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Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 10-Q

 


 

x Quarterly report pursuant to section 13 or 15(d) of the Securities Exchange Act of 1934.

 

For the three month period from October 4, 2004 to January 2, 2005.

 

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 0-20225

 


 

ZOLL MEDICAL CORPORATION

(Exact name of registrant as specified in its charter)

 


 

Massachusetts   04-2711626

(State or other jurisdiction of

incorporation or organization)

 

(IRS Employer

Identification number)

269 Mill Road, Chelmsford, MA   01824-4105
(Address of principal executive offices)   (Zip Code)

 

(978) 421-9655

(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 (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  ¨

 

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).    Yes  x    No  ¨

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock:

 

Class


 

Outstanding at January 24, 2005


Common Stock, $0.02 par value

  9,571,897

 

This document consists of 30 pages.

 



Table of Contents

ZOLL MEDICAL CORPORATION

 

INDEX

 

         Page No.

PART I. FINANCIAL INFORMATION     
ITEM 1.   Financial Statements:     
    Consolidated Balance Sheets (unaudited)
January 2, 2005 and October 3, 2004
   3
    Consolidated Income Statements (unaudited)
Three Months Ended January 2, 2005 and January 4, 2004
   4
    Consolidated Statements of Cash Flows (unaudited)
Three Months Ended January 2, 2005 and January 4, 2004
   5
    Notes to Consolidated Financial Statements (unaudited)    6
ITEM 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations    12
ITEM 3.   Quantitative and Qualitative Disclosures About Market Risk    28
ITEM 4.   Controls and Procedures    29
PART II. OTHER INFORMATION     
ITEM 1.   Legal Proceedings    29
ITEM 2.   Unregistered Sales of Equity Securities and Use of Proceeds    29
ITEM 3.   Defaults Upon Senior Securities    29
ITEM 4.   Submission of Matters to a Vote of Security Holders    29
ITEM 5.   Other Information    29
ITEM 6.   Exhibits    30
    Signatures    30

 

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PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

ZOLL MEDICAL CORPORATION

CONSOLIDATED BALANCE SHEETS

(000’s omitted, except per share data)

(Unaudited)

 

     January 2,
2005


    October 3,
2004


 
ASSETS                 

Current assets:

                

Cash and cash equivalents

   $ 27,285     $ 40,685  

Marketable securities

     17,919       18,325  

Accounts receivable, less allowance of $5,026 at January 2, 2005, and $4,855 at October 3, 2004

     48,006       51,038  

Inventories:

                

Raw materials

     14,999       12,284  

Work-in-process

     4,477       4,379  

Finished goods

     18,069       15,039  
    


 


       37,545       31,702  

Prepaid expenses and other current assets

     7,597       7,273  
    


 


Total current assets

     138,352       149,023  

Property and equipment, at cost:

                

Land and building

     1,144       1,136  

Machinery and equipment

     42,338       39,949  

Construction in progress

     4,278       3,834  

Tooling

     8,289       8,155  

Furniture and fixtures

     2,997       2,796  

Leasehold improvements

     4,429       4,417  
    


 


       63,475       60,287  

Less: accumulated depreciation

     38,187       36,066  
    


 


Net property and equipment

     25,288       24,221  
    


 


Investments

     1,580       9,858  

Notes receivable

     1,508       7,129  

Goodwill

     27,646       3,281  

Intangibles and other assets, net

     19,839       13,680  
    


 


     $ 214,213     $ 207,192  
    


 


LIABILITIES AND STOCKHOLDERS’ EQUITY                 

Current liabilities:

                

Accounts payable

   $ 11,330     $ 12,321  

Accrued expenses and other liabilities

     22,089       21,917  
    


 


Total current liabilities

     33,419       34,238  

Deferred income taxes

     2,008       2,008  

Commitments and contingencies

                

Stockholders’ equity:

                

Preferred stock, $0.01 par value, authorized 1,000 shares, none issued and outstanding

                

Common stock, $0.02 par value, authorized 19,000 shares, 9,548 and 9,309 issued and outstanding at January 2, 2005 and October 3, 2004, respectively

     191       186  

Capital in excess of par value

     114,439       105,916  

Accumulated other comprehensive loss

     (2,140 )     (2,018 )

Retained earnings

     66,296       66,862  
    


 


Total stockholders’ equity

     178,786       170,946  
    


 


     $ 214,213     $ 207,192  
    


 


 

See notes to unaudited consolidated financial statements.

 

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ZOLL MEDICAL CORPORATION

CONSOLIDATED INCOME STATEMENTS

(000’s omitted, except per share data)

(Unaudited)

 

     Three Months Ended

     January 2,
2005


    January 4,
2004


Net sales

   $ 50,629     $ 50,842

Cost of goods sold

     22,200       22,139
    


 

Gross profit

     28,429       28,703

Expenses:

              

Selling and marketing

     19,667       17,756

General and administrative

     4,273       3,185

Research and development

     5,828       4,340
    


 

Total expenses

     29,768       25,281

Income (loss) from operations

     (1,339 )     3,422

Investment and other income

     344       579
    


 

Income (loss) before income taxes

     (995 )     4,001

Provision (benefit) for income taxes

     (429 )     1,320
    


 

Net income (loss)

   $ (566 )   $ 2,681
    


 

Basic earnings (loss) per common share

   $ (0.06 )   $ 0.29
    


 

Weighted average common shares outstanding

     9,522       9,103

Diluted earnings (loss) per common and common equivalent share

   $ (0.06 )   $ 0.29
    


 

Weighted average common and common equivalent shares outstanding

     9,522       9,248

 

See notes to unaudited consolidated financial statements.

 

 

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ZOLL MEDICAL CORPORATION

CONSOLIDATED STATEMENTS OF CASH FLOWS

(000’s omitted)

(Unaudited)

 

     Three Months Ended

 
    

January 2,

2005


   

January 4,

2004


 
    

OPERATING ACTIVITIES:

                

Net income (loss)

   $ (566 )   $ 2,681  

Charges not affecting cash:

                

Depreciation and amortization

     2,889       2,221  

Tax benefit from the exercise of stock options

     67       315  

Unrealized loss from hedging activities

     18       40  

Changes in current assets and liabilities:

                

Accounts receivable

     4,644       (1,767 )

Inventories

     (5,064 )     143  

Prepaid expenses and other current assets

     (144 )     (172 )

Accounts payable and accrued expenses

     (5,965 )     (5,693 )
    


 


Cash used for operating activities

     (4,121 )     (2,232 )

INVESTING ACTIVITIES:

                

Purchases of marketable securities

     (2,000 )     (7,500 )

Sales of marketable securities

     2,289       4,400  

Additions to property and equipment

     (2,995 )     (3,102 )

Acquisition of Revivant Corporation, net of cash acquired

     (6,530 )     —    

Milestone payment related to prior year acquisition

     (405 )     —    

Other assets, net

     (101 )     262  
    


 


Cash used for investing activities

     (9,742 )     (5,940 )

FINANCING ACTIVITIES:

                

Exercise of stock options

     229       1,537  
    


 


Cash provided by financing activities

     229       1,537  

Effect of exchange rates on cash and cash equivalents

     234       388  
    


 


Net decrease in cash and cash equivalents

     (13,400 )     (6,247 )

Cash and cash equivalents at beginning of period

     40,685       40,780  
    


 


Cash and cash equivalents at end of period

   $ 27,285     $ 34,533  
    


 


SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:

                

Cash paid during the period:

                

Income taxes

   $ 285     $ 1,184  

 

See notes to unaudited consolidated financial statements.

 

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ZOLL MEDICAL CORPORATION

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

1. Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. In the opinion of management, all adjustments (consisting only of adjustments of a normal recurring nature) considered necessary for a fair presentation have been included. Preparing financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. Examples include provisions for returns, bad debts and the estimated lives of fixed assets. Actual results may differ from these estimates. The results for the interim periods are not necessarily indicative of results to be expected for the entire year. The information contained in the interim financial statements should be read in conjunction with the Company’s audited financial statements as of and for the year ended October 3, 2004 included in its Form 10-K, as amended, filed with the Securities and Exchange Commission (“SEC”).

 

2. Segment and Geographic Information

 

Segment information: The Company operates in a single business segment: the design, manufacture and marketing of a range of non-invasive resuscitation devices and software solutions. These devices and software help healthcare professionals, emergency medical service providers, and first responders diagnose and treat victims of trauma, as well as sudden cardiac arrest. In order to make operating and strategic decisions, ZOLL’s chief operating decision maker evaluates revenue performance based on the worldwide revenues of four customer/product categories but, due to shared infrastructures, profitability is based on an enterprise-wide measure. These customer/product categories consist of (1) the sale of resuscitation devices and accessories to the North American hospital market including the military marketplace, (2) the sale of the same items and data collection management software to the North American pre-hospital market, (3) the sale of disposable/other products in North America, (4) the sale of resuscitation devices, accessories, disposable electrodes and data collection management software to the international market.

 

Net sales by customer/product categories were as follows:

 

     Three Months Ended

(000’s omitted)


   January 2,
2005


   January 4,
2004


Hospital Market - North America

   $ 13,869    $ 19,254

Pre-hospital Market – North America

     18,173      14,820

Other - North America

     4,599      5,289

International Market

     13,988      11,479
    

  

     $ 50,629    $ 50,842
    

  

 

The Company reports assets on a consolidated basis to the chief operating decision maker.

 

Geographic information: Net sales by major geographical area, determined on the basis of destination of the goods, are as follows:

 

     Three Months Ended

(000’s omitted)


  

January 2,

2005


  

January 4,

2004


     

United States

   $ 34,672    $ 35,555

Foreign

     15,957      15,287
    

  

     $ 50,629    $ 50,842
    

  

 

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No individual foreign country represented 10% or more of our revenues for the three months ended January 2, 2005 and January 4, 2004.

 

3. Comprehensive Income

 

The Company computes comprehensive income in accordance with Statement of Financial Accounting Standards No. 130 (“SFAS 130”) “Reporting Comprehensive Income.” SFAS 130 establishes standards for the reporting and display of comprehensive income and its components in the financial statements. Other comprehensive income, as defined, includes all changes in equity during a period from non-owner sources, such as unrealized gains and losses on available-for-sale securities, foreign currency translation and the changes in fair value of the effective portion of our outstanding cash flow hedge contracts. Total comprehensive income for the three months ended January 2, 2005 and January 4, 2004, were as follows:

 

     Three Months Ended

 

(000’s omitted)


  

January 2,

2005


   

January 4,

2004


 
    

Net income (loss)

   $ (566 )   $ 2,681  

Unrealized gain (loss) on available-for-sales securities, net of tax

     (41 )     1  

Foreign currency translation adjustment

     (99 )     562  

Net unrealized gain (loss) on cash flow hedges

     18       (246 )
    


 


Total comprehensive income

   $ (688 )   $ 2,998  
    


 


 

4. Stock Option Plans

 

At January 2, 2005, the Company had three stock-based compensation plans. The Company’s 1992 and 2001 stock option plans provide for the granting of options to officers and other key employees to purchase the Company’s Common Stock at a purchase price, in the case of incentive stock options, at least equal to the fair market value per share of the outstanding Common Stock of the Company at the time the option is granted, as determined by the Compensation Committee of the Board of Directors. Options are no longer granted under the 1992 plan. The options vest in equal annual installments over two or four years and have a maximum life of 10 years. The Company’s Non-employee Director Stock Option Plan provides for the grant of options to purchase 10,000 shares of Common Stock to Directors of the Company who are not also employees of the Company or any of its subsidiaries upon the Directors’ initial appointment to the Board of Directors. The Non-employee Director options vest in equal annual installments over a four year period. The Non-employee Director options are granted at an exercise price equal to the fair market value of the Common Stock on the date the option is granted.

 

The Company has adopted the Financial Accounting Standards Board (“FASB”) Statement of Financial Accounting Standard (“SFAS”) No. 148, “Accounting for Stock-Based Compensation—Transition and Disclosure—an amendment of SFAS No. 123”, which amends the disclosure requirements of SFAS No. 123 to require prominent disclosures in both annual and interim financial statements about the method of accounting for stock-based employee compensation and the effect of the method used on reported results. Statement of Financial Accounting Standards No. 123, “Accounting for Stock-Based Compensation” (“SFAS 123”) provides a fair value-based model of accounting for stock options and awards. As permitted by SFAS 123, the Company measures compensation expense for its stock-based compensation plans using the intrinsic method prescribed by Accounting Principles Board No. 25, “Accounting for Stock Issued to Employees.” Under the intrinsic value method, compensation expense is measured as the difference, if any, between the exercise price of the stock option or award and the fair value of the Company’s common stock on the date of the grant. In accordance with SFAS 123, the Company has provided the pro forma disclosures of the effect on net income and earnings per share as if SFAS 123 had been applied in measuring compensation expense for all periods presented using a fair value model. Stock options and awards issued to non-employees are accounted for based on fair value.

 

No stock-based employee compensation cost is reflected in net income, as all options granted under the Company’s stock compensation plans had an exercise price equal to the market value of the underlying common stock on the grant date. The following

 

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table illustrates the effect on net income and earnings per share if the Company had applied the fair value model of SFAS 123, to the stock-based employee compensation. The estimated fair value of each option is calculated using the Black-Scholes option-pricing model:

 

     Three Months Ended

 

(000’s omitted, except per share data)


  

January 2,

2005


   

January 4,

2004


 
    

Net income (loss)-as reported

   $ (566 )   $ 2,681  

Deduct: Total stock-based employee compensation expense determined under fair value based methods for all awards, net of related tax effects

     (646 )     (621 )
    


 


Net income (loss)-pro forma

   $ (1,212 )   $ 2,060  
    


 


Earnings per share:

                

Basic – as reported

   $ (0.06 )   $ 0.29  
    


 


Basic – pro forma

   $ (0.13 )   $ 0.23  
    


 


Diluted – as reported

   $ (0.06 )   $ 0.29  
    


 


Diluted – pro forma

   $ (0.13 )   $ 0.22  
    


 


 

The above pro forma amounts may not be representative of the effects on reported net income for future years. The fair value of each option grant is estimated on the date of the grant using the Black-Scholes option-pricing model with the following weighted average assumptions for the three months ended January 2, 2005 and January 4, 2004:

 

     2005

    2004

 

Dividend yield

   0 %   0 %

Expected volatility

   67.2 %   66.4 %

Risk-free interest rate

   3.71 %   3.43 %

Expected lives

   5 years     5 years  

 

5. Earnings per Share

 

The shares used for calculating basic earnings per common share were the weighted average shares of common stock outstanding during the period and the shares used for calculating diluted earnings per common share were the weighted average shares of common stock outstanding during the period plus the dilutive effect of stock options. During the three months ended January 2, 2005, the effect of stock options was excluded from the calculation of diluted earnings per share because their inclusion would have been anti-dilutive due to the net loss incurred.

 

(000’s omitted)


   Three Months Ended

   January 2,
2005


   January 4,
2004


Average shares outstanding for basic earnings per share

   9,522    9,103

Dilutive effect of stock options

   0    145
    
  

Average shares outstanding for diluted earnings per share

   9,522    9,248
    
  

 

6. Derivative Instruments and Hedging Activities

 

The Company operates globally, and its earnings and cash flows are exposed to market risk from changes in currency exchange rates. The Company addresses these risks through a risk management program that includes the use of derivative financial instruments. The program is operated pursuant to documented corporate risk management policies. The Company does not enter into any derivative transactions for speculative purposes.

 

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The Company uses foreign currency forward contracts to manage its currency transaction exposures with intercompany receivables denominated in foreign currencies. These currency forward contracts are not designated as cash flow, fair value or net investment hedges under Statement of Financial Accounting Standards No. 133 (“SFAS 133”), “Accounting for Derivative Instruments and Hedging Activities” and therefore, are marked-to-market with changes in fair value recorded to earnings. These derivative instruments do not subject the Company’s earnings or cash flows to material risk since gains and losses on those derivatives offset losses and gains on the assets and liabilities being hedged. These derivative instruments are entered into for periods consistent with the currency transaction exposures, generally three months.

 

The Company had one foreign currency forward contract outstanding, serving as a hedge of a substantial portion of our Euro-denominated intercompany balances, in the notional amount of approximately 4.5 million Euros at January 2, 2005. The net settlement amount of this contract at January 2, 2005, was an unrealized gain of approximately $138,000.

 

The Company occasionally uses foreign currency forward contracts to manage its currency transaction exposures from forecasted foreign currency denominated sales to its subsidiaries. These currency forward contracts are designated as cash flow hedges under SFAS 133; therefore, the effective portion of the gain or loss is reported as a component of other comprehensive income and will be reclassified into earnings in the same period or periods during which the hedged forecasted transaction affects earnings. The ineffective portion of the derivative’s change in fair value would be recognized currently through earnings regardless of whether the instrument is designated as a hedge.

 

At January 2, 2005, the Company had no outstanding foreign currency forward contracts serving as cash flow hedges.

 

Net realized losses from foreign currency forward contracts totaled $639,000 during the quarter ended January 2, 2005 and are included in the consolidated statement of income compared to net realized losses of $509,000 for the prior year’s quarter.

 

7. Product Warranties

 

The Company typically offers one-year and five-year product warranties for most of its products. The Company provides for the estimated cost of product warranties at the time product revenue is recognized. Factors that affect the Company’s warranty reserves include the number of units sold, historical and anticipated rates of warranty repairs and the cost per repair. The Company periodically assesses the adequacy of the warranty reserve and adjusts the amount as necessary.

 

Product warranty activity for the three months ended January 2, 2005 is as follows:

 

 

(000’s omitted)

 

Balance at

October 3, 2004


  Accruals for
warranties issued
during the period


  Decrease to pre-
existing
warranties


 

Balance at

January 2, 2005


    $ 2,679   $ 363   $ 67   $ 2,975

 

8. Acquisitions

 

Revivant Corporation

 

On October 4, 2004, the Company exercised its option to acquire Revivant Corporation (“Revivant”) of Sunnyvale, California, the manufacturer of the AutoPulse Non-invasive Cardiac Support Pump (“AutoPulse”). The option was part of an agreement entered into in August 2003, through which ZOLL invested $7 million in Revivant preferred stock and provided $5 million of debt financing in exchange for a 15% stake in Revivant and the option to acquire their remaining outstanding shares. On October 12, 2005, the Company completed its acquisition of 100 percent of the equity of Revivant. The AutoPulse is an FDA-approved device that offers the potential of restoring near-normal blood flow levels in victims of Sudden Cardiac Arrest (SCA). The acquisition presents an opportunity to expand the Company’s presence in the resuscitation market.

 

In addition to the existing $7 million preferred stock investment and the $5 million of debt financing previously provided to Revivant, upon the consummation of the acquisition, the Company paid initial merger consideration of approximately $15 million comprised of 50% cash and 50% ZOLL common stock (224,300 shares). The agreement provides that the Company will make (i) milestone payments targeted at $15 million, contingent on the completion of certain clinical trials with the AutoPulse through 2006 and (ii) additional payments for the years 2005 through 2007 based on the growth of AutoPulse sales. In general, these additional payments will be a combination of cash and ZOLL common stock. These additional payments, if and when made, will be allocated to goodwill.

 

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The Company has registered under the applicable securities laws an additional 765,509 shares of ZOLL common stock that may be issued upon achievement of these milestones. During the quarter ended January 2, 2005, the Company had accrued $1 million for Revivant’s attainment of a milestone related to the publication of clinical data, which will be paid $500,000 in cash and the remainder in shares of ZOLL common stock (15,188 shares).

 

From October 12, 2004, the results of operations of Revivant are included in the consolidated income statement of the Company.

 

The following is a summary of the Company’s estimate of the fair values of the assets acquired and liabilities assumed at the date of acquisition. The results of the Company’s estimate are preliminary at this time and the final results may differ from the preliminary estimate of the fair value of the acquired intangible assets. The Company will finalize the purchase price allocation upon finalizing the valuation of the intangible assets and obtaining other relevant information relating to the acquisition.

 

(000’s omitted)


    

Assets:

      

Current Assets

   $ 3,560

Property and equipment

     226

Goodwill

     23,966

Intangible assets subject to amortization (estimated 11 year weighted-average useful life)

     6,600

Other assets

     9
    

Total assets acquired

   $ 34,361
    

Liabilities:

      

Current liabilities

   $ 3,910
    

Total liabilities assumed

     3,910
    

Net assets acquired

   $ 30,451
    

 

The $24.0 million of goodwill will be assigned to our only reportable segment which is the design, manufacture and marketing of an integrated line of proprietary non-invasive resuscitation devices, and systems used for the treatment of victims of trauma, including sudden cardiac arrest. The goodwill is not deductible for income tax purposes. The intangibles acquired included $6.4 million developed technology and $200,000 of backlog. The backlog has been expensed in the first quarter of fiscal 2005. The developed technology will be amortized on a straight-line basis over its 11 year estimated useful life.

 

Supplemental Pro Forma Information – Unaudited

 

The unaudited pro forma combined condensed statements of income for the period ended January 2, 2005 give effect to the acquisition of Revivant as if the acquisition had occurred at the beginning of the year, October 4, 2004, and the corresponding period in the prior year after giving effect to certain adjustments, including amortization of the intangibles subject to amortization and related income taxes.

 

The unaudited pro forma combined condensed statements of income are not necessarily indicative of the financial results that would have occurred if the Revivant acquisition had been consummated on October 4, 2004, or the corresponding period in the prior year, nor are they necessarily indicative of the financial results which may be attained in the future.

 

The proforma statement of income is based upon available information and upon certain assumptions that ZOLL’s management believes are reasonable. The Revivant acquisition is being accounted for using the purchase method of accounting. The allocation of the purchase price is preliminary. Final amounts could differ from those reflected in the pro forma statement of income, and such differences could be significant.

 

     Three Months Ended
(Unaudited)


 

(000’s omitted, except per share data)


   January 2,
2005


    January 4,
2004


 

Net sales

   $ 50,629     $ 50,842  

Net loss

   $ (822 )   $ (1,413 )

Net loss per common share

                

Basic

   $ (0.09 )   $ (0.15 )

Diluted

   $ (0.09 )   $ (0.15 )

 

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Infusion Dynamics, Inc.

 

The prior year acquisition of Infusion Dynamics, Inc. (“Infusion”) provided for additional earn out and royalty payments (contingent payments) based on performance of the business. For the quarter ended January 2, 2005, the Company made a $405,000 earn out payment to Infusion. Payment of this additional consideration was allocated to goodwill.

 

9. Intangibles and Other Assets

 

Intangibles and other assets consist of:

 

    

Weighted
Average
Life

   January 2, 2005

   October 3, 2004

(000’s omitted)


      Gross Carrying
Amount


   Accumulated
Amortization


   Gross Carrying
Amount


   Accumulated
Amortization


Prepaid license fees

   20 years    $ 9,578    $ 1,327    $ 9,413    $ 1,158

Patents

   10 years      11,022      918      4,583      665

Other assets

   —        2,960      1,476      2,937      1,430
         

  

  

  

          $ 23,560    $ 3,721    $ 16,933    $ 3,253
         

  

  

  

 

Amortization of acquired intangibles for the three months ended January 2, 2005 and January 4, 2004 was approximately $302,000 and $0, respectively, and is included in operating expenses in the consolidated income statement.

 

10. Income Taxes

 

The Company’s effective tax rate for the three months ended January 2, 2005 was a tax benefit of 43% as compared to tax provision of 33% for the same period in fiscal 2004. The difference in the effective tax rate is due to a discrete $130,000 U.S. research and development tax credit recorded during the quarter ended January 2, 2005, due to the enactment into law of the American Jobs Creation Act subsequent to October 3, 2004. Without the impact of the one-time benefit, the effective tax rate is 30%.

 

11. Legal Proceedings

 

On December 10, 2004, a complaint was filed against Revivant Corporation by Dr. Thomas Fogarty and his affiliate, alleging that Revivant owes a 4% royalty on all of its sales. The Company believes the suit is without merit. Moreover, in connection with the Company’s acquisition of Revivant, the former stockholders of Revivant specifically agreed to indemnify the Company against Dr. Fogarty’s claim for all amounts up to $15 million. The Company has the right to set-off these indemnity claims against future contingent amounts payable by it as part of the purchase price for Revivant.

 

The Company has been informed by the federal government that it is conducting an investigation regarding two sales of defibrillators in fiscal 2000 to a distributor, which were then allegedly trans-shipped to Iran without the required export licenses. The Company is cooperating with the Department of Justice in connection with its ongoing investigation, and has provided requested information. The two sales in question represented approximately $150,000 of net income in fiscal 2000. Although it is premature to determine the likely outcome of the investigation, it is possible that the Company may be subject to civil or criminal fines and sanctions as a result of this matter.

 

In addition to these matters the Company is, from time to time, involved in the normal course of its business in various other litigation matters and regulatory issues, including product recalls. Although the Company is unable to quantify at the present time the exact financial impact in any of these matters, it believes that none of these other matters currently pending will have an outcome material to its financial condition or business.

 

12. Recent Accounting Pronouncements

 

On December 16, 2004, the Financial Accounting Standards Board (FASB) issued FASB Statement No. 123 (revised 2004), Share-Based Payment, which is a revision of FASB Statement No. 123, Accounting for Stock-Based Compensation. Statement 123(R) supersedes APB Opinion No. 25, Accounting for Stock Issued to Employees, and amends FASB Statement No. 95, Statement of Cash Flows. Generally, the approach in Statement 123(R) is similar to the approach described in Statement 123. However, Statement 123(R) requires all share-based payments to employees, including grants of employee stock options, to be recognized in the income statement based on their fair values. Pro forma disclosure is no longer an alternative.

 

Statement 123(R) must be adopted no later than the first interim or annual period beginning after June 15, 2005. We expect to adopt Statement 123(R) in our fourth quarter of fiscal 2005.

 

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Statement 123(R) permits public companies to adopt its requirements using one of two methods.

 

  1. A “modified prospective” method in which compensation cost is recognized beginning with the effective date (a) based on the requirements of Statement 123(R) for all share-based payments granted after the effective date and (b) based on the requirements of Statement 123 for all awards granted to employees prior to the effective date of Statement 123(R) that remain unvested on the effective date.

 

  2. A “modified retrospective” method which includes the requirements of the modified prospective method described above, but also permits entities to restate based on the amounts previously recognized under Statement 123 for purposes of pro forma disclosures for either (a) all prior periods presented or (b) prior interim periods of the year of adoption.

 

The Company has not completed its analysis of the different methods and has not yet determined which method it will adopt. However, based upon our previous Statement 123 proforma disclosure including those in Footnote 4, we estimate our adoption to dilute our earnings as reported by approximately $600,000-$700,000 per quarter. Consequently, this impact has not been included in the historical financial statements for any period presented, nor has it been included in the comparable forward-looking guidance regularly provided by the Company.

 

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

 

We are committed to developing technologies that help advance the practice of resuscitation. With products for pacing, defibrillation, circulation, ventilation, and fluid resuscitation, we provide a comprehensive set of technologies that can help clinicians, EMS professionals, and lay rescuers resuscitate sudden cardiac arrest or trauma victims. We also design and market software that automates the documentation and management of both clinical and non-clinical data.

 

We continue to be in a strong financial position despite the negative impact of the Revivant acquisition. Our balance sheet remains healthy with $45.2 million of cash, cash equivalents and short-term investments, and no long-term debt. Revenue for the first quarter was flat due to lower than expected sales in the North American hospital business as well as the anticipated reduction in U.S. military volume. The performance in the North American hospital business was offset by sales to the North American pre-hospital market and international market.

 

In an effort to reduce expenses on a go forward basis, on January 20, 2005, we reduced our headcount by approximately thirty employees during the quarter and will continue to pare back spending where possible in order to return to profitability. We expect to see the full benefit of these actions during the third quarter.

 

Three Months Ended January 2, 2005 Compared To Three Months Ended January 4, 2004

 

Sales

 

Net sales by customer/product categories are as follows:

 

(000’s omitted)


   2005

   2004

   % Change

 

Devices and Accessories to the Hospital Market-North America

   $ 13,869    $ 19,254    (28 )%

Devices, Accessories, and Data Management Software to the Pre-hospital Market-North America

     18,173      14,820    23 %

Other Products to North America

     4,599      5,289    (13 )%
    

  

  

Subtotal North America

     36,641      39,363    (7 )%

All Products to the International Market

     13,988      11,479    22 %
    

  

  

Total Sales

   $ 50,629    $ 50,842    0 %
    

  

  

 

Net sales were flat at $51 million for the three months ended January 2, 2005, as compared to the same period a year earlier. A significant reason for this lack of total growth was due to the fact that approximately $6 million of equipment sales to the U.S. military was included in the prior year’s comparable quarter which did not repeat in the current year’s quarter. We anticipated that this prior year’s military business was unlikely to repeat in the current year. We were unable to grow sufficiently in other areas to compensate for this reduction of military sales.

 

Sales to the North American hospital market decreased approximately $5.4 million compared to the same period a year prior. This

 

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decrease was attributable to a decreased volume of our capital equipment sold to the U.S. military due to the completion of the PMI (Patient Movement Item) contract, and our inability to replace that business in the current year’s quarter with sufficient volume of other hospital business. We believe that the introduction of the AutoPulse to our sales force in the current quarter may have disrupted their focus and ability to close deals on the defibrillator business.

 

Sales to the North American pre-hospital market increased approximately $3.4 million compared to the same period a year ago. The growth in the North American pre-hospital market was driven by $1.6 million in sales of the AutoPulse product included from October 12th forward with the acquisition of Revivant and approximately $800,000 due to improved volume with our AED Plus product. We also saw a modest increase in the volume of equipment sales to the EMS market.

 

Total sales of the AED Plus product to all our markets were $8.2 million in comparison to $6.8 million for the same period last year. This increase reflects additional sales force resources assigned to the AED market and was driven by volume from increased market share.

 

International sales increased by approximately $2.5 million in comparison to the same period a year earlier. This increase included a favorable impact of approximately $400,000 from foreign currency exchange rate movements. The growth in our international sales include approximately $1.6 million of increased sales volume through our European subsidiaries and approximately $700,000 of increased sales volume in our Latin American distributors.

 

Gross Margins

 

Gross margin for the three months ended January 2, 2005 remained constant at approximately 56% of revenue as compared to the comparable prior year quarter. Margins for the quarter ended January 2, 2005 were reduced approximately 1% from the quarter ended January 4, 2004 due to a lower volume of M Series options in the current year period which carry a higher margin and were offset, in part, by an increased volume of data management sales.

 

Backlog

 

We ended the quarter January 2, 2005 with a capital equipment backlog of approximately $1.5 million compared to approximately $4 million at the end of fiscal year 2004. As we grow, in order to facilitate shipments given heavy end of quarter orders, we believe we need to establish a permanent backlog of orders that will not be shipped at the end of each quarter. Due to possible changes in delivery schedules, cancellation of orders and delays in shipments, our backlog at any particular date is not necessarily an accurate predictor of revenue for any succeeding period. Over the course of fiscal 2005, we hope to establish a permanent backlog of approximately $2 to $3 million.

 

Costs and Expenses

 

Operating expenses for the three months ended January 2, 2005 and January 4, 2004 are as follows:

 

(000’s omitted)


   2005

   % of
Sales


    2004

   % of
Sales


   

Change

%


 

Selling and marketing

   $ 19,667    39 %   $ 17,756    35 %   11 %

General and administrative

     4,273    8 %     3,185    6 %   34 %

Research and development

     5,828    12 %     4,340    9 %   34 %
    

  

 

  

 

Total expenses

   $ 29,768    59 %   $ 25,281    50 %   18 %
    

  

 

  

 

 

Selling and marketing expenses increased $1.9 million for the three months ended January 2, 2005 compared to the three months ended January 4, 2004. The increase in selling and marketing expense was driven by $1.2 million of personnel costs of our expanded sales force, approximately $500,000 for expanded marketing programs, and approximately $300,000 of additional depreciation expense related to our newly deployed AutoPulse demonstration units and for amortization of our newly acquired technology. Approximately $500,000 of the total increase year over year is related to selling and marketing expenses of Infusion Dynamics and Revivant Corporation whose results were not included in the prior year’s quarter’s expenses.

 

General and administrative expenses increased $1.1 million for the three months ended January 2, 2005 compared to the three months ended January 4, 2004. This increase is primarily due to increased legal fees of approximately $350,000, approximately $100,000 of increased consulting fees due to Sarbanes-Oxley compliance and approximately $150,000 due to increased amortization of patents as we introduce our new products. In addition, approximately $300,000 of the total increase year over year is due to the acquisitions of Infusion Dynamics and Revivant Corporation which were not included in the prior year’s quarter’s expenses.

 

Research and development expenses increased $1.5 million for the three months ended January 2, 2005 compared to the three months

 

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ended January 4, 2004. Approximately $1.1 million of this change is attributable to spending at Infusion Dynamics and Revivant Corporation which were not included in comparable quarter of the prior year. The remaining increase reflects continued expenditures on existing product platforms and on new projects.

 

Income Taxes

 

Our effective tax benefit rate was 43% for the three months ended January 2, 2005 as compared to an effective tax provision rate of 33% for the same period in fiscal 2004. The difference in the effective tax rate is due to a discrete $130,000 research and development tax credit recorded during the quarter ended January 2, 2005 due to the enactment into law of the American Jobs Creation Act subsequent to October 3, 2004. We believe our effective tax rate for the full fiscal year of 2005 will approximate 30%.

 

Liquidity and Capital Resources

 

Our overall financial condition remains strong. Our cash and cash equivalents at January 2, 2005 totaled $27.3 million compared with $40.7 million at October 3, 2004. In addition, we had marketable securities of $17.9 million at January 2, 2005 in comparison to $18.3 million at October 3, 2004. We have no long-term debt.

 

Cash Requirements:

 

We believe that the combination of existing cash, cash equivalents, and highly liquid short-term investments on hand, along with future cash to be generated by operations and amounts available under our line of credit will be sufficient to meet our ongoing operating and capital expenditure requirements for the foreseeable future. We believe we have, and will maintain, sufficient cash to meet future milestone contingency payments related to the Revivant acquisition. We may also need to draw on these funds in the future for potential acquisitions.

 

Sources and Uses of Cash:

 

To assist with the discussion, the following table presents the abbreviated cash flows for the three months ended January 2, 2005, and January 4, 2004:

 

(000’s omitted)


   Three
months
ended
January
2, 2005


    Three
months
ended
January
4, 2004


 

Net income (loss)

   $ (566 )   $ 2,681  

Changes not affecting cash

     2,974       2,576  

Changes in current assets and liabilities

     (6,529 )     (7,489 )
    


 


Cash used for operating activities

     (4,121 )     (2,232 )

Cash used for investing activities

     (9,742 )     (5,940 )

Cash provided by financing activities

     229       1,537  

Effect of foreign exchange rates on cash

     234       388  
    


 


Net change in cash and cash equivalents

     (13,400 )     (6,247 )

Cash and cash equivalents – beginning of period

     40,685       40,780  
    


 


Cash and cash equivalents – end of period

   $ 27,285     $ 34,533  
    


 


 

Operating Activities

 

The increase in cash used for operating activities was primarily attributable to a decrease from net income in the prior year quarter to a net loss in the current year quarter which was responsible for $3.2 million of this change. The current quarter net loss results from lower U.S. military sales which occurred in the prior year quarter which did not recur in the current quarter. Offsetting the decrease in net income was an approximate $6.4 million increase in cash provided by a reduction in accounts receivable. This increase in cash was primarily due to successful collection efforts. We also used approximately $5.2 million of cash to build up inventory at the end of the quarter January 2, 2005 when compared to the prior year quarter. This increase in inventory relates to approximately $2.3 million of inventory associated with a recent U.S. military contract award, approximately $1.5 million due to the revenue shortfall in the quarter ended January 2, 2005, which left us with more product on hand than expected, and $700,000 of additional AutoPulse inventory built subsequent

 

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to the acquisition date, October 12, 2004, of Revivant. Our recent U.S. military contract award requires us to build a certain number of M Series CCTs and to store such units in our warehouse to be able to ship these units on an accelerated schedule to the government should they decide to purchase them. The government is responsible for reimbursing our costs to build and maintain these units until they decide whether or not to purchase the units.

 

Investing Activities

 

The $3.8 million increase in cash used in investing activities stems from the October 2004 purchase of Revivant for approximately $6.5 million in net cash offset by lower net purchases of marketable securities in the current fiscal year quarter compared to the prior year. During the current quarter, we also made our first milestone earn-out payment to the former owners of Infusion Dynamics, totaling approximately $405,000.

 

Financing Activities

 

Cash provided by financing activities decreased by approximately $1.3 million from the previous year period. The change reflects a lower number of stock options exercised during the current quarter (15,682 shares in the current quarter verses 73,359 in the previous year quarter) at a lower weighted-average exercise price per share ($17.96 in the current quarter verses $20.93 in the previous year quarter).

 

Investments

 

As of January 2, 2005, we had investments in privately held technology companies with a carrying value of $1.6 million. We have performed a review of these investments and determined the carrying value of these investments approximates their fair value.

 

In March 2004, we acquired substantially all the assets of Infusion Dynamics, Inc. (“Infusion”). Under the terms of the acquisition, we are obligated to make additional earn out payments through 2006 and royalty payments through 2011 (“contingencies”) based on performance of the acquired business. Because additional consideration is based on the growth of sales, a reasonable estimate of the future payments to be made cannot be determined. When these contingencies are resolved and the consideration is distributable, we will record the fair value of the additional consideration as additional cost of the acquired assets.

 

We exercised our option to acquire Revivant Corporation (“Revivant”) on October 12, 2004. We paid $15 million in the form of cash and shares of our Common Stock as the initial merger consideration. As of January 2, 2005, we accrued $1 million for the first milestone payment. We may be required to make future milestone payments, estimated to be approximately $14 million, tied to the completion of certain clinical trials of the AutoPulse Resuscitation System through 2006. As of January 2, 2005, we may also make additional payments for the years 2005 through 2007 based on the growth of the AutoPulse sales. Because additional consideration is based on the growth of the AutoPulse sales, a reasonable estimate of the potential total purchase price cannot be determined. All payments will generally be a combination of cash and shares of our Common Stock.

 

We also have an option exercisable through October 2005 to acquire the remainder of LifeCOR, Inc. (“LifeCOR”) assets. If the option is exercised, we will make earn out payments to LifeCOR’s shareholders based upon future revenue growth of the acquired business over a five-year period. Because additional consideration is based on the growth of sales over a five-year period, a reasonable estimate of the total acquisition cost cannot be determined. As of January 2, 2005, we are also providing a $700,000 working capital line of credit to LifeCOR secured by LifeCOR’s accounts receivable and other assets. We provided LifeCOR an additional $350,000 to the working capital line of credit subsequent to the end of the quarter.

 

Debt Instruments and Related Covenants

 

We maintain a working capital line of credit with our bank. Under this working capital line, we may borrow on a demand basis. Currently, we may borrow up to $12.0 million at an interest rate equal to the bank’s base rate. No borrowings were outstanding on this line during the quarter ended January 2, 2005. There are no covenants related to this line of credit.

 

Off-Balance Sheet Arrangements

 

Our only off-balance sheet arrangements consist of non-cancelable operating leases entered into in the ordinary course of business and one minimum purchase commitment contract for a critical raw material component. The table shown below in the next section titled “Contractual Obligations and Other Commercial Commitments” shows the amounts of our operating lease commitments and purchase commitments payable by year. For liquidity purposes, we choose to lease our facilities and automobiles instead of purchasing them.

 

 

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Contractual Obligations and Other Commercial Commitments

 

The following table sets forth certain information concerning our obligations and commitments to make future payments under contracts, such as debt and lease agreements, and under contingent commitments.

 

(000’s omitted)


   Payments Due by Period

Contractual Obligations


   Total

   Less than
1 Year


   1-3
Years


   4-5
Years


   After 5
Years


Non-Cancelable Operating Lease Obligations

   $ 9,958    $ 2,083    $ 3,364    $ 2,879    $ 1,632

Purchase Obligations

     383      383      —        —        —  
    

  

  

  

  

Total Contractual Obligations

   $ 10,341    $ 2,466    $ 3,364    $ 2,879    $ 1,632
    

  

  

  

  

 

Purchase obligations include all legally binding contracts which are non-cancelable. Purchase orders or contracts for the purchase of raw materials and other goods and services are not included in the table above. Purchase orders represent authorizations to purchase rather than binding agreements. For the purposes of this table, purchase obligations for purchase of goods and services are defined as agreements that are enforceable and legally binding and that specify all significant terms, including: fixed or minimum quantities to be purchased; fixed, minimum or variable price provisions; and the approximate timing of the transaction. Our purchase orders are based upon our current inventory needs and are fulfilled by our suppliers within short time periods. We also enter into contracts for outsourced services; however, the obligations under these contracts are not significant and the contracts generally contain clauses allowing for cancellation without significant penalty.

 

Contractual obligations that are contingent upon the achievement of certain milestones are not included in the table above. These include the milestone payments, tied to the completion of certain clinical trials of the AutoPulse Resuscitation System through 2006. These arrangements are not considered contractual obligations until the milestone is met. Assuming all future milestones were met, additional required payments would be approximately $15 million in cash and ZOLL stock.

 

In addition, contractual obligations that are contingent upon future performance and growth of sales are not included in the table above. These include the additional earn out payments and royalty payments for Infusion Dynamics through fiscal 2006; additional earn out payments for Revivant Corporation through fiscal 2007; and if we exercise our option, the additional earn out payments for LifeCOR through fiscal 2009. Because all of these earn out and royalty payments are based upon the growth of sales over several years, a reasonable estimate of the future payment obligations cannot be determined.

 

Hedging Activities

 

We use forward contracts to reduce our exposure to foreign currency risk due to fluctuations in exchange rates underlying the value of intercompany accounts receivable denominated in foreign currencies as well as forecasted sales to subsidiaries denominated in foreign currencies. We had one forward exchange contract outstanding serving as a hedge of our Euro intercompany receivables in the notional amount of approximately 4.5 million Euros at January 2, 2005. The contract serves as a hedge of a substantial portion of our Euro-denominated intercompany balances. The fair value of the foreign currency derivative contract outstanding at January 2, 2005 was approximately $6.0 million resulting in an unrealized gain of $138,000. We had no forward exchange contracts outstanding serving as a hedge of a portion our forecasted sales to our subsidiaries at January 2, 2005.

 

Net realized losses from foreign currency forward contracts totaled $639,000 during the quarter ended January 2, 2005 and are included in the consolidated statement of income compared to net realized losses of $509,000 for the prior year’s quarter. Any gains or losses on the fair value of the derivative contract would be largely offset by the losses and gains on the underlying transaction. These offsetting gains and losses are not reflected above.

 

Legal and Regulatory Affairs

 

On December 10, 2004, a complaint was filed against Revivant Corporation by Dr. Thomas Fogarty and his affiliate, alleging that Revivant owes a 4% royalty on all of its sales. The Company believes the suit is without merit. Moreover, in connection with the Company’s acquisition of Revivant, the former stockholders of Revivant specifically agreed to indemnify the Company against Dr. Fogarty’s claim for all amounts up to $15 million. The Company has the right to set-off these indemnity claims against future contingent amounts payable by it as part of the purchase price for Revivant.

 

The Company has been informed by the federal government that it is conducting an investigation regarding two sales of defibrillators in fiscal 2000 to a distributor, which were then allegedly trans-shipped to Iran without the required export licenses. The Company is cooperating with the Department of Justice in connection with its ongoing investigation, and has provided requested information. The

 

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two sales in question represented approximately $150,000 of net income in fiscal 2000. Although it is premature to determine the likely outcome of the investigation, it is possible that the Company may be subject to civil or criminal fines and sanctions as a result of this matter.

 

In addition to these matters the Company is, from time to time, involved in the normal course of its business in various other litigation matters and regulatory issues, including product recalls. Although the Company is unable to quantify at the present time the exact financial impact in any of these matters, it believes that none of these other matters currently pending will have an outcome material to its financial condition or business.

 

Critical Accounting Estimates

 

Our management strives to report our financial results in a clear and understandable manner, even though in some cases accounting and disclosure rules are complex and require us to use technical terminology. We follow accounting principles generally accepted in the United States in preparing our consolidated financial statements. These principles require us to make certain estimates of matters that are inherently uncertain and to make difficult and subjective judgments that affect our financial position and results of operations. Our most critical accounting policies include revenue recognition, and our most critical accounting estimates include accounts receivable reserves, warranty reserves, inventory reserves, and the valuation of long lived assets. Management continually reviews its accounting policies, how they are applied and how they are reported and disclosed in our financial statements. Following is a summary of our more significant accounting policies, which include revenue recognition and those that require significant estimates and judgments and uncertainties, and potentially could result in materially different results under different assumptions and conditions, and how they are applied in preparation of the financial statements.

 

Revenue Recognition

 

Revenues from sales of cardiac resuscitation devices, disposable electrodes and accessories are recognized when a signed non-cancelable purchase order exists, the product is shipped, title and risk have passed to the customer, the fee is fixed and determinable, and collection is considered probable. Circumstances which generally preclude the immediate recognition of revenue include shipping terms of FOB destination or the existence of a customer acceptance clause in a contract based upon customer inspection of the product. In these instances, revenue is deferred until adequate documentation is obtained to ensure that these criteria have been fulfilled. Similarly, revenues from the sales of our products to distributors fall under the same guidelines. For all significant orders placed by our distributors, we require an approved purchase order, we perform a credit review, and we ensure that the terms on the purchase order or contract are proper and do not include any contingencies which preclude revenue recognition. We do not typically offer any special right of return, stock rotation or price protection to our distributors or the end customers.

 

Our sales to customers often include a cardiac resuscitation device, disposable electrodes and other accessories. For the vast majority of our shipments, all deliverables are shipped together. In cases where some elements of a multiple element arrangement are not delivered as of a reporting date, we defer the fair value of the undelivered elements and only recognize the revenue related to the delivered elements in accordance with Emerging Issues Task Force (EITF) 00-21 “Revenue Arrangements with Multiple Deliverables”. Revenues are recorded net of estimated returns. Some sales to customers of our cardiac resuscitation devices may include some data collection software. The cardiac resuscitation device and software product can operate independently of each other and one does not impede the functionality of the other. In cases where both elements are included in a customer’s order but only one has been delivered by the reporting date, we defer the fair value of the undelivered element and recognize the revenue related to the delivered item.

 

We also license software under non-cancelable license agreements and provide services including training, installation, consulting and maintenance, which consist of product support services, periodic updates and unspecified upgrade rights (collectively, post-contract customer support (“PCS”)). Revenue from the sale of software is recognized in accordance with the American Institute of Certified Public Accountants (“AICPA”) Statement of Position (“SOP”) 97-2, “Software Revenue Recognition,” as amended. License fee revenues are recognized when a non-cancelable license agreement has been signed, the software product has been delivered, there are no uncertainties surrounding product acceptance, the fees are fixed and determinable, and collection is considered probable. Revenues from maintenance agreements and upgrade rights are recognized ratably over the period of service. Revenue for services, such as software deployment, is recognized when the deployment is completed.

 

Our software arrangements contain multiple elements, which include software products, services and PCS. Generally, we do not sell computer hardware products with our software products. We will occasionally facilitate the hardware purchase by providing information to the customer such as where to purchase the equipment. We do not have vendor specific objective evidence of fair value for our software products. We do, however, have vendor specific objective evidence of fair value for items such as technical services, maintenance, upgrades and support for the software products based upon the price charged when such items are sold separately. Accordingly, for transactions where vendor specific objective evidence exists for undelivered elements but not for delivered elements,

 

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we use the residual method as discussed in SOP 98-9, “Modification of SOP 97-2, With Respect to Certain Transactions.” Under the residual method, the total fair value of the undelivered elements, as indicated by vendor specific objective evidence, is deferred and the difference between the total arrangement fee and the amount deferred for the undelivered elements is recognized as revenue related to the delivered elements.

 

We do not ship any of our software products to distributors or resellers. Our software products are sold only by our sales force directly to the end user. We may sell software to system integrators who provide complete solutions to end users on a contract basis.

 

We have been awarded a contract by the U.S. government to achieve a “state of readiness” to supply defibrillators on short notice. Based on the award, we will be receiving two types of payments from the U.S. government. The first payment is to reimburse us for the cost to acquire inventories required to meet potentially short notice delivery schedules. This payment will be carried on our balance sheet as a liability under government contract.

 

We also are receiving a second payment from the U.S. government to compensate us for managing the purchase, build, storage and inventory rotation process. This payment also compensates us for making future production capacity available. The portion of this second payment associated with the purchase and build aspects of the contract is being recognized on a percentage of completion basis while the portion of the second payment for the storage, inventory rotation and facilities charge is being recognized ratably over the year.

 

This government contract is for one year and the U.S. government has four one-year extension options that require the payment of additional fees to us if exercised. The U.S. government has two ways to acquire defibrillators under this contract. They may buy on a replenishment basis, which means we will record a sale under our normal U.S. government price list and maintain our “state of readiness” or they may buy on a non-replenishment basis which will still allow us to obtain normal margins but it will reduce our future obligations under this arrangement.

 

During the first quarter, we recognized approximately $500,000 of percentage completion revenue under this contract. During the second quarter, we anticipate recognition of approximately $400,000 of percentage completion revenue under this contract as we complete our “state of readiness”. In addition, over the course of the four quarters of 2005, we are recognizing approximately $500,000 of revenue ratably related to the storage, inventory rotation and maintenance of capacity.

 

Allowance for Doubtful Accounts / Sales Returns and Allowances

 

We maintain an allowance for doubtful accounts for estimated losses, which are included in bad debt expense, resulting from the inability of our customers to make required payments. We determine the adequacy of this allowance by regularly reviewing the aging of our accounts receivable and evaluating individual customer receivables, considering customers’ financial condition, historical experience, credit history and current economic condition. We also maintain an estimate of potential future product returns and discounts given related to trade-ins and to current period product sales. We analyze the rate of historical returns when evaluating the adequacy of the allowance for sales returns, which are included with the allowance for doubtful accounts on our balance sheet.

 

As of January 2, 2005, our accounts receivable balance of $48 million is reported net of allowances of $5 million. We believe our reported allowances at January 2, 2005 are adequate. If the financial conditions of our customers were to deteriorate, however, resulting in their inability to make payments, we may need to record additional allowances, resulting in additional expenses being recorded for the period in which such determination was made.

 

Warranty Reserves

 

Our products are sold with warranty provisions that require us to remedy deficiencies in quality or performance over a specified period of time, usually one to five years. We provide for the estimated cost of product warranties at the time product is shipped and revenue is recognized. The costs which we estimate include material, labor, and shipping. While we engage in product quality programs and processes, our warranty obligation is affected by product failure rates, material usage and service delivery costs incurred in correcting a product failure. We believe that our recorded liability of $3.6 million at January 2, 2005 is adequate to cover future costs for the servicing of our products sold through that date and under warranty. If actual product failure rates, material usage or service delivery costs differ from our estimates, revisions to the estimated warranty liability would be required.

 

Inventory Reserves

 

Significant management judgment is required to determine the reserve for obsolete or excess inventory. Inventory on hand may exceed future demand either because the product is outdated, obsolete, or because the amount on hand is in excess of future needs. We provide for the total value of inventories that we determine to be obsolete based on criteria such as customer demand and changing technologies. We estimate excess inventory amounts by reviewing quantities on hand and comparing those quantities to sales forecasts for the next 12 months; identifying historical service usage trends and matching that usage with the installed base quantities to estimate future needs. At January 2, 2005, our inventory reserves were $3.6 million, or 8.8% of our $41.1 million gross inventories.

 

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We value our inventories at the lower of cost or market. Cost is determined by the first-in, first-out (“FIFO”) method, including material, labor and factory overhead.

 

Goodwill and Other Intangibles

 

At January 2, 2005, we had approximately $27.6 million in goodwill primarily resulting from our acquisitions of Revivant Corporation and Infusion Dynamics. In accordance with SFAS 142, Goodwill and Other Intangible Assets, we test our goodwill for impairment at least annually by comparing the fair value of our reporting units to the carrying value of those reporting units. Fair value is determined based on an estimate of the discounted future cash flows expected from the reporting units. The determination of fair value requires significant judgment on the part of management about future revenues, expenses and other assumptions that contribute to the net cash flows of the reporting units. Additionally, we periodically review our goodwill for impairment whenever events or changes in circumstances indicate that an impairment indicator has occurred.

 

Investments

 

At January 2, 2005, we had $1.6 million in investments in privately held companies focused in the medical devices industry. These investments are carried at cost. We periodically review the fair value of our investments to determine if impairment has occurred. We estimate the fair value of these investments based on an analysis of discounted cash flows. If we determine that the carrying value of an investment exceeds its fair value, we record an impairment charge to adjust the carrying value to estimated fair value, if the impairment is deemed other-than-temporary. The estimate of fair value of these investments, and the determination of whether impairment is temporary, requires that management make significant judgments that could affect the timing and amount of any impairment charge recorded.

 

Long Lived Assets

 

We periodically review the carrying amount of our long lived assets, including property and equipment, and intangible assets, to assess potential impairment whenever events or changes in circumstances indicate that their carrying amount may not be recoverable. The determination includes evaluation of factors such as current market value, business climate and future cash flows expected to result from the use of the related assets. Our policy is to use discounted cash flows in assessing potential impairment and to record an impairment loss in the period when it is determined that the carrying amount of the asset may not be recoverable. This process requires judgment on the part of management.

 

Safe Harbor Statements

 

Certain statements contained herein constitute “forward-looking statements” as that term is defined under the Private Securities Litigation Reform Act of 1995 (the “Act”) and releases issued by the Securities and Exchange Commission and within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Exchange Act of 1934. The words “believe,” “expect,” “anticipate,” “intend,” “estimate” and other expressions which are predictions of or indicate future events and trends and which do not relate to historical matters identify forward-looking statements. Particularly, the Company’s expectations regarding future operational liquidity, contractual obligations and other commercial commitments, and capital requirements are forward-looking statements. Reliance should not be placed on forward-looking statements because they involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of the Company to differ materially from anticipated future results, performance or achievements expressed or implied by such forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, the length and severity of the current economic slowdown and its impact on capital spending budgets, the potential disruption in the transportation industry on the Company’s supply chain and product distribution channels, adoption of the Financial Accounting Standards Board Statement No. 123R, Share-Based Payment, and those other risks and uncertainties contained under the heading “Risk Factors”.

 

Risk Factors

 

If We Fail to Compete Successfully in the Future against Existing or Potential Competitors, Our Operating Results May Be Adversely Affected

 

Our principal global competitors with respect to our entire cardiac resuscitation equipment product line are Medtronic Emergency Response Systems (Physio-Control) and Royal Philips Electronics. Physio-Control is a subsidiary of Medtronic, Inc., a

 

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leading medical technology company. Physio-Control has been the market leader in the defibrillator industry for over twenty years. As a result of Physio-Control’s dominant position in this industry, many potential customers have relationships with Physio-Control that could make it difficult for us to continue to penetrate the markets for our products. In addition, Physio-Control, its parent and Royal Philips Electronics and other competitors each have significantly greater resources than we do. Accordingly, Physio-Control, Royal Philips Electronics and other competitors could substantially increase the resources they devote to the development and marketing of products that are competitive with ours. These and other competitors may develop and successfully commercialize medical devices that directly or indirectly accomplish what our products are designed to accomplish in a superior and/or less expensive manner. In addition, although our biphasic waveform technology is unique, our competitors have devised alternative biphasic waveform technology. We have also licensed our biphasic waveform technology to GE Medical Systems Information Technologies.

 

There are a number of smaller competitors in the United States, which include Welch Allyn, Inc., Cardiac Science, Inc., HeartSine Technology, and Defibtech. Internationally, we face the same competitors as in the United States as well as Nihon Kohden, Corpuls, Schiller, and other local competitors. It is possible the market may embrace these competitors’ products which could negatively impact our market share.

 

In addition to external defibrillation and external pacing with cardiac resuscitation equipment, it is possible that other alternative therapeutic approaches to the treatment of sudden cardiac arrest may be developed. These alternative therapies or approaches, including pharmaceutical or other alternatives, could prove to be superior to our products.

 

There is significant competition in the business of developing and marketing software for data collection, billing, dispatching and management in the emergency medical system market. Our principal competitors in this business include Medusa Medical Technologies, Inc. Healthware Technologies, Inc., Safety Pad Software, Geac Computer Corporation, Ltd., DocuMed, Inc., Tritech Software Systems, Inc., Ortivus AB, RAM Software Systems, Inc., Intergraph Corporation and AmbPac, Inc., some of which have greater financial, technical, research and development and marketing resources than we do. Because the barriers to entry in this business are relatively low, additional competitors may easily enter this market in the future. It is possible that systems developed by competitors could be superior to our data management system. Consequently, our ability to sell our data management system could be materially affected and our financial results could be materially and adversely affected.

 

Our Operating Results are Likely to Fluctuate Which Could Cause Our Stock Price to be Volatile, and the Anticipation of a Volatile Stock Price Can Cause Greater Volatility

 

Our quarterly and annual operating results have fluctuated and may continue to fluctuate. Various factors have and may continue to affect our operating results, including:

 

    high demand for our products which could disrupt our normal factory utilization and cause shipments to occur in uneven patterns;

 

    variations in product orders;

 

    timing of new product introductions;

 

    temporary disruptions on buying behavior due to changes in technology (e.g. shift to biphasic technology);

 

    changes in distribution channels;

 

    actions taken by our competitors such as the introduction of new products or the offering of sales incentives;

 

    the ability of our sales forces to effectively market our products;

 

    supply interruptions from our single source vendors;

 

    temporary manufacturing disruptions;

 

    regulatory actions, including actions taken by the FDA or similar agencies; and

 

    delays in obtaining domestic or foreign regulatory approvals.

 

A large percentage of our sales are made toward the end of each quarter. As a consequence, our quarterly financial results are often dependent on the receipt of customer orders in the last weeks of a quarter. The absence of these orders could cause us to fall short of our quarterly sales targets, which in turn could cause our stock price to decline sharply. As we grow in size, and these orders are received closer to the end of a period, we may not be able to manufacture, test, and ship all orders in time to recognize the shipment as revenue for that quarter.

 

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Based on these factors, period-to-period comparisons should not be relied upon as indications of future performance. In anticipation of less successful quarterly results, parties may take short positions in our stock. The actions of parties shorting our stock might cause even more volatility in our stock price. The volatility of our stock may cause the value of a stockholder’s investment to decline rapidly.

 

The AED PAD (Public Access Defibrillation) Business is New to Us. If We are Not Successful in Competing In This Market, Our Operating Results May be Affected.

 

The PAD market has many dynamics. This market involves many new types of non-traditional healthcare distributors, and the efficiency of these distributors may not be as robust as we expect. These new types of distributors may present credit risks since they may not be well established and may not have the necessary business volumes. In addition, we may not be successful in gaining market acceptance of our AED Plus into alternative PAD markets if our PAD Distributors are not successful. Also, our focus upon the PAD market may distract our operations from our core M Series business. All of these items could cause our operating results to be unfavorably affected.

 

We have noticed that as the PAD market has grown, there have been an increasing number of smaller, start-up companies entering the market. In order to gain market share, these companies compete mainly on price. If these companies are able to capture a larger market share with lower prices, this may cause declining prices and negatively affect our operating results.

 

Two of our major competitors have entered the home market. We also sell to the home market and if our plan turns out to be less effective or efficient, we might have difficulty building market share.

 

We May be Required to Implement a Costly Product Recall

 

In the event that any of our products proves to be defective, we can voluntarily recall, or the FDA could require us to redesign or implement a recall of any of our products. Both our larger competitors and we have, on numerous occasions, voluntarily recalled products in the past, and based on this experience, we believe that future recalls could result in significant costs to us and significant adverse publicity, which could harm our ability to market our products in the future. Though it is not possible to quantify the economic impact of a recall, it could have a material adverse effect on our business, financial condition and results of operations. For example, in 2004, we issued a device safety alert on some M Series with the AED feature to correct a potential problem that some of the units may have with the software installed on them. Under certain conditions, the unit may skip the “press shock” screen prompt after correctly advising the user of a shockable ECG rhythm, charging, and enabling/illuminating the shock button. The devices were operating properly in all other respects. The cost of implementing this corrective action was less than $50,000.

 

Changes in the Healthcare Industry May Require Us to Decrease the Selling Price for Our Products or Could Result in a Reduction in the Size of the Market for Our Products, Each of Which Could Have a Negative Impact on Our Financial Performance

 

Trends toward managed care, healthcare cost containment, and other changes in government and private sector initiatives in the United States and other countries in which we do business are placing increased emphasis on the delivery of more cost-effective medical therapies which could adversely affect the sale and/or the prices of our products. For example:

 

    major third-party payers of hospital and pre-hospital services, including Medicare, Medicaid and private healthcare insurers, have substantially revised their payment methodologies during the last few years which has resulted in stricter standards for reimbursement of hospital and pre-hospital charges for certain medical procedures;

 

    Medicare, Medicaid and private healthcare insurer cutbacks could create downward price pressure in the cardiac resuscitation pre-hospital market;

 

    numerous legislative proposals have been considered that would result in major reforms in the U.S. healthcare system that could have an adverse effect on our business;

 

    there has been a consolidation among healthcare facilities and purchasers of medical devices in the United States who prefer to limit the number of suppliers from whom they purchase medical products, and these entities may decide to stop purchasing our products or demand discounts on our prices;

 

    there is economic pressure to contain healthcare costs in international markets;

 

    there are proposed and existing laws and regulations in domestic and international markets regulating pricing and profitability of companies in the healthcare industry; and

 

    there have been initiatives by third party payers to challenge the prices charged for medical products which could affect our ability to sell products on a competitive basis.

 

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Both the pressure to reduce prices for our products in response to these trends and the decrease in the size of the market as a result of these trends could adversely affect our levels of revenues and profitability of sales, which could have a material adverse effect on our business.

 

General Economic Conditions May Cause Our Customers to Delay Buying Our Products Resulting in Lower Revenues

 

The national economy of the United States and the global economy are both subject to economic downturns. An economic downturn in any market in which we sell our products may have a significant impact on the ability of our customers, in both the hospital and pre-hospital markets, to secure adequate funding to buy our products or might cause purchasing decisions to be delayed. Any delay in purchasing our products may result in decreased revenues and also allow our competitors additional time to develop products which may have a competitive edge over our M Series products, making future sales of our products more difficult.

 

For example, in the face of a difficult economic climate in the U.S., many states experienced deficits and shortfalls of revenue to cover expenditures. As a result, states cut their spending and support to local cities and towns, who then in-turn have reduced their spending for capital equipment purchases for their EMS services. We believe that this has had a negative impact on our revenues and may continue to do so.

 

The War on Terrorism and the Impact of a Bio-Terror Threat May Cause Our Customers to Stop or Delay Buying Our Products, Resulting in Lower Revenues

 

The current war on terrorism and a threat of a bio-terror attack may have a significant impact on our customers’ ability or willingness to buy our products, as well as our ability to timely deliver the product to the customers. Our customers may have to divert their funding, earmarked for capital equipment purchases to the purchase of other medical equipment and supplies to fight any potential bio-terror attack. The war on terrorism may cause the diversion of any government funding of hospitals and EMS services for capital equipment purchases. This could result in decreased revenues.

 

We Can be Sued for Producing Defective Products and We May be Required to Pay Significant Amounts to Those Harmed If We are Found Liable, and Our Business Could Suffer from Adverse Publicity

 

The manufacture and sale of medical products such as ours entail significant risk of product liability claims. Our quality control standards comply with FDA requirements and we believe that the amount of product liability insurance we maintain is adequate based on past product liability claims in our industry. We cannot be assured that the amount of such insurance will be sufficient to satisfy claims made against us in the future or that we will be able to maintain insurance in the future at satisfactory rates or in adequate amounts. Product liability claims could result in significant costs or litigation. A successful claim brought against us in excess of our available insurance coverage or any claim that results in significant adverse publicity against us could have a material adverse effect on our business, financial condition and results of operations.

 

Recurring Sales of Electrodes to Our Customers May Decline

 

We typically have recurring sales of electrodes to our customers. Other vendors have developed electrode adaptors which allow generic electrodes to be compatible with our defibrillators. If we are unable to continue to differentiate the superiority of our electrodes over these generic electrodes, our future revenue from the sale of electrodes could be reduced, or our pricing and profitability could decline.

 

Failure to Produce New Products or Obtain Market Acceptance for Our New Products in a Timely Manner Could Harm Our Business

 

Because substantially all of our revenue comes from the sale of cardiac resuscitation devices and related products, our financial performance will depend upon market acceptance of, and our ability to deliver and support, new products. We cannot be assured that we will be able to produce viable products in the time frames we currently estimate. Factors which could cause delay in these schedules or even cancellation of our projects to produce and market these new products include: research and development delays, the actions of our competitors producing competing products and the actions of other parties who may provide alternative therapies or solutions which could reduce or eliminate the markets for pending products.

 

The degree of market acceptance of any of our products will depend on a number of factors, including:

 

 

    our ability to develop and introduce new products in a timely manner;

 

    our ability to successfully implement new product technologies;

 

    the market’s readiness to accept new products such as our data management products and our PAD product;

 

    the standardization of an automated platform for data management systems;

 

 

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    the clinical efficacy of our products and the outcome of clinical trials;

 

    the ability to obtain timely regulatory approval for new products; and

 

    the prices of our products compared to the prices of our competitors’ products.

 

If our new products do not achieve market acceptance, our financial performance could be adversely affected.

 

Our Dependence on Sole and Single Source Suppliers Exposes Us to Supply Interruptions and Manufacturing Delays Caused by Faulty Components That Could Result in Product Delivery Delays and Substantial Costs to Redesign Our Products

 

Although we use many standard parts and components for our products, some key components are purchased from sole or single source vendors for which alternative sources at present are not readily available. For example, we currently purchase proprietary components, including capacitors, display screens, gate arrays and integrated circuits, for which there are no direct substitutes. Our inability to obtain sufficient quantities of these components as well as our limited ability to deal with faulty components may result in future delays or reductions in product shipments which could cause a fluctuation in our results of operations.

 

These or any other components could be replaced with alternatives from other suppliers, which could involve a redesign of our products. Such a redesign could involve considerable time and expense. We could be at risk that the supplier might experience difficulties meeting our needs.

 

If our manufacturers are unable or unwilling to continue manufacturing our components in required volumes, we will have to transfer manufacturing to acceptable alternative manufacturers whom we have identified, which could result in significant interruptions of supply. The manufacture of these components is complex, and our reliance on the suppliers of these components exposes us to potential production difficulties and quality variations, which could negatively impact the cost and timely delivery of our products. Accordingly, any significant interruption in the supply, or degradation in the quality, of any component would have a material adverse effect on our business, financial condition and results of operations.

 

We May Not be Able to Obtain Appropriate Regulatory Approvals for Our New Products

 

The manufacture and sale of our products are subject to regulation by numerous governmental authorities, principally the FDA and corresponding state and foreign agencies. The FDA administers the Federal Food, Drug and Cosmetic Act, as amended, and the rules and regulations promulgated hereunder. Some of our products have been classified by the FDA as Class II devices and others, such as our automated external defibrillators, have been classified as Class III devices. All of these devices must secure a 510(k) pre-market notification clearance before they can be introduced into the U.S. market. The process of obtaining 510(k) clearance typically takes several months and may involve the submission of limited clinical data supporting assertions that the product is substantially equivalent to an already approved device or to a device that was on the market before the Medical Device Amendments of 1976. Delays in obtaining 510(k) clearance could have an adverse effect on the introduction of future products. Moreover, approvals, if granted, may limit the uses for which a product may be marketed, which could reduce or eliminate the commercial benefit of manufacturing any such product.

 

We are also subject to regulation in each of the foreign countries in which we sell products. Many of the regulations applicable to our products in such countries are similar to those of the FDA. However, the national health or social security organizations of certain countries require our products to be qualified before they can be marketed in those countries. We cannot be assured that such clearances will be obtained.

 

If We Fail to Comply With Applicable Regulatory Laws and Regulations, The FDA and Other U.S. and Foreign Regulatory Agencies Could Exercise Any of Their Regulatory Powers, which Could Have a Material Adverse Effect on Our Business

 

Every company that manufactures or assembles medical devices is required to register with the FDA and to adhere to certain quality systems, which regulate the manufacture of medical devices and prescribe record keeping procedures and provide for the routine inspection of facilities for compliance with such regulations. The FDA also has broad regulatory powers in the areas of clinical testing, marketing and advertising of medical devices. To ensure that manufacturers adhere to good manufacturing practices, medical device manufacturers are routinely subject to periodic inspections by the FDA. If the FDA believes that a company may not be operating in compliance with applicable laws and regulations, it could take any of the following actions:

 

    place the company under observation and re-inspect the facilities;

 

    issue a warning letter apprising of violating conduct;

 

    detain or seize products;

 

    mandate a recall;

 

 

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    enjoin future violations; and

 

    assess civil and criminal penalties against the company, its officers or its employees.

 

We, like most of our U.S. competitors, have received warning letters from the FDA in the past, and may receive warning letters in the future. We have always complied with the warning letters we have received. However, our failure to comply with FDA regulations could result in sanctions being imposed on us, including restrictions on the marketing or recall of our products. These sanctions could have a material adverse effect on our business.

 

If a foreign regulatory agency believes that we are not operating in compliance with their laws and regulations, they could prevent us from selling our products in their country, which could have a material adverse effect on our business.

 

We have been informed by the federal government that it is conducting an investigation regarding two sales of defibrillators in fiscal 2000 to a distributor, which were then allegedly trans-shipped to Iran without the required export licenses. We are cooperating with the Department of Justice in connection with its ongoing investigation, and have provided requested information. The two sales in question represented approximately $150,000 of net income in fiscal 2000. Although it is premature to determine the likely outcome of the investigation, it is possible that the Company may be subject to civil or criminal fines and sanctions as a result of this matter. There can be no assurance that the penalty will not be material.

 

We are Dependent upon Licensed and Purchased Technology for Upgradeable Features in Our Products, and We May Not Be Able to Renew These Licenses or Purchase Agreements in the Future

 

We license and purchase technology from third parties for upgradeable features in our products, including 12 lead analysis program, pulse oximetry, EtCO2, and NIBP technologies. We anticipate that we will need to license and purchase additional technology to remain competitive. We may not be able to renew our existing licenses and purchase agreements or to license and purchase other technologies on commercially reasonable terms or at all. If we are unable to renew our existing licenses and purchase agreements or we are unable to license or purchase new technologies, we may not be able to offer competitive products.

 

Fluctuations in Currency Exchange Rates May Adversely Affect Our International Sales

 

Our revenue from international operations can be denominated in or significantly influenced by the currency and general economic climate of the country in which we make sales. A decrease in the value of such foreign currencies relative to the U.S. dollar could result in downward price pressure for our products or losses from currency exchange rate fluctuations. As we continue to expand our international operations, downward price pressure and exposure to gains and losses on foreign currency transactions may increase.

 

We may continue our use of forward contracts and other instruments in the future to reduce our exposure to exchange rate fluctuations from intercompany accounts receivable and budgeted intercompany sales to our subsidiaries denominated in foreign currencies, and we may not be able to do this successfully. Accordingly, we may experience economic loss and a negative impact on our results of operations and equity as a result of foreign currency exchange rate fluctuations.

 

We Have Licensed Our Biphasic Technology to GE Medical Systems Information Technologies and We May Experience a Competitive Product Utilizing Our own Patented Technology

 

In 2001, we entered into a five-year license agreement with GE Medical Systems Information Technologies that permits GE to incorporate our patented biphasic waveform technology into their defibrillator and monitoring systems. At this time GE has taken only limited action to incorporate our technology into their products. However, GE has significantly greater resources than we do. If they bring our technology to market, it could impact our ability to market and sell our products, potentially lowering our revenues.

 

Our Current and Future Investments May Lose Value in the Future

 

We hold investments in Advanced Circulatory Systems, Inc. (formerly ResQSystems, Inc.) and AED@Home and may in the future invest in the securities of other companies and participate in joint venture agreements. These investments and future investments are subject to the risks that the entities in which we invest will become bankrupt or lose money. Investing in securities involves risks and no assurance can be made as to the profitability of any investment. Our inability to identify profitable investments could adversely affect our financial condition and results of operations. Unless we hold a majority position in an investment or joint venture, we will not be able to control all of the activities of the companies in which we invest or the joint ventures in which we are participating. Because of this, such entities may take actions against our wishes and not in furtherance of, and even opposed to, our business plans and objectives. These investments are also subject to the risk of impasse if no one party exercises ultimate control over the business decisions.

 

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Our Adoption of FASB Statement 123(R) Will Result in Additional Expense Being Charged to Our Income Statement Which Might Cause Our Stock Price to Fluctuate

 

We will adopt FASB Statement 123(R) in the fourth quarter of 2005. While we have disclosed the historical impact under FASB Statement 123, we have not determined the impact adoption of FASB Statement 123(R) will have on our financial statements nor have we determined our method of adoption. Adoption may result in results that are different than what investors anticipate. This may cause volatility in our stock price.

 

Future Changes in Applicable Laws and Regulations Could Have an Adverse Effect on Our Business

 

Although we are not aware of any pending changes in applicable laws and regulations governing our industry, we cannot be assured that federal, state or foreign governments will not change existing laws or regulations or adopt new laws or regulations that regulate our industry. Changes in or adoption of new laws or regulations could result in the following consequences that would have an adverse effect on our business:

 

    regulatory clearance previously received for our products could be revoked;

 

    costs of compliance could increase; or

 

    we may be unable to comply with such laws and regulations so that we would be unable to sell our products.

 

Compliance With Changing Regulation of Corporate Governance, Public Disclosure and Accounting Matters May Result in Additional Expenses

 

Changing laws, regulations and standards relating to corporate governance and public disclosure, including the Sarbanes-Oxley Act of 2002 and new rules subsequently implemented by the SEC and The NASDAQ Stock Market, as well as new accounting pronouncements, are creating uncertainty and additional complexities for companies. To maintain high standards of corporate governance and public disclosure, we continue to invest resources to comply with evolving standards. This investment may result in increased general and administrative expenses and a diversion of management time and attention from revenue generating and cost management activities.

 

The provisions of Section 404 of the Sarbanes-Oxley Act of 2002 apply to us for the fiscal year 2005. We are in the middle of a project to document, review, test, evaluate and conclude on our systems of internal controls. We expect to complete our testing of our internal control systems by the end of fiscal 2005. There is a potential for identifying a significant deficiency or material weakness in our system of internal controls. Disclosure of a material weakness in our system of internal control may cause our stock price to fluctuate significantly.

 

Uncertain Customer Decision Processes May Result in Long Sales Cycles Which Could Result in Unpredictable Fluctuations in Revenues and Delay the Replacement of Cardiac Resuscitation Devices

 

Many of the customers in the pre-hospital market consist of municipal fire and emergency medical systems departments. As a result, there are numerous decision-makers and governmental procedures in the decision-making process. In addition, decisions at hospitals concerning the purchase of new medical devices are sometimes made on a department-by-department basis. Accordingly, we believe the purchasing decisions of many of our customers may be characterized by long decision-making processes, which have resulted in and may continue to result in long sales cycles for our products. For example, the sales cycles for cardiac resuscitation products typically have been between six and nine months, although some sales efforts have taken as long as two years.

 

Our International Sales Expose Our Business to a Variety of Risks That Could Result in Significant Fluctuations in Our Results of Operations

 

Approximately 32% of our sales for the quarter ended January 2, 2005 were made to foreign purchasers and we plan to increase the sale of our products to foreign purchasers in the future. As a result, a significant portion of our sales is and will continue to be subject to the risks of international business, including:

 

    fluctuations in foreign currencies;

 

    trade disputes;

 

    changes in regulatory requirements, tariffs and other barriers;

 

    the possibility of quotas, duties, taxes or other changes or restrictions upon the importation or exportation of the products being implemented by the United States or these foreign countries;

 

 

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    timing and availability of import/export licenses;

 

    political and economic instability;

 

    higher credit risk and difficulties in accounts receivable collections;

 

    increased tax exposure if our revenues in foreign countries are subject to taxation by more than one jurisdiction;

 

    accepting customer purchase orders governed by foreign laws which may differ significantly from U.S. laws and limit our ability to enforce our rights under such agreements and to collect damages, if awarded;

 

    war on terrorism;

 

    disruption in the international transportation industry; and

 

    use of international distributors.

 

As international sales become a larger portion of our total sales, these risks could create significant fluctuations in our results of operations. These risks could affect our ability to resell trade-in products to domestic distributors, who in turn often resell the trade-in products in international markets. Our inability to sell trade-in products might require us to offer lower trade-in values, which might impact our ability to sell new products to customers desiring to trade in older models and then purchase newer products.

 

We have recently expanded the size and number of our direct sales forces and our marketing support for these sales forces. We intend to continue to expand these areas, but if our sales forces are not effective, or if there is a sudden decrease in the markets where we have direct operations, we could be adversely affected.

 

We May Fail to Adequately Protect or Enforce Our Intellectual Property Rights or Secure Rights to Third Party Intellectual Property, and Our Competitors Can Use Some of Our Previously Proprietary Technology

 

Our success will depend in part on our ability to obtain and maintain patent protection for our products, methods, processes and other technologies, to preserve our trade secrets and to operate without infringing the proprietary rights of third parties. To date, we have been issued 35 U.S. patents for our various inventions and technologies. Additional patent applications have been filed with the U.S. Patent and Trademark Office and are currently pending. The patents that have been granted to us are for a definitive period of time and will expire. We have filed certain corresponding foreign patent applications and intend to file additional foreign and U.S. patent applications as appropriate. We cannot be assured as to:

 

    the degree and range of protection any patents will afford against competitors with similar products;

 

    if and when patents will be issued;

 

    whether or not others will obtain patents claiming aspects similar to those covered by our patent applications;

 

    whether or not competitors will use information contained in our expired patents;

 

    whether or not others will design around our patents or obtain access to our know-how; or

 

    the extent to which we will be successful in avoiding any patents granted to others.

 

We have, for example, patents and pending patent applications for our proprietary biphasic technology. Our competitors could develop biphasic technology that has comparable or superior clinical efficacy to our biphasic technology and if our patents do not adequately protect our technology, our competitors would be able to obtain patents claiming aspects similar to our biphasic technology or our competitors could design around our patents.

 

If certain patents issued to others are upheld or if certain patent applications filed by others issue and are upheld, we may be:

 

    required to obtain licenses or redesign our products or processes to avoid infringement;

 

    prevented from practicing the subject matter claimed in those patents; or

 

    required to pay damages.

 

There has been substantial litigation regarding patent and other intellectual property rights in the medical device industry. Litigation or administrative proceedings, including interference proceedings before the U.S. Patent and Trademark Office, related to intellectual property rights could be brought against us or be initiated by us. Adverse determinations in any patent litigation could subject us to significant liabilities to third parties, could require us to seek licenses from third parties and could, if licenses are not available, prevent us from manufacturing, selling or using certain of our products, some of which could have a material adverse effect on the Company. In addition, the costs of any such proceedings may be substantial whether or not we are successful.

 

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Our success is also dependent upon the skills, knowledge and experience, none of which is patentable, of our scientific and technical personnel. To help protect our rights, we require all U.S. employees, consultants and advisors to enter into confidentiality agreements, which prohibit the disclosure of confidential information to anyone outside of our Company and require disclosure and assignment to us of their ideas, developments, discoveries and inventions. We cannot be assured that these agreements will provide adequate protection for our trade secrets, know-how or other proprietary information in the event of any unauthorized use or disclosure of the lawful development by others of such information.

 

Reliance on Overseas Vendors for Some of the Components for Our Products Exposes Us to International Business Risks, Which Could Have an Adverse Effect on Our Business

 

Some of the components we use in our products are acquired from foreign manufacturers, particularly countries located in Europe and Asia. As a result, a significant portion of our purchases of components is subject to the risks of international business. The failure to obtain these components as a result of any of these risks can result in significant delivery delays of our products, which could have an adverse effect on our business.

 

We May Acquire Other Businesses, and We May Have Difficulty Integrating These Businesses or Generating an Acceptable Return from Acquisitions

 

We recently acquired Revivant Corporation, and we may acquire other companies or make strategic purchases of interests in other companies related to our business in order to grow, add product lines, acquire customers or otherwise attempt to gain a competitive advantage in new or existing markets. Such acquisitions and investments may involve the following risks:

 

    our management may be distracted by these acquisitions and may be forced to divert a significant amount of time and energy into integrating and running the acquired businesses,

 

    we may face difficulties associated with financing the acquisitions,

 

    we may face the inability to achieve the desired outcomes justifying the acquisition, and

 

    we may face difficulties integrating the acquired business’ operations and personnel.

 

    we may face difficulties incorporating the acquired technology into our existing product lines.

 

Intangibles and Goodwill We Currently Carry on Our Balance Sheet May Become Impaired.

 

At January 2, 2005, we had approximately $46 million of goodwill and intangible assets on our balance sheet. These assets are subject to impairment if the cash flow that we generate from these assets specifically, or our business more broadly, are insufficient to justify the carrying value of the assets. Factors affecting our ability to generate cash flow from these assets include, but are not limited to, general market conditions, product acceptance, pricing and competition, distribution, costs of production and operations.

 

Provisions in Our Charter Documents, Our Shareholder Rights Agreement and State Law May Make It Harder for Others To Obtain Control of ZOLL Even Though Some Stockholders Might Consider Such a Development to be Favorable

 

Our board of directors has the authority to issue up to 1,000,000 shares of undesignated preferred stock and to determine the rights, preferences, privileges and restrictions of such shares without further vote or action by our stockholders. The rights of the holders of common stock will be subject to, and may be adversely affected by, the rights of the holders of any preferred stock that may be issued in the future. The issuance of preferred stock could have the effect of making it more difficult for third parties to acquire a majority of our outstanding voting stock. In addition, our restated articles of organization provide for staggered terms for the members of the board of directors which could delay or impede the removal of incumbent directors and could make a merger, tender offer or proxy contest involving the Company more difficult. Our restated articles of organization, restated by-laws and applicable Massachusetts law also impose various procedural and other requirements that could delay or make a merger, tender offer or proxy contest involving us more difficult.

 

We have also implemented a so-called poison pill by adopting our shareholders rights agreement. This poison pill significantly increases the costs that would be incurred by an unwanted third party acquirer if such party owns or announces its intent to commence a tender offer for more than 15% of our outstanding common stock. The existence of this poison pill could delay, deter or prevent a takeover of the Company.

 

All of these provisions could limit the price that investors might be willing to pay in the future for shares of our common stock which could preclude our shareholders from recognizing a premium over the prevailing market price of our stock.

 

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We Have Only One Manufacturing Facility for Each of Our Major Products and Any Damage or Incapacitation of Any of the Facilities Could Impede Our Ability to Produce These Products

 

We have only one manufacturing facility for each of our major products. Damage to any such facility could render us unable to manufacture the relevant product or require us to reduce the output of products at the damaged facility. In addition, a severe weather event or other natural disaster affecting a facility occurring late in a quarter could make it difficult to meet product shipping targets. Any of these events could materially and adversely impact our business, financial condition and results of operations.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

We have cash equivalents and marketable securities that primarily consist of money market accounts and fixed rate asset-backed corporate securities. The majority of these investments have maturities within one to five years. We believe that our exposure to interest rate risk is minimal due to the term and type of our investments and that the fluctuations in interest rates would not have a material adverse effect on our results of operations.

 

We have international offices in Canada, United Kingdom, Netherlands, France, Germany, Austria, and Australia. These subsidiaries transact business in their functional or local currency. Therefore, we are exposed to foreign currency exchange risks and fluctuations in foreign currencies, along with economic and political instability in the foreign countries in which we operate, all of which could adversely impact our results of operations and financial condition.

 

We use forward contracts to reduce our exposure to foreign currency risk due to fluctuations in exchange rates underlying the value of intercompany accounts receivable denominated in foreign currencies as well as forecasted sales to subsidiaries denominated in foreign currencies. A forward contract obligates us to exchange predetermined amounts of specified foreign currencies at specified exchange rates on specified dates. These forward contracts are denominated in the same currency in which the underlying foreign currency receivables and forecasted sales are denominated and bear a contract value and maturity date that approximate the value and expected settlement date, respectively, of the underlying transactions. Unrealized gains and losses on open contracts at the end of each accounting period, resulting from changes in the fair value of these contracts, are recognized in earnings generally in the same period as exchange gains and losses on the underlying foreign denominated receivables and forecasted sales are recognized.

 

We had one forward exchange contract outstanding serving as a hedge of our Euro intercompany receivables in the notional amount of approximately 4.5 million Euros at January 2, 2005. The contract serves as a hedge of a substantial portion of our Euro-denominated intercompany balances. The fair value of the foreign currency derivative contract outstanding at January 2, 2005 was approximately $6.0 million resulting in an unrealized gain of $138,000. A sensitivity analysis of a change in the fair value of the Euro derivative foreign exchange contract outstanding at January 2, 2005 indicates that, if the U.S. dollar weakened by 10% against the Euro, the fair value of this contract would decrease by $597,000 resulting in a total loss on the contract of $459,000. Conversely, if the U.S. dollar strengthened by 10% against the Euro, the fair value of this contract would increase by $543,000 resulting in a total gain on the contract of $681,000. Any gains and losses on the fair value of the derivative contract would be largely offset by losses and gains on the underlying transaction. These offsetting gains and losses are not reflected in the analysis above.

 

Intercompany Receivable Hedge

Exchange Rate Sensitivity: January 2, 2005

(Amounts in $)

 

     Expected Maturity Dates

   Total

  

Unrealized

Gain


     2005

   2006

   2007

   2008

   2009

   Thereafter

         

Forward Exchange Agreements (Receive $/Pay Euro) Contract Amount

   $ 6,109,000                             $ 6,109,000    $ 138,000

Average Contract Exchange Rate

     1.3576    —      —      —      —      —        1.3576       

 

We had no forward exchange contracts outstanding serving as a hedge of a portion our forecasted sales to our subsidiaries at January 2, 2005.

 

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Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

As of the end of the period covered by this report, an evaluation had been performed under the supervision and with the participation of the Company’s management, including the Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of the Company’s disclosure controls and procedures. Based upon that evaluation, the Company’s management, including the CEO and CFO, concluded that, as of January 2, 2005, the Company’s disclosure controls and procedures were effective in ensuring that material information relating to the Company required to be included in the Company’s periodic SEC filings was made known to them on a timely basis.

 

Changes in Internal Controls Over Financial Reporting

 

There have been no significant changes in the Company’s internal controls over financial reporting that occurred during the quarter ended January 2, 2005, that have materially affected, or are reasonably likely to materially affect our internal control over financial reporting.

 

PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings

 

On December 10, 2004, a complaint was filed against Revivant Corporation by Dr. Thomas Fogarty and his affiliate, alleging that Revivant owes a 4% royalty on all of its sales. The Company believes the suit is without merit. Moreover, in connection with the Company’s acquisition of Revivant, the former stockholders of Revivant specifically agreed to indemnify the Company against Dr. Fogarty’s claim for all amounts up to $15 million. The Company has the right to set-off these indemnity claims against future contingent amounts payable by it as part of the purchase price for Revivant.

 

The Company has been informed by the federal government that it is conducting an investigation regarding two sales of defibrillators in fiscal 2000 to a distributor, which were then allegedly trans-shipped to Iran without the required export licenses. The Company is cooperating with the Department of Justice in connection with its ongoing investigation, and has provided requested information. The two sales in question represented approximately $150,000 of net income in fiscal 2000. Although it is premature to determine the likely outcome of the investigation, it is possible that the Company may be subject to civil or criminal fines and sanctions as a result of this matter.

 

In addition to these matters the Company is, from time to time, involved in the normal course of its business in various other litigation matters and regulatory issues, including product recalls. Although the Company is unable to quantify at the present time the exact financial impact in any of these matters, it believes that none of these other matters currently pending will have an outcome material to its financial condition or business.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

Not applicable.

 

Item 3. Defaults Upon Senior Securities

 

Not Applicable.

 

Item 4. Submission of Matters to a Vote of Security Holders

 

Not Applicable.

 

Item 5. Other Information

 

  (a) Not Applicable.

 

  (b) During the period covered by this report there were no material changes to the procedures by which security holders may recommend nominees to the Board of Directors.

 

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Item 6. Exhibits

 

  1. Exhibit 10.18 – Form of Non-Qualified Stock Option Agreement under the ZOLL Medical Corporation Non-Employee Directors’ Stock Option Plan (1)

 

  2. Exhibit 31.1 – Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

  3. Exhibit 31.2 – Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

  4. Exhibit 32.1* – Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

  5. Exhibit 32.2* – Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

* This certification shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liability of that section, nor shall it be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934.
(1) Incorporated by reference from the Company’s Form 8-K filed with the Securities and Exchange Commission on November 15, 2004.

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized on February 11, 2005.

 

    ZOLL MEDICAL CORPORATION
Date: February 11, 2005   By:  

/s/ Richard A. Packer


       

Richard A. Packer,

Chairman and Chief Executive Officer

        (Principal Executive Officer)
Date: February 11, 2005   By:  

/s/ A. Ernest Whiton


        A. Ernest Whiton,
        Vice President of Administration and Chief Financial Officer
        (Principal Financial and Accounting Officer)

 

 

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