Juxtapid Phase 3 Achieves in HoFH; Needham & Company Maintains Aegerion (AEGR) at 'Hold' Pending Better Visibility

Needham & Company affirms Aegerion Pharmaceuticals, Inc. (Nasdaq: AEGR) with a Hold rating after the company announced the primary endpoint was achieved in the Company's open-label, multicenter study to evaluate the efficacy and safety of lomitapide in nine Japanese patients with homozygous familial hypercholesterolemia (HoFH).

Chad Messer, Ph.D., commented, We expect Aegerion to file a Japanese NDA around YE15, with an approval decision 9 months thereafter. We maintain our Hold pending better visibility into Juxtapid and Myalept sales. Improvement or stabilization in the U.S. Juxtapid patient retention rate is also key to any improvement in our outlook.

Messer noted that Juxtapid sales growth has been lackluster amid a recent bump in Brazil. The analyst said, 1Q15 Juxtapid sales were $57.3MM, up 11% q/q, driven mainly by a surge in Brazilian sales. Sales in Brazil occur in batched orders and have historically been lumpy. Management recently reiterated guidance for $195-215MM in 2015 Juxtapid sales, which implies a slower run rate than 1Q for the remainder of the year. AEGR also continues to expect a negative impact on sales with the launch of PCSK9 inhibitors in 2H15. We note that the cumulative dropout rate through 4/24/15 had climbed to 46%. While management commented on the most recent earnings call that the short-term dropout rate trend is "directionally positive," it continues to show variability monthto-month and sits at an all time high. Despite multiple initiatives to manage dropout rate, we believe AEGR clearly has additional work to do.

For an analyst ratings summary and ratings history on Aegerion Pharmaceuticals click here. For more ratings news on Aegerion Pharmaceuticals click here.

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