Aegerion Pharmaceuticals, Inc. (AEGR) reported third-quarter 2014 net loss per share of 20 cents, wider than the Zacks Consensus Estimate of a loss of 18 cents but narrower than the year-ago loss of 43 cents.
In the reported quarter, net product sales increased 167.4% from the year-ago quarter to $43.7 million, but missed the Zacks Consensus Estimate of $49 million. 91% 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 $10.4 million, up 32.3% from the year-ago quarter. The rise in R&D expenditure was primarily due to increased headcount and international regulatory activities, pharmacovigilance and manufacturing process development activities in the U.S. and pipeline development.
Selling, general and administrative (SG&A) expenses increased 66.8% year over year to $31.4 million mainly due to a higher headcount, commercialization of Juxtapid in the U.S., global expansion and increased legal fees.
2014 Outlook Lowered
Aegerion lowered its 2014 expectations for Juxtapid sales which are now expected in the range of $150 million − $160 million (previous guidance: lower end of $180 million − $200 million). This reflects higher patient dropout rates and lower-than-expected U.S. prescription growth rates. The Zacks Consensus Estimate for 2014 revenues is $175 million.
In addition, Aegerion anticipates continued reimbursement challenges in Brazil and reimbursement delays in Mexico, Canada and Taiwan. Juxtapid’s revenues from named patient sales in the ex-U.S. countries will continue to fluctuate on a sequential basis.
Aegerion currently expects operating expenses (including stock-based compensation) in the range of $165 − $175 million (previous guidance: $185 million − $195 million).
Aegerion also provided its outlook for 2015. The company expects revenue growth of 30% – 40% on 2014 projected revenue.
Meanwhile, some PCSK9 therapies include Amgen’s (AMGN) evolocumab and Sanofi (SNY)/ Regeneron’s (REGN) alirocumab. Approval of one or more of these products by mid-2015 will create competition for Juxtapid.
Our Take
Aegerion’s third-quarter results were disappointing with the company missing the Zacks Consensus Estimate on the top-as well as bottom-line. Moreover, we are disappointed with the company’s lowered outlook for Juxtapid sales this year. Additionally, the 2015 revenue outlook lags growth expectations significantly.
With Aegerion depending on Juxtapid for growth, the reimbursement issues and potential competition remain a matter of concern. Shares are already down on the disappointing results and outlook.
Aegerion carries a Zacks Rank #3 (Hold). Regeneron is a better-ranked stock carrying a Zacks Rank #2 (Buy).
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