Aegerion Pharmaceuticals, Inc. (AEGR) reported fourth-quarter 2014 net loss per share of 12 cents, narrower than the year-ago loss of 47 cents. The Zacks Consensus Estimate was a gain of 5 cents.
In the reported quarter, net product sales shot up 111.1% from the year-ago quarter to $51.7 million surpassing the Zacks Consensus Estimate of $49 million. 86% of net product sales were from the U.S. and the rest came from ex-U.S. markets, primarily Brazil.
The Quarter in Detail
Research and development (R&D) expenses were $10.7 million, up 25.8% from the year-ago quarter. The rise in R&D expenditure was primarily due to increased headcount, international regulatory activities and pipeline development.
Selling, general and administrative (SG&A) expenses increased 36.8% year over year to $37.2 million mainly due to a higher headcount, commercialization of Juxtapid in the U.S., global expansion and increased legal fees.
2014 Results
In 2014, Aegerion reported a loss of $1.10 per share, up 49.4% year over year. Revenues increased to $158.4 million from $48.5 million in the previous year. The massive upside was mainly driven by increased reach of Juxtapid on sales force expansion in the U.S. 91% of net product sales were from the U.S. and the rest came from ex-U.S. markets, primarily Brazil. By the end of 2014, approximately 745 patients were on Juxtapid therapy, out of which 632 patients were in the U.S.
Pipeline Update
Aegerion intends to complete the 25-week efficacy base of a Japanese study on Juxtapid in the second quarter of 2015 and file for its approval in Japan by mid-2015. Additionally, the company is working on finalizing the protocol for a pediatric study on Juxtapid for homozygous familial hypercholesterolemia (HoFH).
2015 Outlook
The company expects net product sales in the range of $205 million – $235 million. Juxtapid sales are now expected in the range of $195 million – $215 million (previous projection: $150 million − $160 million) and that of Myalept in the range of $10 million – $20 million. The company expects operating expenses in the range of $195 million – $205 million.
In 2015, Aegerion intends to maintain focus on expanding its business in new ex-U.S. markets. The company believes that over the long haul, the affect of the prospective approval of some PCSK9 therapies like Repatha and Praluent and their impact on Juxtapid sales can be counteracted by increased disease awareness and diagnosis of additional HoFH patients who can be potentially treated with Juxtapid. Additionally, Aegerion intends to file for its approval in the EU for the same indication in 2016.
Our Take
We are pleased with the raised guidance for Juxtapid revenues in 2015. However, the company expectations of quarterly fluctuation in demand for Juxtapid in Brazil as a result of unpredictable size and timing of the orders remains a matter of concern. Moreover, reimbursement challenge for Lojuxta (EU trade name for Juxtapid) in the EU is a constant predicament. Given that Juxtapid is the cornerstone of the Aegerion’s business, potential competition for the product in 2015 may make it difficult for the company to maintain its revenues, going forward.
Aegerion carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. (ANIP), Cytokinetics, Inc. (CYTK) and Alnylam Pharmaceuticals, Inc. (ALNY). While ANI Pharma and Cytokinetics carry a Zacks Rank #1 (Strong Buy), Alnylam holds a Zacks Rank #2 (Buy).
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