BioSphere Medical Reports First Quarter 2004 Financial Results; Consolidated Revenue Up 4%; Net Loss Decreased 28% from Prior Year period.Business Editors ROCKLAND, Mass.--(BUSINESS WIRE)--April 29, 2004 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), a medical device company that is pioneering 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 by occluding their blood supply, today reported its financial results for the first quarter ended March 31, 2004. Highlights -- The American College of Obstetricians and Gynecologists The American College of Obstetricians and Gynecologists (ACOG) is a professional association of medical doctors specializing in obstetrics and gynecology in the United States. It has a membership of over 49,000[1] and represents 90 percent of U.S. (ACOG ACOG American College of Obstetricians and Gynecologists. ACOG American College of Obstetricians & Gynecologists ) issued a revised committee opinion that, for the first time, conditionally supports 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 ) -- The Society of 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 (SIR) annual conference featured 36 separate presentations on UFE and 7 on liver 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. ; many featuring Embosphere Microspheres both in comparative studies and as an 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. material preference -- Worldwide product revenue in the first quarter increased 4% from corresponding period of prior year -- Net loss in the quarter decreased 28% to $1.56 million ($0.11 loss 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) from $2.18 million ($0.16 loss per basic and diluted share) from the corresponding prior year Review of Financial Results For the first quarter of 2004, BioSphere Medical reported consolidated revenues of $3.18 million, an increase of approximately 4% compared with consolidated revenues of $3.05 million in the corresponding 2003 period. The company reported a consolidated net loss of $1.56 million, or ($0.11) per basic and diluted share, for the first quarter of 2004. This compares with a consolidated net loss of $2.18 million, or ($0.16) per basic and diluted share, for the first quarter of 2003. 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 were $6.19 million as of March 31, 2004. 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, "We believe that the growth of the UFE procedures will primarily involve changing physician habits and referral patterns. Our strategy is to encourage collaboration between gynecologists and interventional radiologists by educating providers about the benefits of UFE over traditional surgical treatments. In February 2004, the gynecologist gynecologist /gy·ne·col·o·gist/ (-kol´ah-jist) a person skilled in gynecology. gy·ne·col·o·gist n. A physician specializing in gynecology. community favorably fa·vor·a·ble adj. 1. Advantageous; helpful: favorable winds. 2. Encouraging; propitious: a favorable diagnosis. 3. responded to our efforts through its practice committee, the American College of Obstetricians and Gynecologists, issuing a revised committee opinion that UFE is effective and strongly recommending physician collaboration." Mr. Looney continued, "We remain confident in our ability to grow the UFE procedure awareness among patients and referring physicians that may provide an alternative to those 5 million women who are symptomatic symptomatic /symp·to·mat·ic/ (simp?to-mat´ik) 1. pertaining to or of the nature of a symptom. 2. indicative (of a particular disease or disorder). 3. from uterine fibroids. We have identified and invested in key programs that we believe will grow procedures in this developing market and technology." The Company will host its quarterly conference call today at 11 A.M. ET. The number to dial into the teleconference is (719) 867-0640. 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) today, April 29, 2004 until 12:00 A.M. (ET) on May 6th, 2004. The dial-in number is: (719) 457-0820. The Access Code is 468899; or by accessing the investor section of our company website at www.biospheremed.com. 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 applying our 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 to medical applications using embolotherapy techniques. Our core technologies, patented bio-engineered polymers and manufacturing methods, are used to produce miniature spherical spher·i·cal adj. Having the shape of or approximating a sphere; globular. beads with uniquely beneficial properties for a variety of medical applications. Our principal focus is the treatment of symptomatic uterine fibroids using a procedure called uterine fibroid embolization, or UFE. Our products have already gained wide acceptance in this rapidly emerging procedure as well as in a number of other, new and established medical treatments. Our strategy is two fold. First, we are seeking to grow the embolotherapy business world-wide, specifically the UFE procedure, by increasing awareness of availability of this procedure. Second, we are seeking to maintain our current technology leadership by the continuous introduction of new products and product improvements, both through internally developed and externally acquired technologies, that improve and broaden the use of embolotherapy techniques. 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 successfully market and sell its products. 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 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 product candidates; the failure of the Company to successfully develop, commercialize and achieve widespread market acceptance of its Microsphere products 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-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, 2003, 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 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 CIRCUMSTANCES, evidence. The particulars which accompany a fact. 2. The facts proved are either possible or impossible, ordinary and probable, or extraordinary and improbable, recent or ancient; they may have happened near us, or afar off; they are public or after the date of this press release. Financial Tables Follow
BioSphere Medical, Inc.
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SELECTED FINANCIAL INFORMATION
CONSOLIDATED CONDENSED BALANCE SHEETS
As of March 31, 2004 and December 31, 2003
(in thousands, unaudited)
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March 31, December 31,
2004 2003
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ASSETS
Cash, cash equivalents and marketable
securities $ 6,188 $ 7,575
Accounts receivable, net 2,309 2,534
Inventories, net 3,290 3,496
Prepaid and other current assets 725 405
Property and equipment, net 1,383 1,497
Goodwill, net 1,443 1,443
Other assets 53 52
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Total assets $ 15,391 $ 17,002
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LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $ 2,783 $ 3,157
Debt and capital lease obligations 435 320
Stockholders' equity 12,173 13,525
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Total liabilities and
stockholders' equity $ 15,391 $ 17,002
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CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
For the three months ended March 31, 2004 and 2003
(in thousands, except per share amounts, unaudited)
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Three Months Ended
March 31,
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2004 2003
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Product revenues $ 3,180 $ 3,050
Costs and expenses:
Cost of product revenues 1,562 1,027
Research and development 589 706
Sales 1,224 1,424
Marketing 463 1,289
General and administrative 805 906
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Total costs and expenses 4,643 5,352
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Loss from operations (1,463) (2,302)
Other income and expenses, net (93) 126
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Net loss $ (1,556) $ (2,176)
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Net loss per common share
Basic and diluted $ (0.11) $ (0.16)
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Weighted average common shares outstanding
Basic and diluted 13,976 13,226
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