U.S. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-QSB (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, 2001 OR ( ) TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ___________ TO ____________ Commission File Number 0-23153 VOLU-SOL, INC. (Exact name of small business issuer as specified in its charter) Utah 87-0543981 (State or other jurisdiction of (IRS Employer Identification No.) incorporation or organization) 5095 West 2100 South Salt Lake City, Utah 84120 (Address of principal executive offices) (Zip Code) (801) 974-9474 (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. Yes X No __ As of May 10, 2001, the issuer had issued and outstanding 3,570,421 shares of common stock, par value $.0001. Transitional Small Business Disclosure Format (Check One): Yes __ No X --- 1 TABLE OF CONTENTS PART I. FINANCIAL INFORMATION Page No. 1. Financial Statements Unaudited Condensed Consolidated Balance Sheet as of March 31, 2001...3 Unaudited Condensed Consolidated Statements of Operations for the Three and Six Months Ended March 31, 2001 and 2000................4 Unaudited Condensed Consolidated Statements of Cash Flows for the Three and Six Months ended March 31, 2001 and 2000................5 Notes to Unaudited Condensed Consolidated Financial Statements........6 2. Management's Discussion and Analysis or Plan of Operation.............8 PART II. OTHER INFORMATION....................................................11 5. Other Information....................................................11 2 PART I Item 1 - Financial Statements VOLU-SOL, INC. AND SUBSIDIARY CONDENSED CONSOLIDATED BALANCE SHEET (Unaudited) March 31, 2001 ------------ ASSETS Current assets: Cash and cash equivalents $ 188,894 Accounts receivable, less allowance for doubtful accounts of $21,188 78,066 Inventories 52,671 ------------ Total current assets 319,631 Property and equipment, net 45,685 Note receivable 150,710 Other assets - deposits 3,624 ------------ Total assets $ 519,650 ============ LIABILITIES AND SHAREHOLDERS' DEFICIT Current liabilities: Accounts payable $ 141,601 Accrued liabilities 86,550 Preferred stock dividends payable 152,920 ------------ Total current liabilities 381,071 Long-Term Liabilities: Debentures 500,000 ------------ Total Liabilities 881,070 ------------ Stockholders' equity: Preferred stock, $.0001 par value; 30,000 shares authorized 22,228 shares outstanding (aggregate liquidation preference $59,286) 7,963,895 Common Stock, par value $.0001; 50,000,000 shares authorized, 3,570,421 shares issued and outstanding 357 Additional paid-in capital 2,050,506 Preferred stock subscriptions receivable (338,300) Accumulated deficit (10,037,879) ------------ Total stockholders' equity (361,421) ------------ Total liabilities and stockholders' deficit $ 519,650 ============ The accompanying notes are an integral part of these unaudited condensed consolidated balance sheets. 3 VOLU-SOL, INC. AND SUBSIDIARY CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) Three Months Ended Six Months Ended March 31, March 31, 2001 2000 2001 2000 ---- ---- ---- ---- Sales $ 141,560 $ 141,384 $ 255,765 $ 256,734 Cost of goods sold 87,725 92,093 158,575 165,144 ----------- ----------- ----------- ----------- Gross Margin 53,835 49,291 97,190 91,596 ----------- ---------- ----------- ----------- Selling, general and administrative expenses 1,521,925 1,068,682 2,176,629 1,249,301 ----------- ----------- ----------- ----------- Loss from operations (1,468,090) (1,019,391) (2,079,439) (1,157,711) Other income (expense): Interest income 1,661 1,961 3,905 1,961 Interest expense 13,050 - (13,050) - Net loss before provision for income taxes (1,479,479) (1,017,430) (2,088,584) (1,155,750) Provision for income taxes - - - - Net loss (1,479,479) (1,017,430) (2,088,584) (1,155,750) Dividends on Series A preferred stock (80,690) (76,987) (152,920) (117,087) Preferred stock accretion (2,885,823) (42,936) (2,904,783) (85,873) Net loss applicable to common stock $(4,445,992) (1,137,353) (5,146,287) (1,358,710) ----------- ----------- ----------- ----------- Net loss per common share - basic and diluted $ (1.40) $ (0.96) $ (1.68) $ (1.58) ----------- ----------- ----------- ----------- Weighted average common shares outstanding 3,183,591 1,177,545 3,066,420 859,454 ----------- ----------- ----------- ----------- The accompanying notes are an integral part of these unaudited condensed consolidated statements. 4 VOLU-SOL, INC. AND SUBSIDIARY CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) For the Six Months Ended March 31, 2001 2000 --------- -------- CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $(2,088,584) $(1,272,837) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 13,730 38,895 Stock issued for services 400,000 220,000 Options issued for services 12,799 - Preferred stock issued for services 695,000 220,00 Increase (decrease) in: Accounts receivable 39 (9,047) Inventories (1,781) 6,774 Other assets (352) 100 Increase (decrease) in: Accounts payable (49,029) (20,650) Accrued liabilities 47,461 (2,157) ------------ ------------ Net cash used in operating activities: (970,717) (1,038,922) ------------ ------------ Cash flows from investing activities: Equipment purchases (3,100) - Note receivable (150,710) - ----------- ------------ Net cash used in investing activities (153,810) - ------------ ------------ Cash flows from investing activities: Proceeds from notes payable 535,000 - Proceeds from debentures 500,000 - Proceeds from sale of preferred stock - 236,000 Proceeds from sale of common stock - 1,700,000 ------------ ------------ Net cash provided by financing activities 1,035,000 1,936,000 ------------ ------------ Net increase (decrease) in cash (89,527) 1,079,723 Cash, beginning of period 278,421 44,123 ------------ ------------ Cash, end of period $ 188,894 $ 1,123,846 ============ ============ The accompanying notes are an integral part of these unaudited condensed consolidated statements. 5 VOLU-SOL, INC. AND SUBSIDIARY Notes to Condensed Consolidated Financial Statements (Unaudited) Organization and Business Activity The unaudited condensed consolidated financial statements consist of Volu-Sol, Inc., which is incorporated in the state of Utah, and its wholly owned subsidiary, Volu-Sol Reagents Corporation, which was incorporated on March 5, 1998 in the state of Utah (collectively, the "Company"). The Company engages in the manufacturing, marketing and distribution of medical diagnostic stains. (1) PRESENTATION OF CONDENSED CONSOLIDATED FINANCIAL STATEMENTS The accompanying interim condensed consolidated financial statements of the Company have been prepared consistent with generally accepted accounting principles for interim financial information in accordance with the instructions to Form 10-QSB and Item 310 of Regulation S-B. Accordingly, such unaudited financial statements do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments, consisting only of normal recurring adjustments, necessary to present fairly the financial position, results of operations and cash flows of the Company for the interim periods presented, have been included. Operating results for the three and six months ended March 31, 2001 are not necessarily indicative of the results that may be expected for the year ending September 30, 2001. The Company suggests that these condensed consolidated financial statements be read in conjunction with the financial statements and notes thereto included in the Company's Form 10-KSB for the year ended September 30, 2000. (2) RELATED-PARTY TRANSACTIONS During the six months ended March 31, 2001, the Company borrowed $535,000 from an entity controlled by a major shareholder. The Company exchanged 2,675 Series A Preferred Stock for extinguishment of this debt. The Company may borrow up to $2,000,000 against the note. The note bears interest at 12%, matures September 2001, and is secured by the right of the note holder to convert the debt to Series A Convertible Preferred Stock of the Borrower at $3.00 per share. (3) INVENTORIES Inventories are stated at the lower of cost (first-in, first-out method) or market value. Inventories consist of the following as of March 31, 2001: Raw materials, packaging and supplies $30,990 Instruments, biological stains and reagents 21,681 -------- $52,671 (4) CONVERTIBLE DEBENTURES The Company issued 15% Convertible Debentures, due on or before August 1, 2001. The Debentures are convertible into common stock at an initial conversion rate of $3.00 per share. Total debentures outstanding at March 31, 2001 were $500,000. (5) SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES During the six months ended March 31, 2001, the Company: o Accrued preferred stock dividends payable of $152,920. 6 o Increased preferred stock and decreased additional paid-in-capital for $2,904,806 due to accretion. o The Company issued 2,675 shares of Series A Preferred Stock in exchange for $535,000 of debt to an entity controlled by a major shareholder. During the six months ended March 31, 2000, the Company: o Accrued preferred stock dividends payable of $102,645. o Increased preferred stock and decreased additional paid-in-capital for $85,873 due to accretion. Actual amounts paid for interest and income taxes are as follows: Six Months Ended March 31, 2001 2000 -------------------------- Interest $ - $ - ========================== Income taxes $ - $ - ========================== (6) SERIES A PREFERRED STOCK On September 8, 1997, the Company amended its Articles of Incorporation to create a series of preferred stock. The Series A 10% Convertible Non-Voting Preferred Stock, consists of 30,000 shares with $.0001 par value. This series is part of the Company's 10,000,000 authorized shares of non-voting preferred stock. The holders of the shares are entitled to dividends at the rate of ten percent (10%) per annum on the stated value of the Series A Preferred Stock (or $200 per share), payable in cash or in additional shares of Series A Preferred Stock at the discretion of the Board of Directors. Dividends are fully cumulative and accrue from the date of original issuance. (7) NET LOSS PER COMMON SHARE Basic net loss per common share ("Basic EPS") excludes dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per common share ("Diluted EPS") reflects the potential dilution that could occur if stock options or other contracts to issue common stock including convertible preferred stock were exercised or converted into common stock. The computation of Diluted EPS does not assume exercise or conversion of securities that would have an anti-dilutive effect on net loss per common share. Because the Company has incurred a loss for the periods presented, no exercises or conversions have been considered, as they would be anti-dilutive, thereby decreasing the net loss applicable to common shares. During the six months ended March 31, 2001 the Company issued 183,924 shares of common stock as part of the original divestiture of the Company from Biomune Systems, Inc. in the nature of a dividend. At March 31, 2001, there were outstanding options to purchase 2,600,500 shares of common stock and there were 16,138 shares of Series A Preferred Stock outstanding, convertible into a minimum of 5,971,060 shares of common stock. Approximately 500,500 options relate to options to purchase Biomune common stock outstanding at the time of the Company's divestiture from Biomune Systems, Inc. The holders of such Biomune options were also granted options to purchase Volu-Sol common stock. 7 Item 2 - Management's Discussion and Analysis or Plan of Operation Introduction The Company was incorporated in Utah on July 27, 1995, as a wholly owned subsidiary of Biomune Systems, Inc., a Nevada corporation ("Biomune"). Volu-Sol was organized to engage in the business of manufacturing and marketing medical diagnostic stains and solutions and related equipment, which business operations were conducted before that time as an unincorporated division of Biomune called the Volu-Sol Medical Division. Biomune purchased the assets comprising the Volu-Sol Medical Division in December 1991 from Logos Scientific, Inc. Biomune transferred all of the net assets of the Volu-Sol Medical Division to the Company. Through the fiscal year ended September 30, 1995, Volu-Sol operated out of leased facilities in Henderson, Nevada. In October 1995, the Company relocated to West Valley City, Utah, where its manufacturing facility and corporate offices are presently located. A total of 422,244 shares of the Company's common stock were distributed pro rata as a stock dividend to the holders of the common stock of Biomune in 1997 (the "Distribution"). As a consequence of the Distribution, Volu-Sol ceased to be a subsidiary of Biomune and commenced operations as a separate, independent company. Volu-Sol continues to conduct the operations it conducted as a subsidiary of Biomune. The Company's management has recently developed a new business plan to broaden the business emphasis of the Company to include remote medical diagnostics and medical alert technologies and services. Special Note Regarding Forward-looking Information Certain statements in this Item 2 - "Management's Discussion and Analysis or Plan of Operation" are "forward-looking statements" within the meaning of the Exchange Act. For this purpose, any statements contained or incorporated in this report that are not statements of historical fact may be deemed to be forward-looking statements. The words "believes," "plans," "anticipates," "expects" and similar expressions are intended to identify forward-looking statements. A number of important factors could cause the actual results of the Company to differ materially from those anticipated by forward-looking statements. These factors include those set forth under the caption "Risk Factors" in Item 6 - "Management's Discussion and Analysis or Plan of Operation" in the Company's annual report on Form 10-KSB for the year ended September 30, 2000. Business Strategy Until recently, Volu-Sol's primary business strategy has been to capitalize on the global medical diagnostic industry by providing "building block" stains and reagents and to grow through the selective acquisition of complimentary businesses, devices and product lines. Management recently determined to pursue a more expanded role in the medical diagnostic industry. The new business strategy of the Company is outlined in greater detail below. New Business Direction Volu-Sol's management has determined to expand the scope of its operations to develop products that provide a powerful way to manage patient medical information and to link patients, physicians and payors. The Company will continue to conduct its medical stains and solutions business under the Volu-Sol(TM) name and will operate its remote health monitoring and diagnostic business under the name RemoteMDx(TM). The Company believes that its management team has a breadth of experience and knowledge in the medical diagnostic arena needed to pursue development of new technologies in the medical device and electronics fields. Under the RemoteMDx brand the Company will introduce the "ROSE System(TM)"-- a family of healthcare monitoring and remote diagnostic products and services, which will position the Company in a market with high growth and profitability potential. The Company is developing the ROSE System to compete in the home healthcare and telemedicine markets. The Company estimates this market to be approximately $100 billion annually, based on industry publications. The ROSE System combines innovative hardware and software technologies with a powerful medical data capture and communication network. 8 The new business model is based on providing solutions to some of the most substantial problems in healthcare today. This new product is intended to provide the patient power to decide when and where they have their "examination" while providing the physician with increased flexibility and efficiency in diagnosis. The healthcare market provides a significant opportunity for the Company to create new products and services that improve the quality and cost of care given. According to industry reports, total healthcare expenditures in the United States for 1998 were in excess of $1 trillion (14% of the gross domestic product). Expenditures are projected to grow to $2 trillion by 2007 (17% of the gross domestic product). The Company has formed a strategic alliance with Battelle Memorial Institute ("Battelle"), a not-for-profit research organization to collaborate with the Company to develop the ROSE System. The Company anticipates that it will continue to use Battelle to collaborate on development and design for the foreseeable future. The Company anticipates that after its products have been introduced it will continue to refine and develop enhancements to the products, as well as look for opportunities for future product offerings. Battelle has completed a demonstration unit with core components of the ROSE Acute Diagnostic system. The Company will continue to revise the demonstration model as product development continues. Collaborative Relationships In addition to its relationship with Battelle, the Company intends to continue to form strategic alliances with industry leaders to achieve and fulfill its business plan. The Company has two additional areas in which the Company believes strategic alliances will better serve its needs. These areas include product marketing, distribution and access to patient markets and data transfer and processing. In order to enhance its marketing strength and augment its distribution channels, the Company is in the process of developing marketing and distribution alliance partners for its products and services. The Company is currently in contact with Veterans Affairs and regional HMO/PPO organizations with significant networks of physicians and patients. The Company is exploring an alliance with HMO/PPO organizations and other organizations for testing and receiving input on final technology design of its products. Volu-Sol is also in the process of evaluating acquisitions that would be good strategic fits with the product development and distribution plans of the Company. The Company anticipates that these additional strategic alliance partners would provide the following: o A consortium of providers, specific to chronically ill care, to act as a focus group on product definition matched to specific care areas. o The opportunity to conduct prototype review and gain decision-making input into final technology design for test markets. o Sites to conduct trials, to establish protocols, to track outcomes and to act as early-adopter organizations for acquiring the technology. o Access to significant channels of distribution. Results of Operations Comparison of the Three Months Ended March 31, 2001 to the Three Months Ended March 31, 2000. During the three months ended March 31, 2001, the Company's revenues totalled $141,560 compared to $141,384 for the three months ended March 31, 2000. Revenues have remained constant due to maintaining a customer base similar to that in the prior year period. The Company is not aggressively marketing sales for the reagent product line, which accounts for substantially all revenues, due to its new business direction. 9 Cost of revenues for the three months ended March 31, 2001 totalled $87,725 compared to $92,093 for the three months ended March 31, 2000. The overall gross margin for the quarter ended March 31, 2001 was approximately 38% of revenues compared to 35% of revenues for the comparable quarter in 2000. The increase in the gross margin on sales is primarily the result of improved inventory management and a continued effort to create a leaner production team and better inventory management, as well as the implementation of a price increase. Selling, general and administrative expenses totalled $1,521,925 for the three months ended March 31, 2001, compared to $1,068,682 for the three months ended March 31, 2000, an overall increase of $453,243. The increase is due to costs associated with new product development. The Company incurred a net loss applicable to common shares of $4,445,992 for the three months ended March 31, 2001 compared to a net loss applicable to common shares of $1,137,353 for the three months ended March 31, 2000. This increase in net loss is attributable to the expenses incurred in connection with issuance of Common and Preferred Stock for services in the quarter ended March 31, 2001. Comparison of the Six Months Ended March 31, 2001 to the Six Months Ended March 31, 2000. During the six months ended March 31, 2001, the Company's revenues totalled $255,765 compared to $256,734 for the six months ended March 31, 2000. Revenues have remained constant due to maintaining a customer base similar to that in the prior year period. The Company is not aggressively marketing sales for the reagent product line, which accounts for substantially all revenues, due to its new business direction. Cost of revenues for the six months ended March 31, 2001 totalled $158,575 compared to $165,144 for the six months ended March 31, 2000. The overall gross margin for the six months ended March 31, 2001 was approximately 38% of revenues compared to 36% of revenues for the comparable period in fiscal year 2000. The increase in the gross margin on sales is primarily the result of improved inventory management and a continued effort to create a leaner production team, as well as the implementation of a price increase. Selling, general and administrative expenses totalled $2,176,629 for the six months ended March 31, 2001, compared to $1,249,301 for the six months ended March 31, 2000, an overall increase of $927,328. The increase is due to costs associated with new product development. The Company incurred a net loss applicable to common shares of $5,146,287 ($1.68 per share) for the six months ended March 31, 2001 compared to a net loss applicable to common shares of $1,358,710 ($0.57 per share) for the six months ended March 31, 2000. Liquidity and Capital Resources The Company currently is unable to finance its operations solely from its cash flows from operating activities. From October 1, 1993 through March 31, 1999, Biomune financed the Company's operations through a series of loans and other capital contributions totalling approximately $2,900,000. The Company also sold shares of Series A Preferred Stock to provide additional working capital. The Company believes that cash generated by operations, together with the proceeds from additional sales of its securities will be sufficient to meet its capital requirements for a minimum of twelve months. However funds from equity sales may not be available. As of March 31, 2001, the Company had cash of $188,894 and working capital deficit $61,440 compared to cash of $278,421 and working capital deficit of $177,697 as of September 30, 2000. During the six months ended March 31, 2001, the Company's operating activities used cash of ($970,717), much of which was funded by the issuance of convertible debentures and a related party note payable. During the six months ended March 31, 2000, the Company's operating activities used cash in the amount of $1,038,922, which was funded by the sale of Series A Preferred Stock. 10 The Company has no credit facility with any commercial lending institution. In the past, the Company borrowed and received capital from time to time from Biomune, but the Company has no formal financing arrangement, agreement or understanding for debt financing with Biomune in the future. During the six months ended March 31, 2001, the Company entered into an agreement with ADP Management, an entity controlled by a major shareholder, in which the Company may borrow up to $2,000,000. The Note bears interest at 12%, matures September, 2001, and is secured by the right of the note holder to covert the debt to Series A Convertible Preferred Stock of the borrower at $200 per share, or to Common Stock at $3 per share. The unaudited condensed consolidated financial statements of the Company have been prepared on the assumption that the Company will continue as a going concern. The Company's product line is limited and the Company has relied upon borrowings and financing from the sale of its equity securities to sustain operations. Additional financing will be required if the Company is to continue as a going concern. If such additional funding cannot be obtained, the Company may be required to scale back or discontinue its operations. Even if such additional financing is available to the Company, there can be no assurance that it will be on terms favorable to the Company. In any event, such financing will result in immediate and possible substantial dilution to existing shareholders. PART II - OTHER INFORMATION Item 5. Other Information During the quarter ended March 31, 2001, the Company's Board of Directors was reorganized. Ken Westover and Barry Edwards resigned to pursue other interests. The Board nominated and approved David G. Derrick and James Dalton as their successors. The Board now comprises David G. Derrick, Chairman and CEO, James Dalton, Co-Chairman, and Wilford W. Kirton, III. The Board also approved the creation of three operating divisions and appointed management to be responsible for those divisions and operations as follows: o Technology - David G. Derrick has primary responsibility for this division. o P.A.L. - James Dalton is President of this Division. o Diagnostics - Wilford W. Kirton heads this division, in addition to his responsibilities for operations generally. James Dalton, 56, from 1987 to present, Mr. Dalton has been the owner and President of Dalton Development, a real estate development company, and in that capacity has developed and managed several real estate projects. Mr. Dalton was as a director of Biomune from February 1996 until 1998. He also served as a director of Optim from 1996 until 1998. He was our General Manager until January 1996. David G. Derrick, 48, has agreed to serve as Chairman of the Board of Directors after the closing of this Offering. Mr. Derrick served as the Chief Executive Officer and as Chairman of the Board of Directors of Biomune and its subsidiary Optim, Inc. between 1989 and 1998. From 1996 to 1999 Mr. Derrick served as Chairman of the Board of Directors of The Purizer Company (formerly Bioxide Corporation). From September 1979 to June 1983, Mr. Derrick was a faculty member at the University of Utah College of Business, Department of Finance. Mr. Derrick graduated from the University of Utah College of Business with a Bachelor of Science degree in Economics in 1975 and with a Masters in Business Administration degree with an emphasis in Finance in 1976. Mr. Derrick is the brother-in-law of Bill Kirton, our President. Mr. Derrick is also one of our significant shareholders. Also during the quarter ended March 31, 2001, the Company entered into a loan agreement with ADP Management, a company owned by Mr. Derrick. ADP also agreed to loan up to an aggregate of $2,000,000 in principal. Amounts loaned under the agreement are repayable at the option of ADP in cash or in shares of Series A Preferred Stock or a series with terms and preferences substantially the same as the Series A. The Board approved a new series of preferred as required to accommodate eventual conversion of the Loans made under the agreement. 11 SIGNATURES In accordance with the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. VOLU-SOL, INC. Date: May 18, 2001 By: /s/ David G. Derrick ------------------------------ David G. Derrick, Chief Executive Officer Date: May 18, 2001 By: /s/ Michael G. Acton --------------------------------------- Michael G. Acton, Chief Financial Officer 12