Aegerion Pharmaceuticals, Inc. (AEGR) reported fourth quarter 2012 net loss per share of 86 cents, wider than the Zacks Consensus Estimate of a loss of 62 cents and the year-ago loss of 61 cents.
Net loss for the full-year 2012 was $2.64 compared with a net loss of $2.03 in 2011.
Aegerion did not generate any revenues in 2012.
In the fourth quarter of 2012, research and development expenses were $8.6 million, compared with $8.4 million in the year-ago quarter. Expenses were driven by production validation runs and increased headcount in support of Aegerion’s regulatory and medical affairs activities.
Selling, general and administrative expenses soared 204.7% year over year to $13.1 million, mainly due to administrative expenses and costs related to increased headcount for the launch of Juxtapid.
The launch of Juxtapid is in progress with the company set to achieve the earlier guidance of 250-300 patients worldwide by the end of 2013.
Juxtapid was approved by the US Food and Drug Administration (:FDA) in Dec 2012. It gained approval for the treatment of patients suffering from homozygous familial hypercholesterolemia (HoFH) as an adjunct to a low-fat diet and other lipid-lowering therapies, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B) and non-high-density-lipoprotein cholesterol (non-HDL) in patients with HoFH.
Juxtapid could gain EU approval in mid-2013.
Total operating expenses, including share-based compensation, are expected in the range of $75 million to $85 million in 2013.
Aegerion expects net revenues in the range $15 million to $25 million in 2013. The company expects 250 to 300 patients to be on Juxtapid therapy worldwide in 2013.
Aegerion expects to generate an annualized worldwide net revenue run rate of $100 million in the second half of 2014 and also achieve breakeven cash flow from operations.
We are encouraged with the progress on the launch of Juxtapid. We note that Isis Pharmaceuticals Inc. (ISIS) is also looking to enter the market with its HoFH candidate, Kynamro, approved in the US in Jan 2013.
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