Zoll Medical 10-Q 2007
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
For the quarterly period ended April 1, 2007.
For the transition period from to .
Commission file number 0-20225
ZOLL MEDICAL CORPORATION
(Exact name of registrant as specified in its charter)
(Registrants telephone number, including area code)
(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 a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in Rule 12b-2 of the Exchange Act (Check one):
Large accelerated filer ¨ Accelerated filer x Non-accelerated filer ¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
Indicate the number of shares outstanding of each of the issuers classes of common stock as of the latest practicable date:
This document consists of 33 pages.
ZOLL MEDICAL CORPORATION
Except for historical information, the matters discussed in this Quarterly Report on Form 10-Q are forward-looking statements that involve risks and uncertainties. ZOLL Medical Corporation (the Company) makes such forward-looking statements under the provisions of the Safe Harbor section of the Private Securities Litigation Reform Act of 1995. Actual future results may vary materially from those projected, anticipated, or indicated in any forward-looking statements as a result of certain risk factors. Readers should pay particular attention to the considerations described in Part I, Item 2 of this report under the section of Managements Discussion and Analysis of Financial Conditions and Results of Operations entitled Risk Factors. Readers should also carefully review the risk factors described in the other documents that we file from time to time with the Securities and Exchange Commission. In this report, the words anticipates, believes, expects, intends, future, could, and similar words or expressions (as well as other words or expressions referencing future events, conditions or circumstances) identify forward-looking statements. The Company assumes no obligation to update forward-looking statements or update the reasons why actual results, performances or achievements could differ materially from those provided in the forward-looking statements.
Explanatory Note: The share and per-share data presented in this Quarterly Report on Form 10-Q gives effect to the 2-for-1 stock split effected by Articles of Amendment to the Companys Restated Articles of Organization filed on February 12, 2007, with a record date of February 20, 2007. As a result of the stock split, the par value of the Companys Common Stock changed from $0.02 per share to $0.01 per share (the Common Stock), and the Companys authorized Common Stock increased from 19,000,000 shares to 38,000,000 shares.
ZOLL MEDICAL CORPORATION
(000s omitted, except per share data)
See notes to unaudited consolidated financial statements.
ZOLL MEDICAL CORPORATION
(000s omitted, except per share data)
See notes to unaudited consolidated financial statements.
ZOLL MEDICAL CORPORATION
See notes to unaudited consolidated financial statements.
ZOLL MEDICAL CORPORATION
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 Companys audited financial statements as of and for the year ended October 1, 2006 included in its Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on December 15, 2006.
On January 24, 2007, the Board of Directors approved a 2-for-1 stock split. The stock split, which was effected by Articles of Amendment to the Companys Restated Articles of Organization filed on February 12, 2007, with a record date of February 20, 2007, changed each issued share and each authorized and unissued share of Common Stock, par value $0.02 per share, into two shares of Common Stock, par value $0.01 per share. The Companys stock option plans and restricted stock plan contain antidilution provisions, which require the shares and related exercise price to be adjusted for the impact of the stock split. All share and per share information herein have been retroactively restated to reflect the 2-for-1 stock split.
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, the Companys chief executive officer (the 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 resuscitation devices, accessories and data collection management software to the North American pre-hospital market, (3) the sale of disposable/other products in North America, and (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:
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:
No individual foreign country represented 10% or more of our revenues for the three months and six months ended April 1, 2007 and April 2, 2006, respectively.
3. Comprehensive Income
The Company computes comprehensive income in accordance with Statement of Financial Accounting Standards (SFAS) No. 130 (SFAS 130) Reporting Comprehensive Income. SFAS 130 establishes standards for the reporting and display of comprehensive income and its components in 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, and foreign currency translation. Total comprehensive income for the three and six months ended April 1, 2007 and April 2, 2006, respectively, was as follows:
4. Stock Option Plans
At April 1, 2007, the Company had two active stock-based compensation plans under which stock-based grants may be issued, and two other stock-based compensation plans under which grants are no longer being made. No further grants are being made under the Companys 1992 Stock Option Plan (1992 Plan) and 1996 Non-Employee Directors Stock Option Plan (1996 Plan), and option grants remain outstanding under both plans. The Companys active plans are the Amended and Restated 2001 Stock Incentive Plan (2001 Plan) and the 2006 Non-Employee Director Stock Option Plan (2006 Plan).
At the 2006 Annual Meeting of Stockholders, the Companys stockholders approved (giving effect to the 2-for-1 stock split effected on February 12, 2007, with a record date of February 20, 2007) (i) an additional 630,000 shares available for issuance (for a total authorized of 2,520,000 shares) pursuant to nonqualified stock options to be granted from time to time under the 2001 Plan, plus 120,000 shares to be issued as restricted Common Stock from time to time under the 2001 Plan; and (ii) the adoption of the 2006 Plan, with 110,000 shares authorized for issuance, to replace the existing 1996 Plan, which expired in April 2006 (in addition, 12,500 shares not subject to option grants under the 1996 Plan at the time of its expiration were transferred to the 2006 Plan).
Stock options outstanding under the 1992 Plan, the 1996 Plan, the 2001 Plan, and the 2006 Plan generally vest over a four-year period and have exercise prices equal to the fair market value of the Common Stock at the date of grant. All options have a 10-year term. All options issued under the 2001 Plan and 2006 Plan must have an exercise price no less than fair market value on the date of grant. Restricted Common Stock grants made under the 2001 Plan will generally vest over a four-year period.
The Company adopted the provisions of SFAS No. 123R, Share-Based Payment (SFAS 123R), beginning October 3, 2005, using the modified prospective transition method. SFAS 123R requires the Company to measure the cost of employee services in exchange for an award of equity instruments based on the grant-date fair value of the award and to recognize cost over the requisite service period. Under the modified prospective transition method, financial statements for periods prior to the date of adoption are not adjusted for the change in accounting. However, compensation expense is recognized for (a) all share-based payments granted after the effective date under SFAS 123R, and (b) all awards granted under SFAS 123 to employees prior to the effective date that remain unvested on the effective date. The Company recognizes compensation expense on fixed awards with pro rata vesting on a straight-line basis over the vesting period.
Prior to October 3, 2005, the Company used the intrinsic value method to account for stock-based employee compensation under Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees, and, therefore, the Company did not recognize compensation expense in association with options granted at or above the market price of the Companys Common Stock at the date of grant.
As a result of adopting SFAS 123R, stock-based compensation charges totaled approximately $419,000 and $682,000 during the three and six months ended April 1, 2007, respectively, and totaled approximately $163,000 and $268,000 during the three and six months ended April 2, 2006, respectively. 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 six months ended April 1, 2007 and April 2, 2006:
At April 1, 2007, there was approximately $5.3 million of unrecognized compensation cost related to non-vested awards, which we expect to recognize over a weighted-average period of 3.16 years.
The weighted-average, grant-date fair value of options granted (estimated using the Black-Scholes option-pricing model) was $10.47 and $5.91 for the six months ended April 1, 2007 and April 2, 2006, respectively. During the six months ended April 1, 2007, the Company issued 942,010 shares of Common Stock pursuant to exercised options for proceeds of approximately $14 million. Total intrinsic value of options exercised for the six months ended April 1, 2007 and April 2, 2006 was approximately $11.7 million and $14,000, respectively. It is the Companys policy to issue new shares upon the exercise of options.
The following table summarizes the status of outstanding stock options as of April 1, 2007 as well as changes during the six months ended April 1, 2007:
The following table summarizes the status of unvested restricted stock awards as of April 1, 2007 as well as changes during the six months ended April 1, 2007:
5. Earnings per Share
The shares used for calculating basic earnings per share of Common Stock were the weighted average shares of Common Stock outstanding during the period, and the shares used for calculating diluted earnings per share of Common Stock were the weighted average shares of Common Stock outstanding during the period plus the dilutive effect of stock options and restricted stock.
Average shares outstanding for diluted earnings per share for the three and six months ended April 1, 2007 does not include options to purchase 14,000 and 330,000 shares of Common Stock, respectively, as their effect would have been antidilutive. Average shares outstanding for diluted earnings per share for the three and six months ended April 2, 2006 does not include options to purchase 2,368,724 shares of Common Stock, respectively, as their effect would have been antidilutive.
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.
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 SFAS 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 Companys 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 at April 1, 2007, serving to mitigate the foreign currency risk of a substantial portion of our Euro-denominated intercompany balances, in the notional amount of approximately 5 million Euros. The net settlement amount of these contracts at April 1, 2007 is an unrealized gain of approximately $14,000, which is included in earnings.
Net realized losses from foreign currency forward contracts totaled approximately $79,000 during the quarter ended April 1, 2007 and are included in the consolidated income statement within investment and other income, compared to net realized gains of $59,000 for the prior years quarter.
7. Product Warranties
The Company typically offers one-year or 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 Companys 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 six months ended April 1, 2007 and April 2, 2006 is as follows:
In March 2006, the Company exercised its option to acquire the assets of Lifecor, Inc. (Lifecor), a privately owned medical equipment company that designs, manufactures and markets a wearable external defibrillator system (LifeVest). In April 2006, the Company closed on the acquisition of the assets of Lifecor and now utilizes those assets in its subsidiary, ZOLL Lifecor Corporation. The Company believes that the acquisition presents an opportunity to expand its presence in the resuscitation market because the LifeVest provides patients with the benefit of unhindered mobility. As a result of the transaction, ZOLL acquired Lifecors assets and business, assumed Lifecors outstanding debt (which included the forgiveness of approximately $3 million of debt owed to the Company), and also assumed certain stated liabilities, for a total consideration of approximately $10 million. Additional consideration will be in the form of earn-out payments to Lifecor based upon future revenue growth over certain stipulated threshold amounts of the acquired business over a five-year period through fiscal 2011. Beginning April 3, 2006, the results of operations of Lifecor were included in the consolidated income statement of the Company. In connection with the acquisition of Lifecor, a manufacturing agreement was terminated. The terms of the agreement were deemed to be at fair value, and therefore no gain or loss was recognized.
The following is a summary of the Companys estimate of the fair values of the assets acquired and liabilities assumed.
Supplemental Pro Forma Information
The unaudited pro forma combined condensed statements of income for the three and six month periods ended April 2, 2006 give effect to the acquisition of the assets of Lifecor as if the acquisition had occurred at the beginning of the prior year period, October 3, 2005, 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 Lifecor asset acquisition had been consummated on October 3, 2005, nor are they necessarily indicative of the financial results that may be attained in the future.
The pro forma statement of income is based upon available information and upon certain assumptions that the Companys management believes are reasonable. The Lifecor asset acquisition is being accounted for using the purchase method of accounting.
The terms of the October 2003 acquisition of Revivant Corporation (Revivant), as well as the terms of the March 2004 acquisition of the assets of Infusion Dynamics, Inc. (Infusion Dynamics), and the April 2006 acquisition of the assets of Lifecor, provide for possible annual earn-out payments based upon revenue growth over a multi-year period. Such payments may be due with respect to Revivant through fiscal 2007 and with respect to Infusion Dynamics and Lifecor through fiscal 2011. Because all of these prospective earn-out payments will be based upon revenue growth over several years, a reasonable estimate of the future payment obligations cannot be determined. Annual earn-out payments to Infusion Dynamics, in the form of cash, for fiscal 2005 and 2006 were approximately $544,000 and $445,000, respectively. The Company also paid approximately $1.6 million in earn-out payments for fiscal 2005 to the former shareholders of Revivant, approximately $783,000 in the form of cash and the remainder in the form of 47,600 shares of the Companys Common Stock. On January 9, 2007, the Company paid approximately $2.4 million in earn-out payments for fiscal 2006 to the former shareholders of Revivant, in the form of approximately $1.2 million of cash and 72,128 shares of the Companys Common Stock. The earn-out payment for fiscal 2006 paid to Lifecor was an amount less than $100,000.
9. Intangibles and Other Assets
Intangibles and other assets consist of:
Amortization of acquired intangibles for the three months ended April 1, 2007 and April 2, 2006 was approximately $567,000 and $400,000, respectively, and is included in operating expenses in the consolidated income statement. For the six months ended April 1, 2007 and April 2, 2006, amortization of acquired intangibles was approximately $1.1 million and $800,000, respectively, and is included in operating expenses in the consolidated income statement.
10. Income Taxes
The Companys effective tax rate for the three months ended April 1, 2007 was a tax provision of 36% compared to 35% for the same period in fiscal 2006. The difference in the effective tax rate reflects relatively stable permanent tax benefits having a lower percentage rate impact as taxable income rises.
The Companys effective tax rate for the six months ended April 1, 2007, was a tax provision of 33% as compared to 34% for the same period in fiscal 2006. The difference in the effective tax rate is due to a discrete $176,000 U.S. research and development tax credit recorded during the quarter ended December 31, 2006, due to the enactment into law of the Tax Relief and Healthcare Act of 2006 on December 20, 2006. It also reflects relatively stable permanent tax benefits having a lower percentage rate impact as taxable income rises.
11. Legal Proceedings
The Company is, from time to time, involved in the normal course of its business in various legal proceedings, including intellectual property, employment and product liability suits. Although the Company is unable to quantify the exact financial impact of any of these matters, it believes that none of the currently pending matters will have an outcome material to its financial condition or business.
12. Recent Accounting Pronouncements
In February 2007, the Financial Accounting Standards Board (FASB) issued SFAS No. 159, The Fair Value Option for Financial Assets and Financial Liabilities Including an Amendment of SFAS 115 (SFAS 159). SFAS 159 provides entities with the option to measure financial instruments and certain other items at fair value. Unrealized gains and losses on items for which the fair value option has been elected are reported in earnings. SFAS 159 is effective with fiscal years beginning after November 15, 2007, provided that the entity also elects to apply the provisions of SFAS No. 157, Fair Value Measurement (SFAS 157). We are currently evaluating the impact that the implementation of SFAS 159 may have on our consolidated results and financial position.
In September 2006, the FASB issued SFAS 157. SFAS 157 defines fair value, establishes a framework for measuring fair value in accounting principles generally accepted in the United States and expands disclosures about fair value measurements. SFAS 157 applies under other accounting pronouncements that require or permit fair value measurements, the FASB having previously concluded in those accounting pronouncements that fair value is the relevant measurement attribute. Accordingly, SFAS 157 does not require any new fair value measurements. However, for some companies, the application of SFAS 157 will change current practice. SFAS 157 is effective with fiscal years beginning after November 15, 2007. We are currently evaluating the impact that the implementation of SFAS 157 may have on our consolidated results and financial position.
In September 2006, the SEC issued Staff Accounting Bulletin No. 108, Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements (SAB 108). SAB 108 provides guidance on the consideration of the effects of prior year misstatements in quantifying current year misstatements for the purpose of a materiality assessment. SAB 108 establishes an approach that requires quantification of financial statement errors based on the effects of each of the Companys balance sheet and statement of operations and the related financial statement disclosures. We are required to adopt SAB 108 in our annual financial statements covering the fiscal years ending after November 15, 2006. The adoption of SAB 108 had no impact on our consolidated results of operations and financial position.
In July 2006, the FASB issued Interpretation No. 48 (FIN 48), Accounting for Uncertainty in Income Taxes, an interpretation of FASB Statement No. 109, Accounting for Income Taxes, to create a single model to address accounting for uncertainty in tax positions. FIN 48 requires the use of a two-step approach for recognizing and measuring tax benefits taken or expected to be taken in a tax return and disclosures regarding uncertainties in income tax positions, including a roll forward of tax benefits taken that do not qualify for financial statement recognition. The cumulative effect of initially adopting FIN 48 will be recorded as an adjustment to opening retained earnings for that year and will be presented separately. FIN 48 is effective with fiscal years beginning after December 15, 2006. Only tax positions that are more likely than not to be realized at the effective date may be recognized upon adoption of FIN 48. The Company is currently evaluating the impact this new standard will have on its future results of operations and financial position.
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 information.
We intend for this discussion and analysis to provide you with information that will assist you in understanding our consolidated financial statements. Our consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States. This discussion and analysis should be read in conjunction with our consolidated financial statements as of April 1, 2007 and for the quarter then ended, and the notes thereto.
On January 24, 2007, the Board of Directors approved a 2-for-1 stock split. The stock split, which was effected by Articles of Amendment to the Companys Restated Articles of Organization filed on February 12, 2007, with a record date of February 20, 2007, changed each issued share and each authorized and unissued share of Common Stock, par value $0.02 per share, into two shares of Common Stock, par value $0.01 per share. The Companys stock option plans and restricted stock plan contain antidilution provisions, which require the shares and related exercise price to be adjusted for the impact of the stock split. All share and per share information have been retroactively restated to reflect the 2-for-1 stock split.
Three Months Ended April 1, 2007 Compared To Three Months Ended April 2, 2006
Net sales by customer/product categories are as follows:
Net sales increased 20% for the three months ended April 1, 2007, compared to the prior-year period.
Sales to the North American hospital market decreased approximately $3.2 million, or 17%, compared to the same quarter in the prior year. This decrease primarily reflects a lower volume of U.S. military sales of approximately $4.0 million. This decrease was partially offset by an increase in professional non-military defibrillators, AEDs and AutoPulse sales.
Sales to the North American pre-hospital market increased approximately $9.3 million, or 44%, compared to the same period a year ago. The North American pre-hospital market includes the results of ZOLL Lifecor, which were not included in the comparable period in the prior year. A portion of the increase in sales was the result of increased shipments of AEDs and professional defibrillator equipment and a greater volume of data management software revenues contributed to the increased revenues during the quarter as compared to the prior-year quarter.
International sales increased approximately $5.0 million, or 40%, in comparison to the prior-year period, driven by increased sales volume of professional defibrillators, including the E Series, M Series and the first shipments of the R Series. AutoPulse sales also contributed to the increase, predominantly driven by greater sales volume, particularly from first shipments to the Companys distributor in Japan. Sales by our international subsidiaries, excluding approximately $738,000 of foreign exchange gains, increased approximately $1.9 million and were particularly strong in the UK. Sales to our international distributors increased approximately $2.4 million, predominantly in Japan, Europe, Latin America and China.
Total sales of the AutoPulse product in all our markets were $3.3 million, compared to $2.4 million in the prior-year quarter. The increase predominantly reflects volume growth internationally, especially in Japan through the Companys first distributor relationship in Japan. We believe that the increase in the number of units of the AutoPulse being sold reflects continued market acceptance of the product.
As previously announced, a major competitor of the Company, Medtronics Physio-Control business, has suspended U.S. shipments because of quality control issues. We continue to believe that this development may have a positive impact on our future business, depending on how long shipments of Physio-Control products remain suspended. We have modestly increased expenditures in the short term to build inventory and expand sales and marketing efforts to be able to capture potential additional business.
Cost of sales consists primarily of material, direct labor, overhead, and freight associated with the manufacturing of our various medical equipment devices, data collection software and disposable electrodes. Material is the largest component of our products, comprising more than half the cost. Overhead includes indirect labor for such activities as supervision, procurement and shipping. Other components of overhead include such items as related employee benefits, rent and electricity. Our consolidated gross margin may fluctuate considerably depending on unit volume levels, mix of product and customer class, and overall market conditions.
Gross margin for the three months ended April 1, 2007 increased slightly from 55.7% to 56.0% as compared to the same period in the prior year. Typical of fluctuations in our gross margin from period to period, the slight increase is a result of product and geographical mix. Each of the factors affecting the fluctuation in gross margin represents one and a half percentage points or less on our overall gross margin.
Backlog decreased to approximately $8.1 million at the end of the three months ended April 1, 2007 as compared to approximately $9.8 million at the end of the first quarter of 2007. Backlog at the end of the three months ended April 2, 2006 was approximately $8 million. Typically, our backlog decreases during the first and second quarters and increases during the fourth quarter due to the purchasing practices of our customers. We believe the maintenance of a modest backlog will help improve our efficiency, lower our costs and improve our profitability as it will make it less likely that we will be required to incur substantial additional costs at the end of the 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.
Costs and Expenses
Operating expenses for the three months ended April 1, 2007 and April 2, 2006 were as follows:
Selling and marketing expenses increased approximately $2.6 million for the three months ended April 1, 2007 compared to the three months ended April 2, 2006. As a percentage of sales, selling and marketing expenses for the three months ended April 1, 2007 decreased approximately 1% as compared to the three months ended April 2, 2006. A portion of the dollar spending increase was the inclusion of ZOLL Lifecor expenses, following the April 2006 acquisition of Lifecor, as these expenses were not included in the prior years second quarter expenses. Other factors contributing to the increase included higher personnel-related expenses for the sales force and related sales organization, including commission and salaries and fringe benefits. In addition, increased expenses related to expanded marketing programs were partially offset by a lower provision for bad debts.
General and administrative expenses increased approximately $1.6 million for the three months ended April 1, 2007 compared to the three months ended April 2, 2006. As a percentage of sales, general and administrative expenses increased approximately 1% compared to the three months ended April 2, 2006. The inclusion of ZOLL Lifecor expenses, following the April 2006 acquisition of Lifecor, accounted for a portion of the dollar spending increase as these expenses were not included in the prior years second quarter expenses. In addition, personnel-related costs for general and administrative employees increased, of which almost half related to an increase in the Companys matching contribution to its 401(K) Plan.
Research and development expenses increased by approximately $1.2 million for the three months ended April 1, 2007 compared to the three months ended April 2, 2006. As a percentage of sales, research and development expenses for the three months ended April 1, 2007 were flat as compared to the three months ended April 2, 2006. The reasons for the dollar spending increase included personnel-related costs for research and development employees, expenses attributable to the ZOLL Lifecor business, following the April 2006 acquisition of Lifecor, and clinical trial work related to the AutoPulse. We currently anticipate that our research and development expenses related to clinical trial work will continue to increase throughout the year and beyond as our clinical trial activities related to the AutoPulse continue to ramp up.
The Companys effective tax rate for the three months ended April 1, 2007 was a tax provision of 36%, as compared to a tax provision of 35% for the same period in fiscal 2006. The rate was affected by the elimination of the deduction for extraterritorial income, which was only available for the first quarter of fiscal 2007. It also reflects relatively stable permanent tax benefits having a lower percentage rate impact as taxable income rises. The Company expects the effective tax rate for fiscal year 2007 to be approximately 35%.
Six Months Ended April 1, 2007 Compared To Six Months Ended April 2, 2006
Net sales by customer/product categories are as follows:
Net sales increased 18% for the six months ended April 1, 2007 compared to the same period a year earlier.
North American hospital sales decreased approximately $2.0 million, or 6%, from the comparable prior year period. This decrease is due to a decline in military sales of approximately $4.9 million. Excluding military sales, North American hospital sales increased $2.9 million, or 11% over the comparable prior-year period. This increase reflects increased shipments of our professional, non-military defibrillators, AEDs and AutoPulse product.
Sales to the North American pre-hospital market increased approximately $13.5 million, or 32%, compared to the same period in fiscal 2006. The North American pre-hospital market includes the results of ZOLL Lifecor, which were not included in the comparable period in the prior year. In addition, the increase resulted from increased unit sales of our AEDs and professional defibrillators and increased volume of data management product sales.
International sales increased by approximately $8.1 million, or 31%, in comparison to the prior-year six-month period. This increase was driven by increased sales volume of professional defibrillators including the M Series, E Series and the first shipments of the new R Series. The volume of Autopulse sales also contributed to the increase. Sales by our international subsidiaries, excluding approximately $1.4 million of foreign exchange gains, increased approximately $3.9 million and were particularly strong in the UK. Sales to our international distributors increased approximately $2.8 million, predominantly in Japan, China, Latin America and Europe.
Total sales of the AutoPulse product to all our markets were $6.1 million, in comparison to $3.9 million for the same six-month period in the prior year. We believe we are seeing increased market acceptance of the AutoPulse as customers assess the results of various clinical trials and develop experience with the product.
Gross margin for the six months ended April 1, 2007 increased slightly from 55.8% to 56.0% compared to the same period a year ago. Typical of fluctuations in our gross margin from period to period, the slight increase is a result of product and geographical mix. Each of the factors affecting the fluctuation in gross margin represents one and a half percentage points or less on our overall gross margin.
Costs and Expenses
Operating expenses for the six months ended April 1, 2007 and April 2, 2006 were as follows:
Selling and marketing expenses increased approximately $4.3 million for the six months ended April 1, 2007 compared to the six months ended April 2, 2006. As a percentage of sales, selling and marketing expenses for the six months ended April 1, 2007 decreased approximately 2% compared to the six months ended April 2, 2006. The increased dollar spending reflected the inclusion of ZOLL Lifecor expenses, following the April 2006 acquisition of Lifecor, as these expenses were not included in the prior years six months expenses. In addition, there were higher personnel-related expenses for the salesforce and related sales organization, including commission and salaries and fringe benefits. The remaining increase reflected expanded marketing programs and promotions, salaries, trade shows and other related spending, substantially offset by a lower provision for bad debts.
General and administrative expenses increased approximately $2.8 million for the six months ended April 1, 2007 compared to the six months ended April 2, 2006. As a percentage of sales, general and administrative expenses for the six months ended April 1, 2007 increased approximately 1% compared to the six months ended April 2, 2006. The increased dollar spending reflected the inclusion of ZOLL Lifecor expenses, following the April 2006 acquisition of Lifecor, as these expenses were not included in the prior years six month expenses. In addition, there were higher personnel-related costs, including stock-based compensation expense.
Research and development expenses increased approximately $2.3 million for the six months ended April 1, 2007 compared to the six months ended April 2, 2006. As a percentage of sales, research and development expenses for the six months ended April 1, 2007 increased approximately 1% compared to the six months ended April 2, 2006. This increase in the dollar spending is due to increased personnel-related costs, increased spending related to clinical matters, including clinical trials related to the AutoPulse, and the inclusion of ZOLL Lifecor expenses, following the April 2006 acquisition of Lifecor, as these expenses were not included in the prior years six month expenses.
Our effective tax rate for the six months ended April 1, 2007, was a tax provision of 33% as compared to 34% for the same period in fiscal 2006. The difference in the effective tax rate is related to the availability of a discrete $176,000 U.S. research and development tax credit, which was enacted during the quarter ended December 31, 2006, along with the impact of relatively stable permanent tax benefits having a lower percentage rate impact as taxable income rises.
Liquidity and Capital Resources
Our overall financial condition remains strong. Our cash, cash equivalents and marketable securities at April 1, 2007 totaled $78.8 million, compared with $63.4 million at October 1, 2006. We continue to have no long-term debt.
We believe that the combination of existing cash, cash equivalents, and highly liquid short-term investments, together 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 contingency payments related to the Revivant, Infusion Dynamics, and Lifecor acquisitions. We may also need to draw on these funds in the future for potential acquisitions.
As previously discussed, with the recent suspension of U.S. shipments from the Medtronic Physio-Control unit, we anticipate using cash to build inventory levels to ensure capacity is not an issue as we pursue additional customers. We also may assist new customers who transition to our products with various financing arrangements. We expect funding for these initiatives, initially estimated at $10 million, to build over the course of the suspension.
Sources and Uses of Cash
To assist with the discussion, the following table presents the abbreviated cash flows for the six months ended April 1, 2007 and April 2, 2006:
The $11.5 million decrease in cash provided by operating activities to $5.2 million for the six-month period ended April 1, 2007 from $16.7 million for the six-month period ended April 2, 2006 was primarily attributable to increased inventory purchases. The increase in inventory includes the impact of level loading our production and building inventory of evaluation units. This decrease in cash provided by operating activities is also due to a $3.0 million increase in cash used for payments of accounts payable and accrued expenses.
The $10.5 million decrease in cash used in investing activities reflects a decrease in net purchases of marketable securities of approximately $10.1 million as compared to the investing activities in the prior year period.
Cash provided by financing activities during the six-month period ended April 1, 2007 increased by approximately $17.9 million from the previous year period. The change reflects a substantially higher number of stock options exercised during the current six-month period (options for 942,010 shares in the current period compared to options for 4,950 shares in the previous year period), at a higher weighted-average exercise price per share ($14.84 in the current period compared to $9.90 in the previous year period).
As of April 1, 2007, we had investments in privately held technology companies with a carrying value of $1.3 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, a manufacturer of fluid resuscitation products. Under the terms of the acquisition, we are obligated to make earn out payments through 2011 (contingencies) based on the performance of the acquired business. Earn-out payments to Infusion Dynamics were made in the form of cash for fiscal 2005 and 2006 in the approximate amounts of $544,000 and $445,000, respectively. 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 the outstanding stock of Revivant (now ZOLL Circulation, Inc.), the manufacturer of the AutoPulse, on October 12, 2004. We paid $15 million in the form of cash and shares of our Common Stock as the initial acquisition consideration. Additional contingent consideration under the acquisition agreement is tied to certain clinical developments (milestone payments related to already approved devices) and increases in revenue (earn-out payments). In January 2005, we paid $1 million as a milestone payment, in the form of a cash payment of $500,000 and the issuance of 30,376 shares of Common Stock. In February 2006, we paid approximately $783,000 in cash and issued 47,600 shares of Common Stock in payment of the 2005 earn-out to the former shareholders of Revivant. In January 2007, we paid approximately $1.2 million in cash and issued 72,128 shares of Common Stock in payment of the 2006 earn-out to the former shareholders of Revivant. We may make additional earn-out payments for fiscal 2007 based on the growth of AutoPulse sales. Because additional earn-out payments are based on the growth of 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 exercised our option to acquire the assets and business of Lifecor on March 22, 2006, and acquired the assets and business on April 10, 2006. We assumed Lifecors outstanding debt (plus an additional $3.0 million owed to us, which was cancelled), and certain stated liabilities as discussed in Note 8 to the consolidated financial statements. We paid the third-party debt in April 2006. Additional consideration will be in the form of earn-out payments to Lifecor based upon future revenue growth of the acquired business over a five-year period. An earn-out payment to Lifecor was made in the form of cash for fiscal 2006 in an amount less than $100,000. Because additional consideration will be based on the growth of sales over a five-year period, a reasonable estimate of the total acquisition cost cannot be determined.
Debt Instruments and Related Covenants
We maintain a working capital line of credit with a commercial 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 banks base rate. No borrowings were outstanding on this line during the quarter ended April 1, 2007. There are no covenants related to this line of credit.
Off-Balance Sheet Arrangements
The Company leases certain office and manufacturing space under operating leases. Purchase obligations include all legally binding contracts that are non-cancelable. 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 motor vehicles instead of purchasing them.
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 lease agreements.
Purchase obligations include all legally binding contracts that 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 the table above, 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 provisions allowing for cancellation without significant penalty.
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 for the assets of Infusion Dynamics through fiscal 2011; additional earn-out payments for Revivant through fiscal 2007; and additional earn-out payments for the assets of Lifecor through fiscal 2011. Because all of these earn-out payments are based upon the growth of sales over several years, a reasonable estimate of the future payment obligations cannot be determined.
We use forward contracts to reduce our exposure to foreign currency risks due to fluctuations in exchange rates underlying the value of intercompany accounts receivable denominated in foreign currencies. We had one forward exchange contract outstanding serving to mitigate foreign currency risk of our Euro intercompany receivables in the notional amount of approximately 5 million Euros at April 1, 2007. 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 April 1, 2007 was approximately $6.7 million, resulting in an unrealized gain of $14,000.
Net realized losses from foreign currency forward contracts totaled $79,000 during the quarter ended April 1, 2007 and are included in the consolidated statement of income compared to net realized gains of $59,000 for the prior years 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
The Company is, from time to time, involved in the normal course of its business in various legal proceedings, including intellectual property, employment and product liability suits. Although the Company is unable to quantify the exact financial impact of any of these matters, it believes that none of the currently pending matters 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.
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 that 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 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 (EITF 00-21). 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 affect the functionality of the other. In cases where both elements are included in a customers 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 in accordance with EITF 03-05, Applicability of AICPA Statement of Position 97-2, Software Revenue Recognition to Non-Software Deliverables in an Arrangement Containing More-Than-Incidental Software and EITF 00-21.
We also license software under non-cancelable license agreements and provide services including training, installation, consulting and maintenance, which consists of product support services, 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 and consulting, is recognized when the service is performed. 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 generally 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 consulting and technical services, deployment and PCS 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, we use the residual method as discussed in SOP 98-9, Modification of SOP 97-2. 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 typically ship any of our software products to distributors or resellers. Our software products are sold 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.
In fiscal 2005, we began performance under a state of readiness contract awarded by the U.S. government to supply defibrillators on short notice. Based on the award, we received two types of payments from the U.S. government. The first payment of approximately $5 million was to reimburse us for the cost to acquire inventories required to meet potentially short-notice delivery schedules. This payment is recorded within Deferred revenue on our balance sheet as a liability under government contract.
We also received a payment from the U.S. government to compensate us for managing the purchase, build, storage and inventory rotation process. This payment also compensated us for making future production capacity available. The portion of this payment associated with the purchase and build aspects of the contract was recognized on a percentage of completion basis while the portion of the payment for the storage, inventory rotation and facilities charge was recognized ratably over the contract period.
This government contract is for a one-year term, and the U.S. government has four one-year extension options that require the payment of additional fees to us if exercised (the contract is currently in its second extension). These fees are for the storage, inventory rotation and facilities charge and are recognized ratably over the contract period. The U.S. government has two options 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 will reduce our future obligations under this arrangement.
Under a separate contract awarded under the U.S. militarys Patient Movement Initiative (PMI) Program, the Company shipped defibrillators to the U.S. military in 2003. The U.S. military has been a long-time customer of ours, but the PMI Program represented a large, discrete purchase of many additional units. In 2004, we shipped additional defibrillators under the PMI Program and completed performance under this contract.
For information concerning the accounting treatment of Trade-In Allowances, see the next section Allowance for Doubtful Accounts / Sales Returns and Allowances / Trade-In Allowances.
For those markets for which we sell separately priced extended warranties, revenue is deferred and recognized over the applicable warranty period, based upon the fair value of the contract.
Allowance for Doubtful Accounts / Sales Returns and Allowances / Trade-In Allowances
We maintain an allowance for doubtful accounts for estimated losses, for which related provisions are included in bad-debt expense, resulting from the inability of our customers to make required payments. Specifically identified reserves are charged to selling and marketing expenses. Provisions for general reserves are charged to general and administrative expenses. 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, communications with the customers, credit history and current economic condition. We also maintain an estimated reserve for potential future product returns and discounts given related to trade-ins and to current period product sales, which is recorded as a reduction of revenue. We analyze the rate of historical returns when evaluating the adequacy of the allowance for sales returns, which is included with the allowance for doubtful accounts on our balance sheet.
As of April 1, 2007, our accounts receivable balance of $58.1 million is reported net of allowances of $9.5 million. We believe our reported allowances at April 1, 2007 are adequate. If the financial conditions of our customers were to deteriorate, however, resulting in their inability to make payments, we might need to record additional allowances, resulting in additional expenses being recorded for the period in which such determination was made.
Although we are not typically contractually obligated to provide trade-in allowances under existing sales contracts, we may offer such allowances when negotiating new sales arrangements. When pricing sales transactions, we contemplate both cash consideration and the net realizable value of any used equipment to be traded in. The trade-in allowance value stated in a sales order may differ from the estimated net realizable value of the underlying equipment. Any excess in the trade-in allowance over the estimated net realizable value of the used equipment represents additional sales discount.
We account for product sales transactions by recording as revenue the total of the cash consideration and the estimated net realizable value of the trade-in equipment less a modest profit margin. Any difference between this estimate and the trade-in allowance granted is recorded as a reduction to revenue at the time of the sale.
Used Company equipment is recorded at the lower of cost or market consistent with Accounting Research Bulletin No. 43. We regularly review our reserves to assure that the balance sheet value associated with our trade-in equipment is properly stated.
If the trade-in equipment is a competitors product, we will usually resell the product to a third-party distributor who specializes in sale of used medical equipment, without any refurbishment. We typically do not recognize a profit upon the resale of a competitors used equipment, although as a result of the inherent nature of the estimation process, we could recognize either a nominal gain or loss.
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 year for pre-hospital and international customers and five years for hospital customers. Revenue is deferred for pre-hospital customers who receive warranties beyond one year. Such revenue is then recognized over the period of extended warranty. We provide for the estimated cost of product warranties at the time product is shipped and revenue is recognized. The costs that 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 April 1, 2007 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.
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.
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 April 1, 2007, our inventory was recorded at net realizable value requiring adjustments of $6.4 million, or 12.6% of our $51.0 million gross inventories.
At April 1, 2007 we had approximately $24 million in goodwill, primarily resulting from our acquisitions of Revivant (approximately $20 million) and the assets of Infusion Dynamics (approximately $4 million). In accordance with SFAS No. 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 has occurred.
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 undiscounted cash flows in assessing potential impairment and to record an impairment loss based on fair value 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.
The Company adopted the provisions of SFAS No. 123R, Share Based Payment (SFAS 123R), beginning October 3, 2005, using the modified prospective transition method. SFAS 123R requires the Company to measure the cost of employee services in exchange for an award of equity instruments based on the grant-date fair value of the award and to recognize cost over the requisite service period. Under the modified prospective transition method, financial statements for periods prior to the date of adoption are not adjusted for the change in accounting. However, compensation expense is recognized for (a) all share-based payments granted after the effective date under SFAS 123R, and (b) all awards granted under SFAS 123 to employees prior to the effective date that remain unvested on the effective date. The Company recognizes compensation expense on fixed awards with pro rata vesting on a straight-line basis over the vesting period.
Prior to October 3, 2005, the Company used the intrinsic value method to account for stock-based employee compensation under Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees, and, therefore, the Company did not recognize compensation expense in association with options granted at or above the market price of the Companys common stock at the date of grant.
Refer to Note 4 to the consolidated financial statements for further discussion and analysis of the impact of adoption in our income statement.
The following Risk Factors contain no material changes from the Risk Factors contained in the Companys Annual Report on Form 10-K for the fiscal year ended October 1, 2006 and filed on December 15, 2006, and are repeated for the readers convenience.
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 Physio-Control, Inc. (Physio-Control) and Royal Philips Electronics (Philips). Physio-Control is a subsidiary of Medtronic, Inc., a leading medical technology company and has been the market leader in the defibrillator industry for over 20 years. As a result of Physio-Controls 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 and Philips and other competitors each have significantly greater resources than we do. Accordingly, Physio-Control, Philips 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. Medtronic recently announced its intention to spin off its external defibrillator business into a separate publicly-traded company, and more recently announced a suspension of U.S. shipments of its products because of system quality issues. How these developments will affect the competitive landscape is unclear, but the Company has taken steps to pursue additional customers.
There are a number of smaller competitors in the United States, which include Cardiac Science Corporation, Welch Allyn, 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.
Additional companies may enter the market. For example, GE Healthcare has announced its intention to enter the hospital market through cooperation with Cardiac Science Corporation. Their success may impair our ability to gain 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, scheduling, 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, ImageTrend, Inc., eCore Software Solutions, Inc., PDSI Software, Inc., EnRoute Emergency Systems (formerly Geac Computer Corporation, Ltd.), DocuMed, Inc., Tritech Software Systems, Inc., Ortivus AB, RAM Software Systems, Inc., Intergraph Corporation, AmbPac, Inc., Roam-IT, ESO Solutions, Golden Hour and Innovative Engineering, 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.
It is Possible that if Competitors Increase Their Use of Price Discounting, Our Gross Margins Could Decline.
Some competitors have, from time to time, used price discounting in order to attempt to gain market share. If this activity were to increase in the future it is possible that our gross margin and overall profitability could be adversely affected if we decided to respond in kind.
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:
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.
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 stockholders investment to decline rapidly.
The AED PAD (Public Access Defibrillation) Business is Highly Dynamic. If We are Not Successful in Competing In This Market, Our Operating Results May be Affected.
The PAD market has many new 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 greater market acceptance of our AED Plus into alternative PAD markets if our PAD distributors are not successful. 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. Also, the internet is playing a bigger role in generating sales of AEDs. This could result in lower pricing.
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 Acquired New Products Such as the AutoPulse, Power Infuser, and LifeVest. If We Are Not Successful in Growing Our Business with These Products, Our Operating Results May Be Affected.
We have acquired the AutoPulse, an automated non-invasive cardiac support pump, the Power Infuser, a device that provides highly controlled, rapid delivery of intraveneous (IV) fluids to trauma victims, and the LifeVest, a wearable external defibrillator system. As part of the successful development of the market for these products, where applicable, we must:
If we are delayed or fail to achieve these market development initiatives, we may encounter difficulties building our customer base for these products. Sub-par results from any of these items, such as inconclusive results from clinical trials (for example, the ASPIRE trial of the AutoPulse), could cause our operating results to be unfavorably affected.
Our Approach to Our Backlog Might Not Be Successful.
We maintain a backlog in order to generate operating efficiencies. If order rates are insufficient to maintain such a backlog, we may be subject to operating inefficiencies.
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 may not be 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.
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:
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 that may have a competitive edge, making future sales of our products more difficult.
For example, over the last few years 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 reduced their spending for capital equipment purchases for their EMS services. We believe that this had a negative impact on our revenues in the North American EMS market.
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, and product liability claims are made against us from time to time. 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 product liability lawsuit is currently pending. 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 that 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:
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 thereunder. Some of our products have been classified by the FDA as
Class II devices and others, such as our AEDs, 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:
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 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 a 12 lead analysis program, SPO2, 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.
Our Current and Future Investments May Lose Value in the Future.
We hold an investment in Advanced Circulatory Systems, Inc. (formerly ResQSystems, Inc.) 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 other businesses 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.
Future Changes in Applicable Laws and Regulations Could Have an Adverse Effect on Our Business.
Federal, state or foreign governments may 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:
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 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 first applied to us for the fiscal year 2005. Accordingly, we completed a project to document, review, test, evaluate and conclude on our systems of internal controls. We have also completed our testing of our internal control systems and we did not identify any material weaknesses in our system of internal controls in either fiscal 2005 or fiscal 2006. As we move through fiscal 2007, we will continue to monitor our internal control environment and perform testing as required by Section 404 rules. There can be no guarantee that, in the future, we will not detect the existence of a material control weakness. 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 to nine months, although some sales efforts have taken as long as two years.
Reliance on Domestic and International Distributors to Sell Our Products Exposes Us to Business Risks That Could Result in Significant Fluctuations in Our Results of Operations.
Although we perform credit assessments with sales to distributors, payment by the distributor may be affected by the financial stability of the customers to which the distributor sells. Future sales to distributors may also be affected by the distributors ability to successfully sell our products to their customers. Either of these scenarios could result in significant fluctuations in our results of operations.
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 period ended April 1, 2007 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:
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 intend to continue to expand 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. We hold approximately 85 U.S. and 30 foreign patents for our various inventions and technologies. Additional patent applications have been filed with the U.S. Patent and Trademark Office and outside the U.S. 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:
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:
There is substantial litigation regarding patent and other intellectual property rights in the medical device industry, some of which involves the Company. Litigation or administrative proceedings, including interference proceedings before the U.S. Patent and Trademark Office, related to intellectual property rights have been and in the future 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.
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 acquired Revivant (now ZOLL Circulation, Inc.) and the assets of Infusion Dynamics and Lifecor (now ZOLL Lifecor 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:
Intangibles and Goodwill We Currently Carry on Our Balance Sheet May Become Impaired.
At April 1, 2007, we had approximately $52.8 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 or otherwise triggers the poison pill by exceeding the applicable stock ownership threshold. 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.
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, other natural disaster or any other significant disruption 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.
The Impact on the Company of the Suspension of Shipments by Physio-Control, a Division of Medtronics, May Be Difficult to Predict.
Physio-Control, a division of Medtronics, announced the suspension of product shipments in January 2007 due to internal quality control issues. We believe our order flow may benefit from this suspension into 2008 and 2009. Any benefit we receive prior to the latter part of 2007 is not anticipated to have a material impact on the Company as we plan to increase spending on our marketing programs and our selling organization. We cannot be assured that increased spending initiatives will be effective. If our expectations of future benefits do not materialize, our stock price could fluctuate.
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 subsidiaries in Canada, the United Kingdom, the Netherlands, France, Germany, Austria, Australia, and New Zealand. 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. 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 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 are recognized.
We had one forward exchange contract outstanding serving as a hedge of our Euro intercompany receivables in the notional amount of approximately 5 million Euros at April 1, 2007. 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 April 1, 2007 was approximately $6.7 million, resulting in an unrealized gain of $14,000. A sensitivity analysis of a change in the fair value of the Euro derivative foreign exchange contract outstanding at April 1, 2007 indicates that, if the U.S. dollar weakened by 10% against the Euro, the fair value of this contract would decrease by $668,000 resulting in a total loss on the contract of $654,000. Conversely, if the U.S. dollar strengthened by 10% against the Euro, the fair value of this contract would increase by $607,000 resulting in a total gain on the contract of $621,000. 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: April 1, 2007
(Amounts in $)
Evaluation of Disclosure Controls and Procedures
Our Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal financial officer, respectively) have evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended) as of April 1, 2007, the end of the period covered by this quarterly report on Form 10-Q. Based on this evaluation, our principal executive officer and principal financial officer have concluded that, as of the end of the period covered by this report, the Companys disclosure controls and procedures are effective.
Changes in Internal Controls Over Financial Reporting
There have been no changes in the Companys internal controls over financial reporting that occurred during the quarter ended April 1, 2007 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
There have been no material changes from the Risk Factors previously disclosed in the Companys Annual Report on Form 10-K for the fiscal year ended October 1, 2006, filed with the SEC on December 15, 2006 and are repeated for the readers convenience in Part I, Managements Discussion and Analyses of Financial Condition and Results of Operations Risk Factors.
In January 2007, as additional contingent consideration in connection with the Companys 2004 acquisition of Revivant Corporation (Revivant), the Company issued 72,128 shares of common stock, par value $0.01 per share, to former stockholders of Revivant in reliance on the exemption from registration provided by Rule 506 of Regulation D promulgated under the Securities Act of 1933, as amended.
Note: The share numbers in this Item 4 reflect the shares issued and outstanding as of January 24, 2007, without giving effect to the 2-for-1 stock split effected on February 20, 2007.
The Companys 2007 Annual Meeting of Stockholders was held on January 24, 2007. As of the December 8, 2006 record date, 9,950,130 shares of common stock were outstanding and entitled to vote, and a total of 9,363,207 shares of common stock were voted at the meeting.
Messrs. James W. Biondi and Robert J. Halliday were reelected as Class III Directors for a three-year term. Votes were cast for the nominees as follows:
The terms of office of the following Class I Directors and Class II Directors continued after the meeting:
Class I Directors (terms expire in 2008)
Daniel M. Mulvena
Benson F. Smith
Class II Directors (terms expire in 2009)
Thomas M. Claflin, II
Richard A. Packer
The other matter submitted for stockholder approval at the 2007 Annual Meeting of Stockholders was the ratification of the selection of Ernst & Young LLP as the Companys independent registered public accounting firm for 2007. The following votes were cast in connection with this matter:
Ratification of the selection of Ernst & Young LLP as the Companys independent registered public accounting firm for 2007.
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 May 11, 2007.