BioSphere Medical Reports Third Quarter 2007 Financial Results.Announces Planned Expansion of U.S. Sales Force Third Quarter 2007 Highlights Compared to Third Quarter 2006 * Total revenue up 18% to $6.64 million * U.S. revenue increased 21% to $4.98 million * Gross margin rose to 71.4% of revenue * Net loss narrowed to $0.45 million, or ($0.03) per share 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) ("BioSphere"), 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, today reported that total revenue for the third quarter of 2007 increased 18% to $6.64 million from total revenue of $5.64 million for the third quarter of 2006. In the third quarter of 2007, revenue in the U.S. was $4.98 million, an increase of 21% from revenue of $4.09 million in the third quarter of 2006. Revenue in Europe, Mid-East and Africa (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) was $1.37 million for the third quarter of 2007, compared to $1.32 million for the same period in 2006, an increase of 4%. Greater than expected seasonality in Europe produced sluggish sales in that region during the third quarter of 2007. Revenue in Rest of World markets rose to $0.29 million for the third quarter of 2007 from $0.23 million for the same period in 2006, an increase of 29%. Gross margin rose to $4.74 million, or 71.4% of revenue, for the third quarter of 2007, from gross margin of $3.94 million, or 69.7% of revenue, for the third 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. for the third quarter of 2007 were $5.17 million compared to $4.56 million for the third quarter of 2006, an increase of 13%. The net loss applicable to common stockholders for the third quarter of 2007 narrowed to $0.45 million, or $0.03 per basic and diluted share, from a net loss applicable to common stockholders of $0.50 million, or $0.03 per basic and diluted share, in the same period last year. In the third 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 $0.33 million, or $0.02 per basic and diluted share. In the third quarter of 2006, the portion of net loss attributable to SFAS 123R was $0.29 million, or $0.02 per basic and diluted share. For the nine months ended September 30, 2007, total revenue rose to $20.20 million from $16.55 million for the same period last year, an increase of 22%. Revenue in the U.S. was $14.59 million, an increase of 23%. Revenue in EMEA was $4.78 million, an increase of 14%. Revenue in Rest of World markets was $0.83 million, an increase of 73%. The net loss for the nine months ended September 30, 2007 narrowed to $2.03 million, or $0.12 per share, from a net loss of $2.51 million, or $0.15 per share, for the comparable period in 2006. For the nine months ended September 30, 2007, $1.10 million, or $0.06 per basic and diluted share, was attributable to a compensation charge for share-based payments resulting from the adoption of SFAS 123R. For the nine months ended September 30, 2006, $0.94 million, or $0.06 per basic and diluted share, was attributable to a compensation charge for share-based payments resulting from the adoption of SFAS 123R. At September 30, 2007, the Company had cash, cash equivalents and marketable securities Marketable Securities Very liquid securities that can be converted into cash quickly at a reasonable price. Notes: Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has of $21.36 million. In the third quarter of 2007, the Company generated $0.72 million of positive cash flow from operations Cash flow from operations A firm's net cash inflow resulting directly from its regular operations (disregarding extraordinary items such as the sale of fixed assets or transaction costs associated with issuing securities), calculated as the sum of net income plus noncash expenses . Richard Faleschini, BioSphere Medical's president and chief executive officer, said, "We generated double-digit sales increases in the U.S. across each of our primary product categories - interventional gynecology embolics, interventional oncology embolics, and 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. delivery systems - and have maintained a dominant share of the U.S. 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. Following our success in earning competitive UFE product conversions in our domestic markets, we are now focused on seeking to increase the number of uterus-sparing, minimally invasive UFE procedures performed in the U.S. We believe that the planned sales force expansion from 18 territories up to 24 territories will allow us to achieve this objective. It is also expected to favorably impact BioSphere's operating results beginning in 2008, as our current territories generate, on average, approximately $1.1 million in annual sales." Significant highlights, activities and developments in the third quarter of 2007 and subsequent weeks include: * Third quarter 2007 worldwide sales of embolics used in interventional gynecology (UFE) rose to $4.53 million, an increase of 12% compared to the third quarter of 2006, with U.S. sales of $3.97 million, an increase of 15%, and sales outside of the U.S. of $0.56 million, a decrease of 7%, compared to the third quarter of 2006. * Third quarter 2007 worldwide sales of embolics used in interventional oncology of $1.16 million, an increase of 33% compared to the same period last year, with U.S. sales of $0.78 million, an increase of 39%, and sales outside of the U.S. of $0.38 million, an increase of 23%, compared to the third quarter of 2006. * At the September 2007 Cardiovascular and Interventional Radiological Society of Europe The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) is the professional body of European interventional radiologists. The Society, which has its headquarters in Vienna, Austria, was founded in 1985 and currently comprises approximately 1,300 members from (CIRSE CIRSE Cardiovascular and Interventional Radiological Society of Europe ) Annual Meeting, J. F. Geschwind, MD, presented an update on the Phase II Trial of Bevacizumab (Avastin) Combined with Transarterial Chemoembolization (TACE n. 1. The cross, or church, of St. Antony. See Illust. (6), under Cross, n. os> 1. See Tasse. ) using Embosphere[R] Microspheres for the treatment of Hepatocellular Carcinoma hep·a·to·cel·lu·lar carcinoma n. A carcinoma derived from parenchymal cells of the liver. Also called hepatocarcinoma, malignant hepatoma. . Dr. Geschwind reported on the first seven patients, and based on the EASL EASL European Association for the Study of the Liver EASL European Association of Sinological Librarians EASL English As a Second Language EASL Existing Automation System Level (FAA) (European Association for the Study of the Liver) and RECIST RECIST Response Evaluation Criteria in Solid Tumors (oncology review criteria) (Response Evaluation Criteria in Solid Tumors Response Evaluation Criteria In Solid Tumors (RECIST) - is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatments. ) criteria, these patients have shown no disease progression. This is a promising result, albeit on a small number of patients. Recruitment to this trial has been constrained by the strict inclusion criteria
Inclusion criteria are a set of conditions that must be met in order to participate in a clinical trial. originally set by Genentech, so the study is continuing with an amended protocol and the addition of a second clinical site. The second site will be Northwestern University Northwestern University, mainly at Evanston, Ill.; coeducational; chartered 1851, opened 1855 by Methodists. In 1873 it absorbed Evanston College for Ladies. Hospital in Chicago under the direction of Riad Salem, MD. * Planned expansion of the U.S. sales force by up to six new territories, each of which is expected to be operational within the first quarter of 2008. * Appointment of Jean-Marc Lavigne du Cadet as director of sales and marketing for Europe, Mid-East and Africa. The Company will host its quarterly conference call on October 25, 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 20865140. 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 at www.biospheremed.com. A replay of the call will be available from 11:30 a.m. Eastern Time on October 25, 2007 through 11:59 p.m. Eastern Time on November 15, 2007. The replay dial-in number is 1-800-642-1687, or 1-706-645-9291 for international callers. The code for the replay is 20865140. A replay of the webcast will be available at the "Investor" section of BioSphere Medical's web site. 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 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 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 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. , Canada, and Australia, as well as the countries of the European Community, and certain of the countries of Latin America, which allows the Company to sell its products for use in general 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. 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 - 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 expected favorable impact of the Company's planned sales force expansion on its ability to increase the number of UFE procedures performed in the U.S. and on its operating results in future periods. 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: * 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[TM] Microsphere and QuadraSphere[TM] Microsphere products, and its delivery system product line; * the failure of the Company to increase the rate of UFE procedures, and concomitant use of its products for UFE, with its expanded sales force; * 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 affect 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 * 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 June 30, 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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