BioSphere Medical Reports Escalating Product Revenues in First-Quarter 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)--April 19, 2001 Revenues Rise 36 Percent from Sequential One after the other in some consecutive order such as by name or number. Fourth Quarter of 2000; 139 Percent from Prior-Year Comparable Quarter 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 first quarter ended March 31, 2001. For the first quarter of 2001, BioSphere Medical reported net revenues of $1.85 million, an increase of 139 percent from $774,000 in net revenue reported for the comparable period in 2000. The company reported a net loss of $2.5 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, for the first quarter of 2001. This compares with a net loss of $1.5 million, or $(0.16) per basic and diluted share, for the first quarter of 2000. "We are very excited to report that in the first quarter of 2001, we continued the strong momentum built in fiscal year 2000," said John M. Carnuccio, BioSphere Medical's president and chief executive officer. "In particular, U.S. revenues of our lead product, Embosphere(R) Microspheres, grew by more than 45 percent from the fourth quarter of 2000, resulting in BioSphere's first million-dollar quarter of U.S. revenues." "During the quarter we continued to make excellent progress in our pivotal Phase II 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 ") trial, as well as in pursuing opportunities in the treatment of primary liver cancer Liver Cancer Definition Liver cancer is a relatively rare form of cancer but has a high mortality rate. Liver cancers can be classified into two types. with targeted 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. ("TLE TLE Temporal Lobe Epilepsy TLE The Living End (band) TLE Two Line Elements (for satellite tracking) TLE The Learning Equation TLE Taxe Locale d'Équipement ") therapy. At the same time, we continued to invest in technology and product development. We believe that these investments position BioSphere Medical for growth in a wide range of new embolotherapy applications that are just beginning to emerge." First-Quarter Highlights "Our Phase II UFE clinical trial is proceeding very well," Carnuccio said. "We have already enrolled one third of the UFE patients, and believe we can complete patient enrollment by the end of the third quarter of 2001. We expect that if we can achieve our enrollment goals, we will be poised to file with the 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 510(k) clearance to market Embosphere Microspheres specifically for UFE therapy early in 2002." "We also made excellent progress in pursuing opportunities to deploy our 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 as a platform for treatment of primary liver cancer," Carnuccio said. "We are working with several of the thought leaders in the field to identify the scientific studies necessary to determine the best embolotherapy approach. Through this effort, we expanded physician awareness of our product advantages. Our initiatives continue to focus on the Asian-Pacific markets where there is a very high incidence of primary liver cancer, and therefore we believe a strong pre-existing Adj. 1. pre-existing - existing previously or before something; "variations on pre-existent musical themes" pre-existent, preexistent, preexisting antecedent - preceding in time or order market for this application." "As a result of the rapid market acceptance of our lead product, we remain committed to strengthening BioSphere Medical's marketing and sales effort. We continued to expand our U.S. field sales and clinical support teams. During the quarter, we more than doubled our direct U.S. field sales team, helping us to capture an estimated 25 to 30 percent of our target markets. We also increased our U.S. hospital account base by over 50 percent in the quarter." "This was also an excellent quarter from an operational standpoint The Standpoint is a newspaper published in the British Virgin Islands. It was originally published under the name Pennysaver, largely as a shopping-coupon promotional newspaper, but since emerged as one of the most influential sources of journalism in the ," Carnuccio said. "As sales of Embosphere Microspheres continued to grow, we expanded our manufacturing capacity at BioSphere Medical's existing facilities near Paris, France, and made progress toward establishing new manufacturing facilities in the U.S. On the Research & Development front, we completed a laboratory expansion at our 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. facility. This expansion will allow us to step up our hiring in the second and subsequent quarters to support continued growth of our U.S. research and development team. The team is working aggressively and successfully to leverage our core technology into a broad pipeline of embolotherapy products." "Emerging from that pipeline during the first quarter were BioSphere Medical's latest new products, including our EmboGold colored Embosphere and a new pre-filled syringe syringe /sy·ringe/ (si-rinj´) (sir´inj) an instrument for injecting liquids into or withdrawing them from any vessel or cavity. package configuration, which will be commercially available later this year," Carnuccio said. "Among the other new products under development are a new class of embolization delivery catheters, called mini-catheters, designed to take full advantage of our unique microsphere technology. Our pipeline also includes several improvements that we expect will enhance product performance and broaden the choices available to physicians. We also made progress during the first quarter in our efforts to develop new microspheres and to explore temporary and liquid 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. platforms." Outlook "We began 2001 with aggressive milestones, and BioSphere is meeting them," Carnuccio said. "We believe that we are on track toward expanding our market presence and increasing our sales in worldwide embolotherapy markets while pursuing additional non-embolotherapy opportunities with strategic partners. As a result, we are maintaining our previous revenue projections of between $9.0 million and $11.0 million for fiscal year 2001. We believe that our first-quarter gross margin percentage of 71.9 percent may be sustainable through fiscal year 2001. Consequently, should our recent business trends continue further into fiscal year 2001 and into 2002, we believe that BioSphere Medical may reach profitability as early as in the second half of 2002 as we have previously reported." "We are seeking to aggressively support the rapid growth of our target markets and increase our direct field organization, accelerate product development and clinical research initiatives, as well as expand our manufacturing capacity. For these reasons, we believe BioSphere Medical is well positioned to dominate embolotherapy markets," concluded Carnuccio. First-Quarter 2001 Conference Call BioSphere Medical will host its first-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. About BioSphere Medical, Inc. BioSphere Medical, Inc., based in Rockland, Massachusetts, 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. 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's words such as "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," and similar expressions 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 UFE and TLE, the ability of the Company to sign strategic partners and commercialize microspheres for non-embolotherapy applications, 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 reg·u·late tr.v. reg·u·lat·ed, reg·u·lat·ing, reg·u·lates 1. To control or direct according to rule, principle, or law. 2. approvals, either 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. or internationally, with respect to the manufacture and sale of its products; to successfully develop and commercialize the Embosphere(R) Microspheres and HepaSphere SAP sap, fluid in plants consisting of water and dissolved substances. Cell sap refers to this fluid present in the large vacuole, or cell cavity, that occupies most of the central portion of mature plant cells. (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; the delay 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 December: see month. 31, 2000 filed by the Company with the Securities and Exchange Commission.
BioSphere Medical, Inc.
SELECTED FINANCIAL INFORMATION
CONDENSED CONSOLIDATED BALANCE SHEETS
As of March 31, 2001 and December 31, 2000
(in thousands/unaudited)
March 31, December 31,
2001 2000
ASSETS
Cash and cash equivalents $ 12,437 $ 15,276
Accounts receivable, net 1,472 1,142
Inventories 668 639
Prepaid and other current assets 166 124
Property and equipment, net 928 694
Goodwill, net 1,258 1,144
Other assets 323 287
Total assets $ 17,252 $ 19,306
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $ 3,106 $ 3,018
Deferred revenue 250 -
Minority interest acquisition obligation 629 478
Notes payable and long-term debt 110 124
Stockholders' equity 13,157 15,686
Total liabilities and stockholders' equity $ 17,252 $ 19,306
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS For
the three months ended March 31, 2001 and 2000
(in thousands, except share and per share amounts / unaudited)
Three Months Ended
March 31,
2001 2000
Product revenues $ 1,847 $ 774
Costs and expenses:
Cost of product revenues 519 282
Research and development 949 549
Selling, general and administrative (1) 3,116 1,281
Stock based compensation to non-employees - 269
Total costs and expenses 4,584 2,381
Loss from operations (2,737) (1,607)
Other income, net 236 151
Net loss before minority interest (2,501) (1,456)
Minority interest - (20)
Net loss $ (2,501) $ (1,476)
Net loss per common share
Basic and diluted net loss per share $ (0.24) $ (0.16)
Weighted average common shares outstanding
Basic and diluted 10,597 8,950
(1) Excludes compensation charge for issuance of stock options to
non-employee advisors.
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