CHROMAVISION MEDICAL SYSTEMS INC
10-Q, 1999-11-12
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, 1999

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           (IRS Employer Identification Number)
 of incorporation or organization)

                 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 8, 1999 there were 19,487,629 shares outstanding of the Issuer's
Common Stock, $.01 par value.


<PAGE>   2

                       CHROMAVISION MEDICAL SYSTEMS, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)

                                TABLE OF CONTENTS

<TABLE>
<CAPTION>
                                                                                                             Page
                                                                                                             ----
<S>            <C>
PART I         FINANCIAL INFORMATION

     ITEM 1    FINANCIAL STATEMENTS

               Condensed Consolidated Balance Sheets as of September 30, 1999 and December 31, 1998            3

               Condensed Consolidated Statements of Operations for the three and nine months ended
               September 30, 1999 and 1998; and the period from April 1, 1993
               (Inception) through September 30, 1999                                                          4

               Condensed Consolidated Statements of Cash Flows for the nine
               months ended September 30, 1999 and 1998; and the period from
               April 1, 1993 (Inception) through September 30, 1999                                            5

               Notes to Condensed Consolidated Financial Statements                                            6

     Item 2    Management's Discussion and Analysis of Financial                                               7
               Condition and Results of Operations

     Item 3    Quantitative and Qualitative Disclosures About Market Risk                                     10


PART II OTHER INFORMATION

     Item 2    Changes in Securities and Use of Proceeds                                                      10

     Item 5    Other Information                                                                              10

     Item 6    Exhibits and Reports on Form 8-K                                                               10

SIGNATURES                                                                                                    12
</TABLE>


<PAGE>   3


PART I - ITEM 1

                       CHROMAVISION MEDICAL SYSTEMS, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)

                      CONDENSED CONSOLIDATED BALANCE SHEETS
                                   (Unaudited)

<TABLE>
<CAPTION>
                                                                              SEPTEMBER 30,        DECEMBER 31,
                                                                                 1999                  1998
                                                                              ------------         ------------
                              ASSETS
<S>                                                                           <C>                  <C>
 Current assets:
    Cash and cash equivalents ........................................        $  2,376,120         $  2,853,546
    Short-term investments ...........................................                 -0-            3,533,747
    Note receivable - affiliate ......................................                 -0-            5,000,000
    Other ............................................................             423,652              229,889
                                                                              ------------         ------------

         Total current assets ........................................           2,799,772           11,617,182
 Other ...............................................................             279,605              122,302
 Property and equipment, net .........................................           3,675,823            2,891,471
                                                                              ------------         ------------

         Total assets ................................................        $  6,755,200         $ 14,630,955
                                                                              ============         ============

                 LIABILITIES AND STOCKHOLDERS' EQUITY

 Current liabilities:

    Accounts payable .................................................        $    581,591         $    466,156
    Accrued liabilities ..............................................             579,670              777,579
                                                                              ------------         ------------
        Total current liabilities ....................................           1,161,261            1,243,735

 Commitments and contingencies

 Stockholders' equity:

    Series A convertible preferred stock, $.01 par value,
      authorized 7,246,000 shares, none issued and outstanding .......                 -0-                  -0-
    Series B convertible preferred stock, $.01 par value,
      authorized 221,850 shares, none issued and outstanding .........                 -0-                  -0-
    Series C preferred stock, $.01 par value, authorized 200,000
      shares, none issued and outstanding ............................                 -0-                  -0-
    Common stock $.01 par value, authorized 50,000,000 shares,
      issued and outstanding 17,710,379 shares in 1999 and
      17,270,816 in 1998 .............................................             177,104              172,708

    Additional paid-in capital .......................................          37,104,344           36,442,784
    Accumulated other comprehensive loss .............................             (10,036)                 -0-
    Deficit accumulated during the development stage .................         (31,677,473)         (23,228,272)
                                                                              ------------         ------------
        Total stockholders' equity ...................................           5,593,939           13,387,220
                                                                              ------------         ------------
 Total liabilities and stockholders' equity ..........................        $  6,755,200         $ 14,630,955
                                                                              ============         ============
</TABLE>

     See accompanying notes to condensed consolidated financial statements.



                                      -3-
<PAGE>   4


                       CHROMAVISION MEDICAL SYSTEMS, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)

                 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
                                   (UNAUDITED)

<TABLE>
<CAPTION>
                                                                                                                PERIOD FROM
                                                                                                                APRIL 1, 1993
                                                                                                                (Inception)
                                                  THREE MONTHS ENDED                NINE MONTHS ENDED             THROUGH
                                                     SEPTEMBER 30,                    SEPTEMBER 30,             SEPTEMBER 30,
                                                1999             1998            1999              1998            1999
                                            ------------     ------------     ------------     ------------     ------------
<S>                                         <C>              <C>              <C>              <C>              <C>
Revenue ................................     $    32,669      $     7,194      $    96,816      $     7,194      $ 1,354,025

Cost of revenue ........................          24,956            4,523           59,032            4,523          611,347
                                            ------------     ------------     ------------     ------------     ------------


   Gross profit ........................           7,713            2,671           37,784            2,671          742,678
                                            ------------     ------------     ------------     ------------     ------------

Operating expenses:
   Selling, general and administrative .       1,671,625          974,060        4,345,340        2,985,509       16,601,956
   Research and development ............       1,627,707        1,176,330        4,447,085        3,427,820       17,575,890
   Legal settlement ....................             -0-              -0-              -0-          300,000          300,000
                                            ------------     ------------     ------------     ------------     ------------

     Total operating expenses ..........       3,299,332        2,150,390        8,792,425        6,713,329       34,477,846
                                            ------------     ------------     ------------     ------------     ------------

     Loss from operations ..............      (3,291,619)      (2,147,719)      (8,754,641)      (6,710,658)     (33,735,168)
                                            ------------     ------------     ------------     ------------     ------------
Other income:

   Interest income .....................          55,975          223,940          292,403          771,101        1,621,133
   Other income ........................             -0-            1,140           13,037            1,140          436,562
                                            ------------     ------------     ------------     ------------     ------------

     Total other income ................          55,975          225,080          305,440          772,241        2,057,695
                                            ------------     ------------     ------------     ------------     ------------

     Loss before income taxes ..........      (3,235,644)      (1,922,639)      (8,449,201)      (5,938,417)     (31,677,473)

Income taxes ...........................             -0-              -0-              -0-              -0-              -0-
                                            ------------     ------------     ------------     ------------     ------------

     Net loss ..........................     $(3,235,644)     $(1,922,639)     $(8,449,201)     $(5,938,417)    $(31,677,473)
                                            ============     ============     ============     ============     ============

Basic and diluted net loss per common
     share .............................     $      (.18)     $      (.11)     $      (.48)     $      (.35)
                                            ============     ============     ============     ============

Weighted average number of common
   shares outstanding ..................      17,687,939       17,257,745       17,581,006       17,221,604
                                            ============     ============     ============     ============
</TABLE>

     See accompanying notes to condensed consolidated financial statements.



                                      -4-
<PAGE>   5



                       CHROMAVISION MEDICAL SYSTEMS, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)

                 CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
                                   (UNAUDITED)

<TABLE>
<CAPTION>
                                                                                                PERIOD FROM
                                                                                               APRIL 1, 1993
                                                                                                (Inception)
                                                                  NINE MONTHS ENDED               THROUGH
                                                                     SEPTEMBER 30,              SEPTEMBER 30,
                                                                1999              1998             1999
                                                            ------------      ------------      ------------
<S>                                                         <C>               <C>               <C>
       Cash flows from development stage activities:
Net loss ..............................................     $ (8,449,201)     $ (5,938,417)     $(31,677,473)
Adjustments to reconcile net loss to net cash used
   in operating activities:
     Depreciation and amortization ....................        1,002,563           447,829         1,945,386
     Issuance of preferred stock for services .........              -0-               -0-           770,192
     Write-off of note receivable .....................              -0-               -0-            40,000
  Changes in operating assets and liabilities:
     Other assets .....................................         (352,734)          (29,622)         (704,925)
     Accounts payable .................................          114,033           230,303           580,189
     Accrued liabilities ..............................         (204,875)          223,765           572,704
                                                            ------------      ------------      ------------
     Net cash used in operating activities ............       (7,890,214)       (5,066,142)      (28,473,927)
                                                            ------------      ------------      ------------
Cash flows from investing activities:

Note receivable from affiliate ........................              -0-               -0-        (5,825,000)
Collections on notes receivable from affiliate ........        5,000,000               -0-         5,785,000
Proceeds from (purchases of) investments ..............        3,533,747        (1,476,549)              -0-
Additions to property and equipment ...................       (1,786,915)       (1,520,375)       (5,621,209)
                                                            ------------      ------------      ------------
     Net cash provided by (used in) investing
         activities ...................................        6,746,832        (2,996,924)       (5,661,209)
                                                            ------------      ------------      ------------
Cash flows from financing activities:
Proceeds from exercise of stock options ...............          665,956            87,749           782,205
Sale of common stock ..................................              -0-               -0-        30,115,450
Sale of preferred stock ...............................              -0-               -0-         7,363,196
Offering costs ........................................              -0-               -0-        (1,749,595)
                                                            ------------      ------------      ------------
       Net cash provided by financing activities ......          665,956            87,749        36,511,256
                                                            ------------      ------------      ------------
       Net increase (decrease) in cash and cash
         equivalents ..................................         (477,426)       (7,975,317)        2,376,120

Cash and cash equivalents beginning of period .........        2,853,546        12,926,398               -0-
                                                            ------------      ------------      ------------

Cash and cash equivalents end of period ...............     $  2,376,120      $  4,951,081      $  2,376,120
                                                            ============      ============      ============
</TABLE>


     See accompanying notes to condensed consolidated financial statements.



                                      -5-
<PAGE>   6


                       CHROMAVISION MEDICAL SYSTEMS, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)

              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 the Company's 1998 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 the Company's operations for any interim period are
not necessarily indicative of the results to be obtained for a full fiscal year.

(2)     DEVELOPMENT STAGE

        From the inception of ChromaVision on April 1, 1993, the Company 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". The Company will be considered in the development stage
until it begins to realize significant revenue from its planned operations

(3)     NET LOSS PER SHARE

        Options to purchase 2,026,625 and 1,957,313 shares of common stock were
outstanding at September 30, 1999 and 1998, respectively, and were excluded from
the computation of diluted net loss per share as the effect would be
antidilutive.


                                      -6-
<PAGE>   7

(4)     CURRENCY TRANSLATION

        The financial position and results of operations of the Company's
foreign subsidiaries are generally determined using 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 year.

(5)     COMPREHENSIVE LOSS

        The Company's total comprehensive loss is summarized as follows:

<TABLE>
<CAPTION>
                                          Three Months Ended September 30,  Nine Months Ended September 30,
                                             1999             1998              1999             1998
                                          -----------      -----------      -----------      -----------
<S>                                       <C>              <C>              <C>              <C>
Net loss ............................     $(3,235,644)     $(1,922,639)     $(8,449,201)     $(5,938,417)
Foreign currency translation loss ...         (10,036)             -0-          (10,036)             -0-
                                          -----------      -----------      -----------      -----------
Comprehensive loss ..................     $(3,245,680)     $(1,922,639)     $(8,459,237)     $(5,938,417)
                                          ===========      ===========      ===========      ===========
</TABLE>


(6)     SUBSEQUENT EVENTS

        On October 7, 1999, the Company closed the sale of a private placement
of 1,775,000 newly issued shares of its common stock to selected institutional
and other accredited investors. The purchase price per share was $11.25. The net
proceeds to the Company from the sale of the shares are approximately $18.6
million. The funds will be used to provide working capital to continue to
develop and commercialize the ACIS products and for general corporate purposes.

PART I - ITEM 2

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

        Statements in this report describing the plans, goals, strategies,
intentions, and expectations of the Company 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: an inadequate supply of biological samples could delay
completion of the clinical trials; the clinical trials could fail to demonstrate
the efficacy of the ChromaVision Automated Cellular Imaging System ("ACIS")
applications; new applications may not be successfully developed; the ability to
commercialize new applications is 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; manufacture of the ACIS is subject
to FDA regulation; commercialization of the Company's products is dependent on
acceptance by the medical community and medical insurance industry, which could
be delayed or not obtained; and the impact of the Company's efforts to remediate
potential Year 2000 problems.

OVERVIEW

        ChromaVision is a laboratory medicine diagnostics company that develops
and manufactures an automated cellular imaging system for a wide variety of
clinical and research applications. The ACIS and one application, leukocyte
alkaline phosphatase ("LAP"), were cleared for commercial distribution in the
U.S. by the F.D.A in June of 1997. In July 1999, an additional application was
cleared by the F.D.A for use with the ACIS. The application,
immunohistochemistry ("IHC"), is a widely used staining method for the
evaluation of numerous disease conditions. The IHC clearance enables
ChromaVision to introduce tests for the ACIS using that method without having to
apply for FDA clearance. Currently, five ACIS tests are scheduled for commercial
release in 1999 using the IHC method.

        The ChromaVision ACIS is designed to identify cells with specific
characteristics within a sample of cells on a microscope slide by detecting
color produced by the reaction between common laboratory reagents and the cells
of interest. The intelligent microscope platform automates the scanning of up to
100 patient samples (slides) and uses proprietary imaging software to capture
digital images of the cell samples to detect the presence, count the number and
measure the intensity of targeted cells. The system offers substantial
flexibility because the software can be configured to identify different stains
and cellular staining characteristics, thereby allowing the system to be adapted
for use with different reagents to identify a broad range of targeted cellular
conditions. The Company seeks to establish the ChromaVision ACIS as the
preferred platform for multiple diagnostic applications.

                                      -7-
<PAGE>   8

REVENUE AND GROSS PROFITS

        Revenue of approximately $33,000 and $97,000 for the three and nine
months ended September 30, 1999 is primarily due to monthly rental charges
generated from the commercial placement of the ACIS. The Company is a
development stage company and has just recently begun its commercial phase.
Therefore there is no significant revenue or gross profit for the comparable
periods in 1998.

SELLING, GENERAL AND ADMINISTRATIVE EXPENSES

        Expenses for the three and nine months ended September 30, 1999
increased approximately 72% and 46%, respectively, over the comparable periods
in 1998. These increases are primarily due to increases in the Company's sales
and marketing staff necessary to support the commercialization of the Company's
applications. The Company anticipates selling, general and administrative
expenses to continue to increase in the near future as the Company enters the
commercial phase of its development.

RESEARCH AND DEVELOPMENT EXPENSES

        Expenses for the three and nine months ended September 30, 1999
increased approximately 38% and 30%, respectively, over the comparable periods
in 1998. These increases are primarily due to the addition of technical
personnel to further develop the Company's pipeline of applications. The Company
anticipates that research and development expenses will continue to increase in
the near future due to the development of new applications, additional clinical
trials and the continuation of technological advances to the ChromaVision ACIS.

LEGAL SETTLEMENT

        In April 1998, the Company paid $300,000 for legal settlement costs.

OTHER INCOME

        Other income for the three and nine months ended September 30, 1999
decreased approximately $169,000 and $467,000, respectively, over the comparable
periods in 1998 due to a drop in interest income. The decrease in interest
income resulted primarily from a decrease in the remaining funds generated from
the Company's initial public offering that were used to fund operations.

UNCERTAINTIES AS TO FUTURE OPERATIONS

        During 1999, the Company has begun the transition from being focused
almost entirely on the development of the ACIS system to focusing more on
marketing and sales of the system as tests performed with the ACIS become
available for commercial distribution. The Company faces significant
uncertainties in this regard, including its ability to achieve market acceptance
of the ACIS, manufacture the components of the system in commercial quantities
and achieve satisfactory reimbursement from third-party payers for tests
performed using the ACIS. The Company also faces uncertainties with respect to
its ability to complete development of tests it is working on. In order to
mitigate the risk that any one test will not be successfully developed, the
Company maintains a pipeline of tests in a prioritized cue so that if any one
test is not successfully developed, the Company can move other tests up in
priority. As an example of this, the clinical trials for the Company's proposed
screen for Down Syndrome known as the Triple Plus TM have taken longer than
expected and some preliminary data indicate that the test may not be as strong a
predictor of Down Syndrome as had been expected. While the Company is still
evaluating the data and the implications for the commercial release of the test,
the Company is concentrating more of its efforts on other tests that presently
show more promise.

        Other uncertainties affecting the Company include its ability to
collaborate successfully with other companies in the development of 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 the Company's operations and
its ability to generate sufficient cash flow to reduce its dependence on
additional financing.

LIQUIDITY AND CAPITAL RESOURCES

        On August 13, 1997, the Company completed its initial public offering of
6,020,000 shares of Common Stock. The Company received net proceeds of
approximately $28.4 million after deducting underwriting discounts and offering
expenses. On October 7, 1999, the Company completed a private placement of
1,775,000 shares of Common Stock to selected institutional and other accredited
investors. The net proceeds to the Company from the sale of the shares are
approximately $18.6 million.

        The Company has an agreement with its principal bank for a $5,000,000
revolving line of credit. The line expires May 30, 2000. At the Company's
option, the interest rate is prime less .25% or LIBOR plus 1.75%. There were no
borrowings outstanding under the line of credit during the period. Any
borrowings outstanding under the line of credit will be collateralized by the
Company's investment in securities held by the principal bank having a market
value equal to 111% of the principal balance of the loans. At September 30, 1999

                                      -8-
<PAGE>   9

and without giving effect to the receipt on October 7, 1999 of the proceeds of
the private placement referred to above, the Company had approximately $2.4
million of cash and cash equivalents and investments and working capital of
approximately $1.6 million and no long-term debt.

        Capital expenditures for the nine months ended September 30, 1999 were
approximately $1.8 million and related primarily to the manufacture of the
ChromaVision ACIS systems placed with customers. Capital expenditures are
expected to total approximately $3 million in 1999, and are expected to be
primarily related to the manufacture of the ChromaVision ACIS for placements
with customers, although the Company's present plans could change and this
amount could be materially different. The Company's business plan anticipates
placing these instruments with users and charging a "per-click" 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. The Company intends to fund these expenditures with current cash reserves,
which may be partially supplemented by third-party asset based financing for
these instruments. The Company presently has an agreement for such financing
totaling $1 million.

        The Company anticipates that existing cash resources and investments,
including the proceeds from the private placement completed on October 7, 1999,
will be sufficient to satisfy its operating cash needs for the next twelve
months. Management expects that losses from operations and increases in working
capital requirements will produce significant negative cash flows from
operations for at least the next twelve months and beyond. In addition, to
support the Company's future cash needs, it intends to seek additional debt or
equity financing. However there can be no assurance that any such financing will
be available to the Company or that adequate funds for the Company's operations
will be available when needed or on terms attractive to the Company. If the
Company is unable to obtain sufficient additional funds, the Company may have to
delay, scale back or eliminate some or all of its development activities,
clinical studies and/or regulatory activities or cease operations entirely.

YEAR 2000 PROBLEMS

        The Company purchases computer hardware and software and also develops
software for use in its ChromaVision ACIS(TM). In addition, purchased software
is run on in-house computer networks. During the second quarter, the Company
completed an inventory, assessment and final testing of the Company's product,
in-house network software and its reliance on embedded technology. The Company
did not note any Year 2000 problems, which would prevent its products and
systems from being capable of correctly interpreting dates beyond the Year 1999.

        The Company has surveyed its key suppliers to determine whether they
will be Year 2000 ready and has found a reluctance by the key suppliers to give
complete assurance as to their Year 2000 readiness. In addition, due to the
Company's development stage status, currently it does not have a customer base
from which to survey Year 2000 problems. The Company's most reasonably likely
worst case scenario would be an interruption in key suppliers' and potential
customers' activities due to Year 2000 problems and interruption in the ability
of one or more governmental entities or insurance companies to reimburse health
care providers. Either or both of these possibilities could have a material
adverse effect on the Company's financial results, cash flow and operations.

          The Company is in the process of finalizing its contingency plans to
handle Year 2000 problems that may develop. The contingency plans are expected
to include: methods of dealing with third parties that are not dependent upon
computer or micro controller technology, an increase in year-end inventory
levels for key components, accelerated replacement of affected equipment or
software and increased work hours for our personnel. The Company estimates that
it will complete its contingency plans in advance of the end of 1999.

        The Company does not expect that the cost of its Year 2000 program will
be material to its business, financial condition or results of operations.
Substantially all of the costs of the program have consisted and are expected to
continue to consist of compensation expense allocable to employees who work on
the Year 2000 project. All costs are expensed as incurred.

        All statements in this Report regarding the Year 2000 problem involve
forward-looking information as to which there is great uncertainty. The actual
results of the Company's program to deal with the Year 2000 problem could differ
materially from what the Company plans and anticipates because of the lack of
experience of the Company and others with problems of this kind, the extent to
which computer and other systems of business and other entities are
inter-related and the lack of control over, and access to information of, third
parties upon whom the Company's business is dependent. The failure of the
Company to correctly analyze and anticipate Year 2000 problems in its own
operations or those of third parties or the failure or inability to develop
effective contingency plans could have a material adverse effect on the
Company's business.

                                      -9-
<PAGE>   10

ITEM 3 -QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK

        The Company invests 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 the Company's financial statements because
of the short term nature of the securities in which the Company invests. Credit
risk refers to the possibility that the issuer of the debt securities will not
be able to make principal and interest payments. The Company has limited its
investments to investment grade or comparable securities and has not experienced
any losses on its investments to date due to credit risk.

PART II

ITEM 2-CHANGES IN SECURITIES AND USE OF PROCEEDS

        On October 7, 1999 the Company completed a private placement of
1,775,000 shares of its Common Stock to a limited number of institutional and
other accredited investors. The shares were sold for $11.25 per share,
resulting in gross proceeds from the offering of $19,968,750. Net proceeds were
approximately $18, 600,000. Prudential Vector Healthcare Group, a division of
Prudential Securities, acted as placement agent for the offering and received a
fee equal to 6% of the gross proceeds of the offering, or approximately
$1,198,000, plus reimbursement of certain expenses of the offering. The shares
were issued in reliance upon the exemption from the registration requirement of
the Securities Act of 1933 afforded to transactions not involving a public
offering by Section 4(2) of that Act and Rule 506 of the Securities and Exchange
Commission. The shares issued in the offering have been registered for resale by
the purchasers of the shares.

        The Company completed its initial public offering pursuant to a
registration statement (Registration No. 333-26129) which became effective on
July 1, 1997. Of the $28.4 million of net proceeds of the offering,
approximately $5.5 million were used for repayment of the bank line of credit
indebtedness and reduction of an inter-company payable to XL Vision, Inc. and an
additional $20.5 million were used to fund working capital and research and
development through September 30, 1999.

ITEM 5  OTHER INFORMATION

        Stockholders intending to present proposals at the next Annual Meeting
of Stockholders to be held in 2000 must notify the Company of the proposal no
later than December 30, 1999 if they wish to include the proposal on the
Company's proxy card and, along with any supporting statement, in the Company's
proxy statement. As to any proposal presented by a stockholder at the Annual
Meeting of Stockholders that has not been included in the Proxy Statement, the
management proxies will be allowed to use their discretionary voting authority
unless notice of such proposal is received by the Company no later than March
31, 2000.

ITEM 6- EXHIBITS AND REPORTS ON FORM 8-K

<TABLE>
<CAPTION>
(a)     Exhibits
<S>       <C>
  3.1     Certificate of Incorporation of the Company (as amended)**.........................
  3.2     By-laws of the Company, as amended**...............................................
 10.13    Form of Stock Purchase Agreement, dated September 24, 1999 by and among
          ChromaVision Medical Systems, Inc. and the purchaser***............................
  27      Financial Data Schedule*...........................................................
</TABLE>

(b)     Report on Form 8-K

        The Company filed a Form-8-K with the Commission on October 15, 1999 to
report the completion of a private placement of 1,775,000 newly issued shares of
it's common stock to selected investors. No financial statements were filed with
this report.

*       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.

                                      -10-
<PAGE>   11

***     Filed on September 28, 1999 as an exhibit to the Company's Registration
        Statement on Form S-3 (No. 333-87969) and incorporated by reference.



                                      -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 12, 1999               BY:  /s/  Douglas S. Harrington, M.D.
      ------------------------------         -----------------------------------
                                             Douglas S. Harrington, M.D.
                                             President & Chief Executive Officer


DATE:   November 12, 1999               BY:  /s/  Kevin C. O'Boyle
      ------------------------------         -----------------------------------
                                             Kevin C. O'Boyle
                                             Senior Vice President Operations &
                                             Chief Financial Officer

                                      -12-
<PAGE>   13

                                 Exhibit Index



<TABLE>
<CAPTION>
Exhibit
Number    Description
- ------    -----------
<S>       <C>
  3.1     Certificate of Incorporation of the Company (as amended)**
  3.2     By-laws of the Company, as amended**
 10.13    Form of Stock Purchase Agreement, dated September 24, 1999 by and among
          ChromaVision Medical Systems, Inc. and the purchaser***
  27      Financial Data Schedule*
</TABLE>

  * Filed herewith.

 ** Filed on April 30, 1997 as an exhibit to the Company's Registration
    Statement on Form S-1 (No. 333.261-2629) and incorporated by reference.

*** Filed on September 28, 1999 as an exhibit to the Company's Registration
    Statement on Form S-3 (No. 333-87969) and incorporated by reference.


                                      -13-

<TABLE> <S> <C>

<ARTICLE> 5

<S>                             <C>
<PERIOD-TYPE>                   9-MOS
<FISCAL-YEAR-END>                          DEC-31-1999
<PERIOD-START>                             JAN-01-1999
<PERIOD-END>                               SEP-30-1999
<CASH>                                       2,376,120
<SECURITIES>                                         0
<RECEIVABLES>                                        0
<ALLOWANCES>                                         0
<INVENTORY>                                          0
<CURRENT-ASSETS>                             2,799,772
<PP&E>                                       5,499,242
<DEPRECIATION>                               1,823,419
<TOTAL-ASSETS>                               6,755,200
<CURRENT-LIABILITIES>                        1,161,261
<BONDS>                                              0
                                0
                                          0
<COMMON>                                       177,104
<OTHER-SE>                                    (10,036)
<TOTAL-LIABILITY-AND-EQUITY>                 6,755,200
<SALES>                                         96,816
<TOTAL-REVENUES>                                96,816
<CGS>                                           59,032
<TOTAL-COSTS>                                        0
<OTHER-EXPENSES>                             8,792,425
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                                   0
<INCOME-PRETAX>                            (8,449,201)
<INCOME-TAX>                                         0
<INCOME-CONTINUING>                                  0
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                               (8,449,201)
<EPS-BASIC>                                      (.48)
<EPS-DILUTED>                                    (.48)


</TABLE>


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