BioSphere Medical Reports Record Second Quarter 2002 Financial Results.Business Editors and Health/Medical Writers ROCKLAND, Mass.--(BW HealthWire)--July 24, 2002 Quarterly Consolidated Revenues Increased 40% From Prior Year; 510(k) Application for 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. Marketing Clearance Under Review 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(TM), Inc. (Nasdaq: BSMD), a medical device company that is pioneering the use of bioengineered microspheres to treat hypervascularized tumors and vascular malformations Vascular malformation A poorly formed blood or lymph vessels. Mentioned in: Birthmarks by occluding their blood supply, today reported its financial results for the second quarter ended June 30, 2002. Highlights -- Worldwide Embosphere(R) Microspheres revenues in the quarter increased 69% from corresponding period of prior year -- Net loss in the second quarter decreased to $2.14 million ($0.16 loss per share) from $2.28 million ($0.22 loss per share) from corresponding period of prior year -- Paul A. Looney appointed Chairman of Board of Directors -- Submission of 510(k) application with 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. for Uterine Fibroid Embolization (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 ) specific labeling clearance -- Launch of two Embosphere(R) Microspheres product enhancements: pre-filled syringe syringe /sy·ringe/ (si-rinj´) (sir´inj) an instrument for injecting liquids into or withdrawing them from any vessel or cavity. and new vial vial a small bottle. -- Initial market testing and qualification of new catheter catheter /cath·e·ter/ (kath´e-ter) 1. a tubular, flexible surgical instrument that is inserted into a cavity of the body to withdraw or introduce fluid. 2. urethral c. and guide wire accessory accessory, in criminal law, a person who, though not present at the commission of a crime, becomes a participator in the crime either before or after the fact of commission. products -- EmboGold(TM) Microspheres launched in Europe -- Redesigned corporate website with improved physician resources and patient education Review of Financial Results For the second quarter of 2002, BioSphere Medical reported consolidated revenues of $3.38 million, an increase of approximately 40 percent compared with consolidated revenues of $2.41 million in the corresponding period last year. The company reported a net loss of $2.14 million, or ($0.16) per basic and diluted di·lute tr.v. di·lut·ed, di·lut·ing, di·lutes 1. To make thinner or less concentrated by adding a liquid such as water. 2. To lessen the force, strength, purity, or brilliance of, especially by admixture. share, for the second quarter of 2002. This compares with a net loss of $2.28 million, or ($0.22) per basic and diluted share, for the second quarter of 2001. For the six-month period ended June 30, 2002, BioSphere Medical reported consolidated revenues of $5.98 million, an increase of approximately 40 percent compared with consolidated revenues of $4.26 million in the corresponding six-month period last year. The company reported a net loss of $4.46 million, or ($0.35) per basic and diluted share, for the first six months of 2002. This compares with a net loss of $4.78 million, or ($0.45) per basic and diluted share, for the first six months of 2001. Management Comments on Progress Commenting on the Company's results, Paul A. Looney, BioSphere Medical's Chairman of the Board stated, "We are very pleased with this quarter's progress and results. Despite the risk of disruption disruption /dis·rup·tion/ (dis-rup´shun) a morphologic defect resulting from the extrinsic breakdown of, or interference with, a developmental process. with management changes in the quarter, we remained focused and grew our embolotherapy business 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 Europe. We successfully launched two new 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 and completed the initial market testing of our catheter and guide wire accessory products, in addition to filing our 510(k) application with FDA for UFE marketing clearance," Looney continued, "Through the end of the year, we are focused on further advancing our leadership position in embolotherapy and developing our core markets. Through the expansion of our product portfolio, we will be able to provide innovative applications to the interventional radiology interventional radiology Imaging A subspecialty of radiology that provides Diagnostic information–eg, CT-guided 'skinny' needle biopsies and dye injection for analysis of various lumina and tracts–eg, arteriography, cholangiography, antegrade market while leveraging our sales force infrastructure. Our commitment to our worldwide customer base continues to strengthen as we strive to improve patient care." Financial Outlook and Guidance Based on current assumptions, the Company expects consolidated revenues for fiscal 2002 to be approximately $12.5-13.5 million, of which it anticipates U.S. revenues to increase approximately 40-50% over 2001. The Company expects to spend approximately $4.0 million in research and development activities in 2002, and approximately $13.0 million in 2002 in sales, marketing and administrative expenses. Based on these projections, the Company expects to achieve operational profitability in the first half of 2003. The Company will host its quarterly conference call today at 11 A.M. ET. The number to dial into the teleconference is (203)-830-6633. Please call in approximately ten minutes before the call is scheduled to begin. A live web cast of the conference call will also be available on the BioSphere Medical web site: www.biospheremed.com. A replay of the teleconference will be available from 2:30 P.M. (ET), Wednesday, July 24 until 12:00 A.M. (ET), Tuesday, July 29, 2002. The dial-in number is: (719) 457-0820, Access Code # 287663. About BioSphere Medical, Inc. BioSphere Medical, Inc., 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. , is a medical device company focused on embolotherapy, the treatment of tumors and vascular malformations by occluding their blood supply. The Company is pioneering the use of patented and proprietary bioengineered microspheres as a new class of embolics. BioSphere Medical's lead products, Embosphere(R) Microspheres and EmboGold(TM) Microspheres, have been cleared by the FDA for marketing for hypervascularized tumors and vascular malformations. The Company has recently completed a clinical trial of Embosphere(R) Microspheres for uterine fibroid embolization (UFE) in the United States under an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE (1) (Integrated Development Environment) A set of programs run from a single user interface. For example, programming languages often include a text editor, compiler and debugger, which are all activated and function from a common menu. ) granted by the FDA. BioSphere Medical has received CE Mark approval in 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 approvals in Canada and Australia which allow the Company to sell Embosphere(R) Microspheres 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. 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 statements with respect to the company's expected results of operations in 2002 and 2003, and expectations with respect to distribution of new products by the company and its distribution partners, and the timing and outcome of its regulatory approval efforts. The Company uses words such as "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," "should," 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 Terumo to successfully market and sell the company's products, 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; to successfully develop, commercialize and achieve widespread market acceptance of the Embosphere(R) Microspheres and EmboGold(TM) 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. technologies for uterine fibroid embolization, targeted liver embolization and other applications; to provide patent and other proprietary protection for the Company's products; the absence of or delays and cancellations of, product orders; delays, difficulties or unanticipated costs in the introduction of new products; competitive pressures; the inability of the Company to raise additional funds to finance the development, marketing, and sales of its products; general economic conditions; as well as those risk factors detailed in 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. for the year ended December 31, 2001 and Form 10-Q Form 10-Q See 10-Q. for the quarter ended March 31, 2002 filed by the Company with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent BioSphere Medical's estimates as of the date of this release. BioSphere Medical anticipates that subsequent events and developments will cause its estimates to change. However, while BioSphere Medical may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing BioSphere Medical's estimates or views as of any date subsequent to the date of this release.
BIOSPHERE MEDICAL, INC.
SELECTED FINANCIAL INFORMATION
CONDENSED CONSOLIDATED BALANCE SHEETS
As of June 30, 2002 and December 31, 2001
(in thousands, Unaudited)
June 30, December 31,
2002 2001
ASSETS
Cash, cash equivalents and marketable securities $17,509 $23,119
Accounts receivable, net 2,398 1,809
Inventories, net 2,167 1,111
Due from related party -- 276
Prepaid and other current assets 353 282
Property and equipment, net 1,716 1,570
Goodwill, net 1,443 1,443
Other assets 381 374
Total assets $25,967 $29,984
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $ 3,683 $ 3,723
Debt and capital lease obligations 402 388
Stockholders' equity 21,882 25,873
Total liabilities and stockholders' equity $25,967 $29,984
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the three and six months ended June 30, 2002 and 2001
(in thousands, except per share amounts - Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2002 2001 2002 2001
REVENUES:
Product revenues $ 3,379 $ 2,163 $ 5,982 $ 4,010
Collaboration revenues -- 250 -- 250
Total revenues 3,379 2,413 5,982 4,260
COSTS AND EXPENSES:
Cost of product revenues 879 589 1,592 1,108
Research and development 1,066 1,249 2,113 2,198
Sales 1,170 1,702 2,590 2,903
Marketing 803 584 1,838 1,443
General and administrative 1,695 673 2,531 1,729
Total costs and expenses 5,613 4,797 10,664 9,381
LOSS FROM OPERATIONS (2,234) (2,384) (4,682) (5,121)
Other income and
expenses, net 93 102 222 339
NET LOSS $ (2,141) $ (2,282) $ (4,460) $ (4,782)
BASIC AND DILUTED NET
LOSS PER SHARE $ (0.16) $ (0.22) $ (0.35) $ (0.45)
Weighted average common
shares outstanding
Basic and diluted 12,997 10,597 12,897 10,597
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