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Aegerion Pharmaceuticals: Juxtapid And Financials

May 1, 2013

Aegerion Pharmaceuticals has a 1st Quarter 2013 earnings conference call on April 30, 2013. Investors are watching closely to see what the status and finances are for the commercialization and launch of the company’s orphan drug Juxtapid (Lomitapide) for the treatment of Homozygous Familial Hypercholesterolemia (HoFH).

Aegerion Pharmaceuticals faces strong competition from Isis Pharmaceuticals and Genzyme’s orphan drug Kynamro (Mipomersen). The competition between the two drugs is well documented in the media and by the Orphan Druganaut Blog. Juxtapid, an oral once-a-day treatment for HoFH, beat competitor Kynamro to market. Juxtapid’s price of $235,000-$295,000/year is much higher than Kynamro’s $176,000/year. Both drugs have serious side effects. The FDA Advisory Committee votes 13-to-2 for Juxtapid & 9-to-6 for Kynamro. It will be interesting to observe over time, whether Aegerion Pharmaceuticals’ pricing and launch strategy changes due to the competitor’s much lower price.

Here are some of the highlights of Aegerion Pharmaceuticals’ 1st Quarter 2013 earnings conference call showing that Juxtapid’s launch is going according to plan :

•   185+ global patient prescriptions written
•   75 patients currently on Juxtapid therapy
•   Approximately 3,000+ patients in US with a clinical or laboratory diagnosis of HoFH
•   Re-orders are on track & minimal dropouts
•   Foundation of REMS-trained physicians is set up & growing
•   April 9, 2013, meeting with European Union (EU) regulators on Marketing Authorization Application (MAA) for Juxtapid
•   Optimistic about receiving positive EU CHMP opinion in 2nd Quarter 2013, mid-2013 approval, & launch in the second half of 2013
•   Study of Juxtapid in Japanese HoFH patients continue
•   Japan is an important market fr Juxtapid
•   Non-clinical rodent study initiated in 1st Quarter 2013 for HoFH in pediatric patients + start of clinical study planned for 2014.

Net product sales for the 1st Quarter ending March 31, 2013, are $1.2 million. Net loss was $18.1 million, or $0.64 per share, for the 1st Quarter ending March 31, 2013, compared with a net loss of $11.7 million, or $0.55 per share, for the same period in 2012.

References

Aegerion Pharmaceuticals’ April 30, 2013, Q1 2013 Earnings Conference Call

Aegerion Pharmaceuticals’ April 30, 2013, Q1 2013 Financial Results Press Release

SeekingAlpha.com’s Aegerion Pharmaceuticals Earnings Call Transcript.

Please Note #1: “Dollar Symbol Gold” by Rugby471 (Own work) [GFDL] | Wikimedia Commons.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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