Alexza Pharmaceuticals Inc. (ALXA) SEC Filing 10-Q Quarterly report for the period ending Tuesday, March 31, 2015

Exhibit 99.1

 

NEWS RELEASE - for immediate release

Alexza Reports 2015 First Quarter Financial Results

Management to Review Results and Provide a General Update

in a Conference Call Scheduled Today for 5:00 p.m. Eastern Time

Mountain View, California - May 6, 2015

- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today reported financial results for the quarter ended March 31, 2015. The net loss and the loss from operations for the first quarter were $0.4 million and $13.0 million, respectively, compared to $10.7 million and $8.8 million during the same quarter in 2014, respectively. At March 31, 2015, Alexza had consolidated cash, cash equivalents, marketable securities, and restricted cash of $23.9 million.

“We continue to focus on ways in which to drive value in Alexza and our validated Staccato^® platform, including continuing the development of AZ-002 (Staccato alprazolam) and AZ-007 (Staccato zaleplon), and in evaluating licensing opportunities for our Staccato technology and opportunities to license ADASUVE in geographies that are not currently partnered,” said Thomas B. King, President and Chief Executive Officer of Alexza Pharmaceuticals. “Another key component to that strategy is the need to reduce cost of goods for ADASUVE, which have been unsustainably high during the launch stage of the product.”

King continued, “To date, ADASUVE sales have been lower than originally projected, reflecting the challenges of launching a novel hospital-based product. We believe the sales during the initial global launch of ADASUVE do not reflect the clinical benefits ADASUVE can convey to patients, and we remain confident in ADASUVE’s long-term commercial prospects. At the same time, we realize that we cannot sustain a commercial production facility with capacity that exceeds the initial uptake of the product, and we must look to increase efficiencies and reduce the costs of producing ADASUVE.”

During 2013 and 2014, Alexza completed production of ADASUVE for commercial launch and initial stocking, which did not utilize Alexza’s full manufacturing capacity. In collaboration with Teva and Ferrer, Alexza conducted an analysis to evaluate need for the product and cost-effective strategies for ADASUVE commercial production. The analysis included supply chain requirements, production volume and timelines, commercial batch sizes and possible scenarios to make global production more efficient and cost-effective. Earlier this year, Teva and Ferrer provided longer-term ADASUVE orders, allowing Alexza to manufacture ADASUVE in a consistent manner to take advantage of the efficiencies of continued batch production.

Alexza plans to produce ADASUVE until early in the third quarter of 2015. Once existing orders are filled and shipped, the Company intends to suspend ADASUVE commercial production operations and resume commercial production in the future as additional commercial product is required by Teva and Ferrer. As the Company considers future commercial manufacturing strategies, it may also seek third parties who could manufacture ADASUVE on a more efficient basis, possibly in multi-product facilities.

 

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The following information was filed by Alexza Pharmaceuticals Inc. (ALXA) on Wednesday, May 6, 2015 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-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.