Exhibit 99.1

 

LOGO

NEWS RELEASE - for immediate release

Alexza Reports 2011 Year-End Financial Results

and Provides General Business Update

Conference Call Scheduled Today for 5:30 p.m. Eastern Time

Mountain View, California - March 12, 2012

- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today reported financial results for the fiscal quarter and year ended December 31, 2011 and provided a general business update. Alexza recorded a net loss of $9.7 million and $40.5 million in the quarter and year ended December 31, 2011, respectively, as reported in accordance with accounting principles generally accepted in the United States (GAAP), compared to net income of $25.4 million in the quarter ended December 31, 2010 and a net loss of $1.5 million for the year ended December 31, 2010. At December 31, 2011, Alexza had consolidated cash, cash equivalents and marketable securities of $16.9 million.

“We continue to make solid progress on our global commercial strategy for ADASUVE,” said Thomas B. King, President and CEO of Alexza. “In the past five months, we have established a key commercial partnership with Grupo Ferrer, filed our MAA in Europe and have continued to push the ADASUVE NDA through its FDA review.”

Alexza General Business Update

The following key events occurred since the beginning of the fourth quarter of 2011:

 

 

On October 5, 2011, Alexza entered into a commercial partnership for ADASUVE™ (Staccato® loxapine) with Grupo Ferrer Internacional, S.A. (Grupo Ferrer) for the commercialization of ADASUVE in Europe, Latin America, Russia and the Commonwealth of Independent States countries.

 

 

On October 26, 2011, Alexza filed a Marketing Authorization Application (MAA) for ADASUVE with the European Medicines Agency (EMA).

 

 

On November 8, 2011 Alexza presented an abstract and poster, entitled “Treating Agitation with Inhaled Loxapine (AZ-004): Responder Analyses in Patients with Schizophrenia or Bipolar Disorder” at the 24th Annual U.S. Psychiatric and Mental Health Congress.

 

 

On December 12, 2011 the Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) voted to recommend that ADASUVE be approved for use as a single dose in 24 hours when used with the FDA recommended Risk Evaluation and Mitigation Strategy (REMS), for the treatment for agitation in patients with schizophrenia or bipolar mania. The vote on this question was 9/8/1 (yes/no/abstain).

 

 

On December 16, 2011, Alexza announced that it had retained Lazard to assist in exploring strategic options to enhance stockholder value, including a possible sale or disposition of one or more corporate assets, a strategic business combination, partnership or other transactions.

 

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The following information was filed by Alexza Pharmaceuticals Inc. (ALXA) on Monday, March 12, 2012 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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