BioSphere Medical Reports Third Quarter Financial Results; Worldwide Revenues Double and U.S. Revenues Triple Over Prior Year.Business/Technology Editors & Health/Medical Writers ROCKLAND, Mass.--(BW HealthWire)--Oct. 18, 2001 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 third quarter ended September 30, 2001. For the third quarter of 2001, BioSphere Medical reported consolidated revenues of $2.0 million, or a 100 percent increase from the $1.0 million in consolidated revenues reported in the comparable period in 2000. The Company reported a net loss in the third quarter of 2001 of $3.1 million, or $(0.24) 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, compared with a net loss of $2.5 million, or $(0.24) per basic and diluted share, in the third quarter of 2000. For the nine months ended September 30, 2001, BioSphere Medical reported consolidated revenues of $6.3 million, or a 142 percent increase from the $2.6 million in consolidated revenues reported in the comparable nine-month period in 2000. The Company reported a net loss in the nine months ended September 30, 2001 of $7.9 million, or $(0.70) per basic and diluted share, compared with a net loss of $6.1 million, or $(0.64) per basic and diluted share, in the nine months ended September 30, 2000. Stated president and chief executive officer John Carnuccio, "I am pleased to report that our business continued to strengthen during the third quarter." "In September, we launched our new, premium-priced product, EmboGold Microspheres, 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. . These are colored microspheres packaged in a sterile sterile /ster·ile/ (ster´il) 1. unable to produce offspring. 2. aseptic. ster·ile adj. 1. Not producing or incapable of producing offspring. 2. pre-filled syringe syringe /sy·ringe/ (si-rinj´) (sir´inj) an instrument for injecting liquids into or withdrawing them from any vessel or cavity. for even simpler handling and preparation. Consistent with our new product strategy, we have offered EmboGold in a number of configurations, presenting our customers with choices and convenience, and enabling a more efficient and controlled embolotherapy procedure. The initial phase of the launch has been very successful with our first month's sales exceeding our initial projections for the product," continued Carnuccio. "Follow-up reports from our Phase I 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. clinical trial of Embosphere Microspheres continued to be excellent. In September, the Phase I investigators published their six month follow-up results in the peer reviewed Journal of Vascular and 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 . They reported significant decreases in symptom symptom /symp·tom/ (simp´tom) any subjective evidence of disease or of a patient's condition, i.e., such evidence as perceived by the patient; a change in a patient's condition indicative of some bodily or mental state. impact including a reduction to 0% at six months of the women who had reported `... a substantial or severe symptom impact during menstrual menstrual /men·stru·al/ (men´stroo-al) pertaining to the menses or to menstruation. men·stru·al or men·stru·ous adj. Of or relating to menstruation. periods at baseline ....' Ultimately, we believe that the growth of 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 is going to be driven by improvements that women see in their clinical symptoms. We believe that the Phase I results are very exciting and portend por·tend tr.v. por·tend·ed, por·tend·ing, por·tends 1. To serve as an omen or a warning of; presage: black clouds that portend a storm. 2. well for the results of the Phase II pivotal clinical trial. Based on the progress being made in the Phase II trial, we anticipate completing patient enrollment in this quarter and an 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. filing to seek regulatory clearance during the second quarter of 2002," Carnuccio continued. "We also made operational progress, illustrated by our broadened manufacturing capabilities," said Carnuccio. "During the quarter, we completed a move to a new, modern and more efficient manufacturing plant outside of Paris, near Charles de Gaulle Airport. We believe that this plant has the potential to support up to a fourfold fourfold Adjective 1. having four times as many or as much 2. composed of four parts Adverb by four times as many or as much Adj. 1. increase in 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. unit volume sales. We have already put processes in place that are improving our manufacturing capacity to more than twice the production levels at the beginning of the year." Continued Carnuccio, "During the quarter, we completed a successful secondary stock offering that netted the company over $20 million. We believe that this is sufficient capital to support our product development and other operating plans for the foreseeable fore·see tr.v. fore·saw , fore·seen , fore·see·ing, fore·sees To see or know beforehand: foresaw the rapid increase in unemployment. future." Outlook "We believe that we have the best products with more in the pipeline, a highly trained sales force to market them in growing markets and a strong management team. The general reduction in embolotherapy procedures in the summer months was compounded by the unfortunate events of September 11, which caused a brief slowdown For articles with similar titles, see Slow Down (disambiguation). A slowdown is an industrial action in which employees perform their duties but seek to reduce productivity or efficiency in their performance of these duties. in our business for the third quarter. Early orders for the first half of October have already rebounded and are trending to be one of the strongest months ever. As a result, we believe that we are back on track to achieve revenues for fiscal year 2001 of approximately $9 million. Further, we believe that we can sustain our gross margin at approximately 73 percent. We also expect that the proceeds of our recently completed offering will enable us to continue to execute our growth strategy past the point where we reach profitability. As we move forward in 2002 our objectives are clear. We plan to continue to grow our existing markets and capture dominant market share within those markets, improve and expand our technology platform, and continue to seek to enhance shareholder value," concluded Carnuccio. About BioSphere Medical, Inc. BioSphere Medical will host its third-quarter conference call this morning at 11:00 a.m., Eastern Time. The call will be broadcast live on the company's Web site at http://www.biospheremed.com. 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 Microspheres and EmboGold Microspheres, have been cleared by the FDA for marketing for hypervascularized tumors and vascular malformations. The company is currently conducting clinical trials of Embosphere 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 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. The Company uses words such as "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," 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. These forward-looking statements include the Company's expectations regarding the Company's revenue, gross margin and operating expense Operating Expense The essential things that a company must purchase in order to maintain business. Notes: For example, the payment of employees wages are an operating expense. Also known as OPEX. projections for fiscal 2001, the Company's projections regarding the time required to reach profitability, the ability of the Company to commercialize its products for an array of applications, including uterine fibroid embolization and targeted liver embolization, the Company's expectations regarding the market acceptance and benefits of its EmboGold Microspheres, the Company's plans with respect to its manufacturing capabilities, the expected benefits of cash received by the Company in its recent financing, and the 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" of the Company's embolotherapy and non-embolotherapy products. 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 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 HepaSphere SAP(TM) Microsphere 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, 2000 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 September 30, 2001 and December 31, 2000
(in thousands / unaudited)
September 30, December 31,
2001 2000
ASSETS
Cash and cash equivalents $ 26,684 $ 15,276
Accounts receivable, net 1,455 1,142
Inventories 1,108 639
Prepaid and other current assets 616 124
Property and equipment, net 1,333 694
Goodwill, net 1,443 1,144
Other assets 374 287
Total assets $ 33,013 $ 19,306
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued
expenses $ 3,601 $ 3,045
Minority interest acquisition
obligation 906 478
Notes payable and long term debt 92 97
Stockholders' equity 28,414 15,686
Total liabilities and
stockholders' equity $ 33,013 $ 19,306
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the three months and nine months ended September 30,
2001 and 2000 (in thousands, except per share amounts / unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2001 2000 2001 2000
Product revenues $ 2,017 $ 1,016 $ 6,027 $ 2,605
Collaboration revenues -- -- 250 --
Total revenues 2,017 1,016 6,277 2,605
Costs and expenses:
Cost of product revenues 547 375 1,655 1,061
Research and development 1,417 518 3,615 1,631
Selling, general and
administrative (1) 3,294 1,836 9,369 5,234
Stock based compensation
to non-employees -- 991 -- 1,261
Total costs and expenses 5,258 3,720 14,639 9,187
Loss from operations (3,241) (2,704) (8,362) (6,582)
Other income, net 166 251 504 506
NET LOSS $ (3,075) $ (2,453) $ (7,858) $ (6,076)
NET LOSS PER COMMON SHARE
Basic and diluted net
loss per share $ (0.24) $ (0.24) $ (0.70) $ (0.64)
WEIGHTED AVERAGE COMMON
SHARES OUTSTANDING
Basic and diluted 12,621 10,103 11,279 9,428
(1) Excludes compensation charge for issuance of stock options to
non-employee advisors.
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