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CAMBRIDGE, Mass., Mar 09, 2010 (BUSINESS WIRE) -- Javelin Pharmaceuticals, Inc. (NYSE - Amex: JAV) recently reported its audited financial results for the full year and quarter ending December 31, 2009.
Corporate Highlights:
-- On January 15, 2009 Javelin entered into an exclusive European marketing partnership for Dyloject(TM) with Therabel N.V., worth up to $71.0 million, including $7 million upfront, future milestone payments and royalties on sales.
-- On June 15, 2009 Javelin announced that a study showed Dyloject was well tolerated in patients with impaired renal and hepatic function.
-- On June 23, 2009 Javelin announced that it had completed a large open label safety study of Dyloject.
-- On December 2, 2009, Javelin submitted its NDA for Dyloject and was successfully accepted for filing with the US FDA on February 2, 2010. Dyloject has received a PDUFA date of October 3, 2010.
-- On December 18, 2009, Javelin entered into a definitive merger agreement with Myriad Pharmaceuticals, Inc. (Nasdaq: MYRX). Additional information relating to the transaction can be found by accessing the registration statement on Form S-4 (File No. 333-164890) filed by Myriad Pharmaceuticals, Inc. with the SEC.
Financial Highlights for the Year Ended December 31, 2009:
-- Ended the year with $0.77 million in cash, and cash equivalents.
-- Total revenues for the year ended December 31, 2009 were $3.8 million compared to $1.1 million for the same period a year ago. For the three months ended December 31, 2009 total revenues were $.3 million compared to $.5 million in 2008.
-- Partner revenue was $3.6 million in 2009 as a result of our January 2009, EU marketing partnership with Therabel. There were no partner revenues in 2008. Partner revenue was $.3 million in the quarter 2009. There were no partner revenues in the fourth quarter of 2008.
-- Product revenues for the year ended December 31, 2009 were $.188 million and $1.1 million for the same period in 2008. For the three months ended December 31, 2009 there were no product revenues compared to $.5 million for the same period in 2008.
-- Net loss decreased to approximately $37.6 million, or $0.62 per share, for the 12 months ended December 31, 2009, from $43.5 million, or $0.77 per share, for the same period in 2008. Net loss decreased to approximately $8.1 million, or $0.13 per share, in the fourth quarter of 2009, from $13.8 million, or $0.23 per share, in the fourth quarter of 2008.
-- Javelin incurred approximately $41 million in total operating expenses for the full year ending December 31, 2009 compared to $45 million in the prior year. For the three months ended December 31, 2009 operating expenses were $8.4 million compared to $14 million for the same period in 2008.
-- Cost of product revenues for the year ended December 31, 2009 was approximately $3.0 million compared to $.85 million for the same period in 2008. For the three months ended December 31, 2009 cost of product revenues were $.08 million compared to $.4 million for the same period a year ago.
-- Research and development expenses decreased to $24.5 million for the year ended December 31, 2009 from $26.8 million for the same period in 2008. For the three months ended December 31, 2009, research and development expenses were $3.2 as compared to $9.8 million for the same period a year ago.
-- Reported non-cash stock based compensation expense for the year ended December 31, 2009 was approximately $5.4 million, or $0.09 per share impact on operations, compared to $3.3 million, or $0.06 per share impact on operations for 2008.
Selected Financials
| JAVELIN PHARMACEUTICALS, INC | ||||||||
| (A Development Stage Enterprise) | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| December 31, | December 31, | |||||||
| 2009 | 2008 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 767,484 | $ | 20,057,937 | ||||
| Accounts receivable, product sales | - | 470,288 | ||||||
| Inventory | - | 1,847,904 | ||||||
| Prepaid expenses and other current assets | 601,708 | 511,820 | ||||||
| Total current assets | 1,369,192 | 22,887,949 | ||||||
| Long term marketable securities available-for-sale | - | 1,586,910 | ||||||
| Fixed assets, net | 551,330 | 1,195,670 | ||||||
| Intangible assets, net of accumulated amortization | 2,892,037 | 3,480,248 | ||||||
| Other assets | 143,149 | 154,918 | ||||||
| Total assets | $ | 4,955,708 | $ | 29,305,695 | ||||
| Liabilities and Stockholders' Equity (Deficit) | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued expenses | $ | 6,384,533 | $ | 8,119,006 | ||||
| Deferred revenue, current | 1,204,301 | - | ||||||
| Deferred lease liability | 391,475 | 513,519 | ||||||
| Total current liabilities | 7,980,309 | 8,632,525 | ||||||
| Deferred revenue, noncurrent | 4,716,846 | - | ||||||
| Total liabilities | 12,697,155 | 8,632,525 | ||||||
| Commitments and contingencies | - | - | ||||||
| Stockholders' Equity (Deficit) | ||||||||
|
Preferred stock, $0.001 par value, 5,000,000 shares authorized; as of December 31, 2009 and 2008, none of which are outstanding |
- | - | ||||||
|
Common stock, $0.001 par value; 200,000,000 shares authorized as of December 31, 2009 and 2008; 63,879,541 and 60,649,358 shares issued and outstanding as of December 31, 2009 and 2008, respectively |
63,879 | 60,649 | ||||||
| Additional paid-in capital | 183,697,912 | 174,534,897 | ||||||
| Other comprehensive income | 6,935 | 10,383 | ||||||
| Deficit accumulated during the development stage | (191,510,173 | ) | (153,932,759 | ) | ||||
| Total stockholders' equity (deficit) | (7,741,447 | ) | 20,673,170 | |||||
| Total liabilities and stockholders' equity (deficit) | $ | 4,955,708 | $ | 29,305,695 | ||||
| JAVELIN PHARMACEUTICALS, INC | ||||||||||||||||
| (A Development Stage Enterprise) | ||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended | Full Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2009 | 2008 | 2009 | 2008 | |||||||||||||
| Revenues | ||||||||||||||||
| Partner revenue | $ | 301,076 | $ | - | $ | 3,631,925 | $ | - | ||||||||
| Product revenue | - | 490,261 | 188,172 | 1,101,613 | ||||||||||||
| Total revenues | 301,076 | 490,261 | 3,820,097 | 1,101,613 | ||||||||||||
| Costs and expenses | ||||||||||||||||
| Cost of product revenue | 79,326 | 397,828 | 2,978,694 | 849,591 | ||||||||||||
| Research and development | 3,168,822 | 9,787,316 | 24,488,994 | 26,830,617 | ||||||||||||
| Selling, general and administrative | 5,094,638 | 3,819,359 | 13,248,593 | 17,219,518 | ||||||||||||
| Depreciation and amortization | 76,904 | 86,948 | 322,042 | 293,509 | ||||||||||||
| Total costs and expenses | 8,419,690 | 14,091,451 | 41,038,323 | 45,193,235 | ||||||||||||
| Operating loss | (8,118,614 | ) | (13,601,190 | ) | (37,218,226 | ) | (44,091,622 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest expense | - | - | - | - | ||||||||||||
| Interest income | 59 | 113,478 | 49,691 | 921,238 | ||||||||||||
| Other income (expense) | 18,249 | (279,055 | ) | (397,078 | ) | (276,241 | ) | |||||||||
| Total other income (expense), net | 18,308 | (165,577 | ) | (347,387 | ) | 644,997 | ||||||||||
| Loss before income tax provision | (8,100,306 | ) | (13,766,767 | ) | (37,565,613 | ) | (43,446,625 | ) | ||||||||
| Income tax provision | 5,589 | (6,924 | ) | 11,801 | 16,451 | |||||||||||
| Net loss attributable to common stockholders | $ | (8,105,895 | ) | $ | (13,759,843 | ) | $ | (37,577,414 | ) | $ | (43,463,076 | ) | ||||
|
Net loss per share attributable to common stockholders: |
||||||||||||||||
| Basic and diluted | $ | (0.13 | ) | $ | (0.23 | ) | $ | (0.62 | ) | $ | (0.77 | ) | ||||
| Weighted average shares | 62,706,276 | 60,402,537 | 61,029,991 | 56,184,146 | ||||||||||||
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 approved drug in the UK, a submitted NDA for Dyloject and two drug candidates in US Phase III clinical development. For additional information about Javelin, please visit the Company's website at http://www.javelinpharmaceuticals.com.
Javelin Pharmaceuticals, Inc. Forward Looking Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the expected timing of results and development of our drug candidates, the proposed merger between Javelin Pharmaceuticals, Inc. and Myriad Pharmaceuticals, Inc., and potential FDA approval and commercial launch of Dyloject. These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that we may be unable to further identify, develop and achieve commercial success for new products and technologies; the risk that we may be unable to discover drugs that are safer and more efficacious than our competitors; the risk that we may be unable to develop and maintain manufacturing capabilities for our products; the possibility of delays in the research and development necessary to select drug development candidates and delays in clinical trials; the risk that clinical trials may not result in marketable products; the risk that we may be unable to successfully finance and secure regulatory approval of and market our drug candidates, or that clinical trials will not be completed on the timelines we have estimated; uncertainties about our ability to obtain new corporate collaborations and acquire new technologies on satisfactory terms, if at all; the development of competing products and services; the risk that we may be unable to protect our proprietary technologies; the risk of patent-infringement claims; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading "Risk Factors" contained in our Form 10-K, for the year ended December 31, 2009, which was filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Javelin Pharmaceuticals undertakes no duty to update this information unless required by law.
Important Additional Information Will Be Filed with the SEC
This press release does not constitute an offer of any securities for sale. In connection with the proposed merger between Javelin Pharmaceuticals, Inc. and Myriad Pharmaceuticals, Inc. On February 12, 2010, MPI filed with the SEC a registration statement on Form S-4 (File No. 333-164890) (the "S-4"). A preliminary joint proxy statement/prospectus of MPI and Javelin was included in the S-4 and copies of the final joint proxy statement/prospectus will be mailed to shareholders prior to special meetings of shareholders to be held to vote on the proposed merger and other proposals. Investors and security holders are urged to read the S-4 and the joint proxy statement/prospectus (including all amendments and supplements thereto) and the other relevant material because they contain important information about MPI, Javelin and the proposed transaction. The S-4, joint proxy statement/prospectus and other relevant materials, and any and all documents filed by MPI with the SEC, may be obtained free of charge at the SEC's web site at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC by MPI by directing a written request to Myriad Pharmaceuticals, Inc., 305 Chipeta Way, Salt Lake City, UT 84108, Attention: Secretary. Investor may also request free copies of the documents by directing a written request to Javelin Pharmaceuticals, Inc., 125 CambridegePark Drive, Cambridge, MA 02140, Attention: Secretary. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS AND THE OTHER RELEVANT MATERIALS BEFORE MAKING ANY VOTING OR INVESTMENT DECISION WITH RESPECT TO THE PROPOSED TRANSACTIONS.
Myriad Pharmaceuticals, Javelin and their respective executive officers and directors and other persons may be deemed to be participants in the solicitation of proxies from the stockholders of Myriad Pharmaceuticals and Javelin in connection with the proposed merger. Information about the executive officers and directors of Myriad Pharmaceuticals and their ownership of Myriad Pharmaceuticals common stock is set forth in Myriad Pharmaceuticals' annual report on Form 10-K for the year ended June 30, 2009, filed with the SEC on September 28, 2009. Information regarding Javelin's directors and executive officers is available in its annual report on Form 10-K for the year ended December 31, 2008, filed with the SEC on March 12, 2009, and the proxy statement for Javelin's 2009 annual meeting of stockholders, filed with the SEC on April 30, 2009. Certain directors and executive officers of Javelin may have direct or indirect interests in the merger due to securities holdings, pre-existing or future indemnification arrangements and rights to severance payments if their employment is terminated prior to or following the merger. If and to the extent that any of the Myriad Pharmaceuticals or Javelin participants will receive any additional benefits in connection with the merger, the details of those benefits will be described in the final joint proxy statement/prospectus relating to the merger. Investors and security holders may obtain additional information regarding the direct and indirect interests of Myriad Pharmaceuticals, Javelin and their respective executive officers and directors in the merger by reading the final joint proxy statement/prospectus regarding the merger
JAV-E
SOURCE: Javelin Pharmaceuticals, Inc.
Javelin Pharmaceuticals, Inc.
Stephen J. Tulipano, CPA, 617-349-4500
Chief Financial Officer
stulipano@javelinpharma.com
or
Javelin Pharmaceuticals, Inc.
Rick Pierce, 617-349-4500
VP Investor Relations
rpierce@javelinpharmaceuticals.com
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