Acusphere, Inc. Reports Q3 2006 Financial Results and Accomplishments.WATERTOWN, Mass. -- 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 quarter ended September 30, 2006 and commented on operational progress. The Company indicated that its primary focus during the three months ended September 30, 2006 was on positioning the Imagify[TM] RAMP-2 trial for success by training the RAMP-2 echo blinded readers with recently unblinded RAMP-1 images. Imagify is an ultrasound contrast agent designed to screen for coronary heart disease coronary heart disease: see coronary artery disease. coronary heart disease or ischemic heart disease Progressive reduction of blood supply to the heart muscle due to narrowing or blocking of a coronary artery (see atherosclerosis). , the leading cause of death in the U.S. Imagify-enhanced ultrasound is being evaluated in two Phase 3 clinical trials phase 3 clinical trial Phase 3 study. See Phase study. , RAMP-1 and RAMP-2, designed to demonstrate non-inferiority to nuclear stress tests, the leading imaging technique used to screen for coronary heart disease. Operating Progress During the third quarter ended September 30, 2006, the Company studied the results of its RAMP-1 trial; created a training program for echo blinded readers using 100 images from the recently completed RAMP-1 trial; and trained the RAMP-2 echo blinded readers to read more aggressively for sensitivity. Subsequently, the Company tested the results of this training. In October, the Company announced that the training results demonstrated that all three RAMP-2 echo blinded readers had successfully increased their sensitivity while maintaining accuracy levels. Based on these training results, all three echo blinded readers read aggressively, which means their sensitivity was higher than specificity. The three echo blinded readers in the RAMP-2 trial have begun reading the RAMP-2 images. The Company expects to report RAMP-2 results in the second quarter of 2007. Following production of commercial scale development batches in the second quarter of 2006, the Company reported that it continues to make progress with respect to qualifying its commercial manufacturing facility under good manufacturing practices Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products. (cGMPs). The Company expects that these qualification efforts should be ready to support the Company's plan to submit an NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any for Imagify in the second half 2007. During the third quarter, Dr. Jonathan Jaffe joined the Company as Vice President of Medical Affairs. Dr. Jaffe is a board certified board certified, adj the status of a dental specialist such as an orthodontist who has become a board diplomate by successfully completing the certification program of the recognized certification board in that area of practice. cardiologist Cardiologist Doctor who specializes in diagnosing and treating heart diseases. Mentioned in: Electrophysiology Study of the Heart, Lithotripsy cardiologist a physician who specializes in the diagnosis and treatment of heart disease. and most recently was at Merck where he was responsible for 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. medical affairs. "The recent training results have increased our confidence in the prospects for RAMP-2. With newly trained echo blinded readers, we are confident that the sensitivity of Imagify enhanced stress echo will be non-inferior to nuclear stress in RAMP-2. These expected RAMP-2 results, in combination with the non-inferior accuracy and superior specificity demonstrated in RAMP-1, should provide a strong rationale for regulatory approval," stated Sherri C. Oberg, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Acusphere. "We believe that Imagify can provide a compelling alternative to nuclear stress testing Determining the durability of a system by pushing it to its limits. Stress testing a network is performed by transmitting excessive numbers of packets or attempting to break in illegally. and we continue to prepare the company in support of a broad commercial opportunity." Financial Results The Company's financial results for the quarter ended September 30, 2006 are summarized in the accompanying table and detailed in Acusphere's Form 10-Q Form 10-Q See 10-Q. to be filed today with the U.S. Securities and Exchange Commission. Reflecting the Company's primary focus on the success of Imagify, the majority of operating results in the third quarter reflect Imagify related activities, including costs associated with the RAMP-2 clinical trial and qualification of a commercial manufacturing facility for Imagify. 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. in the third quarter of 2006 totaled $12.9 million, of which $10.0 million related to research and development. The $12.9 million in total operating expenses includes $2.5 million for depreciation and amortization expense and $0.7 million for stock-based compensation expense. The Company's $2.3 million increase in total operating expenses between Q3 2006 and the same quarter of 2005 primarily resulted from a $1.9 million increase in depreciation expense. The Company's net loss for the third quarter of 2006, after $0.6 million in dividends on outstanding preferred stock Stock shares that have preferential rights to dividends or to amounts distributable on liquidation, or to both, ahead of common shareholders. Preferred stock is given preference over common stock. Holders of preferred stock receive dividends at a fixed annual rate. , was $13.3 million, or $0.46 per common share, compared to $10.4 million, or $0.58 per common share, for the same period in the previous year. Weighted average common shares outstanding in the third quarter of 2006 were approximately 28.8 million, compared to approximately 17.9 million in the prior year period. The Company's net change in cash and short-term investments, or net cash burn, in the third quarter of 2006 was $10.0 million. The majority of this net cash burn was incurred from operating activities which include Imagify clinical trials and manufacturing-related costs. As of September 30, 2006, the Company's balance sheet reflects $85.5 million in total assets, including $47.6 million in cash and short-term investments, which compares to $51.1 million as of December 31, 2005. The Company estimates that its cash balance at the end of 2006 will be approximately $35 million. The Company in the third quarter of 2006 continued to defer recognition of $6.0 in future collaboration revenues from the initial license fees paid previously to the Company by its European partner, Nycomed. As of September 30, 2006, there were approximately 28.8 million shares of the Company's common stock outstanding and approximately 5.3 million common stock equivalents outstanding underlying the Company's outstanding preferred stock, excluding dividends. Conference Call Information Acusphere plans to hold a conference call with investors today, Tuesday, November 14, 2006, commencing at 11:00 a.m. (Eastern Time). The conference call will include discussion of the Company's operating results, financing results, priorities, and other operational matters and disclosures followed by answers to investor questions. The conference may be heard live via the investor relations Investor relations The process by which the corporation communicates with its investors. section of the Company's website at www.acusphere.com or by dialing 1-866-202-1971, using the confirmation code: 41716214. For participants dialing in from outside the U.S. please call 1-617-213-8842 using the same confirmation code. After the conference call, a replay of the call will be made available via the Company's web site and telephone replay by dialing 1-888-286-8010, or internationally 1-617-801-6888, using the confirmation code: 70740375. About Imagify[TM] (perflubutane polymer microspheres) injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. suspension Imagify (pronounced i-maj'-i-fE'), formerly known as AI-700, is an investigational ultrasound contrast agent in Phase 3 clinical development, designed to provide physicians with valuable information on myocardial myocardial /myo·car·di·al/ (-kahr´de-al) pertaining to the muscular tissue of the heart. myocardial pertaining to the muscular tissue of the heart (the myocardium). perfusion perfusion /per·fu·sion/ (-zhun) 1. the act of pouring over or through, especially the passage of a fluid through the vessels of a specific organ. 2. a liquid poured over or through an organ or tissue. . Acusphere is developing Imagify to enable stress echo to assess myocardial perfusion and compete more effectively with nuclear stress testing, the leading procedure for detecting coronary heart disease. The Company believes that Imagify enhanced ultrasound has the potential to be a cost effective and convenient method to screen for coronary heart disease. An estimated 11.9 million procedures are done each year in the U.S. to detect coronary heart disease, 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. and the Company estimates that the U.S. commercial opportunity for Imagify approaches $2.4 billion. Imagify was designed to be used with commercially available ultrasound equipment and established imaging techniques and has been studied in more than 1000 patients to date. Glossary of Terms Used Above Accuracy: the ability to correctly diagnose all the patients in the study. Blinded Readers: physicians with expertise in reading stress echo images Echo Image is a Norwegian synthpop band. The band unofficially started in 1997 when Pål Magnus Rybom started experimenting with electronic music. Later that year Fredrik Hansen joined and Echo Image was officially formed with Trine Bilet joining towards the end of the year (echo blinded reader) or nuclear stress images (nuclear blinded reader). The physicians have access to no clinical information about the patient, and so blinded reading is much more difficult than reading in the normal clinical setting, where physicians have access to patient history, symptoms and other test results. Non-inferiority: a statistical type of trial analysis, which is designed to show that one test is comparable to another test, within a certain statistical margin of error. RAMP-1 and RAMP-2: The two pivotal Phase 3 trials conducted by Acusphere to assess the safety and efficacy of Imagify. The purpose of these trials is to demonstrate that stress echo with Imagify[TM] is non-inferior to nuclear stress testing. RAMP is an abbreviation abbreviation, in writing, arbitrary shortening of a word, usually by cutting off letters from the end, as in U.S. and Gen. (General). Contraction serves the same purpose but is understood strictly to be the shortening of a word by cutting out letters in the middle, of Real-time Assessment of Myocardial Perfusion with echocardiography Echocardiography Definition Echocardiography is a diagnostic test that uses ultrasound waves to create an image of the heart muscle. Ultrasound waves that rebound or echo off the heart can show the size, shape, and movement of the heart's valves and . Sensitivity: The ability to correctly diagnose patients with confirmed disease. Specificity: The ability to correctly diagnose patients confirmed to be without disease. About Acusphere, Inc. Acusphere (NASDAQ: ACUS) 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 designed to address large unmet clinical needs within cardiology, oncology and asthma. These product candidates were created using proprietary technology that enables Acusphere to control the porosity 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, Imagify, is a cardiovascular drug in Phase 3 clinical development. For more information about Acusphere visit the Company's web site at www.acusphere.com. "Acusphere" and "Imagify" are trademarks of Acusphere, Inc. 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. The above press release contains forward-looking statements 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, including statements regarding the successful completion of clinical trials, including the likelihood of regulatory approval, the ability of echo blinded readers to read at higher levels of sensitivity while maintaining accuracy and acceptable specificity, upcoming milestone timing, capital requirements Capital requirements Financing required for the operation of a business, composed of long-term and working capital plus fixed assets. , commercial prospects for the Company's product candidates and qualification of a commercial manufacturing facility. 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. and existing capital obligations, uncertainties associated with research, development, testing and related regulatory approvals, including uncertainties regarding the ultimate outcome of Acusphere's Phase 3 clinical trials for Imagify and uncertainties regarding the number of patients required to complete the Phase 3 clinical trials, future capital needs and uncertainty of additional financing, uncertainties regarding the cost, timing and ultimate success of the qualification of the Company's commercial manufacturing facility in accordance with applicable regulatory requirements, complex manufacturing, high quality requirements, lack of commercial manufacturing experience, dependence on third-party manufacturers, suppliers and collaborators, uncertainties associated with intellectual property, competition, loss of key personnel, uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation, and other risks and challenges detailed in the Company's filings with the U.S. Securities and Exchange Commission, including the Company's Annual Report on 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. and most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2006. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this press release or to reflect the occurrence of unanticipated events. [TABLE OMITTED] [TABLE OMITTED] |
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