UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the quarterly period ended March 29, 2008
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
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For the transition period from _________ to _________
Commission file number: 0-24663
ASPECT MEDICAL SYSTEMS, INC.
(Exact Name of Registrant as Specified in Its Charter)
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Delaware
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04-2985553
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(State or Other Jurisdiction of
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(I.R.S. Employer Identification No.)
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Incorporation or Organization)
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One Upland Road, Norwood, Massachusetts
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02062
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(Address of Principal Executive Offices)
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(Zip Code)
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(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.
YES
þ
NO
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Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in
Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer
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Accelerated filer
þ
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Non-accelerated filer
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Smaller reporting company
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(Do not check if a smaller reporting company)
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
YES
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NO
þ
The
Registrant had 17,208,212 shares of Common Stock, $0.01 par value per share, outstanding as of May 1,
2008.
ASPECT MEDICAL SYSTEMS, INC.
TABLE OF CONTENTS
PART I FINANCIAL INFORMATION
Item 1. FINANCIAL STATEMENTS.
ASPECT MEDICAL SYSTEMS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share data and per share amounts)
(unaudited)
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March 29,
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December 31,
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2008
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2007
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ASSETS
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Current assets:
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Cash and cash equivalents
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$
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11,806
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$
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19,828
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Short-term investments
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83,580
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82,134
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Accounts receivable, net of allowance of $324 at March
29, 2008 and $322 at December 31, 2007
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13,270
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12,544
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Current portion of investment in sales-type leases
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1,369
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1,473
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Inventory
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6,012
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7,113
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Deferred tax assets
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4,729
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4,729
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Other current assets
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3,266
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2,677
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Total current assets
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124,032
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130,498
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Property and equipment, net
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8,571
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8,455
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Long-term portion of restricted cash
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1,007
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1,004
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Long-term investments
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14,454
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6,518
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Long-term investment in sales-type leases
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2,265
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2,618
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Deferred financing fees
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4,050
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4,213
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Long-term deferred tax assets
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19,958
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20,171
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Total assets
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$
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174,337
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$
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173,477
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LIABILITIES AND STOCKHOLDERS EQUITY
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Current liabilities:
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Accounts payable
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$
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1,465
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$
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1,836
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Accrued liabilities
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8,810
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9,723
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Current portion of obligation under capital lease
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28
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28
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Deferred revenue
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34
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87
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Total current liabilities
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10,337
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11,674
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Long-term portion of obligation under capital lease
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82
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89
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Long-term portion of deferred revenue
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36
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39
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Long-term debt
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125,000
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125,000
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Commitments and contingencies
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Stockholders equity:
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Preferred stock, $.01 par value; 5,000,000 shares
authorized, no shares issued or outstanding
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Common stock, $.01 par value; 60,000,000 shares
authorized, 17,190,974 and 17,118,037 shares issued
and outstanding at March 29, 2008 and December 31,
2007, respectively
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174
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174
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Treasury stock, at cost; 276,493 shares
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(5,008
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(5,008
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Additional paid-in capital
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181,055
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178,837
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Accumulated other comprehensive income
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404
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180
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Accumulated deficit
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(137,743
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(137,508
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Total stockholders equity
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38,882
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36,675
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Total liabilities and stockholders equity
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$
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174,337
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$
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173,477
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The accompanying notes are an integral part of these condensed consolidated financial statements.
1
ASPECT MEDICAL SYSTEMS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
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Three Months Ended
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March 29, 2008
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March 31, 2007
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Product revenue
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$
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24,428
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$
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22,435
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Strategic alliance revenue
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1,684
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Total revenue
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24,428
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24,119
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Costs of revenue (1)
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6,486
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6,079
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Gross profit
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17,942
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18,040
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Operating expenses: (1)
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Research and development
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3,939
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4,221
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Sales and marketing
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10,202
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10,045
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General and administrative
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3,942
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3,663
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Total operating expenses
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18,083
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17,929
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(Loss) income from operations
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(141
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111
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Other income:
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Interest income
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1,278
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982
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Interest expense
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(948
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Income before income taxes
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189
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1,093
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Provision for income taxes
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424
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576
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Net (loss) income
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$
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(235
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$
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517
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Net (loss) income per share:
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Basic
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$
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(0.01
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$
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0.02
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Diluted
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$
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(0.01
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$
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0.02
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Weighted average shares used in
computing net (loss) income per
share:
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Basic
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17,148
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22,411
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Diluted
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17,148
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23,027
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(1) Stock-based compensation
included in costs and expenses:
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Costs of revenue
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$
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119
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$
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145
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Research and development
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469
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524
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Sales and marketing
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676
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808
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General and administrative
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678
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740
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The accompanying notes are an integral part of these condensed consolidated financial statements.
2
ASPECT MEDICAL SYSTEMS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
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Three Months Ended
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March 29,
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March 31,
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2008
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2007
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Cash flows from operating activities:
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Net (loss) income
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$
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(235
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$
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517
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Adjustments to reconcile net (loss) income to net cash
provided by operating activities
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Depreciation and amortization
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730
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509
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Provision for doubtful accounts
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12
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15
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Stock-based compensation expense
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1,916
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2,193
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Tax benefit for stock option exercises
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16
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Deferred taxes
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213
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Changes in assets and liabilities
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(Increase) decrease in accounts receivable
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(738
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1,169
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Decrease (increase) in inventory
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1,101
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(352
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Increase in other current assets
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(589
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(741
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Decrease (increase) in investment in sales-type leases
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457
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(211
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Decrease in accounts payable
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(371
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(248
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(Decrease) increase in accrued liabilities
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(913
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173
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Decrease in deferred revenue
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(56
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(1,406
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Net cash provided by operating activities
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1,543
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1,618
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Cash flows from investing activities:
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(Increase) decrease in restricted cash
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(3
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40
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Acquisitions of property and equipment
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(684
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(1,283
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Purchases of marketable securities
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(33,683
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(22,598
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Proceeds from sales and maturities of marketable securities
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24,525
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21,550
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Net cash used for investing activities
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(9,845
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(2,291
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Cash flows from financing activities:
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Proceeds from issuance of common stock
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287
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471
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Repayment of capital lease
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(7
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Net cash provided by financing activities
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280
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471
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Net decrease in cash and cash equivalents
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(8,022
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(202
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Cash and cash equivalents, beginning of period
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19,828
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9,724
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Cash and cash equivalents, end of period
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$
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11,806
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$
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9,522
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(tabular amounts in thousands, except percentages and per share amounts)
(unaudited)
(1) Basis of Presentation
The accompanying unaudited condensed 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 Quarterly Report on Form 10-Q and Regulation S-X promulgated pursuant to the
Securities Exchange Act of 1934, as amended. 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 unaudited
condensed consolidated financial statements and notes included herein should be read in
conjunction with the audited consolidated financial statements and accompanying notes thereto for
the year ended December 31, 2007 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.
The Company follows a system of fiscal quarters as opposed to calendar quarters. Therefore,
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.
(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 condensed consolidated financial statements include the accounts of the Company and its
wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated.
Foreign Currency
The functional currency of the Companys international subsidiaries is the U.S. dollar.
Foreign currency transaction gains and losses are recorded in the consolidated statements of
operations and have not been material.
Cash, Cash Equivalents and Marketable Securities
The Company invests its excess cash in money market accounts, certificates of deposit,
high-grade commercial paper, high grade corporate bonds 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, 2008 and December 31,
2007. The investments are reported at fair value, with any unrealized gains or losses excluded
from earnings and reported as a separate component of stockholders equity as accumulated other
comprehensive income in the accompanying condensed consolidated balance sheets. Investments that
have contractual maturity dates of more than twelve months from the balance sheet date are
included in long-term investments in the accompanying condensed consolidated balance sheets.
4
ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(tabular amounts in thousands, except percentages and per share amounts)
(unaudited)
Revenue Recognition
The Company primarily sells its BIS monitors through a combination of a direct sales force
and distributors. The Company sells its BIS Module Kits to original equipment manufacturers who
in turn sell them to the end user. BIS Sensors are sold through a combination of a direct sales
force, distributors and original equipment manufacturers. Direct product sales are structured as
sales, sales-type lease arrangements or sales under the Companys Equipment Placement (EP)
program. Sales, sales-type lease agreements and sales under the EP program are subject to the
Companys standard terms and conditions of sale and do not include any customer acceptance
criteria, installation or other post shipment obligations (other than warranty) or any rights of
return. The Companys BIS monitor is a standard product and does not require installation as it
can be operated with the instructions included in the operators manual.
The Company recognizes revenue when earned in accordance with Staff Accounting Bulletin
(SAB) No. 104,
Revenue Recognition,
and Emerging Issues Task Force (EITF) 00-21,
Revenue
Arrangements with Multiple Deliverables
. Revenue is recognized when persuasive evidence of an
arrangement exists, product delivery has occurred or services have been rendered, the price is
fixed or determinable and collectibility is reasonably assured. For product sales, revenue is
not recognized until title and risk of loss have transferred to the customer. The Companys
revenue arrangements with multiple elements are divided into separate units of accounting if
specified criteria are met, including whether the delivered element has stand-alone value to the
customer and whether there is objective and reliable evidence of the fair value of the
undelivered items. The consideration received is allocated among the separate units based on
their respective fair values, and the applicable revenue recognition criteria are applied to each
of the separate units.
The Company follows SFAS No. 13,
Accounting For Leases
, for its sales-type lease agreements.
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 agreement, is recorded as the net investment in sales-type leases. The Company
recognizes equipment revenue under sales-type lease agreements either at shipment or delivery in
accordance with the agreed upon contract terms with interest income recognized over the life of
the sales-type lease. The cost of the BIS monitor acquired by the customer is recorded as costs
of revenue in the same period.
In addition, the Company reviews and assesses the net realizability of its investment in
sales-type leases at each reporting period. This review includes determining, on a customer
specific basis, if a customer is significantly underperforming relative to the customers
cumulative level of committed BIS Sensor purchases as required by the sales-type lease agreement.
If a customer is underperforming, the Company records an allowance for lease payments as a
charge to revenue to reflect the lower estimate of the net realizable investment in sales-type
lease balance.
As of March 29, 2008, the Company has determined that no sales-type lease agreement, against
which an allowance for lease payments has been established, constitutes an impaired asset.
Under the Companys 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 the Company. Under the EP program, no equipment
revenue is recognized as the equipment remains the Companys property and title does not pass to
the customer, and the criteria for sales-type leases under SFAS No. 13 are not met. The BIS
monitors under the EP program are depreciated over two years and the depreciation is charged to
costs of revenue. BIS Sensor revenue is recognized either at shipment or delivery of the BIS
Sensors in accordance with the agreed upon contract terms.
The Companys obligations under warranty are limited to repair or replacement of any product
that the Company reasonably determines to be covered by the warranty. The Company records an
estimate for its total warranty obligation in accordance with SFAS No. 5,
Accounting for
Contingencies
.
5
ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(tabular amounts in thousands, except percentages and per share amounts)
(unaudited)
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.
Allowance for Doubtful Accounts
The Company makes estimates and judgments in determining its allowance for doubtful accounts
based on the Companys historical collections experience, historical write-offs of its
receivables, current trends, credit policies 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 its credit policies. The Company continually monitors collections and payments
from its customers and adjusts the allowance for doubtful accounts as needed.
Inventory
The Company values inventory at the lower of cost or estimated market value, 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 device 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 would 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 the form of a charge to its costs of
revenue at the time of the determination.
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. Accrued warranty cost, included in accrued liabilities
in the condensed consolidated balance sheet at March 29, 2008 and warranty expense, included in
costs of revenue in the condensed consolidated statements of operations, for the three months
ended March 29, 2008 and March 31, 2007, were as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
March 29,
|
|
|
March 31,
|
|
|
|
2008
|
|
|
2007
|
|
Beginning balance
|
|
$
|
250
|
|
|
$
|
220
|
|
Warranty expense
|
|
|
(11
|
)
|
|
|
4
|
|
Deductions and other
|
|
|
(13
|
)
|
|
|
(9
|
)
|
|
|
|
|
|
|
|
Ending balance
|
|
$
|
226
|
|
|
$
|
215
|
|
|
|
|
|
|
|
|
Shipping and Handling Costs
Shipping and handling costs are included in costs of revenue in the condensed consolidated
statements of operations.
Advertising Costs
Advertising costs are expensed as incurred. These costs are included in sales and marketing
expense in the condensed 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 property and equipment. The costs of improvements
to the Companys leased building are capitalized
6
ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(tabular amounts in thousands, except percentages and per share amounts)
(unaudited)
as leasehold improvements and amortized on the straight-line method over the shorter of the life
of the lease or the useful life of the asset. Repair and maintenance expenditures are charged to
expense as incurred. The Company does not develop software for internal use and the costs of
software acquired for internal use are accounted for in accordance with the American Institute of
Certified Public Accountants Statement of Position 98-1,
Accounting for the Costs of Computer
Software Developed or Obtained for Internal Use
.
During the first quarter of 2008, the Company changed its depreciation period for its
furniture and fixtures and business systems from 3 years to 5 years in order to better reflect
the useful lives of these assets. This change in accounting estimate was applied prospectively
from January 1, 2008 in accordance with SFAS No. 154,
Accounting For Changes and Error
Corrections
. As a result of the change in estimated life of these assets, loss from operations
was $42,000 less and net loss after tax was $9,000 less for the first quarter of 2008. No
material effect on net loss per share, basic and diluted, resulted from this change.
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. See Note 6 for additional
disclosure relating to income taxes and the adoption and application of the Financial Accounting
Standards Board (FASB) Interpretation No. (FIN) 48,
Accounting for Uncertainty in Income
Taxes an Interpretation of FASB Statement No. 109
.
Concentration of Credit Risk
Financial instruments that potentially expose the Company to concentrations of credit risk
primarily consist of cash, cash equivalents, investments, accounts receivable and investment in
sales-type lease receivables. The Company does not require collateral or other security to
support financial instruments subject to credit risk. 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 the reserves established by management. The Company maintains cash, cash equivalents and
investments with various financial institutions. The Company performs periodic evaluations of the
relative credit quality of investments and the Companys 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.
Single or Limited Source Suppliers
The Company currently obtains certain key components of its products from single or limited
sources. The Company purchases components pursuant to purchase orders, and in select cases,
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. The Company may experience similar shortages and delays in the future. The disruption
or termination of the supply of components or a significant increase in the costs of these
components from these sources could have a material adverse effect on the Companys business,
financial position and results of operations and cash flows.
7
ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(tabular amounts in thousands, except percentages and per share amounts)
(unaudited)
Net (Loss) Income Per Share
In accordance with SFAS No. 128,
Earnings Per Share
, basic net (loss) income per share
amounts for the three months ended March 29, 2008 and March 31, 2007, were computed by dividing
net (loss) income by the weighted average number of common shares outstanding during those
periods and diluted net (loss) income per share was computed using the weighted average number of
common shares outstanding and other dilutive securities, including stock options and unvested
restricted stock, during those periods.
For the three months ended March 29, 2008 and March 31, 2007, approximately 4,113,000 and
2,172,000, respectively, of potentially dilutive instruments, consisting of common stock options
and unvested restricted stock, have been excluded from the computation of diluted weighted
average shares outstanding as their effect would be antidilutive.
Comprehensive (Loss) Income
Comprehensive (loss) income 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) income, the only other element of comprehensive (loss) income
impacting the Company is the unrealized gains (losses) on its marketable securities for all
periods presented.
Stock-Based Compensation
The Company has three stock-based employee compensation plans, one stock-based non-employee
director compensation plan and an employee stock purchase plan. Stock options and restricted
common stock generally vest over three to four years and provide, in certain instances, for the
acceleration of vesting upon a change of control of the Company. Options under these plans
terminate ten years from the date of grant. The Companys stock option plans provide for the
grant, at the discretion of the Board of Directors, of options for the purchase of up to
11,410,000 shares of common stock to employees, directors, consultants and advisors.
Effective January 1, 2006, the Company adopted SFAS No. 123R,
Share Based Payment,
using the
modified prospective transition method. Under this transition method, compensation expense
recognized during the three months ended March 29, 2008 and March 31, 2007 included: (a)
compensation expense for all share-based awards granted prior to, but not yet vested, as of
December 31, 2005, based on the grant date fair value estimated in accordance with the original
provisions of SFAS No. 123, and (b) compensation expense for all share-based awards granted
subsequent to December 31, 2005, based on the grant date fair value estimated in accordance with
the provisions of SFAS No. 123R. In accordance with the modified prospective transition method,
the Companys results of operations and financial position for prior periods have not been
restated to reflect the impact of SFAS No. 123R.
Stock Option Activity:
A summary of stock option activity as of March 29, 2008 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
Average
|
|
|
Aggregate
|
|
|
|
Number of
|
|
|
Average
|
|
|
Remaining
|
|
|
Intrinsic
|
|
|
|
Shares
|
|
|
Exercise Price
|
|
|
Contractual Life
|
|
|
Value
|
|
Outstanding at December 31, 2007
|
|
|
4,266
|
|
|
$
|
17.31
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
272
|
|
|
|
11.82
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(62
|
)
|
|
|
4.64
|
|
|
|
|
|
|
|
|
|
Canceled
|
|
|
(23
|
)
|
|
|
16.59
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at March 29, 2008
|
|
|
4,453
|
|
|
$
|
17.16
|
|
|
|
5.88
|
|
|
$
|
882
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested or expected to vest at March 29, 2008
|
|
|
4,394
|
|
|
$
|
17.14
|
|
|
|
5.85
|
|
|
$
|
882
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at March 29, 2008
|
|
|
3,340
|
|
|
$
|
16.54
|
|
|
|
5.02
|
|
|
$
|
882
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash received from stock option exercises under all stock-based compensation plans for the
three months ended March 29, 2008 and March 31, 2007 was approximately $287,000 and $471,000,
respectively. The intrinsic value of options exercised during the three months ended March 29,
2008 and March 31, 2007 was approximately $389,000 and
$681,000, respectively. The estimated fair value of options that vested during the three
months ended March 29, 2008 and March 31, 2007 was approximately $1,425,000 and $1,783,000,
respectively.
8
ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(tabular amounts in thousands, except percentages and per share amounts)
(unaudited)
A summary of unvested restricted stock activity as of March 29, 2008 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average
|
|
|
|
Number of
|
|
|
Grant Date
|
|
|
|
Shares
|
|
|
Fair Value
|
|
Unvested at December 31, 2007
|
|
|
275
|
|
|
$
|
16.90
|
|
Granted
|
|
|
281
|
|
|
|
11.82
|
|
Vested and cancelled
|
|
|
(38
|
)
|
|
|
16.25
|
|
|
|
|
|
|
|
|
Unvested at March 29, 2008
|
|
|
518
|
|
|
$
|
14.19
|
|
|
|
|
|
|
|
|
As of March 29, 2008, total compensation cost related to unvested restricted stock not yet
recognized was $7,357,000, which is expected to be recognized in the statement of operations over
a weighted-average period of 38 months. The fair value of shares that vested for the three
months ended March 29, 2008 was approximately $517,000.
Grant-date fair value
:
The Company uses the Black-Scholes option pricing model to calculate the grant-date fair
value of an award. During the three months ended March 29, 2008 and March 31, 2007, the Company
calculated the grant-date fair value using the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
March 29,
|
|
March 31,
|
|
|
2008
|
|
2007
|
|
|
|
|
|
|
|
|
|
Options granted
|
|
|
272
|
|
|
|
393
|
|
Weighted average exercise price
|
|
$
|
11.82
|
|
|
$
|
16.15
|
|
Weighted average grant date fair value
|
|
$
|
5.54
|
|
|
$
|
7.62
|
|
|
|
|
|
|
|
|
|
|
Assumptions:
|
|
|
|
|
|
|
|
|
Risk-free interest rate
|
|
|
2.96
|
%
|
|
|
4.53
|
%
|
Expected term
|
|
5.76 years
|
|
5.20 years
|
Expected volatility
|
|
|
46
|
%
|
|
|
46
|
%
|
Expected dividend yield
|
|
|
|
|
|
|
|
|
Risk-free interest rate: the implied yield currently available on U.S. Treasury zero-coupon
issues with a remaining term equal to the expected term used as the assumption in the model.
Expected term: the expected term of an employee option is the period of time for which the
option is expected to be outstanding. The Company uses a Monte Carlo simulation model to estimate
the expected term assumption in connection with determining the grant date valuation as it believes
that this information is currently the best estimate of the expected term of a new option.
Expected volatility: in estimating its expected volatility, the Company considers both trends
in historical volatility and the implied volatility of its publicly traded options. The Company
has used a combination of its implied volatility and historical volatility to estimate expected
volatility for the three months ended March 29, 2008. The Company believes that in addition to the
relevance of historical volatility, consideration of implied volatility achieves the objectives of
SFAS No. 123R since it represents the expected volatility that marketplace participants would
likely use in determining an exchange price for an option, and is therefore an appropriate
assumption to use in the calculation of grant date fair value.
Expected dividend yield: this assumption is not applicable in the Companys calculation as the
Company has not declared, nor does it expect to declare in the foreseeable future, any dividends.
9
ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(tabular amounts in thousands, except percentages and per share amounts)
(unaudited)
Expense
:
The Company uses the straight-line attribution method to recognize expense for all options and
restricted stock granted prior to the adoption of SFAS No. 123R and for all options and restricted
stock granted after January 1, 2006, the adoption date of SFAS No. 123R. The amount of stock-based
compensation expense recognized during a period is based on the value of the portion of the awards
that is ultimately expected to vest. Stock-based compensation expense is recorded on a
straight-line basis over the requisite service period, which is generally the vesting period. SFAS
No. 123R requires forfeitures to be estimated at the time of grant and revised, if necessary, in
subsequent periods if actual forfeitures differ from those estimates. The term forfeitures is
distinct from cancellations or expirations and represents only the unvested portion of the
surrendered option. For the three months ended March 29, 2008, the Company applied a forfeiture
rate of approximately 5.3%. The Company re-evaluates its forfeiture rate on a quarterly basis and
adjusts the rate as necessary. Prior to the adoption of SFAS No. 123R, the Company recorded
forfeitures on an actual basis as they occurred. The Companys results for the three months ended
March 29, 2008 and March 31, 2007 include stock-based compensation expense of approximately
$1,942,000 and $2,217,000, respectively, of which approximately $26,000 and $24,000, respectively,
relates to tax on deferred compensation which is included in the condensed consolidated statement
of operations within the applicable operating expense where the Company reports the option holders
and restricted stock holders compensation cost.
As of March 29, 2008, total compensation cost related to unvested stock options not yet
recognized was $9,130,000, which is expected to be recognized in the statement of operations over a
weighted-average period of approximately 26 months.
For the three months ended March 29, 2008, the Company recorded stock-based compensation
expense for non-employees of approximately $6,000 resulting from the grant of 500 shares of
restricted stock to a consultant.
For the three months ended March 31, 2007, the Company recorded stock-based compensation
expense for non-employees of approximately $6,000 resulting from the grant of stock options to
purchase 800 shares of common stock to a consultant.
Use of Estimates
The preparation of financial statements in conformity with generally accepted accounting
principles 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, investments, accounts receivable, investment in sales-type leases, accounts payable
and long-term debt, approximate their carrying values.
Reclassifications
Certain amounts in the prior years financial statements have been reclassified to conform
with the current year presentation.
Recent Accounting Pronouncements
In September 2006, the FASB issued SFAS No. 157,
Fair Value Measurements
. SFAS No. 157
defines fair value, establishes a framework for measuring fair value under United States generally
accepted accounting principles, or GAAP, and expands disclosures about fair value measurements in
interim and annual periods subsequent to initial recognition. SFAS No. 157 applies under other
accounting pronouncements that require or permit fair value measurements. SFAS No. 157 is
effective for financial statements issued for fiscal years beginning after November 15, 2007, and
interim periods within those
years. The adoption of SFAS No. 157 did not have a material impact on the Companys financial
statements or condition. See Note 7 for additional disclosure relating to the adoption of SFAS No.
157.
10
ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(tabular amounts in thousands, except percentages and per share amounts)
(unaudited)
In June 2007, the FASB ratified EITF Issue No. 07-3,
Accounting for Nonrefundable Advance
Payments for Goods or Services Received for Use in Future Research and Development Activities
. The
scope of EITF Issue No. 07-3 is limited to nonrefundable advance payments for goods and services to
be used or rendered in future research and development activities pursuant to an executory
contractual arrangement. EITF Issue No. 07-3 is effective for financial statements issued for
fiscal years beginning after December 15, 2007 and interim periods within those fiscal years. An
entity may not apply it before that date. The adoption of EITF No. 07-3 did not have a material
impact on its results of operations, financial position or cash flow.
In December 2007, the FASB issued SFAS No. 141 (revised 2007),
Business Combinations
. The
objective of SFAS No. 141R is to improve the representational faithfulness and comparability of the
information that a reporting entity provides in its financial reports about a business combination
and its effects. SFAS No. 141R applies prospectively to business combinations for which the
acquisition date is on or after December 15, 2008. An entity may not apply it before that date.
The Company does not believe that the adoption of SFAS No. 141R will have an immediate impact on
its results of operations, financial position or cash flow; however, the adoption of SFAS No. 141R
on January 1, 2009 could materially change the accounting for business combinations subsequent to
that date.
In December 2007, the FASB issued SFAS No. 160,
Noncontrolling Interest in Consolidated
Financial Statements an amendment of ARB No. 51
. The objective of SFAS No. 160 is to improve the
relevance, comparability and transparency of the financial information that a reporting entity
provides in its consolidated financial statements. This statement is effective for fiscal years
and interim periods within those fiscal years, beginning on or after December 15, 2008. An entity
may not apply it before that date. The Company does not believe that the adoption of SFAS No. 160
will have a material impact on its results of operations, financial position or cash flow.
In March 2008, the FASB issued SFAS No. 161,
Disclosures about Derivative Instruments and
Hedging Activities, an Amendment of FASB Statement No. 133.
The objective of this statement is to
require enhanced disclosures about an entitys derivative and hedging activities to improve the
transparency of financial reporting. This statement is effective for financial statements issued
for fiscal years and interim periods beginning after November 15, 2008 with early application
encouraged. The Company does not believe that the adoption of SFAS No. 161 will have a material
impact on its results of operations, financial position or cash flow.
(3) Comprehensive (Loss) Income
The Companys total comprehensive (loss) income is as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
March 29,
|
|
|
March 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
$
|
(235
|
)
|
|
$
|
517
|
|
|
Other comprehensive income:
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on
marketable securities
|
|
|
224
|
|
|
|
(4
|
)
|
|
|
|
|
|
|
|
Comprehensive (loss) income
|
|
$
|
(11
|
)
|
|
$
|
513
|
|
|
|
|
|
|
|
|
11
ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(tabular amounts in thousands, except percentages and per share amounts)
(unaudited)
(4) Investment in Sales-Type Leases
The components of the Companys net investment in sales-type leases are as follows:
|
|
|
|
|
|
|
|
|
|
|
March 29,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
Total minimum lease payments receivable
|
|
$
|
5,119
|
|
|
$
|
5,655
|
|
Less:
|
|
|
|
|
|
|
|
|
Unearned interest income
|
|
|
744
|
|
|
|
849
|
|
Allowance for lease payments
|
|
|
741
|
|
|
|
715
|
|
|
|
|
|
|
|
|
Net investment in sales-type leases
|
|
|
3,634
|
|
|
|
4,091
|
|
Less current portion
|
|
|
1,369
|
|
|
|
1,473
|
|
|
|
|
|
|
|
|
|
|
$
|
2,265
|
|
|
$
|
2,618
|
|
|
|
|
|
|
|
|
(5) Inventory
Inventory consists of the following:
|
|
|
|
|
|
|
|
|
|
|
March 29,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
Raw materials
|
|
$
|
3,108
|
|
|
$
|
4,027
|
|
Work-in-progress
|
|
|
|
|
|
|
52
|
|
Finished goods
|
|
|
2,904
|
|
|
|
3,034
|
|
|
|
|
|
|
|
|
|
|
$
|
6,012
|
|
|
$
|
7,113
|
|
|
|
|
|
|
|
|
(6) Income Taxes
The Company is subject to income tax in numerous jurisdictions and at various rates
worldwide and the use of estimates is required in determining the provision for income taxes.
For the three-month period ended March 29, 2008, the Company recorded a tax provision of $424,000
on income before tax of $189,000 resulting in an effective income tax rate of 224%. For the
three months ended March 29, 2008, the difference between the effective tax rate of 224% and the
U.S. federal statutory income tax rate of 34% was due mainly to the impact of state income taxes
and the disallowance for tax purposes of certain stock-based compensation deductions in
accordance with SFAS No. 123R. In addition, there was an increase in the valuation allowance on
a portion of the Companys federal research and development, or R&D, credits. For the
three-month period ended March 31, 2007, the Company recorded a tax provision of $576,000 on
income before tax of $1,093,000 resulting in an effective income tax rate of 53%.
Through the third quarter of 2006, the Company maintained a full valuation allowance on its
deferred tax assets. Upon achieving three years of cumulative profitability, the Company began to
weigh the positive and negative evidence included in SFAS No. 109
Accounting For Income Taxes
,
on a quarterly basis to determine, whether, in its view, it was more likely than not that some
or all of its deferred tax assets would be realized. In connection with this analysis, the
Company reviewed its cumulative history of earnings before taxes over a three-year period and its
projections of future taxable income. As of December 31, 2006, after finalizing the 2007
forecast, the Company concluded that these projections support taxable income for the foreseeable
future, and therefore, the Company reversed $28.2 million of its valuation allowance. The
projections of future taxable income include significant judgment and estimation. If the Company
is not able to achieve sufficient taxable income in future periods, it might need to record
additional valuation allowances on its deferred tax assets in future periods that could be
material to the Companys consolidated financial
statements. As stated above, in the first quarter of 2008 the Company re-established a
valuation allowance for a portion of its federal R&D credits since these credits are expected to
expire unused based on current projections.
The Company adopted the provisions of FIN 48 on January 1, 2007. As of January 1, 2008, the
Company had gross unrecognized tax benefits of $661,500 (net of the federal benefit on state
issues) which represents the amount of
12
ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(tabular amounts in thousands, except percentages and per share amounts)
(unaudited)
unrecognized tax benefits that, if recognized, would favorably affect the effective income tax rate
in any future periods. Also as of the adoption date, the Company had not accrued interest expense
related to these unrecognized tax benefits. When appropriate, the Company will recognize interest
accrued and penalties incurred, related to unrecognized tax benefits as a component of income tax
expense. There were no significant changes to any of these amounts during the first quarter of
2008. The Company does not reasonably estimate that the unrecognized tax benefit will change
significantly within the next twelve months.
The Company or one of its subsidiaries files income tax returns in the U.S. federal
jurisdiction and various states and foreign jurisdictions. The Company is generally no longer
subject to income tax examinations by U.S. federal, state and local or non-U.S. income tax
examinations by tax authorities for years before 1992.
(7) Fair Value Measurements
The Company adopted SFAS No. 157,
Fair Value Measurements
on January 1, 2008. SFAS No. 157
defines and establishes a framework for measuring fair value and expands disclosure about fair
value measurements. The standard creates a fair value hierarchy which prioritizes the inputs to
valuation techniques used to measure fair value into three broad levels as follows: Level 1
inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities;
Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable
for the asset or liability, either directly or indirectly; and Level 3 inputs are unobservable
inputs that reflect the Companys own assumptions about the assumptions market participants would
use in pricing the asset or liability.
Financial assets and liabilities are classified in their entirety based on the lowest level
of input that is significant to the fair value measurement. In accordance with SFAS No. 157, the
Company has classified its financial assets and liabilities that are required to be measured at
fair value as of March 29, 2008 as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
|
|
|
|
|
March 29,
|
|
Fair Value Measurements at March 29, 2008
|
|
|
2008
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
Cash, cash
equivalents and
restricted cash
|
|
$
|
12,813
|
|
|
$
|
12,315
|
|
|
$
|
498
|
|
|
$
|
|
|
Available for sale
securities
|
|
$
|
98,034
|
|
|
$
|
|
|
|
$
|
98,034
|
|
|
$
|
|
|
(8) 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 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 region and as a percentage of total revenue by geographic region is as
follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
March 29,
|
|
|
March 31,
|
|
|
|
2008
|
|
|
2007
|
|
Geographic area by region
|
|
|
|
|
|
|
|
|
Domestic
|
|
$
|
17,063
|
|
|
$
|
18,374
|
|
International
|
|
|
7,365
|
|
|
|
5,745
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
24,428
|
|
|
$
|
24,119
|
|
|
|
|
|
|
|
|
13
ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(tabular amounts in thousands, except percentages and per share amounts)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
March 29,
|
|
March 31,
|
|
|
2008
|
|
2007
|
|
|
|
|
|
|
|
|
|
Geographic area by region
|
|
|
|
|
|
|
|
|
Domestic
|
|
|
70
|
%
|
|
|
76
|
%
|
International
|
|
|
30
|
|
|
|
24
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
100
|
%
|
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
The Company did not have sales in any individual country, other than the United States, or
to any individual customer, that accounted for more than 10% of the Companys total revenue or
accounts receivable for the three months ended March 29, 2008 and March 31, 2007.
(9) Commitments and Contingencies
Leases
In February 2006, the Company entered into a lease agreement pursuant to which the Company
agreed to lease approximately 136,503 square feet of research and development, sales and
marketing, production and general and administrative space in Norwood, Massachusetts. The lease
expires in December 2016, and the Company has been granted the option to extend the term for
three additional five-year periods. In connection with this lease, the Company provided a
security deposit in the amount of $911,000 to the lessor in accordance with the terms of the
lease agreement. This lease is classified as an operating lease. The lease contains a rent
escalation clause that requires additional rental amounts in the later years of the term. Rent
expense is being recognized on a straight-line basis over the minimum lease term.
Effective January 1, 2007, the Company entered into an operating lease for the Companys
international organization for approximately 9,280 square feet of office space in De Meern, The
Netherlands. This lease expires in December 2011.
In July 2007, the Company entered into an equipment lease with a term of 48 months. The
lease contains a bargain purchase option and is classified as a capital lease. As of March 29,
2008, gross assets under capital lease totaled approximately $127,000 and related accumulated
depreciation was approximately $17,000.
Legal Proceedings
On October 10, 2007, a purported holder of the Companys common stock (the plaintiff), filed
suit in the U.S. District Court for the Western District of Washington against Morgan Stanley and
Deutsche Bank AG, the lead underwriters of the Companys 2000 initial public offering, alleging
violations of Section 16(b) of the Securities Exchange Act of 1934 (the Exchange Act). The
complaint alleges that the combined number of shares of the Companys common stock beneficially
owned by the lead underwriters and certain of the Companys unnamed officers, directors and
principal stockholders exceeded ten percent of the Companys outstanding common stock from the
date of its initial public offering on January 28, 2000, through at least January 27, 2001. The
complaint further alleges that those entities and individuals were subject to the reporting
requirements of Section 16(a) of the Exchange Act and the short-swing trading prohibition of
Section 16(b) of the Exchange Act, and failed to comply with those provisions. The
complaint seeks to recover from the lead underwriters any short-swing profits obtained by
them in violation of Section 16(b) of the Exchange Act. The Company was named as a nominal
defendant in the action, but has no liability for the asserted claims. None of its directors or
officers serving in such capacities at the time of its initial public offering (many of whom
still serve as officers or directors of the Company) are currently named as defendants in this
action, but there can be no guarantee that the complaint will not be amended, or a new complaint
or suit filed, naming such directors or officers as defendants in this action or another action
alleging a violation of the same provisions of the Exchange Act. On February 25, 2008, the
plaintiff filed an amended complaint asserting substantially similar claims as those set forth in
the initial complaint. At the initial status conference on April 28,
2008, the Judge established a time line for submitting motions to
dismiss, and responses in opposition and replies in support of such
motions, and also stayed discovery pursuant to the Private Securities Litigation Reform Act
(PSLRA) until the Judge rules on all motions to dismiss. If the
motions to dismiss are denied, the Judge will then set a status
hearing to discuss the scope of discovery. The Company anticipates filing a motion to dismiss pursuant to the Courts
briefing schedule. The Company currently believes that the
outcome of this litigation will not have a material adverse impact on its consolidated financial
position and results of operations.
14
ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(tabular amounts in thousands, except percentages and per share amounts)
(unaudited)
The underwriters of the Companys 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 the Companys common stock between January 28, 2000 and December 6, 2000.
These complaints allege violations of the Securities Act and the Exchange Act. Primarily, the
complaints allege that there was undisclosed compensation received by our underwriters in
connection with the Companys initial public offering. While the Company and its 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 the Company and its officers and directors
will not be named in similar complaints in the future.
(10) Loan Agreements
In May 2007, the Company renewed its revolving line of credit agreement with a commercial
bank. The Company is entitled to borrow up to $5,000,000 under the revolving line of credit,
which expires in May 2008 and is currently being renegotiated. The line of credit may be
extended on an annual basis 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 the London Inter-Bank Offer Rate, or 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, 2008, the
Company had outstanding standby letters of credit with the commercial bank of approximately
$987,000. At March 29, 2008, there was no outstanding balance under this revolving line of
credit.
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 condensed consolidated balance
sheets. The Company is required to maintain restricted cash in an amount equal to 102% of the
outstanding amounts under the revolving line of credit agreement. At March 29, 2008, the Company
had $1,007,000 classified as restricted cash on the condensed consolidated balance sheet relating
to standby letters of credit issued in connection with the Companys leased building in Norwood,
Massachusetts and an international service provider. At March 29, 2008, the Company was in
compliance with all covenants contained in the revolving line of credit agreement.
(11) Termination and Repurchase Agreement with Boston Scientific Corporation
On June 11, 2007, the Company entered into a Termination and Repurchase Agreement with
Boston Scientific Corporation. Under the terms of the agreement, the Company and Boston
Scientific Corporation agreed to terminate the following agreements:
|
|
the OEM Product Development Agreement dated as of August 7, 2002 (as amended January
31, 2005 and February 5, 2007, the 2002 Agreement), pursuant to which the Company was to
develop certain products that Boston Scientific Corporation would then commercialize in
the area of monitoring patients under sedation in a range of less invasive medical
specialties, and pursuant to which the Company granted Boston Scientific Corporation an
exclusive option to become the distributor for a period of time of certain products;
|
|
|
the Product Development and Distribution Agreement dated as of May 23, 2005 (the 2005
Agreement), pursuant to which the Company was to develop new applications of its
brain-monitoring technology in the area of the diagnosis and treatment of neurological,
psychiatric and pain disorders and Boston Scientific was appointed the exclusive
distributor of such products; and
|
|
|
the Letter Agreement dated August 7, 2002, and Security Agreement dated August 7, 2002,
pursuant to which Boston Scientific Corporation agreed to make revolving interest-bearing
loans to Aspect from time to time at the request of Aspect, such revolving loans being
evidenced by a promissory note in the original principal amount of $5,000,000 dated August
7, 2002.
|
In addition to the termination of the agreements referenced above, on June 13, 2007, the
Company repurchased 2,000,000 shares of its common stock held by Boston Scientific Corporation at
a price of approximately $15.91 per share, for an aggregate repurchase price of $31,816,000. The
per share price represents the average of the closing prices of the Companys common stock as
reported on the NASDAQ Global Market for the 20 consecutive trading days up to and including the
date of the Termination and Repurchase Agreement. These shares have been cancelled and retired.
In
15
ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(tabular amounts in thousands, except percentages and per share amounts)
(unaudited)
accordance with the agreement, for a period of 180 days following the date of the agreement, the
Company had the right to purchase any or all of the balance of its shares of common stock held by
Boston Scientific Corporation at a price of $15.00 per share or the average of the closing prices
for the Companys common stock over the 10 trading days prior to the Companys exercising its right
to repurchase, whichever is higher. Additionally, Boston Scientific Corporation had agreed that
for a period of 180 days after the effective date of the agreement that it would not sell, contract
to sell, grant any option to purchase or dispose of any of the shares of the Companys common stock
held of record by Boston Scientific Corporation on the effective date. On July 10, 2007, the
Company exercised its right under the Termination and Repurchase Agreement and repurchased an
additional 2,500,000 shares of common stock from Boston Scientific Corporation for $37,655,000.
The repurchased shares were cancelled and retired. On November 7, 2007, the Company agreed to
waive the lock-up and the call option set forth in the Termination and Repurchase Agreement with
respect to the remaining 1,513,239 shares of the Companys common stock held by Boston Scientific
Corporation because Boston Scientific Corporation and a third party reached an agreement pursuant
to which that third party agreed to purchase all of such shares.
Additionally, in connection with the termination of the 2002 Agreement and the 2005
Agreement, the Company recognized approximately $3,550,000 of strategic alliance revenue in June
2007. Approximately $3,835,000 had been recorded previously as deferred revenue relating to the
2002 Agreement, which represented the unamortized portion of the purchase price of $7.00 per
share in excess of the closing price of the Companys common stock on August 7, 2002 of $2.59 per
share. The $3,835,000 of deferred revenue was offset by approximately $285,000 for a receivable
from Boston Scientific Corporation which had been recognized by the Company during the quarter
ended March 31, 2007 relating to the 2005 Agreement with Boston Scientific Corporation. Upon the
termination of the 2005 Agreement, the Company reversed the receivable against strategic alliance
revenue where it was originally recorded in the statement of operations.
(12) Convertible Debt
In June 2007, the Company completed a private placement of $125,000,000 aggregate principal
amount of 2.5% convertible notes due 2014 (the notes). The notes are senior unsecured
obligations and will rank equally with all of the Companys existing and future senior debt and
to all of the Companys subordinated debt. Interest on the notes is payable semiannually in cash
on June 15th and December 15th of each year with the first payment being made on December 15,
2007. The notes will mature on June 15, 2014. Net proceeds received from the issuance of the
notes were approximately $121,000,000, which is net of the underwriters discount of
approximately $4,000,000. In connection with the notes offering, the Company incurred total
offering costs of approximately $4,559,000 which have been recorded as deferred financing fees in
the consolidated balance sheet and are being amortized on a straight-line basis over the term of
the notes. During the three months ended March 29, 2008, approximately $163,000 of the offering
costs have been amortized to interest expense.
Holders may convert notes at their option on any day prior to the close of business on the
scheduled trading day immediately preceding March 15, 2014 only under the following
circumstances:
|
|
|
during the five business day period after any five consecutive trading day period
(the measurement period) in which the price per note for each trading day of that
measurement period was less than 97% of the product of the last reported sale price of
the Companys common stock and the conversion rate on each such day;
|
|
|
|
|
during any calendar quarter (and only during such quarter) after the calendar
quarter ending September 30, 2007, if the last reported sale price of the Companys
common stock for 20 or more trading days in a period of 30 consecutive trading days
ending on the last trading day of the immediately preceding calendar quarter
exceeds 120% of the applicable conversion price in effect on the last trading day of the
immediately preceding calendar quarter; or
|
|
|
|
|
upon the occurrence of specified corporate events.
|
The notes will be convertible, regardless of the foregoing circumstances, at any time from,
and including, March 15, 2014 through the scheduled trading day immediately preceding the
maturity date of the notes.
The initial conversion rate for the notes is 52.4294 shares of common stock per $1,000 in
principal amount of notes, which is equivalent to an initial conversion price of approximately
$19.07 per share of common stock. The conversion rate will be subject to adjustment in some
events but will not be adjusted for accrued interest. In addition, if a make-
16
ASPECT MEDICAL SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(tabular amounts in thousands, except percentages and per share amounts)
(unaudited)
whole fundamental change (as defined in the indenture dated as of June 20, 2007 between the
Company and U.S. Bank National Association, (the Indenture)) occurs prior to the maturity date
of the notes, the Company will in some cases increase the conversion rate for a holder that
elects to convert its notes in connection with such make-whole fundamental change. No
adjustment to the conversion rate will be made if the Companys stock price is less than $15.57
per share or if the stock price exceeds $50.00 (in each case subject to adjustment).
Unless the Company obtains stockholder authorization to utilize the net share settlement
feature of the notes and the Company irrevocably elects such settlement method at any time on or
prior to the 45th scheduled trading day preceding the maturity date of the notes, upon conversion
the Company will deliver a number of shares of its common stock equal to the conversion rate on
the related conversion date for each $1,000 principal amount of notes. The Company will deliver
cash in lieu of any fractional shares of its common stock based on the last reported sale price
of its common stock on the related conversion date (or, if the conversion date is not a trading
day, on the next succeeding trading day). If the Company obtains stockholder approval of the net
share settlement feature in connection with the potential conversion of the notes, then upon
conversion of the notes the Company would (1) pay cash in an amount equal to the lesser of
one-fortieth of the principal amount of the notes being converted and the daily conversion value
(the product of the conversion rate and the current trading price) of the notes being converted
and (2) issue shares of its common stock only to the extent that the daily conversion value of
the notes exceeded one-fortieth of the principal amount of the notes being converted for each
trading day of the relevant 40 trading day observation period.
The Company will not make any sinking fund payments in connection with the notes and the
notes may not be redeemed by the Company prior to maturity date.
In connection with the offering of the notes, the Company repurchased an additional
1,000,000 shares of its common stock for $15,570,000 in privately negotiated transactions. These shares have been cancelled and retired.
(13) Stock Repurchase Program
On August 3, 2006, the Companys Board of Directors authorized the repurchase of up to
2,000,000 shares of the Companys common stock through the open market or in privately negotiated
transactions. The repurchase program may be suspended or discontinued at any time. There were no
repurchases under this plan in 2007 or the first quarter of 2008. As of March 29, 2008, the
Company has repurchased a total of 276,493 shares of common stock under this repurchase program
for $5,008,000. Repurchased shares are held in treasury pending use for general corporate
purposes, including issuances under various employee stock plans. As of March 29, 2008, the
Company is authorized to repurchase an additional 1,723,507 shares of common stock in the future.
17
Item 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
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 assess
and manage a patients level of consciousness in the operating room, intensive care and procedural
sedation settings and is intended to assist the clinician in better determining the amount of
anesthesia or sedation needed by each patient. Our proprietary BIS system includes our BIS
monitor, BIS Module Kit or BISx system, which allows original equipment manufacturers to
incorporate the BIS index into their monitoring products, and our group of sensor products, which
we collectively refer to as BIS Sensors.
The following chart summarizes our principal product offerings:
|
|
|
|
|
|
|
|
|
Initial
|
|
|
|
|
Commercial
|
|
|
Product
|
|
Shipment
|
|
Description
|
|
|
|
|
|
|
|
EQUIPMENT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BIS VIEW
|
|
|
2007
|
|
|
Basic-featured standalone monitor which has fewer optional user
configurations compared with the BIS VISTA monitor.
|
|
|
|
|
|
|
|
BIS VISTA
|
|
|
2006
|
|
|
Monitor that offers an enhanced display and user interface as well as
greater processing capability compared to our other monitors.
|
|
|
|
|
|
|
|
BISx system
|
|
|
2004
|
|
|
BIS monitoring solution that provides the processing technology required
to obtain BIS information from a single device the approximate size of a
hockey puck. The BISx system is designed to integrate with a wide range
of patient monitoring platforms sold by original equipment
manufacturers.
|
|
|
|
|
|
|
|
BIS XP System
|
|
|
2001
|
|
|
BIS system offering enhanced performance capabilities and expanded
benefits as compared to the previous version of the BIS system, designed
to enable more precise measurement of brain activity to assess the level
of consciousness.
|
|
|
|
|
|
|
|
BIS Module Kit
4 Channel
Support
|
|
|
2001
|
|
|
Same as standard BIS Module Kit plus 4 channel EEG monitoring capability.
|
|
|
|
|
|
|
|
A-2000 BIS Monitor
|
|
|
1998
|
|
|
Compact, lightweight, portable third-generation BIS monitor.
|
|
|
|
|
|
|
|
BIS Module Kit
|
|
|
1998
|
|
|
Components of BIS monitoring technology that are integrated into
equipment sold by original equipment manufacturers.
|
|
|
|
|
|
|
|
SENSORS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Semi-Reusable
(SRS) Sensor
|
|
|
2005
|
|
|
Semi-reusable version of a BIS Sensor that uses the same algorithm and
hardware as our disposable sensors. Currently available only in markets
outside the United States, excluding Japan.
|
|
|
|
|
|
|
|
BIS Extend Sensor
|
|
|
2002
|
|
|
Disposable sensor with electronic memory device for use with our BIS
Monitors, BIS Module Kit and BISx System that was designed for patients
who are typically monitored for extended periods.
|
18
|
|
|
|
|
|
|
|
|
Initial
|
|
|
|
|
Commercial
|
|
|
Product
|
|
Shipment
|
|
Description
|
|
|
|
|
|
|
|
BIS Pediatric
Sensor
|
|
|
2001
|
|
|
Disposable sensor with electronic memory device for use with our
BIS Monitors, BIS Module Kit and BISx System that is smaller and
easier to apply to children.
|
|
|
|
|
|
|
|
BIS Quatro Sensor
|
|
|
2001
|
|
|
Disposable sensor with electronic memory device for use with our
BIS Monitors, BIS Module Kit and BISx System that is designed to
offer enhanced performance in deep anesthetic states and enhanced
resistance to interference from noise sources.
|
|
|
|
|
|
|
|
BIS Sensor Plus
|
|
|
2001
|
|
|
Second-generation disposable sensor for use with our BIS Monitors
and BIS Module Kit.
|
|
|
|
|
|
|
|
BIS Standard
Sensor
|
|
|
1997
|
|
|
Disposable sensor for use with our BIS Monitors and BIS Module Kit.
|
We derive our revenue primarily from sales of BIS monitors, our original equipment
manufacturer products (including BIS Module Kits and the BISx system) and related accessories,
which we collectively refer to as Equipment, and sales of BIS Sensors. We have also historically
derived a portion of our revenue from our strategic alliances, primarily our alliance with Boston
Scientific Corporation, which we terminated in June 2007. To assist management in assessing and
managing our business, we segregate our revenue by sales by region, sales by products and revenue
derived from our strategic alliance, as shown in the following table:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
March 29,
|
|
March 31,
|
|
|
2008
|
|
2007
|
Domestic revenue
|
|
$
|
17,063
|
|
|
$
|
18,374
|
|
Percentage of total revenue
|
|
|
70
|
%
|
|
|
76
|
%
|
|
|
|
|
|
|
|
|
|
International revenue
|
|
$
|
7,365
|
|
|
$
|
5,745
|
|
Percentage of total revenue
|
|
|
30
|
%
|
|
|
24
|
%
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
$
|
24,428
|
|
|
$
|
24,119
|
|
|
|
|
|
|
|
|
|
|
BIS Sensor revenue
|
|
$
|
20,636
|
|
|
$
|
17,554
|
|
Percentage of total revenue
|
|
|
84
|
%
|
|
|
73
|
%
|
|
|
|
|
|
|
|
|
|
Equipment revenue
|
|
$
|
3,792
|
|
|
$
|
4,881
|
|
Percentage of total revenue
|
|
|
16
|
%
|
|
|
20
|
%
|
|
|
|
|
|
|
|
|
|
Strategic alliance revenue
|
|
$
|
|
|
|
$
|
1,684
|
|
Percentage of total revenue
|
|
|
|
|
|
|
7
|
%
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
$
|
24,428
|
|
|
$
|
24,119
|
|
At March 29, 2008, we had cash, cash equivalents, restricted cash and investments of
approximately $110.8 million and working capital of approximately $113.7 million.
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 believe our ability to grow our revenue is directly related to our ability to influence our
customers after they purchase our Equipment to continue to purchase and use our BIS Sensors. We
believe the primary reason for the growth in product revenue is a
direct result of continuing to shift the focus of our sales and marketing emphasis from
expanding our customer base to developing our existing customers and increasing their sensor
utilization and procedure penetration. Seeking to continue to achieve this growth, we plan to
expand our sales force and to implement new sales and marketing programs, particularly in the area
of clinical education programs. We expect that as we grow our business, revenue from the sale of
BIS Sensors will contribute an increasing
percentage of product revenue. Additionally, we believe that, over time, revenue from the
sale of BIS Module Kits and our BISx system will increase as a percentage of total Equipment
revenue as healthcare organizations purchase our technology as part of an integrated solution
offered by our original equipment manufacturers.
19
In order to sustain profitability, we believe that we need to continue to maintain our gross
margin and control the growth of our operating expenses. To maintain our gross profit margin we
believe we must continue to focus on maintaining our average unit sales prices of our BIS Sensors,
increasing revenue from the sale of BIS Sensors as a percentage of total revenue, as BIS Sensors
have a higher gross margin than Equipment, and continuing to reduce the costs of manufacturing our
products.
For those healthcare organizations desiring to acquire our BIS monitors directly from us, we
offer two primary 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
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. We also grant these customers
an option to purchase the BIS monitors at the end of the term of the agreement, which is typically
three to five years. We recognize Equipment revenue under sales-type lease agreements either at
shipment or delivery in accordance with the agreed upon contract terms with interest income
recognized over the life of the sales-type lease. The cost of the BIS monitor acquired by the
customer is recorded as costs of revenue in the same period.
Under certain limited 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.
We have subsidiaries in The Netherlands, United Kingdom, Germany and France 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.
We are party to a distribution agreement with Nihon Kohden Corporation to distribute BIS
monitors in Japan. Nihon Kohden has received approval from the Japanese Ministry of Health, Labor
and Welfare for marketing in Japan our A-1050 EEG Monitor with BIS, our A-2000 BIS Monitor, our BIS
module (our product that integrates BIS monitoring technology into equipment sold by original
equipment manufacturers), our BIS XP system and, most recently in December 2007, our BISx and the
BIS VISTA monitor. 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.
Sales to Nihon Kohden represented approximately 15% and 14%, respectively, of our international
revenue in the three months ended March 29, 2008 and March 31, 2007.
During the first quarter of 2006, we adopted the Financial Accounting Standards Boards, or
FASB, Statement of Financial Accounting Standard 123 (revised 2004),
Share-Based Payment
, or SFAS
No. 123R, using the modified prospective transition method. Prior to the adoption of SFAS No. 123R,
we accounted for share-based payments to employees using the intrinsic value method under
Accounting Principles Bulletin, or APB, Opinion No. 25,
Accounting for Stock Issued to Employees
,
and, as such, generally recognized no compensation expense for employee stock options. For the
three months ended March 29, 2008 and March 31, 2007, we recognized approximately $1.9 million and
$2.2 million, respectively, of stock-based compensation expense in our condensed consolidated
statements of operations. See Note 2 of the Notes to our Condensed Consolidated Financial
Statements contained in Item 1 of this Quarterly Report on Form 10-Q for further information
regarding our adoption of SFAS No. 123R.
Various factors may adversely affect our quarterly operating results through the second
quarter of 2008 and beyond. For example, a third party study recently published in the
New England
Journal of Medicine
compared BIS monitoring with a protocol based
on targeted end-tidal gas anesthetic levels in a
patient population considered to be at high risk of awareness and concluded that, based upon a
similar occurrence of awareness in both groups, no benefit of BIS
monitoring versus this alternative approach was demonstrated. The study results were consistent with
earlier studies that showed a low incidence of awareness using BIS.
However, we believe some of the conclusions drawn by the authors were not supported by
their data and that there were several flaws in the design and
execution of the trial. In the weeks since the
publication of the
New England Journal of Medicine
article,
sensor sales growth has been within the range that existed prior to the
publication. Nonetheless, it is possible that the
publication of this study may have an adverse effect on the rate at which existing or potential new
customers purchase and use our products and we cannot provide any
assurance that sensor sales growth will continue after the date of
this quarterly report on
Form 10-Q within the range of sensor
growth that existed before the
New England Journal of Medicine
publication. Additionally, we are currently finalizing
plans to expand our sales force and expect that such expansion would increase our operating
expenses in future periods. We also are continuing to shift the focus of our sales
and marketing efforts from expanding our customer base to developing
our existing customers and increasing their sensor utilization and procedure penetration. As
a result of this shift in focus, we expect our revenue from the sale
of equipment to decrease. Finally,
we may not realize expected benefits of favorable industry pronouncements on anesthesia awareness,
including the position statements issued by the Joint Commission on Accreditation of Healthcare
Organizations, the American Society of Anesthesiologists House of Delegates, and the American
Association of Nurse Anesthetists. We also face risks beyond our control with respect to the
continued challenges of the U.S. and worldwide economies.
20
Critical Accounting Policies and Estimates
Managements discussion and analysis of financial condition and results of operations is based
upon our consolidated financial statements, which have been prepared in accordance with accounting
principles generally accepted in the United States. Note 2 of the Notes to Consolidated Financial
Statements included elsewhere in this Quarterly Report on Form 10-Q 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 in determining
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 significant
likelihood that materially different amounts would be reported under different conditions or using
different assumptions. We believe that our critical accounting policies and estimates are as
follows:
Revenue Recognition
We sell our BIS monitors primarily through a combination of a direct sales force and
distributors. Our original equipment manufacturer products are sold to original equipment
manufacturers who in turn sell them to the end-user. BIS Sensors are sold through a combination of
a direct sales force, distributors and original equipment manufacturers. Direct product sales are
structured as sales, sales-type lease arrangements or sales under our EP program. We recognize
revenue when earned in accordance with Staff Accounting Bulletin, or SAB, No. 104,
Revenue
Recognition,
and Emerging Issues Task Force, or EITF, 00-21,
Revenue Arrangements with Multiple
Deliverables
. Revenue is recognized when persuasive evidence of an arrangement exists, product
delivery has occurred or services have been rendered, the price is fixed or determinable and
collectibility is reasonably assured. For product sales, revenue is not recognized until title and
risk of loss have transferred to the customer.
In May 2005, we entered into a product development and distribution agreement with Boston
Scientific Corporation, which we refer to as the 2005 product development and distribution
agreement. Pursuant to this agreement, Boston Scientific Corporation agreed to provide to us up to
$25.0 million to fund the development of products that incorporate EEG analysis technology for the
diagnosis of neurological, psychiatric or pain disorders or screening or monitoring patient
response to treatment options for such disorders. In June 2007, we terminated the 2005 product
development and distribution agreement with Boston Scientific Corporation. In connection with the
termination of the agreement, we reversed a receivable of approximately $285,000 which we had
recorded in March 2007 against the strategic alliance revenue that had originally been recorded in
the statement of income. Revenue was being recognized on allowable product development activities
pursuant to this agreement as the services were performed and costs were incurred.
We follow SFAS No. 13,
Accounting For Leases
, in connection with our sales-type lease
agreements. 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. 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 the net
investment in sales-type leases. We recognize Equipment revenue under sales-type lease agreements
either at shipment or delivery in accordance with the agreed upon contract terms with interest
income recognized over the life of the sales-type lease. The cost of the BIS monitor acquired by
the customer is recorded as costs of revenue in the same period it is acquired. We review and
assess the net realizability of our investment in sales-type leases at each reporting period. This
review includes determining, on a customer specific basis, if a customer is significantly
underperforming relative to the customers cumulative level of committed BIS Sensor purchases as
required by the sales-type lease agreement. If a customer is underperforming, we record an
allowance for lease payments as a charge to revenue to reflect the lower estimate of the net
realizable investment in sales-type lease balance. Changes in the extent of underperformance in
the agreements could increase or decrease the amount of revenue recorded in future periods.
We recognize revenue either at shipment or delivery in accordance with the agreed upon
contract terms with distributors and original equipment manufacturers in accordance with SAB No.
104. Contracts executed for sales to distributors and original equipment manufacturers include a
clause that indicates that customer acceptance is limited to confirmation that our products
function in accordance with our applicable product
specifications in effect at the time of delivery. Formal acceptance by the distributor or
original equipment manufacturer is not necessary to recognize revenue provided that we objectively
demonstrate that the criteria specified in the acceptance provisions are satisfied. Each product is
tested prior to shipment to ensure that it meets the applicable product specifications in effect at
the time of delivery. Additionally, we have historically had a minimal number of defective products
shipped to distributors and original equipment manufacturers, and any defective products are
subject to repair or replacement under warranty as distributors and original equipment
manufacturers do not have a right of return.
21
We exercise judgment in determining the specific time periods in which we can recognize
revenue in connection with sales of our products and with respect to our strategic alliances. To
the extent that actual facts and circumstances differ from our initial judgments, our revenue
recognition could change accordingly and any such change could affect our reported results.
Stock-Based Compensation
SFAS No. 123R, which we adopted in the first quarter of fiscal 2006, requires that stock-based
compensation expense associated with equity instruments be recognized in the condensed consolidated
statement of operations, rather than being disclosed in a pro forma footnote to the condensed
consolidated financial statements. Determining the amount of stock-based compensation to be
recorded requires us to develop estimates to be used in calculating the grant-date fair value of
stock options. We calculate the grant-date fair value using the Black-Scholes valuation model.
The use of valuation models requires us to make estimates with respect to the following
assumptions:
Risk-free interest rate: the implied yield currently available on U.S. Treasury zero-coupon
issues with a remaining term equal to the expected term used as the assumption in the model.
Expected term: the expected term of an employee option is the period of time for which the
option is expected to be outstanding. We use a Monte Carlo simulation model to estimate the
expected term assumption for the grant date valuation as we believe that this information is
currently the best estimate of the expected term of a new option.
Expected volatility: in estimating expected volatility, we consider both trends in
historical volatility and the implied volatility of our publicly traded options. We used a
combination of our implied volatility and historical volatility to estimate expected
volatility for the three months ended March 29, 2008. We believe that in addition to the
relevance of historical volatility, consideration of implied volatility achieves the
objectives of SFAS No. 123R since it represents the expected volatility that marketplace
participants would likely use in determining an exchange price for an option, and is
therefore an appropriate assumption to use in the calculation of grant date fair value.
Additionally, we are required to make assumptions regarding the forfeiture rate. SFAS No.
123R requires forfeitures to be estimated at the time of grant and revised, if necessary, in
subsequent periods if actual forfeitures differ from those estimates. We used a forfeiture rate of
approximately 5.3% in our calculation at March 29, 2008. We re-evaluate this forfeiture rate on a
quarterly basis and adjust the rate as necessary.
These assumptions involve significant judgment and estimates. Future stock-based compensation
expense could vary significantly from the amount recorded in the current period due to changes in
assumptions and due to the extent of stock option activity and restricted stock issued in future
periods.
As of March 29, 2008, the total unrecognized compensation cost related to unvested stock
options and unvested restricted stock awards was $9.1 million and $7.4 million, respectively, which
will be amortized over the weighted average remaining requisite service periods of 26 months and 38
months, respectively.
Allowance for Doubtful Accounts
We determine our allowance for doubtful accounts by making estimates and judgments 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 that 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 value, 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 device 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 would need to change our estimate of the provision required for excess
or obsolete inventory. If revisions are deemed necessary, we would recognize the
22
adjustments in the form of a charge to costs of revenue at the time of the determination.
Therefore, although we continually update our forecasts of future product demand, any significant
unanticipated declines in demand or technological developments, such as the introduction of new
products by our competitors, could have a significant negative impact on the value of our
inventory, results of operations and cash flows in future periods.
Warranty
Equipment that we sell generally is 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 an increased number of warranty claims or
increased costs associated with servicing those claims, our warranty expenses will increase, and we
may experience decreased gross profit margin and cash flow.
Income Taxes
Our provision for income taxes is composed of a current and a deferred portion. The current
income tax provision is calculated as the estimated taxes payable or refundable on tax returns for
the current year. The deferred income tax provision is calculated for the estimated future tax
effects attributable to temporary differences and carryforwards using expected tax rates in effect
in the years during which the differences are expected to reverse.
Effective January 1, 2007, we adopted the provisions of the Financial Accounting Standards
Board Interpretation No., or FIN 48,
Accounting for Uncertainty in Income Taxes an
Interpretation of FASB Statement No. 109
. FIN 48 clarifies the accounting for uncertainty in
income taxes recognized in an enterprises financial statements in accordance with SFAS No. 109 and
prescribes a recognition threshold of more-likely-than-not to be sustained upon examination. Upon
adoption of FIN 48, our policy to include interest and penalties related to gross unrecognized tax
benefits within our provision for income taxes did not change. We did not accrue interest expense
related to these unrecognized tax benefits due to our historical carryforward loss position, the
uncertain benefits have not yet reduced taxes payable and, accordingly, no interest expense has
been accrued. The net adjustment to retained earnings upon adoption to FIN 48 on January 1, 2007
was $371,000.
Results of Operations
The following tables present, for the periods indicated, financial information expressed as a
percentage of revenue and a summary of our total revenue. This information has been derived from
our condensed 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 31,
|
|
|
2008
|
|
2007
|
Revenue
|
|
|
100
|
%
|
|
|
100
|
%
|
Costs of revenue
|
|
|
26
|
|
|
|
25
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
74
|
|
|
|
75
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
16
|
|
|
|
18
|
|
Sales and marketing
|
|
|
42
|
|
|
|
42
|
|
General and administrative
|
|
|
16
|
|
|
|
15
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
74
|
|
|
|
75
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income from operations
|
|
|
|
|
|
|
|
|
Other income, net
|
|
|
1
|
|
|
|
4
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes
|
|
|
1
|
|
|
|
4
|
|
Provision for income taxes
|
|
|
2
|
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
|
(1
|
)%
|
|
|
2
|
%
|
|
|
|
|
|
|
|
|
|
23
Three Months Ended March 29, 2008 Compared with the Three Months Ended March 31, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
|
|
|
|
|
|
|
|
Percentage
|
|
|
|
March 29,
|
|
|
March 31,
|
|
|
Increase
|
|
|
|
2008
|
|
|
2007
|
|
|
(Decrease)
|
|
|
|
(in thousands, except
|
|
|
|
|
|
|
|
unit amounts)
|
|
|
|
|
|
Revenue Worldwide
|
|
|
|
|
|
|
|
|
|
|
|
|
BIS Sensor
|
|
$
|
20,636
|
|
|
$
|
17,554
|
|
|
|
18
|
%
|
BIS monitor
|
|
|
2,097
|
|
|
|
2,895
|
|
|
|
(28
|
)%
|
Original equipment manufacturer products
|
|
|
981
|
|
|
|
1,117
|
|
|
|
(12
|
)%
|
Other equipment and accessories
|
|
|
714
|
|
|
|
869
|
|
|
|
(18
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
Total equipment
|
|
|
3,792
|
|
|
|
4,881
|
|
|
|
(22
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
Total product revenue
|
|
|
24,428
|
|
|
|
22,435
|
|
|
|
9
|
%
|
Strategic alliance
|
|
|
|
|
|
|
1,684
|
|
|
|
(100
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
$
|
24,428
|
|
|
$
|
24,119
|
|
|
|
1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unit Analysis Worldwide
|
|
|
|
|
|
|
|
|
|
|
|
|
BIS Sensors
|
|
|
1,486,000
|
|
|
|
1,237,000
|
|
|
|
20
|
%
|
BIS monitors
|
|
|
718
|
|
|
|
958
|
|
|
|
(25
|
)%
|
Original equipment manufacturer
|
|
|
|
|
|
|
|
|
|
|
|
|
BIS products
|
|
|
1,560
|
|
|
|
1,474
|
|
|
|
6
|
%
|
Installed base
|
|
|
49,295
|
|
|
|
41,515
|
|
|
|
19
|
%
|
Revenue.
Revenue from the sale of BIS Sensors increased approximately 18% in the three months
ended March 29, 2008 compared with the three months ended March 31, 2007. The increase in revenue
from the sale of BIS Sensors during this period was primarily attributable to the continued shift
of the focus of our sales and marketing efforts from expanding our customer base to seeking to
develop our existing customers and increasing their sensor utilization and procedure penetration.
During this period, we experienced an increase of approximately 20% in the number of BIS Sensors
sold which we believe was a result of the change in the focus of our sales and marketing strategy
and growth in the installed base of BIS monitors. The number of domestic sensors sold was
approximately 851,000 during the first quarter of 2007 and increased to approximately 961,000
during the first quarter of 2008, an increase of approximately 13%, while the number of
international sensors sold increased approximately 36% from approximately 386,000 during the first
quarter of 2007 to approximately 525,000 during the first quarter of 2008. Our installed base of
BIS monitors and original equipment manufacturer products increased approximately 19% to 49,295
units at March 29, 2008 compared with 41,515 units at March 31, 2007.
During the three months ended March 29, 2008 compared with the three months ended March 31,
2007, total Equipment revenue decreased by approximately 22%. The decrease in Equipment revenue
during this period was a result of a decrease of approximately 28% in BIS monitor revenue, a
decrease of approximately 18% in other equipment revenue and a decrease of approximately 12% in
original equipment manufacturer product revenue. We believe this decrease in Equipment revenue
reflects the shift in our sales and marketing emphasis from expanding our customer base to
developing our existing customers and increasing their sensor utilization and procedure
penetration. The decrease in monitor revenue was a result of a decrease of approximately 25% in
the number of monitors sold combined with a decrease in the average selling price of approximately
3%. In the first quarter of 2008, we sold 718 monitors compared with 958 sold in the first quarter
of 2007. Domestically, we sold 180 monitors in the first quarter of 2008 compared with 528
monitors sold in the first quarter of 2007. The decrease in original equipment manufacturer
product revenue was a result of a decrease in the average selling price of approximately 17% offset
by an increase of approximately 6% in the number of products sold to our original equipment
manufacturers.
In the three months ended March 29, 2008, we recorded no strategic alliance revenue compared
with strategic alliance revenue of approximately $1.7 million in the three months ended March 31,
2007. The strategic alliance revenue is primarily attributable to the revenue we recognize from
our agreements with Boston Scientific Corporation. In June 2007, we entered into a termination and
repurchase agreement with Boston Scientific Corporation pursuant to which all agreements with
Boston Scientific Corporation, including
the 2002 OEM product development and distribution agreement and the 2005 product development
and distribution agreement were terminated.
Our gross margin was approximately 73.4% of revenue in the first quarter of 2008 compared with
a gross margin of approximately 74.8% of revenue in the first quarter of 2007. The decrease in the
gross profit margin in the first quarter of 2008 compared with the same quarter in the prior year
is primarily the result of three factors. First, in the first quarter of 2007, we
24
recognized approximately $1.7 million in strategic alliance revenue compared with no strategic
alliance revenue recognized in the first quarter of 2008. Second, in the first quarter of 2008, we
experienced increased sales of monitors on the international side of the business. International
monitors have a higher average cost of sales per unit. Finally,
during the quarter we shipped approximately 200 no charge units that
we provided to two of our OEM partners.
Expense Overview
|
|
|
|
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Three Months Ended
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Percentage
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March 29,
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March 31,
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Increase
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|
|
2008
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|
2007
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|
(Decrease)
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|
(in thousands)
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|
Expenses
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|
|
|
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|
|
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|
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Research and development
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$
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3,939
|
|
|
$
|
4,221
|
|
|
|
(7
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)%
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Sales and marketing
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|
$
|
10,202
|
|
|
$
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10,045
|
|
|
|
2
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%
|
General and administrative
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|
$
|
3,942
|
|
|
$
|
3,663
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|
|
|
8
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%
|
Research and Development.
The decrease in research and development expenses in the three
months ended March 29, 2008 compared with the three months ended March 31, 2007 was primarily
attributable to a decrease in clinical study expenses resulting from our completion of enrollment
for the BRITE study in March 2007. We expect research and development expenses in the second
quarter of 2008 to increase compared to the level of research and development expenses in the first
quarter of 2008 as we continue to invest in spending for our ongoing clinical trials and initiate
new trials.
Sales and Marketing.
The increase in sales and marketing expenses in the three months ended
March 29, 2008 compared with the three months ended March 31, 2007 was primarily attributable to an
increase of approximately $355,000 in operating expenses associated with our international
subsidiaries offset by a decrease of approximately $198,000 in domestic operating expenses. The
$355,000 increase in operating expenses for our international subsidiaries relates primarily to an
increase in consultant fees of approximately $132,000, an increase in travel and entertainment
expenses of approximately $103,000, an increase in salaries and benefits of approximately $63,000,
and an increase in meeting expenses of approximately $47,000. The $198,000 decrease in domestic
operating expenses relates primarily to a decrease in group purchasing commission expenses of
approximately $122,000 and a decrease in print collateral expense of approximately $74,000. We
expect sales and marketing expenses in the second quarter of 2008 to increase compared to the level
of sales and marketing expenses in the first quarter of 2008
principally as a result of a retention program
instituted for our sales force.
General and Administrative.
The increase in general and administrative expenses in the three
months ended March 29, 2008 compared with the three months ended March 31, 2007 was primarily
attributable to an increase of approximately $134,000 in professional services, including legal
services and accounting and tax related services, and an increase in compensation and benefits to
general and administrative personnel of approximately $129,000. The $129,000 increase in
compensation and benefits was primarily the result of approximately $103,000 in salaries and wages
primarily as a result of annual salary increases. We expect general and administrative expenses in
the second quarter of 2008 will decrease compared to the level of general and administrative
expenses in the first quarter of 2008.
Interest Income.
Interest income increased to approximately $1,278,000 in the three months
ended March 29, 2008 from approximately $982,000 in the three months ended March 31, 2007, an
increase of approximately 30%. The increase in interest income in the three months ended March 29,
2008 compared with the three months ended March 31, 2007 was primarily attributable to a higher
cash and investment balance resulting from the proceeds received in connection with the sale of
$125.0 million aggregate principal amount of our 2.5% convertible senior notes due 2014 that we
issued in June 2007. We expect interest income in the second quarter of 2008 to decrease compared
to interest income in the first quarter of 2008.
Interest Expense.
Interest expense increased to approximately $948,000 in the three months
ended March 29, 2008 compared with no interest expense in the three months ended March 31, 2007.
The increase in interest expense in the three months ended March 29, 2008 was the result of the
2.5% convertible senior notes
due 2014 that we issued in June 2007. We expect interest expense in the second quarter of
2008 to be comparable with the level of interest expense in the first quarter of 2008.
25
Income Taxes.
We are subject to income tax in numerous jurisdictions and at various rates
worldwide and the use of estimates is required in determining the provision for income taxes. For
the three-month period ended March 29, 2008, we recorded a tax provision of $424,000 on income
before tax of $189,000 resulting in an effective income tax rate of 224%. For the three months
ended March 29, 2008, the difference between our effective tax rate of 224% and the U.S. federal
statutory income tax rate of 34% was due mainly to the impact of state income taxes and the
disallowance for tax purposes of certain stock-based compensation deductions in accordance with by
SFAS No. 123R. In addition, there was an increase in the valuation allowance on a portion of our
federal research and development, or R&D, credits. For the three-month period ended March 31,
2007, we recorded a tax provision of $576,000 on income before tax of $1,093,000 resulting in an
effective income tax rate of 53%.
Through the third quarter of 2006, we maintained a full valuation allowance on our deferred
tax assets. Upon achieving three-year cumulative profitability, we began to weigh the positive and
negative evidence included in SFAS No. 109
Accounting For Income Taxes
, on a quarterly basis to
determine whether, in our view, it was more likely than not that some or all of our deferred tax
assets would be realized. In connection with this analysis, we reviewed our cumulative history of
earnings before taxes over a three-year period and our projections of future taxable income. As of
December 31, 2006, after finalizing our 2007 forecast, we concluded that our projections support
future taxable income for the foreseeable future, and therefore, we reversed $28.2 million of our
valuation allowance. Our projections of future taxable income include significant judgment and
estimation. If we are not able to achieve sufficient taxable income in future periods, we might
need to record additional valuation allowances on our deferred tax assets in future periods that
could be material to the consolidated financial statements. As stated above, in the first quarter
of 2008 we re-established a valuation allowance for a portion of our
Federal R&D credits since these
credits are expected to expire unused based on current projections.
We adopted the provisions of FIN 48 on January 1, 2007. As of January 1, 2008, we had gross
unrecognized tax benefits of $661,500 (net of the federal benefit on state issues) which represents
the amount of unrecognized tax benefits that, if recognized, would favorably affect the effective
income tax rate in any future periods. Also as of the adoption date, we had not accrued interest
expense related to these unrecognized tax benefits. When appropriate, we will recognize interest
accrued and penalties, if incurred, related to unrecognized tax benefits as a component of income
tax expense. There were no significant changes to any of these amounts during the first quarter of
2008. We do not reasonably estimate that the unrecognized tax benefit will change significantly
within the next twelve months.
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 and
administrative expenses. From our inception through March 29, 2008, we have raised approximately
$212.2 million from equity and debt financings, including the following:
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net proceeds of approximately $54.6 million from our initial public offering of an
aggregate of 4,025,000 shares of common stock in February 2000;
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approximately $3.4 million in equipment financing;
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approximately $5.1 million related to our investment in sales-type leases;
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proceeds of approximately $10.0 million related to our 2002 OEM product development
and distribution agreement with Boston Scientific Corporation;
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proceeds of approximately $8.1 million from the sale of our common stock to Boston
Scientific Corporation in 2004;
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$10.0 million in installment payments from Boston Scientific Corporation received in
May 2005 and May 2006 pursuant to the 2005 product development and distribution
agreement with Boston Scientific Corporation; and
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net proceeds of $121.0 million received from the issuance of our 2.5% convertible
senior notes in June 2007.
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In May 2001, we entered into an agreement with Bank of America for a $5.0 million revolving
line of credit, which expires in May 2008 and is currently being renegotiated. The revolving line
of credit contains restrictive covenants that require us to maintain liquidity and net worth ratios
and is secured by certain
investments, which are shown as restricted cash on our consolidated balance sheets. In
connection with this revolving line of credit agreement, we are required to maintain restricted
cash in an amount equal to 102% of the outstanding amounts under the revolving line of credit. At
March 29, 2008, we were in compliance with all covenants contained in the revolving line of credit
agreement. Interest on any borrowings under the revolving line of credit is, at our election,
either the prime rate or the London Inter-Bank Offer Rate, or LIBOR, plus 2.25%. Up to $1.5
million of the $5.0 million revolving line of credit is available for standby letters of credit.
At March 29, 2008, the interest rate on the line of credit was 5.25%, there was no amount
outstanding under this line of credit and we had standby letters of credit outstanding relating to
our leased facility and an international service provider in the amount of approximately $1.0
million which is shown on our consolidated balance sheet as restricted cash.
26
In June 2007, we completed a private placement of $125.0 million aggregate principal amount of
2.5% convertible notes due 2014. Net proceeds received from the issuance of the notes were $121.0
million, which is net of the underwriters discount of $4.0 million. As of March 29, 2008, we have
used approximately $85.0 million of these proceeds to repurchase 5.5 million shares of our common
stock, of which 4.5 million shares were repurchased from Boston Scientific Corporation and 1.0
million shares were repurchased in connection with our 2.5% convertible senior note offering that
we completed in June 2007.
On August 3, 2006, our Board of Directors authorized the repurchase of up to 2,000,000 shares
of our common stock from time to time on the open market or in privately negotiated transactions.
As of March 29, 2008, we had repurchased 276,493 shares of our common stock for approximately $5.0
million under this plan.
We expect to meet our near-term liquidity needs through the use of cash and short-term
investments on hand at March 29, 2008 and cash generated from operations. We believe that the
financial resources available to us, including our current working capital, our long-term
investments and available revolving line of credit will be sufficient to finance our planned
operations and capital expenditures for at least the next 12 months. 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, to meet market demand for our products and to repay our convertible
notes.
We expect to fund the growth of our business over the long term through cash flow from
operations and through issuances of capital stock, promissory notes or other securities. Any sale
of additional equity or debt securities may result in dilution to our stockholders, and we cannot
be certain that additional public or private financing will be available in amounts or on terms
acceptable to us, or at all. If we are unable to obtain this additional financing, we may be
required to delay, reduce the scope of, or eliminate one or more aspects of our business
development activities, which could harm the growth of our business.
Currently, our 2.5% convertible senior notes due 2014 are convertible, under certain
circumstance, solely into shares of our common stock. However, under the terms of the Indenture
and such notes, we have the option to settle potential conversions of these notes with cash and, if
applicable, shares of our common stock, commonly referred to as net share settlement, if we first
obtain stockholder approval of this net share settlement feature, and we irrevocably elect to use
such settlement method. If we obtain stockholder approval of the net share settlement feature in
connection with the potential conversion of such notes and we irrevocably elect to use such
settlement method, then upon conversion of such notes we would (1) pay cash in an amount equal to
the lesser of one-fortieth of the principal amount of the notes being converted and the daily
conversion value (the product of the conversion rate and the current trading price) of the notes
being converted and (2) issue shares of our common stock only to the extent that the daily
conversion value of the notes exceeded one-fortieth of the principal amount of the notes being
converted for each trading day of the relevant 40 trading day observation period. In order to fund
the cash payments due upon conversion, we may be required to use a significant portion or all of
our existing cash or raise the cash for such payments through the sale of shares of our common
stock or additional debt securities or through one or more other financing transactions. We may
not have sufficient cash on hand or be able to acquire the necessary funds via financing on terms
favorable to us or our stockholders, or at all, which would result in an event of default under the
notes. Moreover, the use of a substantial portion of our existing cash may adversely affect our
liquidity and cash available to fund the growth of our business.
Working capital at March 29, 2008 was approximately $113.7 million compared with approximately
$118.8 million at December 31, 2007.
Cash provided by operations.
We received approximately $1.5 million of cash from operations
in the three months ended March 29, 2008 compared with cash received from operations of
approximately $1.6 million in the three months ended March 31, 2007. The cash received in the
three months ended March 29, 2008 was primarily attributable to $1.9 million of non-cash
stock-based compensation expense and a decrease of approximately $1.1 million in inventory. These
were offset by a decrease in accrued liabilities of approximately $939,000 and an increase in
accounts receivable of $738,000.
Cash used for investing activities.
We used approximately $9.8 million of cash in investing
activities in the three months ended March 29, 2008 compared with the use of cash of approximately
$2.3 million in the three months ended March 31, 2007. The cash used in the three months ended
March 29, 2008 was primarily the result of net purchases of marketable securities of approximately
$9.2 million. We anticipate the level of capital expenditures in the second quarter of 2008 will
increase compared with the level of capital expenditures in the first quarter of 2008.
Cash provided by financing activities.
We received approximately $280,000 of cash from
financing activities in the three months ended March 29, 2008 compared with receiving approximately
$471,000 in the three months ended March 31, 2007 as a result of proceeds from the issuance of our
common stock upon the exercise of stock options granted under our stock option plans.
27
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements or relationships with unconsolidated
entities or financial partnerships, such as entities often referred to as structured finance or
special purpose entities, which are typically established for the purpose of facilitating
off-balance sheet arrangements or other contractually narrow or limited purposes.
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.
Recent Accounting Pronouncements
In September 2006, the FASB issued SFAS No. 157,
Fair Value Measurements
. SFAS No. 157
defines fair value, establishes a framework for measuring fair value under United States generally
accepted accounting principles, or GAAP, and expands disclosures about fair value measurements in
interim and annual periods subsequent to initial recognition. SFAS No. 157 applies under other
accounting pronouncements that require or permit fair value measurements. SFAS No. 157 is
effective for financial statements issued for fiscal years beginning after November 15, 2007, and
interim periods within those years. The adoption of SFAS No. 157 did not have a material impact on
our financial statements or condition. See Note 7 of the Notes to our Condensed Consolidated
Financial Statements contained in Item 1 of this Quarterly Report on Form 10-Q for further
information regarding our adoption of SFAS No. 157.
In June 2007, the FASB ratified EITF Issue No. 07-3,
Accounting for Nonrefundable Advance
Payments for Goods or Services Received for Use in Future Research and Development Activities.
The
scope of EITF Issue No. 07-3 is limited to nonrefundable advance payments for goods and services to
be used or rendered in future research and develop0ment activities pursuant to an executory
contractual arrangement. EITF Issue No. 07-3 is effective for financial statements issued for
fiscal years beginning after December 15, 2007 and interim periods within those fiscal years. An
entity may not apply it before that date. The adoption of EITF No. 07-3 did not have a material
impact on our results of operations, financial position or cash flow.
In December 2007, the FASB issued SFAS No. 141 (revised 2007),
Business Combinations
. The
objective of SFAS No. 141R is to improve the representational faithfulness and comparability of the
information that a reporting entity provides in its financial reports about a business combination
and its effects. SFAS No. 141R applies prospectively to business combination for which the
acquisition date is on or after December 15, 2008. An entity may not apply it before that date.
We do not believe that the adoption of SFAS No. 141R will have an immediate impact on our results
of operations, financial position or cash flow, however, the adoption of SFAS 141R on January 1,
2009 could materially change the accounting for business combinations subsequent to that date.
In December 2007, the FASB issued SFAS No. 160,
Noncontrolling Interest in Consolidated
Financial Statements an amendment of ARB No.51.
The objective of SFAS No. 160 is to improve the
relevance, comparability and transparency of the financial information that a reporting entity
provides in its consolidated financial statement. This statement is effective for fiscal years and
interim periods within those fiscal years, beginning on or after December 15, 2008. An entity may
not apply it before that date. We do not believe that the adoption of SFAS No. 160 will have a
material impact on our results of operations, financial position or cash flow.
In March 2008, the FASB issued SFAS No. 161,
Disclosures about Derivative Instruments and
Hedging Activities
, an Amendment of FASB Statement No. 133. The objective of this statement is to
require enhanced disclosures about an entitys derivative and hedging activities to improve the
transparency of financial reporting. This statement is effective for financial statements issued
for fiscal years and interim periods beginning after November 15, 2008 with early application
encouraged. We do not believe that the adoption of SFAS No. 161 will have a material impact on our
results of operations, financial position or cash flow.
28
Forward-Looking Statements
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, including information relating to our ability to maintain profitability, information with
respect to market acceptance of our BIS system, continued growth in sales of our BIS monitors,
original equipment manufacturer products and BIS Sensors, our dependence on the BIS system,
regulatory approvals for our products, 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, 2008 and thereafter. 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. The important factors discussed under Part II Item 1A. Risk
Factors below represent some of the current challenges to us that create risk and uncertainty. 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.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Interest Rate Exposure
Our investment portfolio consists primarily of money market accounts, certificates of deposit,
high-grade commercial paper, high grade corporate bonds and debt obligations of various
governmental agencies. We manage our investment portfolio in accordance with our investment
policy. The primary objectives of our investment policy are to preserve principal, maintain a high
degree of liquidity to meet operating needs, and obtain competitive returns subject to prevailing
market conditions. Investments are made with an average maturity of 12 months or less and a
maximum maturity of 24 months. These investments are subject to risk of default, changes in credit
rating and changes in market value. These investments are also subject to interest rate risk and
will decrease in value if market interest rates increase. Due to the conservative nature of our
investments and relatively short effective maturities of the debt instruments, we believe interest
rate risk is mitigated. Our investment policy specifies the credit quality standards for our
investments and limits the amount of exposure from any single issue, issuer or type of investment.
Our investment in sales-type leases and line of credit agreement are also subject to market
risk. The interest rates implicit in our sales-type leases are fixed and not subject to interest
rate risk. In addition, the interest rate on the 2.5% convertible senior notes due 2014 is fixed
and not subject to interest rate risk. The interest rate on our line of credit agreement is
variable and subject to interest rate risk. The interest rate risk experienced to date related to
the line of credit has been mitigated primarily by the fact that the line of credit, when drawn on,
is generally outstanding for short periods of time in order to fund short-term cash requirements.
Foreign Currency Exposure
Most of our revenue, expenses and capital spending are transacted in U.S. dollars. The
expenses and capital spending of our two international subsidiaries are transacted in the
respective countrys local currency and subject to foreign currency exchange rate risk. Our
foreign currency transactions are translated into U.S. dollars at prevailing rates. Gains or
losses resulting from foreign currency transactions are included in current period income or loss
as incurred. Currently, all material transactions are denominated in U.S. dollars, and we have not
entered into any material transactions that are denominated in foreign currencies.
Item 4. Controls and Procedures.
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(a)
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Evaluation of Disclosure Controls and Procedures.
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Our management, with the participation of our chief executive officer and chief financial
officer evaluated the effectiveness of our disclosure controls and procedures as of March
29, 2008. The term disclosure controls and procedures, as defined in Rules 13a-15(e) and
15d-15(e) under the Exchange Act, means controls and other procedures of a company that are
designed to ensure that information
required to be disclosed by a company in the reports that it files or submits under the
Exchange Act is recorded, processed, summarized and reported, within the time periods
specified in the SECs rules and forms. Disclosure controls and procedures include, without
limitation, controls and procedures designed to ensure that information required to be
disclosed by a company in the reports that it files or submits under the Exchange Act is
accumulated and communicated to the companys management, including its principal executive
and principal financial officers, as appropriate to allow timely decisions regarding
required disclosure. Management recognizes that any controls and procedures, no matter how
well designed and operated, can provide only reasonable assurance of achieving
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their objectives and management necessarily applies its judgment in evaluating the
cost-benefit relationship of possible controls and procedures. Based on the evaluation of
our disclosure controls and procedures as of March 29, 2008, our chief executive officer and
chief financial officer concluded that, as of such date, our disclosure controls and
procedures were effective at the reasonable assurance level.
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(b)
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Changes in Internal Controls.
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No change in our internal control over financial reporting (as defined in Rules 13a-15(f)
and 15d-15(f) under the Exchange Act) occurred during the fiscal quarter ended March 29,
2008 that has materially affected, or is reasonably likely to materially affect, our
internal control over financial reporting.
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PART II OTHER INFORMATION
Item 1A. Risk Factors
You should carefully consider the following risk factors, in addition to other information
included in this Quarterly Report on Form 10-Q, in evaluating our business. Failure to adequately
overcome or address any of the following challenges could have a material adverse effect on our
results of operations, business or financial condition. The following risk factors supersede the
risk factors previously disclosed in Item 1A. of our 2007 Annual Report on Form 10-K.
We will not continue to be profitable if hospitals and anesthesia providers do not buy and use our
BIS system and purchase our BIS Sensors in sufficient quantities.
Although we were profitable for the years ended December 31, 2007 and 2006, we will not
continue to be profitable or increase our level of profitability 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 that may result from use of the BIS system. Also, if third party reimbursement is based on
charges or costs, patient monitoring with the BIS system may have the effect of reducing
reimbursement because the charges or costs for surgical procedures may decline as a result of
monitoring with the BIS system. In addition, hospitals and anesthesia providers may not accept the
BIS system as an accurate or superior means of assessing a patients level of consciousness during
surgery or in the intensive care unit. If extensive or frequent malfunctions occur, healthcare
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 continue to be profitable.
Moreover, additional clinical research we or third parties undertake may fail to support the
benefit of our products, including failing to provide further support evidence of a link between the use of BIS
monitoring and a reduction in the incidence of awareness. For example, a third-party study
recently published in the
New England Journal of Medicine
compared BIS monitoring with a protocol
based on targeted end-tidal gas anesthetic levels in a patient population considered to be at high risk of
awareness and concluded that, based upon a similar occurrence of awareness in both groups, no
benefit of BIS monitoring versus this alternative approach was demonstrated. If the patient safety benefits of BIS monitoring are
not persuasive enough to lead to a wider adoption of our BIS technology, our business, financial
condition and results of operations could be adversely affected.
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. If use of our BIS system, and accordingly, sales of our
BIS Sensors, do not increase, our ability to grow our revenue and maintain profitability could be
adversely affected.
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 commercially the latest
version, the BIS XP system, at the end of the third fiscal quarter of 2001. We also offer BIS
monitoring systems, including the BISx system, for integration into equipment sold by original
equipment manufacturers. 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 from healthcare providers or
professional anesthesia organizations. Because we depend on our BIS system for substantially all of
our revenue and we have no other significant
30
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 factors may adversely affect our quarterly operating results through the second fiscal
quarter of 2008 and beyond.
Various factors may adversely affect our quarterly operating results through the second fiscal
quarter of 2008 and beyond. Among these factors are the following:
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a third party study recently published in the
New England Journal of
Medicine
compared BIS monitoring with a protocol based on end-tidal
gas anesthetic in a patient population considered to be at high risk
of awareness and concluded that, based upon a similar occurrence of
awareness in both groups, no benefit of BIS monitoring was
demonstrated. The publication of this study may have an adverse
effect on the rate at which existing or potential new customers
purchase and use our products, which could adversely affect our
operating results;
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we are currently finalizing
plans to expand our sales force and expect that such expansion would increase our operating
expenses in future periods and may adversely affect our operating
results in such periods;
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we continue to shift the focus of our sales and marketing efforts from
expanding our customer base to developing our existing customers and
increasing their sensor utilization and procedure penetration. As a
result of this shift in focus, we expect our revenue from the sale of
equipment to decrease. As such, if we do not increase revenue from
sales of our BIS Sensors as quickly as we plan, or at all, our
operating results could be adversely affected;
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we may not realize expected benefits of favorable industry
pronouncements on anesthesia awareness, including the position
statements issued by the Joint Commission on Accreditation of
Healthcare Organizations, the American Society of Anesthesiologists
House of Delegates, and the American Association of Nurse
Anesthetists.; and
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we face risks beyond our control with respect to the continued
challenges of the U.S. and worldwide economies.
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If these or any other adverse
factors cause a decline in our operating results, or
if the market perceives that any such adverse factors could cause a decline in our operating
results, in the second quarter of 2008 or beyond, then the trading price of our common stock may
decline and your investment may loose value.
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:
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the timing and volume of customer orders for our BIS system;
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market acceptance of our BIS VISTA monitor;
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use of and demand for our BIS Sensors;
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transition of sales focus from expanding our customer base to developing our existing
customers and increasing their sensor utilization and procedure penetration;
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customer cancellations;
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introduction of competitive products;
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regulatory approvals;
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changes in management;
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turnover in our direct sales force;
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we are currently finalizing
plans to expand our sales force and expect that such expansion would increase our operating
expenses in future periods and may adversely affect our operating
results in such periods;
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effectiveness of new marketing and sales programs;
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communications published by industry organizations or other professional entities in
the anesthesia community that are unfavorable to our business, including publications
of the results of clinical studies;
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trading in our convertible debt instruments;
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repurchases of shares of our common stock;
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the amount of our outstanding indebtedness and interest payments under debt obligations;
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reductions in orders by our distributors and original equipment manufacturers; and
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the timing and amount of our expenses.
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Because of these factors, it is likely that in some future quarter or quarters our operating
results could 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
likely decrease. In addition, because we do not have a substantial backlog of customer orders for
our BIS system or our BIS Sensors, 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 continue to experience 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 debt allowances 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 financial
statements.
Our financial statements have been prepared in accordance with accounting principles generally
accepted in the United States. 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 and related disclosure of contingent assets and
liabilities. This includes estimates and judgments regarding revenue recognition, warranty
reserves, inventory valuations, valuation allowances for deferred tax assets, allowances for
doubtful accounts and share-based compensation expense. We base our estimates and judgments on
historical experience and on various other assumptions that we believe to be reasonable under the
circumstances at the time such estimates and judgments were made. There can be no assurance,
however, that our estimates and judgments, or the assumptions underlying them, will be correct.
Compliance with changing regulation of corporate governance and public disclosure as well as
potential new accounting pronouncements are likely to impact our future financial position or
results of operations.
Changing laws, regulations and standards relating to corporate governance and public
disclosure, new SEC regulations and NASDAQ Global Market rules are creating uncertainty for
companies such as ours. These new or changed laws, regulations and standards are subject to
varying interpretations in many cases due to their lack of specificity, and as a result, their
application in practice may evolve over time as new guidance is provided by regulatory and
governing bodies, which could result in continuing uncertainty regarding compliance matters and
higher costs necessitated by ongoing revisions to disclosure and governance practices. In
addition, future changes in financial accounting standards may cause adverse, unexpected revenue
fluctuations and affect our financial position or results of operations. New accounting
pronouncements and varying interpretations of pronouncements have occurred with frequency in the
past and may occur again in the future and as a result we may be required to make changes in our
accounting policies, for example the 2006
requirement under Statement of Financial Accounting Standards No. 123(R),
Share-Based Payment,
to expense stock options.
Our efforts to comply with evolving laws, regulations and standards have resulted in, and are
likely to continue to result in, increased general and administrative expenses and management time
related to compliance activities. We expect these efforts to require the continued commitment of
significant resources. If our efforts to comply with new or changed laws, regulations and
standards differ from the activities intended by regulatory or governing bodies due to ambiguities
related to practice, our reputation may be harmed and we might be subject to sanctions or
investigation by regulatory authorities, such as the SEC. Any such action could adversely affect
our financial results and the market price of our common stock.
32
Failure to maintain effective internal controls in accordance with section 404 of the
Sarbanes-Oxley act could have a material adverse effect on our business and stock price.
Section 404 of the Sarbanes-Oxley Act of 2002 requires managements annual review and
evaluation of our internal controls, and attestations of the effectiveness of our internal controls
by our independent auditors. Our failure to maintain the effectiveness of our internal controls in
accordance with the requirements of Section 404 of the Sarbanes-Oxley Act, as such standards are
modified, supplemented or amended from time to time, could have an adverse effect on our business,
operating results and stock price.
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 available revolving line of credit, will be sufficient to finance our planned operations and
capital expenditures through at least the next 12 months. If we are unable to increase our revenue
and continue to maintain positive cash flow, we will need to raise additional funds. We may also
need additional financing if:
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the research and development costs of our products or technology
currently under development, including costs to fund our neuroscience
program following termination in June 2007 of our alliance with Boston
Scientific Corporation, increase beyond current estimates;
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we decide to expand faster than currently planned;
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we develop new or enhanced services or products ahead of schedule;
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we decide to undertake new sales and/or marketing initiatives;
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we are required to defend or enforce our intellectual property rights,
or respond to other legal challenges with respect to our products,
including product liability claims;
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sales of our products do not meet our expectations domestically or
internationally, including sales of our BIS Sensors;
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we are required or elect to pay the principal under our 2.5%
convertible senior notes due 2014 in cash at or prior to maturity;
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we need to respond to competitive pressures; or
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we decide to acquire complementary products, businesses or technologies.
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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 operations which would significantly limit our ability to
implement our business plan and could result in a default under our 2.5% convertible senior notes
due 2014. In addition, we may have to issue equity securities that may have rights, preferences and
privileges senior to our common stock or issue debt securities that may contain limitations or
restrictions on our ability to engage in certain transactions in the future.
Cases of awareness with recall during monitoring with the BIS system could limit market acceptance
of the BIS system and could expose us to product liability claims.
Clinicians have reported to us cases of possible awareness with recall 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 with recall in these
patients. However, in a small number of these reported cases, awareness with recall may not have
been detected by monitoring with the BIS system. We have not systematically solicited reports of
awareness with recall. It is possible that additional cases of awareness
with recall during surgical procedures monitored with the BIS system have not been reported to
us. Anesthesia providers and hospitals may elect not to purchase and use the BIS system if there is
adverse publicity resulting from the report of
33
cases of awareness with recall 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 our multi-center, multinational clinical studies
have demonstrated that the use of BIS monitoring to help guide anesthetic administration may be
associated with the reduction of the incidence of awareness with recall in adults using general
anesthesia and sedation, we may be subject to product liability claims for cases of awareness with
recall during surgical procedures monitored with the BIS system. Any of these claims could require
us to spend significant time and money in litigation or to pay significant damages.
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 device industry in which we market our products is characterized by rapid product
development and technological advances. Our competitors have received clearance by the United
States Food and Drug Administration, or FDA, for, and have introduced commercially, anesthesia
monitoring products. If we do not compete effectively with these monitoring products, our revenue
could be adversely affected. Our current and planned products are at risk of obsolescence from:
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other new monitoring products, based on new or improved technologies;
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new products or technologies used on patients or in the operating room during
surgery in lieu of monitoring devices;
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electrical or mechanical interference from new or existing products or technologies;
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alternative techniques for evaluating the effects of anesthesia;
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significant changes in the methods of delivering anesthesia; and
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the development of new anesthetic agents.
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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 to grow our business.
If we do not maintain our relationships with the anesthesia community and if anesthesiologists and
other healthcare providers do not recommend and endorse our products, our sales may decline or we
may be unable to increase our sales and profits.
Physicians typically influence the medical device purchasing decisions of the hospitals and
other healthcare institutions in which they practice. Consequently, our relationships with
anesthesiologists are critical to our growth. We believe that these relationships are based on the
quality of our products, our long-standing commitment to the consciousness monitoring market, our
marketing efforts and our presence at medical society and trade association meetings. Any actual or
perceived diminution in our reputation or the quality of our products, or our failure or inability
to maintain our commitment to the consciousness monitoring market and our other marketing and
product promotion efforts could damage our current relationships, or prevent us from forming new
relationships, with anesthesiologists and other anesthesia professionals and cause our growth to be
limited or decline and our business to be harmed.
In order for us to sell our products, anesthesia professionals must recommend and endorse
them. We may not obtain the necessary recommendations or endorsements from this community.
Acceptance of our products depends on educating the medical community as to the distinctive
characteristics, perceived benefits, safety, clinical efficacy and cost-effectiveness of our
products compared to traditional methods of consciousness monitoring and the products of our
competitors, and on training healthcare professionals in the proper application of our products.
For example, the recent publication of a study in the
New England Journal of Medicine
that
concluded that no benefit of BIS monitoring was demonstrated when compared to an alternative
protocol for consciousness monitoring could adversely affect market perceptions of the benefits of
our BIS monitoring products and, accordingly, the degree to which anesthesia professionals and
other healthcare providers endorse those products. If we are not successful in obtaining and
maintaining the
recommendations or endorsements of anesthesiologists and other healthcare professionals for
our products, our sales may decline or we may be unable to increase our sales and profits.
Negative publicity or unfavorable media coverage could damage our reputation and harm our
operations.
Certain companies that manufacture medical devices have received significant negative
publicity in the past when their products did not perform as the medical community or patients
expected. This publicity, and the perception such products may not have functioned properly, may
result in increased litigation, including large jury awards, legislative activity, increased
regulation and governmental review of company and industry practices. If we were to receive such
negative publicity or unfavorable media
34
attention, whether warranted or unwarranted, our reputation would suffer, our ability to market our
products would be adversely affected, we may be required to change our products and become subject
to increased regulatory burdens and we may be required to pay large judgments or fines. Any
combination of these factors could further increase our cost of doing business and adversely affect
our financial position, results of operations and cash flows.
If we do not successfully develop or acquire and introduce enhanced or new products we could lose
revenue opportunities and customers.
Our success in developing or acquiring and commercializing new products and enhancements of
current products is affected by our ability to:
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identify and respond, in a timely manner, to new market trends or opportunities;
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assess customer needs;
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successfully develop or acquire competitive products;
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complete regulatory clearance in a timely manner;
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successfully develop cost effective manufacturing processes;
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introduce such products to our customers in a timely manner; and
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achieve market acceptance of the BIS system.
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If we are unable to continue to develop or acquire and market new products and technologies,
we may experience a decrease in demand for our products, and a loss of market share and our
business would suffer. As the market for our BIS system matures, we need to develop or acquire and
introduce new products for anesthesia monitoring or other applications. Additionally, we have
begun to research the use of BIS monitoring to diagnose, track and manage neurological diseases,
including Alzheimers disease and depression. We face at least the following two risks with respect
to our planned development of new products and our entrance into potential new markets:
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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
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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.
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We are focused on the market for brain monitoring products. The projected demand for our
products could materially differ from actual demand if our assumptions regarding this market and
its trends and acceptance of our products by the medical community prove to be incorrect or do not
materialize or if other products or technologies gain more widespread acceptance, which in each
case would adversely affect our business prospects and profitability.
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 our clinical trials are delayed or unsuccessful, our business could be adversely affected.
We are conducting several clinical studies, including studies in the areas of interoperative
awareness in children, depression and Alzheimers disease, and the association between deep
anesthesia and long-term patient outcomes. Clinical trials require sufficient patient enrollment,
which is a function of many factors, including the size of the patient population, the nature of
the protocol and the eligibility criteria for the clinical trial. Delays in patient enrollment can
result in increased costs and longer development times.
We cannot predict whether we will encounter problems with respect to any of our completed,
ongoing or planned clinical trials that will cause us or regulatory authorities to delay or suspend
our clinical trials or delay the analysis of data from our completed or ongoing clinical trials.
Moreover, the final results of our clinical trials may not support or confirm any preliminary or
interim results and we may not successfully reach the endpoints in these trials. Even if we
successfully complete our clinical trials the FDA or other regulatory agencies may not accept the
results.
35
Any of the following could delay the completion of our ongoing and planned clinical trials, or
result in a failure of these trials to support our business:
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delays or the inability to obtain required approvals from institutional review
boards or other governing entities at clinical sites selected for participation in
our clinical trials;
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delays in enrolling patients and volunteers into clinical trials;
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lower than anticipated retention rates of patients and volunteers in clinical trials;
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negative results from clinical trials for any of our potential products, including
those involving the management of depression and the early diagnosis and tracking of
Alzheimers disease; and
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failure of our clinical trials to demonstrate the efficacy or clinical utility of
our potential products.
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If we determine that the costs associated with attaining regulatory approval of a product
exceed the potential financial benefits or if the projected development timeline is inconsistent
with our determination of when we need to get the product to market, we may choose to stop a
clinical trial and/or development of a product.
If we do not develop and implement a successful sales and marketing strategy, we will not expand
our business.
In the past, we have experienced high turnover in our direct sales force. It is possible that
high turnover may occur in the future. If new sales representatives do not acquire the
technological skills to sell our products in a timely and successful manner or we experience high
turnover in our direct sales force, we may not be able to sustain and grow our product revenue. In
addition, in order to increase our sales, we need to continue to strengthen our relationships with
our international distributors and continue to add international distributors. Also, we need to
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 need to develop and
introduce new sales and marketing programs and clinical education programs to promote the use of
the BIS system by our customers. We are currently shifting the focus of our sales and marketing
emphasis from expanding our customer base to developing our existing customers and increasing their
sensor utilization and procedure penetration. If we do not implement these new sales and marketing
and education 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. 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. Among other things, we need to:
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provide or assure that distributors and original equipment manufacturers provide the
technical and educational support customers need to use the BIS system successfully;
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promote frequent use of the BIS system so that sales of our disposable BIS Sensors increase;
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establish and implement successful sales and marketing and education programs that
encourage our customers to purchase our products or the products that are made by original
equipment manufacturers incorporating our technology;
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manage geographically dispersed operations; and
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modify our products and marketing and sales programs for foreign markets.
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We encourage our direct sales force, distributors and original equipment manufacturers to maximize
the amount of our products they sell and they may engage in aggressive sales practices that may
harm our reputation.
We sell our products through a combination of a direct sales force, third party distributors
and original equipment manufacturers. As a means to incentivize the sales force, distributors and
original equipment manufacturers, the compensation we pay increases with the amount of our products
they sell. For example, the compensation paid to the members of our direct sales force consists, in
part, of commissions and, the greater the amount of sales, the higher the commission we pay. The
participants in our sales channels may engage in sales practices that are aggressive or considered
to be inappropriate by existing or potential customers. In addition, we do not exercise control
over, and may not be able to provide sufficient oversight of, the sales practices and techniques
used by third party distributors and original equipment manufacturers. Negative public opinion
resulting from these sales practices can adversely affect our ability to keep and attract customers
and could expose us to litigation.
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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. In addition, 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 international 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
international markets. Revenue from international activities may not offset the expense of
establishing and maintaining these international 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:
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failure of local laws to provide adequate protection against infringement of our intellectual property;
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protectionist laws and business practices that favor local competitors, which could slow or prohibit
our growth in international markets;
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difficulties in terminating or modifying distributor arrangements because of restrictions in markets
outside the United States;
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less acceptance by foreign anesthesia providers of the use of disposable products, such as BIS Sensors;
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delays in regulatory approval of our products;
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currency conversion issues arising from sales denominated in currencies other than the United States
dollar;
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foreign currency exchange rate fluctuations;
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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
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longer accounts receivable payment cycles and difficulties in collecting accounts receivable.
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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 and could adversely impact our results
of operations.
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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, original equipment manufacturer products 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 for any reason, including damage or destruction of the 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. Even if we are able to
identify alternative facilities to manufacture our products, if necessary, we may experience
disruption in the supply of our products until such facilities are available. Although we believe
we possess adequate insurance for damage to our property and the disruption of our business from
casualties, such insurance may not be sufficient to cover all of our potential losses and may not
be available to us on acceptable terms or at all. Additionally, 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, and in select cases,
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. If a supplier is no longer willing or able to
manufacture components that we purchase and integrate into the BIS system, we may attempt to design
replacement components ourselves that would be compatible with our existing technology. In doing
so, we would incur additional research and development expenses, and there can be no assurance that
we would be successful in designing or manufacturing any replacement components. 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 system products 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. Any patents we have obtained or will obtain in the future might also be invalidated or
circumvented by third parties. Our pending patent applications may not issue as patents or, if
issued, may not provide commercially meaningful protection, as competitors may be able to design
around our patents or produce alternative, non-infringing designs. 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 business and may not be adequate to protect our
intellectual property rights.
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 subject 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:
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cease selling, incorporating or using any of our products that incorporate the
challenged intellectual property, which would adversely affect our revenue;
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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
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redesign our products, which may be costly, time-consuming and may not be successful.
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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. There
may be increased risk of misuse of our products if persons not skilled in consciousness monitoring
attempt to use our BIS monitoring products. 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 and could lead to product recalls.
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 and the Securities Exchange Act of 1934, as amended, or the
Securities Exchange Act. 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 the 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. Even if we are not named as defendants in these lawsuits,
we may also be required to incur significant costs and our management may be distracted by being
required to provide information, documents or testimony in connection with the actions against our
underwriters. 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.
We and Boston Scientific recently jointly terminated our strategic alliance and other agreements
and, as a result, we may not have sufficient funding to finance our neuroscience programs.
On June 11, 2007, we and Boston Scientific Corporation entered into a termination and
repurchase agreement under which we jointly agreed to terminate the following agreements between
the parties:
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the original equipment manufacturer product development agreement dated as of
August 7, 2002, pursuant to which we were seeking to develop certain products that
Boston Scientific Corporation would then commercialize in the area of monitoring
patients under sedation in a range of less invasive medical specialties, and pursuant
to which we granted Boston Scientific Corporation an exclusive option to become the
distributor for a period of time of certain of our products.
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the product development and distribution agreement dated as of May 23, 2005,
pursuant to which we were seeking to develop new applications of its brain-monitoring
technology in the area of the diagnosis and treatment of neurological, psychiatric and
pain disorders and Boston Scientific Corporation was appointed the exclusive
distributor of such products. Under this agreement, which we refer to as the
neuroscience alliance, Boston Scientific Corporation had agreed to provide $25.0
million of funding over a five year period. We received $10.0 million under this
agreement.
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the letter agreement dated August 7, 2002, and the security agreement dated August
7, 2002, pursuant to which Boston Scientific Corporation agreed to make revolving
interest-bearing loans to us from time to time at our request, such revolving loans
being evidenced by a promissory note in the original principal amount of $5,000,000
dated August 7, 2002 made by us in favor of Boston Scientific Corporation.
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As a result of the termination of our alliance with Boston Scientific Corporation, we have
regained the commercial rights to products subject to the alliance that we previously shared, but
we have lost the support that Boston Scientific Corporation would have provided under the alliance
to develop and market products for monitoring patients under sedation and for neuroscience
applications. Specifically, we will lose funding and distribution support from Boston Scientific
Corporation for these products. Consequently, we may need to find alternative sources of funds,
which may not be available, and we may need to develop our own distribution capabilities or use a
third-party distributor. There can be no guarantee that we will be able to develop these new
products successfully on our own or that we will be able to reach any agreement with a third-party
distributor on terms acceptable to us, or at all.
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 a number of competitors monitoring systems which have been cleared for marketing 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. We are seeking to develop new
products and technologies in the areas of depression and Alzheimers disease. If we are not
successful in developing new products or technologies, or if we experience delays in development or
release of such products, we may not be able to compete successfully.
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.
Our products are classified as medical devices and are subject to extensive regulation in the
United Sates by the FDA and other federal, state, and local authorities. These regulations relate
to the manufacturing, labeling, sale, promotion, distribution, importing, exporting and shipping of
our products. Before we can market new products or a new use of, or claim for, an existing product
in the United States, we must obtain clearance or approval from the 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
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Act, then we would be required to file a premarket approval application. For example, there
can be no guarantee that the FDA will accept the results from our depression clinical trial as
supportive of a 510(k) notification without requiring additional studies and/or a premarket
approval application. Both of these processes can be lengthy, expensive, may require extensive
data from preclinical studies and clinical trials and may require significant user fees. The
premarket approval process typically is more burdensome, expensive, time-consuming and uncertain
than the premarket notification process. We may not obtain clearance of a 510(k) notification or
approval of a premakret 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 determinations,
it will require us to file a new 510(k) notification for the modification, and we may be prohibited
from marketing the modified devices until we obtain FDA clearance, or be required to recall devices
that may be on the market, or be subject to other sanctions.
Medical devices may be marketed only for the indications for which they are approved or
cleared. The FDA may fail to approve or clear indications that are necessary or desirable for
successful commercialization of our products. The FDA also may refuse our request for 510(k)
clearance or premarket approval of new products, new intended uses, or modification to products
once they are approved or cleared. Our approvals or clearance can be revoked if safety or
effectiveness problems develop.
Our promotional materials and training methods must comply with the FDA and other applicable
laws and regulations. If the FDA determines that our promotional materials or training constitute
promotion of an unapproved use, it could request that we modify our training or promotional
materials or subject us to regulatory or enforcement actions, including the issuance of an untitled
letter, a warning letter, injunction, seizure, civil monetary penalties, or criminal prosecution.
It also is possible that other federal, state, or foreign enforcement authorities might take action
if they consider our promotional or training materials to constitute promotion of an unapproved
use, which could result in significant fines or penalties under other statutory authorities, such
as laws prohibiting false claims for reimbursement. In that event, our reputation could be
damaged, adoption of the products could be impaired, and we might not be able to promote the
products for certain uses for which we had expected to promote them.
The FDA also requires us to adhere to current Good Manufacturing Practices regulations, also
known as the Quality System Regulation (QSR) in the case of medical devices, which include
production controls, design controls, testing, quality control, documentation procedures,
verification and validation of the design and of the production process, purchasing controls for
materials and components, implementation of corrective and preventive actions, and servicing, among
other requirements. The FDA may at any time inspect our facilities to determine whether adequate
compliance with QSR requirements has been achieved. Compliance with the QSR 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 issue a warning letter, withdraw marketing
clearance, require product recall, seize products, seek an injunction or consent decree, or seek
criminal prosecution, among other possible remedies. When any change or modification is made to a
device or its intended use, the manufacturer may be required to reassess compliance with the QSR
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.
Even if we obtain the necessary FDA clearances or approvals, if we or our suppliers fail to comply
with ongoing regulatory requirements our products could be subject to restrictions or withdrawal
from the market.
We are subject to the Medical Device Reporting, or MDR, regulations that require us to report
to the FDA if our products may have caused or contributed to patient death or serious injury, or if
our device malfunctions and a recurrence of the malfunction would likely result in a death or
serious injury. We must also file reports of device corrections and removals and adhere to the
FDAs rules on labeling and promotion. Our failure to comply with these or other applicable
regulatory requirements could result in enforcement action by the FDA, which may include any of the
following:
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untitled letters, warning letters, fines, injunctions and civil penalties;
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administrative detention, which is the detention by the FDA of medical devices believed to be
adulterated or misbranded;
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customer notification, or orders for repair, replacement or refund;
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voluntary or mandatory recall or seizure of our products;
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operating restrictions, partial suspension or total shutdown of production;
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refusal to review pre-market notification or pre-market approval submissions;
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rescission of a substantial equivalence order or suspension or withdrawal of a pre-market approval; and
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criminal prosecution.
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Any of the foregoing actions by the FDA could have a material adverse effect on our business
and results of operations.
We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws and
regulations and, if we are unable to fully comply with such laws, could face substantial penalties.
Our operations may be directly or indirectly affected by various state and federal healthcare
fraud and abuse laws, including the federal Anti-Kickback Statute, which prohibits any person from
knowingly and willfully offering, paying, soliciting or receiving remuneration, directly or
indirectly, to induce or reward either the referral of an individual, or the furnishing or
arranging for an item or service, for which payment may be made under federal healthcare programs,
such as the Medicare and Medicaid programs. If our past or present operations are found to be in
violation of these laws, we or our officers may be subject to civil or criminal penalties,
including large monetary penalties, damages, fines, imprisonment and exclusion from Medicare and
Medicaid program participation. If enforcement action were to occur, our business and financial
condition would be harmed.
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, or if we do not maintain good relationships with
our employees, 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.
In addition, we may be subject to claims that we engage in discriminatory or other unlawful
practices with respect to our hiring, termination, promotion and compensation processes for our
employees. Such claims, with or without merit, could be time consuming, distracting and expensive
to defend, could divert attention of our management from other tasks important to the success of
our business and could adversely affect our reputation as an employer.
If we make any acquisitions, we will incur a variety of costs and may never successfully integrate
the acquired business into ours.
We may attempt to acquire businesses, technologies, services or products that we believe are a
strategic complement to our business. We may encounter operating difficulties and expenditures
relating to integrating an acquired business, technology,
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service or product. These acquisitions may also absorb significant management attention that would otherwise be available for ongoing
development of our business. Moreover, we may never realize the anticipated benefits of any
acquisition. We may also make dilutive issuances of equity securities, incur debt or experience a decrease in the cash
available for our operations, or incur contingent liabilities in connection with any future
acquisitions, all of which could have a material adverse affect on our business, financial
condition and results of operations.
Our employees may engage in misconduct or other improper activities, including insider trading.
We are exposed to the risk that employee fraud or other misconduct could occur. Misconduct by
employees could include intentional failures to comply with FDA regulations, to provide accurate
information to the FDA, to comply with manufacturing standards we have established, to comply with
federal and state healthcare fraud and abuse laws and regulations, to accurately report financial
information or data or to disclose unauthorized activities to us. Employee misconduct could also
involve the improper use of customer information or information obtained in the course of clinical
trials, which could result in regulatory sanctions and serious harm to our reputation. We have
adopted a Code of Business Conduct and Ethics, but it is not always possible to identify and deter
employee misconduct, and the precautions we take to detect and prevent this activity may not be
effective in controlling unknown or unmanaged risks or losses.
In addition, during the course of our operations, our directors, executives and employees may
have access to material, non-public information regarding our business, our results of operations
or potential transactions we are considering. Despite the adoption of an Insider Trading Policy, we
may not be able to prevent a director or employee from trading in our common stock on the basis of
or while having access to material, non-public information. If a director or employee was to be
investigated, or an action was to be brought against a director or employee, for insider trading,
it could have a negative impact on our reputation and our stock price. Such a claim, with or
without merit, could also result in substantial expenditures of time and money, and divert
attention of our management team from other tasks important to the success of our business.
Failure of users of the BIS system, or users of future products we may develop, to obtain adequate
reimbursement from third-party payors could limit market acceptance of the BIS system and other
products, which could prevent us from sustaining 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 sustaining profitability.
In addition, market acceptance of future products serving the depression and Alzheimers
disease markets could depend upon adequate reimbursement from third-party payors. The ability and
willingness of third-party payors to authorize coverage and sufficient reimbursement to compensate
and encourage physicians to use such products is uncertain.
The market price of our stock is highly volatile, and this volatility could cause your investment
in our stock to suffer a decline in value and cause us to incur significant costs from class action
litigation.
The market price of our stock is highly volatile. For example, from January 1, 2008 through
May 1, 2008, the price of our common stock has ranged from a high of $14.25 to a low of $4.87. As
a result of this volatility, your investment in our stock could rapidly lose its value. Our stock
price could fluctuate for many reasons, including without limitation:
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variations in our quarterly operating results or those of companies that are perceived
to be similar to us;
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third-party sales of large blocks of our common stock;
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rumors relating to us or our competitors;
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changes to our research and development plans and/or announcements regarding new
technologies by us or our competitors;
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adverse results in clinical trials of our BIS monitoring system products and products
under development;
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lawsuits involving us;
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sales by us of equity or debt to fund our operations;
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the loss of any of our key scientific or management personnel;
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FDA or international regulatory actions or lawsuits concerning the safety of our
products; and
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market conditions, both in the medical device sector and generally.
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In addition, the stock markets in general have been extremely volatile, and have experienced
fluctuations that have often been unrelated or disproportionate to the operating performance of the
companies whose stock is trading. These broad market fluctuations could result in extreme
fluctuations in the price of our common stock, which could cause a decline in the value of our
shares.
Transactions engaged in by our largest stockholders, our directors or executives involving our
common stock may have an adverse effect on the price of our stock.
Sales of our shares by our largest stockholders could have the effect of lowering our stock
price. The perceived risk associated with the possible sale of a large number of shares by these
stockholders, or the adoption of significant short positions by hedge funds or other significant
investors, could cause some of our stockholders to sell their stock, thus causing the price of our
stock to decline. In addition, actual or anticipated downward pressure on our stock price due to
actual or anticipated sales of stock by directors or officers of Aspect could cause other
institutions or individuals to engage in short sales of our common stock, which may further cause
the price of our stock to decline.
From time to time our directors and executive officers sell shares of our common stock on the
open market. These sales are publicly disclosed in filings made with the SEC. In the future, our
directors and executive officers may sell a significant number of shares for a variety of reasons
unrelated to the performance of our business. Our stockholders may perceive these sales as a
reflection on managements view of the business and result in some stockholders selling their
shares of our common stock. These sales could cause the price of our stock to drop.
We have various mechanisms in place to discourage takeover attempts, which may reduce or eliminate
our stockholders ability to sell their shares for a premium in a change of control transaction.
Various provisions of our certificate of incorporation and by-laws and of Delaware corporate
law may discourage, delay or prevent a change in control or takeover attempt of our company by a
third party that is opposed by our management and board of directors. Public stockholders who might
desire to participate in such a transaction may not have the opportunity to do so. These
anti-takeover provisions could substantially impede the ability of public stockholders to benefit
from a change of control or change in our management and board of directors. These provisions
include:
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preferred stock that could be issued by our board of directors to make it more difficult for a third
party to acquire, or to discourage a third party from acquiring, a majority of our outstanding voting
stock;
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classification of our directors into three classes with respect to the time for which they hold office;
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non-cumulative voting for directors;
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control by our board of directors of the size of our board of directors;
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limitations on the ability of stockholders to call special meetings of stockholders;
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inability of our stockholders to take any action by written consent; and
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advance notice requirements for nominations of candidates for election to our board of directors or
for proposing matters that can be acted upon by our stockholders at stockholder meetings.
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Risks
Related to our Issuance of $125 Million Principal Amount of
2.5% Convertible Senior Notes due 2014
Our increased indebtedness as a result of the issuance of $125 million principal amount of 2.5%
convertible senior notes, or the notes, may harm our financial condition and results of operations.
Our level of indebtedness could have important consequences to investors, because:
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it could adversely affect our ability to satisfy our obligations under the notes;
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a substantial portion of our cash flows from operations will have to be dedicated to
interest payments, principal payments and, if we irrevocably elect to net share settle the
notes, conversion payments and may not be available for operations, working capital,
capital expenditures, expansion, acquisitions or general corporate or other purposes;
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it may impair our ability to obtain additional financing in the future;
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it may limit our flexibility in planning for, or reacting to, changes in our business
and industry; and
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it may make us more vulnerable to downturns in our business, our industry or the economy
in general.
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Our operations may not generate sufficient cash to enable us to service our debt. If we fail
to make a payment on the notes, we could be in default on the notes, and this default could cause
us to be in default on our other indebtedness outstanding at that time. Conversely, a default on
our other outstanding indebtedness may cause a default under the notes.
We may not have the cash necessary to pay interest on the notes, to settle conversions of the notes
(if we have obtained stockholder approval to elect net share settlement of the notes, and we
irrevocably elect such settlement method) or to repurchase the notes upon a fundamental change.
The notes bear interest semi-annually at a rate of 2.5% per annum. In addition, we may in
certain circumstances be obligated to pay additional interest. If at any time on or prior to the
45th scheduled trading day preceding the maturity date of the notes we obtain stockholder approval
of the net share settlement feature in connection with the potential conversion of the notes, and
if we irrevocably elect to use such feature, then upon conversion of the notes we would:
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pay cash in an amount equal to the lesser of one-fortieth of the principal amount of the
notes being converted and the daily conversion value (the product of the conversion rate
and the current trading price) of the notes being converted and,;
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issue shares of our common stock only to the extent that the daily conversion value of
the notes exceeded one-fortieth of the principal amount of the notes being converted for
each trading day of the relevant 40 trading day observation period.
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Holders of notes also have the right to require us to repurchase all or a portion of their
notes for cash upon the occurrence of a fundamental change. Any of our future debt agreements or
securities may contain similar provisions. We may not have sufficient funds to pay interest, pay
any such cash amounts to the note holders upon conversion or make the required repurchase of the
notes at the applicable time and, in such circumstances, may not be able to arrange the necessary
financing on favorable terms, if at all. In addition, our ability to pay interest, pay cash to the
note holders upon conversion or make the required repurchase, as the case may be, may be limited by
law or the terms of other debt agreements or securities. Our failure to pay such cash amounts to
holders of notes or make the required repurchase, as the case may be, however, would constitute an
event of default under the indenture governing the notes which, in turn, could constitute an event
of default under other debt agreements or securities, thereby resulting in their acceleration and
required prepayment and further restrict our ability to make such payments and repurchases.
The net share settlement feature of the notes, if available, may have adverse consequences.
If we have obtained stockholder approval to elect net share settlement of the notes, the net
share settlement feature of the notes may:
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result in holders receiving no shares of our common stock upon conversion or fewer shares of our common stock relative to the conversion value of the notes;
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reduce our liquidity because we will be required to pay the principal portion in cash;
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delay holders receipt of the proceeds upon conversion; and
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subject holders to market risk before receiving any shares upon conversion.
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If we obtain stockholder approval of the net share settlement feature in connection with the
potential conversion of the notes, and if we irrevocably elect to use such feature, then upon
conversion of the notes we would (1) pay cash in an amount equal to the lesser of one-fortieth of
the principal amount of the notes being converted and the daily conversion value (the product of
the conversion rate and the current trading price) of the notes being converted and (2) issue
shares of our common stock only to the extent that the daily conversion value of the notes exceeded
one-fortieth of the principal amount of the notes being converted for each trading day of the
relevant 40 trading day observation period.
Because the consideration due upon conversion of notes is based in part on the trading prices
of our common stock, any decrease in the price of our common stock after notes are tendered for
conversion may significantly decrease the value of the consideration received upon conversion.
Furthermore, because under net share settlement we must settle at least a portion of our conversion
obligation in cash, the conversion of notes may significantly reduce our liquidity.
Future sales of our common stock in the public market or the issuance of securities senior to our
common stock could adversely affect the trading price of our common stock and the value of the
notes and our ability to raise funds in new securities offerings.
Future sales of our common stock, the perception that such sales could occur or the
availability for future sale of shares of our common stock or securities convertible into or
exercisable for our common stock could adversely affect the market prices of our common stock and
the value of the notes prevailing from time to time and could impair our ability to raise capital
through future offerings of equity or equity-related securities. In addition, we may issue common
stock or equity securities senior to our common stock in the future for a number of reasons,
including to finance our operations and business strategy, to adjust our ratio of debt to equity,
to satisfy our obligations upon the exercise of options or for other reasons.
As of March 29, 2008, we had outstanding options to purchase 4,453,259 shares of our common
stock at a weighted average exercise price of $17.16 per share (1,113,118 of which have not yet
vested) issued to employees, directors and consultants pursuant to our 1991 Amended and Restated
Stock Option Plan, 1998 Stock Incentive Plan, Amended and Restated 1998 Director Equity Incentive
Plan and 2001 Stock Incentive Plan, as amended. In order to attract and retain key personnel, we
may issue additional securities, including stock options, restricted stock grants and shares of
common stock, in connection with our employee benefit plans, or may lower the price of existing
stock options. No prediction can be made as to the effect, if any, that the sale, or the
availability for sale, of substantial amounts of common stock by our existing stockholders pursuant
to an effective registration statement or under Rule 144, through the exercise of registration
rights or the issuance of shares of common stock upon the exercise of stock options, or the
perception that such sales or issuances could occur, could adversely affect the prevailing market
prices for our common stock and the value of the notes.
Conversion of the notes will dilute the ownership interest of existing stockholders, including
holders who had previously converted their notes.
To the extent we issue any shares of our common stock upon conversion of the notes, the
conversion of some or all of the notes will dilute the ownership interests of existing
stockholders, including holders who have received shares of our common stock upon prior conversion
of the notes. Any sales in the public market of the common stock issuable upon such conversion
could adversely affect prevailing market prices of our common stock. In addition, the existence of
the notes may encourage short selling by market participants because the conversion of the notes
could depress the price or our common stock.
Provisions in the indenture for the notes may deter or prevent a business combination that may be
favorable to note holders.
If a fundamental change occurs prior to the maturity date of the notes, holders of the notes
will, have the right, at their option, to require us to repurchase all or a portion of their notes.
In addition, if a make-whole fundamental change occurs prior to the maturity date of the notes, we
will in some cases increase the conversion rate for a holder that elects to convert its notes in
connection with such make-whole fundamental change. In addition, the indenture governing the notes
prohibits us from engaging in certain mergers or acquisitions unless, among other things, the
surviving entity assumes our obligations under the notes. These and other provisions could prevent
or deter a third party from acquiring us.
The notes may not be rated or may receive a lower rating than anticipated.
We do not intend to seek a rating on the notes. However, if one or more rating agencies rates
the notes and assigns the notes a rating lower than the rating expected by investors, or reduces or
indicates that they may reduce their rating in the future, the market price of the notes and our
common stock could be harmed.
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The effective subordination of the notes to our secured indebtedness to the extent of the
collateral securing such indebtedness may limit our ability to satisfy our obligations under the
notes.
The notes will be our senior unsecured obligations and rank equally with any senior debt and
senior to any subordinated debt. However, the notes will be effectively subordinated to our secured
indebtedness to the extent of the value of the collateral securing such indebtedness. As of March
29, 2008, we did not have any secured indebtedness outstanding. The provisions of the indenture
governing the notes do not prohibit us from incurring secured indebtedness in the future.
Consequently, in the event of a bankruptcy, liquidation, dissolution, reorganization or similar
proceeding with respect to us, the holders of any secured indebtedness will be entitled to proceed
directly against the collateral that secures such secured indebtedness. Therefore, such collateral
will not be available for satisfaction of any amounts owed under our unsecured indebtedness,
including the notes, until such secured indebtedness is satisfied in full.
The structural subordination of the notes to our secured liabilities and all liabilities and
preferred equity of our subsidiaries may limit our ability to satisfy our obligations under the
notes.
The notes will be effectively subordinated to all unsecured and secured liabilities and
preferred equity of our subsidiaries. In the event of a bankruptcy, liquidation, dissolution,
reorganization or similar proceeding with respect to any such subsidiary, we, as a common equity
owner of such subsidiary, and, therefore, holders of our debt, including holders of the notes, will
be subject to the prior claims of such subsidiarys creditors, including trade and other payables,
but excluding intercompany indebtedness. As of March 29, 2008, our subsidiaries had an accounts
payable and accrued liabilities balance of approximately $1,280,000. The provisions of the
indenture governing the notes do not prohibit our subsidiaries from incurring additional
liabilities or issuing preferred equity in the future.
Item 6. Exhibits.
The exhibits listed in the Exhibit Index immediately preceding the exhibits are filed
as part of this Quarterly Report on Form 10-Q.
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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.
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ASPECT MEDICAL SYSTEMS, INC.
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Date: May 8, 2008
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By:
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/s/ Michael Falvey
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Michael Falvey
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Vice President and Chief Financial Officer
(Principal Financial and Accounting Officer)
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48
EXHIBIT INDEX
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EXHIBIT
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NUMBER
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EXHIBIT
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10.1
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BISx International License Agreement by and between Aspect Medical
Systems, Inc. and Nihon Kohden Corporation dated as of March 21,
2008.
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31.1
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Certification by Chief Executive Officer Pursuant to Rule
13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as
amended.
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31.2
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Certification by Chief Financial Officer Pursuant to Rule
13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as
amended.
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32.1
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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.
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32.2
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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.
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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.
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