BioSphere Medical Reports Third-Quarter 2000 Financial Results; Company Achieves First $1Million Revenue Quarter Driven by Ramping Sales of Embosphere Microspheres.Business Editors & Health/Medical Writers ROCKLAND, Mass.--(BUSINESS WIRE)--Oct. 24, 2000 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 and nine months ended September 30, 2000. "We are very pleased with the rapid adoption to date of our lead product, Embosphere(R) Microspheres, since its U.S. launch this past summer," said John Carnuccio, BioSphere Medical's president and chief executive officer. "Embosphere(R) Microspheres are receiving increased visibility in the worldwide 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 community as an innovative embolotherapy technology. We have worked diligently dil·i·gent adj. Marked by persevering, painstaking effort. See Synonyms at busy. [Middle English, from Old French, from Latin d to penetrate the U.S. general embolotherapy market and, as a result, revenues exceeded our expectations during the third quarter. We plan to expand our newly created direct sales team in an effort to capture an even greater share of this market in the future." "Biosphere Medical has been achieving impressive clinical and regulatory milestones while generating increasing product revenues in both 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. and Europe," Carnuccio said. The Company completed patient enrollment for its Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I of Embosphere(R) Microspheres in uterine artery embolization Uterine artery embolization (UAE) or Uterine Fibroid Embolization (UFE) is a procedure where an interventional radiologist uses a catheter to deliver small particles that block the blood supply to the fibroids. See also
A noncancerous tumor of the uterus that can range from the size of a pea to the size of a grapefruit. Small fibroids require no treatment, but those causing serious symptoms may need to be removed. disease. Three-month Phase I results were recently presented at a conference in Washington, D.C., and results 12 months following UAE treatment were presented at a major conference in Europe. 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. recently gave the Company conditional approval to commence the Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II , and Biosphere Medical is currently commencing patient enrollment and expanding the study to a greater number of clinical sites. "In addition to these clinical and regulatory advances and the expansion of our sales efforts, we strengthened our balance sheet through the completion of a private placement of equity, and positioned the company to continue its pursuit of expanding opportunities in the global embolotherapy market." For the third quarter of 2000, BioSphere Medical's product revenues were $1.02 million, compared with product revenues of $594,000 in the third quarter of 1999. The Company reported a net loss of $2.45 million, or $0.24 per share, for the third quarter of 2000. This compares to a net loss of $979,000, or $0.12 per share, for the corresponding period last year. Included in operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. for the third quarter of 2000 was $991,000 of non-cash compensation charges related to the acceleration of vesting Vesting The process by which employees accrue non-forfeitable rights over employer contributions that are made to the employee's qualified retirement plan account. Notes: on options granted to non-employee advisors. For the nine months ended September 30, 2000, product revenues were $2.61 million, compared with product revenues of $1.59 million for the same period last year. For the first nine months of 2000, the Company reported a net loss from continuing operations continuing operations Parts of a business that are expected to be maintained as an ongoing segment of an overall business operation. Income and losses from continuing operations are reported separately if any segments have been discontinued during the of $6.08 million, or $0.64 per share. This compares with a net loss from continuing operations of $2.54 million, or $0.30 per share, during the first nine months of 1999. Included in operating expenses for the first nine months of 2000 was $1.26 million of non-cash compensation charges related to the grant of options to non-employee advisors and the subsequent acceleration of vesting of those options. Third-quarter Highlights Following receipt of FDA 510(k) clearance in late April 2000, the Company launched Embosphere(R) Microspheres for general embolotherapy in the United States during the third quarter, while also expanding its distribution channels in Europe. The Company also is pursuing U.S. regulatory approval for the use of Embosphere(R) Microspheres in UAE for the treatment of uterine fibroid disease, and these efforts accelerated during the third quarter. BioSphere Medical completed patient enrollment in April for its Phase I clinical trial of Embosphere(R) Microspheres for UAE 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 U.S. FDA. The results of a three-month follow-up of 30 Phase I patients were recently presented at the Uterine Artery Embolization Conference in Washington, D.C. In October 2000, the FDA granted the Company conditional approval to commence the Phase II clinical trial. The Company is currently initiating patient enrollment and expanding the study to a greater number of clinical sites. In September 2000, results of a clinical UAE study performed in Europe on patients over a 12-month period were presented to the Congress of Interventional Radiology Society of Europe (CIRSE CIRSE Cardiovascular and Interventional Radiological Society of Europe ) meeting at Maastricht, Netherlands. The results demonstrated substantial and durable decreases in each of the symptoms of uterine fibroid disease. The Company continued to expand its international distribution channels during the third quarter of 2000, with a primary focus on the Pacific Rim Pacific Rim, term used to describe the nations bordering the Pacific Ocean and the island countries situated in it. In the post–World War II era, the Pacific Rim has become an increasingly important and interconnected economic region. nations where interest appears to be growing in BioSphere Medical's 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 treatment for 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. as well as uterine fibroid disease. The Company opened a new office and research laboratory in Osaka, Japan and appointed and trained key new distributors in Korea, Taiwan, Hong Kong Hong Kong (hŏng kŏng), Mandarin Xianggang, special administrative region of China, formerly a British crown colony (2005 est. pop. 6,899,000), land area 422 sq mi (1,092 sq km), adjacent to Guangdong prov. and China. Previously, the Company had appointed a new distributor in Australia where Embosphere(R) Microspheres have already been approved. BioSphere Medical also enhanced its financial position during the third quarter of 2000. The Company completed a private placement of equity resulting in net proceeds Net Proceeds The amount received after all costs are deducted from the sale of a piece of property or security. Notes: In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). of approximately $11.8 million to finance continued pursuit of the Company's growth strategy. Outlook "While revenues grew more aggressively than anticipated during the third quarter, the Company's operating expenses were lower than expected due mainly to timing issues relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc clinical studies and development project payments," Carnuccio said. "Although there can be no assurance of continued 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" , the Company anticipates that its third-quarter Embosphere(R) Microspheres product adoption rates and level of repeat business will continue in the fourth quarter. At the same time, operating expenses are expected to increase in support of our product launch and research and development efforts. With increased sales of Embosphere(R) Microspheres in the U.S. and Europe in the third quarter, with our UAE clinical trials in the U.S. progressing nicely, and with our distribution and sales channels now located in each of the three major world markets, we look toward the fourth quarter and next year with excitement and optimism." Third-quarter Conference Call 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. About BioSphere Medical 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. The company's lead product, Embosphere(R) Microspheres, was cleared by the FDA in April 2000 for marketing in the treatment of hypervascularized tumors and vascular malformations. The company is currently conducting clinical trials of Embosphere(R) Microspheres for uterine artery embolization in the United States under an Investigational Device Exemption (IDE) granted by the FDA. BioSphere Medical 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 market Embosphere(R) 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 artery embolization. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement This press release contains 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. that involve risks and uncertainties, including those relating to the ability of the Company to achieve necessary regulatory approvals and market acceptance for UAE and the Company's expectations that its product adoption rates and repeat customers will continue in the fourth quarter. There are important factors that could cause actual results to differ materially from those indicated by forward-looking statements in this release. These include the risk that the Company will not achieve market acceptance of its products, in which case the Company will not be able to increase sales of its products or achieve profitability. Other factors that could cause actual results to differ materially are 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, including FDA approval of its Embosphere(R) Microspheres product for UAE; failure to successfully develop and commercialize the Embosphere(R) Microspheres and HepaSphere SAP(TM) Microsphere technologies for uterine artery embolization, targeted liver embolization and other applications; failure 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, if needed, to finance the development, marketing, and sales of its products; general economic conditions; as well as those risk factors detailed in the Company's Quarterly Report on form 10-Q Form 10-Q See 10-Q. for the quarter ended June 30, 2000 and other periodic reports filed by the Company with the Securities and Exchange Commission.
BioSphere Medical, Inc.
SELECTED FINANCIAL INFORMATION
CONDENSED CONSOLIDATED BALANCE SHEETS
As of September 30, 2000 and December 31, 1999
(in thousands, except per share amounts)
(unaudited)
September 30, December 31,
2000 1999
ASSETS
Cash and cash equivalents $17,178 $ 5,368
Accounts receivable, net 972 645
Inventories 569 389
Prepaid and other current assets 119 51
Property and equipment, net 648 322
Goodwill, net 1,076 713
Other assets 264 8
Total assets $20,826 $ 7,496
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $ 2,236 $ 1,963
Minority interest acquisition obligation 406 945
Notes payable and long term debt 123 --
Stockholders' equity 18,061 4,588
Total liabilities and stockholders' equity $20,826 $ 7,496
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the three months and nine months ended
September 30, 2000 and 1999
(in thousands, except per share amounts)
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2000 1999 2000 1999
Product revenues $1,016 $594 $2,605 $1,587
Costs and expenses:
Cost of product revenues 375 382 1,061 956
Research and development 518 295 1,631 494
Selling, general and
administrative (1) 1,836 1,008 5,234 2,773
Stock-based compensation
to non-employees 991 -- 1,261 --
Total costs and
expenses 3,720 1,685 9,187 4,223
Loss from continuing
operations (2,704) (1,091) (6,582) (2,636)
Other income, net 251 71 506 88
Net loss before taxes
and minority interest (2,453) (1,020) (6,076) (2,548)
Income tax -- 20 -- --
Net loss before
minority interest (2,453) (1,000) (6,076) (2,548)
Minority interest -- 21 -- 6
Net loss from
continuing operations $(2,453) $(979) $(6,076) $(2,542)
Loss from discontinued
operations -- -- -- (539)
Net loss $(2,453) $(979) $(6,076) $(3,081)
Net loss per common share
Basic and diluted net
loss per share from
continuing operations $(0.24) $(0.12) $(0.64) $(0.30)
Basic and diluted net
loss per share from
discontinuing operations $-- $-- $-- $(0.06)
Basic and diluted net
loss per share $(0.24) $(0.12) $(0.64) $(0.36)
Weighted average common
shares outstanding
Basic and diluted 10,103 8,456 9,428 8,456
(1) Excludes compensation charge for issuance of stock options to
non-employee advisors
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