Aegerion Pharmaceuticals, Inc. (AEGR) reported third quarter 2013 net loss per share of 43 cents, narrower than the Zacks Consensus Estimate of a loss of 49 cents and the year-ago loss of 59 cents.
Net product revenues for the quarter were $16.3 million from Juxtapid, which is the sole marketed product at Aegerion. The company did not report any revenues in the year-ago quarter. Juxtapid revenues rose sequentially by 150.8%. Revenues surpassed the Zacks Consensus Estimate of $13 million.
In the third quarter of 2013, research and development (R&D) expenses were $7.9 million, compared with $6.5 million in the year-ago quarter. The increase in R&D spend reflects expenses in support of Juxtapid's development in Japan and increased headcount in support of Aegerion’s regulatory and medical affairs activities.
Selling, general and administrative (SG&A) expenses swelled 130.8% year over year to $18.8 million, mainly due to a higher headcount and selling and marketing expenses for the launch of Juxtapid. Aegerion’s efforts to expand also pushed up SG&A costs.
Juxtapid, for the treatment of patients suffering from homozygous familial hypercholesterolemia (HoFH), was launched in the U.S. in late Jan 2013. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency gave a positive opinion on the drug in May 2013 and Aegerion gained EU approval in Jul 2013 under the brand name Lojuxta. Lojuxta will be launched in Europe on a limited basis at the end of the year.
Japan's Ministry of Labour, Health and Welfare granted orphan drug status to Juxtapid for the treatment of HoFH in Sep 2013. The first patient in this therapeutic study is expected to be dosed by year end/early 2014. Aegerion plans to submit a new drug application in Japan in the first half of 2015.
Data from a phase III extension study will be presented on Nov 18, at the American Heart Association Scientific Sessions.
Outlook Upped
Aegerion raised its net revenue expectation to $45 – $50 million in 2013 from the earlier guidance of $30 – $35 million, reflecting Juxtapid’s performance in the U.S. The Zacks Consensus Estimate currently stands at $41 million for 2013. Aegerion maintained its total operating expense guidance, excluding share-based compensation, in the range of $75 million to $85 million in 2013.
Aegerion carries a Zacks #2 Rank (Buy). Currently, companies like Isis Pharmaceuticals, Inc. (ISIS), AMAG Pharmaceuticals Inc. (AMAG) and Actelion Ltd. (ALIOF) look more attractive with a Zacks Rank #1 (Strong Buy).
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