================================================================================ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-QSB/A (AMENDMENT NO. 1) (Mark One) [X] QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2005 [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from ________ to ___________ Commission File No.: 0-32523 DOBI MEDICAL INTERNATIONAL, INC. -------------------------------- (Name of small business issuer in its charter) DELAWARE 98-0222710 --------------------------------------- ------------------------------------ (State or other jurisdiction of (I.R.S. Employer Identification No.) incorporation or organization) 1200 MACARTHUR BLVD. MAHWAH, NJ 07430 --------------------------------------- ------------------------------------ (Address of principal executive offices) (Zip Code) (201) 760-6464 --------------------------- (Issuer's telephone number) Check whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. [ X ] Yes [ ] No As of May 5, 2005, 65,257,155 shares of the issuer's Common Stock were outstanding. Transitional Small Business Disclosure Format (check one): Yes No X . ---- ---- ================================================================================ EXPLANATORY NOTE DOBI Medical International, Inc. is filing this Amendment No. 1 to its Quarterly Report on Form 10-QSB for the three months ended March 31, 2005 (the "Form 10-QSB"), which was originally filed on May 16, 2005, solely to amend and replace Item 2 of the Form 10-QSB. When originally filed, the Form 10-QSB contained an incorrect reference in the "Liquidity and Capital Resources" section of Item 2 with respect to the date through which DOBI Medical believes that its recent financing transaction will meet its funding needs. ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATION We completed a reverse merger transaction on December 9, 2003 with Lions Gate Investment Limited, a Nevada corporation formed on October 29, 1999. Until the merger, Lions Gate engaged in oil and gas exploration activities, which Lions Gate discontinued following the merger and succeeded to the business of DOBI Medical Systems, Inc. The directors and management of DOBI Medical Systems thereupon became the directors and management of Lions Gate. On January 30, 2004, we changed our corporate name from Lions Gate Investment Limited to DOBI Medical International, Inc. and changed our state of incorporation from Nevada to Delaware pursuant to an Agreement and Plan of Merger, dated as of January 29, 2004, between Lions Gate and DOBI Medical International. DOBI Medical Systems currently remains a wholly-owned subsidiary of DOBI Medical International. DOBI Medical Systems, LLC was formed as a Delaware limited liability company in October 1999. In December 1999, DOBI Medical Systems, LLC acquired substantially all the assets of Dynamics Imaging, Inc., including a number of patents and trade secrets that form the basis for its current proprietary technology. On January 1, 2003, DOBI Medical was incorporated in Delaware and became DOBI Medical Systems, Inc. Since the reverse merger transaction on December 9, 2003, DOBI Medical Systems, Inc. has been a wholly-owned subsidiary of DOBI Medical International, Inc. Since our future business will be that of DOBI Medical only, the information in this report is that of DOBI Medical International as if DOBI Medical Systems. had been the registrant for all the periods presented in this report. Management's Discussion and Analysis or Plan of Operation presented in this Item 2 and the audited consolidated financial statements presented in Item 1 of this report include those of DOBI Medical Systems prior to the reverse merger, as these provide the most relevant information for us on a continuing basis. For accounting purposes DOBI Medical Systems was the acquirer in the reverse merger transaction, and consequently the transaction is treated as a recapitalization of the company. DOBI Medical's financial statements are the historical financial statements of the post-merger entity, DOBI Medical International. OVERVIEW We are a developmental-stage company with no significant revenues. Our goal is to establish the ComfortScan(TM) system as the new standard of breast imaging diagnostic care in the United States and international medical community. The first steps in attaining this goal are to receive U.S. Federal Food and Drug Administration ("FDA") approval for our ComfortScan(TM) system as an adjunct to mammography and establish our ComfortScan system as a recognized and widely utilized technology to aid physicians in the effective diagnosis of breast cancer. During 2004, we released version 1.0 of our ComfortScan system, renewed our CE Mark, established FDA and quality systems standards, invested in production-level tooling, established a manufacturing facility compliant with good manufacturing practices, received our FDA Export Certificate, finalized agreements with several international distributors in select countries in Latin America, Europe and the Asia-Pacific regions, verified and validated our first release of the ComfortScan system, and sold and shipped 12 revenue-producing and production level ComfortScan investigative units to international markets for the purpose of conducting local clinical regulatory and marketing studies. In addition, our PMA clinical trial protocol was accepted by the FDA, we delivered and installed our first ComfortScan system in our first three PMA sites, and we trained and commenced the collection of patient scan data pursuant to our PMA clinical trial protocol. 1 In 2005, we intend to complete our PMA clinical trial and submit our PMA application to the FDA, sell ComfortScan systems through our international distributors in order to generate clinical results supporting the use of our ComfortScan system as an adjunct to mammography. We plan to continue to seek distribution alliances in international markets in order to obtain local regulatory approval and acquire patient scans in our research and development efforts. We will continue to develop and enhance our ComfortScan system by releasing new versions of our software and perhaps hardware to the international marketplace. We intend to place added emphasis internationally in developing clinical research sites with physicians, and have them publish peer review clinical papers so as to better seed the international market and more quickly gain physician adoption, assuming the ComfortScan system obtains local regulatory approval for commercial sale as a medical device. In November 2004, after successful completion of verification and validation testing in accordance with current quality systems regulations, and with outside, independent physicians as readers, we released our first production level version 1.0 ComfortScan system as an investigational device. In late 2004, we sold and shipped 12 revenue producing, production level ComfortScan investigational systems to international distributors for conducting local clinical studies. Subsequently, in January 2005, in connection with the development of version 2.0 of our ComfortScan system, internal testing by non-physician employees raised concerns about scan acceptance rates, repeatability performance, and the overall diagnostic accuracy. With the assistance of leading academic and clinical experts, we have made significant progress towards successfully resolving these concerns. We have released our ComfortScan 2.0 acquisition software to our PMA sites, and we have installed our beta ComfortView 2.0 reading software for testing in a few international clinical sites. We have substantially resolved the acceptance rate issue and have made substantial progress towards resolving the repeatability issue. We are currently on target to release version 2.0 of our ComfortScan system in the 2005 second quarter, although there can be no assurance that we will do so. We believe that the emergence and resolution of concerns such as these arise within the ordinary course of medical device product development efforts and result in the continued improvement of the medical device and its underlying technology. We do not currently believe that the improvements we have made to our software and hardware in connection with the development of ComfortScan system 2.0 will require reinitiating our PMA clinical trial. If there were to be such a delay, our best estimate is that our PMA submission to the FDA may be delayed by up to twelve months. In connection with our 2005 goals, we expect our expenses to be approximately $1.8 million per quarter. In addition, we expect that PMA clinical trial project costs, including PMA site fees, clinical research organization fees, PMA site monitoring fees, and physician fees will be approximately $3.0 million in 2005. While we believe that we will achieve these goals, there can be no assurance that we will do so. We have generated insignificant ComfortScan system revenues to date and, therefore, can draw no conclusions regarding the seasonality of our business. The accompanying financial statements in Item 1 of this report have been prepared assuming that we will continue as a going concern. We are currently a development stage enterprise and, as such, our continued existence is dependent upon our ability to resolve our liquidity problems, principally by obtaining additional debt or equity financing. We have yet to generate a positive internal cash flow and, until meaningful sales of our product begin, we are totally dependent upon debt and equity funding. In the event that we are unable to obtain debt or equity financing or we are unable to obtain financing on terms and conditions that are acceptable to us, we may have to cease or severely curtail our operations. These factors raise substantial doubt about our ability to continue as a going concern.. So far we have been able to raise the capital necessary to reach this stage of product development and have been able to obtain funding for operating requirements, but there can be no assurance that we will be able to continue to do so. Moreover, there is no assurance that if and when FDA premarket approval is obtained, that our ComfortScan system will achieve market acceptance or that we will achieve a profitable level of operations. The accompanying financial statements in Item 1 of this report do not include any adjustments that might be necessary should we be unable to continue as a going concern. 2 APPLICATION OF CRITICAL ACCOUNTING POLICIES We generally recognize revenue upon the shipment of our product to our customers except for the initial maintenance component. That component is deferred and is recognized on a straight-line basis over the initial maintenance term. In order to achieve our goals, we incur research and development expenses, general and administrative expenses, clinical expenses and sales and marketing expenses. Research and development expenses consist primarily of compensation, benefits and related expenses for personnel engaged in research and development activities, outside contract and consulting expenses, material and supplies, and personnel costs to produce prototype units and develop manufacturing processes, methods and templates. General and administrative expenses consist of compensation, benefits and related expenses for personnel engaged in general management, finance and administrative positions. They also include expenses for financial advisory, legal and accounting fees, medical and scientific advisory board expenses, insurance and other expenses. Clinical program expenses consist of compensation, benefits and related expenses for personnel engaged in clinical related activities. These expenses also include costs of developmental studies, consultants, and that portion of travel and general corporate expenses allocated to that department. Sales and marketing expenses consist of compensation, benefits and related expenses for personnel engaged in sales, marketing, and related business development activities. These expenses also include consultants, printing of promotional materials, trade shows and that portion of travel and general corporate expenses allocated to that department. We account for income taxes under Statement of Financial Accounting Standards No. 109, Accounting for Income Taxes ("SFAS No. 109). SFAS No. 109 requires the recognition of deferred tax assets and liabilities for both the expected impact of differences between the financial statements and tax basis of assets and liabilities, and for the expected future tax benefit to be derived primarily from tax loss carry forwards. The Company has established a valuation allowance related to the benefits of net operating losses for which utilization in future periods is uncertain. We believe it is more likely than not that we will not realize the benefits of these deductible differences in the near future and therefore a full valuation allowance of approximately $4,900,000 is provided. As of December 31, 2004, we had approximately $12,000,000 of federal net operating losses available to offset future taxable income, which if not utilized will expire in 2024. No provision for income taxes has been recorded in the financial statements as a result of continued losses. Any benefit for income taxes as a result of utilization of net operating losses may be limited as a result of change in control. The preparation of financial statements are in conformity with accounting principles generally accepted in the United States and requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. As a development stage enterprise, we have not had to make material estimates which have an effect on financial presentation. OFF-BALANCE SHEET ARRANGEMENTS Our office facilities are subject to a five-year operating lease requiring monthly lease payments of approximately $20,000 per month. We have no other material off-balance sheet arrangements or liabilities. 3 RESULTS OF OPERATIONS COMPARISON OF THREE MONTHS ENDED MARCH 31, 2005 AND 2004 Revenues for the quarter ended March 31, 2005 was approximately $62,000. Limited sales began in the quarter ended December 31, 2004 and therefore, there were no sales to compare with for the prior year. Cost of sales was approximately $246,000 for the three months ended March 31, 2005 creating a gross loss of approximately $183,000 due to the limited sales for the period. We maintain a manufacturing facility with a break-even point of approximately 15 devices per quarter. Production volumes of less than 15 units per quarter will continue to negatively affect gross profit margins. In 2005, we plan to produce approximately 40 devices in order to meet our PMA clinical site and international sales requirements. Research and development expenses decreased approximately $56,000, or 11%, from $504,000 to approximately $448,000 for the three months ended March 31, 2005 compared to the prior year. Approximately $82,000 in various resources that were within the research and development group in the 2004 have been reassigned to manufacturing as part of the establishment of the production facilities. We expended approximately $20,000 more for the three months ended March 31, 2005 compared to the prior year for additional personnel as part of the upgrading and documentation of our investigational prototypes of the ComfortScan system for developmental testing and for refining the engineering of the hardware and software. In addition, we expended an additional $78,000 over the prior year's corresponding period to obtain clinical scans solely for research and development purposes, to upgrade previously built prototypes, to modify initial tooling for pre-production units, and for other research and development purposes. Costs related to design and materials for construction of prototype equipment decreased approximately $81,000 for the three months ended March 31, 2005 compared to the comparative prior year. General and administrative expenses increased approximately $318,000, or 67%, from $477,000 to approximately $795,000 for the three months ended March 31, 2005 compared to the prior year. This increase was primarily due to higher payroll costs including performance bonuses to the Chief Executive Officer and Chief Financial Officer of approximately $173,000 and other payroll costs of approximately $83,000 related to the increase staffing compared to the prior year. In addition, outside consulting and board of director costs of approximately $56,000. Clinical program expenses increased approximately $257,000, to $386,000 for the three months ended March 31, 2005 compared to the prior year due to the commencement of the PMA clinical trials. These additional costs included device costs, site costs, personnel and consulting costs and travel expenses. Sales and marketing expenses of approximately $260,000 for the three months ended March 31, 2005 reflect an increase of approximately $54,000 compared to the three months ended March 31, 2004. This was primarily due to having additional costs for participation it exhibits increasing an awareness of the Company and its products of $56,000, additional personnel costs in the amount of $76,000, offset by a decreased costs of approximately $93,000 in investor relations programs. Interest expense for the three months ended March 31, 2005 and March 31, 2004 was insignificant. LIQUIDITY AND CAPITAL RESOURCES We have financed our operations since inception through private issuances of equity and debt securities, generating approximately $38,500,000 in gross proceeds to date, described chronologically below. Prior to its merger into a publicly traded company in December 2003, DOBI Medical raised approximately $14.58 million in gross proceeds through the sale of common stock, preferred stock and convertible debt, which were converted into shares of the publicly-traded company, DOBI Medical International, Inc. in December 2003. 4 In December 2003, DOBI Medical Systems merged into a publicly-traded company, Lions Gate Investment Limited, which became the surviving entity (in January, 2004 Lions Gate changed its corporate name to DOBI Medical International, Inc.), and simultaneously completed the first tranche of a two-tranche private placement in which we issued 5,500,000 shares of common stock at a price of $1.00 per share and three-year warrants to purchase 2,750,000 shares of common stock at an exercise price of $1.54 per share, generating gross proceeds of $5,500,000. In July 2004, we completed the private placement of approximately $5.16 million in shares of our series A preferred convertible stock and associated warrants. The shares of series A preferred stock sold in the private placement carry a dividend of 8% per year and were initially convertible into 2,580,667 shares of common stock. We also issued four-year investor warrants to purchase 2,580,667 shares of common stock at a price of $3.00 per share. In connection with the closing of the second tranche of the December 2003 private placement and the March 2005 private placement, the number of common shares into which the series A preferred stock is convertible was increased to approximately 3,839,496 shares, reflecting anti-dilution adjustments. At the closing of the performance milestone-based second tranche in December 2004, we issued 6,000,002 shares of common stock at a price of $.50 per share, generating gross proceeds of approximately $3,000,000. In that connection, we issued three-year warrants to purchase 3,000,000 shares of common stock at an exercise price of $1.54 per share. On March 30, 2005, we completed a private placement of 21,000,000 shares of our common stock at a price of $.50 per share, and warrants to purchase 10,500,000 shares of our common stock at an exercise price of $.75 for the first 5,250,000 warrant shares and $1.25 for the next 5,250,000 warrant shares, resulting in aggregate gross cash proceeds of $10,500,000 and approximate net cash proceeds of $9,665,000. We believe that with these proceeds we will meet our funding needs into the first half of 2006. As of March 31, 2005, we had cash and cash equivalents of approximately $10,250,000. Net cash used in operating activities during 2004 totaled approximately $6,500,000, and capital expenditures totaled approximately $720,000. For 2005, we have no significant capital expenditure commitments. Our goals for 2005 are to submit our PMA application for the ComfortScan system as an adjunct to mammography to the FDA by the end of 2005 and sell ComfortScan systems through our international distributors. In connection with our 2005 goals, we expect our expenses to be approximately $1.8 million per quarter. In addition, we expect that PMA clinical trial project costs, including PMA site fees, clinical research organization fees, PMA site monitoring fees, and physician fees will be approximately $3.0 million in 2005. While we believe that we will achieve these goals, we cannot guarantee that we will do so. CAUTIONARY STATEMENT FOR FORWARD-LOOKING STATEMENTS Statements in this report contain information that includes or is based upon certain "forward-looking statements" relating to our business. These forward-looking statements represent management's current judgments and assumptions as of the date of this report. Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts, and are frequently accompanied by the use of such words as "may," "will," "anticipates," "plans," "believes," "expects," "projects," "intends," "seeks," "anticipates," and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors, including without limitation, successful verification and validation for release of our ComfortScan 2.0 system; those relating to our ability to timely and successfully complete our patient clinical trials; our ability to timely and successfully complete and submit our premarket approval application to the FDA; the timely and final approval by the FDA of our ComfortScan system as a adjunct to mammography, which approval in the U.S. cannot be assured; the submission and final approval of our ComfortScan system in various international markets, which approval cannot be assured; the success and continued improvements in our product development and research efforts; 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 to maintain our ISO, UL and FDA export certifications; our ability to timely and successfully ship and deliver our products into international markets; the acceptance and use of our ComfortScan system by physicians, hospitals, 5 imaging clinics, and patients; and our ability to obtain adequate third party coverage, coding and reimbursement from U.S. and foreign government and private payers. Any one of these or other risks, uncertainties, other factors or any inaccurate judgments and assumptions could 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 any such statements were made. Certain of these risks, uncertainties, and other factors are described in greater detail in our filings from time to time with the U.S. 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 our Registration Statement on Form SB-2 filed with the U.S. Securities and Exchange Commission, 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. SIGNATURES In accordance with Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized. Dated: May 26, 2005 DOBI MEDICAL INTERNATIONAL, INC. By: /s/ Phillip C. Thomas ---------------------------------- Phillip C. Thomas Chief Executive Officer (principal executive officer) By:: /s/ Michael R. Jorgensen ---------------------------------- Michael R. Jorgensen Executive Vice President and Chief Financial Officer (principal financial and accounting officer)