Aegerion Pharmaceuticals, Inc. reported first quarter 2013 net loss per share of 64 cents, narrower than the Zacks Consensus Estimate of a loss of 72 cents, but wider than the year-ago loss of 51 cents.
Net product sales for the quarter were $1.2 million from Juxtapid. The company did not report any revenues in the year-ago quarter.
In the first quarter of 2013, research and development expenses were $5.8 million, compared with $4.6 million in the year-ago quarter. The increase in R&D spend, reflected expenses in support of Juxtapid's development in Japan and increased headcount in support of Aegerion’s regulatory and medical affairs activities.
Expenses were driven by clinical development expenses to support potential marketing authorization application (MAA) for Juxtapid in Japan and increased headcount in support of Aegerion’s regulatory and medical affairs activities.
Selling, general and administrative expenses soared 158.8% year over year to $13.2 million, mainly due to costs related to increased headcount and selling and marketing expenses for the launch of Juxtapid as well as increased headcount in administrative functions.
Juxtapid was approved by the US Food and Drug Administration (FDA) in Dec 2012 for the treatment of patients suffering from homozygous familial hypercholesterolemia (HoFH). Juxtapid could gain a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in the second quarter and EU approval in mid-2013.
Aegerion maintained its guidance with total operating expenses, excluding share-based compensation, expected in the range of $75 million to $85 million in 2013. Additionally, 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.
We are encouraged with the progress on the launch of Juxtapid. Currently, 75 patients are under Juxtapid therapy which means the company is on track to achieve its guidance by the end of 2013. We expect investor focus to remain on the sales ramp up of Juxtapid. We note that Kynamro, approved in the US in Jan 2013, has also entered the HoFH market.
Aegerion carries a Zacks #3 Rank (Hold). Right now, Cleveland BioLabs, Inc. , Athersys, Inc. (ATHX - Free Report) and Osiris Therapeutics, Inc. look more attractive with a Zacks Rank #1 (Strong Buy).