ALEXIONâS SMITHFIELD FACTORY, above, has been approved by European regulators and may get an OK from the FDA later this year.
By Ted Nesi PBN Web Editor
SMITHFIELD â Alexion Pharmaceuticals Inc. on Thursday said European regulators have given the green light for the company to manufacture its fast-selling drug Soliris at its factory here.
Cheshire, Conn.-based Alexion posted a profit of $237.13 million, or $2.59 per diluted share, in the three months ended Dec. 31, primarily thanks to a tax gain of $214.5 million. That compared with a profit of $15.34 million, or 17 cents a share, a year earlier.
Excluding one-time items, the biopharmaceutical company said it earned 31 cents a share. Revenue rose 43 percent to $110.65 million.
The results beat investor expectations. Analysts polled by Thomson Reuters had forecast a profit of 24 cents on $109.2 million in sales. The companyâs shares fell 2.2 percent to $46.42 at 12:40 p.m. in Nasdaq trading.
âOur global team executed consistently as it focused on patientsâ needs, enabling us to exceed our operational, clinical and financial objectives for 2009,â said Chief Executive Officer Leonard Bell. âWe ended the year with strong momentum to continue achieving our three central growth initiatives: serving more patients in existing countries, expanding into new territories, and advancing our development programs for Soliris.â
For the full year, Alexion posted a profit of $295.17 million, or $3.26 per diluted share, compared with a profit of $33.15 million, or 39 cents a share, in 2008. Annual revenue rose 59 percent to $386.8 million.
Soliris, Alexionâs only product on the market, is a treatment for paroxysmal nocturnal hemoglobinuria, or PNH, a disorder that destroys red blood cells and causes anemia. It received FDA approval for sale in the U.S. and Europe in 2007, and last year also was approved for sale in Canada and Australia.
Last year, Alexion paid off the $44 million remaining on its mortgage for the 56,500-square-foot former Alpha-Beta Technology Inc. plant in Smithfield, which it bought in July 2006.
The company said it has received final approval from European Union officials to manufacture Soliris in Smithfield, and it expects to get approval from the FDA by the end of this year. The drug is currently made by the Swiss chemicals and biotech company Lonza Group.
Alexion forecast earnings, excluding one-time items, of $1.60 to $1.65 per share this year on worldwide net revenue of $505 million to $520 million.
The company also said it has 12 clinical trials currently under way to test Soliris as a treatment for eight other rare conditions beyond PNH.