BioSphere Medical Reports Strong Fourth-Quarter and Year-End 2000 Financial Results.Business/Technology Editors & Health/Medical Writers ROCKLAND, Mass.--(BW HealthWire)--Jan. 18, 2001 Sales Grow 33 Percent from Third Quarter 2000; Company Reports Progress on Phase II Clinical Trials 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 for 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
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 fourth quarter and year ended December 31, 2000. For the fourth quarter of 2000, BioSphere Medical reported revenues of $1.4 million, an increase of 100 percent compared with revenues of $0.7 million in the corresponding period last year. BioSphere reported a net loss of $2.4 million, or ($0.23) per basic and diluted share, for the fourth quarter of 2000. This compares with a net loss of $1.5 million, or ($0.17) per basic and diluted share, for the fourth quarter of 1999. For the year ended December 31, 2000, BioSphere Medical reported revenues of $4.0 million compared with revenues of $2.3 million in 1999. 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 $8.4 million, or ($0.87) per basic and diluted share, in 2000. This compares with a net loss from continuing operations of $4.0 million, or ($0.47) per basic and diluted share, in 1999. 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 2000 was a $1.26 million non-cash compensation charge related to the grant of options to non-employee advisors and the subsequent acceleration of vesting of those options. "BioSphere Medical made significant progress toward its goal of becoming a worldwide embolotherapy company in the fourth quarter," said John Carnuccio, BioSphere Medical's president and chief executive officer. "Sales increased substantially in embolotherapy markets, particularly in the U.S., where we began to add a direct sales force in the second quarter. In addition, we completed the first patient treatment in the pivotal Phase II clinical trial of our lead product, Embosphere(R) Microspheres, for Uterine Artery Embolization ("UAE (Uninterruptible Application Error) The name given to a crash in Windows 3.0. In subsequent versions of Windows, a crash was called a "General Protection Fault," "Application Error" or "Illegal Operation." See crash in Windows and abend. ") in the U.S. and we are currently enrolling UAE patients in five of seven clinical sites." "Looking toward the future, we believe our microspheres offer a broad technology platform that has applications that extend beyond embolotherapy to include treatments for a variety of diseases, such as urinary incontinence Urinary Incontinence Definition Urinary incontinence is unintentional loss of urine that is sufficient enough in frequency and amount to cause physical and/or emotional distress in the person experiencing it. , gastroesophageal reflux disease gastroesophageal reflux disease (GERD) Disorder characterized by frequent passage of gastric contents from the stomach back into the esophagus. Symptoms of GERD may include heartburn, coughing, frequent clearing of the throat, and difficulty in swallowing. , gene therapy and tissue repair," Carnuccio said. "During the fourth quarter of 2000, we forged a new strategic partnership that marks a major step in our strategy to penetrate these and other emerging markets. Under this strategic agreement, BioSphere Medical will supply its proprietary microspheres to Inamed Corporation for use in dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin. der·mal or der·mic adj. Of or relating to the skin or dermis. applications - the first in what we expect will be a wide array of non-embolotherapy applications where our unique microspheres represent a compelling new treatment option." Year 2000 Highlights "BioSphere Medical accomplished all of the goals that we set out to achieve for 2000," Carnuccio said. "We received 510(k) approval of Embosphere(R) Microspheres for general embolotherapy in the U.S., conducted an aggressive commercial launch, and surpassed even our own high expectations for growth by reporting $4.0 million in sales for the year. At the same time, we advanced rapidly in our effort to gain U.S. regulatory approval for use of Embosphere(R) Microspheres in the promising UAE market. Highlighting this effort was the start of the Phase II trial, which marks the first time that patients treated with UAE have been systematically compared with patients treated with hysterectomy hysterectomy (hĭstərĕk`təmē), surgical removal of the uterus. A hysterectomy may involve removal of the uterus only or additional removal of the cervix (base of the uterus), fallopian tubes (salpingectomy), and ovaries , the standard surgical alternative for 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. in this country." "The past 12 months were also highlighted by rapid expansion overseas," Carnuccio said. "We received regulatory approvals and launched Embosphere(R) Microspheres in Australia and Canada. We also strengthened our sales and distribution channels in Europe and 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. , substantially increasing BioSphere Medical's international presence during the year." "In addition to these results, we significantly expanded and strengthened our global management team, presented one-year clinical results of Embosphere(R) Microspheres for UAE at a major European congress, presented three-month results of our 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 at the SCVIR SCVIR Society of Cardiovascular and Interventional Radiology - sponsored UAE Conference held in Washington D.C., and secured the strategic Inamed supply agreement," continued Carnuccio. Outlook "In summary, during 2000, we expanded our management team, launched our lead product in the U.S. and established BioSphere Medical as a force in our core market worldwide," continued Carnuccio. "We believe that the market for embolotherapy continues to grow, and we are well positioned to capture an increasing share of this market. Our goals for 2001 are as ambitious as our goals for 2000, and in light of what BioSphere Medical was able to accomplish last year, we are confident in our ability to achieve them. We intend to expand our presence and increase our sales in worldwide embolotherapy markets while pursuing additional non-embolotherapy opportunities comparable to our agreement with Inamed. We look forward to continued growth in market share and generating enhanced shareholder value in 2001." Fourth-quarter and year-end 2000 Conference Call BioSphere Medical will host its fourth-quarter and year-end 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 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. 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. 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. 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 ability of the Company to commercialize its products for an array of applications, including UAE, the success of the Company's agreement with Inamed, 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. 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 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(TM) 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. technologies for uterine artery embolization, 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. 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, 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 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, 1999, Form 10-Q Form 10-Q See 10-Q. for the quarter ended September 30, 2000, and other periodic reports filed by the Company with the Securities and Exchange Commission. Financial statements follow
CONSOLIDATED BALANCE SHEETS
As of December 31, 2000 and 1999
(in thousands)
December 31, December 31,
2000 1999
ASSETS
Cash and cash equivalents $ 15,276 $ 5,368
Accounts receivable, net 1,142 564
Inventories 639 389
Prepaid and other current assets 124 132
Property and equipment, net 694 322
Goodwill, net 1,144 713
Other assets 287 8
Total assets $ 19,306 $ 7,496
LIABILITIES AND STOCKHOLDERS'
EQUITY
Accounts payable and
accrued expenses $ 3,018 $ 1,963
Minority interest
acquisition obligation 478 945
Notes payable and
long term debt 124 -
Stockholders' equity 15,686 4,588
Total liabilities and
stockholders' equity $ 19,306 $ 7,496
CONSOLIDATED STATEMENTS OF OPERATIONS
For the three months and twelve months
ended December 31, 2000 and 1999
(in thousands, except per share amounts)
Three Months Ended Twelve Months Ended
December 31, December 31,
2000 1999 2000 1999
Product revenues $ 1,356 $ 679 $ 3,961 $ 2,266
Costs and expenses:
Cost of product revenues 400 448 1,461 1,404
Research and development 886 474 2,517 968
Selling, general and
administrative (1) 2,613 1,230 7,847 4,003
Stock based compensation
to non-employees -- -- 1,261 --
Total costs and
expenses 3,899 2,152 13,086 6,375
Loss from continuing
operations (2,543) (1,473) (9,125) (4,109)
Other income, net 172 27 678 115
Net loss before minority
interest (2,371) (1,446) (8,447) (3,994)
Minority interest -- (6) -- --
Net loss from continuing
operations $ (2,371) $ (1,452) $ (8,447) $ (3,994)
Loss from discontinued
operations -- -- -- (539)
Net loss $ (2,371) $ (1,452) $ (8,447) $ (4,533)
Net loss per common share
Basic and diluted net loss
per share from continuing
operations $ (0.23) $ (0.17) $ (0.87) $ (0.47)
Basic and diluted net loss
per share from
discontinued
operations $ -- $ -- $ -- $ (0.06)
Basic and diluted net loss
per share $ (0.23) $ (0.17) $ (0.87) $ (0.53)
Weighted average
common shares outstanding
Basic and diluted 10,508 8,456 9,700 8,456
(1) Excludes compensation charge for issuance of stock options to
non-employee advisors.
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