Acusphere, Inc. Reports Q4 Financial Results and Operating Highlights.Business Editors/Health/Medical Writers WATERTOWN, Mass.--(BUSINESS WIRE)--March 17, 2004 Acusphere, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ACUS acus (a´kus) a needle or needle-like process. acus a needle or needle-like process. ) today reported financial results for the year and quarter ended December 31, 2003 and commented on recent AI-700 operational progress. Financial Results Financial results for our fourth quarter and year ended December 31, 2003 are summarized in the accompanying table, and are detailed in Acusphere's Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. , which is being filed today with the U.S. Securities and Exchange Commission. 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. for both the quarter and year ended December 31, 2003 increased compared to the corresponding periods in the prior year due to increased research and development costs incurred in 2003 relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the Company's Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA clinical program for AI-700 and to higher general administrative expenses associated with business development and operating as a public company. These increases were partially offset by lower expenses associated with stock-based compensation. The Company commenced its Phase III clinical program for AI-700 in early 2003 and commenced the pivotal trials under this program in late 2003. The Company's cash and working capital balances increased in 2003 over 2002 due to the Company's completion of an initial public offering ("IPO (Initial Public Offering) The first time a company offers shares of stock to the public. While not a computer term per se, many founders, employees and insiders of computer companies have found this acronym more exciting than any tech term they ever heard. "), which closed on October 14, 2003 and resulted in net proceeds Net Proceeds The amount received after all costs are deducted from the sale of a piece of property or security. Notes: In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). for use by Acusphere of approximately $47.6 million, and due to a private financing of $19.4 million in the second quarter of 2003 from the Company's existing investors. These increases in cash and working capital were partially offset by net losses incurred in both the quarter and year ended December 31, 2003 reflecting the Company's continued investment in research and development. Operating Progress The Company reported that clinical enrollment continues in its AI-700 Phase III clinical program. Training of clinical sites is continuing under the pilot program. Clinical sites that successfully complete training in the pilot program advance into the pivotal trials on a rolling basis. The Company confirmed that it is on schedule to enroll at least 300 patients in the trials before the end of 2004. Commenting on the Company's operations, Sherri C. Oberg, President and Chief Executive Officer, said, "Successful completion of our AI-700 clinical program remains our top priority. We are pleased with our continued progress under this program. We currently have initiated more than 20 of the 25 to 30 clinical sites we estimate will be required to meet our enrollment projections in our AI-700 Phase III clinical program, and we have established a clinical support network covering both the U.S. and Europe." Conference Call Information Acusphere will host a conference call today at 5:00 p.m. (EST EST electroshock therapy. EST abbr. electroshock therapy ) to discuss its financial results, operating progress and business outlook. The conference may be heard live via the investor relations Investor relations The process by which the corporation communicates with its investors. section of Acusphere's web site at www.acusphere.com or by dialing 1-800-901-5226, using the confirmation code: 25574654. After the conference call, a replay of the call will be made available for thirty days via our web site and a telephone replay will be available through March 23, 2004 by dialing 888-286-8010, using the confirmation code: 17946975. About Acusphere, Inc. Acusphere is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microparticle technology. Acusphere's three initial product candidates are in clinical development and are designed to address large unmet clinical needs within cardiology cardiology Medical specialty dealing with heart diseases and disorders. It began with the 1749 publication by Jean Baptiste de Sénac of contemporary knowledge of the heart. Diagnostic methods improved in the 19th century, and in 1905 the electrocardiograph was invented. , oncology and asthma. These product candidates were created using proprietary technology that enables Acusphere to control the porosity porosity /po·ros·i·ty/ (por-os´it-e) the condition of being porous; a pore. po·ros·i·ty n. 1. The state or property of being porous. 2. and size of nanoparticles and microparticles in a versatile manner that allows particles to be customized to address the delivery needs of a variety of drugs. Acusphere's lead product candidate, AI-700, is a cardiovascular drug in Phase III clinical development. AI-700 is designed to be a preferred alternative to the estimated 9.5 million procedures performed each year in the U.S. to detect coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. , the leading cause of death in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . For more information about Acusphere visit the Company's web site at www.acusphere.com. This 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. which are made pursuant to the safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding the plans, objectives and future financial performance of Acusphere, including statements regarding training clinical sites and enrolling patients in the AI-700 Phase III clinical program, constitute forward-looking statements which involve risks and uncertainties. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including anticipated operating losses operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. , uncertainties associated with research, development, testing and related regulatory approvals, unproven unproven Dubious, nonscientific, not proven, quack, questionable, unscientific adjective Relating to that which has not been validated by reproducible experiments or other scientific methods for determining effect or efficacy markets, future capital needs and uncertainty of additional financing, competition, uncertainties associated with intellectual property, complex manufacturing, high quality requirements, dependence on third-party manufacturers, suppliers and collaborators, lack of sales and marketing experience, loss of key personnel, uncertainties associated with market acceptance and adequacy of reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. , technological change, and government regulation. For a more detailed description of the risk factors associated with the Company, please refer to the Company's periodic reports filed with the U.S. Securities and Exchange Commission from time to time, including its Annual Report on Form 10-K for the year ended December 31, 2003. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this Release. The Company undertakes no obligation to update any forward-looking information contained in this press release or with respect to the announcements described herein.
ACUSPHERE, INC.
FINANCIAL HIGHLIGHTS
-- In Thousands --
CONDENSED CONSOLIDATED OPERATING RESULTS
(Unaudited)
Three Months Ended Twelve Months Ended
Dec. 31, Dec. 31, Dec. 31, Dec. 31,
2002 2003 2002 2003
Operating expenses:
Research and
development $2,610 $4,604 $13,545 $14,228
General and
administrative 1,056 1,402 3,906 4,173
Stock-based
compensation 528 235 2,195 1,307
Total operating
expenses 4,194 6,241 19,646 19,708
Equity in loss of
joint venture 1 -- 1,183 --
Interest expense and
other 226 491 1,067 2,215
Net loss ($4,421) ($6,732) ($21,896) ($21,923)
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
Dec. 31, ec. 31,
2002 2003
Cash and short-term investments $7,992 $54,562
Current assets 8,421 55,275
Total assets 13,367 58,924
Current liabilities 5,522 4,344
Long-term debt 1,726 205
Stockholders' equity (deficit) (85,348) 54,375
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