SALIVA DIAGNOSTIC SYSTEMS INC
10KSB/A, 1997-06-10
SURGICAL & MEDICAL INSTRUMENTS & APPARATUS
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                     U.S. SECURITIES AND EXCHANGE COMMISSION
                              WASHINGTON, DC 20549
   
                                   FORM 1O-KSB/A

[X] AMENDMENT TO ANNUAL REPORT UNDER  SECTION 13 OR 15(D) OF THE SECURITIES 
    EXCHANGE ACT OF 1934
    
                   For the fiscal year ended December 31, 1996

[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OF 15(D) OF THE SECURITIES
    EXCHANGE ACT OF 1934

               For the transition period from ________ to ________

                        Commission File Number : 0-21284

                         SALIVA DIAGNOSTIC SYSTEMS, INC.
                 (Name of small business issuer in its charter)

                                    DELAWARE
         (State or other jurisdiction of incorporation or organization)

                                   91-1549305
                        (IRS Employer Identification No.)

                              11719 NE 95TH STREET
                               VANCOUVER, WA 98682
              (Address of principal executive offices and zip code)

                                 (360) 696-4800
                           (Issuer's telephone number)

SECURITIES REGISTERED UNDER SECTION 12(B) OF THE EXCHANGE ACT: NONE

SECURITIES REGISTERED UNDER SECTION 12(G) OF THE EXCHANGE ACT: COMMON STOCK, PAR
VALUE $.01 PER SHARE

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 in response 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 the Form 10-KSB or any amendment to
this Form 10-KSB. [ ]

Issuer's revenues for its most recent fiscal year were $ 840,068.

The aggregate market value of voting stock held by non-affiliates of the
Registrant at March 14, 1997 was $33,945,110, computed by reference to the last
traded sale price as reported on the Nasdaq Small Cap Market on such date.

The number of shares outstanding of the Registrant's Common Stock as of March
14, 1997 was 22,040,785 shares.

Transitional Small Business Disclosure Format (check one):  Yes [ ]  No [X]

                       DOCUMENTS INCORPORATED BY REFERENCE

The issuer has incorporated into Part III of Form 10-KSB, by reference, portions
of its Proxy Statement for its 1997 Annual Meeting of Shareholders.

<PAGE>

ITEM 7. FINANCIAL STATEMENTS

The Consolidated Financial Statements, together with the report thereon of
Hollander, Gilbert & Co. are included in this report as follows:

                SALIVA DIAGNOSTIC SYSTEMS, INC. AND SUBSIDIARIES

                   INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
                     YEARS ENDED DECEMBER 31, 1996 AND 1995


Report of Independent Auditors                                              F-1

Consolidated Balance Sheets as of December 31, 1996 and 1995                F-2

Consolidated Statements of Operations -                                     F-3
  For the Years Ended December 31, 1996 and 1995

Consolidated Statement of Stockholders' Equity -                            F-4
  For the Years Ended December 31, 1996 and 1995

Consolidated Statements of Cash Flows -                                     F-5
  For the Years Ended December 31, 1996 and 1995

Notes to Consolidated Financial Statements                                  F-6

<PAGE>
                         REPORT OF INDEPENDENT AUDITORS

To the Board of Directors and Stockholders
Saliva Diagnostic Systems, Inc.

We have audited the accompanying consolidated balance sheets of Saliva
Diagnostic Systems, Inc. and subsidiaries as of December 31, 1996 and 1995, and
the related consolidated statements of operations, stockholders' equity and cash
flows for the years then ended. These financial statements are the
responsibility of the Company's management. Our responsibility is to express an
opinion on these financial statements based on our audits.

We conducted our audits 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
misstatements. 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 audits provide a reasonable basis for our opinion.

In our opinion, the consolidated financial statements referred to above present
fairly, in all material respects, the financial position of Saliva Diagnostic
Systems, Inc. and subsidiaries as of December 31, 1996 and 1995 and the results
of operations, stockholders' equity and cash flows for the years then ended, in
conformity with generally accepted accounting principles.

The accompanying financial statements have been prepared assuming that the
Company will continue as a going concern. As discussed in Note 2 to the
financial statements, the Company's significant operating losses and significant
capital requirements raise substantial doubt about the Company's ability to
continue as a going concern. The financial statements do not include any
adjustments that might result from the outcome of these uncertainties.

                                       Hollander, Gilbert & Co.

Los Angeles, California
March 21, 1997

                                      F-1
<PAGE>
<TABLE>
                                 SALIVA DIAGNOSTIC SYSTEMS, INC. AND SUBSIDIARIES

                                            CONSOLIDATED BALANCE SHEETS
                                            DECEMBER 31, 1996 AND 1995
<CAPTION>
                                                                                          1996            1995
                                                                                      ------------    ------------
<S>                                                                                   <C>             <C>
                                                      ASSETS
CURRENT ASSETS
    Cash ..........................................................................   $    776,380    $  2,688,014
    Accounts receivable ...........................................................        178,436          43,291
    Inventories (Note 4) ..........................................................        268,431         300,161
    Prepaid expenses ..............................................................         34,425          28,956
                                                                                      ------------    ------------

        TOTAL CURRENT ASSETS ......................................................      1,257,672       3,060,422
                                                                                      ------------    ------------
PROPERTY AND EQUIPMENT, Net (Note 5) ..............................................        493,649         470,593
                                                                                      ------------    ------------
OTHER ASSETS
    Deposits ......................................................................        188,647          70,019
    Restricted cash (Note 8) ......................................................        120,500
    Patents and trademarks, net of accumulated
      amortization of $39,183 in 1996 and $29,983 in 1995 .........................        117,733         127,057
    Goodwill, net of accumulated amortization
      of $15,000 in 1995 (Note 3) .................................................                        585,000
    Prepaid loan fees (Note 6) ....................................................                         45,367
                                                                                      ------------    ------------
        TOTAL OTHER ASSETS ........................................................        426,880         827,443
                                                                                      ------------    ------------
                                                                                      $  2,178,201    $  4,358,458
                                                                                      ============    ============
                                       LIABILITIES AND STOCKHOLDERS' EQUITY
   
CURRENT LIABILITIES
    Accounts payable and accrued expenses .........................................   $    818,073    $    500,078
    Accrued interest payable ......................................................         68,240          49,703
    Current portion of long-term debt and
      obligations under capital leases (Note 8) ...................................         35,057          15,869
    Convertible debentures (Note 6) ...............................................                      2,785,000
                                                                                      ------------    ------------
        TOTAL CURRENT LIABILITIES .................................................        921,370       3,350,650
                                                                                      ------------    ------------
LONG-TERM DEBT AND OBLIGATIONS UNDER
  CAPITAL LEASES, net of current portion (Note 8) .................................         96,199          30,497
                                                                                      ------------    ------------
COMMITMENTS AND CONTINGENCIES (Notes 8 and 9)
    
STOCKHOLDERS' EQUITY (Note 6)
    Common stock - authorized 25,000,000 shares, $.01 par value,
      issued and outstanding 22,040,785 in 1996 and 13,126,366 in 1995 ............        220,408         131,264
    Additional paid-in capital ....................................................     22,998,552      17,726,578
    Note receivable related to sale of stock ......................................        (83,825)        (83,825)
    Cumulative foreign translation adjustment .....................................        (60,257)        (34,859)
    Accumulated deficit ...........................................................    (21,914,246)    (16,761,847)
                                                                                      ------------    ------------
        TOTAL STOCKHOLDERS' EQUITY ................................................      1,160,632         977,311
                                                                                      ------------    ------------
                                                                                      $  2,178,201    $  4,358,458
                                                                                      ============    ============
</TABLE>
          See accompanying Notes to Consolidated Financial Statements.

                                      F-2

<PAGE>
                SALIVA DIAGNOSTIC SYSTEMS, INC. AND SUBSIDIARIES

                      CONSOLIDATED STATEMENT OF OPERATIONS
                     YEARS ENDED DECEMBER 31, 1996 AND 1995

                                                       1996            1995
                                                   ------------    ------------

REVENUES
        Product sales ..........................   $    715,780    $    522,814
        Technology licensing income ............         24,870          59,855
        Other fees and interest income .........         99,418          38,630
                                                   ------------    ------------

           TOTAL REVENUES ......................        840,068         621,299
                                                   ------------    ------------


COSTS AND EXPENSES
        Cost of product sold ...................        472,142         149,629
        Research and development ...............      1,040,057         903,386
        Selling, general and administrative ....      3,911,587       3,608,353
        Write-off of Goodwill ..................        540,000
Interest expense and loan fees .................         28,681         557,701
                                                   ------------    ------------

           TOTAL COSTS AND EXPENSES ............      5,992,467       5,219,069
                                                   ------------    ------------

NET LOSS .......................................   $ (5,152,399)   $ (4,597,770)
                                                   ============    ============

NET LOSS PER SHARE .............................   $      (0.26)   $      (0.46)
                                                   ============    ============
WEIGHTED AVERAGE NUMBER OF
  SHARES OUTSANDING ............................     20,100,000       9,900,000
                                                   ============    ============

          See accompanying Notes to Consolidated Financial Statements.

                                       F-3

<PAGE>
   
<TABLE>
                                        SALIVA DIAGNOSTIC SYSTEMS, INC. AND SUBSIDIARIES

                                         CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY
                                             YEARS ENDED DECEMBER 31, 1996 AND 1995
<CAPTION>
                                                     Common Stock                     Note     Cumulative
                                              ----------------------  Additional   Receivable    Foreign
                                                 Shares                Paid-in      (Sale of   Translation  Accumulated
                                              Outstanding    Amount    Capital       Stock)     Adjustment     Deficit     Total
                                              -----------  ---------  -----------  ----------  -----------  ------------  ---------
<S>                                           <C>          <C>        <C>          <C>         <C>          <C>           <C>

BALANCE, December 31, 1994 .................    6,304,332  $  63,043  $12,434,356  $  (83,825) $   (32,644) $(12,164,077) $ 216,853

Sale of common stock in private offerings ..    3,715,000     37,150    1,935,350                                         1,972,500
Issuance of shares to officer for
  compensation..............................      230,000      2,300      127,700                                           130,000
Convertible debentures converted into
  common shares ............................    1,726,572     17,266      945,234                                           962,500
Issuance of warrants to consultants ........                              780,000                                           780,000
Issuance of options in settlement
agreement ..................................                               88,750                                            88,750
Issuance of shares to consultants ..........      100,000      1,000      149,000                                           150,000
Options exercised ..........................      170,000      1,700      154,300                                           156,000
Underwriter's warrants exercised ...........      180,462      1,805      268,888                                           270,693
Consulting warrants exercised ..............      250,000      2,500      247,500                                           250,000
Issuance of shares to acquire minority
  interest in subsidiaries .................      450,000      4,500      595,500                                           600,000
Foreign translation adjustment .............                                                        (2,215)                  (2,215)
Net loss for the year ......................                                                                  (4,597,770)(4,597,770)
                                               ----------  ---------  -----------  ----------  -----------  ------------  ---------

BALANCE, December 31, 1995 .................   13,126,366    131,264   17,726,578     (83,825)     (34,859)  (16,761,847)   977,311

Warrants exercised .........................    2,580,861     25,807    2,444,711                                         2,470,518
Options exercised ..........................      104,750      1,048       75,802                                            76,850
Issuance of shares in settlement agreement .       16,500        166       53,584                                            53,750
Convertible debentures payable converted
  into common shares .......................    6,212,308     62,123    2,697,877                                         2,760,000
Foreign translation adjustment .............                                                       (25,398)                 (25,398)
Net loss for the year ......................                                                                 (5,152,399) (5,152,399)
                                              -----------  ---------  -----------  ----------  -----------  -----------  -----------

BALANCE, December 31, 1996 .................  22,040,785     220,408  $22,998,552  $  (83,825) $   (60,257) $(21,914,246)$1,160,632
                                              ==========   =========  ===========  ==========  ===========  ============ ==========
</TABLE>
    
          See accompanying Notes to Consolidated Financial Statements.

                                       F-4

<PAGE>
<TABLE>
                    SALIVA DIAGNOSTIC SYSTEMS, INC. AND SUBSIDIARIES

                          CONSOLIDATED STATEMENTS OF CASH FLOWS
                         YEARS ENDED DECEMBER 31, 1996 AND 1995
<CAPTION>
                                                                1996          1995
                                                            -----------    -----------
<S>                                                         <C>            <C>

CASH FLOWS FROM OPERATING ACTIVITIES
Net loss ................................................   $(5,152,399)   $(4,597,770)
    Adjustments to reconcile net loss
      to net cash used by operating activities:
        Cumulative foreign translation adjustment .......       (25,398)        (2,215)
        Depreciation and amortization ...................       290,929        749,750
        Expenses satisfied with issuance of shares ......        53,750      1,148,750
        Write-off of goodwill ...........................       540,000
        Changes in operating assets and liabilities:
           (Increase) decrease in accounts receivable ...      (135,145)         3,748
           (Increase) decrease in inventories ...........        31,730       (207,561)
           (Increase) decrease in prepaid expenses ......        (5,469)       (28,956)
           Increase (decrease) in accounts payable
             and accrued expenses .......................       336,532        (65,317)
                                                            -----------    -----------
         NET CASH USED BY OPERATING ACTIVITIES ..........    (4,065,470)    (2,999,571)
                                                            -----------    -----------
CASH FLOWS FROM INVESTING ACTIVITIES
    Placement of restricted cash ........................      (120,500)
    Patents and trademarks ..............................           124         (4,310)
    Deposits ............................................      (118,628)        (5,863)
    Purchase of equipment ...............................      (214,418)      (118,295)
                                                            -----------    -----------
           NET CASH USED BY INVESTING ACTIVITIES ........      (453,422)      (128,468)
                                                            -----------    -----------

CASH FLOWS FROM FINANCING ACTIVITIES
    Convertible debentures ..............................                    3,128,900
    Repayments of convertible debentures ................       (25,000)       (37,500)
    Sale of stock - private placement and exempt offering                    1,972,500
    Proceeds from long-term debt ........................       109,476
    Repayment of long-term and obligations
      under capital leases ..............................       (24,586)       (20,971)
    Stock warrants and options exercised ................     2,547,368        676,693
                                                            -----------    -----------
           NET CASH PROVIDED BY FINANCING ACTIVITIES ....     2,607,258      5,719,622
                                                            -----------    -----------

NET INCREASE (DECREASE) IN CASH .........................    (1,911,634)     2,591,583
CASH BALANCE, Beginning of period .......................     2,688,014         96,431
                                                            -----------    -----------
CASH BALANCE, End of period .............................   $   776,380    $ 2,688,014
                                                            ===========    ===========

INTEREST AND LOAN FEES PAID .............................   $    10,144    $   565,035

SUPPLEMENTAL SCHEDULE OF NONCASH
  INVESTING AND FINANCING ACTIVITIES
    Shares issued in lieu of fees and expenses ..........   $    53,750    $ 1,148,750
    Acquisition of minority interest ....................                  $   600,000

</TABLE>
                                       F-5

<PAGE>
                SALIVA DIAGNOSTIC SYSTEMS, INC. AND SUBSIDIARIES

                   NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
                           DECEMBER 31, 1996 AND 1995

1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

   Description of Business - The Company is primarily engaged in the
   development, manufacture and marketing of rapid immunoassays for use in the
   detection of infectious diseases and other conditions. The Company has also
   developed and distributes medical specimen collection devices.

   Principles of Consolidation - The financial statements include the accounts
   of the Company and its wholly-owned subsidiaries. All significant
   intercompany transactions and balances have been eliminated.

   Use of Estimates - The preparation of financial statements in conformity with
   generally accepted accounting principles requires management to make
   estimates and assumptions that affect certain reported amounts and
   disclosures. Accordingly, actual results could differ from those estimates.

   Impairment of Long-Lived Assets - The Company periodically assesses the
   recoverability of the carrying amounts of long-lived assets, including
   intangible assets. A loss is recognized when expected undiscounted future
   cash flows are less than the carrying amount of the asset. The impairment
   loss is the difference by which the carrying amount of the asset exceeds its
   fair value. As a result of its review, the Company wrote-off goodwill at
   December 31, 1996 in the amount of $540,000.

   Stock-Based Compensation - The Company has adopted the disclosure-only
   provisions of SFAS No. 123, which retains the original accounting prescribed
   by APB Opinion No. 25. As a result, options granted at fair value will not
   result in charges to earnings. Disclosures are made, however, of compensation
   costs determined under SFAS No. 123's fair value methodology.

   Inventories - Inventories are stated at the lower of cost or market
   determined on a first-in, first-out (FIFO) basis.

   Property and Equipment - Property and equipment is stated at cost.
   Depreciation is computed on the straight-line method based upon the estimated
   useful life of the asset. Useful lives are generally as follows;

               Office furniture & equipment        5 to 7 years
               Machinery and Equipment             7 years
               Exhibits                            7 years
               Vehicles                            5 years

   Patents and Trademarks - The costs of patents and trademarks are being
   amortized on the straight line method over a 17 year life.

   Goodwill - Goodwill represents the excess of the cost of companies acquired
   over the fair value of their net assets at the date of acquisition and is
   being amortized on the straight-line method over ten years.

   Product Liability - The Company has not established any allowance for product
   liability at present because of the limited distribution of its product and
   limited history which reflect no instance of problems with liability.

   Income Taxes - The Company utilizes the asset and liability approach for
   financial accounting and reporting for income taxes. If it is more likely
   than not that some portion or all of a deferred tax asset will not be
   realized, a valuation allowance is recognized.

                                      F-6

<PAGE>
                SALIVA DIAGNOSTIC SYSTEMS, INC. AND SUBSIDIARIES
              NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, CONTINUED

   Loss Per Share - Loss per share is based upon the weighted average number of
   common shares and common share equivalents outstanding during the periods.
   Common share equivalents are not included as they are anti-dilutive.

   Revenues - The Company derived revenues from two sources: sale of product and
   licensing. Revenues are recognized as the service or product has been
   delivered.

   Research and Development - Research and development expenditures include
   those costs associated with the Company's own on-going research and
   development activities. All research and development costs are expensed as
   incurred.

   The Company has entered into various informal arrangements with certain
   laboratories/manufacturers of assay kits whereby these
   laboratories/manufacturers will share certain unspecified costs of research
   and development. However, the Company has no obligation to perform research
   and development for these entities.

   Currency Fluctuations - Foreign currency transactions and financial
   statements are to be translated into U.S. dollars at current rates, except
   that revenues, costs and expenses are translated at average current rates
   during each reporting period. The resulting translation adjustments are
   recorded directly into a separate component of stockholders' equity. Gains
   and losses resulting from foreign currency transactions, which are
   insignificant, are included in income currently.

   Reclassifications - Certain 1995 balances have been reclassified to conform
   with the current year's presentation.

2. GOING CONCERN

   Significant Operating Losses - Accumulated Deficit - The Company has incurred
   significant operating losses since its inception, resulting in an accumulated
   deficit of $21,914,246 and $16,761,847, at December 31, 1996 and December 31,
   1995, respectively. Such losses are expected to continue through 1997 and
   until such time, if ever, as the Company is able to attain sales levels
   sufficient to support its operations.

   Significant Capital Requirements - Need for Additional Financing - The
   Company's capital requirements have been and will continue to be significant.
   The Company has been dependent on private placements of its debt and equity
   securities and on a public offering of securities in March 1993 to fund such
   requirements. The Company is dependent upon its other efforts to raise
   capital resources, including proceeds received from the exercise of Warrants
   to finance the cost of manufacturing, marketing and conducting clinical
   trials and submissions for FDA approval of its products and continuing the
   design and development of the Company's new products which utilize its rapid
   testing format. Marketing, manufacturing and clinical testing may require
   capital resources substantially greater than the resources currently
   available to the Company. There can be no assurance that the Company will be
   able to obtain the additional capital resources necessary to permit the
   Company to implement or continue its programs. The Company has no current
   arrangements with respect to, or sources of, additional financing and there
   can be no assurance that such financing will be available on commercially
   reasonable terms or at all. It is not anticipated that any of the officers,
   directors or shareholders of the Company will provide any portion of the
   Company's future financing requirements. (See Note 11).

   The accompanying financial statements have been prepared assuming that the
   Company will continue as a going concern.

3. ACQUISITIONS

   On September 30, 1995, the Company purchased the minority interest in its 90%
   owned subsidiary, Saliva Diagnostic Systems (Asia) Ltd. and the minority
   interest in Asia's 83% owned subsidiary. The Company issued 350,000 shares of
   its common stock valued at $500,000 to a director/stockholder of the foreign
   subsidiaries and

                                      F-7
<PAGE>
                SALIVA DIAGNOSTIC SYSTEMS, INC. AND SUBSIDIARIES
              NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, CONTINUED

   100,000 shares to unrelated stockholder valued at $100,000. The assets
   acquired were valued at fair market value based on the estimates of the
   management of the Company which approximate the adjusted fair market value of
   the shares issued.

   The transaction was accounted for as a purchase and resulted in an excess of
   purchase price over net assets acquired of $600,000. Amortization of goodwill
   amounted to $45,000 in 1996 and $15,000 in 1995. At December 31, 1996, the
   Company assessed the recoverability of the Goodwill that resulted to the
   write-off of the Goodwill in the amount of $540,000.

   Management of the Company has reviewed the need for the Singapore operations
   as were originally anticipated and have concluded that use of this location
   as their primary manufacturing source is no longer required and as such have
   deemed it appropriate to write off the remaining Goodwill associated with
   this location.

4. INVENTORIES

   Inventories consisted of the following at December 31, 1996 and 1995:

                                                1996                1995
                                               ------               -----

               Raw materials              $         253,000    $         186,492
               Work in process                        2,495               66,807
               Finished goods                        12,936               46,862
                                          -----------------    -----------------
                                          $         268,431    $         300,161
                                          =================    =================

5. PROPERTY AND EQUIPMENT

   Property and Equipment consisted of the following at December 31, 1996 and
   1995:

                                                1996                 1995
                                               ------               -----

   Office Furniture & Equipment           $         114,041    $          76,711
   Machinery, Laboratory Equipment and
       Tooling                                      861,957              806,918
   Leasehold Improvements                            97,582               38,727
   Vehicle                                          181,423              126,388
   Exhibits                                          30,955               60,710
                                          -----------------    -----------------
                                                  1,285,958            1,109,454
   Less: accumulated depreciation and
       amortization                                 792,309              638,861
                                          -----------------    -----------------
                                          $         493,649    $         470,593
                                          =================    =================

6. STOCKHOLDERS' EQUITY

   Increase in Authorized Capital Stock - On February 20, 1997, the stockholders
   of the Company approved an amendment to the Company's Certificate of
   Incorporation to increase the authorized number of shares of stock from
   25,000,000 to 33,000,000 shares.

                                      F-8

<PAGE>
                SALIVA DIAGNOSTIC SYSTEMS, INC. AND SUBSIDIARIES
              NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, CONTINUED

   Public Offering - In March 1993 the Company closed a public offering in which
   it sold 1,300,000 shares of its common stock at $6.00 per share and 1,380,000
   warrants to purchase 1,380,000 shares of the Company's common stock for $7.20
   per share, at $.10 per warrant. The Company received net proceeds of
   $6,364,630 after expenses related to the offering of $1,573,490. The warrants
   have been extended to June 30, 1997 and the exercise price has been reduced
   from $7.20 to $3.00 per share.

   The Company also sold for $120 to the underwriter a five-year warrant to
   purchase up to 120,000 shares of common stock at $9 per share, exercisable
   for four years commencing March 3, 1995 at a price of 110% of the public
   offering price, as adjusted, of the common stock. During 1995, the
   underwriter exercised a portion of its warrants and purchased 180,462 shares
   for an aggregate amount of $270,693. During 1996, the underwriter exercised
   the remaining warrants and purchased 756,361 shares at $1.00 per share.
   During 1996, the Company granted new warrants to the underwriter to purchase
   1,000,000 shares of common stock at $1.00 per share, all of which have been
   exercised by the underwriter in 1996.

   Note Receivable Related to Sale of Stock - In January 1992 the Company sold
   to its President, who resigned in December 1996, 366,912 shares of common
   stock for $92,970. The officer paid $9,145 and issued a note to the Company
   for $83,825, payable in three years with interest of 6% per annum. These
   shares were considered outstanding for all periods in the calculation of
   earnings per share. The note which was originally due December 1994 was
   extended until December 1995. In December 1995, the Company extended the note
   for another year (see Note 8).

   Convertible Debentures - During 1992, the Company sold privately $630,000 of
   its 8% convertible debentures payable in May 1994 to various investors,
   including $25,000 to an affiliate of the Company. These debentures can be
   converted into the Company's common stock at a rate of $7.00 per share. In
   May 1994 certain debenture holders converted $580,000 principal amount of
   debentures into an aggregate of 580,000 shares of common stock. In November
   1995, the Company repaid $25,000 principal amount of debentures including all
   accrued and unpaid interest. In January 1996, the Company repaid the
   remaining $25,000 debenture including all accrued and unpaid interest.

   The Company raised $75,000 and $324,500 in 1993 and 1994, respectively, in a
   combination of common shares, non-negotiable two year 8% convertible
   debentures convertible at a rate of $2.00 per share after one year from the
   date of issuance and three year warrant to purchase additional shares of
   common stock at $3.50 per share. Each $50,000 unit consisted of 12,500 common
   shares, a $25,000 convertible debenture and a warrant to purchase 5,000
   shares of common stock. The Company issued a total of 99,875 shares of common
   stock and $199,750 convertible debentures and warrants to purchase a total of
   39,950 shares of common stock. In July 1994, certain debenture holders
   converted $149,750 principal amount of debentures into an aggregate of
   149,750 shares of common stock. In September 1995, certain debenture holders
   converted $37,500 principal amount of debentures into an aggregate of 37,500
   shares of common stock. In November 1995, the Company repaid $12,500
   principal amount of debentures including all accrued and unpaid interest.

   During 1995, the Company sold privately $3,685,000 of its 9% convertible
   debentures payable on October 31, 1996. The holders of the debentures are
   entitled, at their option, at any time commencing 45 days after issue to
   convert any or all of the original principal amount of the debentures into
   shares of common stock of the Company at a conversion price for each share of
   common stock equal to seventy percent (70%) of the market price (as defined
   in the debenture agreement) of the common stock. In December 1995, certain
   debenture holders converted $925,000 principal amount of debentures into an
   aggregate of 1,689,072 shares of common stock. The Company incurred $556,100
   in loan fees of which $510,733 and $45,367 was charged to expense in 1995 and
   1996, respectively. During 1996, certain debenture holders converted
   $2,760,000 principal amount of debentures into 6,212,308 shares of common
   stock. All of the convertible debentures in these transactions have been
   converted to common stock as of December 31, 1996.

                                       F-9
<PAGE>
                SALIVA DIAGNOSTIC SYSTEMS, INC. AND SUBSIDIARIES
              NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, CONTINUED

   Private Placements - In December 1994 the Company sold 860,000 shares of
   common stock for an aggregate consideration of $430,000. During 1995, the
   Company, sold an additional 3,645,000 shares of common stock for $1,802,500,
   including 200,000 shares issued to its President.

   In November 1995, the Company, in a new private placement, sold 300,000
   shares of common stock for an aggregate consideration of $300,000, including
   30,000 shares to its President. The units sold included warrants to purchase
   a total of 450,000 shares of common stock at an exercise price of 50% of the
   closing bid price of the stock on the exercise date. All of the warrants were
   exercised in 1996.

   Warrants and Shares Issued to Consultants - During 1995, the Company issued
   warrants to purchase a total of 650,000 shares of common stock at an exercise
   price of $1.00 per share for consulting services rendered. The warrants were
   valued at $1.20 per share. As of December 31, 1996, 327,500 warrants have
   been exercised.

   In 1995, the Company issued 100,000 shares of common stock to consultants
   valued at a total of $150,000.

   Settlement Agreements - During 1995, the Company reached a settlement
   agreement with a director of its subsidiary whereby the Company granted the
   director options to purchase 100,000 shares of common stock at an exercise
   price of $.60 per share. The options were valued at a total of $88,750. As of
   December 31, 1996, all of these options have been exercised.

   During 1996, the Company issued a total of 12,500 shares of common stock
   valued at approximately $43,750 to certain unrelated individuals to settle a
   dispute. Also during 1996, the Company issued 4,000 shares of common stock
   valued at $10,000 as a consideration for extension of a previous note payable
   to an individual.

   Warrants Issued to Licensee - In March 1994, as a result of entry into a
   license agreement with Orgenics, Ltd. Orgenics Ltd. was granted a three year
   option, expiring in March 1997, to purchase up to $1,000,000 of shares of
   common stock (but not more than 19% of the then-outstanding common stock) at
   60% of the average of the closing bid and asked price for the common stock
   during the ten trading days prior to such purchase.

   Shares Issued to Officer - During 1995, the Company issued 230,000 shares of
   common stock to its former President valued at $130,000 as additional
   compensation for the year 1995.

   Stock Option Plans - In March 1992, the Company established a stock option
   plan (1992 Plan). The 1992 Plan, as amended, covers 350,000 shares of its
   common stock. Under the terms of the 1992 Plan, the Company is authorized to
   issue options to employees and directors of the Company or its subsidiaries.
   Decisions such as grants to employees, the selection of recipients, number of
   options, the exercise price, duration and other terms, including whether the
   options shall be incentive stock options as defined by the Internal Revenue
   Code of 1986 or non-qualified options, are subject to the discretion of the
   Board of Directors except that the exercise price may not be less than 110%
   of the fair market value at the time of grant to holders of in excess of 10%
   of the Company's common stock.

   In addition, the 1992 Plan provides for automatic grants to each non-employee
   director of the Company of 3,000 shares of common stock at the date of the
   public offering or, in the case of election to the Board of Directors after
   consummation of said offering, upon such election at a price of 100% of fair
   market value of the common stock at the time of grant. The options may be
   exercised after six months and before five years from the date of grant.

   In July 1994, the Company established a stock option plan (1994 Plan). The
   1994 Plan, covers 350,000 shares of its common stock. Under the terms of the
   1994 Plan, the Company is authorized to issue incentive and non-statutory
   stock options to employees, consultants, advisors and/or directors. Options
   shall be exercisable at the fair market value at the date of the grant except
   options issued to persons who own in excess of 10% of the Company's stock may
   be no less than 110% of the fair market value.

   In addition, the 1994 Plan provides for automatic grants to all directors and
   advisors who are not employees of the Company or its subsidiaries of 3,000
   fully vested non-qualified options at the time this Plan was adopted by

                                      F-10
<PAGE>
                SALIVA DIAGNOSTIC SYSTEMS, INC. AND SUBSIDIARIES
              NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, CONTINUED

   the Board or upon election or appointment to the Board, if not a member of
   the Board at the time this plan was adopted by the Board.

   On March 2, 1995, the Company's Board of Directors granted options to
   purchase 997,000 shares, including 400,000 shares to its former President, of
   the Company's common stock to its employees, outside of the above Stock
   Option Plans. Such options are exercisable on March 2, 1995, at $1.00 per
   share and expire on March 2, 1998.

   The following table summarizes the stock options activity for the years 1996
   and 1995:

                                                    Number       Option Price
                                                  of Shares          Range
                                                  ---------   ------------------

   Outstanding at December 31, 1994 ..........      660,000    $ .60 to $ 6.875
       Options granted .......................      997,000          $1.00
       Options exercised .....................     (170,000)   $ .60 to $ 1.375
       Options expired or canceled ...........      (53,000)   $ 1.00 to $ 6.875
                                                  ---------

   Outstanding at December 31, 1995 ..........    1,434,000    $ .60 to $ 5.50
       Options granted .......................      302,500    $ .43 to $ $ 2.38
       Options exercised .....................     (104,750)   $ .60 to $ 1.00
       Options expired or canceled ...........       (1,000)          $.60
                                                  ---------

Outstanding at December 31, 1996 .............    1,630,750    $ .60 to $ 5.50
                                                  =========

   The Company has adopted the disclosure-only provisions of Statement of
   Financial Accounting Standards No. 123, "Accounting for Stock-Based
   Compensation". Accordingly, no compensation cost has been recognized for the
   stock options. Had compensation cost for the Company's stock options been
   determined based on the fair value at the grant date for options granted in
   1996 and 1995 consistent with the provisions of SFAS No. 123, the Company's
   net loss and loss per common share would have been increased to the pro forma
   amounts indicated below:

                                                 1996                 1995
                                                ------               -----

   Net loss - as reported                $      (5,152,399)   $      (4,497,770)
   Net loss - pro forma                  $      (5,518,599)   $      (5,325,580)
   Loss per common share - as reported   $           (0.26)   $           (0.46)
   Loss per common share - pro forma     $           (0.27)   $           (0.54)

   The fair value of each option grant is estimated on the date of grant using
   the Black-Scholes option-pricing model with the following assumptions:

                                                 1996                 1995
                                                ------               -----

   Expected dividend yield                          0%                   0%
   Expected stock price volatility                150%                 106%
   Risk-free interest rate                          6%                   6%
   Expected life of options - years                 3                    3

   The weighted average fair value of options granted during 1996 and 1995 was
   $1.21 and $0.73, respectively.

                                      F-11
<PAGE>
                SALIVA DIAGNOSTIC SYSTEMS, INC. AND SUBSIDIARIES
              NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, CONTINUED

7. INCOME TAXES

   The Company has a net operating loss carryforward of approximately $17.5
   million which is available to offset future taxable income, if any, expiring
   through the year 2011. The Company has not recorded any deferred tax asset as
   a result of the net operating loss carryforward as it has provided a 100%
   allowance against this asset.

8. COMMITMENTS AND CONTINGENCIES

   Employment Agreements - The Company has entered into various three year
   employment agreements with certain officers. These employment agreements
   provide for minimum annual compensation of between $65,000 and $126,000. In
   addition, each employment agreement provides for bonuses, cost of living
   increases, reimbursement of business expenses, health insurance and related
   benefits.

   In January 1997, a lawsuit was filed by the former President of the Company,
   who resigned in December 1996. The complaint in the lawsuit alleged various
   breach of contract claims. This lawsuit was recently dismissed without
   prejudice as a prerequisite to a settlement agreement between the former
   President and the Company currently in the process of being documented.

   Long-Term Debt and Obligations under Capital Leases - The Company borrowed
   $109,476 from a certain bank in 1996. The note carried an interest rate of
   6.940% and is payable $2,162.54 per month for 60 months. The note is secured
   by a time deposit in the amount of $120,500. The Company has acquired
   vehicles under notes requiring 48 to 60 payments of $1,842 per month
   including interest at 6% to 10% per annum.

   The following represents the maturity schedule as of December 31, 1996:

          1997                   $ 35,057
          1998                     36,792
          1999                     22,536
          2000                     24,151
          2001                     12,720
                                 --------
          Total                   121,256

          Less current portion     35,057
                                 --------
                                 $ 96,199
                                 ========

   Litigation - A former director and officer of the Company has filed a
   complaint in Federal court listing several causes of action against the
   Company and the individual defendants, including breach of employment
   agreement with the Company, intentional interference with contract by the
   individual defendants, slander and deceptive trade practices. The complaint
   seeks damages and punitive damages in an unspecified amount. The Company
   believes this complaint is without merit as the plaintiff was fired for cause
   and intends to vigorously defend itself.

9. OPERATING LEASES

   The Company leases its offices and laboratory spaces, under operating leases
   with initial terms of three to seven years. Future minimum lease payments by
   year and in the aggregate, under noncancelable operating leases with initial
   or remaining lease terms in excess of one year, consisted of the following at
   December 31, 1996:

                                      F-12
<PAGE>
                SALIVA DIAGNOSTIC SYSTEMS, INC. AND SUBSIDIARIES
              NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, CONTINUED

Year Ended December 31,
- -----------------------
1997                              $199,101
1998                               150,552
1999                               148,180
2000                               153,036
2001                               153,036
Thereafter                         102,024
                                  --------
                                  $905,929

   Rent expense for the years ended December 31, 1996 and 1995 was $301,016 and
   $237,855, respectively.

10. SEGMENT INFORMATION

   Information about the Company's operations in different geographic areas
   follows:

                                              1996                 1995
                                         -----------          -----------
         Product sales:
            United States ......         $   393,635          $   317,812
            Asia ...............              79,218               70,696
            United Kingdom .....             242,927              134,306
                                         -----------          -----------
                   Total .......         $   715,780          $   522,814
                                         ===========          ===========

         Operating profit (loss)
            United States ......         $(4,407,954)         $(3,959,955)
            Asia ...............            (621,958)            (497,969)
            United Kingdom .....            (122,487)            (139,846)
                                         -----------          -----------
                   Total .......         $(5,152,399)         $(4,597,770)
                                         ===========          ===========
         Identifiable assets
            United States ......         $ 1,687,866          $ 3,342,815
            Asia ...............             368,562              955,776
            United Kingdom .....             121,773               59,867
                                         -----------          -----------
                   Total .......         $ 2,178,201          $ 4,358,458
                                         ===========          ===========

   Customer Concentration - During 1996, three customers accounted for
   approximately 20%, 18% and 11% of total sales, respectively. During 1995, two
   customers accounted for approximately 40% and 10% of total sales,
   respectively.


11. BORROWINGS SUBSEQUENT TO YEAR-END

   In March 1997, the Company raised net proceeds of $1,370,000 from private
   placement of 7.5% convertible debentures. The principal amounts of the
   debentures are due on February 28, 1999.

                                      F-13

<PAGE>
                                   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.
   
Dated: June 10, 1997
    
                                       SALIVA DIAGNOSTIC SYSTEMS, INC.

                                       By:  /s/ KENNETH J. MCLACHLAN
                                            ------------------------------------
                                            Kenneth J. McLachlan
                                            President and Chief Executive
                                            Officer (and Director)
                                            (Principal Executive Officer)


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