BioSphere Medical Reports Fourth Quarter and Full Year 2005 Financial Results; Record Revenues of $5.2 Million in the Fourth Quarter of 2005 with 20% Revenue Growth Compared to the Fourth 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 fourth quarter of 2005 were a record $5.15 million, compared with total revenues of $4.28 million for the fourth quarter 2004, an increase of 20%. In the fourth 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 $3.68 million, compared to revenues of $2.91 million in the fourth quarter of 2004, an increase of 26%. Revenues outside of the United States were $1.47 million for the fourth quarter of 2005, compared to revenues of $1.37 million in the fourth quarter of 2004. Global sales of Embosphere(R) Microspheres were $4.38 million in the fourth quarter of 2005, compared to $3.49 million in the fourth quarter of 2004, an increase of 26%. Gross margin was $3.44 million, or 67% of revenues for the fourth quarter of 2005, compared to the gross margin of $2.64 million, or 62% of revenue, in the fourth quarter of 2004. Selling, general and administrative expenses were $2.96 million for the fourth quarter of 2005, compared to $3.59 million for the fourth quarter of 2004. Research and development expenses were $.71 million for the fourth quarter of 2005, and $.48 million in the fourth quarter of 2004. The increase in research and development spending was largely from the HepaSphere(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. and next generation catheter and guidewire development programs. The net loss applicable to common stockholders for the fourth quarter of 2005 was $.27 million, or $0.02 per basic and diluted share. This compares with a net loss of $1.96 million, or $0.14 per basic and diluted share, for the fourth quarter of 2004. For the year ended December 31, 2005, revenues were $18.48 million, compared with $14.16 million for the 2004 full- year period, a year-over-year increase of 31%. Revenues in 2005 in the United States increased to $12.66 million from $9.08 million in 2004, an increase of 39%. Gross margin was $12.18 million, or 66% of revenues for the year ended December 31, 2005, compared to gross margin of $7.51 million, or 53% of revenues for 2004. Selling, general and administrative expenses increased to $12.48 million for the year ended December 31, 2005, from $11.70 million for the year ended December 31, 2004. Research and development expenses for the year ended December 31, 2005 were $2.36 million, compared with $2.11 million for 2004. For the year ended December 31, 2005, the net loss was $3.30 million, or $0.22 per basic and diluted share, compared to a net loss of $6.91 million, or $0.49 per basic and diluted share, for 2004. At December 31, 2005, the Company had cash and cash equivalents of $8.77 million. Richard Faleschini, BioSphere Medical's president and chief executive officer, said, "We are very pleased with our record results in the fourth quarter and the year ended December 31, 2005. These results were achieved because we made substantive progress in every aspect of our enterprise during the year, including growing our core businesses, developing new products and expanding our geographical reach within and outside the United States." Significant activities and developments in the fourth quarter of 2005 and subsequent weeks include: --Revenue growth for the fourth quarter of 2005 of 20% compared to the same period last year. --Sequential revenue growth of 17% in the fourth quarter of 2005 compared to the third quarter of 2005. --Revenue growth of 31% for the full year 2005 compared to the full year 2004, with United States full year 2005 revenue growth of 39% compared to 2004. --An increase in the direct sales force in the United States to 16. --Publication in the November 2005 issue of Obstetrics obstetrics (ŏbstĕ`trĭks), branch of medicine concerned with the treatment of women during pregnancy, labor, childbirth (see birth), and the time after childbirth. & Gynecology - Long-term outcome of 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
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 , where after 5 years 73% of the women that underwent a UFE experienced continuous symptom relief. --Publication in the November 2005 Journal of Vascular 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 - Uterine Artery Embolization: Current Implications 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. Choice: Spherical Polyvinyl Alcohol polyvinyl alcohol, n a complex alcohol that is soluble in water and is used as an emulsifier and adhe-sive. Versus Tris-acryl Gelatin gelatin or animal jelly, foodstuff obtained from connective tissue (found in hoofs, bones, tendons, ligaments, and cartilage) of vertebrate animals by the action of boiling water or dilute acid. Microspheres for Uterine Artery Embolization for Leiomyomas: Results of a limited Randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. Comparative Study; Spies, et al. This study demonstrates the clinical advantages of Embosphere Microspheres compared to spherical Polyvinyl Alcohol, or PVA PVA polyvinyl alcohol. . --Publication in the December 2005 issue of Obstetrics & Gynecology of the one-year symptom and quality of life results based on 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. This study concluded that 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. results in substantial symptom improvement in most patients at 12 months, with 87% of the patients judging their procedure a success. --Presentation by Dr. Mark Ryan For the Irish author and nationalist see Dr. Mark F. Ryan. Mark Ryan (born 7 June 1956) is a British actor. Mark Ryan is a multi-talented performer, combining his acting, singing, writing, and action direction talents and has enjoyed a successful , Consultant Interventional Radiologist, Department of Radiology, St. James Hospital and Trinity College Trinity College, Ireland: see Dublin, Univ. of. Trinity College Private liberal arts college in Hartford, Conn., founded in 1823. It is historically affiliated with the Episcopal church, though its curriculum is nonsectarian. Dublin, of "HepaSphere: A new Embolic for the Treatment of 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. " at the International Symposium on Endovascular Therapy The International Symposium on Endovascular Therapy (ISET) is an educational meeting for physicians, scientists, engineers and allied health professionals working in the multidisciplinary field of peripheral and cardiac interventional medicine. on January 25, 2006 in Miami, Florida “Miami” redirects here. For the Native American tribe, see Miami tribe. Miami is a major city in southeastern Florida, in the United States. It is the county seat of Miami-Dade County. Miami is a gamma world city with an estimated population of 404,048. . --Publication in the December 2005 Journal of Vascular Interventional Radiology - Effects of the Type of 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. Particles on Carboplatin Concentration in Liver Tumors after Transcatheter Arterial Chemoembolization
n. os> 1. See Tasse. , as it contributed to greater delivery of chemotherapy to tumor in the present study." This study reports that a significantly greater tumor concentration of cytotoxic drug cytotoxic drug Oncology An anticancer drug which acts by killing or preventing the cell division Adverse effects Damage to noncancerous tissues or organs with a high proportion of actively dividing cells–eg, BM, hair follicles, GI tract, thereby limiting the can be achieved when TACE is performed with the use of Embosphere Microspheres than with PVA particles. --Market clearance of BioSphere's Embocath(R) Infusion Catheter and Segway(R) Guidewire in the People's Republic People's Republic n. A political organization founded and controlled by a national Communist party. of China. The Company will host its quarterly conference call today at 11 AM ET. The number to dial into the call is 1-888-603-7990 or 1-706-679-7298 and the conference ID is 4453680. 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 PM ET today through 12:00 AM on February 16, 2006. The replay can be accessed by dialing 1-800-642-1687 or 1-706-645-9291 access code 4453680, 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 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 (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. ) are generally used interchangeably in the literature. The most common side-effect of uterine fibroid embolization (UFE) is "post-embolization syndrome," a collection of symptoms including abdominal pain Abdominal pain can be one of the symptoms associated with transient disorders or serious disease. Making a definitive diagnosis of the cause of abdominal pain can be difficult, because many diseases can result in this symptom. Abdominal pain is a common problem. , discomfort, low grade fever and nausea. UFE is currently contraindicated for women who are, or who intend to become, pregnant, because the effects of UFE on the ability of a woman to conceive, and to carry a fetus to term, have not been determined. 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, durability of UFE over time, 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 September 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)
December 31, December 31,
2005 2004
------------ ------------
ASSETS
Cash, cash equivalents and marketable
securities $ 8,774 $ 10,222
Accounts receivable, net 3,521 2,999
Inventories, net 2,435 3,311
Prepaid and other current assets 407 222
Property and equipment, net 858 1,134
Goodwill, net 1,443 1,443
Other assets 57 60
------------ ------------
Total assets $ 17,495 $ 19,391
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $ 4,180 $ 4,188
Debt and capital lease obligations 228 367
Stockholders' equity 13,087 14,836
------------ ------------
Total liabilities and stockholders'
equity $ 17,495 $ 19,391
============ ============
BioSphere Medical, Inc.
Selected Financial Information
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
Three Months Ended Twelve Months Ended
December 31, December 31,
------------------------- -------------------------
2005 2004 2005 2004
------------ ------------ ------------ ------------
Revenues $ 5,154 $ 4,279 $ 18,484 $ 14,158
Costs and
expenses:
Cost of revenues 1,716 1,635 6,303 6,646
Research and
development 711 484 2,359 2,112
Sales 1,554 1,526 6,185 5,322
Marketing 362 461 2,080 2,228
General,
administrative
and patent
costs 1,047 1,603 4,219 4,155
Litigation costs - 874 - 874
------------ ------------ ------------ ------------
Total costs and
expenses 5,390 6,583 21,146 21,337
------------ ------------ ------------ ------------
Loss from
operations (236) (2,304) (2,662) (7,179)
Other income and
expenses, net 91 411 (139) 338
------------ ------------ ------------ ------------
Net loss (145) (1,893) (2,801) (6,841)
Preferred stock
dividends (127) (68) (495) (68)
------------ ------------ ------------ ------------
Net loss
applicable to
common
stockholders $ (272) $ (1,961) $ (3,296) $ (6,909)
============ ============ ============ ============
Net loss per
common share
Basic and
diluted $ (0.02) $ (0.14) $ (0.22) $ (0.49)
============ ============ ============ ============
Weighted average
common shares
outstanding
Basic and
diluted 14,820 14,295 14,653 14,152
============ ============ ============ ============
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