The reward is huge, I see CLDN open $100+ if results are good,
here is the reason why:
Credit Suisse initiated CLDN a outperform on 10/13/2014 and indicates that
it expects upon approval that MYDICAR dosages would be $36,000 in the U.S.
and $23,000 in the E.U.
CLDN estimate US first target patient population is 350000 and assume EU with the same number
patients, if MYDICAR reach peak 25% in US and EU conservatively, the peak sales for systolic HF:
US(350K X 25% X$36k) + EU(350K X 25% X $23K)=$3.15B + $2B=$5.15 Billion.
Nomura analyst M. Ian Somaiya commented, "Our Buy rating is based on our view that eravacycline could be a best-in-class antibiotic for the treatment of complicated urinary tract infection (cUTI) and complicated intra-abdominal infection (cIAI), generating peak sales of $1.6bn. This is based on data that demonstrated broader coverage versus legacy and recently launched antibiotics. Combined with its oral step-down option, eravacycline would enable cUTI patients to begin treatment at the hospital (IV dose) and complete it at home (oral dose), which should lead to shorter hospital stays and more rapid adoption. TTPH in our view also carries lower relative clinical and regulatory risk given the release of positive top-line results from Phase III IGNITE 1 in cIAI and lead-in portion of the Phase III IGNITE 2 cUTI trial. We expect presentation of detailed data from these trials in 2015 (page 11) to support continued upside. However, the greatest potential source of upside is the passage of the DISARM Act, which could support higher pricing and the faster adoption rate of drugs approved after January 1, 2015."
At very very conservative buyout of 3 times peak sales will be 4.8B, so far I have seen analysts peak sales
from $1b to $1.6, using mid of the range is $1.3B, 3 times 1.3 is $3.9, low end is $3B.
IF we agree BIIB has the best data so far, compare to what LLY has gained
$37B from its positive subset data, BIIB has some upside to catch up, IMO.
The results clearly show BIIB037 is a very effective drug against AD,
the safety is a concern, and hopefully manageable. BIIB gets another
megabillion drug on the way. TYSABRI may cause death for very few
patients, but the risk/reward is worth for patients to demand for FDA
to put it back on market few years ago. Since the ARIA-E goes away
in 4 weeksby stopping the treatments, BIIB may manage the risk by lowing the dose to 6mg,
a drug holiday for 4 weeks, new ways to identify AD patients early
to put on 3mg BIIB037 to prevent the build up of the amyloids(I think
this last point is a good answer) which makes BIIB037 potential sales
even bigger than $10+b many are saying now IMO.
LLY release PIII AD results on Aug 24 with positve results for subset
mild patients, LLY was trading at 42, now at 76, 81% gain or 36B
market cap. LLY 2012 sales 23B+earnings $4.32, 2015 estimate sales
20B+earnings $3.16, no major drugs waiting approval, so I assume
most of the $36B gain is from the positive AD results. BIIB has the
best AD results so far that all agrees, so adding $47B market cap($200
stock gain)to BIIB start from Dec 2nd the first PR about positive PI results
which is about 308+200=$508, that is most of the price target analysts
raise to today, that is fair price in weeks, IMO.
CEMP did ouptform TTPH since CEMP earnings CC,
and after last two presentations, CEMP added about
$8 to the stock.
I think comparing BIIB to BMY is not good one.
Here is the numbers:
Trailing P/E (ttm, intraday): 56.47
Forward P/E (fye Dec 31, 2016)1: 29.72
PEG Ratio (5 yr expected)1: 2.45
EBITDA (ttm)6: 3.92B
Net Income Avl to Common (ttm): 2.00B
Trailing P/E (ttm, intraday): 38.48
Forward P/E (fye Dec 31, 2016)1: 23.89
PEG Ratio (5 yr expected)1: 1.42
EBITDA (ttm)6: 4.60B
Net Income Avl to Common (ttm): 2.93B
BIIB beats BMY in all the important measures of growth and profits,
if market uses those BMY measures to value BIIB, BIIB may be close
$600/share. All is relative, SP 500 is trading at 18X2015 earnings estimate
of 3 to 4% growth, 10 year bonds get 2%, savings get 0.25%.
Why you do not compare to REGN with similar growth trading at
11.5 time of 2016 sales? By the way, it is $10B today, next week
BIIB may gain another $10B, but nothing wrong taking profits.
Hope so too, they may be waiting for PIII results to settle the buyout
price. It is the best for the buyer to pay a fair price and to take control
of the NDA. It is a too big a task for a small company like TTPH
to scale up manufacturing for tens of millions dose to pass Q&A
with FDA, SRPT and ACAD say no problem to scale up, a simple
process, look at the results, has taken them two or more years to
scale up, in ACAD case, still going to year 3.
TTPH skipped two conferences this month that TTPF attended last
year, and CEMP CEO is going to every conference she can, and
she is talking billions market potential.
TTPH is going to present the full data for CIAI phase 3 trial and
lead-in data for CUTI PIII trial by end of April. The lead-in data
should tell the market with 95+% confidence what the final CUTI
PIII trial results may be. so I think the sales auction may be starting
in May, complete it by July, the buyer may want to take control of the
filing NDA, IMO.
It is a good idea to sell the company, look at ACAD, it is very hard
to get every thing right for a small company to file NDA, get approval
and launch a blockbuster drug. One more point about the buyout,
if DISARM becomes the law before the buyout(highly likely), TTPH may
be worth more than $3B, IMO.
Both are very good bets, but TTPH may has better gains in next 4 to 6 month.
TTPH may get the second PIII trial results early than CEMP's, after the positive
PIII results, TTPH CEO has said TTPH is on the market for sale for a right price,
my guess is $2.5 to $3B, $70 to $80 offer. I do not think CEMP is willing to sell
this year. Next year is a different story, IMO.
I am very surprised you do not know that IMPRESS and Opdivo's have the
same log rank analysis with HR and P value.
To my limited knowledge, FDA has only one analysis rule for primary OS end point,
that is the log rank analysis with HR and P value. nhyujm6 example is just like my
of MDVN's, beautiful KM curve separating very early which means the drug effects
most patient in trial arm. IF IMPRESS has a KM curve like that, CEO Link has no need
to talk to FDA changing the analysis plan, second look is 100% stop, IMO.
Check out PCYC stock actions pre-buyout, people having "leaks" are not ready
to issue rumors, next few days are different story, Friday may be the day, IMO.
By the way, if it is a buyout, there may be a rumor coming very soon, today
or tomorrow, IMO.
which means what ever ACAD is working on, we may have the news
next Monday.Now the logical reasoning is there is no need to pull out
two conferences if it is the partnership talking, only thing that may required
them to pull out is buyout and I think there is bidding war going on right now,