Exhibit 99.1
Javelin Pharmaceuticals, Inc. Reports Second Quarter 2008 Results and Corporate Highlights
CAMBRIDGE, Mass., Aug 07, 2008 (BUSINESS WIRE) — Javelin Pharmaceuticals, Inc. (Amex: JAV), a leading developer of novel products for pain management, today reported its unaudited financial results for the second quarter ended June 30, 2008. The Company’s milestones in the second quarter included the following:
• | | Completed a $25.7 million net financing, thus finishing Q2 2008 with $44.6 million in cash |
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• | | Robust partnership discussions continue |
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• | | Dosed the first patient in our pivotal Phase 3 study for PMI-150 |
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• | | Received issuance of European patent for PMI-150 extending protection into 2023 |
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• | | Tripled the number of UK hospital formulary inclusions; approval rate greater than 90% |
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• | | Signed a European supply agreement with Baxter Healthcare for the production of Dyloject(R) serving to potentially increase future gross margins and significantly increasing our European manufacturing capacity |
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• | | Implemented organization and personnel changes to deliver more timely clinical and regulatory results and bolster organizational accountability |
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• | | Focused the organization on prioritizing cash expenditures and becoming more efficient with our use of capital |
Martin J. Driscoll, Chief Executive Officer of Javelin comments, “I have made accountability to our shareholders an organizational priority. While there is much yet to accomplish, I am pleased with our second quarter performance. Changes in a number of business areas are beginning to pay off. These include organizational changes in our clinical and regulatory functions to expedite our clinical timelines. I am most pleased with the progress of our partnering discussions. We are also recognizing efficiencies in our use of capital as evidenced by our second quarter financial performance.”
Financial Performance
The Company ended the second quarter of 2008 with $44.6 million in cash, cash equivalents, and short term investments.
Dyloject revenue for the three and six months ended June 30, 2008 was $179,509 and $245,302, respectively. Javelin did not record any revenue during the same periods in 2007.
Net loss increased to approximately $9.1 million, or $0.16 per share, for the three months ended June 30, 2008, up from approximately $7.2 million, or $0.16 per share, for the comparable period in 2007. For the six months ended June 30, 2008, net loss was approximately $18.8 million or $0.36 per share, up from $13.1 million or $0.31 per share, for the comparable period in 2007.
Javelin incurred approximately $9.5 million in total operating expenses in the second quarter of 2008. In the comparable period in 2007, Javelin incurred $7.7 million in total operating expenses. For the six months ended June 30, 2008 and 2007, Javelin incurred $19.7 million and $13.8 million, respectively in total operating expenses.
For the three and six months ended June 30, 2008, our cost of product revenues were $129,498 and $179,409, respectively.
Research and development expenses decreased slightly from approximately $4.6 million for the three months ended June 30, 2007 to $4.5 million for the three months ended June 30, 2008. Total research and development expenses increased from approximately $8.0 million for the six months ended June 30, 2007 to $10.2 million for the six months ended, June 30, 2008.
Selling, general and administrative expenses for the three months ended June 30, 2008 were $4.8 million compared to $3.0 million for the second quarter of 2007, and $9.2 million for the six months ended June 30, 2008 compared to $5.8 million for the six months ended June 30, 2007.
Selected Financials
JAVELIN PHARMACEUTICALS, INC
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED BALANCE SHEETS
| | | | | | | | |
| | (Unaudited) | | | | |
| | June 30, | | | December 31, | |
| | 2008 | | | 2007 | |
Assets | | | | | | | | |
Current Assets: | | | | | | | | |
Cash and cash equivalents | | $ | 41,627,954 | | | $ | 15,931,243 | |
Short term investments | | | 2,975,000 | | | | 21,319,150 | |
Accounts receivable, product sales | | | 158,190 | | | | — | |
Inventory | | | 1,755,839 | | | | 116,143 | |
Prepaid expenses and other current assets | | | 629,581 | | | | 1,289,809 | |
| | | | | | |
Total current assets | | | 47,146,564 | | | | 38,656,345 | |
Fixed assets, at cost, net of accumulated depreciation | | | 1,011,202 | | | | 545,195 | |
Intangible assets, net of accumulated amortization | | | 3,683,393 | | | | 3,795,577 | |
Other assets | | | 157,730 | | | | 154,498 | |
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Total assets | | $ | 51,998,889 | | | $ | 43,151,615 | |
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| | | | | | | | |
Liabilities and Stockholders’ Equity | | | | | | | | |
Current liabilities: | | | | | | | | |
Accounts payable and accrued expenses | | $ | 7,778,693 | | | $ | 8,156,788 | |
Deferred lease liability | | | 565,370 | | | | 484,141 | |
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Total current liabilities | | | 8,344,063 | | | | 8,640,929 | |
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Commitments and contingencies | | | — | | | | — | |
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Stockholders’ Equity | | | | | | | | |
Preferred stock, $0.001 par value, 5,000,000 shares authorized as of December 31, 2007 and December 31, 2006; none of which are outstanding | | | — | | | | — | |
Common stock, $0.001 par value; 200,000,000 shares authorized as of June 30, 2008 and December 31, 2007; 60,620,473 and 40,409,421 shares issued and outstanding as of June 30, 2008 and December 31, 2007, respectively | | | 60,620 | | | | 48,990 | |
Additional paid-in capital | | | 172,917,825 | | | | 144,922,785 | |
Other comprehensive income (loss) | | | (21,259 | ) | | | 8,594 | |
Deficit accumulated during the development stage | | | (129,302,360 | ) | | | (110,469,683 | ) |
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Total stockholders’ equity | | | 43,654,826 | | | | 34,510,686 | |
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Total liabilities and stockholders’ equity | | $ | 51,998,889 | | | $ | 43,151,615 | |
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JAVELIN PHARMACEUTICALS, INC
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| | | | | | | | | | | | | | | | |
| | Three Months Ended | | Six Months Ended |
| | June 30, | | June 30, |
| | 2008 | | 2007 | | 2008 | | 2007 |
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Revenues | | | | | | | | | | | | | | | | |
Product revenue | | $ | 179,509 | | | $ | — | | | $ | 245,302 | | | $ | — | |
Government grants and contracts | | | — | | | | — | | | | — | | | | — | |
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Total revenues | | | 179,509 | | | | — | | | | 245,302 | | | | — | |
Costs and expenses | | | | | | | | | | | | | | | | |
Cost of goods sold | | | 129,498 | | | | — | | | | 179,405 | | | | — | |
Research and development | | | 4,489,899 | | | | 4,638,715 | | | | 10,155,349 | | | | 7,970,442 | |
Selling, general and administrative | | | 4,760,242 | | | | 3,023,496 | | | | 9,236,513 | | | | 5,797,142 | |
Depreciation and amortization | | | 79,850 | | | | 23,565 | | | | 120,603 | | | | 43,582 | |
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Total operating expenses | | | 9,459,489 | | | | 7,685,776 | | | | 19,691,870 | | | | 13,811,166 | |
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Operating loss | | | (9,279,980 | ) | | | (7,685,776 | ) | | | (19,446,568 | ) | | | (13,811,166 | ) |
Other income (expense) | | | | | | | | | | | | | | | | |
Interest expense | | | — | | | | — | | | | — | | | | (699 | ) |
Interest income | | | 220,782 | | | | 451,467 | | | | 577,802 | | | | 674,908 | |
Other income (expense) | | | (514 | ) | | | — | | | | 36,089 | | | | — | |
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Total other income (expense) | | | 220,268 | | | | 451,467 | | | | 613,891 | | | | 674,209 | |
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Net loss | | | (9,059,712 | ) | | | (7,234,309 | ) | | | (18,832,677 | ) | | | (13,136,957 | ) |
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Deemed dividend related to beneficial conversion feature of Series B convertible preferred stock | | | — | | | | — | | | | — | | | | | |
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| | | | | | | | | | | | | | | | |
| | Three Months Ended | | Six Months Ended |
| | June 30, | | June 30, |
| | 2008 | | 2007 | | 2008 | | 2007 |
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Net loss attributable to common stockholders | | $ | (9,059,712 | ) | | $ | (7,234,309 | ) | | $ | (18,832,677 | ) | | $ | (13,136,957 | ) |
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Net loss per share attributable to common stockholders: | | | | | | | | | | | | | | | | |
Basic and diluted | | $ | (0.16 | ) | | $ | (0.16 | ) | | $ | (0.36 | ) | | $ | (0.31 | ) |
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Weighted average shares | | | 55,057,493 | | | | 44,400,030 | | | | 51,924,001 | | | | 42,331,710 | |
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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(TM), 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 athttp://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
Copyright Business Wire 2008
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