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Alexza Reports 2010 Fourth Quarter and Full Year Financial Results and Provides General Corporate Update
Date:3/15/2011

meeting in January 2011.  Alexza anticipates resubmitting its AZ-004 NDA in July 2011.
  • Alexza announced that the British Journal of Psychiatry, a publication of the Royal College of Psychiatrists, published the results of the pivotal Phase 3 study evaluating AZ-004 (inhaled or Staccato loxapine) for the rapid treatment of agitation in patients with schizophrenia, in its January 2011 edition (198:51-58).
  • Alexza received notice that AZ-004 is eligible for submission of a Marketing Authorization Application (MAA) under the centralized registration procedure.  Alexza has been notified of the Rapporteur and co-Rapporteur appointments for the AZ-004 review.  The Company believes that the comprehensive clinical development program for AZ-004 meets the requirements for the MAA filing and expects to submit the MAA in Q3 2011.

  • Financial Results - Periods Ended December 31, 2010 and 2009

    Alexza recorded $42.1 million and $42.9 million of revenues in the quarter and year ended December 31, 2010, and $9.5 million in the year ended December 31, 2009.  The Company recorded no revenues during the quarter ended December 31, 2009.  In October 2010, Biovail terminated the license and supply agreement for AZ-004, at which time Alexza recognized as revenue the $40 million non refundable up-front payment received in February 2010.  In September 2010, the Company began to recognize revenues related to payments received from Cypress Biosciences, Inc. as part of the license agreement signed in August 2010, resulting in revenues of $1.9 million and $2.6 million for the quarter and year ended December 31, 2010, respectively.  In January 2009, Alexza and Endo Pharmaceuticals mutually agreed to terminate their development agreement related to AZ-003 (Staccato fentanyl), at which time Alexza had fulfilled its obligations under the development agreement and recognized $9.5 million in revenues.

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