Aegerion Pharmaceuticals Inc. recently announced its 2013 guidance as the company prepares for the launch of Juxtapid, which gained US Food and Drug Administration (FDA) approval in December.
Juxtapid has been approved for the treatment of patients suffering from homozygous familial hypercholesterolemia (HoFH) as an adjunct to a low-fat diet and other lipid-lowering therapies.
Aegerion, at the end of 2012, started enrollment of Japanese subjects into a phase I, bridging study of the pharmacokinetic and pharmacodynamic properties of Juxtapid. Once study results are out, the company plans to conduct a small therapeutic study of Juxtapid in Japanese HoFH patients so that it can seek approval in Japan.
As part of its post-marketing requirements, the company is required to conduct a juvenile toxicology study in rodents. The study will provide information on the impact of Juxtapid on growth and development. This study needs to be conducted before the company can initiates a study in pediatric patients, potentially in 2014.
Cash and cash equivalents at the end of 2012 was roughly $78 million to $83 million.
For 2013, Aegerion expects to generate revenue between $15 million to $25 million assuming 250 to 300 patients are on Juxtapid therapy by the end of the year.
Once Juxtapid is approved in the EU, the company expects to achieve an annualized worldwide net revenues run rate of $100 million eighteen months after EU approval. The company also expects to achieve cash flow breakeven from operations eighteen motnhs after EU approval.
We are encouraged with the US approval of Juxtapid. We note that Isis Pharmaceuticals Inc. is also looking to enter the market with its HoFH candidate, Kynamro, which is currently under review in the US.
We currently have a Neutral recommendation on Aegerion. The stock carries a Zacks #3 Rank (Hold). Other stocks in the pharma sector that carry a Zacks #1 Rank (Strong Buy) are Targacept, Inc. and Repligen Corporation (RGEN - Free Report) .