UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
FORM 10-Q
(Mark One)
[X] | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 29, 2003
[ ] | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number: 0-24663
Delaware | 04-2985553 | |
(State or Other Jurisdiction of | (I.R.S. Employer Identification No.) | |
Incorporation or Organization) | ||
141 Needham Street, Newton, Massachusetts | 02464-1505 | |
(Address of Principal Executive Offices) | (Zip Code) |
(617) 559-7000
Registrants Telephone Number, Including Area Code
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).
The Registrant had 19,388,510 shares of Common Stock, $0.01 par value per share, outstanding as of May 6, 2003.
ASPECT MEDICAL SYSTEMS, INC.
TABLE OF CONTENTS
Page | |||||||||
PART I. | FINANCIAL INFORMATION |
1 | |||||||
Item 1. | Financial Statements (Unaudited) |
1 | |||||||
Consolidated Balance Sheets as of March 29, 2003 and December 31, 2002 |
1 | ||||||||
Consolidated Statements of Operations for the Three Months Ended
March 29, 2003 and March 30, 2002 |
2 | ||||||||
Consolidated Statements of Cash Flows for the Three Months Ended
March 29, 2003 and March 30, 2002 |
3 | ||||||||
Notes to Consolidated Financial Statements |
4 | ||||||||
Item 2. | Managements Discussion and Analysis of Financial Condition and Results of Operations |
12 | |||||||
Item 3. | Quantitative and Qualitative Disclosures About Market Risk |
29 | |||||||
Item 4. | Controls and Procedures |
29 | |||||||
PART II. | OTHER INFORMATION |
30 | |||||||
Item 1. | Legal Proceedings |
30 | |||||||
Item 2. | Changes in Securities and Use of Proceeds |
30 | |||||||
Item 3. | Defaults Upon Senior Securities |
30 | |||||||
Item 4. | Submission of Matters to a Vote of Security Holders |
30 | |||||||
Item 5. | Other Information |
30 | |||||||
Item 6. | Exhibits and Reports on Form 8-K |
30 | |||||||
SIGNATURE | 31 | ||||||||
CERTIFICATIONS | 32 |
PART I FINANCIAL INFORMATION
Item 1. Financial Statements.
ASPECT MEDICAL SYSTEMS, INC.
CONSOLIDATED BALANCE SHEETS
March 29, | December 31, | |||||||||
2003 | 2002 | |||||||||
(Unaudited) | ||||||||||
ASSETS |
||||||||||
Current assets: |
||||||||||
Cash and cash equivalents |
$ | 11,903,390 | $ | 11,542,833 | ||||||
Restricted cash |
5,100,000 | 5,100,000 | ||||||||
Marketable securities |
16,031,340 | 20,222,500 | ||||||||
Accounts receivable, net of allowances of $351,000 at
March 29, 2003 and $408,000 at December 31, 2002 |
5,406,182 | 4,666,098 | ||||||||
Current portion of investment in sales-type leases |
1,842,593 | 1,859,237 | ||||||||
Inventory, net |
1,683,371 | 2,333,385 | ||||||||
Other current assets |
1,593,991 | 1,319,091 | ||||||||
Total current assets |
43,560,867 | 47,043,144 | ||||||||
Property and equipment, net |
3,618,801 | 4,121,560 | ||||||||
Long-term investment in sales-type leases |
2,210,383 | 2,282,751 | ||||||||
Long-term portion of notes receivable from related parties |
1,029,933 | 1,032,572 | ||||||||
Total assets |
$ | 50,419,984 | $ | 54,480,027 | ||||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||||
Current liabilities: |
||||||||||
Current portion of long-term debt |
853,012 | 887,538 | ||||||||
Accounts payable |
1,290,041 | 1,246,567 | ||||||||
Accrued liabilities |
5,799,167 | 7,127,091 | ||||||||
Deferred revenue |
983,264 | 1,047,651 | ||||||||
Total current liabilities |
8,925,484 | 10,308,847 | ||||||||
Long-term portion of deferred revenue |
6,149,301 | 6,359,210 | ||||||||
Long-term debt |
938,764 | 1,015,101 | ||||||||
Commitments and contingencies
|
||||||||||
Stockholders equity: |
||||||||||
Preferred Stock, $.01 par value; 5,000,000 shares
authorized, no shares issued or outstanding |
| | ||||||||
Common Stock, $.01 par value; 60,000,000 shares
authorized, 19,388,510 and 19,370,823 shares issued
and outstanding at March 29, 2003 and December 31,
2002, respectively |
193,885 | 193,708 | ||||||||
Additional paid-in capital |
130,644,436 | 130,606,576 | ||||||||
Notes receivable from employees and directors |
(186,504 | ) | (271,049 | ) | ||||||
Accumulated other comprehensive income |
31,560 | 20,900 | ||||||||
Accumulated deficit |
(96,276,942 | ) | (93,753,266 | ) | ||||||
Total stockholders equity |
34,406,435 | 36,796,869 | ||||||||
Total liabilities and stockholders equity |
$ | 50,419,984 | $ | 54,480,027 | ||||||
The accompanying notes are an integral part of these consolidated financial statements.
1
ASPECT MEDICAL SYSTEMS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended | ||||||||||
March 29, | March 30, | |||||||||
2003 | 2002 | |||||||||
(Unaudited) | (Unaudited) | |||||||||
Revenue |
$ | 10,127,290 | $ | 9,686,566 | ||||||
Costs of revenue |
2,549,460 | 3,517,536 | ||||||||
Gross profit margin |
7,577,830 | 6,169,030 | ||||||||
Operating expenses: |
||||||||||
Research and development |
1,880,956 | 1,936,544 | ||||||||
Sales and marketing |
6,316,618 | 7,356,505 | ||||||||
General and administrative |
2,098,788 | 1,850,064 | ||||||||
Total operating expenses |
10,296,362 | 11,143,113 | ||||||||
Loss from operations |
(2,718,532 | ) | (4,974,083 | ) | ||||||
Interest income |
249,986 | 344,611 | ||||||||
Interest expense |
(55,130 | ) | (70,046 | ) | ||||||
Net loss |
$ | (2,523,676 | ) | $ | (4,699,518 | ) | ||||
Net loss per share: |
||||||||||
Basic and diluted |
$ | (0.13 | ) | $ | (0.26 | ) | ||||
Weighted average shares used in
computing net loss per share: |
||||||||||
Basic and diluted |
19,380,916 | 17,815,859 |
The accompanying notes are an integral part of these consolidated financial statements.
2
ASPECT MEDICAL SYSTEMS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
Three Months Ended | ||||||||||||
March 29, | March 30, | |||||||||||
2003 | 2002 | |||||||||||
(Unaudited) | (Unaudited) | |||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ | (2,523,676 | ) | $ | (4,699,518 | ) | ||||||
Adjustments to reconcile net loss to net cash used for
operating activities
Depreciation and amortization |
578,345 | 661,104 | ||||||||||
Provision for doubtful accounts |
(50,000 | ) | | |||||||||
Compensation expense related to stock options |
13,537 | 12,824 | ||||||||||
Changes in assets and liabilities |
||||||||||||
(Increase) decrease in accounts receivable |
(690,084 | ) | 650,688 | |||||||||
Decrease in inventory |
650,014 | 1,042,859 | ||||||||||
Increase in other assets |
(346,722 | ) | (267,340 | ) | ||||||||
Decrease (increase) in investment in sales-type leases |
89,012 | (110,963 | ) | |||||||||
Increase in accounts payable |
43,474 | 26,231 | ||||||||||
Decrease in accrued liabilities |
(1,327,924 | ) | (1,535,853 | ) | ||||||||
Decrease in deferred revenue |
(274,296 | ) | (21,002 | ) | ||||||||
Net cash used for operating activities |
(3,838,320 | ) | (4,240,970 | ) | ||||||||
Cash flows from investing activities: |
||||||||||||
Payments on loans to related parties |
74,461 | 6,458 | ||||||||||
Acquisition of property and equipment |
(75,586 | ) | (310,134 | ) | ||||||||
Purchases of marketable securities |
(900,000 | ) | (763,674 | ) | ||||||||
Proceeds from sales and maturities of marketable securities |
5,101,820 | 13,408,934 | ||||||||||
Net cash provided by investing activities |
4,200,695 | 12,341,584 | ||||||||||
Cash flows from financing activities: |
||||||||||||
Proceeds from sale of investment in sales-type leases |
141,221 | 184,905 | ||||||||||
Principal payments on debt related to investment in sales-type
leases |
(252,084 | ) | (255,530 | ) | ||||||||
Proceeds
from payments on notes receivable from employees & directors |
84,545 | | ||||||||||
Proceeds from issuance of common stock |
24,500 | 144,004 | ||||||||||
Net cash (used for) provided by financing activities |
(1,818 | ) | 73,379 | |||||||||
Net increase in cash and cash equivalents |
360,557 | 8,173,993 | ||||||||||
Cash and cash equivalents, beginning of period |
11,542,833 | 14,325,348 | ||||||||||
Cash and cash equivalents, end of period |
$ | 11,903,390 | $ | 22,499,341 | ||||||||
Supplemental disclosure of cash flow information: |
||||||||||||
Interest paid |
$ | 55,130 | $ | 69,850 | ||||||||
The accompanying notes are an integral part of these consolidated financial statements.
3
ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
(1) Basis of Presentation
The accompanying unaudited consolidated financial statements of Aspect Medical Systems, Inc. (the Company) 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 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 normal, recurring adjustments considered necessary for a fair presentation have been included. The consolidated financial statements and notes included herein should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2002 included in the Companys Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC). Interim results of operations are not necessarily indicative of the results to be expected for the full year or any other interim period.
(2) Summary of Significant Accounting Policies
A summary of the significant accounting policies used by the Company in the preparation of its financial statements follows:
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and all wholly-owned subsidiaries. All material intercompany accounts and transactions have been eliminated.
Foreign Currency Translation
The functional currency of the Companys international subsidiaries is the U.S. dollar; therefore, transaction gains and losses from such entities are recorded in the consolidated statements of operations. Foreign currency transaction gains and losses have not been material.
Cash, Cash Equivalents and Marketable Securities
The Company invests its excess cash in money market accounts, certificates of deposit, U.S. Treasury bills, high-grade commercial paper and debt obligations of various government agencies. The Company considers all highly liquid debt instruments purchased with an original maturity of three months or less to be cash equivalents.
The Company accounts for its investments in marketable securities in accordance with Statement of Financial Accounting Standards (SFAS) No. 115, Accounting for Certain Investments in Debt and Equity Securities. In accordance with SFAS No. 115, the Company has classified all of its investments in marketable securities as available-for-sale at March 29, 2003 and December 31, 2002. The marketable securities are reported at fair value, with any unrealized gains and losses excluded from earnings and reported as a separate component of stockholders equity as other comprehensive income (loss).
Revenue Recognition
The Company recognizes revenue from equipment sales, disposable product sales and sales-type leases at the time of product shipment when collectibility is reasonably assured. Payments received prior to shipment are recorded as deferred revenue. The Company has entered into certain licensing and distribution agreements for which payments received in advance are recorded as deferred revenue. Revenue under these agreements is recognized as earned per the terms of the respective agreements. The Company does not record a provision for estimated sales returns because historically the Company has experienced only minimal returns that were not covered by warranty reserves. All shipping and handling costs are included in cost of revenue.
4
ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
In connection with the Stock Purchase Agreement with Boston Scientific Corporation (BSC) discussed in Note 9, the Company recorded approximately $6,300,000 of deferred revenue. The deferred revenue is being recognized ratably over the term of the OEM product development and distribution agreement with BSC. The term of this agreement continues until such time that BSC is no longer distributing the Companys products, but in no event will extend beyond December 31, 2012.
Research and Development Costs
The Company charges research and development costs to operations as incurred. Research and development costs include costs associated with new product development, product improvements and extensions, clinical studies and project consulting expenses.
Accounts Receivable
Estimates are used in determining the Companys allowance for doubtful accounts based on the Companys historical collections experience, historical write-offs of its receivables, current trends, credit policy and a percentage of the Companys accounts receivable by aging category. The Company also reviews the credit quality of its customer base as well as changes in the Companys credit policies. The Company continually monitors collections and payments from its customers.
Inventory
The Company values inventory at the lower of cost or estimated market, and determines cost on a first-in, first-out basis. The Company regularly reviews inventory quantities on hand and records a provision for excess or obsolete inventory primarily based on production history and on its estimated forecast of product demand. The medical industry in which the Company markets its products is characterized by rapid product development and technological advances that could result in obsolescence of inventory. Additionally, the Companys estimates of future product demand may prove to be inaccurate, in which case it will need to change its estimate of the provision required for excess and obsolete inventory. If revisions are deemed necessary, the Company would recognize the adjustments in its costs of revenue at the time of the determination.
Investment in Sales-Type Leases
The Company follows SFAS No. 13, Accounting For Leases, for its investment in sales-type leases. Under the Companys sales-type leases, customers purchase BIS Sensors and the BIS monitor for the purchase price of the BIS Sensors plus an additional charge per BIS Sensor to pay for the purchase price of the BIS monitor and related financing costs over the term of the agreement. In accordance with SFAS No. 13, the minimum lease payment, consisting of the additional charge per BIS Sensor, less the unearned interest income, which is computed at the interest rate implicit in the lease, is recorded as net investment in sales-type leases. The cost of the BIS monitor acquired by the customer is recorded as costs of revenue in the same period.
In addition, the Company periodically reviews and assesses the net realizability of its investment in sales-type leases. This review includes determining if a customer who entered into a sales-type lease is significantly underperforming relative to the customers committed level of BIS Sensor purchases. If this review results in a lower estimate of the net realizable investment balance, an allowance for the unrealized amount is established in the period in which the estimate is changed and is charged to revenue.
5
ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Warranty
Equipment that the Company sells is generally covered by a warranty period of one year. The Company accrues a warranty reserve for estimated costs to provide warranty services. The Companys estimate of costs to service its warranty obligations is based on historical experience and an expectation of future conditions. Warranty expense for the three months ended March 29, 2003, and accrued warranty cost, included in accrued liabilities in the consolidated balance sheet at March 29, 2003, was as follows:
Product | ||||
Warranty | ||||
Balance as of December 31, 2002 |
$ | 367,798 | ||
Warranty expense |
(183,728 | ) | ||
Deductions and other |
(14,163 | ) | ||
Balance as of March 29, 2003 |
$ | 169,907 | ||
Advertising Costs
Advertising costs are expensed as incurred. These costs are included in sales and marketing expense in the consolidated statements of operations.
Property and Equipment
Property and equipment is recorded at cost and depreciated using the straight-line method over the estimated useful lives of the related equipment. Equipment held under capital leases is stated at the lower of the fair market value of the equipment or the present value of the minimum lease payments at the inception of the lease and is amortized on a straight-line basis over the shorter of the lives of the related assets or the term of the leases. Maintenance and repair expenditures are charged to expense as incurred.
Income Taxes
The Company accounts for income taxes in accordance with SFAS No. 109, Accounting for Income Taxes. Under this method, deferred tax assets and liabilities are recognized for the expected future tax consequences, utilizing currently enacted tax rates, of temporary differences between the carrying amounts and the tax basis of assets and liabilities. Deferred tax assets are recognized, net of any valuation allowance, for the estimated future tax effects of deductible temporary differences and tax operating loss and credit carryforwards.
Concentration of Credit Risk and Single or Limited Source Suppliers
Financial instruments that potentially expose the Company to concentrations of credit risk primarily consist of cash, cash equivalents, accounts receivable, investment in sales-type lease receivables and marketable securities. To minimize the financial statement risk with respect to accounts receivable and investment in sales-type lease receivables, the Company maintains reserves for potential credit losses and such losses, in the aggregate, have not exceeded managements expectations. The Company maintains cash, cash equivalents and investments in marketable securities with various financial institutions. The Company performs periodic evaluations of the relative credit quality of investments and Company policy is designed to limit exposure to any one institution or type of investment. The primary objective of the Companys investment strategy is the safety of the principal invested. The Company does not maintain foreign exchange contracts or other off-balance sheet financial investments.
The Company currently obtains certain key components of its products from single or limited sources. The Company purchases components pursuant to purchase orders rather than long-term supply agreements and generally does not maintain large volumes of inventory. The Company has experienced shortages and delays in obtaining certain components of its products in the past. There can be no assurance that the Company will not experience similar shortages or delays in the future. The disruption or termination of the supply of components or a significant increase in the costs of
6
ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
these components from these sources could have a material adverse effect on the Companys business, financial position and results of operations.
Net Loss Per Share
In accordance with SFAS No. 128, Earnings Per Share, basic and diluted net loss per share amounts for the three months ended March 29, 2003 and March 30, 2002, were computed by dividing the net loss available to common stockholders by the weighted average number of shares of common stock outstanding during those periods.
All shares of restricted common stock, stock options and warrants have been excluded from the calculation of diluted net loss per share since the inclusion of such amounts would be antidilutive.
Comprehensive Income (Loss)
Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. Other than the Companys net loss, the only other element of comprehensive income (loss) impacting the Company is the unrealized gains (losses) on its marketable securities for all periods presented.
Stock-Based Compensation
SFAS No. 123, Accounting for Stock-Based Compensation, requires the measurement of the fair value of stock options or warrants to be included in the statement of income or disclosed in the notes to financial statements. The Company accounts for stock-based compensation for employees under APB Opinion No. 25 and follows the disclosure-only alternative under SFAS No. 123. The Company has computed the weighted-average fair value of options granted in the three months ended March 29, 2003 and March 30, 2002 using the Black-Scholes option-pricing model prescribed by SFAS No. 123. The following table shows the weighted average assumptions used in the applicable periods and the weighted average fair market value of the options granted in each period.
Three Months Ended | ||||||||
March 29, | March 30, | |||||||
2003 | 2002 | |||||||
Risk free interest rate |
4.00 | % | 4.40 | % | ||||
Expected dividend yield |
| | ||||||
Expected life of options |
5 years | 5 years | ||||||
Expected volatility |
75 | % | 75 | % | ||||
Weighted average fair market value of options
granted |
$ | 2.98 | $ | 8.14 |
If the Company had recognized compensation cost for these awards consistent with SFAS No. 123, the Companys net loss and pro forma net loss per common share would have been increased to the following pro forma amounts:
Three Months Ended | ||||||||||
March 29, | March 30, | |||||||||
2003 | 2002 | |||||||||
Net loss: |
||||||||||
Net loss as reported |
$ | (2,523,676 | ) | $ | (4,699,518 | ) | ||||
Add: Stock-based compensation expense
included in reported net loss |
13,537 | 12,824 | ||||||||
Deduct: Stock-based compensation expense
determined under fair value based method
for all awards |
(1,863,588 | ) | (1,947,268 | ) | ||||||
Pro forma net loss |
$ | (4,373,727 | ) | $ | (6,633,962 | ) | ||||
Net loss per share: |
||||||||||
Basic and diluted net loss per common share: |
||||||||||
As reported |
$ | (0.13 | ) | $ | (0.26 | ) | ||||
Pro forma |
$ | (0.23 | ) | $ | (0.37 | ) |
7
ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
The Black-Scholes option-pricing model was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable. In addition, option-pricing models require the input of highly subjective assumptions, including expected stock price volatility. Because the Companys employee stock options have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair value estimate, in managements opinion, the existing models do not necessarily provide a reliable single measure of the fair value of its employee stock options. Also, because options vest over several years and the Company expects to grant options in future years, the above pro forma results of applying the provisions of SFAS No. 123 are not necessarily representative of the pro forma results in future years.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Fair Value of Financial Instruments
The estimated fair market values of the Companys financial instruments, which include cash equivalents, marketable securities, accounts receivable, investment in sales-type leases, accounts payable and long-term debt, approximate their carrying values.
Recent Accounting Pronouncements
In June 2002, the FASB issued SFAS No. 146, Accounting for Costs Associated with Exit or Disposal Activities. SFAS 146 requires that a liability for a cost associated with an exit or disposal activity be recognized and measured, initially at fair value, only when the liability is incurred; therefore, nullifying Emerging Issues Task Force, or EITF, Issue No. 94-3, Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity (including Certain Costs Incurred in a Restructuring), which required a liability for an exit cost to be recognized at the date of an entitys commitment to an exit plan. This change in accounting would be expected to result in a delayed recognition of certain types of costs, especially facility closure costs. The provisions of SFAS 146 are effective for exit or disposal activities that are initiated after December 31, 2002. Since SFAS 146 is effective only for new exit or disposal activities, adoption of this standard will not affect amounts currently reported in the Companys consolidated financial statements. However, the adoption of SFAS 146 could affect the types and timing of costs included in any future business consolidation and restructuring programs. The Company adopted SFAS 146 as of January 1, 2003.
In November 2002, the FASB issued Financial Interpretation No. 45, (FIN 45), Guarantors Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others. FIN 45 requires a guarantor to disclose (a) the nature of the guarantee, and the events or circumstances that would require the guarantor to perform under the guarantee; (b) the maximum potential amount of future payments under the guarantee; (c) the carrying amount of the liability, if any, for the guarantors obligations under the guarantee; and (d) the nature and extent of any recourse provisions or available collateral that would enable the guarantor to recover the amounts paid under the guarantee. FIN 45 also clarifies that a guarantor is required to recognize, at the inception of a guarantee, a liability at fair value for the obligations it has undertaken in issuing the guarantee, including its ongoing obligation to stand ready to perform over the term of the guarantee in the event that the specified triggering events or conditions occur. The initial recognition and initial measurement provisions of FIN 45 are applicable on a prospective basis to guarantees issued or modified after December 31, 2002. FIN 45 also addresses the disclosure requirements regarding product warranties. Instead of disclosing the maximum potential amount of future payments under the product warranty guarantee, a guarantor is required to disclose its accounting policy and methodology used in determining its liability for product warranties, as well as a tabular reconciliation of the changes in the guarantors product warranty liability for the reporting period. The Company adopted FIN 45 as of January 1, 2003. The adoption of FIN 45 did not have a material effect on the Companys results of operations, cash flows or financial position.
8
ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
(3) Comprehensive Loss
The Companys total comprehensive loss is as follows:
Three Months Ended | |||||||||
March 29, | March 30, | ||||||||
2003 | 2002 | ||||||||
(Unaudited) | (Unaudited) | ||||||||
Net loss |
$ | (2,523,676 | ) | $ | (4,699,518 | ) | |||
Other comprehensive income (loss): |
|||||||||
Unrealized gain (loss) on
marketable securities |
10,660 | (49,452 | ) | ||||||
Comprehensive loss |
$ | (2,513,016 | ) | $ | (4,748,970 | ) | |||
(4) Investment in Sales-Type Leases
The components of the Companys net investment in sales-type leases are as follows:
March 29, | December 31, | ||||||||
2003 | 2002 | ||||||||
(Unaudited) | |||||||||
Total minimum lease payments receivable |
$ | 5,019,523 | $ | 5,091,303 | |||||
Less unearned interest |
966,547 | 949,315 | |||||||
Net investment in sales-type leases |
4,052,976 | 4,141,988 | |||||||
Less current portion |
1,842,593 | 1,859,237 | |||||||
$ | 2,210,383 | $ | 2,282,751 | ||||||
(5) Inventory
Inventory consists of the following:
March 29, | December 31, | |||||||
2003 | 2002 | |||||||
(Unaudited) | ||||||||
Raw materials |
$ | 1,051,490 | $ | 1,060,709 | ||||
Work-in-progress |
58,930 | 129,673 | ||||||
Finished goods |
572,951 | 1,143,003 | ||||||
$ | 1,683,371 | $ | 2,333,385 | |||||
9
ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
(6) Segment Information and Enterprise Reporting
The Company operates in one reportable segment as it markets and sells one family of anesthesia monitoring systems. The Company does not disaggregate financial information by product or geographically, other than export sales by region and sales by product, for management purposes. Substantially all of the Companys assets are located within the United States. All of the Companys products are manufactured in the United States.
Revenue by geographic destination and as a percentage of total revenue is as follows:
Three Months Ended | |||||||||
March 29, | March 30, | ||||||||
2003 | 2002 | ||||||||
(Unaudited) | (Unaudited) | ||||||||
Geographic Area by Destination |
|||||||||
Domestic |
$ | 7,940,334 | $ | 7,849,723 | |||||
International |
2,186,956 | 1,836,843 | |||||||
$ | 10,127,290 | $ | 9,686,566 | ||||||
Three Months Ended | |||||||||
March 29, | March 30, | ||||||||
2003 | 2002 | ||||||||
(Unaudited) | (Unaudited) | ||||||||
Geographic Area by Destination |
|||||||||
Domestic |
78 | % | 81 | % | |||||
International |
22 | 19 | |||||||
100 | % | 100 | % | ||||||
The Company did not have sales in any individual country, other than the United States, that accounted for more than 10% of the Companys total revenue for the three months ended March 29, 2003 and March 30, 2002.
(7) Related Party Transactions
Through December 31, 2001, the Company loaned, on a full recourse basis, an aggregate of $1,441,000, to an officer, certain employees and a consultant of the Company. In May 2002, the Company loaned, on a full recourse basis, $50,000 to another officer of the Company. On September 27, 2002, that officer left the employ of the Company and the note and accrued interest became due and payable. In March 2003, this note was paid in full. The loans are evidenced by promissory notes bearing interest with rates ranging from 5.00% to 8.00% per annum. The loans are payable over periods ranging from one to five years and in each case are secured by assets of the borrower, including shares of the Companys common stock owned by the borrower. The long-term portion of the loans is included in long-term notes receivable from related parties and the short-term portion of approximately $56,000 and $128,000 at March 29, 2003 and December 31, 2002, respectively, is included in other current assets in the accompanying consolidated balance sheets. The aggregate outstanding balance on these loans at March 29, 2003 and December 31, 2002 was approximately $1,086,000 and $1,160,000, respectively.
In January 2002, the Company entered into a consulting agreement with one of its directors to provide consulting, advisory and neurodiagnostics business planning services to the Company. As of March 29, 2003, the Company has paid approximately $9,000 to this director under this consulting agreement. Effective April 11, 2003, this director resigned from the Companys Board of Directors.
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ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
(8) Loan Agreements
In May 2001, the Company entered into an agreement with a commercial bank for a revolving line of credit. The Company is entitled to borrow up to $5,000,000 under the revolving line of credit, which expires in May 2004 and, subject to annual review by the commercial bank, may be extended at the discretion of the commercial bank. Interest on any borrowings under the revolving line of credit is, at the election of the Company, either the prime rate or at LIBOR plus 2.25%. Up to $1,500,000 of the $5,000,000 revolving line of credit is available for standby letters of credit. At March 29, 2003, the Company had outstanding standby letters of credit totaling $190,137.
The revolving line of credit agreement contains restrictive covenants that require the Company to maintain liquidity and net worth ratios and is secured by certain investments of the Company, which are shown as restricted cash in the accompanying consolidated balance sheets, in an amount equal to 102% of the $5,000,000 commitment, or $5,100,000. At March 29, 2003, there was no outstanding balance under the revolving line of credit, and the Company was in compliance with all covenants contained in the revolving line of credit agreement. At March 29, 2003, the interest rate on the revolving line of credit was 4.25%.
In August 2002, the Company entered into an agreement for a $5,000,000 revolving line of credit with BSC in connection with a strategic alliance (see Note 9).
(9) Strategic Alliance with Boston Scientific Corporation
On August 7, 2002, the Company formed a strategic alliance with BSC. In connection with this strategic alliance, the Company sold 1,428,572 shares of the Companys common stock at a purchase price per share of $7.00 to BSC pursuant to a stock purchase agreement and granted BSC an option to distribute newly developed technology for monitoring patients under sedation in a range of less-invasive medical specialties. Gross cash proceeds from this sale of common stock were $10,000,004. Approximately $5,993,000 of the aggregate purchase price was recorded as deferred revenue in the accompanying consolidated balance sheet at March 29, 2003, which represents the portion of the purchase price in excess of the closing price of the Companys common stock on August 7, 2002. The deferred revenue will be recognized ratably over the term of the OEM product development and distribution agreement that the Company entered into with BSC in August 2002. Approximately $154,000 was recognized as revenue in the three months ended March 29, 2003. The term of the agreement continues until such time that BSC is no longer distributing the Companys products, but in no event will extend beyond December 31, 2012.
As part of the strategic alliance with BSC, the Company also entered into an agreement pursuant to which BSC has agreed to provide the Company a $5,000,000 revolving line of credit which expires in August 2007 and may be extended at the discretion of BSC. Interest on any borrowings under this revolving line of credit is at a rate equal to the LIBOR rate at which BSC, under its own revolving credit facility, is entitled to borrow funds plus any additional amounts payable thereon by BSC under such revolving credit facility, plus eighty basis points. The Companys revolving line of credit with BSC is secured by the Companys inventory and certain of the Companys accounts receivable and contains certain restrictive covenants covering the collateral. At March 29, 2003, there was no outstanding balance under this revolving line of credit, and the Company was in compliance with all covenants contained in the revolving line of credit agreement.
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Item 2. | MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. |
This Quarterly Report on Form 10-Q contains, in addition to historical information, forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. These forward-looking statements involve risks and uncertainties and are not guarantees of future performance. Words such as expect, anticipate, intend, plan, believe, seek, estimate and variations of these words and similar expressions are intended to identify forward-looking statements. Our actual results could differ significantly from the results discussed in these forward-looking statements. In addition, subsequent events and developments may cause our expectations to change. While we may elect to update these forward-looking statements we specifically disclaim any obligation to do so, even if our expectations change. See the important factors in the cautionary statements below under the heading Factors Affecting Future Operating Results that we believe could cause our actual results to differ materially from the forward-looking statements we make.
Overview
We develop, manufacture and market an anesthesia monitoring system that we call the BIS® system. The BIS system is based on our patented core technology, the Bispectral Index, which we refer to as the BIS index. The BIS system provides information that allows clinicians to better assess and manage a patients level of consciousness in the operating room and intensive care settings and administer the precise amount of anesthesia needed by each patient. Our proprietary BIS system includes our BIS monitor, or our BIS Module Kit, which allows original equipment manufacturers to incorporate the BIS index into their monitoring products, and our single-use disposable BIS Sensors. We collectively refer to our group of disposable sensors as BIS Sensors.
Our latest generation monitor, the A-2000® BIS Monitor, was cleared for marketing by the United States Food and Drug Administration, or the FDA, in February 1998. Our latest version of the BIS system, the BIS XP system, was cleared for marketing by the FDA in June 2001. In addition to our A-2000 BIS Monitor, we offer original equipment manufacturers our BIS Module Kit for integration into equipment sold by the original equipment manufacturers.
We follow a system of fiscal quarters as opposed to calendar quarters. Under this system, the first three quarters of each fiscal year end on the Saturday closest to the end of the calendar quarter and the last quarter of the fiscal year always ends on December 31.
We derive our revenue primarily from sales of monitors, BIS Module Kits, and related accessories, which we collectively refer to as Equipment, and sales of BIS Sensors. In the three months ended March 29, 2003 and March 30, 2002, revenue from the sale of Equipment represented approximately 33% and 36%, respectively, of our revenue, and revenue from the sale of BIS Sensors represented approximately 67% and 64%, respectively, of our revenue. We believe our ability to grow our revenue is directly related to our ability to sell our Equipment to healthcare organizations and influence our customers to purchase and use our BIS Sensors. We believe the increase in our installed base of Equipment resulting from the sale of BIS monitors and the sale of original equipment manufacturers equipment incorporating our BIS Module Kit has been the primary reason for the growth in revenue from the sale of BIS Sensors.
We believe that in order to successfully grow our business, we need to continue to focus on both selling our Equipment and improving our per monitor and per module sensor utilization rate. To achieve this growth, we continue to implement new sales and marketing programs. We believe that as we grow our business, revenue from the sale of BIS Sensors should contribute an increasing percentage of total revenue. Additionally, we believe that over time, revenue from the sale of BIS Module Kits will increase as a percentage of total Equipment revenue as healthcare organizations purchase our technology as part of the integrated solution offered by our original equipment manufacturers.
For those healthcare organizations desiring to purchase our BIS monitors, we offer two options. Our customers have the option either to purchase BIS monitors outright or to acquire BIS monitors pursuant to a sales-type lease agreement whereby the customer contractually commits to purchase a minimum number of BIS Sensors per BIS monitor per year. Under this agreement, our customers purchase BIS Sensors and the BIS monitor for the purchase price of the BIS Sensors plus an additional charge per BIS Sensor to pay for the purchase price of the BIS monitor and related financing costs over the term of the agreement. These customers are granted an option to purchase the BIS monitors at the end of the term of the agreement, which is typically three to five years. Revenue related to BIS monitors sold pursuant to sales-type leases is recognized at the time of shipment of the BIS monitors. Sales-type leases accounted for approximately 2% and 3% of total revenue in the three months ended March 29, 2003 and March 30, 2002, respectively.
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Under certain circumstances, we also offer customers the opportunity to use the BIS monitors under our Equipment Placement program, which we refer to as the EP program. Under the EP program, the customer is granted the right to use the BIS monitors for a mutually agreed upon period of time. During this period, the customer purchases BIS Sensors at a price that includes a premium above the list price of the BIS Sensors to cover the rental of the equipment, but without any minimum purchase commitments. At the end of the agreed upon period, the customer has the option of purchasing the BIS monitors, continuing to use them under the EP program or returning them to us. Although we believe that in certain circumstances the EP program may provide an effective method of allowing customers to evaluate and ultimately acquire the BIS technology from us or our original equipment manufacturers, we have substantially reduced our focus on the EP program.
Revenue from domestic sales in the three months ended March 29, 2003 and March 30, 2002 was approximately $7.9 million and $7.8 million, respectively, which represented approximately 78% and 81%, respectively, of our revenue. Revenue from international sales in the three months ended March 29, 2003 and March 30, 2002 was approximately $2.2 million and $1.8 million, respectively, which represented approximately 22% and 19%, respectively, of our revenue.
We have subsidiaries in The Netherlands and the United Kingdom to facilitate the sale of our products into the international market. We are continuing to develop our international sales and distribution program through a combination of distributors and marketing partners, including companies with which we have entered into original equipment manufacturer relationships. In January 1998, we entered into a distribution agreement with Nihon Kohden Corporation to distribute BIS monitors in Japan. In March 2000, Nihon Kohden received approval from the Japanese Ministry of Health, Labor and Welfare for marketing in Japan our A-1050 EEG Monitor with BIS and in May 2001, received approval for marketing in Japan our A-2000 BIS Monitor. Nihon Kohden has requested but has not yet received approval to market the BIS XP system in Japan. In January 2002, the Japanese Ministry of Health, Labor and Welfare granted reimbursement approval for use of our BIS monitors. With this approval, healthcare providers in Japan are eligible to receive partial reimbursement of 1,000 Yen each time BIS monitoring is used. In July 2002, the Japanese Ministry of Health, Labor and Welfare approved our BIS module for marketing in Japan. Sales to Nihon Kohden represented approximately 15% and 33%, respectively, of international revenue for the three months ended March 29, 2003 and March 30, 2002.
We believe that maintaining our gross margin and controlling the growth of our operating expenses are important factors for us to manage in order to successfully grow our business and achieve profitability. To maintain our gross margin we believe we need to continue to focus on maintaining our average unit prices for both monitors and BIS Sensors, increase revenue from the sale of BIS Sensors as a percentage of total revenue and continue to reduce the costs to manufacture our products. In the fourth quarter of 2002, we reduced our headcount. We believe this headcount reduction, in combination with other cost reductions implemented in 2002 and to be implemented in 2003, should drive us closer to our goal of achieving profitability.
Various factors may adversely affect our quarterly operating results through the second quarter of 2003 and the year ending December 31, 2003. These factors include a potentially adverse effect on Equipment revenue as we continue to shift the focus of our placements from BIS monitors to BIS modules. In addition, in Japan, Nihon Kohden is awaiting approval of the BIS XP system, and we believe customers may delay purchases of our products or may choose not to purchase our products pending this approval. Finally, on November 1, 2003, our distribution agreement with Datex-Ohmeda expires and Equipment revenue in the international market may be adversely affected in anticipation of and after the expiration date of this agreement approaches. The master distribution agreement will be replaced by country-specific agreements with Datex-Ohmeda sales subsidiaries and distributors in various countries. To date, several new distribution agreements have been finalized and we continue to negotiate new agreements in numerous other countries.
Critical Accounting Policies
Financial Reporting Release No. 60, which was released by the Securities and Exchange Commission, or SEC, in December 2001, proposes a rule that requires all companies to include a discussion of critical accounting policies or methods used in the preparation of financial statements. Note 2 of the Notes to Consolidated Financial Statements includes a summary of our significant accounting policies and methods used in the preparation of our financial statements. In preparing these financial statements, we have made estimates and judgments of certain amounts included in the financial statements. The application of these accounting policies involves the exercise of judgment and use of assumptions as to future uncertainties and, as a result, actual results could differ from these estimates. We do not believe there is a great likelihood that materially different amounts would be reported under different conditions or using different assumptions. We believe that our critical accounting policies are as follows:
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Revenue Recognition
Our revenue is recognized in accordance with SEC Staff Accounting Bulletin, or SAB, No. 101, Revenue Recognition in Financial Statements, which provides guidance related to revenue recognition in financial statements. We recognize revenue from Equipment sales, disposable product sales and sales-type leases at the time of product shipment when collectibility is reasonably assured. Payments received prior to shipment are recorded as deferred revenue. We have entered into certain licensing and distribution agreements for which payments received in advance are also recorded as deferred revenue. Revenue under these agreements is recognized as earned in accordance with the terms of the respective agreements.
We do not record a provision for estimated sales returns because historically we have experienced only minimal returns that were not covered by warranty reserves. To the extent returns increase in future periods, we would be required to re-evaluate our revenue recognition policy in accordance with Statement of Financial Accounting Standards, or SFAS, No. 48, Revenue Recognition When Right of Return Exists.
Accounts Receivable
We determine our allowance for doubtful accounts by using estimates based on our historical collections experience, current trends, historical write-offs of our receivables, credit policy and a percentage of our accounts receivable by aging category. We also review the credit quality of our customer base as well as changes in our credit policies. We continuously monitor collections and payments from our customers. While credit losses have historically been within our expectations and the provisions established, our credit loss rates in the future may not be consistent with our historical experience. To the extent we experience a deterioration in our historical collections experience or increased credit losses, bad debt expense would likely increase in future periods.
Inventories
We value inventory at the lower of cost or estimated market, and determine cost on a first-in, first-out basis. We regularly review inventory quantities on hand and record a provision for excess or obsolete inventory primarily based on production history and on our estimated forecast of product demand. The medical industry in which we market our products is characterized by rapid product development and technological advances that could result in obsolescence of inventory. Additionally, our estimates of future product demand may prove to be inaccurate, in which case we will need to change our estimate of the provision required for excess and obsolete inventory. If revisions are deemed necessary, we would recognize the adjustments in our costs of revenue at the time of the determination. Therefore, although we continually update our forecasts of future product demand, any significant unanticipated changes in demand or technological developments could have a significant impact on the value of our inventory and our results of operations in future periods.
Investment in Sales-Type Leases
We follow SFAS No. 13, Accounting For Leases, for our investment in sales-type leases. Under our sales-type leases, customers purchase BIS Sensors and the BIS monitor for the purchase price of the BIS Sensors plus an additional charge per BIS Sensor to pay for the purchase price of the BIS monitor and related financing costs over the term of the agreement. In accordance with SFAS No. 13, the minimum lease payment, consisting of the additional charge per BIS Sensor, less the unearned interest income, which is computed at the interest rate implicit in the lease, is recorded as net investment in sales-type leases. The cost of the BIS monitor acquired by the customer is recorded as costs of revenue in the same period.
In addition, we periodically review and assess the net realizability of our investment in sales-type leases. This review includes determining if a customer who entered into a sales-type lease is significantly underperforming relative to the customers committed level of BIS Sensor purchases. If this review results in a lower estimate of the net realizable investment balance, an allowance for the unrealized amount is established in the period in which the estimate is changed and charged to revenue. Therefore, if in any period where we determine that a significant number of customers who entered into sales-type leases are underperforming in their respective commitments, it could have an impact on our results of operations.
Warranty
Equipment that we sell is generally covered by a warranty period of one year. We accrue a warranty reserve for estimated costs to provide warranty services. Our estimate of costs to service our warranty obligations is based on our historical experience and expectation of future conditions. While our warranty costs have historically been within our expectations and the provisions established, to the extent we experience increased warranty claim activity or increased costs associated with servicing those claims, our warranty accrual will increase, and we would experience decreased gross profit.
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Results of Operations
The following table presents, for the three-month periods ended March 29, 2003 and March 30, 2002, certain information from our consolidated statements of operations expressed as a percentage of revenue. This information has been derived from our consolidated statements of operations included elsewhere in this Quarterly Report on Form 10-Q. You should not draw any conclusions about our future results from the results of operations for any period.
Three Months Ended | ||||||||||
March 29, | March 30, | |||||||||
2003 | 2002 | |||||||||
Revenue |
100 | % | 100 | % | ||||||
Costs of revenue |
25 | 36 | ||||||||
Gross profit margin |
75 | 64 | ||||||||
Operating expenses: |
||||||||||
Research and development |
19 | 20 | ||||||||
Sales and marketing |
62 | 76 | ||||||||
General and administrative |
21 | 19 | ||||||||
Total operating expenses |
102 | 115 | ||||||||
Loss from operations |
(27 | ) | (51 | ) | ||||||
Interest income, net |
2 | 3 | ||||||||
Net loss |
(25 | )% | (48 | )% | ||||||
Three Months Ended March 29, 2003 Compared to Three Months Ended March 30, 2002
Revenue. Our revenue increased to approximately $10.1 million in the three months ended March 29, 2003 from approximately $9.7 million in the three months ended March 30, 2002, an increase of approximately 5%.
Revenue from the sale of Equipment decreased to approximately $3.3 million in the three months ended March 29, 2003 from approximately $3.4 million in the three months ended March 30, 2002, a decrease of approximately 3%. The decrease in equipment revenue in the first quarter of 2003 was primarily driven by a 30% decrease in monitor revenue. The lower monitor revenue was a result of a 31% decrease in unit volume as we shipped 371 units in the first quarter of 2003 compared to 536 units in the first quarter of 2002. This decrease in monitor unit volume was related to a reduction of sales in Japan from 135 monitors in the first quarter of 2002 to none in the first quarter of 2003 as Nihon Kohden continued to delay additional monitor purchases or decided not to purchase monitors pending Japanese Ministry of Health, Labor and Welfare approval of the XP technology. This decrease was partially offset by an increase in revenue from the sale of modules of approximately 113% in the first quarter of 2003 compared to the first quarter of 2002. This increase in module revenue was the result of a 54% increase in the number of module kits shipped to our OEM partners during the first quarter of 2003 and an 11% increase in the average unit price for module kits. In the first quarter of 2003, 552 module kits were shipped to our OEM partners as compared to 358 module kits shipped in the first quarter of 2002.
Revenue from the sale of BIS Sensors increased to approximately $6.8 million in the three months ended March 29, 2003 from approximately $6.2 million in the three months ended March 30, 2002, an increase of approximately 9%. The increase in revenue from the sale of BIS Sensors in the three months ended March 29, 2003 compared to the three months ended March 30, 2002 was primarily attributable to an increase of approximately 4% in the number of BIS Sensors sold as a result of growth in the installed base of monitors and modules and an increase of approximately 5% in the average selling price of the BIS Sensors. Our installed base of monitors and modules increased approximately 20% to more than 17,100 units at March 29, 2003 compared to March 30, 2002.
Our gross profit margin was approximately 75% of revenue in the three months ended March 29, 2003 as compared to a gross profit margin of approximately 64% of revenue in the three months ended March 30, 2002. The increase in gross profit margin for the quarter ended March 29, 2003 as compared to the quarter ended March 30, 2002 was the result of five factors. First, we experienced increased sales of our BIS Sensors as a percentage of total revenue and during the same period, there was an increase in the average unit price for BIS Sensors of approximately 5%. BIS Sensors have a higher gross margin than Equipment. Second, we had a lower average unit cost on monitors as a result of selling monitors that were included in our evaluation program and EP program, against which we had previously recorded depreciation in our costs of revenue. Third, we had improved gross margin on ancillary items primarily as a result of an increase in the average unit price for BIS XP upgrade kits of approximately 35%. Fourth, we had a reduction in depreciation expense related to monitors used in the EP program as the existing pool of monitors becomes fully depreciated and only a limited number of new monitors were placed into the pool. Finally, we recognized approximately $154,000 of deferred revenue related to the strategic alliance with Boston Scientific Corporation without any corresponding costs of revenue, increasing the gross profit margin by approximately 2%. In the second quarter of 2003 we expect our gross profit margin to be slightly lower than to the first quarter of 2003.
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Research and Development. Research and development expenses remained flat at approximately $1.9 million in the three month periods ended March 29, 2003 and March 30, 2002. During the first quarter of 2003, we incurred an increase in expenses related to clinical studies of approximately $82,000, consulting expenses of approximately $64,000 and patent related expenses of approximately $29,000. These increases were offset by a decrease in research and development personnel and related payroll and other expenses of approximately $165,000. We expect research and development expenses in the second quarter of 2003 to increase slightly as compared to the first quarter of 2003.
Sales and Marketing. Sales and marketing expenses decreased to approximately $6.3 million in the three months ended March 29, 2003 from approximately $7.4 million in the three months ended March 30, 2002, a decrease of approximately 14%. The decrease in sales and marketing expenses was primarily attributable to decreases in expenses related to advertising, public relations, tradeshows and the internet of approximately $359,000, operating expenses associated with our international subsidiaries of approximately $323,000, approximately $312,000 in travel and entertainment related expenses and approximately $108,000 in recruiting expenses. The decrease of $323,000 in operating expenses associated with our international subsidiaries was driven by a decrease in personnel related payroll and other expenses of approximately $214,000 which relates to the reduction in force announced in November 2002. These decreases were offset by an increase in sales commissions expense of approximately $546,000. We expect sales and marketing expenses in the second quarter of 2003 to increase as compared to the first quarter of 2003.
General and Administrative. General and administrative expenses increased to approximately $2.1 million in the three months ended March 29, 2003 from approximately $1.9 million in the three months ended March 30, 2002, an increase of approximately 13%. The increase in general and administrative expenses was primarily attributable to increases in general and administrative personnel related payroll and other expenses of approximately $232,000. We expect general and administrative expenses in the second quarter of 2003 to increase as compared to the first quarter of 2003.
Interest Income, Net. Net interest income decreased to approximately $195,000 in the three months ended March 29, 2003 from approximately $275,000 in the three months ended March 30, 2002, a decrease of approximately 29%. Interest income decreased to approximately $250,000 in the three months ended March 29, 2003 from approximately $345,000 in the three months ended March 30, 2002, a decrease of approximately 27%. The decrease in interest income was primarily attributable to lower cash and investments balances resulting from continued operating losses and other uses of cash, and lower interest rates on our investments as a result of general interest rate declines. Interest expense decreased to approximately $55,000 in the three months ended March 29, 2003 from approximately $70,000 in the three months ended March 30, 2002, a decrease of approximately 21%. The decrease in interest expense in the three months ended March 29, 2003 was a result of lower average outstanding debt obligations because we did not draw down on our line of credit during the quarter. We expect interest income to decrease in the second quarter of 2003 as compared to the first quarter of 2003 as a result of continuing low interest rates and a lower cash and investment balance.
Net Loss. As a result of the factors discussed above, for the three months ended March 29, 2003, we had a net loss of approximately $2.5 million as compared to a net loss of approximately $4.7 million for the three months ended March 30, 2002.
Liquidity and Capital Resources
Our liquidity requirements have historically consisted of research and development expenses, sales and marketing expenses, capital expenditures, working capital and general corporate expenses. From our inception through January 2000, we financed our operations primarily from the sale of our convertible preferred stock. Through March 29, 2003, we raised approximately $77.6 million from private equity financings and have received approximately $3.4 million in equipment financing and approximately $5.0 million of financing related to our investments in sales-type leases. We also received approximately $2.8 million of financing under a term loan in December 1999. The outstanding principal on the equipment and term loans was paid in May 2001. In February 2000, we closed our initial public offering of an aggregate of 4,025,000 shares of common stock and received net proceeds of approximately $54.6 million. In May 2001, we entered into an agreement with Fleet National Bank for a $5.0 million revolving line of credit which expires in May 2004. The revolving line of credit agreement contains restrictive covenants that require us to maintain liquidity and net worth ratios and is secured by certain of our investments which are shown as restricted cash on our consolidated balance sheets. We are required to maintain restricted cash and securities with a net equity value equal to 102% of the $5.0 million commitment.
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In August 2002, we entered into a strategic alliance with Boston Scientific Corporation whereby we sold 1,428,572 shares of our common stock at a purchase price per share of $7.00 to Boston Scientific Corporation pursuant to a stock purchase agreement. Gross cash proceeds from this sale of common stock were $10,000,004.
We also entered into an agreement with Boston Scientific Corporation for a revolving line of credit under which we are entitled to borrow up to $5.0 million under the revolving line of credit which expires in August 2007 and may be extended at the discretion of Boston Scientific Corporation. Interest on any borrowings under this revolving line of credit is at a rate equal to the LIBOR rate at which Boston Scientific Corporation, under its own revolving credit facility, is entitled to borrow funds plus any additional amounts payable thereon by Boston Scientific Corporation under such revolving credit facility, plus eighty basis points. Our revolving line of credit with Boston Scientific Corporation is secured by our inventory and certain of our accounts receivable and contains certain restrictive covenants covering the collateral. At March 29, 2003, there was no outstanding balance under this revolving line of credit.
We expect to meet our short-term liquidity needs through the use of cash and short-term investments on hand at March 29, 2003.
We believe that the financial resources available to us, including our current working capital and availability under our revolving lines of credit will be sufficient to finance our planned operations and capital expenditures through the end of 2004. However, our future liquidity and capital requirements will depend upon numerous factors, including the resources required to further develop our marketing and sales organization domestically and internationally, to finance our research and development programs, to implement new marketing programs, to finance our sales-type lease program and to meet market demand for our products.
Working capital at March 29, 2003 was approximately $34.6 million compared to approximately $36.7 million at December 31, 2002. The decrease in working capital from December 31, 2002 to March 29, 2003 was primarily attributable to our continued net loss of approximately $2.5 million.
We used approximately $3.8 million of cash for operations in the three months ended March 29, 2003 as compared to approximately $4.2 million in the three months ended March 30, 2002. Cash used for operations in the three months ended March 29, 2003 was primarily driven by operating losses, a decrease in accrued liabilities of approximately $1.3 million, an increase in accounts receivable of approximately $690,000 and an increase in other assets of approximately $347,000, offset by a decrease in inventory of approximately $650,000 and a decrease in our investment in sales-type leases of approximately $89,000.
We received approximately $4.2 million of cash from investing activities in the three months ended March 29, 2003 as compared to approximately $12.3 million in the three months ended March 30, 2002. The cash received from investing activities in the three months ended March 29, 2003 was primarily the result of the sales and maturities of our investments in marketable securities. We received approximately $4.2 million, net, of proceeds from sales and maturities of marketable securities and invested approximately $76,000 primarily for improvements to our information systems. In the three months ended March 30, 2002, we received approximately $12.6 million, net, of proceeds from sales and maturities of marketable securities and invested approximately $310,000 primarily for improvements to our information systems and machinery and equipment.
We used approximately $2,000 of cash from financing activities in the three months ended March 29, 2003 primarily as a result of payments of principal on debt related to our investment in sales-type leases, offset by proceeds from the sales of our investment in sales-type leases of approximately $141,000 and proceeds from payments on notes receivable from employees and directors of approximately $85,000. In the three months ended March 30, 2002, we received approximately $73,000 of cash from financing activities primarily as a result of proceeds from the sale of our investment in sales-type leases and the issuance of shares of our common stock upon the exercise of stock options, partially offset by payments of principal on debt related to our investment in sales-type leases.
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In May 2001, we entered into an agreement with Fleet National Bank for a revolving line of credit, which provides for borrowing of up to $5.0 million. The revolving line of credit expires in May 2004 and, subject to annual review by the bank, may be extended at the discretion of Fleet National Bank. Interest on any borrowings under the revolving line of credit is, at our election, either the prime rate or at LIBOR plus 2.25%. At March 29, 2003, the interest rate on the line of credit was 4.25%. The revolving line of credit agreement contains restrictive covenants that require us to maintain liquidity and net worth ratios and is secured by certain of our investments which are shown as restricted cash on our consolidated balance sheet. We are required to maintain restricted cash and securities with a net equity value equal to 102% of the $5.0 million commitment. Up to $1.5 million of the $5.0 million revolving line of credit is available for standby letters of credit. There was no outstanding balance under the line of credit at March 29, 2003. At March 29, 2003, we had standby letters of credit outstanding in the amount of approximately $190,000.
We guarantee approximately $169,000 of operating lease obligations of our subsidiaries for the lease of office space and automobiles.
In July 1999, we entered into an agreement under which we can sell a portion of our existing and future investments in sales-type leases to Americorp Financial, Inc. Through March 29, 2003, we sold approximately $5.0 million of our investments in sales-type leases. In accordance with SFAS No. 140, Accounting for Transfers and Servicing of Financial Assets and Extinguishments of Liabilities A replacement of FASB Statement No. 125, the proceeds from these sales are classified as debt. Payments on the outstanding principal under this debt match the timing of the payments due on the underlying investments in sales-type leases. At March 29, 2003, approximately $1.8 million is recorded as debt on our consolidated balance sheet.
We had capital expenditures of approximately $76,000 for the three months ended March 29, 2003 primarily for improvements to our information systems. At March 29, 2003, we did not have any commitments for capital expenditures, however, we anticipate that the level of capital expenditures in the second quarter of 2003 will be slightly higher compared to the level of capital expenditures during the first quarter of 2003.
We have summarized below our contractual cash obligations as of March 29, 2003:
Payments Due By Period | ||||||||||||||||||||
Less Than | One to Three | Three to Five | More than | |||||||||||||||||
Contractual Obligations | Total | One Year | Years | Years | Five Years | |||||||||||||||
Operating leases |
$ | 4,116,688 | $ | 1,321,136 | $ | 2,049,155 | $ | 746,397 | $ | | ||||||||||
Debt related to the sale of investment in sales type leases |
1,791,776 | 853,012 | 810,127 | 128,637 | | |||||||||||||||
Total contractual cash obligations |
$ | 5,908,464 | $ | 2,174,148 | $ | 2,859,282 | $ | 875,034 | $ | | ||||||||||
Income Taxes
We have net operating loss and research and development tax credit carryforwards for federal income tax purposes that began expiring in the year 2002 and will continue to expire through the year 2022 if not utilized.
The net operating loss and research and development tax credit carryforwards are subject to review by the Internal Revenue Service. Ownership changes, as defined under Section 382 in the Internal Revenue Code, may limit the amount of these tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on our value immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years.
Effects of Inflation
We believe that inflation and changing prices over the past year have not had a significant impact on our revenue or on our results of operations.
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Conversion to Euro
Twelve of the 15 members of the European Union have adopted the Euro as their legal currency. Our current information systems allow us to process Euro-denominated transactions. We are also assessing the business implications of the conversion to the Euro, including long-term competitive implications and the effect of market risk with respect to financial instruments. The majority of our international sales are denominated in U.S. dollars. We do not believe the Euro has had a significant effect on our business, financial condition or results of operations. However, the expenses and capital spending of our international subsidiaries are transacted in the respective countrys local currency. As a result, changes in foreign currency exchange rates or weak economic conditions in foreign markets could affect our financial condition or results of operations.
Recent Accounting Pronouncements
In June 2002, the FASB issued SFAS No. 146, Accounting for Costs Associated with Exit or Disposal Activities. SFAS 146 requires that a liability for a cost associated with an exit or disposal activity be recognized and measured, initially at fair value, only when the liability is incurred; therefore, nullifying Emerging Issues Task Force, or EITF, Issue No. 94-3, Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity (including Certain Costs Incurred in a Restructuring), which required a liability for an exit cost to be recognized at the date of an entitys commitment to an exit plan. This change in accounting would be expected to result in a delayed recognition of certain types of costs, especially facility closure costs. The provisions of SFAS 146 are effective for exit or disposal activities that are initiated after December 31, 2002. Since SFAS 146 is effective only for new exit or disposal activities, adoption of this standard will not affect amounts currently reported in our consolidated financial statements. However, the adoption of SFAS 146 could affect the types and timing of costs included in any future business consolidation and restructuring programs. We adopted SFAS 146 as of January 1, 2003. The adoption of SFAS 146 did not have a material effect on our results of operations, cash flows or financial position.
In November 2002, the FASB issued Financial Interpretation No. 45, or FIN 45, Guarantors Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others. FIN 45 requires a guarantor to disclose (a) the nature of the guarantee, and the events or circumstances that would require the guarantor to perform under the guarantee; (b) the maximum potential amount of future payments under the guarantee; (c) the carrying amount of the liability, if any, for the guarantors obligations under the guarantee; and (d) the nature and extent of any recourse provisions or available collateral that would enable the guarantor to recover the amounts paid under the guarantee. FIN 45 also clarifies that a guarantor is required to recognize, at the inception of a guarantee, a liability at fair value for the obligations it has undertaken in issuing the guarantee, including its ongoing obligation to stand ready to perform over the term of the guarantee in the event that the specified triggering events or conditions occur. The initial recognition and initial measurement provisions of FIN 45 are applicable on a prospective basis to guarantees issued or modified after December 31, 2002. FIN 45 also addresses the disclosure requirements regarding product warranties. Instead of disclosing the maximum potential amount of future payments under the product warranty guarantee, a guarantor is required to disclose its accounting policy and methodology used in determining its liability for product warranties, as well as, a tabular reconciliation of the changes in the guarantors product warranty liability for the reporting period. We adopted FIN 45 as of January 1, 2003. The adoption of FIN 45 did not have a material effect on our results of operations, cash flows or financial position.
In December 2002, the FASB issued SFAS No. 148, Accounting for Stock-Based Compensation Transition and Disclosure. SFAS 148 amends SFAS 123 and APB No. 28, Interim Financial Reporting, to present alternative methods of transition for an entity that voluntarily adopts the fair value based method of accounting for stock-based employee compensation, and provides modifications to the disclosure provisions to require prominent disclosure about the effects on reported net income of an entitys accounting policy decisions with respect to stock-based employee compensation in quarterly and annual financial statements. At this time, we have not voluntarily adopted the fair value method of accounting under SFAS 123. However, appropriate disclosures about the effects on reported net loss of our accounting policy with respect to stock-based employee compensation is reported in our consolidated financial statements.
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FACTORS AFFECTING FUTURE OPERATING RESULTS
This Quarterly Report on Form 10-Q includes forward-looking statements, including information relating to our ability to achieve profitability, information with respect to market acceptance of our BIS system, continued growth in sales of our BIS monitors, BIS Module Kits and BIS Sensors, our dependence on the BIS system, our ability to remain competitive and achieve future growth, information with respect to other plans and strategies for our business and factors that may influence our revenue for the fiscal quarter ending June 28, 2003 and for the year ending December 31, 2003. The following important factors represent current challenges to us that create risk and uncertainty. Failure to adequately overcome any of the following challenges could have a material adverse effect on our results of operations, business or financial condition.
We will not be profitable if hospitals and anesthesia providers do not buy and use our BIS system in sufficient quantities.
Our customers may determine that the cost of the BIS system exceeds cost savings in drugs, personnel and post-anesthesia care recovery resulting from use of the BIS system. In addition, hospitals and anesthesia providers may not accept the BIS system as an accurate means of assessing a patients level of consciousness during surgery or in the intensive care unit. If extensive or frequent malfunctions occur, these providers may also conclude that the BIS system is unreliable. If hospitals and anesthesia providers do not accept the BIS system as cost-effective, accurate and reliable, they will not buy and use the BIS system in sufficient quantities to enable us to be profitable.
The success of our business also depends in a large part on continued use of the BIS system by our customers and, accordingly, sales by us of BIS Sensors. We expect that over time sales of BIS Sensors will increase as a percentage of our revenue as compared to sales of Equipment as we build our installed base of monitors and modules. Nevertheless, sales of BIS Sensors as a percentage of revenue decreased slightly during 2002 as compared to 2001. If use of our BIS system, and accordingly, sales of our BIS Sensors, do not increase, it could adversely affect our revenue.
We depend on our BIS system for substantially all of our revenue, and if the BIS system does not gain widespread market acceptance, then our revenue will not grow.
We began selling our current BIS system in early 1998 and introduced the latest version, the BIS XP system, at the end of the third fiscal quarter of 2001. In 2002, we introduced commercially the BIS Extend Sensor for patients who are monitored over an extended period of time, such as in intensive care settings. To date, we have not achieved widespread market acceptance of the BIS system for use in the operating room or in the intensive care unit. Because we depend on our BIS system for substantially all of our revenue and we have no other significant products, if we fail to achieve widespread market acceptance for the BIS system, we will not be able to sustain or grow our product revenue.
Various market factors may adversely affect our quarterly operating results through the second fiscal quarter of 2003 and for the year ending December 31, 2003.
In addition to the factors identified herein, various other factors may adversely affect our quarterly operating results through the second fiscal quarter of 2003 and for the year ending December 31, 2003. First, we continue to shift the focus of our placements from BIS monitors to BIS modules which may lead to a reduction in Equipment revenue. Second, in Japan, Nihon Kohden is awaiting approval of the BIS XP system from the Japanese Ministry of Health, Labor and Welfare which may cause possible delays in purchasing decisions by customers in Japan, or these potential customers may choose not to purchase our products. Third, on November 1, 2003, our distribution agreement with Datex-Ohmeda expires and Equipment revenue in the international market may be adversely affected in anticipation of and after the expiration of this agreement. The continuation of difficult worldwide economic conditions, reductions in hospital purchasing programs, and the cost of transitioning our installed base to the new BIS XP system may also adversely impact our revenue and operating results through the second fiscal quarter of 2003 and for the year ending December 31, 2003.
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Fluctuations in our quarterly operating results could cause our stock price to decrease.
Our operating results have fluctuated significantly from quarter to quarter in the past and are likely to vary in the future. These fluctuations are due to several factors relating to the sale of our products, including:
| the timing and volume of customer orders for our BIS system, | ||
| the introduction of the BIS XP system, | ||
| implementation of, and our subsequent reduction on the focus of, our EP program, | ||
| use of and demand for our BIS Sensors, | ||
| transition of sales focus from BIS monitors to BIS module kits, | ||
| customer cancellations, | ||
| introduction of competitive products, | ||
| regulatory approvals, | ||
| changes in management, | ||
| turnover in our direct sales force, | ||
| effectiveness of new marketing and sales programs, | ||
| reductions in orders by our distributors and original equipment manufacturers, and | ||
| the timing and amount of our expenses. |
Because of these fluctuations, it is likely that in some future quarter or quarters our operating results could again fall below the expectations of securities analysts or investors. If our quarterly operating results are below expectations in the future, the market price of our common stock would also likely decrease. In addition, because we do not have a significant backlog of customer orders for our BIS system, revenue in any quarter depends on orders received in that quarter. Our quarterly results may also be adversely affected because some customers may have inadequate financial resources to purchase our products or may fail to pay for our products after receiving them. In particular, hospitals are increasingly experiencing financial constraints, consolidations and reorganizations as a result of cost containment measures and declining third-party reimbursement for services, which may result in decreased product orders or an increase in bad debts in any quarter.
If the estimates we make, and the assumptions on which we rely in preparing our financial statements prove inaccurate, our actual results may vary from those reflected in our projections and accruals.
Our financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of our assets, liabilities, revenues and expenses, the amounts of charges accrued by us, such as those made in connection with our restructurings, and related disclosure of contingent assets and liabilities. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. There can be no assurance, however, that our estimates, or the assumptions underlying them, will be correct.
If approval of our BIS XP system is not obtained in Japan, our revenue and operating results could be adversely affected.
In Japan, Nihon Kohden is awaiting approval of the BIS XP system from the Japanese Ministry of Health, Labor and Welfare. Until approval is obtained, customers in Japan may delay or reconsider their purchasing decisions with respect to our products. As a result, if approval for this product is not obtained in Japan in the near future, or at all, it could limit the growth of our international revenue.
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We may need additional financing for our future capital needs and may not be able to raise additional funds on terms acceptable to us, or at all.
We believe that the financial resources available to us, including our current working capital and availability under our revolving lines of credit, will be sufficient to finance our planned operations and capital expenditures through the end of 2004. If we are unable to increase our revenue and achieve positive cash flow, we will need to raise additional funds. We may also need additional financing if:
| we need additional cash to fund research and development costs of products currently under development, | ||
| we decide to expand faster than currently planned, | ||
| we develop new or enhanced services or products ahead of schedule, | ||
| we decide to undertake new sales and/or marketing initiatives, | ||
| we are required to defend or enforce our intellectual property rights, | ||
| sales of our products do not meet our expectations in the United States or internationally, | ||
| we need to respond to competitive pressures, or | ||
| we decide to acquire complementary products, businesses or technologies. |
We can provide no assurance that we will be able to raise additional funds on terms acceptable to us, if at all. If future financing is not available or is not available on acceptable terms, we may not be able to fund our future needs which would significantly limit our ability to implement our business plan. In addition, we may have to issue securities that may have rights, preferences and privileges senior to our common stock.
Cases of surgical awareness during monitoring with the BIS system could limit market acceptance of BIS systems and could expose us to product liability claims.
Clinicians have reported to us cases of possible surgical awareness during surgical procedures monitored with the BIS system. In most of the cases that were reported to us, when BIS index values were recorded at the time of awareness, high BIS index values were noted, indicating that the BIS index correctly identified the increased risk of awareness in these patients. However, in a small number of these reported cases, surgical awareness may not have been detected by monitoring with the BIS system. It is possible that additional cases of surgical awareness during surgical procedures monitored with the BIS system have not been reported to us, and we have not systematically solicited reports of surgical awareness. Anesthesia providers and hospitals may elect not to purchase and use BIS systems if there is adverse publicity resulting from the report of cases of surgical awareness that were not detected during procedures monitored with the BIS system. If anesthesia providers and hospitals do not purchase and use the BIS system, then we may not sustain or grow our product revenue. Although we do not claim that patient monitoring with the BIS system will reduce the incidence of surgical awareness, we may be subject to product liability claims for cases of surgical awareness during surgical procedures monitored with the BIS system. These claims could require us to spend significant time and money in litigation or to pay significant damages.
We are currently evaluating the data that was collected in our three multi-center, multinational studies to assess the incidence of awareness during BIS monitoring. If the results of these studies do not conclusively demonstrate that patient monitoring with the BIS system will reduce the incidence of surgical awareness, our business could be adversely affected.
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We may not be able to compete with new products or alternative techniques developed by others, which could impair our ability to remain competitive and achieve future growth.
The medical industry in which we market our products is characterized by rapid product development and technological advances. Our competitors have introduced commercially three FDA-approved anesthesia monitoring products. If we do not compete effectively with these monitoring products, our revenue will be adversely affected. Our current or planned products are at risk of obsolescence from:
| other new monitoring products, based on new or improved technologies, | ||
| new products or technologies used on patients or in the operating room during surgery in lieu of monitoring devices, | ||
| electrical or mechanical interference from new or existing products or technologies, | ||
| alternative techniques for evaluating the effects of anesthesia, | ||
| significant changes in the methods of delivering anesthesia, and | ||
| the development of new anesthetic agents. |
We may not be able to improve our products or develop new products or technologies quickly enough to maintain a competitive position in our markets and continue to grow our business.
If we do not successfully develop and introduce enhanced or new products we could lose revenue opportunities and customers.
As the market for our BIS system matures, we need to develop and introduce new products for anesthesia monitoring or other applications. In 2002, we introduced commercially the BIS Extend Sensor for patients who are typically monitored for an extended period of time, such as in intensive care unit settings. We do not know whether the use of the BIS system and the BIS Extend Sensor for use in the intensive care unit will achieve market acceptance. In addition, we have begun to research the use of BIS monitoring to diagnose and track neurological diseases, and face at least the following two related risks:
| we may not successfully adapt the BIS system to function properly for procedural sedation, when used with anesthetics we have not tested or with patient populations we have not studied, such as infants, and | ||
| our technology is complex, and we may not be able to develop it further for applications outside anesthesia monitoring, such as the diagnosis and tracking of neurological diseases. |
If we do not successfully adapt the BIS system for new products and applications both within and outside the field of anesthesia monitoring, or if such products and applications are developed but not successfully commercialized, then we could lose revenue opportunities and customers.
If we do not develop and implement a successful sales and marketing strategy, we will not expand our business.
Throughout 2002, we experienced high turnover in our direct sales force. If our new sales representatives do not acquire the technological skills to sell our products in a timely and successful manner or we continue to experience high turnover in our direct sales force, we may not be able to sustain and grow our product revenue. On an ongoing basis, we develop and introduce new sales and marketing programs. If we do not implement these new sales and marketing programs in a timely and successful manner, we may not be able to achieve the level of market awareness and sales required to expand our business. In the third quarter of 2002, we experienced a change in the management of our North American field operations. If the transition to new management is not effective, we may not be able to sustain or grow our product revenue. In January 2002, we transitioned to new management in our international operations, and as a result of the transition, we combined our international, commercial and clinical groups. If this international reorganization is not successful, we may not be able to expand our international business. We have only limited sales and marketing experience both in the United States and internationally and may not be successful in developing and implementing our strategy. We need to:
| provide or assure that distributors and original equipment manufacturers provide the technical and educational support customers need to use the BIS system successfully, | ||
| promote frequent use of the BIS system so that sales of our disposable BIS Sensors increase, |
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| establish and implement successful marketing and sales programs that encourage our customers to purchase our products or the products that are made by original equipment manufacturers incorporating our technology, | ||
| manage geographically dispersed operations, and | ||
| modify our products and marketing and sales programs for foreign markets. |
In order to reach the level of sales we need to achieve profitability, we need to further develop our direct and indirect sales channels.
In order to increase our sales, we need to continue to strengthen our relationships with our domestic and international distributors and continue to add international distributors. We need to also continue to strengthen our relationships with our original equipment manufacturers and other sales channels and increase sales through these channels. On an ongoing basis we develop and implement new sales and marketing programs and clinical education programs to promote the use of the BIS system by our customers. If we do not further develop our direct and indirect sales channels and successfully implement the new sales and marketing programs and clinical education programs that encourage our customers to purchase and use our products, we will not reach the level of sales necessary to achieve profitability.
Our third-party distribution and original equipment manufacturer relationships could negatively affect our profitability, cause sales of our products to decline and be difficult to terminate if we are dissatisfied.
Sales through distributors could be less profitable than direct sales. Sales of our products through multiple channels could also confuse customers and cause the sale of our products to decline. We do not control our original equipment manufacturers and distribution partners. Our partners could sell competing products, may not incorporate our technology into their products in a timely manner and may devote insufficient sales efforts to our products. Our partners are generally not required to purchase minimum quantities. As a result, even if we are dissatisfied with the performance of our partners, we may be unable to terminate our agreements with these partners or enter into alternative arrangements.
We may not be able to generate enough additional revenue from our international expansion to offset the costs associated with establishing and maintaining foreign operations.
A component of our growth strategy is to expand our presence in foreign markets. We conduct international business primarily in Europe and Japan and we are attempting to increase the number of countries in which we do business. It is costly to establish international facilities and operations and to promote the BIS system in international markets. We have encountered barriers to the sale of our BIS system outside the United States, including less acceptance by anesthesia providers for use of disposable products, such as BIS Sensors, delays in regulatory approvals outside of the United States, particularly in Japan, and difficulties selling through indirect sales channels. In addition, we have little experience in marketing and distributing products in these markets. Revenue from international activities may not offset the expense of establishing and maintaining these foreign operations.
We may not be able to meet the unique operational, legal and financial challenges that we will encounter in our international operations, which may limit the growth of our business.
We are increasingly subject to a number of challenges which specifically relate to our international business activities. These challenges include:
| failure of local laws to provide the same degree of protection against infringement of our intellectual property, | ||
| protectionist laws and business practices that favor local competitors, which could slow our growth in international markets, | ||
| difficulties in terminating or modifying distributor arrangements because of restrictions in markets outside the United States, | ||
| less acceptance by foreign anesthesia providers of the use of disposable products similar to the BIS Sensors, | ||
| delays in regulatory approval of our products, | ||
| currency conversion issues arising from sales denominated in currencies other than the United States dollar, |
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| foreign currency exchange rate fluctuations, | ||
| longer sales cycles to sell products like the BIS system to hospitals and outpatient surgical centers, which could slow our revenue growth from international sales, and | ||
| longer accounts receivable payment cycles and difficulties in collecting accounts receivable. |
If we are unable to meet and overcome these challenges, our international operations may not be successful which would limit the growth of our business.
We may experience customer dissatisfaction and our reputation could suffer if we fail to manufacture enough products to meet our customers demands.
We rely on third-party manufacturers to assemble and manufacture the components of our BIS monitors, BIS Module Kits and a portion of our BIS Sensors. We manufacture substantially all BIS Sensors in our own manufacturing facility. We have only one manufacturing facility. If we fail to produce enough products at our own manufacturing facility or at a third-party manufacturing facility or experience a termination or modification of any manufacturing arrangement with a third party, we may be unable to deliver products to our customers on a timely basis. Our failure to deliver products on a timely basis could lead to customer dissatisfaction and damage our reputation.
Our reliance on sole-source suppliers could adversely affect our ability to meet our customers demands for our products in a timely manner or within budget.
Some of the components that are necessary for the assembly of our BIS system, including some of the components used in our BIS Sensors, are currently provided to us by sole-source suppliers or a limited group of suppliers. We purchase components through purchase orders rather than long-term supply agreements and generally do not maintain large volumes of inventory. We have experienced shortages and delays in obtaining some of the components of our BIS systems in the past, and we may experience similar shortages or delays in the future. The disruption or termination of the supply of components could cause a significant increase in the costs of these components, which could affect our profitability. A disruption or termination in the supply of components could also result in our inability to meet demand for our products, which could lead to customer dissatisfaction and damage our reputation. Furthermore, if we are required to change the manufacturer of a key component of the BIS system, we may be required to verify that the new manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines. The delays associated with the verification of a new manufacturer could delay our ability to manufacture BIS systems in a timely manner or within budget.
We may be required to bring litigation to enforce our intellectual property rights, which may result in substantial expense and may divert our attention from the implementation of our business strategy.
We believe that the success of our business depends, in part, on obtaining patent protection for our products, defending our patents once obtained and preserving our trade secrets. We rely on a combination of contractual provisions, confidentiality procedures and patent, trademark and trade secret laws to protect the proprietary aspects of our technology. These legal measures afford only limited protection and competitors may gain access to our intellectual property and proprietary information. Litigation may be necessary to enforce our intellectual property rights, to protect our trade secrets and to determine the validity and scope of our proprietary rights. Any litigation could result in substantial expense and diversion of our attention from the growth of the business and may not be adequate to protect our intellectual property rights.
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We may be sued by third parties which claim that our products infringe on their intellectual property rights, particularly because there is substantial uncertainty about the validity and breadth of medical device patents.
We may be exposed to litigation by third parties based on claims that our products infringe the intellectual property rights of others. This risk is exacerbated by the fact that the validity and breadth of claims covered in medical technology patents involve complex legal and factual questions for which important legal principles are unresolved. Any litigation or claims against us, whether or not valid, could result in substantial costs, could place a significant strain on our financial resources and could harm our reputation. In addition, intellectual property litigation or claims could force us to do one or more of the following:
| cease selling, incorporating or using any of our products that incorporate the challenged intellectual property, which would adversely affect our revenue, | ||
| obtain a license from the holder of the infringed intellectual property right, which license may not be available on reasonable terms, if at all, and | ||
| redesign our products, which would be costly and time-consuming. |
We could be exposed to significant product liability claims which could divert management attention and adversely affect our cash balances, our ability to obtain and maintain insurance coverage at satisfactory rates or in adequate amounts and our reputation.
The manufacture and sale of our products expose us to product liability claims and product recalls, including those which may arise from misuse or malfunction of, or design flaws in, our products or use of our products with components or systems not manufactured or sold by us. Product liability claims or product recalls, regardless of their ultimate outcome, could require us to spend significant time and money in litigation or to pay significant damages. We currently maintain product liability insurance; however, it may not cover the costs of any product liability claims made against us. Furthermore, we may not be able to obtain insurance in the future at satisfactory rates or in adequate amounts. In addition, publicity pertaining to the misuse or malfunction of, or design flaws in, our products could impair our ability to successfully market and sell our products.
Several class action lawsuits have been filed against the underwriters of our initial public offering which may result in negative publicity and potential litigation against us that would be costly to defend and the outcome of which is uncertain and may harm our business.
The underwriters of our initial public offering are named as defendants in several class action complaints which have been filed allegedly on behalf of certain persons who purchased shares of our common stock between January 28, 2000 and December 6, 2000. These complaints allege violations of the Securities Act of 1933 and the Securities Exchange Act of 1934. Primarily they allege that there was undisclosed compensation received by our underwriters in connection with our initial public offering. While we and our officers and directors have not been named as defendants in these suits, based on comparable lawsuits filed against other companies, there can be no assurance that we and our officers and directors will not be named in similar complaints in the future. In addition, the underwriters may assert that we are liable for some or all of any liability that they are found to have to the plaintiffs, pursuant to the indemnification provisions of an underwriting agreement we entered into as part of the initial public offering, or otherwise.
We can provide no assurance as to the outcome of these complaints or any potential suit against us or our officers and directors. Any conclusion of these matters in a manner adverse to us could have a material adverse affect on our financial position and results of operations. In addition, the costs to us of defending any litigation or other proceeding, even if resolved in our favor, could be substantial. Such litigation could also substantially divert the attention of our management and our resources in general. Uncertainties resulting from the initiation and continuation of any litigation or other proceedings and the negative publicity associated with this litigation could harm our ability to compete in the marketplace.
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Boston Scientific Corporation may be able to impact corporate actions requiring stockholder approval because it owns a significant amount of our common stock, and, if our strategic alliance with Boston Scientific Corporation is not successful, our operating results will be adversely affected.
As of April 11, 2003, Boston Scientific Corporation owned approximately 17.5% of our outstanding common stock. We have an agreement with Boston Scientific Corporation, pursuant to which Boston Scientific Corporation has agreed not to acquire any shares of our common stock in excess of 25% of the outstanding shares of common stock prior to December 31, 2004 without our prior approval. If Boston Scientific Corporation increases its ownership of our outstanding common stock, it may impact corporate actions requiring stockholder approval. In addition, on August 7, 2002, we formed a strategic alliance with Boston Scientific Corporation. In connection with this strategic alliance, we entered into an agreement pursuant to which we granted Boston Scientific Corporation an option to distribute newly developed technology for monitoring patients under sedation in a range of less-invasive medical specialties. If such products are not successfully developed, marketed and sold under the agreement in a manner consistent with our expectations, the growth of our business and our operating results will be adversely affected. Even if we successfully develop new sedation management technology for less-invasive medical procedures, Aspect and Boston Scientific Corporation may not successfully market and sell this new technology.
We may not reserve amounts adequate to cover product obsolescence, claims and returns, which could result in unanticipated expenses and fluctuations in operating results.
Depending on factors such as the timing of our introduction of new products which utilize our BIS technology, as well as warranty claims and product returns, we may need to reserve amounts in excess of those currently reserved for product obsolescence, excess inventory, warranty claims and product returns. These reserves may not be adequate to cover all costs associated with these items. If these reserves are inadequate, we would be required to incur unanticipated expenses which could result in unexpected fluctuations in quarterly operating results.
We may not be able to compete effectively, which could result in price reductions and decreased demand for our products.
We are facing increased competition in the domestic level of consciousness monitoring market as a result of three competitors monitoring systems which have been approved by the FDA. These products are marketed by well-established medical products companies with significant resources. We may not be able to compete effectively with these and other potential competitors. We may also face substantial competition from companies which may develop sensor products that compete with our proprietary BIS Sensors for use with our BIS monitors or with third-party monitoring systems or anesthesia delivery systems that incorporate the BIS index. We also expect to face competition from companies currently marketing conventional electroencephalogram, or EEG, monitors using standard and novel signal-processing techniques. Other companies may develop anesthesia-monitoring systems that perform better than the BIS system and/or sell for less. In addition, one or more of our competitors may develop products that are substantially equivalent to our FDA-approved products, in which case they may be able to use our products as predicate devices to more quickly obtain FDA approval of their competing products. Medical device companies developing these and other competitive products may have greater financial, technical, marketing and other resources than we do. Competition in the sale of anesthesia-monitoring systems could result in price reductions, fewer orders, reduced gross margins and loss of market share.
Our ability to market and sell our products and generate revenue depends upon receipt of domestic and foreign regulatory approval of our products and manufacturing operations.
Before we can market new products in the United States, we must obtain clearance from the United States Food and Drug Administration, or FDA. If the FDA concludes that any of our products do not meet the requirements to obtain clearance of a premarket notification under Section 510(k) of the Food, Drug and Cosmetic Act, then we would be required to file a premarket approval application. The approval process for a premarket approval application is lengthy, expensive and typically requires extensive preclinical and clinical trial data. We may not obtain clearance of a 510(k) notification or approval of a premarket approval application with respect to any of our products on a timely basis, if at all. If we fail to obtain timely clearance or approval for our products, we will not be able to market and sell our products, which will limit our ability to generate revenue. We may also be required to obtain clearance of a 510(k) notification from the FDA before we can market certain previously marketed products which we modify after they have been cleared. We have made certain enhancements to our currently marketed products which we have determined do not necessitate the filing of a new 510(k) notification. However, if the FDA does not agree with our determination, it will require us to file a new 510(k) notification for the modification and we may be prohibited from marketing the modified device until we obtain FDA clearance.
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The FDA also requires us to adhere to current Good Manufacturing Practices regulations, which include production design controls, testing, quality control, storage and documentation procedures. The FDA may at any time inspect our facilities to determine whether adequate compliance has been achieved. Compliance with current Good Manufacturing Practices regulations for medical devices is difficult and costly. In addition, we may not continue to be compliant as a result of future changes in, or interpretations of, regulations by the FDA or other regulatory agencies. If we do not achieve continued compliance, the FDA may withdraw marketing clearance or require product recall. When any change or modification is made to a device or its intended use, the manufacturer may be required to reassess compliance with current Good Manufacturing Practices regulations, which may cause interruptions or delays in the marketing and sale of our products.
Sales of our products outside the United States are subject to foreign regulatory requirements that vary from country to country. The time required to obtain approvals from foreign countries may be longer than that required for FDA approval, and requirements for foreign licensing may differ from FDA requirements.
The federal, state and foreign laws and regulations regarding the manufacture and sale of our products are subject to future changes, as are administrative interpretations of regulatory agencies. If we fail to comply with applicable federal, state or foreign laws or regulations, we could be subject to enforcement actions, including product seizures, recalls, withdrawal of clearances or approvals and civil and criminal penalties.
If we do not retain our senior management and other key employees, we may not be able to successfully implement our business strategy.
Our president and chief executive officer, Nassib Chamoun, joined us at our inception in 1987. Our chairman, J. Breckenridge Eagle, began serving as a director in 1988. Many other members of our management and key employees have extensive experience with us and other companies in the medical device industry. Our success is substantially dependent on the ability, experience and performance of these members of our senior management and other key employees. Because of their ability and experience, if we lose one or more of the members of our senior management or other key employees, our ability to successfully implement our business strategy could be seriously harmed.
If we do not attract and retain skilled personnel, we will not be able to expand our business.
Our products are based on complex signal-processing technology. Accordingly, we require skilled personnel to develop, manufacture, sell and support our products. Our future success will depend largely on our ability to continue to hire, train, retain and motivate additional skilled personnel, particularly sales representatives who are responsible for customer education and training and post-installation customer support. Consequently, if we are not able to attract and retain skilled personnel, we will not be able to expand our business.
Failure of users of the BIS system to obtain adequate reimbursement from third-party payors could limit market acceptance of the BIS system, which could prevent us from achieving profitability.
Anesthesia providers are generally not reimbursed separately for patient monitoring activities utilizing the BIS system. For hospitals and outpatient surgical centers, when reimbursement is based on charges or costs, patient monitoring with the BIS system may reduce reimbursements for surgical procedures, because charges or costs may decline as a result of monitoring with the BIS system. Failure by hospitals and other users of the BIS system to obtain adequate reimbursement from third-party payors, or any reduction in the reimbursement by third-party payors to hospitals and other users as a result of using the BIS system could limit market acceptance of the BIS system, which could prevent us from achieving profitability.
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Item 3. Qualitative and Quantitative Disclosures About Market Risk.
We are exposed to financial market risks, including changes in foreign currency exchange rates and interest rates. Most of our revenue, expenses and capital spending are transacted in U.S. dollars. However, the expenses and capital spending of our international subsidiaries are transacted in the respective countrys local currency. As a result, changes in foreign currency exchange rates or weak economic conditions in foreign markets could affect our financial results. We do not use derivative instruments to hedge our foreign exchange risk. Our exposure to market risk for changes in interest rates relates primarily to our cash and cash equivalent balances, marketable securities, investment in sales-type leases and line of credit agreements. The majority of our investments are in short-term instruments and subject to fluctuations in U.S. interest rates. Due to the nature of our short-term investments, we believe that there is no material market risk.
Item 4. Controls and Procedures.
(a) Evaluation of Disclosure Controls and Procedures.
Within the 90-day period prior to the filing of this Quarterly Report on Form 10-Q, an evaluation was carried out under the supervision and with the participation of our management, including our Chief Executive Officer, or CEO, and Chief Financial Officer, or CFO, of the effectiveness of the design and operation of our disclosure controls and procedures. Based on that evaluation, our CEO and CFO have concluded that our disclosure controls and procedures are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms and are operating in an effective manner. |
(b) Changes in Internal Controls.
There were no significant changes in our internal controls or in other factors that could significantly affect these controls subsequent to the date of their most recent evaluation. |
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PART II OTHER INFORMATION
Item 1. Legal Proceedings.
We are not a party to any material threatened or pending legal proceedings. |
Item 2. Changes in Securities and Use of Proceeds.
On February 2, 2000, we sold 3,500,000 shares of our common stock, at an initial public offering price of $15.00 per share, pursuant to a Registration Statement on Form S-1 (Registration No. 333-86295), which was declared effective by the Securities and Exchange Commission on January 27, 2000. On February 4, 2000, the underwriters exercised in full their over-allotment option to purchase an additional 525,000 shares of our common stock at $15.00 per share. The managing underwriters of our initial public offering were Morgan Stanley & Co. Incorporated, Deutsche Bank Securities Inc. and U.S. Bancorp Piper Jaffray Inc. | |
The aggregate gross proceeds raised in the offering were approximately $60.4 million. Our total expenses in connection with the offering were approximately $5.7 million, of which $4.2 million was for underwriting discounts and commissions and, based on our reasonable estimate, approximately $1.5 million was for other expenses. Our net proceeds from the offering were approximately $54.6 million. From January 27, 2000 through March 29, 2003, we used approximately $9.5 million of the net proceeds for the acquisition of machinery and equipment, leasehold improvements, furniture and fixtures, demonstration and evaluation equipment and new information systems. In addition, from January 27, 2000 through March 29, 2003, we used approximately $42.9 million of the net proceeds for general corporate purposes, including the funding of operating losses, working capital, product development, increasing our sales and marketing capabilities and expanding our international operations. As of March 29, 2003, we had approximately $2.2 million of proceeds remaining from the offering, and pending use of the proceeds, we have invested these funds in short-term, interest-bearing, investment-grade securities. |
Item 3. Defaults Upon Senior Securities.
None. |
Item 4. Submission of Matters to a Vote of Security Holders.
None. |
Item 5. Other Information.
None. |
Item 6. Exhibits and Reports on Form 8-K.
(a) | Exhibits | |
The exhibits listed in the Exhibit Index immediately preceding the exhibits are filed as part of this Quarterly Report on Form 10-Q. | ||
(b) | Reports on Form 8-K | |
We did not file any reports on Form 8-K during the quarter ended March 29, 2003. |
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SIGNATURE
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.
ASPECT MEDICAL SYSTEMS, INC. | ||||
Date: May 12, 2002 | By: | /s/ J. Neal Armstrong | ||
J. Neal Armstrong | ||||
Vice President and Chief Financial Officer | ||||
(Principal Financial and Accounting Officer) |
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CERTIFICATIONS
I, Nassib G. Chamoun, certify that:
1. | I have reviewed this quarterly report on Form 10-Q of Aspect Medical Systems, Inc.; | ||
2. | Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; | ||
3. | Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report; | ||
4. | The registrants other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have: |
a) | Designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; | |
b) | Evaluated the effectiveness of the registrants disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the Evaluation Date); and | |
c) | Presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; |
5. | The registrants other certifying officers and I have disclosed, based on our most recent evaluation, to the registrants auditors and the audit committee of registrants board of directors (or persons performing the equivalent function): |
a) | All significant deficiencies in the design or operation of internal controls which could adversely affect the registrants ability to record, process, summarize and report financial data and have identified for the registrants auditors any material weaknesses in internal controls; and | |
b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls; and |
6. | The registrants other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. |
/s/ NASSIB G. CHAMOUN | |
Nassib G. Chamoun | |
Chief Executive Officer |
Dated: May 12, 2003
32
CERTIFICATIONS
I, J. Neal Armstrong, certify that:
1. | I have reviewed this quarterly report on Form 10-Q of Aspect Medical Systems, Inc.; | ||
2. | Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; | ||
3. | Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report; | ||
4. | The registrants other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have: |
a) | Designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; | |
b) | Evaluated the effectiveness of the registrants disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the Evaluation Date); and | |
c) | Presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; |
5. | The registrants other certifying officers and I have disclosed, based on our most recent evaluation, to the registrants auditors and the audit committee of registrants board of directors (or persons performing the equivalent function): |
a) | All significant deficiencies in the design or operation of internal controls which could adversely affect the registrants ability to record, process, summarize and report financial data and have identified for the registrants auditors any material weaknesses in internal controls; and | |
b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls; and |
6. | The registrants other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. |
/s/ J. NEAL ARMSTRONG | |
J. Neal Armstrong | |
Chief Financial Officer |
Dated: May 12, 2003
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EXHIBIT INDEX
EXHIBIT | ||
NUMBER | EXHIBIT | |
10.1 | OEM Development and Purchase Agreement, dated February 13, 2003, by and between the Registrant and Dixtal Biomedica Ind E Com Ltda. | |
10.2 | Special Bonus Program for Nassib G. Chamoun dated April 24, 2003. | |
99.1 | Certification by Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
99.2 | Certification by Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
| Confidential treatment has been requested as to certain portions of this Exhibit. Such portions have been omitted and filed separately with the Securities and Exchange Commission. |