BioSphere Medical Reports Second Quarter 2007 Financial Results.Quarterly Worldwide Revenues Increase 24% to a Record $6.97 Million with Revenues for Embolics, Delivery Systems and Licensing Increasing 27% Compared to the Same Period Last Year ROCKLAND, Mass. -- BioSphere biosphere, irregularly shaped envelope of the earth's air, water, and land encompassing the heights and depths at which living things exist. The biosphere is a closed and self-regulating system (see ecology), sustained by grand-scale cycles of energy and of Medical, 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 : BSMD), a medical device company that has pioneered the use of bioengineered microspheres to treat uterine fibroids Uterine Fibroids Definition Uterine fibroids (also called leiomyomas or myomas) are benign growths of the muscle inside the uterus. They are not cancerous, nor are they related to cancer. , hypervascularized tumors and vascular malformations Vascular malformation A poorly formed blood or lymph vessels. Mentioned in: Birthmarks , today reported that total revenues for the second quarter of 2007 increased 24% to a record $6.97 million from total revenues of $5.64 million for the second quarter of 2006. In the second quarter of 2007, revenues 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. were $5.01 million, compared to revenues of $4.14 million in the second quarter of 2006, an increase of 21%. Revenues outside of the United States were $1.96 million for the second quarter of 2007, compared to $1.50 million for the same period in 2006, an increase of 31%. Global sales of embolic embolic /em·bol·ic/ (em-bol´ik) pertaining to an embolus or to embolism. em·bol·ic adj. 1. Relating to, or caused by an embolus or embolism. 2. Relating to emboly. products were $5.92 million in the second quarter of 2007, compared to $4.83 million in the second quarter of 2006, an increase of 23%. Gross margin was $5.05 million, or 72.4% of revenues, for the second quarter of 2007, compared to gross margin of $3.97 million, or 70.4% of revenues for the second quarter of 2006. 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. were $5.55 million for the second quarter of 2007, compared to $5.18 million for the second quarter of 2006, an increase of 7% compared to the same period last year. The net loss applicable to common stockholders for the second quarter of 2007 was $0.40 million, or $0.02 per basic and diluted share. This compares with a net loss of $1.11 million, or $0.06 per basic and diluted share, for the second quarter of 2006. In the second quarter of 2007, the portion of net loss attributable to a compensation charge for share-based payments 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 was $0.42 million, or $0.02 per basic and diluted share. In the second quarter of 2006, the portion of net loss attributable to SFAS 123R was $0.47 million, or $0.03 per basic and diluted share. For the six months ended June 30, 2007, revenues were $13.56 million, compared to $10.91 million for the same period last year, an increase of 24%. The net loss for the six months ended June 30, 2007 was $1.58 million, or $0.09 per share, compared to a net loss of $2.02 million, or $0.12 per share, for the comparable period in 2006. For the six months ended June 30, 2007, $0.77 million, or $0.04 per basic and diluted share, was attributable to a compensation charge for share-based payments resulting from the adoption of SFAS 123R. For the six months ended June 30, 2006, $0.65 million, or $0.04 per basic and diluted share, was attributable to a compensation charge for share-based payments resulting from the adoption of SFAS 123R. At June 30, 2007, the Company had cash, cash equivalents and investments of $20.4 million. Richard Faleschini, BioSphere Medical's president and chief executive officer, said, "Following a strong start to 2007, we are pleased to report our seventh consecutive quarter of worldwide sequential revenue growth. The business is performing consistent with the objectives we established nearly three years ago to grow the Company and diversify its sources of organic revenue growth. We continue to enjoy a dominant share of the United States' uterine fibroid embolization Uterine Fibroid Embolization Definition Uterine fibroids are growths in the muscular tissue of the womb (uterus). Uterine fibroid embolization is non-surgical removal of the growths through the use of a tubular device called a catheter. (UFE UFE Uterine Fibroid Embolization UFE United for a Fair Economy UFE Ufficio Federale dell'Energia UFE Uniform Final Examination UFE Urban Challenge Final Event (DARPA) UFE Unidentified Flags and Ensigns UFE Unrestricted Free Agent ) market, and continue to generate consistent double-digit domestic sales increases in this business. We have also gained significant sales momentum in territories outside of the United States across each of our therapeutic product lines. Our interventional oncology and delivery systems businesses, in particular, have demonstrated robust growth and, we believe, are earning a broader market acceptance." Significant highlights, activities and developments in the second quarter of 2007 and subsequent weeks include: * Second quarter 2007 worldwide sales of embolics used in interventional gynecology (UFE) of $4.79 million, an increase of 18% compared to the second quarter of 2006, with United States sales of $4.01 million, an increase of 15%, and sales outside of the United States of $0.78 million, an increase of 32%, compared to the second quarter of 2006. * Second quarter 2007 worldwide sales of embolics used in interventional oncology of $1.13 million, an increase of 49% compared to the same period last year, with United States sales of $0.77 million, an increase of 40%, and sales outside of the United States of $0.36 million, an increase of 72% compared to the second quarter of 2006. * Second quarter 2007 worldwide sales for BioSphere's embolic delivery systems increased 97% to $0.37 million from the second quarter of 2006. United States sales rose to $0.13 million from $0.11 million, an increase of 13%, while sales in markets outside of the United States increased 226% to $0.24 million from the same period one year ago. * Second quarter 2007 sales in Europe for BioSphere's non strategic gastric products declined 6% to $0.58 million from the second quarter of 2006. The Company is finalizing a plan to phase out this non-core distribution business. * Regulatory approval in Brazil for the Company's HepaSphere[TM] Microspheres (HepaSphere) for the treatment of primary and metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. liver cancer Liver Cancer Definition Liver cancer is a relatively rare form of cancer but has a high mortality rate. Liver cancers can be classified into two types. . Brazil is the sixth largest population center in the world. * Presentation of three abstracts at the World Conference on Interventional Oncology held May 14-17, 2007 in Washington, D.C.:
-- C. McMahon, et al. Evaluation of Deformable Superabsorbent
Polymer Microspheres for Treatment of Hypervascular Liver
Tumours.
-- C. Massa Saluzzo, et al. Transarterial hepatic
chemoembolization (TACE) with Oxaliplatin-loaded
microspheres (HepaSphere) and percutaneous radiofrequency
thermal ablation (RFA) as a combined therapy for
unresectable hepatic tumors.
-- C. Massa Saluzzo, et al. TACE with HepaSphere Microspheres
loaded with chemotherapeutic agent: early experience in
Italy of a multi-centre study.
* At the Global Embolization embolization /em·bo·li·za·tion/ (em?bo-li-za´shun) 1. the process or condition of becoming an embolus. 2. therapeutic introduction of a substance into a vessel in order to occlude it. Symposium and Technologies meeting in Barcelona, Spain, in April, BioSphere-sponsored two satellite meetings, one of which was a symposium entitled "HepaSphere Experience in the Treatment of Liver Cancer" moderated by Dr. Robert White Notable persons named Robert White include:
The Company will host its quarterly conference call on July 26, 2007 at 8:30 a.m. Eastern Time. The number to dial in to the call is 1-888-603-7990, or 1-706-679-7298 for international callers, and the conference ID is 7237173. Please call in approximately ten minutes before the call is scheduled to begin. A live webcast of the conference call will also be available on the BioSphere Medical web site. A replay of this conference call will be available from 2:00 p.m. ET today through 2:00 p.m. on August 9, 2007. The replay can be accessed by dialing 1-800-642-1687 or 1-706-645-9291, and using access code 7237173, or you can visit the "Investor" section of our Company's web site at www.biospheremed.com. About BioSphere Medical, Inc. BioSphere Medical, Inc., a medical device company based in Rockland, Massachusetts Rockland is a town in Plymouth County, Massachusetts, United States. The population was 17,670 at the 2000 census. with 10,199 total registered voters as of December 31, 2005. , has pioneered and is commercializing minimally invasive diagnostic and therapeutic products based on its proprietary bioengineered 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. The Company's core technologies, patented bioengineered polymers and manufacturing methods, are used to produce microscopic spherical spher·i·cal adj. Having the shape of or approximating a sphere; globular. materials with unique beneficial properties, which the Company believes have the potential for use in a variety of medical applications. BioSphere's principal focus is the application of its Embosphere[R] Microsphere product for the treatment of symptomatic uterine fibroids using a procedure called uterine fibroid embolization, or UFE. The Company's products have continued to gain acceptance in this emerging procedure as well as in a number of other new and established medical treatments. BioSphere Medical has received clearance in many countries, including the United States, Canada, Australia, as well as the countries of the European Community European Community: see European Union. European Community (EC) Organization formed in 1967 with the merger of the European Economic Community, European Coal and Steel Community, and European Atomic Energy Community. , and certain of the countries of Latin America Latin America, the Spanish-speaking, Portuguese-speaking, and French-speaking countries (except Canada) of North America, South America, Central America, and the West Indies. , which allows the Company to sell its products for use in general embolization procedures, including uterine fibroid embolization. The terms uterine fibroid embolization (UFE) and uterine artery embolization Uterine artery embolization (UAE) or Uterine Fibroid Embolization (UFE) is a procedure where an interventional radiologist uses a catheter to deliver small particles that block the blood supply to the fibroids. See also
Cautionary Statement Regarding 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. - This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995, including, without limitation, statements regarding the Company's expectations for future growth both domestically and internationally and increasing market acceptance of the Company's interventional oncology and delivery system businesses. The Company may use words such as "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," "should," "intend," and similar expressions to identify these forward-looking statements. These statements are subject to risks and uncertainties and are based upon the Company's beliefs and assumptions. There are a number of important factors that may affect the Company's actual performance and results and the accuracy of its forward-looking statements, many of which are beyond the Company's control and are difficult to predict. These important factors include, without limitation, risks relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc : * the failure of the Company to achieve or maintain necessary regulatory approvals, either in the United States or internationally, with respect to the manufacture and sale of its products and product candidates; * the failure of the Company to successfully develop, commercialize and achieve widespread market acceptance of its products, including, without limitation, widespread market acceptance of its lead product, Embosphere Microspheres, for the treatment of UFE, its HepaSphere MicroSphere and QuadraSphere[TM] Microsphere products and its delivery system product line; * the Company's ability to obtain and maintain patent and other proprietary protection for its products and product candidates; * the absence of, or delays and cancellations of, product orders; * delays, difficulties or unanticipated costs in the introduction of new products; * competitive pressures and the risk of product liability claims, either of which may impact market acceptance of products and adversely effect the Company's operating results; * the inability of the Company to raise additional funds in the near term to finance the development, marketing, and sales of its products; * general economic and market conditions; and * the risk factors described in the section titled "Risk Factors" in the Company's Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended March 31, 2007, as filed by the Company with the Securities and Exchange Commission, and described in other filings made by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's estimates as of the date of this release. The Company anticipates that subsequent events and developments may cause its forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances after the date of this press release. [TABLE OMITTED] [TABLE OMITTED] |
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