CHROMAVISION MEDICAL SYSTEMS INC
10-Q, 2000-11-13
LABORATORY ANALYTICAL INSTRUMENTS
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<PAGE>   1
                       SECURITIES AND EXCHANGE COMMISSION
                             WASHINGTON, D.C. 20549

                               ------------------

                                    FORM 10-Q

Mark One

[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
    ACT OF 1934

    For The Quarterly Period Ended September 30, 2000

                                       OR

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

    For the Transition Period from _________________ to _________________


                          COMMISSION FILE NUMBER 0-1000


                       CHROMAVISION MEDICAL SYSTEMS, INC.
--------------------------------------------------------------------------------
             (Exact name of registrant as specified in its charter)


           DELAWARE                                            75-2649072
-------------------------------                           ----------------------
(State or other jurisdiction of                               (IRS Employer
incorporation or organization)                            Identification Number)


          33171 PASEO CERVEZA
        SAN JUAN CAPISTRANO, CA                                   92675
----------------------------------------                 -----------------------
(Address of principal executive offices)                       (Zip code)


                                 (949) 443-3355
--------------------------------------------------------------------------------
              (Registrant's telephone number, including area code)


                                 NOT APPLICABLE
--------------------------------------------------------------------------------
              (Former name, former address and former fiscal year,
                         if changed since last report)


        Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months, and (2) has been subject to such filing
requirements for the past 90 days.

                                 Yes  X      No
                                     ---        ---

As of November 2, 2000 there were 20,092,466 shares outstanding of the Issuer's
Common Stock, $.01 par value.


<PAGE>   2

                       CHROMAVISION MEDICAL SYSTEMS, INC.

                                TABLE OF CONTENTS

                                                                           Page
                                                                           ----
PART I  FINANCIAL INFORMATION

   Item 1 Financial Statements

          Condensed Consolidated Balance Sheets as of September 30,
          2000 and December 31, 1999                                         3

          Condensed Consolidated Statements of Operations for the
          three and nine months ended September 30, 2000 and 1999            4

          Condensed Consolidated Statements of Cash Flows for the
          nine months ended September 30, 2000 and 1999                      5

          Notes to Condensed Consolidated Financial Statements               6

   Item 2 Management's Discussion and Analysis of Financial
          Condition and Results of Operations                                9

   Item 3 Quantitative and Qualitative Disclosures about Market Risk        10

PART II OTHER INFORMATION

   Item 2 Changes in Securities and Use of Proceeds                         11

   Item 6 Exhibits and Reports on Form 8-K                                  11

SIGNATURES                                                                  12


                                      -2-

<PAGE>   3

PART I - ITEM 1

                       CHROMAVISION MEDICAL SYSTEMS, INC.

                      CONDENSED CONSOLIDATED BALANCE SHEETS
                                   (UNAUDITED)
<TABLE>
<CAPTION>
                                                                SEPTEMBER 30,         DECEMBER 31,
                                                                     2000                 1999
                                                                -------------         ------------
                                     ASSETS

<S>                                                              <C>                  <C>
 Current assets:
    Cash and cash equivalents ...........................        $ 13,332,684         $ 11,802,668
    Short-term investments ..............................                 -0-            5,822,451
    Other ...............................................             513,252              257,577
                                                                 ------------         ------------
          Total current assets ..........................          13,845,936           17,882,696
 Other ..................................................             320,270              207,268
 Property and equipment, net ............................           4,551,988            4,344,891
                                                                 ------------         ------------
          Total assets ..................................        $ 18,718,194         $ 22,434,855
                                                                 ============         ============

                      LIABILITIES AND STOCKHOLDERS' EQUITY

 Current liabilities:
    Accounts payable ....................................        $    374,461         $    578,961
    Accrued liabilities .................................           1,196,546              735,836
                                                                 ------------         ------------
         Total current liabilities ......................           1,571,007            1,314,797

 Commitments and contingencies ..........................                  --                   --

 Stockholders' equity:
    Series A convertible preferred stock, $.01 par value,
      authorized 7,246,000 shares, none issued and
      outstanding .......................................                  --                   --
    Series B convertible preferred stock, $.01 par value,
      authorized 221,850 shares, none issued and
      outstanding .......................................                  --                   --
    Series C convertible preferred stock, $.01 par value,
      authorized 200,000 shares, none issued and
      outstanding .......................................                  --                   --
    Common stock $.01 par value, authorized 50,000,000
      shares, issued and outstanding 20,088,716 shares in
      2000 and 19,488,629 in 1999 .......................             200,887              194,886
    Additional paid-in capital ..........................          62,650,235           55,742,904
    Accumulated deficit .................................         (45,643,243)         (34,789,102)
    Accumulated other comprehensive loss ................             (60,692)             (28,630)
                                                                 ------------         ------------
         Total stockholders' equity .....................          17,147,187           21,120,058
                                                                 ------------         ------------
 Total liabilities and stockholders' equity .............        $ 18,718,194         $ 22,434,855
                                                                 ============         ============
</TABLE>

     See accompanying notes to condensed consolidated financial statements.


                                      -3-

<PAGE>   4

                       CHROMAVISION MEDICAL SYSTEMS, INC.

                 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
                                   (UNAUDITED)

<TABLE>
<CAPTION>
                                                       THREE MONTHS ENDED                     NINE MONTHS ENDED
                                                          SEPTEMBER 30,                         SEPTEMBER 30,
                                                 -------------------------------       -------------------------------
                                                     2000               1999               2000               1999
                                                 ------------       ------------       ------------       ------------
<S>                                              <C>                <C>                <C>                <C>
Revenue ...................................      $    211,581       $     32,669       $    753,299       $     96,816
Cost of revenue ...........................            68,417             24,956            249,454             59,032
                                                 ------------       ------------       ------------       ------------
      Gross profit ........................           143,164              7,713            503,845             37,784
                                                 ------------       ------------       ------------       ------------

Operating expenses:
   Selling, general and administrative ....         2,478,963          1,671,625          6,737,545          4,345,340
   Research and development ...............         1,747,496          1,627,707          5,168,673          4,447,085
                                                 ------------       ------------       ------------       ------------
      Total operating expenses ............         4,226,459          3,299,332         11,906,218          8,792,425
                                                 ------------       ------------       ------------       ------------
      Loss from operations ................        (4,083,295)        (3,291,619)       (11,402,373)        (8,754,641)
                                                 ------------       ------------       ------------       ------------
Other income ..............................           119,667             55,975            548,232            305,440
                                                 ------------       ------------       ------------       ------------
      Loss before income taxes ............        (3,963,628)        (3,235,644)       (10,854,141)        (8,449,201)

Income taxes ..............................               -0-                -0-                -0-                -0-
                                                 ------------       ------------       ------------       ------------
      Net loss ............................      $ (3,963,628)      $ (3,235,644)      $(10,854,141)      $ (8,449,201)
                                                 ============       ============       ============       ============

Basic and diluted net loss per common share      $       (.20)      $       (.18)      $       (.56)      $       (.48)
                                                 ============       ============       ============       ============
Weighted average number of common shares
   outstanding ............................        19,527,727         17,687,939         19,510,185         17,581,006
                                                 ============       ============       ============       ============
</TABLE>

     See accompanying notes to condensed consolidated financial statements.


                                      -4-

<PAGE>   5

                       CHROMAVISION MEDICAL SYSTEMS, INC.

                 CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
                                   (UNAUDITED)

<TABLE>
<CAPTION>
                                                                         NINE MONTHS ENDED
                                                                           SEPTEMBER 30,
                                                                  ------------------------------
                                                                      2000               1999
                                                                  ------------       -----------
<S>                                                               <C>                <C>
Cash flows from operating activities:
      Net loss .............................................      $(10,854,141)      $(8,449,201)
Adjustments to reconcile net loss to net cash
  used in operating activities:
      Depreciation and amortization ........................         1,439,282         1,002,563
  Changes in operating assets and liabilities:
      Other assets .........................................          (371,398)         (352,734)
      Accounts payable .....................................          (202,920)          114,033
      Accrued liabilities ..................................           472,871          (204,875)
                                                                  ------------       -----------
      Net cash used in operating activities ................        (9,516,306)       (7,890,214)
                                                                  ------------       -----------

Cash flows from investing activities:
Collections on note receivable from affiliate...............               -0-         5,000,000
Maturities of investments ..................................         9,708,900         3,533,747
Purchases of investments ...................................        (3,886,449)              -0-
Additions to property and equipment ........................        (1,646,537)       (1,786,915)
                                                                  ------------       -----------
      Net cash provided by investing activities ............         4,175,914         6,746,832
                                                                  ------------       -----------

Cash flows from financing activities:
Sale of common stock........................................         7,000,000               -0-
Proceeds from exercise of stock options ....................           211,991           665,956
Offering costs .............................................          (298,659)              -0-
                                                                  ------------       -----------
      Net cash provided by financing activities ............         6,913,332           665,956
                                                                  ------------       -----------

Effect of exchange rate changes on cash and cash equivalents           (42,924)              -0-
      Net increase (decrease) in cash and cash equivalents .         1,530,016          (477,426)
Cash and cash equivalents beginning of period ..............        11,802,668         2,853,546
                                                                  ------------       -----------
Cash and cash equivalents end of period ....................      $ 13,332,684       $ 2,376,120
                                                                  ============       ===========
</TABLE>

     See accompanying notes to condensed consolidated financial statements.


                                       -5-

<PAGE>   6

                       CHROMAVISION MEDICAL SYSTEMS, INC.

              NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
                                   (UNAUDITED)


(1) BASIS OF PRESENTATION

        These interim condensed consolidated financial statements should be read
in conjunction with the consolidated financial statements and notes thereto
included in our 1999 annual report filed on Form 10-K with the Securities and
Exchange Commission.

        The accompanying unaudited condensed consolidated financial statements
reflect all adjustments which, in the opinion of management, are necessary for a
fair presentation of the financial position and the results of operations for
the interim periods presented. All such adjustments are of a normal, recurring
nature. Certain amounts have been reclassified to conform to the current period
presentation. The results of our operations for any interim period are not
necessarily indicative of the results to be obtained for a full fiscal year.

(2) NET LOSS PER SHARE

        Options to purchase 2,384,956 and 2,026,625 shares of common stock were
outstanding at September 30, 2000 and 1999, respectively, and were excluded from
the computation of diluted net loss per share as the effect would be
antidilutive.

(3) CURRENCY TRANSLATION

        The financial position and results of operations of our foreign
subsidiaries are generally determined using the local currency as the functional
currency. Assets and liabilities of these subsidiaries are translated at the
exchange rate in effect at each quarter-end. Income statement accounts are
translated at the average rate of exchange prevailing during the period.

(4) COMPREHENSIVE LOSS

        Our total comprehensive loss is summarized as follows:

<TABLE>
<CAPTION>
                                             Three Months Ended                  Nine Months Ended
                                                September 30,                      September 30,
                                       -----------------------------      -------------------------------
                                           2000              1999              2000               1999
                                       -----------       -----------       ------------       -----------
<S>                                    <C>               <C>               <C>                <C>
Net loss ........................      $(3,963,628)      $(3,235,644)      $(10,854,141)      $(8,449,201)
Foreign currency translation loss          (19,252)          (10,036)           (32,062)          (10,036)
                                       -----------       -----------       ------------       -----------
Comprehensive loss ..............      $(3,982,880)      $(3,245,680)      $(10,886,203)      $(8,459,237)
                                       ===========       ===========       ============       ===========
</TABLE>



                                      -6-

<PAGE>   7

                       CHROMAVISION MEDICAL SYSTEMS, INC.

        NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
                                   (UNAUDITED)

(5) BUSINESS SEGMENTS

        We operate primarily in one business segment engaged in the development,
manufacture and marketing of an Automated Cellular Imaging System (ACIS (TM))
designed to assist in the detection and treatment of cellular disease.

        The following table represents our business segment information by
geographic area:

<TABLE>
<CAPTION>
                                     Three Months Ended                  Nine Months Ended
                                        September 30,                       September 30,
                               -----------------------------       ------------------------------
                                   2000              1999              2000               1999
                               -----------       -----------       ------------       -----------
<S>                            <C>               <C>               <C>                <C>
Net sales
  United States .........      $   180,022       $    32,669       $    363,301       $    96,816
  Europe (a) ............           31,559               -0-            389,998               -0-
                               -----------       -----------       ------------       -----------
     Total net sales ....      $   211,581       $    32,669       $    753,299       $    96,816
                               ===========       ===========       ============       ===========

Operating loss
  United States .........      $(4,077,399)      $(3,182,597)      $(11,275,883)      $(8,590,767)
  Europe (a) ............           (5,896)         (109,022)          (126,490)         (163,874)
                               -----------       -----------       ------------       -----------
     Total operating loss      $(4,083,295)      $(3,291,619)      $(11,402,373)      $(8,754,641)
                               ===========       ===========       ============       ===========
</TABLE>


                                 September 30, 2000        December 31, 1999
                                 ------------------        -----------------
Identifiable assets
  United States .........           $18,430,377               $22,283,123
  Europe (a) ............               287,817                   151,732
                                    -----------               -----------
     Total assets .......           $18,718,194               $22,434,855
                                    ===========               ===========
---------------

(a) European operations represent business activities conducted primarily in
    France, Germany, Italy, Austria, Switzerland and Great Britain.

(6) NEW ACCOUNTING STANDARDS

        In December 1999, the United States Securities and Exchange Commission
issued Staff Accounting Bulletin (SAB) No. 101-"Revenue Recognition in Financial
Statements," as amended, which for the Company is effective October 1, 2000. SAB
No. 101 summarizes certain of the staff's views on applying generally accepted
accounting principles to revenue recognition in financial statements. We believe
that implementation of SAB No. 101 will have no material impact on our financial
statements.

        In March 2000, the Financial Accounting Standards Board ("FASB") issued
FASB interpretation No. 44 ("FIN 44"), "Accounting for Certain Transactions
Involving Stock Compensation-an Interpretation of APB 25." FIN 44 clarifies the
application of Opinion 25 for (a) the definition of employee for purposes of
applying Opinion 25, (b) the criteria for determining whether a plan qualifies
as a non-compensatory plan, (c) the accounting consequences of various
modifications to the terms of a previously fixed stock option or award, and (d)
the accounting for an exchange of stock compensation awards in a business
combination. FIN 44 is effective July 1, 2000, but certain conclusions cover
specific events that occur after either December 15, 1998 or January 12, 2000.
Adoption of FIN 44 did not have a material effect on our financial position or
results of operations.

(7) STOCK TRANSACTIONS

        On September 28, 2000 we completed the private placement of an aggregate
of 560,693 newly issued shares of our Common Stock and warrants to purchase an
aggregate of 56,070 additional shares of our Common Stock to two institutional
investors for an aggregate purchase price of $7 million. The purchase price per
share was $12.48 and was based upon an average of high and low trading prices of
our Common Stock for a 20-day period prior to the sale. Of the $7,000,000
aggregate purchase price, $5,000,000 was purchased by a wholly owned subsidiary
of Safeguard Scientifics, Inc., and $2,000,000 was purchased by incuVest LLC, a
private investment fund. Safeguard Scientifics, Inc. already held approximately
27% of our outstanding shares, and incuVest was also a stockholder.


                                      -7-


<PAGE>   8

                       CHROMAVISION MEDICAL SYSTEMS, INC.

        NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
                                   (UNAUDITED)


        We have also agreed to issue additional shares of our Common Stock and
warrants to purchase Common Stock to incuVest LLC at an aggregate purchase price
of $5,000,000 prior to December 31, 2000. The shares will be priced at a small
premium over the $12.48 per share to reflect the time value of money resulting
from the later closing date. The number of shares subject to warrants to be
issued will be equal to 10% of the number of shares issued at the per share
price.

        On September 28, 2000 we amended our Stockholder Rights Plan, which had
been adopted in March 1999 and was amended by the Amendment to Rights Agreement
dated as of June 21, 1999. The Stockholder Rights Plan provides for the
distribution of rights to purchase additional shares of our capital stock in the
event any person, entity or group acquires beneficial ownership of 15% or more
of our outstanding Voting Shares of ChromaVision. "Voting Shares" is defined in
the Plan to mean Common Stock and any other shares of our capital stock entitled
to vote generally in the election of directors or to approve any merger,
consolidation, sale of all or substantially our assets, liquidation, dissolution
or winding up. Presently the only Voting Shares outstanding are the shares of
Common Stock.

        The Plan included an exception for acquisitions of shares by persons,
entities or groups who, as of February 10, 1999, were the beneficial owner of
more than 15% of the outstanding shares of our Common Stock. (These beneficial
owners are referred to below as "Existing 15% Owners.") That exemption in the
Plan applied only if (1) an Existing 15% Owner continued to own at least 15% of
our Voting Shares and (2) did not acquire additional Voting Shares which would
cause the Existing 15% Owner's beneficial ownership of Voting Shares to exceed
40% of the number of shares outstanding.

        Amendment No. 2 to the Plan makes three changes. First, it exempts from
the provision described above the acquisition of 400,495 shares of Common Stock
and warrants to purchase an additional 40,050 shares of Common Stock acquired by
the subsidiary of Safeguard Securities, Inc. in the private placement described
above. Second, it amends the definition of "15% Stockholder" to exclude any
Exempted Group. Third, it defines Exempted Group as any group consisting of
Safeguard Scientifics, Inc., its affiliates and associates, and incuVest LLC and
its affiliates and associates, but only so long as (i) Safeguard Scientifics,
Inc. and its affiliates and associates beneficially own more than a majority of
our Voting Shares beneficially owned in the aggregate by Safeguard Scientifics,
Inc., its affiliates and associates, incuVest LLC and its affiliates and
associates and (ii) Safeguard Scientifics, Inc., its affiliates and associates,
and incuVest LLC and its affiliates and associates do not beneficially own in
the aggregate more than 45% of our Voting Shares then outstanding.


                                      -8-

<PAGE>   9

PART I

ITEM 2      MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
                            AND RESULTS OF OPERATIONS

        Statements in this report describing our plans, goals, strategies,
intentions, expectations and anticipated events are forward-looking statements.
Important factors which could cause actual results to differ materially from
those described in such forward-looking statements include the following:
commercialization of our products is dependent on acceptance by the medical
community and receipt of satisfactory reimbursement from third-party payers,
which could be delayed or not obtained; any future success depends upon our
ability to establish an effective sales and marketing organization and to
successfully manufacture products in commercial quantities; we will require
additional financing for our business, and it is uncertain whether the financing
will be available on favorable terms or at all; our ability to develop new tests
depends on successful collaboration with third parties that we do not control;
an inadequate supply of biological samples could delay completion of the
clinical trials; the clinical trials could fail to demonstrate the efficacy our
Automated Cellular Imaging System ("ACIS") tests; new tests may not be
successfully developed; the ability to commercialize new tests may be dependent
on obtaining appropriate U.S. Food and Drug Administration (the "FDA") and
foreign regulatory approvals, which may not be obtained when anticipated or at
all; and manufacture of the ACIS is subject to FDA regulation.

OVERVIEW

        We develop, manufacture and market an automated cellular imaging system,
referred to as the ACIS, which is designed to perform a wide variety of tests to
detect cellular disease, including cancer and infectious disease. We designed
the ACIS technology to serve as a tool to assist the pathologist in generating
accurate, quantitative and reproducible results, eliminating the subjectivity
associated with current manual methods. In July 1999, the FDA granted clearance
for the use of the ACIS to perform a large number of tests using a particular
staining method based upon a master validation protocol. The FDA clearance
allows us to introduce new tests for the ACIS using that particular staining
method without applying for additional FDA clearance. Our current test menu for
the ACIS includes eleven released tests with additional tests in various stages
of development.

        From the inception of our business on April 1, 1993 to September 30,
1999, our business was considered to be in the development stage as defined by
Statement of Financial Accounting Standards ("SFAS") No. 7, "Accounting and
Reporting by Development Stage Enterprises". In the fourth quarter of 1999, we
exited the development stage as revenue was realized from planned operations.

RESULTS OF OPERATIONS

        Revenue. Revenue for the three and nine months ended September 30, 2000
increased approximately $179,000 or 548% and $656,000 or 678%, respectively,
over the comparable periods in 1999. These increases are primarily due to sales
of the ACIS to research facilities in Europe and an increase in monthly rental
and per test charges for usage of leased ACIS units. We anticipate continued
revenue growth in 2000 as we accelerate our commercialization activities.

        Selling, general and administrative expenses. Expenses for the three and
nine months ended September 30, 2000 increased approximately $807,000 or 48% and
$2.4 million or 55%, respectively, over the comparable periods in 1999. These
increases are primarily due to significant increases in our sales and marketing
staff and the expansion of commercial launch activities necessary to support the
commercialization of our tests. We anticipate selling, general and
administrative expenses to continue to increase in the near future as we further
penetrate the clinical and research laboratory markets.

        Research and development expenses. Expenses for the three and nine
months ended September 30, 2000 increased approximately $120,000 or 7% and
$722,000 or 16%, respectively, over the comparable periods in 1999. These
increases are primarily due to the addition of technical personnel to further
develop our ACIS tests that included two newly released tests developed during
the quarter and six during 2000 and increased clinical trial costs related to
the expansion of our test menu. We anticipate that research and development
expenses will continue to increase in the near future due to costs related to
the development of new tests, additional clinical trials and the continuation of
technological advances to the ChromaVision ACIS.

        Other income. Other income for the three and nine months ended September
30, 2000 increased approximately $64,000 or 114% and $243,000 or 79%,
respectively, over the comparable periods in 1999 mainly due to increases in
interest earned on our cash balance for 2000. The increase is attributable to
the investment of $18.5 million of net proceeds received from a private
placement of 1,775,000 newly issued shares of common stock in October 1999. We
anticipate interest income to increase in the next quarter due to the investment
of $6.8 million of net proceeds from a private placement completed September 28,
2000 (Note 7 of Notes to Condensed Consolidated Financial Statements).


                                      -9-


<PAGE>   10

LIQUIDITY AND CAPITAL RESOURCES

        On August 13, 1997, we received net proceeds of approximately $28.4
million from our initial public offering of 6,020,000 shares of common stock. On
October 7, 1999, we completed a private placement of 1,775,000 shares of common
stock to selected institutional and other accredited investors. The net proceeds
from the sale of these shares were approximately $18.5 million. On September 28,
2000 we completed a private placement of 560,693 shares of common stock and
warrants to purchase an additional 56,069 shares to two institutional investors,
a wholly owned subsidiary of Safeguard Scientifics, Inc. and incuvest LLC for an
aggregate purchase price of $7 million. We have also agreed to issue additional
shares of our common stock and warrants to purchase our common stock for an
aggregate purchase price of $5,000,000 no later than December 31, 2000 to
incuVest LLC. We have an agreement with a bank for a $5.0 million revolving line
of credit expiring May 30, 2002. The interest rate is prime less 0.25% or LIBOR
plus 1.75% at our option. Currently, there are no borrowings outstanding under
the line of credit. Any borrowings outstanding under the line of credit in the
future will be collateralized by our investment in securities held by the bank
having a market value equal to 111% of the principal balance of the loans. At
September 30, 2000, we had approximately $13.3 million of cash and cash
equivalents and investments, working capital of approximately $12.3 million and
no long-term debt.

        Capital expenditures for the nine months ended September 30, 2000 were
approximately $1.6 million and related primarily to the manufacture of the ACIS
units placed with customers. Capital expenditures are expected to total
approximately $2 million in 2000, and are expected to be related primarily to
manufacturing the ACIS for placements with customers, although our present plans
could change and this amount could be materially different. Our business plan
anticipates placing these instruments with users and charging a per-test fee for
each use of the instrument. The manufacture of these instruments will require a
significant outlay of cash for which revenues will be recognized over the lease
term. We intend to fund these expenditures with our current cash resources.

        We anticipate that existing cash resources and investments will be
sufficient to satisfy our operating cash needs through the end of 2001. We
expect that losses from operations and increases in working capital requirements
will produce significant negative cash flows from operations at least through
the end of 2001. In addition, to support our future cash needs, we intend to
consider additional debt or equity financing. However, there can be no assurance
that any such financing will be available when needed or on terms that would be
attractive to us. If we are unable to obtain sufficient additional funds, we may
have to delay, scale back or eliminate some or all of our development
activities, clinical studies and/or regulatory activities or cease operations
entirely.

UNCERTAINTIES AS TO FUTURE OPERATIONS

        During 1999, we began the transition from being focused almost entirely
on the development of the ACIS system to focus more on marketing and sales of
the system, as tests performed with the ACIS became available for commercial
distribution. We still face significant uncertainties in this regard, including
our ability to establish an effective sales and marketing organization, to
achieve market acceptance of the ACIS, to manufacture the system in commercial
quantities and to achieve satisfactory reimbursement from third-party payers for
tests performed using the ACIS. While the information received from our
customers indicates that approximately 4,000 tests have been reimbursed at
levels consistent with our expectations and no reimbursements have been denied,
our reimbursement experience is limited to date. We also face uncertainties with
respect to our ability to complete development of additional tests for the ACIS.
In order to mitigate the risk that any one test will not be successfully
developed, we maintain a pipeline of tests in a prioritized queue so that if any
one test is not successfully developed, or market feedback on the pipeline
suggests that a test should be given a higher priority, we can prioritize
accordingly.

        Other uncertainties affecting our business include our ability to
collaborate successfully with other companies to develop new tests, initiate and
complete clinical trials of new products and obtain governmental approvals for
the products. Lack of success in these efforts could have a material adverse
effect on the future results of our operations and our ability to generate
sufficient cash flow to fund operations.

ITEM 3 QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

        We invest excess cash in short-term debt securities that are intended to
be held to maturity. These short-term investments have various maturity dates,
which do not exceed one year.

        Two of the main risks associated with these investments are interest
rate risk and credit risk. Typically, when interest rates rise, there is a
corresponding decline in the market value of debt securities. Fluctuations in
interest rates would not have a material effect on our financial statements
because of the short-term nature of the securities in which we invest. Credit
risk refers to the possibility that the issuer of the debt securities will not
be able to make principal and interest payments. We have limited our investments
to investment grade or comparable securities and have not experienced any losses
on investments to date due to credit risk.


                                      -10-


<PAGE>   11

        Changes in foreign exchange rates, and in particular a strengthening of
the U.S. dollar, may negatively affect our consolidated sales and gross margins
as expressed in U.S. dollars. To date, we have not entered into any foreign
exchange contracts to hedge our exposure to foreign exchange rate fluctuations.
However, as our international operations grow, we may enter into foreign
exchange contracts to manage our foreign exchange risk.

PART II

ITEM 2 CHANGES IN SECURITIES AND USE OF PROCEEDS

        See Note 7 to the Notes to the Condensed Consolidated Financial
Statements for information concerning a private placement of newly issued shares
of our Common Stock and information concerning an amendment to our Stockholder
Rights Plan.

ITEM 6 EXHIBITS AND REPORTS ON FORM 8-K

       (a) Exhibits

           3.1 -- Certificate of Incorporation of the Company (as amended)**....
           3.2 -- By-laws of the Company, as amended**..........................
           4   -- Amendment No. 2 to Stockholder Rights Plan***.................
          27   -- Financial Data Schedule*......................................

--------------
*    Filed herewith.

**   Filed on April 30, 1997 as an exhibit to the Company's Registration
     Statement on Form S-1 (No. 333-26129) and incorporated by reference.

***  Filed on October 10, 2000 as an exhibit to the Company's Current Report on
     Form 8-K and incorporated herein by reference.


       (b) Report on Form 8-K

        We filed a Form 8-K with the Securities and Exchange Commission on
October 10, 2000 to report the completion of a private placement of 560,693
newly issued shares of it's Common Stock and warrants to purchase an aggregate
56,070 additional shares of it's Common Stock to two institutional investors and
an amendment to our Stockholders Rights Plan. No financial statements were filed
with this report.


                                      -11-

<PAGE>   12

                                   SIGNATURES

        Pursuant to the requirements of the Securities Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.


                                      CHROMAVISION MEDICAL SYSTEMS, INC.

Date: November 13, 2000               By: /s/ Douglas S. Harrington, M.D.
                                              ---------------------------------
                                              Douglas S. Harrington, M.D.
                                              President, Chief Executive Officer


Date: November 13, 2000               By: /s/ Kevin C. O'Boyle
                                          --------------------------------------
                                              Kevin C. O'Boyle
                                              Senior Vice President Operations,
                                              Chief Financial Officer


                                      -12-


<PAGE>   13

                                 EXHIBIT INDEX

      EXHIBIT
      NUMBER                      DESCRIPTION
      -------                     -----------
        3.1    Certificate of Incorporation of the Company (as amended)**....

        3.2    By-laws of the Company, as amended**..........................

        4      Amendment No. 2 to Stockholder Rights Plan***.................

       27      Financial Data Schedule*......................................

--------------
*    Filed herewith.

**   Filed on April 30, 1997 as an exhibit to the Company's Registration
     Statement on Form S-1 (No. 333-26129) and incorporated by reference.

***  Filed on October 10, 2000 as an exhibit to the Company's Current Report on
     Form 8-K and incorporated herein by reference.


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