Mid Dec. would be the date to pencil in. But the FDA has been fast on some other HEP-C drugs, so do not be surprised to hear from them in the fall.
Regardless, this is not the real play here. Virtually everybody expects the drug combo to be approved. The question for valuation is on the commercial side where it goes head-to-head with the GILD combo coming out in a few months. So instead of the common "pop and drop" that one sees in cancer drugs, I would expect a modest reaction the the FDA decision, but then a nice run up through Q1 '15 as we see revenue numbers.
Though I am very anti-dividends unless a company has a solid balance sheet, there is an issue here.
CLV (the preferred) MUST get paid their 10% (or whatever). The common is now being paid the max permitted, and if they reduce of eliminate it then there is a bit of transfer of value from CLF- CLV.
Don't know if this is enough of a concern to factor into the decision, but it is legit.
First, any short can only go to 0, so the gain (on a single trade) is always limited tp 100%. People who post "Why would one short a stock at $X" just don't understand the concepts here.
Second, it will not replace local therapies (surgery and radiation), it has not been tested for such, and the concept just makes no sense. Yes, it has displaced some chemo use, but so do the new hormonals (X and Z) and they are clearly doing better at such than Provenge.
The line about "only FDA approved [cancer] vaccine" is ignorant, as there are many, and Provenge was not even close to the first. But if your info comes from a Y!MB, I guess that is what you get.
The drug has been on the market for over 4 years. It is losing a significant amount of cash and has no plans in place to correct that. And revenue is falling. Even if they eliminated R&D they are losing cash, costs more to make and sell the drug than they get for it. More competition is coming shortly.
Short/long does not matter here. Many are "talking their books" in the media.
At least he is straightforward and admitting he is shorting it. The majority of people quoted on CNBC et all who make recommendations are doing the same, and rarely do they admit that they are simply pumping/bashing a stock for personal gain. I find that far worse.
Don't really know why people care about these anyway. They are just like the sports betting touts; if they could really tell you how to win, they would not be doing so. They are either trying to make money selling their name, or make money by convincing others to do the wrong thing. They are #$%$.
Sadly (at least here in the US), it is not even illegal for your broker to give "advice" that is intended to benefit them or their company and not you. That sucks.
BTW, Chanos become a name player when he was very vocal in question Enron's books. In the meeting before admitting massive fraud, Kevin Lay called off the Q/A and explicitly said he would not provide a forum for people such as Chanos. But anybody with a clue knew Enron was BS, so this was no big find by him.
His fund took a serious hit last year, and is presumably well down this year (have not looked).
The royalty rate is a little unclear as it is both tiered, and also only on the ENTA portion of the cocktail (the latter itself is unclear). But one could be safe with a 5-6% of total ABBV sales.
Estimates for ABBV sales seam to run 3-4B/year. So we are looking at the 150-240M/y range. There are a lot of analysis who seam to be of the "GILD is God" mindset, so some may think the number will come in lower.
The kicker though is the there is also debate on how long the revenue stream will continue. To some extend there is a pool of existing customers that will drive this, and how that plays it is up for debate. And there are future gen products on the horizon (though ENTA has one also, so that can play either way).
So the present valuation might well be a risk adjusted $150M first year revenue. We lose the launch risk (slight as that is) by EOY, and have the first full Q in next winter. Hopefully all goes well, and we are sitting around $70.
Looking at the neulasta label, it was approved by showing non-inferiority on sever neutropenia against the non pegalated version, but also an improvement in febrile neutropenia against placebo.
Don't know if it is possible to run a trial against placebo any more in this indication.
Sorry, it would of course be neulasta.
Though the primary endpoint matures in 3 weeks, the secondary endpoint of febrile neutropenia (which is a marker for infection) matures in 3 months. This is key, as it is the basis of the FDA approval for Neupogen, and presumably would be such for 2012.
So I would expect they should be able to decide within 4 months
Neupogen's P3 was about 200 patients. So would be as easy to run that trial as the P2. But there is a bit of a catch. If they need to show an improvement in infection over Neupogen, 200 patients will probably not be big enough. Neupogen was trials against placebo, 2012 will have to go against Neupogen.
The effect size seen in the P2 will be key to the trial design. If they do see a decent reduction in infection, they can just plug that into the software and out comes the trial size needed. But if the effect is minimal it gets tricky.
They might try a "non-inferiorty" trial. Or they might try using sever neutropenia as a surrogate. I would be a little skeptical of either without a SPA negotiated with the FDA, and that does take time.
I will not expect a P3 till well into 2014, but maybe I will be happily surprised.
CytomX looks interesting (though still private).
They make "Probodies" out of existing antibodies. They attach a masking agent to the binding surfaces of the mab. This mask is cleaved off in the presence of proteases existing in the tumor environment. Thus the Probody is more selectively targeted towards the cancer.
Probably not a huge improvement, but in the coming age of biosimilars and biobetters, a modest improvement on an existing mabs could be worth serious money.
They have one in-house mab that they have made into a Probody. An anti-Jagged agent, CTX-033. They recently announced a conjugated version, so I assume that is using the IMGN conjugation technology.
On the flip side, one would assume IMGN is checking out the Probody technology on Kadcyla and the pipeline. A win with Pro-Kadcyla would be huge as it would allow a follow on deal with Roche at substantially better terms.
Looking a little deeper, this was not a cashless excise. He excised 25K worth of options and his share count went up by 25K.
My point was correct in general though, one has to watch out for that when making presumptions about what execs are thinking when they excise.
Unless it was a cashless excise. In which case he sold enough shares in the transaction to cover both the excise price and the tax liability.
If so, he even ends up with a win if the stock drops to near 0, as he has put 0 in and will have a tax loss to book.
I also think this is a very good bet.
I assume there are 3 things that are driving the PPS down:
1) The fascination with the knew immuno agents.
2) The consolidation involving partners
3) Market dislike of ATMs
Regardless, we will start getting P3 data in late this year.
Is not the fact that the FDA called BS on the data enough to question your belief?
Plus, your post implies you don't understand the process. They needed to run the P3 to get approved regardless of receiving BTD, break through DESIGNATION (not approval). BTD might grease the skids on the path through approval, but one still needs to run the pivitol trial.
The company will pay the holder of record as of the record date, friday.
But because of the 3 day settle time, anybody buying the stock on or after the ex-div date, wed, will not be the holder of record by Friday, and therefore does not get the dividend. The ex-div date is also part of the "sales contract" in that regardless of what might happen to screw up the 3 day settle, the dividend still belongs to the party who sells wed or buys tue.
Expect the PPS to drop about .50 (whatever that number is) between Tue close and Wed open (ok, this stock is so thin it jumps that much anyway, so who knows).