We keep our 12-month target at $146 on a below peers 1.1X PE-to-growth ratio based on our 2015
EPS estimate. Q1 EPS of $1.07 vs. $0.83 is $0.03 ahead of our estimate. However, sales growth,
including 2% adverse forex impact, of 20.2% was below our 22% growth forecast. Revlimid sales
rose 17%, Abraxane rose 21%, and Pomalyst/Imnovie rose 46%, but Vidaza sales fell 3% on
generic competition. We remain encouraged by the growth of Revlimid and believe further label
expansion will drive continued demand and we see Abraxane sales reaching $1B this year.
Very few certainty's in life except death and taxes, but this is as close to a certainty as you can get. They pretty much always follow the panels recommendation. This was almost a unanimous recommendation, 22 to 1.
Is this independent panel approval a cetainty to persuade the FDA to approve the drug?
T-Vec met its primary endpoint. It failed to meet the secondary endpoint of increasing overall survival but Fierce Biotech thinks it is unlikely that will keep the FDA commitee from recommending its approval on Wednesday: "That's sure to come up when the agency's Cellular, Tissue and Gene Therapies and the Oncologic Drugs advisory committees pore over T-Vec's data. And while the issue is unlikely to derail Amgen's ambitions--the FDA has a well-established penchant for approving cancer treatments with much less supporting data than T-Vec"
Looks like Wednesday is a #$%$ shoot - although on balance - probably a good chance of getting a positive recommendation? What does everone else think?
AMGN was woeful, almost lost everything. The guys over at Ultimate Stock Alerts (they are in Google, do a search) were awesome in helping me save the day
Its hurting it today. Some news could come out tomorrow that reverses sentiment. Probably a little overdone considering they just dropped a new drug on the market a few days ago.
It all assumes that Regeneron executes their rollout effectively. Remember how Immunex botched their rollout of Enbrel? That's why they came to be acquired by Amgen. Also, it allowed Humira to be approved sooner and grow faster. Not saying that that's what will happen but if REGN is slow on the output and AMGN is a model of efficiency, the month may not make any difference.
Look up the article on today's Fierce Biotech about the T-Vec failure. It goes into detail there.
Based on FDA's review, looks like it is going to be a thumbs down on Wed for the vaccine.
How badly is this going to hurt AMGN's stock price? THoughts?
I'd say it's pretty extreme manipulation. A 50 % increase in earnings, increase in forecast and a solid pipeline should have resulted in a substantial gain. Amgen is making a lot of money and management may do smart moves with it. Watch out shorty.
Ok.. I read further .. that's why everyone hopped off the next day.. coming out first kills the market for them, especially if there is no difference in treatment.
Short term thinking investors might be. But the people who want in REGN already know this and have already bought the stock, its fairly common knowledge. REGN also is a very efficient, much smaller company than AMGN. Do they have the late stage pipeline AMGN does in other indications? Probably not. And AMGN already had a drug approved last week for heart disease patients. It could cause a similar pricing war effect, like with ABBV/GILD, but I don't know enough about the differences between each company's drug to say for sure.