-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Td+2eHVNc9TN4tjbveyF1/i7uQnCJc2yILEXLaoiyrorazZdfldHP5ZDvdIzaQgC tboxDo4VcPCk9x0sfc5VRA== 0001157523-06-010711.txt : 20061102 0001157523-06-010711.hdr.sgml : 20061102 20061102084045 ACCESSION NUMBER: 0001157523-06-010711 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20061102 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20061102 DATE AS OF CHANGE: 20061102 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOSPHERE MEDICAL INC CENTRAL INDEX KEY: 0000919015 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 043216867 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23678 FILM NUMBER: 061180813 BUSINESS ADDRESS: STREET 1: 1050 HINGHAM STREET CITY: ROCKLAND STATE: MA ZIP: 02370 BUSINESS PHONE: 7816817900 MAIL ADDRESS: STREET 1: 1050 HINGHAM STREET CITY: ROCKLAND STATE: MA ZIP: 02370 FORMER COMPANY: FORMER CONFORMED NAME: BIOSEPRA INC DATE OF NAME CHANGE: 19940215 8-K 1 a5264310.txt BIOSPHERE MEDICAL, INC. 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 - -------------------------------------------------------------------------------- FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): November 2, 2006 BIOSPHERE MEDICAL, INC. (Exact Name of Registrant as Specified in Charter) Delaware 0-23678 04-3216867 (State or Other Jurisdiction (Commission (IRS Employer of Incorporation) File Number) Identification No.) 1050 Hingham Street Rockland, Massachusetts 02370 (Address of Principal Executive (Zip Code) Offices) Registrant's telephone number, including area code: (781) 681-7900 (Former Name or Former Address, if Changed Since Last Report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: |_| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |_| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |_| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |_| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) - -------------------------------------------------------------------------------- Item 2.02. Results of Operations and Financial Condition. On November 2, 2006, BioSphere Medical, Inc. announced its financial results for the quarter ended September 30, 2006. The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K. The information in Item 2.02 and the Exhibit attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing. Item 9.01. Financial Statements and Exhibits (d) Exhibits 99.1 Press release entitled "BioSphere Medical Reports Third Quarter 2006 Financial Results," issued November 2, 2006. 2 - -------------------------------------------------------------------------------- SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Date: November 2, 2006 BIOSPHERE MEDICAL, INC. By: /s/ MARTIN J. JOYCE ----------------------------- Martin J. Joyce Executive Vice President and Chief Financial Officer 3 - -------------------------------------------------------------------------------- EXHIBIT INDEX Exhibit No. Description - ----------- ---------------------------------------------------------------- 99.1 Press release entitled "BioSphere Medical Reports Third Quarter 2006 Financial Results," issued November 2, 2006. 4 - -------------------------------------------------------------------------------- EX-99.1 2 a5264310ex99_1.txt EXHIBIT 99.1 Exhibit 99.1 BioSphere Medical Reports Third Quarter 2006 Financial Results United States revenue of $4.10 million, an increase of 33%, with worldwide revenues increasing to $5.64 million, an increase of 28%, compared to the same period last year ROCKLAND, Mass.--(BUSINESS WIRE)--Nov. 2, 2006--BioSphere Medical, Inc. (NASDAQ: BSMD), a medical device company that has pioneered the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations, today reported that total revenues for the third quarter of 2006 were $5.64 million, compared with total revenues of $4.41 million for the third quarter of 2005, an increase of 28%. In the third quarter of 2006, revenues in the United States were $4.10 million, compared to revenues of $3.07 million in the third quarter of 2005, an increase of 33%. Revenues outside of the United States were $1.54 million for the third quarter of 2006, compared to $1.34 million for the same period in 2005, an increase of 15%. Global sales of embolic products were $4.91 million in the third quarter of 2006, compared to $3.70 million in the third quarter of 2005, an increase of 32%. The net loss applicable to common stockholders for the third quarter of 2006 was $0.50 million, or $0.03 per basic and diluted share. This compares with a net loss of $0.52 million, or $0.04 per basic and diluted share, for the third quarter of 2005. In the third quarter of 2006, net loss of $0.29 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 123(R) on January 1, 2006. Gross margin was $3.94 million, or 70% of revenues, for the third quarter of 2006, compared to a gross margin of $2.87 million, or 65% of revenues, for the third quarter of 2005. The portion of the overall compensation charge for share-based payments included in the cost of sales in the third quarter of 2006, which resulted from the adoption of SFAS 123(R) on January 1, 2006, was $0.05 million. Selling, general and administrative expenses were $4.04 million for the third quarter of 2006, compared to $2.83 million for the third quarter of 2005. Research and development expenses were $0.51 million for the third quarter of 2006, compared to $0.50 million in the third quarter of 2005. The portion of the overall compensation charge for share-based payments included in research and development and selling, general and administrative expenses in the third quarter of 2006, which resulted from the adoption of SFAS 123(R) on January 1, 2006, was $0.24 million. For the nine months ended September 30, 2006, revenues were $16.55 million, compared with $13.33 million for the same period last year, an increase of 24%. The net loss for the nine months ended September 30, 2006 was $2.51 million, or $0.15 per share, compared to a net loss of $3.02 million, or $0.21 per share, for the comparable period in 2005. For the nine months ended September 30, 2006, $0.94 million, or $0.06 per basic and diluted share, was attributable to a compensation charge for share-based payments resulting from the adoption of SFAS 123(R). At September 30, 2006, the Company had cash and cash equivalents and investments of $21.9 million. Richard Faleschini, BioSphere Medical's president and chief executive officer, said, "We are pleased with our performance this quarter, and continued to forward each of our growth initiatives. Although there was seasonal attenuation in our third quarter sales, we had a number of advances including strong growth in our new sales territories in the U.S., and a return to double-digit growth in our outside-of-U.S. business with a strong performance from Europe, excellent sales growth in Canada, and increased shipments of embolics and delivery systems to the People's Republic of China. We believe that we are positioned well as we move into the fourth quarter, historically our strongest quarter of the year." Significant activities and developments in the third quarter of 2006 and subsequent weeks include: -- Total revenues of $5.64 million, an increase of 28% compared to the third quarter of 2005, with worldwide sales of embolics for use in uterine fibroid embolization, or UFE, of $4.04 million, an increase of 32% compared to the same period last year. -- United States revenues of $4.10 million, an increase of 33% compared to the third quarter of 2005, with United States UFE embolic sales of $3.44 million, an increase of 35% compared to the same period last year. -- U.S. Food and Drug Administration clearance for marketing in the United States of the EmboCath(R) Plus Infusion Microcatheter. -- CE Mark clearance for marketing in the European Union of the EmboCath Plus Infusion Microcatheter. -- Release of HepaSphere(TM) Microspheres into the European market with improved packaging. -- Sponsorship of a (standing-room-only) symposium highlighting the technical and clinical aspects of HepaSphere Microspheres in the treatment of primary and metastatic liver cancer at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Meeting. -- The American College of Obstetricians and Gynecologists (ACOG) invited two leading interventional radiologists, James Spies M.D. and Keith Horton M.D., to a congressional briefing entitled "Exploring Women's Health from Research to Outreach" to present the current clinical perspective on the treatment of uterine fibroids. Congresswoman Stephanie Tubb-Jones (D-OH), who has co-sponsored the bill "Uterine Fibroids Research and Education Act" to increase funding for research on uterine fibroids and provide enhanced public education about this condition, addressed the briefing. The Company will host its quarterly conference call today at 10 a.m. The number to dial into the call is 888-603-7990 or 706-679-7298 and the conference ID is 9131232. 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 16, 2006. The replay can be accessed by dialing 800-642-1687 or 706-645-9291, access code 9131232, 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, 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, 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, and Latin America, 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) 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, 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 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 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 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. CONSOLIDATED CONDENSED BALANCE SHEETS As of September 30, 2006 and December 31, 2005 (in thousands, unaudited) September 30, December 31, 2006 2005 ------------- ------------ ASSETS Cash, cash equivalents and investments $ 21,858 $ 8,774 Accounts receivable, net 3,465 3,521 Inventories 2,558 2,435 Prepaid expenses and other current assets 612 407 Property and equipment, net 935 858 Goodwill 1,443 1,443 Other assets 61 57 ------------- ------------ Total assets $ 30,932 $ 17,495 ============= ============ LIABILITIES AND STOCKHOLDERS' EQUITY Accounts payable and accrued expenses $ 4,419 $ 4,178 Capital lease obligations 127 228 Stockholders' equity 26,386 13,089 ------------- ------------ Total liabilities and stockholders' equity $ 30,932 $ 17,495 ============= ============ BioSphere Medical, Inc. CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS For the three and nine months ended September 30, 2006 and 2005 (in thousands, except per share amounts, unaudited) Three Months Ended Nine Months Ended September 30, September 30, ------------------ ----------------- 2006 2005 2006 2005 --------- -------- -------- -------- Revenues $ 5,644 $ 4,412 $16,550 $13,330 Costs and expenses: Cost of revenues 1,708 1,546 5,067 4,587 Research and development 511 498 1,654 1,648 Sales 2,001 1,372 5,756 4,365 Marketing 806 512 2,595 1,984 General, administrative and patent costs 1,230 949 4,192 3,172 --------- -------- -------- -------- Total costs and expenses 6,256 4,877 19,264 15,756 --------- -------- -------- -------- Loss from operations (612) (465) (2,714) (2,426) Other income and expenses, net 244 71 590 (229) --------- -------- -------- -------- Net loss (368) (394) (2,124) (2,655) Preferred stock dividends (132) (125) (391) (369) --------- -------- -------- -------- Net loss applicable to common stockholders $ (500) $ (519) $(2,515) $(3,024) ========= ======== ======== ======== Net loss per common share Basic and diluted $ (0.03) $ (0.04) $ (0.15) $ (0.21) ========= ======== ======== ======== Weighted average common shares outstanding Basic and diluted 17,381 14,776 16,890 14,597 ========= ======== ======== ======== CONTACT: BioSphere Medical, Inc. Martin Joyce, 781-681-7925 Executive Vice President and Chief Financial Officer or Investor Relations: The Equity Group Inc. Devin Sullivan, 212-836-9608 Senior Vice President -----END PRIVACY-ENHANCED MESSAGE-----