We provide fresh evidence in this report that shows AEGR's management is not only promoting a far greater addressable market than allowed but the company is in fact marketing JUXTAPID off-label. We do not think the market will ignore this reality now that the FDA and DOJ have brought the issue center stage. Even if AEGR escapes regulatory censure, shareholders will likely find that AEGR's avenues to a larger addressable market will have been cut off by the EU requiring genetic testing where possible, insurance companies taking a tough stance on reimbursing non-HoFH patients and intense competition from safer cheaper drugs. In fact, on the competitive front, a BAML analysts' survey found that 52% of physicians expect PCSK9 inhibitors to be prescribed ahead of JUXTAPID and the other currently available treatment, Kynamro, to address HoFH patients. The regulatory and financial consequences of AEGR's off-label product claims and marketing practice could be devastating to the company and its shareholders. Perhaps as a display of their own concerns, in the past year, managers who are the most informed about the business and its prospects sold shares as their options were exercised, with some holding no stock at all. In fact officers and directors as a whole only own around 7% of the stock.
It is easy. The FDA has put a muzzle on the puny pit bull the CEO. He is impotent. They Brazilian government is investigating AEGR for bribery, they have about twelve different law firms going after them, they have only one drug approved, they have only one drug in the pipeline and it is in the exact same area as their approved drug, their composite patent expires next year, their only remaining parent will be a numbers game in regards to the dosing of the drug, there is a chance that India will prirate over their cheesey patent, there is now the unanticipated but real threat from PCSK9 inhibitors, Kynamro will end up being bigger competition than the CEO anticipated, and biotech in general is out of favor for the time being.......besides that everything in regards to AGEr is going great. t