CAMBRIDGE HEART INC
10-Q, 1996-11-13
ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS
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<PAGE>
 
                                 UNITED STATES
                      SECURITIES AND EXCHANGE COMMISSION
                            Washington, D.C. 20549


                                   FORM 10-Q


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


For the quarterly period 
 ended September 30, 1996                    Commission File Number 0-20991

                             CAMBRIDGE HEART, INC.
            (Exact name of Registrant as specified in its charter)

          DELAWARE                                   13-3679946
 (State or other jurisdiction of        (I.R.S. Employer Identification No.)
 incorporation or organization)

         1 Oak Park Drive
       Bedford, Massachusetts                                 01730
(Address of principal executive offices)                   (Zip Code)


                                 617-271-1200
             (Registrant's telephone number, including area code)



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 (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      
- -------   -------

  Number of shares outstanding of the issuer's classes of common stock as of
                              November 8, 1996;


           Class                                   Number of Shares Outstanding
- ---------------------------------                  ---------------------------- 
Common Stock, par value $.001 per share                      10,204,994

                                      -1-
<PAGE>
 
                             CAMBRIDGE HEART, INC.

                                     INDEX


                                                         Page Number 
                                                         -----------

PART I.   FINANCIAL INFORMATION                                4

          Item 1. Financial Statements                         4

                  Balance Sheet at December 31, 
                  1995 and September 30, 1996                  4

                  Statement of Operations
                  for the Three-month and Nine-month 
                  periods ended September 30, 1995
                  and 1996 and the period from
                  inception (January 16, 1990) through
                  September 30, 1996                           5       

                  Statement of Cash Flows
                  for the Nine-month periods ended
                  September 30, 1995 and 1996 and
                  the period from inception (January 16,
                  1990) through September 30, 1996             6            

                  Notes to Condensed Financial 
                  Statements                                   7

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


PART II.  OTHER INFORMATION                                   12

          Item 6. Exhibits and Reports on Form 8-K            12


SIGNATURE                                                     13


     This Quarterly Report on Form 10-Q contains forward-looking statements. For
this purpose, any statements contained herein that are not statements of
historical fact may be deemed to be forward-looking statements. Without limiting
the foregoing, the words "believes," "anticipates," "plans," "expects," and
similar expressions are intended to identify forward-looking statements. The
important factors discussed below under the caption "Certain Factors That May
Affect Future Operating Results," among others, could

                                      -2-
<PAGE>
 
cause actual results to differ materially from those indicated by forward-
looking statements made herein and presented elsewhere by management from time
to time.

                                      -3-
<PAGE>
 
                        PART I - FINANCIAL INFORMATION
                                    ITEM 1
                             FINANCIAL STATEMENTS

                             CAMBRIDGE HEART, INC.
                       (a development stage enterprise)
 
                                 BALANCE SHEET

<TABLE>
<CAPTION>
 
                                                          December 31,   September 30,
                                                              1995           1996
                                                          ------------   -------------
                                                                          (unaudited)
<S>                                                       <C>            <C>  
Current assets:
Cash and cash equivalents...............................   $3,948,147     $20,221,213
Accounts receivable.....................................          -           203,365
Inventory...............................................      118,865         279,812
Prepaid expenses and other current assets...............       48,370         395,243
                                                           ----------     -----------
 
 Total current assets...................................    4,115,382      21,099,633
 
Fixed assets, net.......................................      161,978         266,228
Other assets............................................          -           121,416
                                                           ----------     -----------
                                                           $4,277,360     $21,487,277
                                                           ==========     =========== 
 
Current liabilities:
Accounts payable........................................   $  108,471     $   234,964
Accrued expenses........................................      126,738         197,774
License fees payable....................................       31,212          31,212
                                                           ----------     -----------
 
 Total current liabilities..............................      266,421         463,950
                                                           ----------     -----------
 
Series B convertible preferred stock, $.001 par value;
 2,500,000 shares authorized; 2,333,333 and 0 shares
 issued and outstanding at December 31, 1995 and
 September 30, 1996......................................       2,333             -
Series A convertible preferred stock, $.001 par value;
 6,900,000 shares authorized; 6,578,083 and 0 shares
 issued and outstanding at December 31, 1995 and
 September 30, 1996......................................       6,578             -
Common stock, $.001 par value; 20,000,000 shares
 authorized; 3,163,163 and 10,183,872 shares issued and
 outstanding at December 31, 1995 and September 30, 1996.       3,163          10,184
Additional paid-in-capital...............................   9,079,671      29,211,105
Deficit accumulated during the development stage.........  (5,080,806)     (7,794,087)
                                                           ----------     -----------
 
                                                            4,010,939      21,427,202
Less: deferred compensation..............................         -          (403,875)
                                                           ----------     -----------
 
 Total stockholders' equity..............................   4,010,939      21,023,327
                                                           ----------     -----------
 
                                                           $4,277,360     $21,487,277
                                                           ==========     ===========
</TABLE>

           See accompanying notes to condensed financial statements.

                                      -4-
<PAGE>
 
                             CAMBRIDGE HEART, INC.
                       (a development stage enterprise)

                            STATEMENT OF OPERATIONS
                                  (unaudited)

<TABLE>
<CAPTION>
                                                                                                                 Period from
                                                    Three months ended           Nine months ended                inception
                                                      September 30,                September 30,                 (January 16,
                                                  -----------------------    ----------------------------        1990 through
                                                     1995         1996          1995             1996          September 30, 1996
                                                  ---------   -----------    -----------      -----------      ------------------ 
<S>                                               <C>         <C>             <C>             <C>              <C>
Product revenue.................................  $  68,047   $   235,305     $    68,047     $   475,007          $   543,054
Revenue from research and option agreement......        -             -               -            25,000               50,000
                                                  ---------   -----------     -----------     -----------          -----------
 
 Total revenue..................................     68,047       235,305          68,047         500,007              593,054
Cost of goods sold..............................     81,947       246,416          81,947         553,740              695,052
                                                  ---------   -----------     -----------     -----------          -----------

                                                    (13,900)      (11,111)        (13,900)        (53,733)            (101,998)
 
Cost and expenses:
Research and development........................    372,144       569,205       1,123,417       1,441,947            4,728,052
Selling, general and administrative.............    274,475       638,923         740,710       1,456,107            3,639,800
                                                  ---------   -----------     -----------     -----------          -----------
 
 Loss from operations...........................   (660,519)   (1,219,239)     (1,878,027)     (2,951,787)          (8,469,850)
 
Interest expense................................        -             -               -               -                 (5,620)
Interest income.................................     75,851       158,192         181,204         238,506              681,383
                                                  ---------   -----------     -----------     -----------          -----------
 
Net loss........................................  $(584,668)  $(1,061,047)    $(1,696,823)    $(2,713,281)         $(7,794,087)
                                                  =========   ===========     ===========     ===========          ===========

Net loss per share..............................              $     (0.14)
                                                              ===========                  

Weighted average common
  shares outstanding............................                7,702,234
                                                              ===========                  

Supplementary net loss per share................              $     (0.11)                    $     (0.32)
                                                              ===========                     ===========
                                                                                
Supplementary weighted average
  common shares outstanding.....................                9,300,478                       8,501,685
                                                              ===========                     ===========
                                                                                
</TABLE> 


           See accompanying notes to condensed financial statements.

                                      -5-
<PAGE>
 
                             CAMBRIDGE HEART, INC.
                       (a development stage enterprise)

                            STATEMENT OF CASH FLOWS
                                  (unaudited)
<TABLE>
<CAPTION>

                                                                                                    
                                                                                                    Period from 
                                                                                                     inception
                                                              Nine months ended September 30,    (January 16, 1990) 
                                                             ----------------------------------    1990) through
                                                                  1995              1996         September 30, 1996
                                                             ---------------  -----------------  -------------------
<S>                                                          <C>              <C>                <C>
Cash flows from operaing activities:
Net loss...................................................    $(1,696,823)      $(2,713,281)        $(7,794,087)
                                                               -----------       -----------         -----------
Adjustments to reconcile net loss to net
  cash used for operating activities:
  Issuance of common stock purchase right
    to licensor............................................            -                 -                35,640
  Depreciation.............................................         18,073             41,011             86,921
  Amortization of deferred compensation....................            -               44,875             44,875
  Changes in assets and liabilities:
    Increase in accounts receivable........................         (68,047)          (203,365)         (203,365)
    Increase in inventory..................................         (48,513)          (160,947)         (279,812)
    Increase in prepaid expenses and other
      current assets.......................................          (8,669)          (346,873)         (395,243)
    Increase in other assets...............................         (12,791)          (121,416)         (121,416)
    Increase (decrease) in accounts payable
      and accrued expenses.................................            (681)           197,529           432,738
    Increase in license fees
      payable..............................................              -                 -              31,212
                                                               -----------       -----------         -----------
 
      Net cash used for operating activities...............     (1,817,451)       (3,262,467)         (8,162,537)
                                                               -----------       -----------         -----------
 
Cash flows from investing activities:
Purchases of fixed assets                                          (52,932)         (145,261)           (353,149)
                                                               -----------       -----------         -----------
 
Cash flows from financing activities:
Proceeds from issuance of notes payable....................            -                 -               100,000
Proceeds from issuance of common stock, net
  of issuance costs........................................          2,602        19,680,794          19,686,509
Proceeds from capital contribution.........................            -                 -                 3,100
Proceeds from issuance of Series A preferred
  stock, net of issuance costs.............................            -                 -             5,596,777
Proceeds from issuance of Series B preferred
  stock, net of issuance costs.............................      3,350,513               -             3,350,513
                                                               -----------       -----------         -----------
 
      Net cash provided by financing activities...........       3,353,115        19,680,794          28,736,899
                                                               -----------       -----------         -----------
 
Net increase in cash and cash equivalents.................       1,482,732        16,273,066          20,221,213
Cash and cash equivalents at beginning
  of period...............................................       3,329,490         3,948,147                 -
                                                               -----------       -----------         -----------
Cash and cash equivalents at end
  of period...............................................     $ 4,812,222       $20,221,213         $20,221,213
                                                               ===========       ===========         ===========

</TABLE>
           See accompanying notes to condensed financial statements.

                                      -6-
<PAGE>
 
                             CAMBRIDGE HEART, INC.

                    Notes to Condensed Financial Statements
                                  (unaudited)

1.  NATURE OF BUSINESS
    Cambridge Heart, Inc. (the "Company"), was incorporated in Delaware on
    January 16, 1990 and is engaged in the research, development and
    commercialization of products for the non-invasive diagnosis of cardiac
    disease.

    During the period from inception (January 16, 1990) through September 30,
    1996, the Company devoted substantially all of its efforts to business
    planning, raising financing, recruiting personnel, research and development
    and obtaining regulatory approval for its products. Although the Company
    commenced its planned principal activities and began selling its product in
    1995, it has not generated significant revenue therefrom. Accordingly, the
    Company is considered to be in the development stage, as defined by
    Statement of Financial Accounting Standards No. 7, at September 30, 1996.

2.  BASIS OF PRESENTATION
    The condensed financial statements have been prepared by the Company without
    audit, pursuant to the rules and regulations of the Securities and Exchange
    Commission. Certain information and footnote disclosures normally included
    in financial statements prepared in accordance with generally accepted
    accounting principles have been condensed or omitted pursuant to such rules
    and regulations. These condensed financial statements should be read in
    conjunction with the financial statements and the notes thereto included in
    the Company's filing of its registration statement on Form S-1, dated August
    2, 1996. In the opinion of management, all adjustments, consisting only of
    normal recurring adjustments necessary to present fairly the financial
    position of Cambridge Heart, Inc. as of September 30, 1996, and the results
    of its operations for the three and nine month periods ending September 30,
    1996 and 1995, and cash flows for the nine months ending September 30, 1996
    and 1995, have been made. The results of operations for such interim
    periods are not necessarily indicative of the results for the full year.

    Certain amounts in prior quarters have been reclassified to conform to the
    current quarter presentation. These reclassifications had no effect on the
    Company's results of operations.

3.  INVENTORIES
    Inventories, consisting primarily of purchased components, are stated at the
    lower of cost or market.  Cost is determined using the first in, first out
    (FIFO) method.

4.  INITIAL PUBLIC OFFERING
    The Company completed its initial public offering, selling 2,437,750 shares
    of common stock for net proceeds of approximately $19,660,000. In
    conjunction with the initial public offering, all of the Company's
    outstanding preferred stock was converted to 4,455,708 shares of common
    stock.

                                      -7-
<PAGE>
 
5.  NET LOSS AND SUPPLEMENTARY NET LOSS PER SHARE

    Net loss per share is determined by dividing net loss by the weighted
    average number of common shares outstanding during the period. Common share
    equivalents, consisting of common stock options and warrants and convertible
    preferred stock, have been excluded from the calculation as their effect is
    anti-dilutive.

    Supplementary net loss per share is determined by dividing net loss by the
    weighted average number of common shares and certain common share
    equivalents outstanding during the period, as discussed below. Common share
    equivalents have been excluded from the calculation as their effect is anti-
    dilutive, except that, pursuant to Securities and Exchange Commission Staff
    Accounting Bulletin No. 83, common share equivalents issued and common stock
    sold at prices below the offering price in the twelve month periods
    preceding the initial filing of the Company's Registration Statement and
    through the effective date of the initial public offering have been included
    in the calculation as if outstanding for all periods through June 30, 1996.

    On August 2, 1996, the date of the Company's initial public offering, all of
    the preferred stock was converted to 4,455,708 shares of common stock. The
    supplementary net loss per share information included in the accompanying
    statement of operations for the three and nine months ended September 30,
    1996 reflect the impact on supplementary net loss per share of such
    conversion as of the beginning of each period using the if-converted method.

    Historical net loss per share has not been presented for the nine month
    period ended September 30, 1996 and the three and nine month periods ended
    September 30, 1995 on the basis that it is irrelevant due to the significant
    change in the Company's capital structure and resultant loss per share which
    resulted upon conversion of the convertible preferred stock.

                                      -8-
<PAGE>
 
                                    ITEM 2
        MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
                             RESULTS OF OPERATIONS


OVERVIEW

     Cambridge Heart, Inc., a Delaware corporation (the "Company") is engaged in
the research, development and commercialization of products for the non-invasive
diagnosis of cardiac disease. The Company has generated limited revenues from
the shipment of demonstration units of its first product and has experienced
substantial net losses since its inception, and expects to incur substantial and
increasing net losses for the foreseeable future. The Company believes that its
research and development expenses will increase significantly in the future as
it develops additional products and funds clinical trials of its products. The
Company's research and development expenses may also increase in the future as
it supplements its internal research and development with third party
technology licenses and potential product acquisitions. The Company also expects
that its selling, general and administrative expenses will continue to increase
in connection with the Company's continued expansion of its sales and marketing
activities. Revenues generated from the sale of the Company's products will
depend upon numerous factors, including the timing of regulatory actions,
progress of product development, the extent to which the Company's products gain
market acceptance, varying pricing promotions and volume discounts to customers,
competition and the availability of third party reimbursement. The Company has
incurred cumulative net losses since inception through September 30, 1996 of
approximately $7,794,000.

RESULTS OF OPERATIONS

     The Company's first product is the CH 2000 System. The system received
510(k) clearance from the U.S. Food and Drug Administration FDA in February 1996
and the Company's proprietary HiRes disposable electrode received 510(k)
clearance in August of 1996. This electrode enables the CH 2000 System to
measure T-wave alternans and perform more accurate electrocardiogram ("ECG")
readings.

THREE AND NINE MONTHS PERIODS ENDED SEPTEMBER 30, 1996 AND 1995

     Revenues for the three months ended September 30, 1996 were $235,305. The
revenue for the corresponding period in 1995 was $68,047. Revenues for the nine
month period ended September 30, 1996 were $500,007. The same period in 1995 had
revenues of 68,047. This increase of product revenue reflects continued
shipments of the CH 2000 System to domestic and European sites. The cost of
goods sold for the quarter ended September 30, 1996 was $246,416. The same
period for the previous year had cost of

                                      -9-
<PAGE>
 
goods sold of $81,947. The cost of goods sold for the nine month period ended
September 30, 1996 was $553,740. The same period for 1995 had cost of goods sold
of $81,947. These costs exceeded the product revenue because of fixed overhead
costs, rework and scrap. As the volume of production increases the Company
expects that the cost of goods sold will decrease as a percentage of revenue.

     Research and Development expenses increased to $569,205 in the quarter
ended September 30, 1996 from $372,144 in the same period a year earlier.
Research and Development expenses increased to $1,441,947 in the nine month
period ended September 30, 1996 from $1,123,417 in the same period in 1995.
This increase was principally due to increased staffing in engineering, 
software development and regulatory affairs, as well as higher clinical trial
expenses. The Company expects to continue to selectively increase personnel in
this area and expand clinical trials.

     General and Administrative expenses increased to $638,923 in the quarter
ended September 30, 1996 from $274,475 in the same period in 1995. General and
Administrative expenses increased to $1,456,107 in the nine month period ended
September 30, 1996 from $740,710 for the same period in 1995. Most of this
increase was due to increases in staffing in management and marketing. The
Company expects General and Administrative expenses to increase as the Company
expands its sales and marketing efforts and enters the public reporting
environment.

     Interest income was $158,192 for the three months ended September 30, 1996
compared to $75,851 for the same period in 1995. For the nine months ended
September 30, 1996, interest income was $238,506 compared to $181,204 in the
same period in 1995. This interest income reflects the investment of the
proceeds of a round of private financing in the second quarter of 1995 and the
proceeds of the initial public offering of the Company's common stock in August,
1996.

LIQUIDITY AND CAPITAL RESOURCES

     The Company initially financed operations primarily from the sale of
convertible preferred stock. As of September 30, 1996, the Company had raised
$9,065,000 (net of stock issuance costs) from the private sales of equity
securities, with net proceeds of $5,697,000 received in 1993 and $3,353,000
received in 1995. On August 2, 1996, the Company raised approximately
$19,660,000 (net of stock issuance costs) from the sale of 2,437,750 shares of
Common Stock in the Company's initial public offering. In conjunction with the
initial public offering, 4,455,708 shares of preferred stock were converted to
Common Stock.

     As of September 30, 1996, the Company had cash and cash equivalents of
$20,221,213. The proceeds of the equity offerings have been used primarily to
fund operating losses of $7,794,087, reflecting expenditures made primarily to
support research and development activities, to form a marketing and sales
organization, to support an administrative infrastructure and the investment of
$353,149 in property and equipment as of September 30, 1996. In 1995, the
Company used $2,615,000 to fund operating activities.

     The Company expects its capital expenditures to increase as it continues to
commercialize its products, particularly in connection with the manufacture of
its proprietary Hi-Res electrodes. The Company does not expect capital
expenditures to exceed an aggregate $3,000,000 over the next two years.

     Under the terms of various license, consulting and technology agreements,
the Company is required to pay royalties on sales of its products. Minimum
license maintenance fees under these license agreements, which are creditable
against royalties otherwise payable for each year, range from $20,000 to $45,000
per year in total through 2008. The Company is committed to pay an aggregate of
$470,000 of such minimum license maintenance fees subsequent to September 30,
1996. As part of these agreements, the

                                      -10-
<PAGE>
 
Company is also committed to meet certain development and sales milestones,
including a requirement to spend a minimum of $200,000 in any two-year period
for research and development, clinical trials, marketing, sales and/or
manufacturing of products related to certain technology covered by the
consulting and technology agreements.

     The Company anticipates that its existing capital resources, including the
amounts raised in the initial public offering, will be adequate to satisfy its
capital requirements for at least the next two years. There may be
circumstances, however, that would accelerate the Company's use of this capital.
If this occurs, the Company may from time to time incur additional indebtedness
or issue, in public or private transactions, equity or debt securities. However,
there can be no assurance that suitable debt or equity financing will be
available to the Company on acceptable terms, if at all.


CERTAIN FACTORS THAT MAY AFFECT FUTURE OPERATING RESULTS

     The foregoing forward-looking statements involve risks and uncertainties.
As a direct or indirect result of any or a combination of any of the following
factors, the Company's actual results may differ significantly from the results
discussed in such forward-looking statements: The Company is a development stage
company with a history of operating losses and there is no assurance of market
acceptance of the Company's primary product, the CH 2000 System. The Company's
products, product development activities, manufacturing processes and sales and
marketing are subject to extensive and rigorous regulation by the FDA and
comparable agencies in foreign countries. The process of obtaining marketing
clearance or approval for new medical devices from the FDA can be costly and
time consuming, and there can be no assurance that such clearance or approval
will be granted for the Company's future products on a timely basis, if at all,
or that the FDA review will not involve delays that will adversely affect the
Company's ability to commercialize additional products or expand permitted uses
of existing products. The medical device market is characterized by intensive
development efforts and rapidly advancing technology and is highly competitive,
and there can be no assurance that the Company will keep pace with advancing
technology and competitive innovations. The Company's future success will
depend, in part, on its ability to continue to develop patentable products,
enforce its patents and obtain patent protection for its products both in the
United States and in other countries. However, patent positions of medical
device companies, including the Company, are generally uncertain and involve
complex legal and factual questions. No assurance can be given that patents will
issue from any patent applications owned by or licensed to the Company or that,
if patents do issue, the claims allowed will be sufficiently broad to protect
the Company's technology. In addition, no assurance can be given that any issued
patents owned by or licensed to the Company will not be challenged, invalidated
or circumvented, or that the rights granted thereunder will provide competitive
advantages to the Company. The Company has limited manufacturing and marketing
experience and is dependent upon certain key suppliers. The Company is also
dependent upon certain key management personnel and consultants. The Company has
limited international sales and operations experience. The manufacture and sale
of medical devices entails significant risk of product liability claims in the
event that the use of such devices is alleged to have resulted in adverse
effects to a patient. The Company's product liability insurance coverage is
limited. For additional and more comprehensive discussion of the risks
associated with ownership of Common Stock of the Company, please see the Risk
Factors section of the Company's Registration Statement filed on Form S-1 with
the Securities and Exchange Commission on May 31, 1996. As a result of these and
other factors, there can be no assurance that the Company will not experience
material fluctuations in future operating results on a quarterly or annual
basis.

                                      -11-
<PAGE>
 
                               PART II - OTHER INFORMATION

ITEM 6. Exhibits and Reports on Form 8-K
        --------------------------------   
         
        a. The exhibits listed in the Exhibit Index filed as part of this report
are filed as part of or are included in this report.

        b. The Company filed no reports on Form 8-K during the quarter for which
this report is filed.

                                     -12-

<PAGE>
 
                                   SIGNATURE



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



                                      CAMBRIDGE HEART, INC.


Date: November 13, 1996                    By:   /s/ Thomas V. Hennessey, Jr. 
                                               --------------------------------
                                                 Thomas V. Hennessey, Jr.
                                                 Vice President of Operations,
                                                 Treasurer and Chief
                                                 Financial Officer

                                      -13-
<PAGE>
 
                                 EXHIBIT INDEX




         Exhibit Number                  Description
         --------------                  -----------
              11             Statement re Computation of Per Share Earnings

              27             Financial Data Schedule

                                      -14-

<PAGE>
 
                                                                      Exhibit 11
                              Cambridge Heart, Inc.
     Computation of Net Loss per Share and Supplementary Net Loss per Share
<TABLE> 
<CAPTION> 
                                                                                                      For the nine months ended
                                                    For the three months ended September 30, 1996        September 30, 1996
                                                    --------------------------------------------      --------------------------
                                                         Net loss             Supplementary            Supplementary net loss
                                                         per share          net loss per share               per share
                                                    ------------------    -----------------------     ---------------------------
<S>                                                 <C>                   <C>                         <C> 
Net loss                                               $(1,061,047)             $(1,061,047)                 $(2,713,281)

Weighted average shares outstanding:

Shares attributable to common stock
  outstanding                                            7,702,234                7,702,234                    4,695,368

Shares attributable to certain common
  stock options (1)                                              0                        0                      303,097

Shares attributable to the assumed conversion
  of Series A and B convertible preferred stock
  outstanding upon closing of initial public
  offering                                                       0                1,598,244                    3,503,220
                                                       -----------              -----------                  -----------

Unaudited weighted average common shares
  outstanding                                            7,702,234
                                                       ===========

Unaudited net loss per share                           $     (0.14)
                                                       ===========

Unaudited supplementary weighted average common
  and common equivalent shares outstanding                                        9,300,478                    8,501,685
                                                                                ===========                  =========== 

Unaudited supplementary net loss per share                                      $     (0.11)                 $     (0.32)
                                                                                ===========                  =========== 

</TABLE> 

(1)  Pursuant to Securities and Exchange Commission Staff Accounting Bulletin
     No. 83, stock options issued during the twelve months prior to the
     Company's initial registration statement on Form S-1 have been included in
     the above computation as if outstanding for all periods through June 30,
     1996, even if such impact is anti-dilutive.

                                       1

<TABLE> <S> <C>

<PAGE>
 
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
SEPTEMBER 30, 1996 UNAUDITED FINANCIAL STATEMENTS AND IS QUALIFIED IN ITS
ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
       
<S>                             <C>
<PERIOD-TYPE>                   9-MOS
<FISCAL-YEAR-END>                          DEC-31-1996
<PERIOD-START>                             JAN-01-1996
<PERIOD-END>                               SEP-30-1996
<CASH>                                      20,221,213
<SECURITIES>                                         0
<RECEIVABLES>                                  203,365
<ALLOWANCES>                                         0
<INVENTORY>                                    279,812
<CURRENT-ASSETS>                            21,099,633
<PP&E>                                         353,149
<DEPRECIATION>                                  86,921
<TOTAL-ASSETS>                              21,487,277
<CURRENT-LIABILITIES>                          463,950
<BONDS>                                              0
                                0
                                          0
<COMMON>                                        10,184
<OTHER-SE>                                  21,013,143
<TOTAL-LIABILITY-AND-EQUITY>                21,487,277
<SALES>                                        475,007
<TOTAL-REVENUES>                               500,007
<CGS>                                          553,740
<TOTAL-COSTS>                                  553,740
<OTHER-EXPENSES>                             2,898,054
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                                   0
<INCOME-PRETAX>                            (2,713,281)
<INCOME-TAX>                                         0
<INCOME-CONTINUING>                        (2,713,281)
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                               (2,713,281)
<EPS-PRIMARY>                                        0<F1>
<EPS-DILUTED>                                        0<F1>
<FN>
<F1>HISTORICAL EARNINGS PER SHARE HAS NOT BEEN PRESENTED. SEE FOOTNOTE'S OF THE
CONDENSED FINANCIAL STATEMENTS.
</FN>
        

</TABLE>


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