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CAMBRIDGE, Mass., Nov 10, 2008 (BUSINESS WIRE) -- Javelin Pharmaceuticals, Inc. (Amex: JAV - News), a leading developer of novel products for pain management, today reported its unaudited financial results for the third quarter ended September 30, 2008. The Company's highlights in the third quarter included the following:
Martin J. Driscoll, Chief Executive Officer of Javelin, stated, "We made good progress during the quarter clinically and commercially. The clinical development programs for Dyloject and Ereska in the US continue to progress toward NDA filings in 2009. We generated continued strong hospital formulary acceptance for Dyloject in the UK. Also, we continued to efficiently manage our resources, while advancing our priorities - the U.S. Phase III programs for Dyloject and Ereska."
Financial Performance
The Company ended the third quarter of 2008 with $36.5 million in cash, cash equivalents and long term marketable securities.
Dyloject revenue for the three and nine months ended September 30, 2008 was $366,050 and $611,352, respectively. Javelin did not record any revenue 2007.
Net loss increased to approximately $10.9 million, or $0.18 per share, for the three months ended September 30, 2008, compared to $8.2 million, or $0.17 per share, for the same period a year ago. For the nine months ended September 30, 2008, net loss was approximately $29.7 million, or $0.54 per share, compared to $21.4 million, or $0.48 per share, for the same period in 2007.
Javelin incurred approximately $11.4 million in total operating expenses in the third quarter of 2008. In the comparable period in 2007, Javelin incurred $8.9 million in total operating expenses. For the nine months ended September 30, 2008 and 2007, Javelin incurred $31.1 million and $22.7 million, respectively, in total operating expenses.
For the three and nine months ended September 30, 2008, our cost of product revenues were $272,358 and $451,763 respectively.
Research and development expenses for the three months ended September 30, 2008 were $6.9 million, as compared to $5.4 million for the same period in 2007. Total research and development expenses increased from approximately $13.4 million for the nine months ended September 30, 2007 to $17.0 million for the nine months ended September 30, 2008, primarily due to increased clinical trial expenses for both Dyloject and Ereska.
Selling, general and administrative expenses for the three months ended September 30, 2008 were $4.2 million compared to $3.5 million for the third quarter of 2007, and $13.4 million for the nine months ended September 30, 2008 compared to $9.3 million for the nine months ended September 30, 2007.
Selected Financials
About Javelin Pharmaceuticals, Inc.
With corporate headquarters in Cambridge, MA, Javelin applies innovative proprietary technologies to develop new drugs and improved formulations of existing drugs to target unmet and underserved medical needs in the pain management market. The Company has three drug candidates in US Phase 3 clinical development. One of these US Phase 3 drug candidates, Dyloject™, has received Marketing Authorization Application (MAA) approval and favorable pricing in the UK, where it is now being sold. Previous clinical trials have demonstrated its safety and rapid onset of action. For additional information about Javelin, please visit the company's website at http://www.javelinpharmaceuticals.com.
Forward Looking Statement
This news release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other governmental regulation, our ability to obtain working capital, our ability to successfully develop and commercialize drug candidates, and competition from other pharmaceutical companies.
JAV-E
SOURCE: Javelin Pharmaceuticals, Inc.
Javelin Pharmaceuticals, Inc. Stephen J. Tulipano, CPA, 617-349-4500 Chief Financial Officer stulipano@javelinpharmaceuticals.com or Investor Relations & Media Rick Pierce, 617-349-4500 VP Investor Relations rpierce@javelinpharmaceuticals.com
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