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

-- Announced new findings from recent Phase I pharmacokinetic (PK) study of Dyloject(R) , 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

SOURCE: Javelin Pharmaceuticals, Inc.

Javelin Pharmaceuticals, Inc. 
Investor Relations & Media 
Rick Pierce, 617-349-4500 
VP Investor Relations 
rpierce@javelinpharma.com