EXHIBIT 99.1
Javelin Pharmaceuticals Reports Third Quarter Results for 2007
CAMBRIDGE, Mass., Nov 01, 2007 (BUSINESS WIRE) — Javelin Pharmaceuticals, Inc. (Amex: JAV) today reported its unaudited financial results for the third quarter ended September 30, 2007.
Stephen J. Tulipano, Javelin’s Chief Financial Officer, stated, “We made excellent progress during the third quarter and continued to execute on our commercial and clinical milestones. We were very pleased to receive marketing authorization for Dyloject in the UK and our sales team is poised to introduce this important product into the marketplace.”
Financial and corporate highlights for the three and nine month periods ending September 30, 2007:
— Ended the third quarter with $47.5 million in cash, cash equivalents and short term investments.
— Used approximately $16.5 million to fund operations for the nine months ended September 30, 2007.
— Net loss increased to approximately $8.2 million or $0.17 per share in the third quarter of 2007, from $5.7 million or $0.14 per share in the third quarter of 2006.
— Net loss increased to approximately $21.4 million or $0.48 per share for the nine months ended September 30, 2007, from $12.3 million or $0.30 per share for the same period in 2006.
— Reported non-cash stock based compensation expenses for the three and nine month periods ended September 30, 2007 of approximately $0.9 million and $2.7 million, or $0.02 and $0.06 per share impact on operations, respectively, in accordance with Statement of Financial Accounting Standard 123R.
Clinical and operational updates:
— Announced MAA Approval for Dyloject(R)
— Initiated Phase 3 Breakthrough Cancer Pain Trial for PMI-150 (Intranasal Ketamine)
— Granted commercially important U.S. Patent for PMI-150, extending protection into 2023
— Commenced early commercial activities in the European Union, with the hire of a Country Manager for Germany
— Commenced the Final Pivotal Phase 3 Orthopedic study for Dyloject
Financial Performance
For the third quarter of 2007, Javelin incurred approximately $8.9 million in operating expenses, partially offset by approximately $0.7 million of interest income in the quarter.
Research and development expenses for the third quarter of 2007 were $5.4 million, compared to $3.7 million in the third quarter of 2006. Research and development expenses for the first nine months of 2007
were approximately $13.4 million, compared to $8.0 million in 2006. Total research and development expenses increased in the three and nine month periods ending September 30, 2007 compared to 2006 due primarily to increased clinical trial expenses, headcount, and personnel costs associated with the advancement of each of our three product candidates.
Selling, general and administrative expenses were approximately $3.5 million in the third quarter of 2007 compared to $2.5 million for the third quarter of 2006, and $9.3 million and $6.5 million for the first nine months of 2007 and 2006, respectively. The increases resulted primarily from increased headcount and personnel costs as we expand and improve our administrative infrastructure and from increased promotional and marketing costs associated with the near term launch of Dyloject in the UK.
JAVELIN PHARMACEUTICALS, INC. AND SUBSIDIARIES
UNAUDITED FINANCIAL INFORMATION
Consolidated Statements of Operations
| | | | | | | | | | | | | | | | | |
| | | For the Three | | | For the Nine | |
| | | Months Ended | | | Months Ended | |
| | | September 30, | | | September 30, | |
| | | 2007 | | | 2006 | | | 2007 | | | 2006 | |
| | | | | |
| Revenues: | | | | | | | | | | | | | | | | |
| Government grants and contracts | | $ | — | | | $ | 154,814 | | | $ | — | | | $ | 728,526 | |
| Operating expenses: | | | | | | | | | | | | | | | | |
| Research and development | | | 5,383,688 | | | | 3,693,787 | | | | 13,354,130 | | | | 8,031,320 | |
| Selling, general and administrative | | | 3,486,724 | | | | 2,484,139 | | | | 9,283,866 | | | | 6,482,175 | |
| Depreciation and amortization | | | 25,537 | | | | 16,783 | | | | 69,119 | | | | 41,042 | |
| | | | | | | | | | | | | |
| Total operating expenses | | | 8,895,949 | | | | 6,194,709 | | | | 22,707,115 | | | | 14,554,537 | |
| | | | | | | | | | | | | |
| Operating loss | | | (8,895,949 | ) | | | (6,039,895 | ) | | | (22,707,115 | ) | | | (13,826,011 | ) |
| | | | | | | | | | | | | |
| Other income (expense): | | | | | | | | | | | | | | | | |
| Interest income | | | 675,050 | | | | 342,271 | | | | 1,349,958 | | | | 972,921 | |
| Interest expense | | | — | | | | — | | | | (699 | ) | | | (47 | ) |
| Other income | | | — | | | | 758 | | | | — | | | | 600,758 | |
| | | | | | | | | | | | | |
| Total other income (expense) | | | 675,050 | | | | 343,029 | | | | 1,349,259 | | | | 1,573,632 | |
| | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | |
| Net loss attributable to common stockholders | | $ | (8,220,899 | ) | | $ | (5,696,866 | ) | | $ | (21,357,856 | ) | | $ | (12,252,379 | ) |
| | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | |
| | | For the Three | | | For the Nine | |
| | | Months Ended | | | Months Ended | |
| | | September 30, | | | September 30, | |
| | | 2007 | | | 2006 | | | 2007 | | | 2006 | |
| | | | | |
| Net loss per share attributable to common stockholders: | | | | | | | | | | | | | | | | |
| Basic and diluted | | $ | (0.17 | ) | | $ | (0.14 | ) | | $ | (0.48 | ) | | $ | (0.30 | ) |
| | | | | | | | | | | | | |
| Weighted average shares | | | 48,423,815 | | | | 40,179,868 | | | | 44,384,795 | | | | 40,178,587 | |
| | | | | | | | | | | | | |
JAVELIN PHARMACEUTICALS, INC. AND SUBSIDIARIES
(A Development Stage Enterprise)
Condensed Consolidated Balance Sheets
| | | | | | | | | |
| | | (Unaudited) | | | | |
| | | September 30, | | | December 31, | |
| | | 2007 | | | 2006 | |
| | | | | | | | | |
| Assets | | | | | | | | |
| Current assets: | | | | | | | | |
| Cash and cash equivalents | | $ | 27,428,215 | | | $ | 9,273,479 | |
| Short term marketable securities available for sale | | | 20,041,029 | | | | 11,461,674 | |
| Grant receivable | | | — | | | | 113,645 | |
| Prepaid expenses and other current assets | | | 522,044 | | | | 245,593 | |
| | | | | | | |
| Total current assets | | | 47,991,288 | | | | 21,094,391 | |
| Fixed assets, at cost, net of accumulated depreciation | | | 301,553 | | | | 237,163 | |
| Other assets | | | 154,499 | | | | 109,223 | |
| | | | | | | |
| Total assets | | | 48,447,340 | | | | 21,440,777 | |
| | | | | | | |
| Liabilities and Stockholders’ Equity | | | | | | | | |
| Current liabilities: | | | | | | | | |
| Accounts payable and accrued expenses | | | 5,353,976 | | | | 3,151,379 | |
| Deferred lease liability | | | 171,948 | | | | 57,869 | |
| | | | | | | |
| Total current liabilities | | | 5,525,924 | | | | 3,209,248 | |
| | | | | | | |
| | | | | | | | | |
| Commitments and contingencies | | | | | | | | |
| Stockholders’ equity | | | | | | | | |
| Preferred stock, $0.001 par value, 5,000,000 shares authorized as of September 30, 2007 and December 31, 2006, none of which are outstanding | | | — | | | | — | |
| Common stock, $0.001 par value; 200,000,000 shares authorized as of September 30, 2007 and December 31, 2006; 48,781,559 and 40,409,421 shares issued and outstanding at September 30, 2007 and December 31, 2006, respectively. | | | 48,781 | | | | 40,409 | |
| | | | | | | | | |
| | | (Unaudited) | | | | |
| | | September 30, | | | December 31, | |
| | | 2007 | | | 2006 | |
| Additional paid-in capital | | | 143,661,842 | | | | 97,634,546 | |
| Other comprehensive income (loss) | | | 6,958 | | | | (5,117 | ) |
| Deficit accumulated during the development stage | | | (100,796,165 | ) | | | (79,438,309 | ) |
| | | | | | | |
| Total stockholders’ equity | | | 42,921,416 | | | | 18,231,529 | |
| | | | | | | |
| Total liabilities and stockholders’ equity | | $ | 48,447,340 | | | $ | 21,440,777 | |
| | | | | | | |
About Javelin Pharmaceuticals, Inc.:
Javelin is a specialty pharmaceutical company that applies proprietary technologies to develop new drugs and improved formulations of existing drugs for pain management. Specialty pharmaceutical analysts from six investment firms cover Javelin Pharmaceuticals, Inc. Javelin’s headquarters are located in Cambridge, Massachusetts with European offices in Cambridge, England and Cologne, Germany. For additional information, visitwww.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.
Financial Contact:
Javelin Pharmaceuticals, Inc.
Stephen J. Tulipano, CPA, 617-349-4500
Chief Financial Officer
stulipano@javelinpharma.com
or
Investor Relations & Media Contact:
Rick Pierce, 617-349-4500
VP Investor Relations
rpierce@javelinpharma.com
Copyright Business Wire 2007
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