BioSphere Medical Reports Fourth Quarter and Fiscal Year 2002 Financial Results.Business Editors/Health & Medical Writers ROCKLAND Rockland, industrial town (1990 pop. 16,123), Plymouth co., E Mass.; settled 1673, set off from Abington and inc. 1874. There is light manufacturing. , Mass.--(BUSINESS WIRE)--Jan. 30, 2003 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:BSMD): U.S. Clearance for 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. ; Annual 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. Revenue Up 48%; Net Loss Decreased 38% BioSphere Medical, Inc. (Nasdaq: BSMD), a medical device company that is pioneering the use of bioengineered microspheres to treat uterine fibroids, 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 fourth quarter and fiscal year ended December 31, 2002. Fiscal Year 2002 Highlights - First and only company to receive 510(k) clearance for its product for use in uterine fibroid embolization (UFE) - Worldwide microsphere revenue increased 48% in 2002 compared to the prior year - Annual U.S. product revenue increased 44% compared to the prior year - Annual European microsphere revenue increased 81% compared to the prior year - Net loss in the fiscal year decreased to $6.38 million ($0.49 loss per basic and diluted share) compared to $10.35 million ($0.89 loss per basic and diluted share) in the prior year - The Company launched a comprehensive marketing and education program targeted for UFE - Product launches of EmboCath(TM) Catheter and Segway (TM)Guidewire delivery systems to complement Uterine Fibroid embolization - Product launches of new sterile vial and pre-filled syringe featuring greater convenience and control Review of Financial Results For the fourth quarter of 2002, BioSphere Medical reported consolidated revenues of $3.05 million, an increase of approximately 12% compared with consolidated revenues of $2.73 million in the corresponding 2001 period. The company reported a consolidated net loss of $0.76 million, or ($0.06) 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 fourth quarter of 2002. This compares with a consolidated net loss of $2.49 million, or ($0.20) per basic and diluted share, for the fourth quarter of 2001. For the twelve-month period ended December 31, 2002, BioSphere Medical reported consolidated revenues of $12.15 million, an increase of approximately 35% compared with consolidated revenues of $9.00 million in the corresponding prior year period. The company reported a consolidated net loss of $6.38 million, or ($0.49) per basic and diluted share, for the twelve months ended December 31, 2002. This compares with a consolidated net loss of $10.35 million, or ($0.89) per basic and diluted share, for the corresponding prior year period. As of December 31, 2002, 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 $14.7 million. Management Comments on Progress Commenting on the Company's results, Paul A. Looney, BioSphere Medical's Chairman, 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 President stated, "During the fourth quarter, we achieved our most significant milestone in the development of the 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. procedure to date - the 510(k) clearance of our Embosphere(TM) Microspheres 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. . Being the first and only company to have this regulatory clearance provides us an opportunity to continue our brand name recognition and market leadership in an important part of women's healthcare." Mr. Looney continued, "We expect revenue growth to come from expanding our core markets by increasing the number of procedures performed, developing 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. and 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 and packages, and adding new geographic territories. Our comprehensive marketing program is designed to increase patient and physician awareness of uterine fibroid embolization as an alternative to hysterectomy hysterectomy (hĭstərĕk`təmē), surgical removal of the uterus. A hysterectomy may involve removal of the uterus only or additional removal of the cervix (base of the uterus), fallopian tubes (salpingectomy), and ovaries . For 2003, the Company estimates an approximate 40% annual revenue growth rate in its core microsphere business with a potential second half upside Upside The potential dollar amount by which the market or a stock could rise. Notes: This is basically an educated guess on how high a stock could go in the near future. See also: Bull, Downside from its recently launched 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 marketing program. The Company anticipates that its gross margin should remain in the low to mid- mid- pref. Middle: midbrain. 70 percent range. The Company will host its quarterly conference call today at 11 a.m. EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT . The number to dial into the teleconference is (719) 457-2629. 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. (EDT), January 30, 2003 until 12:00 a.m. February 6, 2003. The dial-in number is: (719) 457-0820, Access Code # 133332. 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 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, Australia and 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. , which allow the Company to sell its products for use in general embolization 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 expectations that it will grow its revenue through market penetration Noun 1. market penetration - the extent to which a product is recognized and bought by customers in a particular market penetration - the act of entering into or through something; "the penetration of upper management by women" and its sales and marketing strategies. The Company uses words such as "plans," "seeks," "projects," expects", "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 the Company and its distributors 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; the failure of the Company to successfully develop, commercialize and achieve widespread market acceptance of the Embosphere(R) Microspheres and EmboGold(TM) Microsphere technologies for uterine fibroid embolization, targeted liver embolization and other applications; risks relating to the Company's ability to obtain and maintain patent and other proprietary protection for its 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; and general economic conditions. These risk factors are further described in the section titled "Certain Factors That May Affect Future Operations" in the Company's Current report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended September 30, 2002, as filed by the Company with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's expectations and beliefs as of the date of this release. The Company anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation or intention to do so.
BIOSPHERE MEDICAL, INC.
SELECTED FINANCIAL INFORMATION
CONDENSED CONSOLIDATED BALANCE SHEETS
As of December 31, 2002 and 2001
(in thousands)
December 31, December 31,
2002 2001
ASSETS
Cash, cash equivalents and marketable
securities $ 14,738 $ 23,119
Accounts receivable, net 2,059 1,809
Inventories, net 3,179 1,111
Due from related party - 276
Prepaid and other current assets 431 282
Property and equipment, net 1,692 1,570
Goodwill, net 1,443 1,443
Other assets 386 374
Total assets $ 23,928 $ 29,984
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $ 3,276 $ 3,723
Debt and capital lease obligations 393 388
Stockholders' equity 20,259 25,873
Total liabilities and
stockholders' equity $ 23,928 $ 29,984
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the three months and years ended December 31, 2002 and 2001
(in thousands, except per share amounts)
Three Months Ended Years Ended
December 31, December 31,
2002 2001 2002 2001
REVENUES:
Product revenue $3,046 $ 2,725 $12,152 $ 8,752
Collaboration revenue - - - 250
Total revenues 3,046 2,725 12,152 9,002
COSTS AND EXPENSES:
Cost of product revenues 869 701 3,261 2,356
Research and development 822 1,140 3,971 4,755
Sales 1,259 1,623 5,035 6,137
Marketing 638 1,052 3,024 3,305
General and administrative 665 795 4,006 3,397
Total costs and expenses 4,253 5,311 19,297 19,950
LOSS FROM OPERATIONS (1,207) (2,586) (7,145) (10,948)
Other income and expenses, net 268 187 583 691
NET LOSS BEFORE INCOME TAXES (939) (2,399) (6,562) (10,257)
Tax benefit (provision) 181 (88) 181 (88)
NET LOSS $(758) $(2,487) $(6,381) $(10,345)
BASIC AND DILUTED
NET LOSS PER SHARE $(0.06) $ (0.20) $ (0.49) $ (0.89)
Weighted average common shares
outstanding
Basic and diluted 13,116 12,721 12,988 11,642
|
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion