Javelin Pharmaceuticals Inc (JAV)

[surf1944]

Javelin Pharmaceuticals, Inc. Reports Second Quarter 2009 Results and Corporate Highlights
Press Release
Source: Javelin Pharmaceuticals, Inc.
On Tuesday August 11, 2009, 7:30 am EDT

Companies:Javelin Pharmaceuticals, Inc.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--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.