Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR)

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Wednesday, May 7, 2014

Comments & Business Outlook

First Quarter 2014 Financial Results

Net product sales for the first-quarter ended March 31, 2014 were $27.0 million, compared with $1.2 million in the first-quarter ended March 31, 2013.
For the first-quarter ended March 31, 2014, non-GAAP net loss, which excludes stock-based compensation, was $7.3 million, or $0.25 per share, compared with a non-GAAP net loss of $14.6 million, or $0.51 per share, for the same period in 2013.

"We have made meaningful progress in the global commercialization of JUXTAPID as a treatment for HoFH, and believe we will be able to continue to grow our business supported by our increased commercial reach and focused execution," said Marc D. Beer, Chief Executive Officer.

Mr. Beer continued, "Five quarters into the U.S. launch, our focus has been centered on optimizing our commercial strategy and execution, specifically with key investments in the sales force and patient support teams. With broader reach and reinforced patient support now in place, and the first quarter expansion and realignment of our sales organization complete, we expect 2014 net product sales growth from the U.S. business to be more weighted toward the second half of the year. Brazil continues to be our number two revenue-generating country, and we expect named patient sales there to grow in the long-term given the number of identified HoFH patients in the country, and the level of interest among physicians. In the near term, we expect quarterly fluctuations to continue as a result of purchase order delays in Brazil. While we do not believe that there have been any violations of the Brazilian anti-corruption laws in our activities, we have adjusted our guidance to reflect the impact of potential delays in orders this year as a result of the investigation."

Business Outlook

Aegerion stated the following financial guidance:

Aegerion now expects global net product sales of between $180 million and $200 million for FY 2014, revised from the prior range of between $190 million and $210 million.
Aegerion expects total operating expenses, excluding stock-based compensation, of between $145 and $155 million for FY 2014. The Company expects GAAP operating expenses in 2014, including stock-based compensation, to be between $185 and $195 million.
Cash flow positive operations anticipated in the second half of 2014.

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Friday, March 28, 2014

Research

It’s not often that evidence gathered in one of our investigations into a company that is not a classic pump and dump or U.S. listed China Based company would lead the GeoTeam to conclude that the subject company’s shares could ultimately become essentially worthless. We believe, however, that the risks facing AEGR are of such gravity that we’re considering that possibility. AEGR is a one-drug company that sells JUXTAPID, a drug that can only be prescribed under the strict and very limited guidelines imposed by the FDA.

While a few articles have highlighted some of the risk to the AEGR stroy,

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 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 current 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 6% of the stock.

Please see our full report here.

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