Javelin Pharmaceuticals Reports Second Quarter 2007 Results.CAMBRIDGE, Mass. -- Javelin Pharmaceuticals, Inc. (Amex: JAV JAV Javanese
JAV Japanese Adult Video
JAV Ilulissat, Greenland (Airport Code)
JAV Jeanne d'Arc de Vaugirard (Paris)
JAV Journey Adventure Vehicle
JAV Java Applet Viewer
JAV Java Alignment Viewer - News) today reported its unaudited financial results for the second quarter ended June 30, 2007.
Stephen J. Tulipano, Javelin's Chief Financial Officer, stated, "We were pleased to attract a number of new institutional investors Institutional Investor
A non-bank person or organization that trades securities in large enough share quantities or dollar amounts that they qualify for preferential treatment and lower commissions. in our follow-on offering Follow-On Offering
An offering of additional shares after a company has had an initial public offering.
This sometimes means the company is strapped for cash. So they need to issue more shares to pay bills or finance a new project. in May and to achieve many clinical and operational milestones during the quarter. We continue to ramp up Ramp Up
To increase a company's operations in anticipation of increased demand.
A company might 'ramp up' operations if they just signed a contract creating substantially more demand for their product.
See also: Demand, Economies of Scale our commercialization efforts in anticipation of and are increasing our investment in an infrastructure that will support a potential product launch initially in Europe. Commensurate with preparation for these activities, our cash outflows are expected to significantly increase over the next twelve to eighteen months."
Financial and corporate highlights for the three and six month periods ending June 30, 2007:
* Ended the second quarter with $52.7 million in cash, cash equivalents and short term investments.
* Used approximately $11 million to fund operations for the six months ended June 30, 2007.
* Net loss increased to approximately $7.2 million or $0.16 per share in the second quarter of 2007, from $4.5 million or $0.11 per share in the second quarter of 2006.
* Net loss increased to approximately $13.1 million or $0.31 per share for the six months ended June 30, 2007, from $6.6 million or $0.16 per share for the same period in 2006.
* Reported non-cash stock based compensation expenses for the three and six month periods ended June 30, 2007 of approximately $0.9 million and $1.8 million, or $0.02 and $0.04 per share impact on operations, respectively, in accordance with Statement of Financial Accounting Standard 123R.
Clinical and operational updates:
* Completed a public stock offering of approximately 7.5 million shares for net proceeds Net Proceeds
The amount received after all costs are deducted from the sale of a piece of property or security.
In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). of approximately 42 million dollars. JP Morgan served as book running manager, and Pacific Growth Equities LLC (Logical Link Control) See "LANs" under data link protocol.
LLC - Logical Link Control , Leerink Swann & Company, Allen & Company, Fortis Securities LLC, and Punk, Ziegel & Company, were co-managers of the offering.
* Signed a commercial supply agreement with Baxter Healthcare Corporation to act as secondary supplier of Dyloject[TM].
* Gained an additional 10 years of patent protection in Europe for Dyloject into 2024.
* Announced successful pivotal Phase 3 top line trial data for Rylomine[TM]. Study met primary endpoint, significantly reduced post surgical orthopedic pain.
* Included in the Russell 2000[R], 3000[R], Microcap microcap
1. Of or relating to the common stock of a company with a small capitalization, usually between $50 million and $250 million. Microcap stocks tend to experience volatile price movements and are subject to investment fraud schemes. and Global Indices.
* Completed accrual accrual,
n continually recurring short-term liabilities. Examples are accrued wages, taxes, and interest. in first of two pivotal Phase 3 Dyloject trials and commenced accrual in the second of the two pivotal trials.
* Completed our manufacturing plant inspection and continue to prepare for expected U.K. launch of Dyloject in the fourth quarter.
For the second quarter of 2007, Javelin incurred approximately $7.7 million in operating expenses Operating expenses
The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. , partially offset by approximately $0.5 million of interest income in the quarter.
Research and development expenses for the second quarter of 2007 were $4.6 million, compared to $3.0 million in the second quarter of 2006. Research and development expenses for the first six months of 2007 were approximately $8.0 million, compared to $4.3 million in 2006. Total research and development expense increased in the three and six month periods of 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 $3.0 million in the second quarter of 2007 compared to $2.3 million for the second quarter of 2006, and $5.8 million and $4.0 million for the first six 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 potential launch of Dyloject in the UK.
JAVELIN PHARMACEUTICALS, INC.
UNAUDITED FINANCIAL INFORMATION
Consolidated Statements of Operations
[TABLE OMITTED] [TABLE OMITTED]
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 Phase 3 clinical development. . One of these Phase 3 drug candidates, Dyloject([TM]), is currently under review for Marketing Authorization Application (MAA MAA
macroaggregated albumin ) approval in Europe. Previous clinical trials have demonstrated its safety and rapid onset of action onset of action Pharmacology The length of time needed for a medicine to become effective. See Therapeutic drug monitoring. . 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 forward-looking statement
A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. . Such statements are valid only as of today, and we disclaim dis·claim
v. dis·claimed, dis·claim·ing, dis·claims
1. To deny or renounce any claim to or connection with; disown.
2. To deny the validity of; repudiate.
3. 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 preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable.
1. development thereof, the completion of clinical trials, the FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. 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.