MOUNTAIN VIEW, Calif., Nov. 7, 2011 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today reported financial results for the fiscal quarter ended September 30, 2011 and provided a business update. The net losses for the quarters ended September 30, 2011 and 2010, as reported in accordance with accounting principles generally accepted in the United States (GAAP), were $13.4 million and $0.6 million, respectively. The net losses for the nine-month periods ended September 30, 2011 and 2010, were $30.8 million and $26.9 million, respectively. At September 30, 2011, Alexza had consolidated cash, cash equivalents and marketable securities of $28.3 million.
"Since the acceptance of the resubmission of our ADSUVE NDA in August, we have made additional progress toward our corporate goals for 2011." said Thomas B. King, President and CEO of Alexza. "We confirmed the FDA advisory committee meeting date on December 12, 2011 to discuss the ADASUVE NDA and we continue to look toward our PDUFA goal date of February 4, 2012."
King continued, "At the same time, we have also made great strides internationally. In addition to submitting the Marketing Authorization Application to the EMA, we announced a partnership with Grupo Ferrer to commercialize ADASUVE in Europe, Latin America, Russia, and the Commonwealth of Independent States (CIS) countries. We believe we are poised to enter 2012 with momentum as we continue developing ADASUVE."
Alexza Business Update
The following key events, listed in chronological order, occurred since the beginning of the third quarter of 2011:
- Alexza conducted a face-to-face meeting with the European Medicines Agency (EMA) assigned Co-Rapporteur and his review team in July 2011.
- In August 2011, the U.S. Food and Drug Administration (FDA) accepted Alexza's resubmission of the Adasuve (Staccato® Loxapine) New Drug Application (NDA) as a complete, class 2 response to the FDA's Complete Response Letter, and indicated a Prescription Drug User Fee Act (PDUFA) goal date of February 4, 2012.
- On October 5, 2011, Alexza entered into a commercial partnership for ADASUVE 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 24, 2011, Alexza announced that the FDA has scheduled a meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) for December 12, 2011, at which the ADASUVE NDA will be discussed.
- On October 26, 2011, Alexza filed a Marketing Authorization Application (MAA) for ADASUVE with the European Medicines Agency (EMA).
Alexza believes that, based on its cash, cash equivalents and marketable securities balance at September 30, 2011, the proceeds from the Grupo Ferrer partnership, net of the $5 million payment to the former Symphony Allegro stockholders, and the Company's current expected cash usage, it has sufficient capital resources to meet its anticipated cash needs, at its current expense levels, into the second quarter of 2012. Changing circumstances may cause Alexza to consume capital significantly faster or slower than currently anticipated, or to alter its operations.
Financial Results - Periods Ended September 30, 2011 and 2010
Alexza recorded $1.3 million and $3.8 million of revenues in the three and nine months ended September 30, 2011, respectively, compared to $0.7 million in both the three and nine months ended September 30, 2010. The revenues were related to the license agreement with Cypress Biosciences, Inc., signed in the third quarter of 2010.
GAAP operating expenses were $11.2 million and $29.6 million in the three and nine-month periods ended September 30, 2011, respectively, compared to operating expenses of $9.3 million and $34.0 million in the same periods in 2010. Research and development expenses were $8.1 million and $21.0 million in the three and nine-month periods ended September 30, 2011, respectively, compared to $6.7 million and $22.5 million in the same periods in 2010. General and administrative expenses were $3.1 million and $8.7 million in the three and nine-month periods ended September 30, 2011, respectively, compared to $2.6 million and $11.5 million for the same periods in 2010.
In connection with the acquisition of Symphony Allegro, Inc. in August 2009, Alexza is obligated to pay the former Symphony Allegro stockholders certain percentages of cash payments that may be generated from collaboration transactions for ADASUVE, AZ-002 (Staccato alprazolam) or AZ-104 (Staccato loxapine, low-dose). The Company records this obligation as a contingent liability and updates the liability each quarter. As a result of the update of the liability, Alexza recorded a non-operating loss of $3.0 million and $3.3 million during the three and nine months ended September 30, 2011 compared to a non-operating gain of $8.5 million and $7.3 million in the three and nine months ended September 30, 2010, respectively. Gains and losses incurred reflect Alexza's change in the estimated probability-weighted cash flows from ADASUVE and the estimated timing of receipt of such cash flows.
