Aegerion Pharmaceuticals, Inc. AEGR reported second-quarter 2015 net loss per share of 2 cents, much narrower than both the Zacks Consensus Estimate of a loss of 27 cents and the year-ago loss of 33 cents.
In the reported quarter, net product sales were at $64.2 million, up 78.3% year over year and well above the Zacks Consensus Estimate of $58 million.
The Quarter in Detail
Net sales of Juxtapid were $57.1 million representing approximately 58.6% year-over-year growth supported by strong prescription growth and net patient addition. Myalept’s revenues increased to $7.1 million compared to $2.1 million in the first quarter of 2015.
Research and development (R&D) expenses were $12.5 million, up 39.5% from the year-ago quarter. The rise in R&D expenditure reflects costs associated with studies to support a potential marketing authorization application for Juxtapid in Japan for homozygous familial hypercholesterolemia (HoFH), preparations for the planned study on pediatric HoFH patients, post-marketing studies related to Juxtapid (initiated in 2014) and costs associated with an increased headcount.
Selling, general and administrative (SG&A) expenses increased 32% year over year to $42.7 million mainly due to commercialization costs related to Juxtapid, an increased headcount and legal fees.
Pipeline Update
Aegerion is planning to file a new drug application in Japan for Juxtapid for the treatment of patients suffering from HoFH in late 2015 or early 2016. Additionally, it is preparing to initiate a study on Juxtapid in pediatric HoFH patients. The company does not intend to initiate the study in 2015. It said on its second-quarter call that it will continue to update on the timing of beginning the study.
Meanwhile, Aegerion intends to study Juxtapid in combination with a PCSK9 inhibitor to evaluate the efficacy of these products versus monotherapy in patients suffering from genetically confirmed HoFH. Patient enrollment is expected to begin in the first half of 2016. Additionally, Aegerion is planning to develop a second-generation Juxtapid for improving tolerability by reducing or eliminating gastrointestinal side effects of the drug. The company will update on its progress by year-end.
The company is also preparing to file a marketing application for Myalept in the EU to treat complications of leptin deficiency in generalized lipodystrophy patients in 2016. In addition, Aegerion is planning to study Myalept for additional indications including severe partial lipodystrophy and congenital leptin deficiency.
2015 Outlook Reiterated
The company continues to expect net sales of Juxtapid in the range of $195 million – $215 million and that of Myalept in the range of $10 million – $20 million. Operating expenses are expected in the range of $195 million – $205 million (excluding stock-based compensation expense and other items).
Aegerion expects named patient sales of Myalept for generalized lipodystrophy in some ex-U.S. markets including Brazil to commence in the second half of 2015.
Our Take
Aegerion’s second-quarter 2015 results were impressive. The company was able to post narrower-than-expected loss on the back of solid Juxtapid sales.
We note that Aegerion is in the early stages of business in the ex-U.S. markets and continues to focus on opening new international markets for Juxtapid in 2015.
Meanwhile, with the approval of PCSK9 inhibitor therapies like Amgen’s AMGN Repatha in the EU and Regeneron Pharmaceuticals REGN/Sanofi’s SNY Praluent in the U.S. in Jul 2015, Aegerion may slowdown in Juxtapid revenues in the second half of 2015. However, the company’s intentions to invest in marketing programs to extend its reach to HoFH patients, to evaluate Juxtapid in combination with a PCSK9 inhibitor and to develop a second-generation version of the drug, are encouraging.
Aegerion holds a Zacks Rank #3 (Hold). Both Regeneron and Amgen carry a Zack Rank #2 (Buy).
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