BioSphere Medical Reports First Quarter 2006 Financial Results; Revenues Increase 19% to a Record $5.3 Million.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 first quarter of 2006 were a record $5.27 million, compared with total revenues of $4.43 million for the first quarter of 2005, an increase of 19%. In the first quarter of 2006, 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 $3.63 million, compared to revenues of $2.92 million in the first quarter of 2005, an increase of 24%. Revenues outside of the United States were $1.64 million for the first quarter of 2006, compared to revenues of $1.51 million in the first quarter of 2005. Global sales of Embosphere(R) Microspheres were $4.43 million in the first quarter of 2006, compared to $3.52 million in the first quarter of 2005, an increase of 26%. Gross margin was $3.58 million, or 68% of revenues, for the first quarter of 2006, compared to a gross margin of $2.89 million, or 65% of revenues, for the first quarter of 2005. Selling, general and administrative expenses were $4.03 million for the first quarter of 2006, compared to $3.22 million for the first quarter of 2005. Research and development expenses were $0.45 million for the first quarter of 2006, compared to $0.64 million in the first quarter of 2005. The net loss applicable to common stockholders for the first quarter of 2006 was $0.90 million, or $0.06 per basic and diluted share. This compares with a net loss of $1.35 million, or $0.09 per basic and diluted share, for the first quarter of 2005. In the first quarter of 2006, $0.18 million, or $0.01 per basic and diluted share, was attributable to a compensation charge related to the adoption of SFAS SFAS Statement of Financial Accounting Standards SFAS Special Forces Assessment and Selection SFAS Student Financial Aid Services SFAS Sport Fishing Association of Singapore SFAS Safety Features Actuation System SFAS Statewide Fixed Assets System 123(R) in connection with BioSphere's employee stock incentive plan. At March 31, 2006, the Company had cash and cash equivalents of $20.7 million. Richard Faleschini, BioSphere Medical's president and chief executive officer, said, "During the quarter we achieved record revenues, continued to invest in and execute our local marketing efforts, and increased the number of U.S. sales territories. Our recently completed financing is allowing us to focus on developing the market for 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 by communicating the new and, we believe, persuasive clinical data now available to patients and to the medical community. At the 2006 31st 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") Annual Scientific Meeting in Toronto, Ontario, Canada, we featured four new products that we are expecting to launch in the coming quarters. " Significant activities and developments in the first quarter of 2006 and subsequent weeks include: --Record revenue growth to $5.27 million, an increase of 19% compared to the same period last year. --At the recent SIR meeting, Dr. James Spies presented his findings on the long-term durability of UFE procedures done with BioSphere's Embosphere Microspheres. For the patients followed for the 3-year term of the study, 83% reported that their symptoms of pelvic pain and discomfort were greatly improved, and 69% reported improvement in urinary problems. 84% of patients were moderately or very satisfied with their outcome. Only 8.3% of patients subsequently required surgery (seven hysterectomies and one myomectomy). These favorable results are consistent with previously published outcomes on UFE. --Publication in the January 2006 issue of Fertility and Sterility - 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
u·ter·ine adj. Of, relating to, or in the region of the uterus. volume, and overall quality of life. Also, the patients had a mean hospital stay - UAE = 1 day, myomectomy = 2.5 days with a return to normal activities - UAE = 15 days, myomectomy = 44 days and a return to work - UAE = 10 days, myomectomy = 37 days. --BioSphere's product showcase at SIR which featured its products under development, including QuadraSphere(TM) (an absorbing, conforming and expanding 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. which is currently the subject of a pending 510(k) submission), Sequitor (TM)(which BioSphere expects will be its next generation steerable guidewire), the EmboCath(R) Plus Infusion Microcatheter delivery systems and MR-Embospheres (a 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. visible under magnetic resonance imaging magnetic resonance imaging (MRI), noninvasive diagnostic technique that uses nuclear magnetic resonance to produce cross-sectional images of organs and other internal body structures. ). The Company's MR-Embospheres product candidate was the topic of a "featured abstract" at the recent SIR meeting and as such merited not only a presentation but an additional commentary presentation by one of the physician panelists. --At the SIR meeting, the Society issued a position statement, previously published in the February 2006 issue of the Journal of Vascular and Interventional Radiology, or JVIR JVIR Journal of Vascular and Interventional Radiology , supporting the use of chemoembolization, which refers to the use of embolics that have been injected with chemotherapeutic agents This is a list of specific pharmacologic agents that are known to be of use in the treatment of cancer, otherwise known as chemotherapeutic agents. This list is organized by "type" of agent, though the subsections are not necessarily definitive and are subject to revision. , for the treatment of liver malignancies. The Society indicates in the position statement that chemoembolization is accepted as "a safe, proven, and effective" treatment for patients with unresectable hepatocellular carcinoma hep·a·to·cel·lu·lar carcinoma n. A carcinoma derived from parenchymal cells of the liver. Also called hepatocarcinoma, malignant hepatoma. (inoperable inoperable /in·op·er·a·ble/ (in-op´er-ah-b'l) not susceptible to treatment by surgery. in·op·er·a·ble adj. Unsuitable for a surgical procedure. 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. ) and adequate preservation of liver function, it "has a palliative palliative /pal·li·a·tive/ (pal´e-a?tiv) affording relief; also, a drug that so acts. pal·li·a·tive adj. Relieving or soothing the symptoms of a disease or disorder without effecting a cure. role for patients with colon carcinoma," and "it may be useful for patients with hepatic-dominant metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. disease from other primary malignancies." --In February 2006, the Company completed a placement of 2,075,000 shares of common stock to selected accredited investors Accredited Investor A term used by the Securities and Exchange Commission (SEC) under Regulation D to refer to investors who are financially sophisticated and have a reduced need for the protection provided by certain government filings. Also known as "qualified purchaser". at a price of $7.00 per share, which resulted 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 $13.4 million. --In March 2006, the Company achieved ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 13485:2003 certification at its Roissy, France, facility. 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 8087781. 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 2:00 PM on May 10, 2006. The replay can be accessed by dialing 1-800-642-1687 or 1-706-645-9291 access code 8087781, 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 products 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 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 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 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 fibroid embolization. The terms uterine fibroid embolization (UFE) and uterine artery embolization (UAE) 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 In medicine, low-grade fever is a continuous or fluctuating low fever, typically defined as never exceeding 38.5 degrees Celsius (about 101 degrees Fahrenheit). It is a non-specific finding, but occurs in many diseases, ranging from infectious (viral infections or infective 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 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. - 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 expectation that market acceptance of UFE and of the Company's products for UFE will increase through the dissemination of clinical and patient data about UFE procedures and the Company's expectations and plans relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the introduction of new 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: --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; --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; --general economic and market conditions; and --the risk factors described in the section titled " Risk Factors" 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, 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 March 31, 2006 and December 31, 2005
(in thousands, unaudited)
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March 31, December 31,
2006 2005
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ASSETS
Cash and cash equivalents $ 20,720 $ 8,774
Accounts receivable, net 4,360 3,521
Inventories 2,393 2,435
Prepaid expenses and other current assets 621 407
Property and equipment, net 809 858
Goodwill 1,443 1,443
Other assets 58 57
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Total assets $ 30,404 $ 17,495
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LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $ 3,665 $ 4,180
Capital lease obligations 193 228
Stockholders' equity 26,546 13,087
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Total liabilities and stockholders' equity $ 30,404 $ 17,495
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BioSphere Medical, Inc.
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CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
For the three months ended March 31, 2006 and 2005
(in thousands, except per share amounts,
unaudited)
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Three Months Ended
March 31,
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2006 2005
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Revenues $ 5,269 $ 4,429
Costs and expenses:
Cost of revenues 1,691 1,541
Research and development 452 643
Sales 1,944 1,503
Marketing 712 617
General, administrative and patent costs 1,374 1,102
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Total costs and expenses 6,173 5,406
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Loss from operations (904) (977)
Other income and expenses, net 131 (248)
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Net loss (773) (1,225)
Preferred stock dividends (128) (121)
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Net loss applicable to common stockholders $ (901) $ (1,346)
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Net loss per common share
Basic and diluted $ (0.06) $ (0.09)
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Weighted average common shares outstanding
Basic and diluted 15,955 14,391
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