition may be the best way out for the Odidi's given the cash crunch the company faces. If Odidi truly wants to pursue the very interesting drugs he has developed, he needs money to do so, and a lot of it. IF he stays independent, he will need a really attractive partnership deal to do justice to what he has developed. I hope such a partnership is the way this thing goes as shareholders will likely do the best under that scenario in the long run. But the Odidi's could sell the company, gain access to the needed monetary and scientific resources to continue their work and get a lucrative contract that gives them further personal financial upside while shareholders would be left with smaller gains.
If you want to take a negative, cynical view of the situation, it could have all been a clever cash raising exercise. The rumor gets placed a week or so ago, then it is added to it with a little more detail yesterday, giving it further credibility. Oh, and make sure the rumor is planted near the end of the day to squeeze the shorts more and then keep the stock closed through the end of trading to make them sweat even more. As the shorts rush to sell, Dominic ramps up the ATM and, just like that, they have enough cash to make it another month or two.
This is not likely a true read of the situation, but it never hurts to consider the dark arts of corporate finance as a possible explanation.
The wording that they are "not aware of any development as of the date of this release" could be important. It makes it sound like something is up.
Release is out - the company is not aware of any corporate developments "At this time" to justify the stock's movement
UNfortunately, the Odidi's are more likely to get additional upside and we will be left with just the buyout amount, which is far less than any of us hoped for in the long term (but sure would be nice in the short term). That is just what often happens when the insiders control things.
Unfortunately, the company bet wrong on generics and it has cost them. They don't have a deal for Keppra and are unlikely to be even pursuing one. Mainly because there is no one to pursue at this point. The original bet on generics seemed sensible but the FDA and market forces undermined them. That is why the company has specifically pointed out in its presentations that it has switched its focus to NDA's.
Should any of the remaining ANDA's get approved, it will most likely be a relatively small bonus for the company and shareholders. If, on the other hand, the company gets Rexista filed, finalizes the patent for PODDRAS and works an attractive partnership deal that supplies it with much needed cash, the stock should really pop. If it just gets the first two but does not secure a nice, cash laden partnership deal, the stock will crater as cash will have to come from a dilutive stock offering.
So, it is white knuckles time for investors. It may not be for management as they may know they have several options to choose from regarding a partnership. Whatever happens, we should know within a couple of months or so.
I agree with a lot of what you said there, as indicated in my previous posts. Here is where I know you (and I suspect many others here) are getting it wrong, however:
1.) Ibalizumab has no side effects and no drug interactions. I am not sure why you think otherwise as there is no evidence to suggest that.
2.) Ibalizumab could well be a monotherapy some time in the future. Taimed's strategy has been to start at the low end of the market and work up. They have plans for a once per month version that could conceivably be utilized as a monotherapy but I doubt they would go that route, but instead would pair it with at least one other drug in testing as that is the normal approach in HIV clinical trials. Basically, CYDY has had a very bad clinical strategy to developing PRO 140 and it is costing them. Taimed has a very sensible strategy and that is why they are in the enviable position they are in. CYDY is still struggling to figure out the clinical path forward as all the struggles with the FDA indicate.
3.) Both PRO 140 and Ibalizumab work very well. Ibalizumab covers the whole HIV marketplace and PRO 140 only a portion. PRO 140 requires an expensive and time consuming tropism test while Ibalizumab does not (since it covers all HIV patients). That has been a problem for CYDY in terms of the cost of testing and the ability to find patients for its study. It is also why the company has been trying to get away from doing tropism tests but the FDA will not let them. IT is a big issue for them.
4.) Ibalizumab will initially hit the market as a once every two week IV but within a year will likely be available in a once every two week injection. The simply need to do a bioequivalence trial, which will take roughly six months and then wait for the FDA to approve it (assuming it shows bioequivalence which seems highly likely).
5.) Many here seem to be vastly underestimating the financing challenge facing CYDY. Its current balance sheet is a disaster with the massive number of warrants. They may be able to continue to find adequate financing via unconventional means but it will certainly be something that should keep current CYDY shareholders awake at night until they pull something off. It is going to be quite a while before CYDY has any phase III test results and longer still before the drug gets to the market and starts generating revenues, so there is a lot of money yet to be raised. The best bet for shareholders would be for CYDY to sell the rights to a well funded company and start working on its next project.
Both drugs work, but Ibalizumab has several key advantages and will have more as time passes. That is one of the benefits of being first to market, you can continue to improve your product while competitors work just to get on the market. Like you said, PRO 140 can still play a role in the HIV market but it has yet to demonstrate it has a clinical pathway to success. PRO 140 might make you a millionaire, but you will likely need to be a buyer of the stock after its last dilutionary stock offering before it starts generating revenues. While the current management team is certainly trying to find the right pathway to the market, the company's struggles with the FDA are a clear indication this is not an easy task. Still, since the drug works, one has to assume it will eventually find a way to help people. So, it is indeed possible that both drugs will one day be on the market and not really competing head to head.
They just filed a $100 million shelf offering with the SEC just after everyone went home for work on Friday hoping you would not notice it. They don't need that much money right away but they will easily need it to complete the two phase III monotherapy tests that the FDA almost certainly will require of them. It is only in special circumstances where this is not required, such as with a breakthrough therapy drug like Ibalizumab.
My previous post addresses the clinical path for the two week injectable version and the likely path for the 4 week version.
You should listen to Dr. Chen and realize the high risk CYDY is taking by trying to go the monotherapy approach. If it works for them, it could be a home run. If it doesn't, the company is bankrupt. The problem is, it may be bankrupt before that anyway unless this recent shelf registration can get them the money they need to do two large, long phase III trials for monotherapy.
You folks really need to look at reality. CYDY needs money to complete their trials but their current financial structure is completely untenable. They can't sell new shares with 55 million warrants out there unless the new shares are sold at such a low price that the warrants will never be converted to equity. At least they cannot sell shares in any conventional fashion. It is unlikely they can raise $100 million under any circumstance, but they may get enough through unconventional means to keep going for a while longer.
Second, what is the point of doing a P III trial just like the Ibalizumab one when Ibalizumab is already a superior drug to PRO 140 and will have a huge head start in the market over it? CYDY should be shooting for the home run on monotherapy as this is its best chance of making it. If a P III monotherapy trial was successful, the company could become quite valuable. It would take two phase III tests to get it approved and those tests would be large tests costing a lot of money. So, if you believed PRO 140 would have 2 successful P III monotherapy tests, which I think is possible, you should not invest in it until they have acquired all the capital needed to pull those tests off. If you buy before that, you are certain to be heavily diluted. Current shareholders are going to be diluted into the dust. The company may survive and the drug may make it to the market in 2020 or so, but current shareholders will not be enriched in the process.