Just curious ,but is Juxtapid the sole product that AEGR has going for it at this time? Are there any other catalysts during the 2014 year other than phase trial news as it relates to Juxtapid abroad? I'm in on the name because my equity research buddy who has been on fire with picks over past year said its his #1 bio pick for 2014- but of course trying to figure the story out a bit for myself. Thanks
This year's potential catalysts are expected sales, which are supposed to increase 4-fold+ for the year (48.5M '13 to 212M expected '14). European sales should also start to increase throughout the year. Furthermore, a Japan Phase 3 study (26 weeks long, with 30 weeks of safety observation to follow) was announced today. Assuming it started today (and not earlier), it will end in Q1 '15, and $AEGR can file in Japan as soon as the 26 week study is complete (with ongoing monitoring) - yet the market may anticipate the filing in late '14. I also expect a bump once AEGR releases its corrective action video, apologizing for misbranding of Juxtapid comments on cNBC made by CEO Marc Beer alone. This video is supposed to be released in May. I would expect another bounce if AEGR does the right thing, by firing CEO Marc Beer, and includes this news in the video. These actions should lead to an FDA closeout, which could provide another bump. AEGR also has one other drug candidate, but it hasn't discussed it recently since it has been focused on the Juxtapid launch.
Possible remaining issues: The DOJ investigation for sales practices - this may or may not be remedied by the corrective actions in response to the FDA, and possible slow or no increased sales. The only competition though is Kynamro from $ISIS (in the U.S. only). Yet, as of now (a year after its approval), it looks as though Kynamro is not selling (due to its lower efficacy and side effects). The upcoming PCSK9 drugs ($AMGNs will likely be the first in maybe late '16), are being hailed as $AEGR competition. However, the drugs have two different mechanisms and the few HoFH patients who actually benefited from PCSK9 (only 1/6 of those on it in the last clinical study), with their extremely high LDL, will most likely take both drugs. Based on what I know (which I've outlined here), I'm long AEGR.