SEC Info  
    Home      Search      My Interests      Help      Sign In      Please Sign In

SMLX Technologies Inc – ‘10KSB’ for 12/31/97

As of:  Tuesday, 4/28/98   ·   For:  12/31/97   ·   Accession #:  948830-98-97   ·   File #:  0-28154

Previous ‘10KSB’:  ‘10KSB’ on 4/15/97 for 12/31/96   ·   Next:  ‘10KSB’ on 5/19/99 for 12/31/98   ·   Latest:  ‘10KSB’ on 4/16/02 for 12/31/01

Find Words in Filings emoji
 
  in    Show  and   Hints

  As Of                Filer                Filing    For·On·As Docs:Size              Issuer               Agent

 4/28/98  SMLX Technologies Inc             10KSB      12/31/97    2:92K                                    Sawyer Jon D P C/FA

Annual Report — Small Business   —   Form 10-KSB
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 10KSB       Annual Report -- Small Business                       35    174K 
 2: EX-27       Financial Data Schedule (Pre-XBRL)                     1      7K 


10KSB   —   Annual Report — Small Business
Document Table of Contents

Page (sequential) | (alphabetic) Top
 
11st Page   -   Filing Submission
2Item 1. Description of Business
3The Company's Products
10Item 2. Description of Property
"Item 3. Legal Proceedings
"Item 4. Submission of Matters to A Vote of Security Holders
11Item 5. Market for Common Equity and Related Stockholder Matters
"Item 6. Management's Discussion and Analysis or Plan of Operation
12Item 7. Financial Statements
13Item 8. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
14Item 9. DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS; COMPLIANCE WITH SECTION 16(a) OF THE EXCHANGE ACT
16Item 10. Executive Compensation
17Item 11. Security Ownership of Certain Beneficial Owners and Management
18Item 12. Certain Relationships and Related Transactions
19Item 13. EXHIBITS AND REPORTS ON FORM 8-K. (a) 3. EXHIBITS
27Earnings Per Share
10KSB1st Page of 35TOCTopPreviousNextBottomJust 1st
 

U.S. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-KSB ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 1997 Commission file number: 0-28154 SIMPLEX MEDICAL SYSTEMS, INC. (Formerly "Music Tones Ltd.") ---------------------------------------------- (Name of small business issuer in its Charter) Colorado 84-1337509 ------------------------------- ----------------- (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 430 Ansin Boulevard, Suite G, Hallandale, Florida 33009 ----------------------------------------------------------- (Address of principal executive offices, including zip code) (954) 455-0110 --------------------------- (Issuer's telephone number) Securities Registered Pursuant to Section 12(b) of the Act: None. Securities Registered Pursuant to Section 12(g) of the Act: Common Stock, No Par Value 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 [ ] Check if disclosure of delinquent filers pursuant to Item 405 of Regulation S-B is not contained in this form, and no disclosure will be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-KSB or any amendment to this Form 10-KSB. [ ] The Issuer's revenues for its most recent fiscal year were $71,461. As of April 21, 1998, 7,500,000 shares of the Registrant's common stock were outstanding, and the aggregate market value of the shares held by non-affiliates was approximately $3,665,000. DOCUMENTS INCORPORATED BY REFERENCE: None. Transitional Small Business Disclosure Format (check one): Yes __ No X
10KSB2nd Page of 35TOC1stPreviousNextBottomJust 2nd
PART I ITEM 1. DESCRIPTION OF BUSINESS. BACKGROUND Simplex Medical Systems, Inc. (the "Company") was incorporated under the laws of the State of Colorado on October 26, 1987, under the name The Trader's Edge Ltd. On March 28, 1996, the name was changed to Music Tones Ltd. The Company was generally inactive through December 31, 1996. On March 28, 1997, the Company's shareholders approved a proposal to change the Company's name to Simplex Medical Systems, Inc. In April 1996, the Company filed a registration statement with the Securities and Exchange Commission on Form 10-SB, wherein it registered its common stock under Section 12(g) of the Securities Exchange Act of 1934, as amended (the "34 Act"). As a result, the Company became a fully reporting company under the 34 Act. On March 5, 1997, the Company completed a reverse acquisition of 100% of the outstanding common stock of Simplex Medical Systems, Inc., a Florida corporation ("Simplex-Florida") in exchange for 3,453,000 shares of the Company's Common Stock which resulted in the shareholders of Simplex-Florida acquiring approximately 46.04% of the shares outstanding in the Company. In connection with the closing of this transaction, several shareholders submitted for cancellation a total of 31,953,000 shares of common stock. As a result, after the acquisition of Simplex-Florida there were a total of 7,500,000 shares outstanding. Unless the context otherwise requires, the term "Company" as used herein refers to the Company and its wholly-owned subsidiary, Simplex-Florida, and its wholly-owned subsidiary Analyte Diagnostics, Inc. ("ADI"). Simplex-Florida was incorporated in Florida in September 1995, and ADI was incorporated in Florida on June 6, 1995. DESCRIPTION OF BUSINESS GENERAL The Company is engaged in the development, acquisition, manufacturing and marketing of medical diagnostic products for point-of-care testing. The Company offers a diagnostic test for HIV which screens saliva instead of blood or urine. The countries which have approved or permitted the sale of these test kits include Hong Kong, Venezuela, Spain, Costa Rica, Italy, Bahamas, New Zealand and Argentina. The Company was also issued an approval in Brazil, but due to a change in their government and a consequent change in the certifying hospital, the Company had to resubmit the documents and redo the clinical trials. This has been completed and the Company expects re-approval during May 1998. The Company has acquired, through internal development, assignment, acquisition, and a series of joint development agreements, certain rights to technology for non-invasive diagnostic products, specifically products for detection of HIV antibodies in saliva, and for the testing of diabetics to monitor their daily dietary and insulin requirements. The non-invasive collection and analysis of biological fluids, specifically, the devices for collection of saliva and biological fluids extracted through the skin of a sample donor, are expected to replace many of the present test regimes for diagnostics products that are currently in use. -2-
10KSB3rd Page of 35TOC1stPreviousNextBottomJust 3rd
THE COMPANY'S PRODUCTS Public Health officials, including specifically the agencies that are responsible for testing defined populations in prisons, military and registered prostitutes, have become increasingly concerned with the need for a rapid and accurate diagnostic test for detection of infectious disease, including specifically HIV, hepatitis and the like. The prospective customers of the Company's saliva collector and diagnostic products require that such diagnostic products be relatively simple to use, and capable of use outside the laboratory (on-site diagnostic testing). In relatively undeveloped countries the on-site testing is of paramount importance to acceptance of such tests. Because the Company's initial marketing and sales efforts are directed outside the United States, FDA approval of certain of the Company's products may not be as restrictive compared to domestic requirements. The customers of the Company's products generally favor products that are manufactured in facilities which are subject to FDA regulation (FDA registered establishment) and thus the Company has had its facilities registered. A. THE SALIVA COLLECTION DEVICE, was designed for the collection, recovery, dispensing and on the spot testing of a fluid sample, including vital biological fluids such as saliva. Other aspects of the technology include an optical window integrated with the device to provide analysis of the sample within the device. The device consists of a recovery container in the shape of a small plastic test tube which embodies a tubular member having an open end and closed end and includes an absorbent element comprised of a polymer foam to absorb a fluid sample in sufficient quantity to permit analysis and testing without elaborate sample preparation or laboratory equipment. In certain designs, by applying a pressure to the flexible tube the fluid can be squeezed into a reservoir which can then be collected for analysis. The volume of saliva collected by the absorbent element is a function of both the size of the element and the time the element is in contact with the donor. The test kit for this technology includes an analyte sensitive element and one sample collection device along with instructions for performance of an analysis of the collected fluid sample. The Company's saliva sample collector is to be used in place of the more traditional, and intrusive, sample collection methodologies (e.g. drawing blood by venous puncture or finger stick) to obtain a biological fluid sample, which, in most instances, is comparable, or preferable, to biological fluids such as blood, urine or fecal matter, for constituent analysis. The market for the Company's fluid sample collector is not restricted by international boundaries and, depending upon the diagnostic test used in conjunction therewith, will be made available to any business or individual having a need to collect a fluid sample by untrained personnel and without the need or assistance of elaborate and intrusive equipment. In clinical tests, it has proven both safe and effective for the collection of a clinically acceptable sample of saliva from a donor's mouth; and the recovery thereof for constituent analysis. Because of the metabolic constituents of saliva, the sample collector can be used with a number of diagnostic tests, including analysis for antibodies indicative of disease states (HIV, hepatitis, measles and mumps) and, for drugs of abuse. During April 1998 the Company received a letter from the FDA that the FDA had reviewed the Company's 510(k) notification regarding the saliva collector and had approved marketing of the product in the United States. The Company next -3-
10KSB4th Page of 35TOC1stPreviousNextBottomJust 4th
intends to submit a 510(k) premarket notification for one of the Company's test kits which incorporate the saliva collector. The fluid collection device to be manufactured and distributed by the Company is also suitable for use with any one of a variety of screening tests for on-site determination of the presence of pollutants in drinking water, waste streams and in environmentally sensitive habitats. The countries which have approved or permitted the sale of these test kits include Hong Kong, Venezuela, Spain, Costa Rica, Italy, Bahamas, New Zealand and Argentina. The Company was also issued an approval in Brazil, but due to a change in their government and a consequent change in the certifying hospital, the Company had to resubmit the documents and redo the clinical trials. This has been completed and the Company expects re-approval during May 1998. During March 1997, the Company signed a Memorandum of Understanding with Sun Biomedical Laboratories, Inc. ("Sun") to collaborate on the development of a new saliva-based diagnostic test for mumps, rubella and pertussis (whooping cough). Sun is a bio-tech product development and manufacturing company located in Cherry Hill, New Jersey. B. DENTAL AIRBRATOR. The Company has developed and applied for patents and FDA approval on a disposable handpiece which attaches to standard air abrasive etching devices used by dentists for tooth bonding procedures. The product effectively abrades the surface of teeth, but has no effect at all on soft tissue. Because it is disposable and there is no need for extensive sterilization procedures, the product increases patient through-put. During April 1997 the Company received a letter from the FDA that the FDA had completed the scientific review portion of the Company's 510(k) premarket notification regarding the airbrator, and the airbrator is approved for marketing in the United States for the use of abrading the surface of teeth. During July 1997, the Company entered into a Distribution Agreement with Sybron Dental Specialties, Inc. ("Sybron") pursuant to which the Company appointed Sybron as the exclusive worldwide distributor for the airbrator. Several of the terms of this agreement were amended during December 1997. The agreement, as amended, provides that, subject to the Company satisfying its obligations under the agreement, Sybron will purchase from the Company at least three million airbrators per year commencing on December 1, 1998, and continuing for the five year term of the agreement. Sybron paid a $30,000 one-time license fee to the Company during 1997 for the grant of this distributorship. Pursuant to the agreement, the Company is responsible for using commercially reasonable efforts to produce, supply and ship the airbrators in accordance with Sybron's orders. C. THE NON-INVASIVE GLUCOSE TEST is a formulation and method for the analysis of interstitial fluids to determine the presence and/or concentration of an analyte of interest such as glucose. The test kit comprises one or more reagents for the extraction and collection of the fluid, a collection device and an analyte sensitive element integrated with the collection device that is responsive to and capable of identifying the analyte contained in the extracted fluid. This product configuration is clearly in the research and development stage as no final commercial embodiment has been created. Nor can the Company determine with certainty if it infringes upon patents and other claims inasmuch as this is an area of active development by a number of competing companies. Neither the Company nor ADI have a patent pending for this technology. -4-
10KSB5th Page of 35TOC1stPreviousNextBottomJust 5th
D. BIOVEN ANTI-INFLAMMATORY/ANTI-ARTHRITIC TREATMENT is a powerful and safe treatment for the symptomatic treatment of Rheumatoid Arthritis ("RA"). The Company's principal scientist developed BIOVEN after fifteen years of extensive research in the field of immunology. BIOVEN has undergone significant clinical trials in several foreign countries and has gained approval for administration in Hong Kong and Nicaragua, but not in the United States. BIOVEN is a result of years of experimentation, evaluation and historical study in the field of peptide use. The product is currently administered as an injectable solution made under the strict guidelines of the FDA, however, the FDA has not approved BIOVEN for use in the United States. The BIOVEN mode of action is believed to function by reversing the body's chemical/immunological imbalances that are present in RA. Hospital studies and laboratory data have confirmed that in the typical case where the RA test is positive, the treatment with BIOVEN returns test results to normal. The immunoglobulin fractions of patients' blood with RA that are abnormal are returned to baseline normal levels after treatment with BIOVEN. The biological results are quantifiable. After treatment with BIOVEN, the joint inflammation is reduced, the joint pain is removed and a general feeling of well-being is reported by most patients. Patients who have previously required high doses of pain medication, such as aspirin, can reduce the amount of medication needed and, in many instances, stop taking all secondary pain medications. BIOVEN has been shown not to have any adverse side effects. In over 2,000 case histories, to the Company's knowledge, there has not been one adverse reaction reported in clinical use. The LD50 studies that have been done along with the other safety tests confirmed BIOVEN's safety and efficacy. BIOVEN has been used to treat Early Onset Rheumatoid Arthritis and to the Company's knowledge in all cases has resulted in a marked and to date, permanent, beneficial result. There are many children today who are leading a normal life due to BIOVEN treatment. The mode of action of BIOVEN has led other scientific groups to use it to develop a clearer understanding of how the RA process works and how it affects the body. Research into the uses of BIOVEN has been an on-going project that has not ended with the anti-inflammatory properties of the drug. New research over the past several years has led to a modified version of BIOVEN with very potent and effective antiviral properties. The modified BIOVEN (BIOVEN-H) has been used to treat Herpes zoster (Shingles), Herpes keratitis (Herpes of the eye) and Herpes varicella (cold sores). All three conditions responded with a 100% cure rate in all cases. Over 100 cases to date have been treated and all report the disappearance of the virus and its effects. BIOVEN-H works in three to five days and has no side effects. BIOVEN-H has been used by the Director of Medicine at the Eye Institute of Nicaragua on dozens of patients with Herpes infections of the eye and found it to be effective in preventing blindness in the patients. The Institute used BIOVEN-H for many years prior to the political changes that restricted trade with the United States and thus made the drug unavailable there. This situation has reversed itself and the Company is planning to reestablish a manufacturing plant in the country as soon as adequate funding becomes available. BIOVEN can be made available for clinical trials worldwide and for sale in countries where approval is currently in force. The Company believes the market for both BIOVENs in the countries where it is currently licensed is very significant. Major steps have been undertaken to gain approval in the European Economic Community and the Company has recently received approval of BIOVEN for -5-
10KSB6th Page of 35TOC1stPreviousNextBottomJust 6th
veterinary use in France. The Company has not applied for FDA approval for Bioven for use in the United States due to the significant expenditure which would be required for the product since it must be injected. If approval was applied for, there be no assurance that such approval would be forthcoming. It should be emphasized that no market test studies have been undertaken by the Company and no patents have been acquired nor are any pending for this product. E. FLAVOR ENHANCEMENT. The Company has developed a proprietary process which allows for the incorporation of flavor essences into an edible support material using food grade materials and approved printable inks. This process has given rise to a new form of advertising sampler which will enable a consumer to sample new food and beverages through newspaper ads, point of sale displays or direct mailings. The encapsulation process and method of manufacturing are proprietary and the Company has applied for patent protection for this technology. RESEARCH AND DEVELOPMENT The Company spent $103,324 on research and development of new products during the year ended December 31, 1997. THE MARKET The Company believes that the general state of the saliva diagnostic market with regard to the products available, the size of the market and the number of competitive manufacturers can be described as in the infancy of an extremely large industry. It must be emphasized that no market or feasibility study has been undertaken by the Company. Commercial development of immunoassays in diagnostic medicine commenced in the 1960's and has increased significantly since then, due principally to the high degree of sensitivity and specificity of such techniques. Tests for hepatitis, HIV, mumps, measles, cancer tumor markers, EBV, CMV, and many others are currently using blood as the source of the specimen. These tests, while effectively performed in the clinical setting, are expensive, time consuming and, at the least, painful for the recipient of the blood collection needle. The skill and expertise of the physician or other highly trained individual needed to obtain the sample of blood for these tests is also adding to the high cost of the testing. The saliva collection and test system not only tends to solve the aforementioned problems but is easy to use and lends itself to home or "point of care" style testing. These advantages effectively reduce the overall cost of immunological testing and allow for the immediate results to be made available to the practitioner or individual. The Company believes that testing with saliva specimens has many potential advantages compared to testing with blood and urine specimens. Unlike obtaining blood specimens, saliva specimens can be collected at any time in any location and the sampling procedure is easy to administer and monitor, and may be conducted on a group basis. The Company believes, that unlike self-administered blood collection, the use of its products will not require special training. Blood specimen testing requires the use of needles, which may accidentally injure or infect the technician collecting the specimen or the subject giving the specimen. Saliva specimen collection does not require the use of sharp objects. Additionally, after collection, blood specimens remain potentially infectious (can contain live HIV virus) whereas saliva specimens are believed not to be infectious. The use of saliva specimens also has advantages compared to the use of urine specimens inasmuch as the integrity of the saliva specimen can be maintained, chain of custody concerns can be addressed and saliva collection can be used without significant invasion of privacy. -6-
10KSB7th Page of 35TOC1stPreviousNextBottomJust 7th
Disadvantages of saliva collection include the stability of saliva as a specimen and the impact of the subject's diet and enzymes on saliva. Provisions must be made to assure that a sufficient amount of saliva is collected, the specimen is adequately stabilized and bacterial growth does not cause test interference. Saliva based testing has been recognized by the World Health Organization ("WHO") and the FDA as efficacious and practical. Several tests have been approved to be used in the clinical market based on saliva samples. Countries such as Thailand, Brazil, Mexico, Russia and many others have already made policy changes which allow for the use, and even encourage the use, of saliva tests for HIV in their overall health programs. The immunoassay diagnostic testing market began in 1960, and, in 1990 was approximately a $2.8 billion market. The immunoassay diagnostic test market in the United States was estimated at $900 million in 1990, with annual growth estimated between 7% and 8%. The overall market currently is divided into three major components; first, the "government" sector, second, the "captive audience" sector (military, criminal, institutional, etc.) and lastly, the "private" sector or individual patient. The international markets for the Company's products include both the government and the private business sectors. More specifically, subject to government approvals, the Company's introduction of its saliva collector will be with an HIV diagnostic screening test. The HIV test kit is initially planned for distribution and use by governmental public health agencies and by the foreign military establishment. In certain foreign markets, the Company's HIV test kits are expected to be advertised for sale directly to the private physicians and to the consuming public. The Company already has products under evaluation in several countries, including Russia, Thailand, Paraguay, Mexico and Venezuela. Several countries have begun testing the ADI HIV saliva test with the goal of introducing the product to the military to replace the currently used blood test. Public Health institutions in several foreign countries have reviewed and tested the Company's HIV saliva collectors. Their goal is to use the test to screen the "at risk" populations present in the major cities and tourist areas. These include the legal prostitutes, the drug addicts, the homosexual population and the prison population. Results of this testing will be used to develop policy for the education programs which must be implemented along with testing to halt the rapid spread of this infection. Additionally, many of these countries will use the results of this testing and mass screening to plan for the future health needs of their country. The tremendous publicity of the HIV/AIDS epidemic has created a very large demand by individuals who would like to have a test. However, individuals are reluctant to submit to organized testing because of a fear of being "reported" and the social consequences even if negative. The testing of partners is a common concern in the socially active. The simple and confidential nature of saliva testing allows for the individual to perform the Company's test in the privacy of his own home at his convenience. As a screening test this will reduce the unnecessary burden on the clinical labs as only the positives must be retested. Doctors office visits will be reduced and a substantial savings in time will be realized. All of this will lead to lower overall health costs for the individual. -7-
10KSB8th Page of 35TOC1stPreviousNextBottomJust 8th
GOVERNMENT REGULATION The development, manufacture, testing and marketing of the Company's diagnostic products are subject to regulation by the FDA and other federal, state and foreign agencies. Under the FDC Act, the FDA regulates almost all aspects of development, marketing and sale, including the introduction, clinical trials, advertising, manufacturing, labeling, distribution of and record keeping for the products in the United States. Diagnostic products marketed for testing drugs of abuse are regulated as medical devices under the FDC Act for which FDA approval is required. The Company may attempt to obtain marketing clearance through 510(k) Premarket Notification for certain of its products used in connection with testing for drugs of abuse. Following submission of a 510(k) Premarket Notification, the manufacturer or distributor may not place the device into commercial distribution until an order is issued by the FDA. The FDA has no specific time limit by which it must respond to a 510(k) Premarket Notification. The FDA may declare that the device is "substantially equivalent" to another legally-marketed device, and allow the device to be marketed in the United States. The FDA may, however, determine that the proposed device is not substantially equivalent, or may require future information, such as additional test data, before the FDA is able to make a determination regarding substantial equivalence. There can be no assurance that the Company will receive approval for any of its products under 510(k) Premarket Notification. There can be no assurance that marketing clearance will be obtained for any of its products. Other than as described below, no FDA approval has yet been received for any of the Company's products and there can be no assurance that such approval will ultimately be obtained. In this regard, special attention should be given to the Company's primary product, the saliva collection device. Although the saliva collection device received FDA approval in April 1998 (See "The Company's Products" above), the test kit which incorporates the collection device has not been approved by the FDA for sale within the United States. It is however, the Company's proposal to export the test kit in compliance with the applicable laws and regulations administered by the FDA. Initially, because the test device has not been approved for use in the United States, the Company would have to comply with the FDC Act, if it wishes to export the device in its finished form. To export the completed saliva test kit from the United States, the Company does not only need to receive permission to export the product into the foreign country, it also had to submit to the FDA, basic data regarding the safety of the finished device in order for the agency to determine that export is not contrary to public health and safety. The FDA has approved the export of both the saliva collection device and the test kit for hepatitis B, provided that the appropriate regulatory agency of the country to which the product is exported has approved the importation and use of the product. During April 1997 the Company received a letter from the FDA that the FDA had completed the scientific review portion of the Company's 510(k) premarket notification regarding the airbrator, and the airbrator is approved for marketing in the United States for the use of abrading the surface of teeth. FOREIGN REGULATION Agencies similar to the FDA regulate medical devices in some foreign countries, whereas other countries allow unregulated marketing of such devices. The Company's products will be required to meet the regulations, if any, of the foreign countries in which they are marketed. -8-
10KSB9th Page of 35TOC1stPreviousNextBottomJust 9th
MANUFACTURING The Company believes that most components used in the manufacture of its current and proposed products are currently available from numerous suppliers located in the United States, Europe and Asia. However, certain components are available only from a limited number of suppliers. Although the Company believes that it will not encounter difficulties in obtaining these components, there can be no assurance that the Company will be able to enter into satisfactory agreements or arrangements for the purchase of commercial quantities of such components. The Company anticipates that it will not be required to maintain significant inventory levels of products until the Company's products are deemed acceptable for sale. The Company does not currently have any material backlog. Until the Company is able to market its products on a broad basis, it does not anticipate that its backlog or inventory level will be material. At that time, the Company intends to cause these products to be manufactured for it shortly before they are required for shipment. The Company does not foresee that an extensive period of time will be required from the time of its manufacturing order to the time of final delivery of its products. COMPETITION The market in which the Company participates, saliva-based collection and diagnostic testing, is highly competitive. The Company is aware of certain other entities, specialized biotechnology firms, as well as universities and other research institutions, which have patented, developed, or are developing technologies and products which are competitive with the Company's products and technologies. These entities, most of which are established, have substantially greater research, marketing and financial resources than the Company. The Company expects that the number of products competing with its products will increase as the potential benefits of saliva-based testing become more widely recognized. The Company is attempting to develop strategic alliances with companies to jointly develop diagnostic tests which use saliva and/or blood as the testing specimen. PATENTS AND PROPRIETARY INFORMATION The Company presently has pending, two (2) patent applications in the United States, on certain aspects of its saliva collection testing device. Inasmuch as the Company intends to sell its products in foreign markets it intends to seek foreign patent protection on such products and technologies, although it has not yet obtained such protection. The patent laws of other countries may differ from those of the United States as to the patentability of the Company's products and technologies and the degree of protection afforded. The Company also has one pending patent application in the United States relating to the dental air abrasion device (airbrator), and three other applications for other technologies which the Company is developing. Much of the technology developed or owned by the Company is subject to trade secret protection. To reduce the risk of loss of trade secret protection through disclosure, the Company generally enters into confidentiality agreements with its employees. There can be no assurance that the Company will be successful in maintaining such trade secret protection or that others will not capitalize on certain of the Company is technology. -9-
10KSB10th Page of 35TOC1stPreviousNextBottomJust 10th
EMPLOYEES The Company currently has five employees. The Company is not subject to any collective bargaining agreement and believes that its relationships with its employees are good. ITEM 2. DESCRIPTION OF PROPERTY. The Company maintains its corporate offices at 430 Ansin Boulevard, Suite G, Hallandale, Florida 33009. Until February 1998, the Company rented approximately 3,700 square feet at this location and paid approximately $1,675 per month for rent pursuant to a lease which was scheduled to expire August 31, 1998. The Company also rented approximately 1,900 square feet of lab space in the same building pursuant to a lease which required monthly payments of approximately $900 and which was scheduled to expire September 30, 1998. On February 11, 1998, the Company entered into a new lease with the same landlord for office and warehouse space at a new nearby location. The five year lease commenced April 1, 1998, and requires monthly rental payments of $4,000 plus tax. The Company has the option to renew the lease for five additional years. This new lease replaces and cancels the two lease agreements described above. The Company expects to move to its new offices during May or June 1998. ITEM 3. LEGAL PROCEEDINGS. Other than the law suit described below, there are no pending legal proceedings in which the Company is a party, and the Company is not aware of any threatened legal proceedings involving the Company. On or about August 11, 1995, Americare Transtech, Inc. ("Americare"), Americare Biologicals, Inc. and International Medical Associates, Inc., through their principal, Joseph D'Angelo ("D'Angelo"), instituted suit against six parties in the Broward County circuit court under case no. 95-011256 (21). The complaint was dismissed and subsequently amended on or about May 17, 1996, and included Simplex-Florida as a defendant in one count of the amended complaint. The complaint alleges that ADI misappropriated Americare's proprietary and trade secret technology relating to the saliva sample collection system and non-invasive glucose detection technology. No specified amount of damages was alleged other than to claim that the amount exceeded $15,000. Nine affirmative defenses have been filed in response to the allegations. Simplex intends on aggressively defending the case and believes that the action lacks merit and has been filed as a retaliatory measure by D'Angelo as a result of an earlier action filed against D'Angelo and Americare by one of Simplex's principals. The suit is currently in the discovery stage and it is expected to go to trial late in 1998. ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS. No matters were submitted to a vote of security holders during the fourth quarter of the fiscal year ended December 31, 1997. -10-
10KSB11th Page of 35TOC1stPreviousNextBottomJust 11th
PART II ITEM 5. MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS. (a) MARKET INFORMATION. The Company's Common Stock trades in the over-the-counter market, under the symbol "SMLX". Other than a few sporadic trades during November 1996, the trading commenced during February 1997. The following table sets forth the high and low bid prices for the Company's Common Stock for the periods indicated as reported by the OTC Bulletin Board. These prices are believed to be inter-dealer quotations and do not include retail mark-ups, mark-downs, or other fees or commissions, and may not necessarily represent actual transactions. QUARTER ENDED HIGH BID LOW BID -------------- -------- ------- March 31, 1997 $3.3125 $.03125 June 30, 1997 $3.0625 $1.75 September 30, 1997 $2.875 $1.4375 December 31, 1997 $2.3125 $1.1875 March 31, 1998 $1.78125 $ .75 (b) HOLDERS. As of March 31, 1998, the Company had approximately 85 shareholders of record. This does not include shareholders who hold stock in their accounts at broker/dealers. (c) DIVIDENDS. The Company has never paid a cash dividend on its common stock and does not expect to pay a cash dividend in the foreseeable future. (d) RECENT SALES OF UNREGISTERED SECURITIES. None. ITEM 6. MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATION. RESULTS OF OPERATIONS The Company s revenues during the year ended December 31, 1997 were $71,461 as compared to $25,840 during the year ended December 31, 1996. The increased revenues were due to increased sales of the Company's saliva test kits to distributors in foreign countries for the purpose of testing the products and obtaining approvals to sell the products in these countries. Costs of goods sold increased from $25,269 in the year ended December 31, 1996 to $48,121 in the year ended December 31, 1997 due to the increased sales. Cost of goods sold as a percentage of sales dropped from 98% in 1996 to 67% in 1997. The margin on the Company s saliva test kits will increase significantly once the Company starts manufacturing the kits in commercial quantities. Selling, general and administrative expenses increased from $403,049 in the year ended December 31, 1996 to $485,086 in the year ended December 31, 1997 due to the increased level of activity in the Company s business, and the fact that the Company completed a reverse acquisition with a public company during March 1997 which caused the Company s legal and accounting expenses to increase. During the year ended December 31, 1997 the Company received other income of $167,360 from the forfeiture of customer deposits for marketing rights to the Company s HIV test kits, and the Company received $30,000 from Sybron Dental Specialities, Inc. pursuant to the distribution agreement relating to the Airbrator. -11-
10KSB12th Page of 35TOC1stPreviousNextBottomJust 12th
Interest expense increased from $6,469 in the year ended December 31, 1996 to $19,505 in the year ended December 31, 1997 due to the increased amount of debt outstanding during 1997. The net loss for the year ended December 31, 1997 declined to $309,944 from $434,640 for the year ended December 31, 1996 due primarily to the other income received during 1997 related to the forfeiture of customer deposits and the license fees. The Company has reviewed the effect that the year 2000 will have on its essential computer systems, especially those related to its ongoing operations and its internal control systems, including the preparation of financial information. The Company has plans underway to ensure that there will be no significant adverse effect on its operations or accounting records related to the year 2000. CAPITAL RESOURCES AND LIQUIDITY The Company's working capital was a negative $19,021 at December 31, 1997 as compared to a positive $32,577 at December 31, 1996. The decrease in working capital was primarily due to the net loss for 1997 of $309,944. During the year ended December 31, 1997, cash used in operating activities was $303,861 as compared to $532,289 of cash used in operating activities for the year ended December 31, 1996. The principal contributing factor was the 1997 loss of $309,944. During the year ended December 31, 1997 net cash used in investing activities was $50,581 as compared to $101,084 in the prior year. During the year ended December 31, 1997 the net cash provided by financing activities was $342,336 as compared to $607,781 in the prior year. In 1997 the Company received $294,990 in loans from a shareholder and an additional $50,000 loan from an investor. The Company has prepared the financial statements on a going concern basis with the assumption that the Company will secure additional financing from the sale of the Company's common stock for up to $1,000,000 in proceeds. The Company also expects to generate revenues from the sale of its test kits in countries where the products have been approved for sale. During March 1998 the Company signed a letter of intent with Automated Health Technologies, Inc. ("AHT") and an investment partnership pursuant to which the Company will acquire a 19% interest in AHT. The Company will also grant a put option for the remaining 81% of AHT whereby the Company would be required to issue its common stock for the remaining 81%. Pursuant to this letter of intent Mr. Colin Jones, the CEO of AHT has become the President and Chairman of the Company. The letter of intent also provides that the investment partnership will raise $1 million for a number of shares which approximates 20% of the Company on a fully diluted basis. The definitive agreement has not been executed as of the filing of this Report, however, the partnership has loaned the Company $200,000 during March and April 1998. The Company has no material commitments for capital expenditures at the time of the filing of this Report. ITEM 7. FINANCIAL STATEMENTS. The financial statements are set forth on pages F-1 through F-6 hereto. -12-
10KSB13th Page of 35TOC1stPreviousNextBottomJust 13th
ITEM 8. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE. No response required. -13-
10KSB14th Page of 35TOC1stPreviousNextBottomJust 14th
PART III ITEM 9. DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS; COMPLIANCE WITH SECTION 16(a) OF THE EXCHANGE ACT. The directors and executive officers of the Company and its wholly-owned subsidiary, their ages and positions held in the Company are as follows: NAME AGE POSITIONS HELD AND TENURE ----------------------------- --- ---------------------------------- Colin N. Jones 77 President and Chairman of the Board Nicholas G. Levandoski, Ph.D. 61 Vice President - Research and Development, Secretary, Treasurer and Director of the Company; and Director of Research and Development for Simplex-Florida Henry B. Schur 53 Vice President - Business Development and Director of the Company; Vice President and a Director of Simplex-Florida Joel Marcus 58 Director There are no family relationships between any officers and directors of the Company. The Company presently has no audit, compensation or nominating committees. BUSINESS EXPERIENCE The following is a brief account of the education and business experience during at least the past five years of the Company's directors, executive officers, and key employees, indicating the principal occupation and employment during that period, and the name and principal business of the organization in which such occupation and employment were carried out. COLIN N. JONES has served as the President and Chairman of the Board of the Company since April 10, 1998. Mr. Jones has served as CEO and Chairman of Automated Health Technologies since November 1996 and was a consultant to that firm from February 1996 to November 1996. From July 1994 until January 1996, he served as Chairman, International of INTEC, an international consulting firm specializing in reengineering. From February 1983 until March 1988, he served as Chairman of Proximity Technologies and continued as Vice President, International until July 1994 for Franklin Electronics, which had purchased Proximity Technologies. From June 1974 until February 1983, he owned and operated his own merger and acquisition firm. From January 1970 until June 1974, he was President and CEO of Sensormatic Electronics and remained a consultant until June 1974. From September 1950 until January 1970, he was employed by IBM in various positions with his final position being Manager of Sales Programs for the Office Products Division. Mr. Jones received a BSME Degree from the University of Texas in 1949. DR. NICHOLAS LEVANDOSKI has served as the Vice President of Research and Development, Secretary, Treasurer and a director of the Company since March 5, 1997. He also served as acting President from March 5, 1997 until April 10, 1998. He has served as Director of Research and Development for Simplex-Florida since June 1995. Dr. Levandoski has extensive research and clinical experience, -14-
10KSB15th Page of 35TOC1stPreviousNextBottomJust 15th
including military, industry and hospital environments. Dr. Levandoski received a B.S. degree in Chemistry/Biology from the University of Notre Dame in 1958. After a brief period in private industry (Abbott Laboratories, N. Chicago, Illinois), Dr. Levandoski enlisted and served in the Medical Service Corps. of the U.S. Army from 1959 to 1962. While on active duty in Medical Service Corps., Dr. Levandoski enrolled and attended the graduate school of the University of Denver where he continued his studies in organic chemistry. Upon release from active duty in 1962, Dr. Levandoski was hired as the Director of Laboratory of Metabolic Division of the U.S. Army Research and Nutrition Laboratory, Denver, Colorado, from 1962 to 1964, and he completed his graduate studies in 1964. He thereafter held responsible positions in industry, including Cordis Corps., Miami, Florida, from 1965 to 1971, in the Diagnostic Products Division; Benasil Corporation, Miami, Florida from 1977 to 1979; and Director of Corporate Compliance (FDA) for North American Biologicals, Miami, Florida. In 1979, Dr. Levandoski returned to active duty in the U.S. Army as Executive Officer and Hospital Administrator for a 1,000-bed general hospital in Miami, Florida. In 1982, Dr. Levandoski was selected to attend the National War College, Ft. McNair, Washington, D.C.; and was thereafter assigned to the Pentagon in Washington, D.C., Division of Reserve Affairs, where he remained until his retirement as a full Colonel in 1984. MR. HENRY SCHUR has served as the Company's Vice President of Marketing and a Director since March 5, 1997. He has served as President of Analyte Diagnostics, Inc., a wholly owned subsidiary of Simplex-Florida since June 1995. He is the Company's principal scientist and one of the principal inventors of the Company's products. Mr. Schur has an undergraduate degree in Health Sciences from Florida International University and post graduate studies in Business Management at the University of Oklahoma. In the course of Mr. Schur's professional career, he has occupied responsible positions with companies engaged in the manufacture of diagnostics products and biochemicals, including specifically, Arcade, Inc., Chattanooga, Tennessee (1986 to 1987), and Cordis Corporation, Miami, Florida (1966 to 1968). Mr. Schur, in 1991, was formerly employed by Americare, with whom Mr. Schur is now in litigation. Mr. Schur is a principal inventor of a number of the Company's products and has a number of issued U.S. and foreign patents to his credit. JOEL MARCUS has served as a Director of the Company since December 1997. He has been self-employed as a certified public accountant in Florida since 1974 when he became a licensed CPA. Mr. Marcus received a Bachelor of Science Degree in Business Administration from Hofstra University in New York in 1960 and completed graduate studies at CW Post Tax Institute in 1963. COMPLIANCE WITH SECTION 16(A) OF THE EXCHANGE ACT Based solely on a review of Forms 3 and 4 and amendments thereto furnished to the Company during its most recent fiscal year, and Forms 5 and amendments thereto furnished to the Company with respect to its most recent fiscal year and certain written representations, no persons who were either a Director, Officer or beneficial owner of more than 10% of the Company's Common Stock, failed to file on a timely basis reports required by Section 16(a) of the Exchange Act during the most recent fiscal year except as follows: International Technologies Ltd., a principal shareholder, failed to file a Form 3 and one Form 4 reporting its initial ownership position and one transfer during 1997. The shareholder has also not filed a Form 5 for 1997. -15-
10KSB16th Page of 35TOC1stPreviousNextBottomJust 16th
ITEM 10. EXECUTIVE COMPENSATION. The following table sets forth information regarding the executive compensation for the Company's President and each other executive officer whose total annual salary and bonus exceeded $100,000 for the year ended December 31, 1996 and December 31, 1997: [Download Table] SUMMARY COMPENSATION TABLE LONG-TERM COMPENSATION ----------------------------------- ANNUAL COMPENSATION AWARDS PAYOUTS ----------------------- -------------------------- ------- SECURI- TIES UNDERLY- OTHER RE- ING ALL ANNUAL STRICTED OPTIONS/ OTHER NAME AND PRINCIPAL COMPEN- STOCK SARs LTIP COMPEN- POSITION YEAR SALARY BONUS SATION AWARD(S) (NUMBER) PAYOUTS SATION ------------------ ---- ------- ----- ------ -------- -------- ------- ------ Nicholas G. 1997 $43,500 -- $19,400 -- 250,000 -- -- Levandoski, Ph.D., 1996 $ -- -- $21,956 -- -- -- -- President AGGREGATED OPTION EXERCISES IN YEAR ENDED DECEMBER 31, 1997 AND DECEMBER 31, 1997 OPTION VALUES SECURITIES UNDER- VALUE OF UNEXER- SHARES LYING UNEXERCISED CISED IN-THE ACQUIRED OPTIONS MONEY OPTIONS/ ON AT 12/31/97 AT 12/31/97 EXERCISE VALUE EXERCISABLE/ EXERCISABLE/ NAME (NUMBER) REALIZED UNEXERCISABLE UNEXERCISABLE ---- -------- -------- ---------------- ---------------- Nicholas Levandoski -0- $ -0- 250,000/250,000 0/0 OPTIONS GRANTS IN LAST FISCAL YEAR Individual Grants NUMBER OF % OF TOTAL SECURITIES OPTIONS UNDERLYING GRANTED TO EXERCISE OR OPTIONS EMPLOYEES IN BASE PRICE EXPIRATION NAME GRANTED(#) FISCAL YEAR ($/SH) DATE ---- ------------ ------------ ----------- ---------- Nicholas Levandoski 250,000 54.3% $1.58 8/27/02 STOCK OPTION PLAN During March 1997, the Board of Directors adopted a Stock Option Plan (the "Plan"), and on March 28, 1997, the Corporation's shareholders approved the Plan. The Plan authorizes the issuance of options to purchase up to 2,000,000 shares of the Company's Common Stock. -16-
10KSB17th Page of 35TOC1stPreviousNextBottomJust 17th
The Plan allows the Board to grant stock options from time to time to employees, officers, directors and consultants of the Company. The Board has the power to determine at the time that the option is granted whether the option will be an Incentive Stock Option (an option which qualifies under Section 422 of the Internal Revenue Code of 1986) or an option which is not an Incentive Stock Option. Vesting provisions are determined by the Board at the time options are granted. The option price for any option will be no less than the fair market value of the Common Stock on the date the option is granted. Since all options granted under the Plan must have an exercise price no less than the fair market value on the date of grant, the Company will not record any expense upon the grant of options, regardless of whether or not they are incentive stock options. Generally, there will be no federal income tax consequences to the Company in connection with Incentive Stock Options granted under the Plan. With regard to options that are not Incentive Stock Options, the Company will ordinarily be entitled to deductions for income tax purposes of the amount that option holders report as ordinary income upon the exercise of such options, in the year such income is reported. During 1997 the Company granted options to seven persons to purchase a total of 490,000 shares of common stock at a price of $1.58 per share. ITEM 11. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT. The following table sets forth, as of March 31, 1998, the stock ownership of each person known by the Company to be the beneficial owner of five percent or more of the Company's Common Stock, each officer and director individually, and all officers and directors as a group. Each person has sole voting and investment power over the shares except as noted. [Download Table] AMOUNT AND NAME AND ADDRESS NATURE OF BENE- PERCENT OF BENEFICIAL OWNERS FICIAL OWNERSHIP OF CLASS ------------------------- ---------------- -------- Henry B. Schur 1,042,500<FN1> 13.9% 430 Ansin Boulevard, Suite G Hallandale, Florida 33009 Debra L. Ross 1,042,500<FN2> 13.9% 430 Ansin Boulevard, Suite G Hallandale, Florida 33009 John E. Trafton 878,000 11.7% 285 Sunrise Drive, Apt. 16 Key Biscayne, Florida 33149 Colin N. Jones -- -- 1025 N.W. 17th Avenue Delray Beach, Florida 33445 Nicholas G. Levandoski 0<FN3> -0- 430 Ansin Boulevard, Suite G Hallandale, Florida 33009 Joel Marcus 90,000<FN4> 1.2% 676 West Prospect Road Fort Lauderdale, Florida 33309 -17-
10KSB18th Page of 35TOC1stPreviousNextBottomJust 18th
International Technologies Ltd. 1,300,000 17.3% c/o William Smith P.O. Box F-40729 Freeport, Bahamas All Directors and Officers 1,312,500<FN1> 17.5% as a Group (4 Persons) _______________________ <FN> <FN1> Includes 862,500 shares held of record by Mr. Schur's wife, Debra Ross, 80,000 shares held by Mr. Schur's daughter, and 100,000 shares held in trust for Mr. Schur's daughter. Does not include options to purchase 100,000 shares since the Company's stock option plan is awaiting shareholder approval. <FN2> Includes 862,500 shares held directly by Ms. Ross, 80,000 shares held by Ms. Ross' daughter, and 100,000 shares held in trust for Ms. Ross' daughter. <FN3> Does not include options to purchase 250,000 shares since the Company's stock option plan is awaiting shareholder approval. <FN4> Does not include options to purchase 100,000 shares since the Company's stock option plan is awaiting shareholder approval. </FN>
The Company knows of no arrangement or understanding, the operation of which may at a subsequent date result in a change of control of the Company. ITEM 12. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS. ACQUISITION OF SIMPLEX-FLORIDA On March 5, 1997, the Company completed the acquisition of 100% of the outstanding common stock of Simplex Medical Systems, Inc. ("Simplex-Florida") in exchange for 3,453,000 shares of the Company's Common Stock (approximately 46.04% of the shares now outstanding). The shares were exchanged on the basis of one share of the Company's common stock for one share of Simplex-Florida common stock. In connection with the closing of this transaction, several current shareholders submitted for cancellation a total of 31,953,000 shares of common stock. As a result, after the acquisition of Simplex-Florida, there are a total of 7,500,000 shares outstanding. The stock issuances were made pursuant to an Agreement ("Agreement") between the Company and Simplex-Florida. The terms of the Agreement were the result of negotiations between the managements of the Company and Simplex-Florida. However, the Board of Directors did not obtain any independent "fairness" opinion or other evaluation regarding the terms of the Agreement, due to the cost of obtaining such opinions or evaluations. TRANSACTIONS INVOLVING THE COMPANY On March 20, 1996, the Company issued to each of Mesdames Colleen E. Schmidt, a Director of the Company, and a Company Director, and Sandra S. Steinberg, a Director of the Company, 15,000,000 shares of the Company's common stock, $.0001 par value per share (a total of 30,000,000 shares of common stock), in consideration, in each case, for the sum of $5,000 in cash (a total of $10,000 in cash). These shares collateralized two non-interest bearing promissory notes in the principal amount of $2,500 each (an aggregate face amount of $5,000), due and payable on May 31, 1996, of which each of Mesdames Schmidt and Steinberg are the makers and the Company is the holder. -18-
10KSB19th Page of 35TOC1stPreviousNextBottomJust 19th
During the year ended December 31, 1997, the Company entered into several short term notes payable with Joel Marcus, a director of the Company, totaling $294,990, bearing interest at 10% per annum. Joel Marcus subsequently assigned these notes to International Technologies Ltd., a shareholder. As a of December 31, 1997, $284,990 of these notes payable had expired terms. On April 2, 1998, the Company entered into an agreement with International Technologies Ltd. to extend the terms of the notes for a three year period with interest at 10% per annum. These notes will be amortized over the three year period with payments on principal to be made only if the Company records pre-tax earnings in excess of the principal amount due. If an additional extension of time is necessary, this agreement grants an extension until such time as pre-tax profits are sufficient to amortize the loans over the three year period. PART IV ITEM 13. EXHIBITS AND REPORTS ON FORM 8-K. (a) 3. EXHIBITS. EXHIBIT NUMBER DESCRIPTION LOCATION 3.1 Articles of Incorporation, Incorporated by reference to as Amended Exhibits 2.1, 2.2 and 2.3 to the Registrant's Form 10-SB Registration Statement filed on April 4, 1996 3.2 Bylaws Incorporated by reference to Exhibit 2.4 to the Registrant's Form 10-SB Registration State- ment filed on April 4, 1996 10.1 Promissory Note dated Incorporated by reference to March 20, 1996 of Exhibit 10.1 to the Registrant's Sandra S. Steinberg Form 10-SB Registration State- ment filed on April 4, 1996 10.2 Promissory Note dated Incorporated by reference to March 20, 1996 of Exhibit 10.2 to the Registrant's Colleen E. Schmidt Form 10-SB Registration State- ment filed on April 4, 1996 (b) REPORTS ON FORM 8-K. No Reports on Form 8-K were filed during the fourth quarter of the Company's fiscal year ended December 31, 1997. INDEX TO FINANCIAL STATEMENTS Independent Auditor's Report F-1 Financial Statements: Balance Sheets F-2 Statements of Operations F-3 Statements of Stockholders' Equity (Deficit) F-4 Statements of Cash Flows F-5 Notes to Financial Statements F-6 -19-
10KSB20th Page of 35TOC1stPreviousNextBottomJust 20th
SCHMIDT, RAINES, TRIEST, DICKENSON & ADAMS, P.L. Certified Public Accountants and Consultants to Business REPORT OF INDEPENDENT CERTIFIED PUBLIC ACCOUNTANT Board of Directors Simplex Medical Systems, Inc. and Subsidiary Hallandale, Florida We have audited the accompanying consolidated balance sheets of Simplex Medical Systems, Inc. and Subsidiary (a development stage company) as of December 31, 1997, and the related statements of operations, changes in stockholders' equity (deficit) and cash flows for the year then ended. These consolidated financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these consolidated financial statements based on our audit. The consolidated financial statements of Simplex Medical Systems, Inc. and Subsidiary as of December 31, 1996 were audited by other auditors whose report dated May 16, 1997 included an explanatory paragraph describing conditions that raised substantial doubt about the Company's ability to continue as a going concern. We conducted our audit in accordance with generally accepted auditing standards. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audit provides a reasonable basis for our opinion. In our opinion, the December 31, 1997 consolidated financial statements referred to above present fairly, in all material respects, the financial position of Simplex Medical Systems, Inc. and Subsidiary as of December 31, 1997 and the results of their operations and their cash flows for the year then ended in conformity with generally accepted accounting principles. The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As shown in the consolidated financial statements, the Company incurred a net loss of $309,944 during the year ended December 31, 1997, and, as of that date, had a negative net worth of $146,949. Those conditions raise substantial doubt about the Company's ability to continue as a going concern. Management's plans regarding these matters are described in Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. /s/ Schnmidt & Co. SCHMIDT, RAINES, TRIESTE, DICKENSON & ADAMS, P. L. Boca Raton, Florida March 26, 1998 F-1
10KSB21st Page of 35TOC1stPreviousNextBottomJust 21st
SIMPLEX MEDICAL SYSTEMS, INC. AND SUBSIDIARY (A Development Stage Company) CONSOLIDATED BALANCE SHEETS DECEMBER 31, 1997 AND 1996 1997 1996 ASSETS Current assets: Cash $ 41,743 $ 53,849 Accounts receivable, net of allowance for uncollectible accounts of $2,321 for 1997 and 1996 3,882 3,416 Inventory 141,565 140,827 --------- --------- Total current assets 187,190 198,092 --------- --------- Equipment, less accumulated depreciation 1997 $51,897; 1996 $25,804 87,451 111,316 --------- --------- Other assets: Patents and trademarks, less accumulated amortization 1997 and 1996 $504 66,861 18,508 Deposits 6,692 5,580 --------- --------- 73,553 24,088 --------- --------- $ 348,194 $ 333,496 ========= ========= LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) Current liabilities: Accounts payable and accrued expenses $ 75,074 $ 24,062 Current portion of notes payable 61,044 2,654 Customer and other deposits 70,093 138,799 --------- --------- Total current liabilities 206,211 165,515 --------- --------- Notes payable, net of current portion 288,932 4,986 --------- --------- Commitments and contingencies Stockholders' equity (deficit): Common stock, $.0001 par value, 100,000,000 shares authorized, 7,500,000 and 3,453,000 shares issued and outstanding at December 31, 1997 and 1996, respectively 750 345 Preferred stock, $.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding -0- -0- Additional paid-in capital 658,197 658,602 Deficit accumulated during the development stage (805,896) (495,952) --------- --------- (146,949) 162,995 --------- --------- $ 348,194 $ 333,496 ========= ========= The accompanying notes are an integral part of these consolidated financial statements. F-2
10KSB22nd Page of 35TOC1stPreviousNextBottomJust 22nd
SIMPLEX MEDICAL SYSTEMS, INC. AND SUBSIDIARY (A Development Stage Company) CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE PERIOD JUNE 6, 1995 (DATE OF INCEPTION) THROUGH DECEMBER 31, 1997 AND FOR THE YEARS ENDED DECEMBER 31, 1997 AND 1996 June 6, 1995 (date of inception) through December 31, 1997 1997 1996 ----------------- --------- --------- Revenues, net $ 119,431 $ 71,461 $ 25,840 Cost of goods sold 83,298 48,121 25,269 ---------- --------- --------- Gross profit 36,133 23,340 571 Operating expenses: Selling, general and administrative expenses 961,084 485,086 403,049 Depreciation and amortization expense 52,401 26,093 26,229 ---------- --------- --------- Total operating expenses 1,013,485 511,179 429,278 ---------- --------- --------- Net loss from operations (977,352) (487,839) (428,707) Other income (expense): Forfeiture of customer deposits 167,360 167,360 -0- License fees 30,000 30,000 -0- Other income 576 40 536 Interest expense (26,480) (19,505) (6,469) ---------- --------- --------- Total other income (expense) 171,456 177,895 (5,933) ---------- --------- --------- Net loss before income taxes (805,896) (309,944) (434,640) Income taxes -0- -0- -0- ---------- --------- --------- Net loss $ (805,896) $(309,944) $(434,640) =========== ========= ========= Loss per common share $ (0.05) $ (0.15) ========= ========= Weighted average number of shares 6,790,389 2,866,651 ========= ========= The accompanying notes are an integral part of these consolidated financial statements. F-3
10KSB23rd Page of 35TOC1stPreviousNextBottomJust 23rd
SIMPLEX MEDICAL SYSTEMS, INC. AND SUBSIDIARY (A Development Stage Company) CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT) FOR THE PERIOD JUNE 6, 1995 (DATE OF INCEPTION) THROUGH DECEMBER 31, 1997 AND FOR THE YEARS ENDED DECEMBER 31, 1997 AND 1996 Total Stock- holders' Common stock Paid-in Accumulated Equity Issued Amount Capital Deficit (Deficit) Analyte Diagnostics, Inc. ----------- ------ ------- ----------- -------- Common stock issued on July 29,1995 24,750,000 $2,475 $ -0- $ -0- $ 2,475 1 for 200 reverse stock split October 31, 1995 (24,626,250)(2,462) -0- -0- (2,462) Merger on October 31, 1995 of Analyte Diagnostics, Inc. into Simplex Medical Systems, Inc. (123,750) (13) -0- -0- (13) Simplex Medical Systems, Inc. and Subsidiary Issuance of one share Simplex Medical Systems, Inc. $.0001 common stock for each two shares of Analyte Diagnostics, Inc. common stock on October 31, 1995 61,875 6 -0- -0- 6 Shares issued for cash at par on October 31, 1995 1,053,625 105 -0- -0- 105 Cancellation of stock on October 31, 1995 (239,375) (24) -0- -0- (24) Net loss -0- -0- -0- (61,312) (61,312) ----------- ----- ------- --------- --------- Balance, December 31, 1995 876,125 87 -0- (61,312) (61,225) Shares issued for cash at par in February 1996 16,475 2 -0- -0- 2 Shares issued for equipment in February 1996 214,375 21 53,198 -0- 53,219 Issuance of shares for private placement on June 7, 1996 619,525 62 605,577 -0- 605,639 Shares issued for 2 for 1 stock split on September 25, 1996 1,726,500 173 (173) -0- -0- Net loss -0- -0- -0- (434,640) (434,640) ----------- ----- -------- --------- --------- Balance, December 31, 1996 3,453,000 345 658,602 (495,952) 162,995 Issue of shares in merger with Music Tones on March 5, 1997 4,047,000 405 (405) -0- -0- Net loss -0- -0- -0- (309,944) (309,944) ----------- ------ -------- --------- --------- Balance, December 31, 1997 7,500,000 $ 750 $658,197 $(805,896) $(146,949) =========== ====== ======== ========= ========= The accompanying notes are an integral part of these consolidated financial statements. F-4
10KSB24th Page of 35TOC1stPreviousNextBottomJust 24th
SIMPLEX MEDICAL SYSTEMS, INC. AND SUBSIDIARY (A Development Stage Company) CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE PERIOD JUNE 6, 1995 (DATE OF INCEPTION) THROUGH DECEMBER 31, 1997 AND FOR THE YEARS ENDED DECEMBER 31, 1997 AND 1996 June 6, 1995 (date of inception) through December 31, 1997 1997 1996 OPERATING ACTIVITIES ------------------ --------- --------- Net loss $ (805,896) $(309,944) $(434,640) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 52,401 26,093 26,229 (Increase) decrease in: Accounts receivable (3,882) (466) (2,608) Inventory (141,565) (738) (131,741) Deposits (6,692) (1,112) (2,188) Increase (decrease) in: Accounts payable and accrued expenses 75,074 51,012 (15,706) Customer and other deposits 70,093 (68,706) 28,365 ---------- --------- --------- Net cash used in operating activities (760,467) (303,861) (532,289) ---------- --------- --------- INVESTING ACTIVITIES Proceeds from the sale of equipment 290 290 -0- Acquisition of fixed assets and patents (207,003) (50,871)(101,084) ---------- --------- --------- Net cash provided by (used in) Investing activities (206,713) (50,581)(101,084) ---------- --------- --------- FINANCING ACTIVITIES Proceeds from private placement 658,947 -0- 605,641 Payments on notes payble (8,154) (2,654) (5,500) Proceeds from notes payable 358,130 344,990 7,640 ---------- --------- -------- Net cash provided by financing activities 1,008,923 342,336 607,781 ---------- --------- ------- Net increase (decrease) in cash 41,743 (12,106) (25,592) Cash - beginning of period -0- 53,849 79,441 ---------- --------- ------- Cash - end of period $ 41,743 $ 41,743 $53,849 ========== ========= ======= The accompanying notes are an integral part of these consolidated financial statements. F-5
10KSB25th Page of 35TOC1stPreviousNextBottomJust 25th
SIMPLEX MEDICAL SYSTEMS, INC. AND SUBSIDIARY (A Development Stage Company) NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 1997 AND 1996 NOTE 1 - NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES NATURE OF OPERATIONS Simplex Medical Systems, Inc. has been in the development stage since its inception on June 6, 1995. Since inception, the Company has been engaged in the development, acquisition, marketing and manufacture of medical diagnostic products, biological products for blood banking, bulk pharmaceuticals, and specialty chemicals, as well as seeking regulatory clearance, patent protection, and raising capital to fund operations. The Company has patented and proprietary technology in the fields of: point of use medical and veterinary diagnostics; dental therapeutic devices; pharmaceutical products; and consumer products. The Company utilizes its own manufacturing facilities for the production of proprietary or quality sensitive materials and contracts out the other products and final packaging to third parties. The Company currently has products approved in several foreign countries and is actively marketing its products in those areas. Within the United States, the Company has received FDA registration on one of its major products and anticipates approval on its second major product during 1998. The financial statements include the accounts of the Company s subsidiary, Analyte Diagnostics, Inc., from the date of its inception, June 6, 1995. Analyte Diagnostics, Inc. was a predecessor corporation to Simplex Medical Systems, Inc. which was formed on September 15, 1995. The two companies were merged into Simplex Medical Systems, Inc., on October 31, 1995, with all account balances recorded at cost. At the time, the Company had a 1 to 200 reverse stock split. Subsequently, the Company had a 2 for 1 stock split. All share references give effect to the post split plans. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES PRINCIPLES OF CONSOLIDATION The consolidated financial statements include the accounts of Simplex Medical Systems, Inc., and its wholly owned subsidiary, Analyte Diagnostics, Inc. All intercompany accounts and transactions have been eliminated in consolidation. INVENTORY Inventory consists of finished goods as of December 31, 1997 and 1996 and is stated at the lower of cost (first-in, first-out method) or market. EQUIPMENT Equipment is stated at cost and is depreciated using the straight-line method over the estimated useful lives of the respective assets. Expenditures for maintenance and repairs are charged against operations as incurred. ESTIMATES The preparation of financial statements in conformity with generally accepted accounting principles require management to make estimates and assumptions that affect certain reported amounts and disclosures. Accordingly, actual results could differ from those estimates. F-6
10KSB26th Page of 35TOC1stPreviousNextBottomJust 26th
SIMPLEX MEDICAL SYSTEMS, INC. AND SUBSIDIARY (A Development Stage Company) NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 1997 AND 1996 NOTE 1 - NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) PATENTS AND TRADEMARKS The cost of patents and trademarks acquired are being amortized on a straight-line basis over their estimated useful lives, ranging from 17 to 40 years, beginning when the trademarks and patents are approved. RESEARCH AND DEVELOPMENT COSTS Research and development costs are charged to operations when incurred and are included in operating expenses. The amounts charged to operations for the year ended December 31, 1997 totaled $103,324. REVENUE RECOGNITION Revenue from sales is recognized upon shipment of goods to the customer. License fee revenue is recognized upon receipt. Revenue is recognized from the forfeiture of customer deposits based upon the individual terms contained in the International Distribution agreements with each customer. These deposits are non-refundable and are considered forfeited when the customer fails to perform certain requirements as described in their contract. IMPAIRMENT OF LONG-LIVED ASSETS The Company adopted Statement of Financial Accounting Standards ("SFAS") No. 121, "Accounting for the Impairment of Long-Lived Assets and For Long-Lived Assets to be Disposed Of" ("SFAS 121") in 1996. SFAS 121 establishes accounting standards for recording the impairment of long-lived assets, certain identifiable intangibles, and goodwill related to those assets to be held and used and for long-lived assets and certain identifiable intangibles to be disposed of. The adoption of SFAS 121 did not have a material impact on the Company s financial position or results of its operations. STOCK BASED COMPENSATION The Company adopted SFAS No. 123, "Accounting for Stock-Based Compensation" in 1996. SFAS 123 allows either the adoption of a fair value method of accounting for stock-based compensation plans or continuation of accounting under Accounting Principles Board ("APB") Opinion No. 25 Accounting for Stock Issued to Employees, and related interpretations with supplemental disclosures. The Company has chosen to account for all stock based arrangements under which employees receive shares of the Company s stock under APB 25 and make the related disclosures under SFAS 123. Since the method of accounting prescribed under SFAS 123 is not to be applied to options granted prior to January 1, 1995, there is no resulting pro forma compensation cost to be disclosed. F-7
10KSB27th Page of 35TOC1stPreviousNextBottomJust 27th
SIMPLEX MEDICAL SYSTEMS, INC. AND SUBSIDIARY (A Development Stage Company) NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 1997 AND 1996 NOTE 1 - NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) EARNINGS PER SHARE The Company adopted SFAS No. 128, "Earnings Per Share", in 1997. SFAS 128 establishes accounting standards for the computation, presentation, and disclosure of earnings per share information for entities with publicly held common stock or potential common stock. CAPITAL STRUCTURE The Company adopted SFAS No. 129, "Disclosure of Information about Capital Structure", in 1997. SFAS 129 establishes disclosure requirements within the financial statements of the pertinent rights and privileges of the various securities outstanding. RECENTLY ISSUED ACCOUNTING STANDARDS COMPREHENSIVE INCOME The Financial Accounting Standards Board recently issued SFAS No. 130, "Comprehensive Income: Financial Statement Presentation". SFAS 130 establishes accounting standards for reporting and presenting comprehensive income and its components in a set of financial statements. For the purpose of this standard, comprehensive income is defined as the change in equity of a company arising from transactions and other events and circumstances from nonowner sources. It includes all changes in equity during a period except those resulting from investments by and distributions to owners. This standard is applicable to financial statements with fiscal years beginning after December 15, 1997. The adoption of SFAS 130 is not expected to have a material impact on the Company s financial position or results of its operations. SEGMENT REPORTING The Financial Accounting Standards Board recently issued SFAS No. 131, "Disclosures about Segments of an Enterprise and Related Information". This standard requires that public companies report certain information about operating segments, products and services, the geographic areas in which they operate, and their major customers. This standard is applicable to financial statements with fiscal years beginning after December 15, 1997. The adoption of SFAS 131 is not expected to have a material impact on the Company s financial position or results of its operations. NET LOSS PER SHARE Net loss per share is computed on the basis of the weighted average number of shares actually outstanding during the years ended December 31, 1997 and 1996. Options to purchase 490,000 shares of common stock and bonds convertible into 50,000 shares of common stock were not included in computing net loss per share because the effect of such inclusion would be to decrease the reported net loss per share. F-8
10KSB28th Page of 35TOC1stPreviousNextBottomJust 28th
SIMPLEX MEDICAL SYSTEMS, INC. AND SUBSIDIARY (A Development Stage Company) NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 1997 AND 1996 NOTE 1 - NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) INCOME TAXES The Company accounts for income taxes under the liability method in accordance with Statement of Financial Accounting Standards No. 109 "Accounting for Income Taxes". Deferred income taxes are determined based upon the difference between the financial statement carrying amount and the tax basis of assets and liabilities using tax rates expected to be in effect in the years in which the differences are expected to reverse. NOTE 2 - BASIS OF PRESENTATION AND CONTINUED EXISTENCE The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. Since inception, the Company has experienced losses aggregating $805,896 and has been dependent upon loans from stockholders and other third parties in order to satisfy operations to date. As described in Note 15, "Subsequent Events", the Company has signed a letter of intent with Robertson & Partners, LLC ("Robertson") and Automated Health Technologies, Inc. ("AHT") in which the Company will purchase 19% of AHT common stock and issue a five year put option on the purchase of the remaining 81% of AHT s common stock. Furthermore, the chairman of AHT will become the Chairman and Chief Executive Officer of the Company. In addition, the letter of intent calls for the sale of 20% of the Company s stock to investors being sought by Robertson for $1,000,000. Management believes that the funds raised through the sale of stock and income generated from the sale of several recently developed products will provide the Company with sufficient cash flow resources to fund the operations of the Company. Furthermore, management believes that the expertise gained through the employment of AHT s chairman will provide the Company with the non-financial resources necessary to efficiently and effectively operate the Company. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the possible inability of the Company to continue as a going concern. NOTE 3 - BUSINESS ACQUISITION AND MERGER On March 5, 1997, the shareholders of the Company received 3,453,000 shares of the outstanding common stock of Music Tones, Ltd. ("MTL"), a publicly traded inactive company, in exchange for the same number of the Company s common stock in a reverse acquisition whereby the Company was deemed to be the acquirer. As of the date of the transaction, MTL had 36,000,000 shares of common stock issued and outstanding. Pursuant to the terms of the merger, MTL canceled 31,953,000 shares of its common stock which reduced its issued and outstanding shares to 4,047,000. After the closing, the Company s shareholders owned approximately 46.04% of the then issued and outstanding shares of MTL. This transaction has been accounted for as a pooling of interests. The combined and separate results of MTL and the Company as of the date of the merger have not been presented and the consolidated financial statements for the periods presented have not been F-9
10KSB29th Page of 35TOC1stPreviousNextBottomJust 29th
SIMPLEX MEDICAL SYSTEMS, INC. AND SUBSIDIARY (A Development Stage Company) NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 1997 AND 1996 NOTE 3 - BUSINESS ACQUISITION AND MERGER (CONTINUED) restated to include the accounts of MTL because management believes they are immaterial. NOTE 4 - EQUIPMENT Equipment consists of the following at December 31, 1997 and 1996 Useful Life (in Years) 1997 1996 ----------- -------- -------- Computer equipment 5 $ 11,215 $ 11,215 Office furniture and equipment 5-7 6,922 4,512 Shop equipment 5-7 80,291 80,579 Computer software 3 1,246 1,140 Molds 5 39,674 39,674 -------- -------- 139,348 137,120 Less: accumulated depreciation (51,897) (25,804) -------- -------- $ 87,451 $111,316 ======== ======== Depreciation expense totaled $26,093 and $25,704 for the years ended December 31, 1997, and 1996, respectively. NOTE 5 - NOTES PAYABLE During the year ended December 31, 1997, the Company entered into several short term notes payable with a shareholder totaling $294,990, bearing interest at 10% per annum. These notes were subsequently assigned to another shareholder. As of December 31, 1997, $284,990 of these notes payable had expired terms. On April 2, 1998, the Company entered into an agreement with the shareholder to extend the terms of the notes for a three year period with interest at 10% per annum. These notes shall be amortized over the three year period with payments on principal to be made only if the Company records pre-tax earnings in excess of the principal amount due. If an additional extension of time is necessary, this agreement grants an extension until such a time as pre-tax profits are sufficient to amortize the loans over the three year period. Accordingly, a portion of these notes payable has been classified as long-term debt as of December 31, 1997. F-10
10KSB30th Page of 35TOC1stPreviousNextBottomJust 30th
SIMPLEX MEDICAL SYSTEMS, INC. AND SUBSIDIARY (A Development Stage Company) NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 1997 AND 1996 NOTE 5 - NOTES PAYABLE (CONTINUED) Notes payable as of December 31, 1997 and 1996 consisted of the following: 1997 1996 Note payable, vendor, due in monthly payments -------- -------- of $318, including interest which is calcu- ated at 18% per annum, final payment due July, 1999; collateralized by equipment with a net book value of $7,714 as of December 31, 1997. $ 4,986 $ 7,640 Note payable, shareholder, interest payable at 10% per annum; payable as described above. 294,990 -0- Convertible note payable, individual, interest payable at 10% per annum on December 18, 1998 and upon maturity on June 18, 1999; convertible into common stock at $1.00 per share (See Note 13). 50,000 -0- -------- ------- 349,976 7,640 Less: current maturities 61,044 2,654 -------- ------- $288,932 $ 4,986 ======== ======= Aggregate annual maturities of the notes payable at December 31, 1997 are as follows: During the year ending December 31, 1998 $ 61,044 ---------------------------------- 1999 146,905 2000 104,733 2001 37,294 -------- $349,976 ======== Interest expense totaled $19,505 and $6,469 during the years ended December 31, 1997 and 1996, respectively. NOTE 6 - CUSTOMER AND OTHER DEPOSITS Included in customer and other deposits at December 31, 1997 is $16,100 received from an individual as a deposit on stock to be issued. NOTE 7 - LEASES The Company is currently renting office and warehouse space in Hallandale, Florida pursuant to two lease agreements which expire in August and September 1998. See Note 15, "Subsequent Events", for disclosure of new lease arrangement. Rent expense for the years ended December 31, 1997 and December 31, 1996 amounted to $27,791 and $27,418, respectively. F-11
10KSB31st Page of 35TOC1stPreviousNextBottomJust 31st
SIMPLEX MEDICAL SYSTEMS, INC. AND SUBSIDIARY (A Development Stage Company) NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 1997 AND 1996 NOTE 8 - RELATED PARTY TRANSACTIONS A director and shareholder loaned the Company a total of $294,990 at various times during the year ended December 31, 1997 that were subsequently assigned to another shareholder of the Company. These notes were outstanding as of December 31, 1997 and are discussed in Note 5. Interest expense incurred in connection with these loans totaled $17,057 during 1997. NOTE 9 - SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES During the years ended December 31, 1997 and 1996 cash paid by the Company for interest totaled $1,163 and $749, respectively. In addition, equipment increased by $8,800 during the year ended December 31, 1996 due to the recording of a related note payable. NOTE 10 - FAIR VALUE OF FINANCIAL INSTRUMENTS The following methods and assumptions were used to estimate the fair value of each class of financial instruments for which it is practicable to estimate that value: NOTES PAYABLE The carrying amount approximates fair value because the same terms and interest rates could be obtained for similar maturities. STOCK OPTIONS It is not practicable to estimate the fair value of the Company s stock options because they are subject to trading restrictions and lack quoted market prices. NOTE 11 - STOCK OPTIONS In August 1997, the Board of Directors granted certain employees, directors and consultants of the Company stock options pursuant to the Company s 1997 Stock Option Plan. A total of 2,000,000 shares of the Company s stock have been reserved for the options to be granted under this plan. Eligible participants include any employee, officer, director or consultant that the Board of Directors, in its sole discretion, designates is eligible to participate in this Plan. The option exercise price is stated on the option grant and shall not be less than 100% of the fair market value of the shares on the date of the grant or the par value, whichever is greater. Unless otherwise stated on the option, each option is exercisable for ten years. As of December 31, 1997, the options granted under this plan totaled 490,000 shares exercisable within ten years at a price of $1.58 per share. The following summarizes the status of the Company s stock options for the year ended December 31, 1997: F-12
10KSB32nd Page of 35TOC1stPreviousNextBottomJust 32nd
SIMPLEX MEDICAL SYSTEMS, INC. AND SUBSIDIARY (A Development Stage Company) NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 1997 AND 1996 NOTE 11 - STOCK OPTIONS (CONTINUED) Weighted-Average Shares Exercise Price ------- ---------------- Outstanding at January 1, 1997 - 0 - Granted and exercisable 490,000 $1.58 Exercised - 0 - Forfeited - 0 - Outstanding at December 31, 1997 490,000 $1.58 The Company applies APB Opinion No. 25, "Accounting for Stock Issued to Employees", and related interpretations in accounting for its stock options. Accordingly, no compensation cost has been recognized in the accompanying financial statements related to stock options. The weighted average fair value of options granted during the year ended December 31, 1997 was $0.97, which was computed using the Black-Scholes option pricing model with the following assumptions: expected life of 3 years; expected volatility of 75%; and a risk free interest rate of 6%. Had compensation cost for the Company's stock options been determined based on the fair value at the grant dates consistent with the method of FASB No. 123, "Accounting for Stock-Based Compensation", the Company's net loss and net loss per share for the year ended December 31, 1997 would have been $785,244 and $0.12, respectively. The Black-Scholes option valuation model was developed for use in estimating the fair value of traded options which have no vesting restrictions and are fully transferable. In addition, option valuation models require the use of highly subjective assumptions. Because the Company s stock options have characteristics that are significantly different from traded options and because changes in the valuation assumptions can materially affect the fair value estimate, in management's opinion, the existing models do not necessarily provide a reliable single measure of the fair value of its employee stock options. NOTE 12 - INCOME TAXES The Company has incurred tax operating losses and therefore has generated no income tax liabilities. As of December 31, 1997, the Company has generated net tax operating loss carryforwards totaling $805,896 which are available to offset future taxable income, if any. These loss carryforwards expire beginning in 2010. Due to limitations on the utilization of loss carryforwards resulting from ownership changes and separate return limitations and the uncertainty that the Company and its subsidiaries will be able to utilize the net operating losses, a 100% valuation allowance has been recorded against the deferred tax assets. The following summarizes the components of the net deferred tax asset at December 31, 1997 and 1996: 1997 1996 Deferred tax assets: -------- -------- Net operating loss carryforward $274,005 $147,778 Valuation allowance (274,005) (147,778) -------- -------- Net deferred tax asset $ - 0 - $ - 0 - ======== ======== F-13
10KSB33rd Page of 35TOC1stPreviousNextBottomJust 33rd
SIMPLEX MEDICAL SYSTEMS, INC. AND SUBSIDIARY (A Development Stage Company) NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 1997 AND 1996 NOTE 13 - STOCKHOLDERS' EQUITY (DEFICIT) PRIVATE PLACEMENT During 1996, the Company completed a private placement of 619,525 shares of common stock for $1 per share and received net proceeds of $605,639. SHARES USED FOR EQUIPMENT In February 1996, the Company issued 214,375 shares of its common stock to a director of the company in exchange for his 100% interest in a private company which was not active. This company manufactured specialty chemicals for the pharmaceutical and agricultural industries. The Company received primarily laboratory equipment as a result of this acquisition. The transaction has been recorded at the fair value of assets acquired. CONVERTIBLE NOTES PAYABLE On December 18, 1997 the Company issued an unsecured convertible note payable to an individual. This note bears interest at 10% per annum and matures on June 18, 1999. Upon issuance and at any time on or prior to the maturity date, any unpaid principal and accrued interest is convertible into fully paid and nonassessable shares of $0.0001 par value common stock at $1.00 per share. NOTE 14 - LEGAL PROCEEDINGS The Company has been named as one of six co-defendants in a lawsuit filed by the Company's principal scientist's previous employer, Americare Transtech, Inc. Americare Transtech, Inc. alleges damages for violation of Florida's Trade Secret Act with regard to the rights to the patent of the Company's saliva sample collection system. The Company has aggressively defended its position in the case and believes that the litigation lacks merit. NOTE 15 - SUBSEQUENT EVENTS LETTER OF INTENT On February 20, 1998, the Company signed a letter of intent with Robertson & Partners, LLC ("Robertson") and Automated Health Technologies, Inc. ("AHT"). According to this letter of intent, the Company has agreed to buy 19% of AHT common stock for 500,000 shares of the Company's common stock and give AHT shareholders a 5 year put option on an additional 1,000,000 shares of the Company's common stock for the remaining 81% of AHT's common stock. In addition, the Company has agreed to issue 20% of its stock to investors being sought by Robertson in exchange for $1,000,000 to be raised during 1998. The Company received $200,000 of this additional capital in March and April 1998. Robertson's fee for raising this additional capital is 100,000 shares of the Company's common stock. LETTER OF INTENT FOR JOINT VENTURE On February 5, 1998, the Company signed a letter of intent for joint venture with S.S. White Technologies, Inc. in which the two companies will work together to introduce and market one of the Company's major products for industrial application. F-14
10KSB34th Page of 35TOC1stPreviousNextBottomJust 34th
SIMPLEX MEDICAL SYSTEMS, INC. AND SUBSIDIARY (A Development Stage Company) NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 1997 AND 1996 NOTE 15 - SUBSEQUENT EVENTS (CONTINUED) NOTES PAYABLE On January 21, 1998, the Company executed two unsecured convertible 10% note agreements totaling $75,000. These notes mature on July 21, 1999 with interest payable on January 21 and July 21, 1999. These notes are convertible into shares of the Company s common stock at a price of $1.00 per share. LEASE On February 11, 1998, the Company entered into a lease agreement for office and warehouse space at a new location. This five year lease begins on April 1, 1998 and requires monthly rental payments of $4,000 plus tax. The Company has the option at the end of the lease term to renew the lease for an additional five years. This lease replaces and cancels the Company's existing lease agreements which expire in August and September, 1998. F-15
10KSBLast Page of 35TOC1stPreviousNextBottomJust 35th
SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized. Date: April 28, 1998 SIMPLEX MEDICAL SYSTEMS, INC. By:/s/ Colin J. Jones Colin N. Jones, President Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated. SIGNATURE TITLE DATE /s/ Colin N. Jones President (Chief Executive April 28, 1998 Colin N. Jones Officer) and Director /s/ Henry B. Schur Vice President of Marketing April 28, 1998 Henry B. Schur and Director /s/ Nicholas G. Levandoski President, Vice President April 28, 1998 Nicholas G. Levandoski, of Research and Development, Ph.D. Secretary, Treasurer and Chief Financial and Accounting Officer) and Director /s/ Joel Marcus Director April 28, 1998 Joel Marcus

Dates Referenced Herein   and   Documents Incorporated by Reference

Referenced-On Page
This ‘10KSB’ Filing    Date First  Last      Other Filings
7/21/9934
6/18/993033
12/31/983010-K/A,  10KSB,  NT 10-K
12/18/9830
12/1/984
9/30/981010QSB
8/31/9810
Filed on:4/28/9835
4/21/981
4/10/9814
4/2/981929
4/1/9810348-K/A
3/31/98111710QSB,  NT 10-K,  NT 10-Q
3/26/9820
2/20/9833
2/11/981034
2/5/9833
1/21/9834
For Period End:12/31/97134NT 10-K
12/18/9733
12/15/9727
9/30/971110QSB
6/30/971110QSB,  NT 10-Q
5/16/9720NT 10-Q
3/31/971110QSB,  NT 10-Q
3/28/97216DEF 14C,  PRES14C
3/5/972288-K,  8-K/A
1/1/9732
12/31/9623410KSB,  NT 10-K
5/31/9618
5/17/9610
4/4/9619
3/28/962
3/20/961819
10/31/952325
9/15/9525
8/11/9510
6/6/95225
1/1/9526
 List all Filings 
Top
Filing Submission 0000948830-98-000097   –   Alternative Formats (Word / Rich Text, HTML, Plain Text, et al.)

Copyright © 2024 Fran Finnegan & Company LLC – All Rights Reserved.
AboutPrivacyRedactionsHelp — Thu., Apr. 25, 5:45:13.2pm ET