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Javelin Pharmaceuticals, Inc. Reports Second Quarter 2009 Results and Corporate Highlights

Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV), a leading developer of novel products for pain management, today reported its unaudited financial results for the second quarter ended June 30, 2009. The Company's milestones in the second quarter included the following:

  • Announced new findings from recent Phase I pharmacokinetic (PK) study of Dyloject® , which showed Dyloject was well tolerated in high risk patients with impaired renal and hepatic function
  • Successful completion of its open-label, multi-day, observational Phase III safety study of Dyloject in the United States, keeping the product candidate on track to file an NDA
  • On track to file a high quality NDA for Dyloject this Fall
  • Significant reduction in Q2 expenses from Q1 2009 as the majority of the current clinical programs at the Company have been completed

Financial Performance

The Company ended the second quarter of 2009 with $8.9 million in cash, cash equivalents, and long term marketable securities available-for-sale.

For the three and six months ended June 30, 2009, total revenues were $0.3 million and $2.4 million, compared to $ 0.2 million, for each of the respective, three and six months period in the prior year.

Javelin’s net loss decreased to approximately $7.9 million, or $0.13 per share, for the three months ended June 30, 2009, from approximately $9.1 million, or $0.16 per share, for the comparable period in 2008. For the six months ended June 30, 2009, the net loss was approximately $22.7 million, or $0.38 per share, up from $18.8 million, or $0.36 per share, for the similar period in 2008.

Javelin incurred approximately $8.2 million in total operating expenses in the second quarter of 2009 compared to $9.5 million for the same period a year ago. For the six months ended June 30, 2009 and 2008, Javelin’s total operating expenses were $25.1 million and $19.7 million, respectively.

For both three months ended June 30, 2009, and 2008 our cost of revenues was approximately $0.1 million. For the six months ended June 30, 2009, cost of revenues was approximately $2.0 million compared to $0.2 million in the similar period in 2008.

Research and development expenses increased from approximately $4.5 million for the three months ended June 30, 2008 to $5.3 million for the three months ended June 30, 2009. Total research and development expenses increased from $10.2 million for the six months ended June 30, 2008 to $17.2 million for the six months ended June 30, 2009.

Selling, general and administrative expenses for the three months ended June 30, 2009 were $2.7 million as compared to $4.8 million for the three months ended June 30, 2008, and $5.8 million for the six months ended June 30, 2009 as compared to $9.2 million for the similar period in 2008.

JAVELIN PHARMACEUTICALS, INC    
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED BALANCE SHEETS
 
(Unaudited)
June 30, December 31,
2009 2008
Assets
Current assets:
Cash and cash equivalents $ 7,227,952 $ 20,057,937
Accounts receivable, product sales - 470,288
Inventory 740,729 1,847,904
Prepaid expenses and other current assets   572,165     511,820  
Total current assets 8,540,846 22,887,949
Long term marketable securities available-for-sale 1,624,896 1,586,910
Fixed assets, at cost, net of accumulated depreciation 1,030,040 1,195,670
Intangible assets, net of accumulated amortization 3,186,142 3,480,248
Other assets   146,331     154,918  
Total assets $ 14,528,255   $ 29,305,695  
 
Liabilities and Stockholders' Equity (Deficit)
Current liabilities:
Accounts payable and accrued expenses $ 7,974,192 $ 8,119,006
Deferred revenue, current 1,204,301 -
Deferred lease liability   458,326     513,519  
Total current liabilities 9,636,819 8,632,525
Deferred revenue, noncurrent   5,318,996     -  
Total liabilities 14,955,815 8,632,525
 
Commitments and contingencies - -
 
Stockholders' Equity (Deficit)
Preferred stock, $0.001 par value, 5,000,000
shares authorized; as of June 30, 2009 and
December 31, 2008, none of which are outstanding - -
 
Common stock, $0.001 par value; 200,000,000 shares authorized
as of June 30, 2009 and December 31, 2008; 60,675,016
60,649,358 shares issued and outstanding as of
June 30, 2009 and December 31, 2008, respectively

60,675

60,649
Additional paid-in capital 176,092,394 174,534,897
Other comprehensive income 63,456 10,383
Deficit accumulated during the development stage  

(176,644,085

)   (153,932,759 )
Total stockholders' equity (deficit)   (427,560 )   20,673,170  
Total liabilities and stockholders' equity (deficit) $ 14,528,255   $ 29,305,695  
JAVELIN PHARMACEUTICALS, INC
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
         
Three Months Ended Six Months Ended
June 30, June 30,
2009   2008   2009     2008  
Revenues:
Partner revenue $ 301,075 $ - $ 2,199,883 $ -
Product revenue   -     179,509     188,172       245,302  
Total revenues 301,075 179,509 2,388,055 245,302
Costs and Expenses
Cost of revenues 105,205 129,498 2,017,829 179,405
Research and development 5,308,385 4,489,899 17,154,456 10,155,349
Selling, general and administrative 2,738,442 4,760,242 5,784,745 9,236,513
Depreciation and amortization   81,651     79,850     165,523       120,603  
Total costs and expenses   8,233,683     9,459,489     25,122,553       19,691,870  
Operating loss (7,932,608 ) (9,279,980 ) (22,734,498 ) (19,446,568 )
Other income (expense):
Interest income 14,234 220,782 43,768 577,802
Other income (expense)   (31,653 )   (514 )   (21,140 )     36,089  
Total other income (expense)   (17,419 )   220,268     22,628       613,891  
Loss before income tax provision (7,950,027 ) (9,059,712 ) (22,711,870 ) (18,832,677 )
Income tax provision   (544 )   -     (544 )     -  
Net loss attributable to common stockholders $ (7,949,483 ) $ (9,059,712 ) $ (22,711,326 )   $ (18,832,677 )
 
Net loss per share attributable to common
stockholders:
Basic and diluted $ (0.13 ) $ (0.16 ) $ (0.38 ) $ (0.36 )
Weighted average shares   60,430,494     55,057,493     60,426,428     51,924,001  

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 acute pain management market. The Company has one marketed drug in the UK and three drug candidates in US Phase 3 clinical development. 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

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