BioSphere Medical, Inc. Reports Second Quarter 2003 Financial Results; Uterine Fibroid Embolization Awareness Program Underway and Making Progress.Business Editors/Health/Medical Writers ROCKLAND, Mass.--(BUSINESS WIRE)--July 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), 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 and six months ended June 30, 2003. Highlights -- Completed launch of the 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 ) Awareness and Education program aimed at patients and referring physicians -- Initiated a direct field marketing program to build OB/Gyn OB/GYN A common abbreviation for obstetrics and gynecology UFE referrals to Interventional Radiologists -- Launched new Embosphere (R) Microspheres product sizes: pre-filled 3 and 4 ML syringes -- Strengthened European European emanating from or pertaining to Europe. European bat lyssavirus see lyssavirus. European beech tree fagussylvaticus. European blastomycosis see cryptococcosis. distribution channels on an individual country basis in certain targeted countries -- Opened new geographic markets in South America South America, fourth largest continent (1991 est. pop. 299,150,000), c.6,880,000 sq mi (17,819,000 sq km), the southern of the two continents of the Western Hemisphere. Review of Financial Results For the second quarter of 2003, BioSphere Medical(TM) reported consolidated revenues of $3.12 million, compared with consolidated revenues of $3.38 million in the corresponding period last year. The company reported a net loss of $2.54 million, or ($0.19) 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 2003. This compares with a net loss of $2.14 million, or ($0.16) per basic and diluted share, for the second quarter of 2002. For the six-month period ended June 30, 2003, BioSphere Medical reported consolidated revenues of $6.17 million, compared with consolidated revenues of $5.98 million in the corresponding six-month period last year. The company reported a net loss of $4.72 million, or ($0.36) per basic and diluted share, for the first six months of 2003. This compares with a net loss of $4.46 million, or ($0.35) per basic and diluted share, for the first six months of 2002. 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 approximately $9.80 million as of June 30, 2003. Management Comments on Progress Commenting on the Company's results, Paul A. Looney, BioSphere Medical's 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 Chairman of the Board stated, "As planned, we invested in sales and marketing in the first half of fiscal 2003 in programs that are tailored directly to consumers as well as to UFE referring physicians. This is a developing market where we believe we are establishing brand name recognition with our customers." Mr. Looney continued, "Although it is still early in our plan, near the end of the second quarter, we received positive feedback from the UFE awareness program. That said, we are relying on success of our UFE awareness program and increased UFE procedural growth during the second half of 2003 to achieve our goals on revenue growth and profitability." The Company will host its quarterly conference call today at 11 A.M. ET. The number to dial into the teleconference is (719) 457-2657, Access Code # 432537. 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 30 until 12:00 A.M. (ET), Wednesday August 6, 2003. The dial-in number is: (719) 457-0820, Access Code # 432537. 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 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. 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. using a procedure called uterine fibroid embolization, or UFE. Our products are already beginning to gain 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 worldwide, 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. We have received clearance in a number of 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 us to sell our 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. 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 promote awareness and market and sell its products through its sales, marketing and education programs and achieve its objectives with respect to revenue and profitability. 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 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; 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; 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 detailed in the in the Company's 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, 2002 and Form 10-Q Form 10-Q See 10-Q. for the quarter ended March 31, 2003 and other periodic reports 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.
SELECTED FINANCIAL INFORMATION
CONSOLIDATED CONDENSED BALANCE SHEETS
As of June 30, 2003 and December 31, 2002
(in thousands, unaudited)
June 30, Dec. 31,
2003 2002
ASSETS
Cash, cash equivalents and marketable
securities $ 9,798 $14,738
Accounts receivable, net 2,324 2,059
Inventories, net 3,770 3,179
Prepaid and other current assets 708 431
Property and equipment, net 1,478 1,692
Goodwill, net 1,443 1,443
Other assets 128 386
Total assets $19,649 $23,928
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $ 3,380 $ 3,276
Debt and capital lease obligations 361 393
Stockholders' equity 15,908 20,259
Total liabilities and
stockholders' equity $19,649 $23,928
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
For the three months and six months ended June 30, 2003 and 2002
(in thousands, except per share amounts, unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2003 2002 2003 2002
Product
revenues $ 3,122 $ 3,379 $ 6,172 $ 5,982
Costs and expenses:
Cost of product
revenues 1,231 879 2,257 1,592
Research and
development 819 1,066 1,526 2,113
Sales 1,331 1,170 2,755 2,590
Marketing 1,335 803 2,491 1,838
International 164 - 295 -
General and
administrative 966 1,695 1,833 2,531
Total costs and
expenses 5,846 5,613 11,157 10,664
Loss from
operations (2,724) (2,234) (4,985) (4,682)
Other income
and expenses,
net 181 93 266 222
Net loss $(2,543) $(2,141) $(4,719) $(4,460)
Net loss per
common share
Basic and
diluted $ (0.19) $ (0.16) $ (0.36) $ (0.35)
Weighted average
common shares
outstanding
Basic and
diluted 13,333 12,997 13,281 12,897
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