BioSphere Medical Reports Third Quarter 2005 Financial Results; Revenues Grow 27% in the Third Quarter of 2005 Compared to the Third Quarter of 2004.ROCKLAND, Mass. -- 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 pioneered the use of bioengineered microspheres to treat 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. , hypervascularized tumors and vascular malformations, today reported that total revenues for the third quarter of 2005 were $4.41 million, compared with total revenues of $3.47 million for the corresponding period in 2004, an increase of 27%. In the third quarter of 2005, revenues 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. were $3.07 million compared to revenues of $2.15 million in the third quarter of 2004, an increase of 43%. Revenues outside of the United States were $1.34 million for the third quarter of 2005, compared to revenues of $1.32 million for the third quarter of 2004. Global sales of Embosphere(R) Microspheres were $3.70 million in the third quarter of 2005 compared to $2.74 million in the third quarter of 2004, an increase of 35%. Gross margin for the third quarter of 2005 was $2.87 million, or 65% of revenue, an increase of $.56 million over the third quarter of 2004 gross margin of $2.31 million. Selling, general and administrative expenses were $2.83 million for the third quarter of 2005 compared to $3.06 million for the third quarter of 2004. Research and development expenses were $.49 million for each of the third quarter of 2005 and the third quarter of 2004. The net loss applicable to common stockholders for the third quarter of 2005 was $.52 million, or $0.04 per basic and diluted share. This compares with a net loss of $1.15 million, or $0.08 per basic and diluted share, for the third quarter of 2004. For the nine months ended September 30, 2005, revenues were $13.33 million, compared with $9.88 million for the same period last year, an increase of 35%. The net loss for nine months ended September 30, 2005 was $3.02 million or $.21 per share compared to a net loss of $4.95 million, or $.35 per share, for the comparable period in 2004. At September 30, 2005, the Company had 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 of $8.14 million. "Our U.S. 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 ) business continued to grow, setting a new record in quarterly sales," said Richard Faleschini, BioSphere Medical's President and Chief Executive Officer. "We are pleased with our results this quarter, particularly in light of the quarterly seasonal attenuation Loss of signal power in a transmission. Attenuation The reduction in level of a transmitted quantity as a function of a parameter, usually distance. It is applied mainly to acoustic or electromagnetic waves and is expressed as the ratio of power densities. of the business. We intend to continue to execute our plan to further expand our U.S. business and improve the performance of our business outside the U.S.," said Faleschini. Significant activities in the third quarter of 2005 and subsequent weeks include: --Quarterly revenue growth in the United States of 43% over the same period last year. --Publication of the first two articles from the FIBROID fibroid /fi·broid/ (fi´broid) 1. having a fibrous structure; resembling a fibroma. 2. fibroma. 3. leiomyoma. 4. in the plural, a colloquial term for leiomyoma of the uterus. Registry in the July issue of Obstetrics & Gynecology. --Submission of the 510(k) notification 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. seeking marketing clearance for HepaSphere(TM) Microspheres in the United States. --Announcement of the planned fourth quarter 2005 launch in Europe of HepaSphere Microspheres for the 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. of liver tumors at the meeting of the Cardiovascular and Interventional Radiological Society of Europe The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) is the professional body of European interventional radiologists. The Society, which has its headquarters in Vienna, Austria, was founded in 1985 and currently comprises approximately 1,300 members from (CIRSE CIRSE Cardiovascular and Interventional Radiological Society of Europe ). --Presentations at CIRSE, from Dr. Alex Laurent, Dr. James Spies and Dr. Jean-Pierre Pelage pelage /pel·age/ (pel´ahj) [Fr.] 1. the hairy coat of mammals. 2. hairs of the body, limbs, and head collectively. pelage [Fr. related to their findings of 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. differences, with the general consensus that Embosphere Microspheres provide the best targeting, less inflammation, and excellent patient outcomes as compared with Contour SE. --Publication of BioSphere Medical's advertorial ad·ver·to·ri·al n. An advertisement promoting the interests or opinions of a corporate sponsor, often presented in such a way as to resemble an editorial. [adver(tisement) + (edi)torial. in the September issue of Essence, the second largest women's magazine dedicated to the African-American women, with a circulation of over 1 million copies. --William Parker's research on ovarian ovarian /ovar·i·an/ (o-var´e-an) pertaining to an ovary or ovaries. ovarian pertaining to an ovary. ovarian agenesis conservation after 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 , which was published in the August issue of Obstetrics & Gynecology. Dr. Parker's conclusion that the common practice of performing a prophylactic prophylactic /pro·phy·lac·tic/ (pro?-fi-lak´tik) 1. tending to ward off disease; pertaining to prophylaxis. 2. an agent that tends to ward off disease. pro·phy·lac·tic n. bilateral oophorectomy bilateral oophorectomy Gyneology The removal of two or more ovaries. See TAH-BSO. after hysterectomy actually increases a woman's risk of heart disease more than her rare chance of developing ovarian cancer ovarian cancer Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast . The Company will host its quarterly conference call today at 11 A.M. (ET). The number to dial into the call is 1-888-603-7990 or 1-706-679-7298 and the conference ID is 1527550. 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. A replay of this conference call will be available from 2:00 P.M. (ET) today through 2:00 P.M. on November 10, 2005. The replay can be accessed by dialing 1-800-642-1687 or 1-706-645-9291 access code 1527550 or you can visit the "Investor" section of our company web site at www.biospheremed.com. About BioSphere Medical, Inc. BioSphere Medical, Inc., a medical device company 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. , has pioneered and is commercializing minimally invasive diagnostic and therapeutic applications based on its proprietary bioengineered 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. The Company's core technologies, patented bioengineered polymers and manufacturing methods, are used to produce microscopic spherical materials with unique beneficial properties for a variety of medical applications. BioSphere's principal focus is the treatment of symptomatic uterine fibroids using a procedure called uterine fibroid embolization, or UFE. The Company's products continue to gain acceptance in this rapidly emerging procedure as well as in a number of other new and established medical treatments. BioSphere Medical has received clearance in many countries, including the United States, Canada, Australia, 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 Latin America Latin America, the Spanish-speaking, Portuguese-speaking, and French-speaking countries (except Canada) of North America, South America, Central America, and the West Indies. which allows the Company to sell its products for use in general embolization procedures, including uterine fibroid embolization. The terms uterine fibroid embolization (UFE) and 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
Cautionary Statement Regarding Forward-Looking Statements - This press release may contain 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 without limitation statements regarding the Company's expectations with regard to the execution of its planned business strategies , increasing market acceptance of its products, improvement of performance of its business outside the United States and expectations with respect to commercialization of its products. The Company uses words such as "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," "should, " "intend," 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 and its distributors to successfully market and sell the Company's products; 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 and product candidates; the failure of the Company to successfully develop, commercialize and achieve widespread market acceptance of its products, including without limitation, widespread market acceptance of its lead product, Embosphere(R) Microspheres for the treatment of UFE; risks relating to the Company's ability to obtain and maintain patent and other proprietary protection for its products and product candidates; 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 in the near term to finance the development, marketing, and sales of its products; and general economic and market conditions, as well as the risk factors described in the section titled " Factors That May Affect Future Results " in the Company's Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended June 30, 2005, as filed by the Company with the Securities and Exchange Commission, and described in other filings made by the Company from time to time 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 after the date of this press release.
BioSphere Medical, Inc.
Selected Financial Information
CONSOLIDATED CONDENSED BALANCE SHEETS
(in thousands)
(unaudited)
September 30, December 31,
2005 2004
------------- -------------
ASSETS
Cash, cash equivalents and marketable
securities $ 8,142 $ 10,222
Accounts receivable, net 2,878 2,999
Inventories, net 2,613 3,311
Prepaid and other current assets 503 222
Property and equipment, net 907 1,134
Goodwill, net 1,443 1,443
Other assets 62 60
------------- -------------
Total assets $ 16,548 $ 19,391
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $ 3,460 $ 4,188
Debt and capital lease obligations 265 367
Stockholders' equity 12,823 14,836
------------- -------------
Total liabilities and stockholders'
equity $ 16,548 $ 19,391
============= =============
BioSphere Medical, Inc.
Selected Financial Information
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
--------------------- ---------------------
2005 2004 2005 2004
---------- ---------- ---------- ----------
Revenues $ 4,412 $ 3,473 $ 13,330 $ 9,879
Costs and expenses:
Cost of revenues 1,546 1,161 4,587 5,010
Research and development 498 498 1,648 1,629
Sales 1,478 1,290 4,631 3,796
Marketing 406 812 1,718 1,767
General, administrative
and patent costs 949 955 3,172 2,551
---------- ---------- ---------- ----------
Total costs and expenses 4,877 4,716 15,756 14,753
---------- ---------- ---------- ----------
Loss from operations (465) (1,243) (2,426) (4,874)
Other income and
expenses, net 71 95 (229) (74)
---------- ---------- ---------- ----------
Net loss (394) (1,148) (2,655) (4,948)
Preferred stock
dividends (125) - (369) -
---------- ---------- ---------- ----------
Net loss applicable to
common stockholders $ (519) $ (1,148) $ (3,024) $ (4,948)
========== ========== ========== ==========
Net loss per common share
Basic and diluted $ (0.04) $ (0.08) $ (0.21) $ (0.35)
========== ========== ========== ==========
Weighted average common
shares outstanding
Basic and diluted 14,776 14,249 14,597 14,102
========== ========== ========== ==========
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