Alexion Speeds Launch, Ups Guidance - Analyst Blog

We are pleased to note that Alexion Pharmaceuticals (ALXN) plans to launch Soliris (eculizumab) in Japan in the third quarter of 2010, earlier than previously expected. Soliris is Alexion’s only approved product, which is meant to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare genetic blood disorder.

 

Alexion’s decision to launch Soliris early follows a recent approval regarding the price of the drug by an advisory committee of Japan's Ministry of Health, Labour and Welfare. As a result of the approval, Soliris is eligible to receive reimbursement from Japan's National Health Insurance (NHI) system.

 

Based on the potential launch of Soliris in Japan during the third quarter, Alexion raised its guidance for 2010. The company now expects revenues and non-GAAP earnings per share in the range of $515−$530 million (previous guidance of $505−$520 million) and $1.63−$1.68 (earlier guidance of $1.60−$1.65), respectively. The guidance has been revised upward despite the impact of health care reform and the recent unfavorable foreign exchange movement.

 

Soliris sales came in at $387 million (US: $160 million; ex US: $227 million) in 2009, a 49% rise compared with 2008. The drug is also being studied for other indications. These include atypical hemolytic uremic syndrome, an inherited genetic complement inhibitor deficiency disorder frequently leading to kidney failure; kidney transplant patients who have a high risk of organ rejection; dense deposit disease, a rare and severe kidney disorder; myasthenia gravis, a rare and severe neuromuscular disorder; and multifocal motor neuropathy, a rare and severe autoimmune disorder.

 

Apart from the US, Soliris is also approved in the European Union, Canada, Latin America and Australia. The drug received marketing approval in South Korea, Switzerland and Japan in 2010. We believe the approval and launch of Soliris in additional territories along with potential label expansion will boost sales in the coming years.

 

We are Neutral on the stock.