BioSphere Medical Reports Second Quarter 2005 Financial Results; Company Records Highest Quarterly Sales to Date with Sales Growth of 39% in the Second Quarter of 2005 Compared to the Second 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 Vascular malformation A poorly formed blood or lymph vessels. Mentioned in: Birthmarks , today reported that total revenues for the second quarter of 2005 were $4.49 million, compared with total revenues of $3.23 million for the corresponding period in 2004, an increase of 39%. In the second 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 $2.99 million compared to revenues of $2.04 million in the second quarter of 2004, an increase of 46%. Revenues outside of the United States were $1.50 million for the second quarter of 2005, compared to revenues of $1.19 million for the second quarter of 2004, an increase of 27%. Global sales of Embosphere(R) microspheres were $3.72 million in the second quarter of 2005 compared to $2.51 million in the second quarter of 2004, an increase of 48%. Gross margin for the second quarter of 2005 was $2.99 million or 67% of revenue, an increase of $2.05 million and an improvement of 38 percentage points over the second quarter of 2004 gross margin of $.94 million. In the second quarter of 2004, gross margin included a write off of $1.13 million for work in process inventory disposals due to manufacturing process improvements, and product replacements for shelf life limitations. Selling, general and administrative expenses increased to $3.30 million for the second quarter of 2005 compared to $2.49 million for the second quarter of 2004, reflecting increased spending in sales and marketing expenses related to the Company's utilization, penetration and conversion marketing initiatives. Research and development expenses were $.68 million for the second quarter of 2005, compared to $.62 million for the second quarter of 2004. The net loss applicable to common stockholders for the second quarter of 2005 was $1.16 million, or $0.08 per basic and diluted share. This compares with a net loss of $2.24 million, or $0.16 per basic and diluted share, for the second quarter of 2004. For the six months ended June 30, 2005 revenues were $8.92 million, compared with $6.41 million for the same period last year, an increase of 39%. The net loss for six months ended June 30, 2005 was $2.51 million or $.17 per share compared to a net loss of $3.80 million or $.27 per share for the comparable period in 2004. At June 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 $8.45 million. "In the second quarter of 2005, we continued to execute on our strategic objectives, and this quarter's year-over-year and sequential sales growth reflected our operating success," said Richard Faleschini, BioSphere Medical's President and Chief Executive Officer. "Robust sales in the U.S. propelled our overall growth, and was primarily achieved by our local marketing activities, which we control through our direct sales organization," said Faleschini. Significant activities in the second quarter of 2005 and subsequent weeks include: --Record quarterly worldwide revenues up 39% year-over-year. --Third quarter of sequential, record revenue growth. --Gross margin up 38 percentage points year-over-year to 67%. --Peer-reviewed and educational articles about 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 published in Obstetrics and Gynecology obstetrics and gynecology Medical and surgical specialty concerned with the management of pregnancy and childbirth and with the health of the female reproductive system. , BJOG BJOG British Journal of Obstetrics and Gynaecology , Diagnostic Imaging, OBG OBG Oldie But Goodie OBG Open Bottom Girdle OBG Oregon Brewers Guild (Portland, OR) OBG Onlay Bone Graft (dental procedure) OBG Oh By Golly Management, CVIR CVIR Commercial Vehicle Inspection Reports , and Contemporary OB/Gyn. In particular, the July issue of the journal Obstetrics and Gynecology published the first two of the five planned papers by the investigators of the Society of 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 (SIR)'s 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 --Sponsor of a continuing medical education continuing medical education See CME. (CME CME See: Chicago Mercantile Exchange CME See Chicago Mercantile Exchange (CME). ) supplement in the May issue of OBG Management which was distributed to 39,000 OB/Gyn's --Congresswoman Stephanie Tubbs Jones ![]() Stephanie Tubbs Jones (born September 10, 1949) is a Democratic politician who currently serves as a member of the United States House of Representatives, for the 11th District of Ohio. (D-OH) and Senator Barbara Mikulski Barbara Ann Mikulski (born July 20, 1936) is an American politician of the Democratic Party, and the senior Senator from the state of Maryland. She is currently the most senior female Senator, having served since 1987. (D-MD) sponsor the Uterine Fibroid Uterine fibroid 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. Research and Education Act. --Positive presentations about various 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 made at key international cancer meetings (in the U.K., Japan and the U.S.), and peer-reviewed articles published favorably comparing embolization procedures using Embosphere microspheres for 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. applications. --Magnetic Resonance (MR) Embosphere (MR-ES) added to the new product development pipeline. 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 7879751. 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 August 12, 2005. The replay can be accessed by dialing 1-800-642-1687 or 1-706-645-9291 access code 7879751 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. , pioneers and commercializes minimally invasive diagnostic and therapeutic applications based on 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 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. , 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 expected benefits of the Company's sales and marketing strategies. The Company uses words such as "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," "should" 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 March 31, 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.
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SELECTED FINANCIAL INFORMATION
CONSOLIDATED CONDENSED BALANCE SHEETS
As of June 30, 2005 and December 31, 2004
(in thousands, unaudited)
----------------------------------------------------------------------
December
June 30, 31,
2005 2004
-------- --------
ASSETS
Cash, cash equivalents and marketable securities $ 8,446 $10,222
Accounts receivable, net 3,063 2,999
Inventories, net 2,851 3,311
Prepaid and other current assets 585 222
Property and equipment, net 929 1,134
Goodwill, net 1,443 1,443
Other assets 58 60
-------- --------
Total assets $17,375 $19,391
======== ========
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $ 3,919 $ 4,188
Debt and capital lease obligations 261 367
Stockholders' equity 13,195 14,836
-------- --------
Total liabilities and stockholders'
equity $17,375 $19,391
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CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
For the three and six months ended June 30, 2005 and 2004
(in thousands, except per share amounts, unaudited)
----------------------------------------------------------------------
Three Months Six Months
Ended Ended
June 30, June 30,
----------------- -----------------
2005 2004 2005 2004
-------- -------- -------- --------
Revenues $ 4,489 $ 3,226 $ 8,918 $ 6,406
Costs and expenses:
Cost of revenues 1,499 2,288 3,041 3,850
Research and development 676 619 1,478 1,208
Sales 1,650 1,210 3,153 2,506
Marketing 695 562 1,312 954
General and administrative 953 714 1,896 1,519
-------- -------- -------- --------
Total costs and expenses 5,473 5,393 10,880 10,037
-------- -------- -------- --------
Loss from operations (984) (2,167) (1,962) (3,631)
Other income and expenses, net (52) (76) (299) (169)
-------- -------- -------- --------
Net loss (1,036) (2,243) (2,261) (3,800)
Preferred stock dividends (123) - (244) -
-------- -------- -------- --------
Net loss applicable to common
stockholders $(1,159) $(2,243) $(2,505) $(3,800)
======== ======== ======== ========
Net loss per common share
Basic and diluted $ (0.08) $ (0.16) $ (0.17) $ (0.27)
======== ======== ======== ========
Weighted average common shares
outstanding
Basic and diluted 14,618 14,079 14,505 14,028
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