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Auxilium Pharmaceuticals, Inc. Announces Fourth Quarter and Full Year 2010 Financial Results, Guidance for 2011
Date:2/10/2011

lment for the double-blind studies in the first quarter of 2011 and reporting top-line results in the first half of 2012.

TESTIM:

  • Worldwide revenues for Testim were $193.0 million for the year ending December 31, 2010, up 20% over 2009.
  • Testim U.S. revenues were up 25% over the prior year to a record $190.0 million.
  • Testim U.S. prescriptions in the fourth quarter of 2010 grew by 10% over the fourth quarter of 2009 to approximately 180,000 according to National Prescription Audit data from IMS Health, Inc. (IMS), a leading market research firm.
  • Total prescriptions for the testosterone replacement gel market segment grew 12% in the fourth quarter of 2010 versus the same period in 2009, according to data from IMS.
  • In October, 2010, the U.S. Food and Drug Administration (FDA) issued a response to the Citizen Petition submitted on behalf of Abbott Laboratories regarding testosterone gel products.  In its response, FDA stated that an application for a potential generic testosterone gel with a different penetration enhancer than the originator must be submitted as a 505(b)(2) New Drug Application (NDA) rather than an Abbreviated New Drug Application.  FDA further stated that the NDA would be treated as a separate application requiring independent patent certification and notification and would be clocked for regulatory purposes from the time it is provided, resulting potentially in a new 30-month stay.

  • 2011 Financial Guidance and Strategic PrioritiesFor 2011, Auxilium anticipates that:

  • XIAFLEX revenues will be in the range of $55 million to $67 million;
  • Testim revenues will be in the range of $200 million to $210 million;
  • Research and development spending will be in the range of $60 million to $70 million;
  • Selling, general and administrative expenses will be in the range of $170 million to $180 million;
  • Net loss will be in the range of $35 million to
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  • SOURCE Auxilium Pharmaceuticals, Inc.
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