Acusphere, Inc. Reports Q1 Financial Results and Operating Highlights.Business Editors/Health/Medical Writers/High-Tech Writers WATERTOWN, Mass.--(BUSINESS WIRE)--May 6, 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. ), a specialty pharmaceutical company, today reported financial results for the quarter ended March 31, 2004 and commented on the operational progress of its lead product candidate, AI-700. Financial Results The Company's financial results the first quarter of 2004 are summarized in the accompanying table and detailed in Acusphere's Form 10-Q Form 10-Q See 10-Q. 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 Q1 2004 increased compared to the corresponding period in the prior year due to increased research and development costs incurred in 2004 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. The increase in research and development costs relating to AI-700 reflect increased clinical activity and increased staffing for the Phase III program, the pivotal phase of which started in December 2003. As of March 31, 2004, the Company's balance of cash and cash equivalents totaled $46.8 million and the Company's balance of outstanding debt from equipment financing totaled $869,000. In April 2004 the Company closed a new $8.0 million equipment financing facility. This facility is available to fund qualified equipment purchases made through March 2005. Operating Progress The Company reported that clinical enrollment continues in its AI-700 Phase III clinical program with training of clinical sites continuing under the pilot program and with clinical sites that successfully complete the pilot program advancing into the pivotal trials on a rolling-basis. The Company indicated that more than 20 clinical sites have been initiated and100 patients have been enrolled in the clinical program. Commenting on the Company's operations, Sherri C. Oberg, President and Chief Executive Officer, said, "Our enrollment rate in our Phase III program has been increasing and we continue to be encouraged by feedback from clinicians about AI-700. We are approximately one-third of the way through the year and we are pleased to have reached one-third of our 2004 enrollment goal." Conference Call Information Acusphere will host a conference call today at 5:00 p.m. (ET) to discuss its financial results, operating progress and business outlook. The conference call may be heard live via the investor relations Investor relations The process by which the corporation communicates with its investors. section of Acusphere's website at www.acusphere.com or by dialing 1-800-299-6183, using the confirmation code: 75417105. After the conference call, a replay of the call will be made available for thirty days via our web site and a telephonic replay will be available through May 14, 2004 by dialing 1-888-286-8010, using the confirmation code: 89224299. 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 un·met adj. Not satisfied or fulfilled: unmet demands. 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 oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. 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 <onlyinclude> This is a list of particles in particle physics, including currently known and hypothetical elementary particles, as well as the composite particles that can be built up from them. to be customized to address the delivery needs of a variety of drugs. Acusphere's lead product candidate, AI-700, is a cardiovascular cardiovascular /car·dio·vas·cu·lar/ (-vas´ku-ler) pertaining to the heart and blood vessels. car·di·o·vas·cu·lar adj. Abbr. 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 the clinical performance of AI-700 and the progress with respect to enrolling patients and training clinical sites as part of our 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2004. 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 (Except Per Share Data) --
Condensed Consolidated Operating Results
(Unaudited)
Three Months Ended
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March 31, March 31,
2003 2004
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Operating expenses:
Research and development $3,102 $5,513
General and administrative 864 1,261
Stock-based compensation 320 233
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Total operating expenses 4,286 7,007
Interest and other income (expense) (202) 82
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Net loss ($4,488) ($6,925)
Accretion of dividends and offering costs
on preferred stock 1,609 -
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Net loss available to common stockholders ($6,097) ($6,925)
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Net loss per common share - basic and diluted ($5.07) ($0.48)
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Weighted-average shares outstanding - basic and
diluted 1,202 14,286
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Condensed Consolidated Balance Sheet Information
December 31, March 31,
2003 2004
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Cash and cash equivalents $54,562 $46,775
Current assets 55,275 47,671
Total assets 58,924 51,843
Current liabilities 4,344 4,127
Long-term obligations 205 15
Stockholders' equity 54,375 47,701
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