Printer Friendly
The Free Library
14,679,288 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

BioSphere Medical Reports Fourth Quarter 2006 Financial Results.


Record Worldwide Revenue of $6.34 Million, a Sequential Increase of 12% over the Third Quarter of 2006 and an Increase of 23% Compared to the Same Period Last Year

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 NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: BSMD), a medical device company that has 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 fourth quarter of 2006 were $6.34 million, compared to total revenues of $5.15 million for the fourth quarter of 2005, an increase of 23%. In the fourth 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 $4.59 million, compared to revenues of $3.68 million in the fourth quarter of 2005, an increase of 25%. Revenues outside of the United States were $1.75 million for the fourth quarter of 2006, compared to $1.47 million for the same period in 2005, an increase of 19%. Global sales 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.
 products were $5.35 million in the fourth quarter of 2006, compared to $4.38 million in the fourth quarter of 2005, an increase of 22%.

The net loss applicable to common stockholders for the fourth quarter of 2006 was $0.33 million, or $0.02 per basic and diluted share. This compares with a net loss of $0.27 million, or $0.02 per basic and diluted share, for the fourth quarter of 2005. In the fourth quarter of 2006, net loss of $0.34 million, or $0.02 per basic and diluted share, was attributable to a compensation charge for share-based payments resulting from 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) on January 1, 2006.

Gross margin was $4.45 million, or 70% of revenues, for the fourth quarter of 2006, compared to a gross margin of $3.44 million, or 67% of revenues, for the fourth quarter of 2005. The portion of the overall compensation charge for share-based payments included in the cost of sales in the fourth quarter of 2006, which resulted from the adoption of SFAS 123(R) on January 1, 2006, was $0.06 million.

Selling, general and administrative expenses were $4.23 million for the fourth quarter of 2006, compared to $2.96 million for the fourth quarter of 2005. Research and development expenses were $0.64 million for the fourth quarter of 2006, compared to $0.71 million in the fourth quarter of 2005. The portion of the overall compensation charge for share-based payments included in research and development, selling, general and administrative expenses in the fourth quarter of 2006, which resulted from the adoption of SFAS 123(R) on January 1, 2006, was $0.28 million.

For the year ended December 31, 2006, revenues were $22.89 million, compared to $18.48 million for the same period last year, an increase of 24%, with full-year 2006 United States revenues of $16.46 million, an increase of 30% compared to the full year 2005. The net loss for the year ended December 31, 2006 was $2.85 million, or $0.17 per share, compared to a net loss of $3.30 million, or $0.22 per share, for the comparable period in 2005. For the year ended December 31, 2006, $1.28 million, or $0.08 per basic and diluted share, was attributable to a compensation charge for share-based payments resulting from the adoption of SFAS 123(R).

At December 31, 2006, the Company had cash, cash equivalents and investments of $22.1 million.

Richard Faleschini, BioSphere Medical's president and chief executive officer, said, "This was a record quarter for the Company, and the most successful year in BioSphere's history in terms of revenue from product sales. Great progress has been made in every facet of our business, with contributions coming from each business function and each major geographic sector. We have at present nearly all the product approvals we've sought, and with the other elements of our marketing mix now in place, we believe that we are well positioned for continued growth in 2007."

Significant highlights, activities and developments in the fourth quarter of 2006 and subsequent weeks include:

* Full-year 2006 worldwide sales of embolics used for 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.
 were $16.19 million, an increase of 28% compared to full-year 2005 worldwide 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.
 embolic sales, with full-year 2006 United States uterine fibroid embolic sales of $13.67 million, an increase of 32% compared to full-year 2005 United States uterine fibroid embolic sales.

* Full-year 2006 worldwide sales of embolics primarily used in the treatment of liver tumors were $3.32 million, an increase of 23% compared to full-year 2005 worldwide sales of liver-related embolic sales, with full-year 2006 United States liver-related embolic sales of $2.27 million, an increase of 26% compared to full-year 2005 United States liver-related embolic sales.

* Fourth quarter 2006 worldwide sales of embolics used for uterine fibroid embolization were $4.39 million, an increase of 20% compared to the same period last year, with United States uterine fibroid embolic sales of $3.71 million, an increase of 22% compared to the fourth quarter of 2005.

* Worldwide sales in the fourth quarter of 2006 were $0.96 million for embolics used in the treatment of liver tumors, an increase of 32% compared to the same period last year.

* The Company received U.S. Food and Drug Administration marketing clearance for QuadraSphere(TM) Microspheres, the Company's third 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.
 approval in 2006.

* In the November 7, 2006 Wall Street Journal, a feature highlighted the results of a survey conducted by BioSphere in partnership with the not-for-profit The National Women's Health Women's Health Definition

Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues.
 Resource Center, or NWHRC NWHRC National Women's Health Resource Center . One finding from the research was that more than 40% of the women surveyed reported they discussed 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
 with their medical professional, and of those, approximately 35% went on to have UFE as the treatment for their symptomatic 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.
 condition. We believe the results of this survey are encouraging because they suggest that women and gynecologists are better informed today about UFE than they were two years ago, and that their decisions are influenced by credible information.

* A live-case and scientific presentation featuring BioSphere Medical's QuadraSphere Microspheres are scheduled at the 2007 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. .

* The January 2007 issue of the New England Journal of Medicine The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world.  includes the results of the following study: Uterine-Artery 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.
 versus Surgery for Symptomatic Uterine Fibroids. This 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.
 study included 157 women and was conducted at 27 hospitals in the United Kingdom This article has recently been split into multiple articles entitled:
  • List of hospitals in England
  • List of hospitals in Wales
  • List of hospitals in Scotland
. Patients were randomly assigned to undergo either 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
  • Uterine fibroids
  • Embolization
 or surgery, with 106 patients undergoing embolization and 51 undergoing surgery (43 hysterectomies and 8 myomectomies). This study showed that uterine fibroid embolization had an equivalent quality-of-life benefit when compared to traditional surgical options, and highlighted the advantages of embolization, including a significant reduction in the length of hospital stay and 24-hour pain level, and a more rapid return to usual activities.

The Company will host its quarterly conference call today at 11:00 a.m. Eastern Standard Time. The number to dial in to the call is 888-603-7990 or 706-679-7298 and the conference ID is 5948844. 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 February 16, 2007. The replay can be accessed by dialing 800-642-1687 or 706-645-9291, access code 5948844, 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 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, which the Company believes have the potential for use in a variety of medical applications. BioSphere's principal focus is the application of its Embosphere[R] Microspheres product for the treatment of symptomatic uterine fibroids using a procedure called uterine fibroid embolization, or UFE. The Company's products have continued 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 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 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 - 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 for future growth. 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 include statements on the market acceptance of UFE and the expected royalty revenue from Boston Scientific and 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 Microspheres, for the treatment of UFE and its recently launched QuadraSphere [TM]Microspheres;

* 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 Quarterly Report on Form 10-Q Form 10-Q

See 10-Q.
 for the quarter ended September 30, 2006, 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.
[TABLE OMITTED]
[TABLE OMITTED]
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Article Type:Financial report
Date:Jan 31, 2007
Words:1906
Previous Article:Telelogic Offers Leading Enterprise Architecture Product, System Architect, with Japanese Character Support.
Next Article:Raymond James Joins DTCC's Growing Global Service on Corporate Actions.
Topics:



Related Articles
BioSphere Medical To Announce 4th Quarter and Year-end 2005 Earnings Results.
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%...
BioSphere Medical Reports First Quarter 2006 Financial Results; Revenues Increase 19% to a Record $5.3 Million.
BioSphere Medical to Announce 2nd Quarter 2006 Earnings Results.
BioSphere Medical Reports Second Quarter 2006 Financial Results.
American Oriental Bioengineering Inc. Reports Record Quarterly Revenue and Earnings and Provides Guidance for Fourth Quarter 2006.
BioSphere Medical Reports Third Quarter 2006 Financial Results.
Allergan Reports Fourth Quarter Operating Results.(Financial report)
Savient Pharmaceuticals Reports Fourth Quarter and Year End 2006 Results.(Financial report)
BioSphere Medical Reports First Quarter 2007 Financial Results.(Financial report)

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles