Acusphere, Inc. Reports 2006 Financial Results and Operating Highlights.Phase 3 Clinical Trial phase 3 clinical trial Phase 3 study. See Phase study. Results Expected in Q2 2007 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 and year ended December 31, 2006 and commented on operating progress. Financial Results The Company's financial results for the periods are summarized in the accompanying table. These results are detailed in Acusphere'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. as recently filed with the U.S. Securities and Exchange Commission. These results primarily reflect costs incurred by the Company to advance its lead product candidate, Imagify[TM], through Phase 3 clinical trials and preparations for submitting the New Drug Application (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 ) later this year. Imagify is a cardiovascular drug designed to increase the effectiveness of ultrasound for the detection of 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 Company's product candidates are not approved for sale and, accordingly, during 2006 the Company did not derive any revenue from product sales. During 2006, the Company recognized $1.8 million in collaboration revenue. The majority of this revenue was recognized in connection with its agreement with Nycomed for European marketing rights to Imagify. As of December 31, 2006, the Company reported $7.3 million in deferred revenues relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc this agreement. 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 2006 increased to $64.1 million, compared to $49.6 million in 2005. This $14.5 million increase primarily reflects an increase of $6.3 million in depreciation expense associated with the Company's commercial manufacturing facility placed into service in October 2005, a $3.9 million increase in intellectual property related costs, a $2.3 million increase in stock-based compensation expense resulting from the adoption of SFAS SFAS Statement of Financial Accounting Standards SFAS Special Forces Assessment and Selection SFAS Student Financial Aid Services SFAS Sport Fishing Association of Singapore SFAS Safety Features Actuation System SFAS Statewide Fixed Assets System 123R, and increased staffing and other costs associated with qualifying the Imagify commercial manufacturing facility. These expenses were partially offset by reduced clinical trial costs, due to the completion of enrollment in December 2005 of Acusphere's RAMP-1 clinical trial and in June 2006 of its RAMP-2 clinical trial. As of December 31, 2006, the Company's total assets were $94.8 million, the two largest components of which were cash and cash equivalents of $59.8 million and net property and equipment of $32.5 million. Operating Update Acusphere is focusing on progressing through Imagify clinical trials, qualifying the Imagify commercial manufacturing facility, preparing for the Imagify New Drug Application (NDA) submission and expanding the Company's product pipeline to leverage the commercial organization the Company plans to build for Imagify. Imagify Clinical Trials During 2006, the Company announced the results from its RAMP-1 clinical trial, the first Phase 3 clinical trial for Imagify, completed enrollment in its RAMP-2 clinical trial, the second Phase 3 clinical trial for Imagify, and completed a revised training program for the RAMP-1 and RAMP-2 ultrasound blinded readers. Our findings from this training program convince us that ultrasound blinded readers can increase their ability to correctly diagnose patients with disease, referred to as increasing reader sensitivity. The ultrasound blinded readers for the RAMP-2 trial are now in the process of reading all RAMP-2 images to take advantage of this new skill level. As of this date, each of the ultrasound blinded readers have completed reading more than 50% of the images. The Company, which is currently blinded to the RAMP-2 efficacy results, expects to unblind Un`blind´ v. t. 1. To free from blindness; to give or restore sight to; to open the eyes of. and announce these results in the second quarter of 2007. As a part of its ongoing clinical program for Imagify, Acusphere will continue investigating the performance of Imagify in a range of circumstances that may be encountered beyond of the scope of the RAMP-1 and RAMP-2 studies. One such trial, named ACCESS (Acquiring Consensus for Contrast Echocardiography contrast echocardiography Cardiology Enhancement of echocardiography with contrast media–eg, with sonicated albumin, which is used to detect coronary disease by IV injection of fluorocarbons. System Settings), is designed to determine the appropriate equipment settings for Imagify on a variety of ultrasound hardware platforms Each hardware platform, or CPU family, has a unique machine language. All software presented to the computer for execution must be in the binary coded machine language of that CPU. Following is a list of the major hardware platforms in existence today. See platform. . The Company has completed enrollment of 39 patients in this trial. Additionally, with RAMP-1 and RAMP-2 focused on the diagnostic value of Imagify, which is the ability to detect the presence or absence of disease at a fixed point in time, Acusphere also anticipates evaluating the prognostic prog·nos·tic adj. 1. Of, relating to, or useful in prognosis. 2. Of or relating to prediction; predictive. n. 1. A sign or symptom indicating the future course of a disease. 2. value of Imagify, which is the ability to predict future cardiovascular events, or outcomes through a trial called PACE (Prognostic Assessment of Contrast Echocardiography). No new administration of Imagify will be required for PACE, as the Company will conduct follow-up analysis on patients from the RAMP-1 and RAMP-2 trials. Imagify Manufacturing The Company has completed all installation qualification, or IQ, and operational qualification, or OQ, requirements relating to its commercial manufacturing facility in Tewksbury, Massachusetts Tewksbury (pronounced IPA: /ˈtʊksbɛriː, ˈtʊksbriː/) is a town in Middlesex County, Massachusetts, United States. The population was 28,851 at the 2000 census. , for Imagify. Final qualification of the Imagify commercial manufacturing facility will continue through 2007 in preparation for the NDA submission. Imagify is delivered intravenously and must be manufactured in a sterile manner. As part of the NDA submission, the Company must demonstrate and verify that the facility is capable of manufacturing sterile product before proceeding to the final step of producing sterile Imagify development batches. The required testing to validate this aseptic processing Aseptic processing is used to sterilize a product (typically food or pharmaceuticals) and package the product in a way that maintains sterility. In aseptic processing, food is sterilized, the container is sterilized, and then the container is filled in a sterile environment. is expected to begin in the third quarter of 2007. NDA Submission Once the RAMP-2 results have been announced, the Company will move to complete and submit the NDA to FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. within the fourth quarter of 2007. The Company is currently working on the application wherever possible. Acusphere recently announced that Dennis Bucceri has been appointed to Senior Vice President of Regulatory Affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: Product Pipeline Expansion Acusphere intends to advance the Company's product pipeline beyond Imagify in 2007 through increased emphasis on new development initiatives. Ideal products will be those that both fit the hospital-based sales model and commercial infrastructure that the Company plans to build for Imagify and those products that leverage Acusphere's proprietary drug delivery technology platform. The Company has been evaluating potential candidates and expects to announce a new product program in the third quarter of 2007. Commenting on the fourth quarter and fiscal year 2006, Sherri C. Oberg, President and Chief Executive Officer, said "We are pleased with the progress we made in 2006 in executing against our goals. As we approach the completion of the Phase 3 Imagify clinical phase, we look forward to moving the product through regulatory evaluation and commercial launch." Upcoming Milestones Looking ahead, in 2007 the Company plans to: * Release RAMP-2 trial results in Q2 * Announce a new product development program in Q3 * Begin aseptic aseptic /asep·tic/ (-tik) free from infection or septic material. a·sep·tic adj. Of, relating to, or characterized by asepsis. validation of the Imagify commercial manufacturing facility in Q3 * Submit the Imagify NDA in Q4 Conference Call Information Acusphere plans to hold a conference call with investors today, Monday, March 19, 2007, commencing at 1:00 PM (Eastern Time). The conference call will cover the Company's financial results, operating results and business outlook and will be led by 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. and John F. Thero, SVP SVP S'il Vous Plaît (French: Please) SVP Senior Vice President SVP Schweizerische Volkspartei (Swiss People~s Party) SVP Society of Vertebrate Paleontology SVP Social Venture Partners SVP St Vincent de Paul and CFO See Chief Financial Officer. of Acusphere, who will also be available for 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 1-866-271-6130, or internationally 1-617-213-8894, using the confirmation code: 18715564. After the conference call, a replay of the call webcast will be made available via the Company's web site and a telephone replay will be available through April 2, 2007 by dialing 1-888-286-8010, or internationally 1-617-801-6888, using the confirmation code: 37720708. 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 is a cardiovascular drug 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, or blood flow to the heart muscle. Acusphere is developing Imagify to enable cardiac stress ultrasound to assess myocardial perfusion and compete more effectively with 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. , the leading procedure for detecting coronary artery disease. The Company believes that Imagify-enhanced cardiac stress ultrasound has the potential to be a cost effective and convenient method to screen for coronary artery disease. The Company estimates that over 10 million procedures are done each year in the U.S. to detect coronary artery 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 believes that the U.S. commercial opportunity for Imagify exceeds $2 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. About Acusphere, Inc. Acusphere (NASDAQ: ACUS) is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere Not to be confused with Glass microphere. This article largely refers to micropheres or protein protocells as small spherical units postulated by some scientists as a key stage in the origin of life. technology. Acusphere's three initial product candidates 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 and size of nanoparticles and microspheres in a versatile manner that allows them 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 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, in particular, successful results for the Company's RAMP-2 trial, and statements regarding the timing and likelihood of regulatory approval of an NDA submission for Imagify, the timing and success of the ACCESS and PACE trials for Imagify, the timing of announcement of a new HDDS HDDS Hazards Data Distribution System HDDS High-Density Data System HDDS Hull Design Database System HDDS Hazardous Device Disposal Squad HDDS Hold Deck Deck Switch HDDS Hydro-Dynamic Device Simulator development program, the timing and success of qualification of a commercial manufacturing facility, including process qualification and aseptic validation, the strength of the Company's intellectual property position, the ability to establish and develop a sales team for Imagify and commercial prospects for the Company's current and future product candidates. 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 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, uncertainties regarding the number of patients required to complete the Phase 3 clinical trials and uncertainties regarding the potential affects of not achieving clinical endpoints, 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 for the year ended December 31, 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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