Message #31 From:
Stock News Bot Date: November 15, 2005 12:30:00 AM
DBMI News DOBI Medical International Announces Third Quarter 2005 Results
MAHWAH, N.J.--(BUSINESS WIRE)--Nov. 15, 2005--DOBI Medical International Inc. (DBMI.OB) reported financial results for the third quarter and nine months ended September 30, 2005.
In the third quarter of 2005, the Company recorded revenue of $65,000 compared to no revenue in the third quarter of 2004. The net loss applicable to common stock for the quarters ended September 30, 2005 and 2004 was approximately $3.2 million and $2.6 million respectively, or $.05 and $.07 per share, respectively. For the nine months ended September 30, 2005 and 2004, the Company recorded a net loss applicable to common stock of approximately $7.5 million and $5.6 million respectively, or $.13 and .15 per share for each of these nine-month periods.
"We have progressed on several fronts during the third quarter," said Phillip C. Thomas, DOBI Medical's Chief Executive Officer. "We have enrolled more than 700 of the approximately 1,200 patients required to complete our PMA clinical trial. We have 23 sites participating in the trial with a combined enrollment capacity of approximately 200 patients per month. Outside the United States, we are conducting clinical trials with several distributors in Europe, Asia and South America for the purpose of supporting local regulatory approval efforts and demonstrating clinical efficacy. We are in active discussions to begin clinical trials in several other locations. Furthermore, we have continued development of the Company's ComfortScan(R) system and its related software components, including some next generation ComfortScan system capabilities."
DOBI Medical International, Inc. and Subsidiary
(A Development Stage Company)
Condensed Consolidated Statements of Operations
(Unaudited)
Three months ended Nine months ended
September 30, September 30,
------------------------------------------------
2005 2004 2005 2004
----------- ----------- ----------- -----------
Revenue $ 64,985 $ - $ 238,149 $ -
Cost of sales 220,373 - 635,458 -
----------- ----------- ----------- -----------
Gross loss (155,388) - (397,309) -
----------- ----------- ----------- -----------
Research and
development expenses 644,223 527,371 1,562,131 1,497,352
General and
administrative
expenses 882,381 566,195 2,373,690 1,558,986
Clinical program
expenses 1,002,004 235,311 2,027,824 512,064
Sales and marketing
expenses 384,230 568,752 868,098 1,281,182
----------- ----------- ----------- -----------
Total operating
expenses 2,912,838 1,897,629 6,831,743 4,849,584
----------- ----------- ----------- -----------
Operating income
(loss) (3,068,226) (1,897,629) (7,229,052) (4,849,584)
Other income (expense)
Interest expense (2,565) (2,632) (7,626) (6,772)
Interest income 43,487 4,478 102,010 8,968
----------- ----------- ----------- -----------
Net loss (3,027,304) (1,895,783) (7,134,668) (4,847,388)
Deemed dividend on
preferred stock (34,681) (645,167) (107,162) (645,167)
Preferred stock
dividends (88,978) (103,227) (275,433) (103,227)
----------- ----------- ----------- -----------
Net loss applicable to
common stock $(3,150,963)$(2,644,177)$(7,517,263)$(5,595,782)
=========== =========== =========== ===========
Basic and diluted loss
per common share $ (0.05)$ (0.07)$ (0.13)$ (0.15)
=========== =========== =========== ===========
Weighted average
common shares, basic
and diluted 65,625,810 37,737,073 58,515,154 37,670,271
=========== =========== =========== ===========
The unaudited financial information included in this document is intended only as a summary provided for your convenience, and should be read in conjunction with the complete consolidated financial statements of the Company (including the Notes thereto, which set forth important information) contained in its Reports on Forms 10-KSB, as amended, 10-QSB and 8-K filed by the Company with the U.S. Securities and Exchange Commission (SEC). All SEC reports are available on the public EDGAR electronic filing system maintained by the SEC or accessed through the Company's website, www.dobimedical.com.
DOBI Medical is a developmental stage, medical imaging company working to create a new means for the improved diagnosis of high risk and malignant breast disease through the identification of abnormal vascularization ("angiogenesis") associated with tumors. DOBI Medical International's first application of the technology is the ComfortScan(R) system, a gentle, noninvasive, and nonionizing, optical imaging system designed to assist physicians in the identification and management of breast disease. The ComfortScan system is intended to achieve this by providing new, physiology-based imagery of abnormal vascularization in the breast that is not readily available today. The ComfortScan system has CE Mark and UL designations, and DOBI Medical is a certified ISO 9001:2000 and ISO 13485:2003 company. The Company currently sells its ComfortScan systems to international distributors for installation at international clinical trial sites. The ComfortScan system is not yet commercially available in the U.S. as it is limited by U.S. law to investigational use as an adjunct to mammography until approved by the FDA, which cannot be guaranteed. For more information on DOBI Medical International or the ComfortScan system, visit www.dobimedical.com.
CAUTIONARY STATEMENT FOR FORWARD-LOOKING STATEMENTS
Statements contained in this press release may contain information that includes or is based upon certain "forward-looking statements" relating to our business. These forward-looking statements represent management's current judgment and assumptions, and can be identified by the fact that they do not relate strictly to historical or current facts. Forward-looking statements are frequently accompanied by the use of such words as "anticipates," "plans," "believes," "expects," "projects," "intends," and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors, including without limitation, those relating to our ability to timely and successfully complete our U.S. Food and Drug Administration ("FDA") patient Pre-Market Approval ("PMA") clinical trials, as well as our other clinical trials being conducted around the world; our ability to timely and successfully complete and submit to the FDA our PMA application of the PMA clinical trial results; the timely and final approval by local foreign governments of our ComfortScan system as an adjunct to mammography in various international markets; the success and continued improvements of our product development and research efforts, including without limitation, our ability to timely and successfully release version 2.0 and subsequent versions of our ComfortScan system; our ability to timely meet U.S. and foreign government laws and industry standards; our ability to meet U.S. and foreign medical device quality regulation standards required to maintain our CE Mark, and ISO, UL and FDA export certifications; our ability to timely deliver our products into international markets; the acceptance, adoption, and use of our ComfortScan system by physicians, imaging clinics, and patients; and our ability to obtain third-party reimbursement from U.S. and foreign governments and private payers.
Any one of these or other risks, uncertainties, other factors, and any inaccurate assumptions, may cause actual results to be materially different from those described herein or elsewhere by us. We caution readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties, and other factors are described in greater detail in our filings from time to time with the Securities and Exchange Commission, which we strongly urge you to read and consider, including the "Investment Considerations" and the "Cautionary Factors That May Affect Future Results" as set forth in our 2004 Annual Report on Form 10-KSB, as amended, and the "Risk Factors" in our Registration Statement on Form SB-2 declared effective on May 11, 2005, our Quarterly Reports on 10-QSB, and our Current Reports on Form 8-K, all of which may be accessed from our website at www.dobimedical.com. Subsequent written and oral forward-looking statements attributable to us or to persons acting on our behalf are expressly qualified in their entirety by the cautionary statements set forth above and elsewhere in our reports filed with the Securities and Exchange Commission. We expressly disclaim any intent or obligation to update any forward-looking statements.