PART
I - FINANCIAL INFORMATION
Item
1. Financial Statements
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NORTH
AMERICAN SCIENTIFIC, INC.
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Consolidated
Balance Sheets
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July
31,
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October
31,
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2007
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2006
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(Unaudited)
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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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1,817,000
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$
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903,000
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Marketable
securities, held to maturity
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---
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8,420,000
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Accounts
receivable, net of reserves
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1,911,000
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2,618,000
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Inventories,
net of reserves
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1,775,000
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1,284,000
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Prepaid
expenses and other current assets
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909,000
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830,000
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Assets
held for sale
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3,634,000
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11,377,000
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Total
current assets
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10,046,000
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25,432,000
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Equipment
and leasehold improvements, net
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1,047,000
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1,318,000
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Goodwill
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---
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---
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Intangible
assets, net
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117,000
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138,000
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Other
assets
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59,000
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310,000
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Total
assets
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$
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11,269,000
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$
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27,198,000
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Liabilities
and Stockholders’ Equity
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Current
liabilities
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Line
of Credit
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$
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1,363,000
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$
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---
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Accounts
payable
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2,468,000
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2,406,000
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Accrued
expenses
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3,422,000
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3,790,000
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Deferred
revenue
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---
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---
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Liabilities
held for sale
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3,263,000
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3,814,000
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Total
current liabilities
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10,516,000
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10,010,000
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Commitments
and contingencies
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Stockholders’
Equity
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Preferred
stock, $0.01 par value, 2,000,000 shares authorized; no
shares
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Issued
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—
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—
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Common
stock, $0.01 par value, 100,000,000 shares and 40,000,000 shares
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authorized,
29,601,352 and 29,447,270 shares issued, 29,395,331 and 29,336,144
shares
outstanding, as of July 31, 2007 and
October
31, 2006, respectively
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299,000
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298,000
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Additional
paid-in capital
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145,264,000
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144,543,000
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Treasury
stock, at cost - 206,021 and 111,126 common shares as of July 31,
2007 and
October
31, 2006, respectively
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(227,000
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(133,000
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Accumulated
deficit
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(144,583,000
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(127,520,000
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Total
stockholders’ equity
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753,000
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17,188,000
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Total
liabilities and stockholders’ equity
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$
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11,269,000
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$
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27,198,000
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See
condensed notes to the consolidated financial
statements.
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NORTH
AMERICAN SCIENTIFIC, INC.
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Consolidated
Statements of Operations
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(Unaudited)
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Three
months ended July 31,
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Nine
months ended July 31,
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2007
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2006
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2007
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2006
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Revenue
-
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Product
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$
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3,438,000
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$
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3,166,000
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$
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11,140,000
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$
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9,245,000
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Total
revenue
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3,438,000
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3,166,000
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11,140,000
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9,245,000
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Cost
of revenue -
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Product
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2,688,000
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2,172,000
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7,792,000
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6,700,000
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Total
cost of revenue
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2,688,000
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2.172,000
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7,792,000
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6,700,000
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Gross
profit
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750,000
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994,000
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3,348,000
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2,545,000
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Operating
expenses
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Selling
expenses
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1,060,000
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654,000
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2,845,000
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1,972,000
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General
and administrative expenses
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2,073,000
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2,605,000
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6,516,000
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6,302,000
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Research
and development
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518,000
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182,000
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1,282,000
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715,000
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Total
operating expenses
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3,651,000
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3,441,000
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10,643,000
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8,989,000
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Loss
from operations
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(2,901,000
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(2,447,000
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(7,295,000
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(6,444,000
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Interest
and other (expense) income, net
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(69,000
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(79,000
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(98,000
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(171,000
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Loss
before provision for income taxes
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(2,970,000
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(2,526,000
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(7,393,000
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(6,615,000
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Loss
from continuing operations
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(2,970,000
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(2,526,000
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(7,393,000
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(6,615,000
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Loss
from discontinued operations, net of
tax
benefits
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(7,718,000
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(2,107,000
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(9,670,000
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(4,388,000
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Net
loss
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$
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(10,688,000
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$
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(4,633,000
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$
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(17,063,000
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$
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(11,003,000
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Basic
and diluted loss per share:
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Net
loss per share from continuing
operations
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$
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(
0.10
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$
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(
0.10
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$
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(
0.25
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$
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(
0.34
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Net
loss per share from discontinued
operations
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$
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(
0.26
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$
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(
0.09
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$
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(
0.33
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$
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(
0.23
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Net
loss per share
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$
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(
0.36
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$
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(
0.19
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$
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(
0.58
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$
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(
0.57
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Weighted
average number of shares
outstanding
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29,317,056
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23,954,948
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29,327,062
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19,327,230
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See
condensed notes to the consolidated financial statements.
NORTH
AMERICAN SCIENTIFIC, INC.
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Consolidated
Statements of Cash Flows
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(Unaudited)
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Nine
months ended July 31,
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2007
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2006
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Cash
flows from operating activities:
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Net
loss
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$
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(17,063,000
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$
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(11,003,000
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Net
loss from discontinued operations
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(9,670,000
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(4,388,000
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Net
loss from continuing operations
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(7,393,000
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(6,615,000
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Depreciation
and amortization
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414,000
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482,000
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Amortization
of warrants
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238,000
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142,000
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Share-based
compensation expense
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490,000
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645,000
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Provision
for doubtful accounts
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(213,000
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39,000
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Provision
for inventory adjustments
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88,000
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(88,000
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Loss
on sale of equipment
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4,000
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---
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Changes
in assets and liabilities, net of discontinued operations:
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Accounts
receivable
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921,000
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(659,000
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Inventories
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(581,000
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(249,000
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Prepaid
and other current assets
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(26,000
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(439,000
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Accounts
payable
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8,000
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62,000
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Accrued
expenses
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40,000
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(159,000
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Net
cash used in continuing operations
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(6,010,000
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(6,839,000
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Net
cash used in discontinued operations
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(2,675,000
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(4,235,000
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Net
cash used in operating activities
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(8,685,000
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(11,074,000
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Cash
flows from investing activities:
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Proceeds
from maturity (purchase) of marketable securities
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8,419,000
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(8,956,000
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)
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Proceeds
from sale of equipment
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15,000
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---
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Capital
expenditures
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(139,000
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)
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(232,000
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Net
cash provided by (used in) investing activities - continuing
operations
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8,295,000
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(9,188,000
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Net
cash used in investing activities - discontinued
operations
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(102,000
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)
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(75,000
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Net
cash provided (used in) by investing activities
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8,193,000
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(9,263,000
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Cash
flow from financing activities:
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Net
borrowings under line of credit
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1,363,000
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---
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Proceeds
from private placement of common stock and warrants, net
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---
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21,961,000
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Proceeds
from exercise of stock options and stock purchase plan
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137,000
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163,000
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Purchase
of stock for treasury
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(94,000
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)
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---
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Net
cash provided by financing activities - continuing
operations
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1,406,000
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22,124,000
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Net
cash provided (used in) by financing activities - discontinued
operations
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---
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---
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Net
cash provided by financing activities
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1,406,000
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22,124,000
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Net
increase in cash and cash equivalents
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914,000
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1,787,000
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Cash
and cash equivalents at beginning of period
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903,000
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2,630,000
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Cash
and cash equivalents at end of period
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$
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1,817,000
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$
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4,417,000
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Supplemental
disclosure:
In
the
nine months ended July 31, 2006, the Company has issued warrants with an
estimated fair value totaling $526,000 to a bank and a debt provider as
consideration for entering into Loan and Security Agreements. See
Note
8 to
the Financial Statements.
See
condensed notes to the consolidated financial statements.
NORTH
AMERICAN SCIENTIFIC, INC.
Condensed
Notes to Consolidated Financial Statements
(Unaudited)
NOTE
1—SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation
The
accompanying consolidated financial statements of the Company are unaudited,
other than the consolidated balance sheet at October 31, 2006, and reflect
all
material adjustments, consisting only of normal recurring adjustments, which
management considers necessary for a fair statement of the Company’s financial
position, results of operations and cash flows for the interim periods. The
results of operations for the current interim periods are not necessarily
indicative of the results to be expected for the entire fiscal
year.
These
consolidated financial statements have been prepared in accordance with the
rules and regulations of the Securities and Exchange Commission (“SEC”). Certain
information and footnotes normally included in financial statements prepared
in
accordance with generally accepted accounting principles in the United States
of
America have been condensed or omitted pursuant to these rules and regulations.
These consolidated financial statements should be read in conjunction with
the
consolidated financial statements and the notes thereto included in the
Company’s Form 10-K, as filed with the SEC for the fiscal year ended October 31,
2006.
Certain
reclassifications have been made to prior period balances in order to conform
to
the current period presentation.
Management’s
Plans
The
accompanying financial statements have been prepared on a going concern basis,
which contemplates the realization of assets and liquidation of liabilities
in
the normal course of business. We have incurred net losses of $17.1
million in the nine months ended July 31, 2007, and $17.1 million, $55.5 million
and $36.3 million for the years ended October 31, 2006, 2005 and 2004,
respectively. We have used cash in operations of $8.7 million in the nine months
ended July 31, 2007, and $15.9 million, $11.9 million and $23.1 million for
the
years ended October 31, 2006, 2005 and 2004, respectively. As of July 31,
2007, we had an accumulated deficit of $144.6 million; cash and cash equivalents
of $1.8 million; borrowings under a line of credit of $1.4 million and no
long-term debt.
Based
on
the Company’s current operating plans, management believes that the Company’s
existing cash resources and cash forecasted by management to be generated by
operations, funds to be raised by the Company through an equity financing,
as
well as the Company’s anticipated available line of credit, will be sufficient
to meet working capital and capital requirements through at least the next
twelve months. In this regard, we must raise additional financing in fiscal
2007
to support launch and continued development of ClearPath and fund our continuing
operations and other activities. However, there is no assurance that the Company
will be successful with its plans. If events and circumstances occur such
that the Company does not meet its current operating plans, the Company is
unable to raise sufficient additional financing, or the Company’s line of credit
(which presently expires on October 3, 2007) is insufficient or not available,
the Company will be required to further reduce expenses or take other steps
which could have a material adverse effect on our future performance, including
but not limited to, the premature sale of some or all of our assets or product
lines on undesirable terms, merger with or acquisition by another company on
unsatisfactory terms, or the cessation of operations.
Management
also expects that in future periods new products and services will provide
additional cash flow, although no assurance can be given that such cash flow
can
be realized, and we are presently placing an emphasis on controlling
expenses.
Use
of Estimates
In
the
normal course of preparing the financial statements in conformity with generally
accepted accounting principles in the United States of America, management
is
required 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 reported amounts of revenue and
expenses during the reporting period. Actual results could differ from
those amounts.
Marketable
Securities
The
Company invests excess cash in marketable securities consisting primarily of
commercial paper, corporate notes and bonds, U.S. Government securities and
money market funds. Investments with maturities of less than one year are
considered to be short term and are classified as current assets.
Debt
securities that the Company has the positive intent and ability to hold to
maturity are classified as "held-to-maturity" and reported at amortized cost.
Debt securities not classified as held-to-maturity and marketable equity
securities are classified as either "trading" or "available-for-sale," and
are
recorded at fair value with unrealized gains and losses included in earnings
or
stockholders' equity, respectively. All other equity securities are accounted
for using either the cost method or the equity method.
The
Company continually reviews its investments to determine whether a decline
in
fair value below the cost basis is other than temporary. If the decline in
fair
value is judged to be other than temporary, the cost basis of the security
is
written down to fair value and the amount of the write-down is included in
the
Consolidated Statements of Operations.
Accounts
Receivable and Allowance for Doubtful Accounts
Accounts
receivable are recorded at the invoiced amount and do not bear interest. The
allowance for doubtful accounts is the Company’s best estimate of the amount of
probable credit losses in our existing accounts receivable. The Company
determines the allowance based on historical write-off experience and customer
economic data. We review our allowance for doubtful accounts monthly. Past
due
balances over 60 days and over a specified amount are reviewed individually
for
collectibility. Account balances are charged off against the allowance when
the
Company believes that it is probable the receivable will not be recovered.
The
Company does not have any off-balance-sheet credit exposure related to our
customers.
Equipment
and Leasehold Improvements
Equipment
and leasehold improvements are stated at cost. Maintenance and repair costs
are
expensed as incurred, while improvements are capitalized. Gains or losses
resulting from the disposition of assets are included in income. Depreciation
and amortization are computed using the straight-line method over the estimated
useful lives as follows:
Furniture,
fixtures and equipment
|
3-7
years
|
Leasehold
improvements
|
Lesser
of the useful life or term of lease
|
Intangible
Assets
License
agreements are amortized on a straight-line basis over periods ranging up to
fifteen years. The amortization periods of patents are based on the lives of
the
license agreements to which they are associated or the approximate remaining
lives of the patents, whichever is shorter. Purchased intangible assets with
finite lives are carried at cost less accumulated amortization and are amortized
on a straight-line basis over periods ranging from three to twelve
years.
The
Company reviews for impairment whenever events and changes in circumstances
indicate that such assets might be impaired. If the estimated future cash flows
(undiscounted and without interest charges) from the use of an asset are less
than the carrying value, a write-down is recorded to reduce the related asset
to
its estimated fair value.
Revenue
Recognition
The
Company sells products for radiation therapy treatment, including brachytherapy
seeds used in the treatment of cancer and non-therapuetic sources used in
calibration devices.
Product
revenue
The
Company applies the provisions of SEC Staff Accounting Bulletin (“SAB”) No. 104,
“Revenue Recognition” for the sale of non-software products. SAB No. 104,
which supercedes SAB No. 101, “Revenue Recognition in Financial Statements”,
provides guidance on the recognition, presentation and disclosure of revenue
in
financial statements. SAB No. 104 outlines the basic criteria that must be
met to recognize revenue and provides guidance for the disclosure of revenue
recognition policies. In general, the Company recognizes revenue related
to product sales when (i) persuasive evidence of an arrangement exists, (ii)
delivery has occurred, (iii) the fee is fixed or determinable, and (iv)
collectibility is reasonably assured.
Stock-based
Compensation
Effective
November 1, 2005, the Company adopted Statement of Financial Accounting
Standards (“SFAS”) No. 123(R),
Share-Based
Payment
(“SFAS
123(R)”), which requires the measurement and recognition of compensation expense
for all share-based payment awards made to employees and directors, including
stock options and employee stock purchases related to the Company’s Employee
Stock Purchase Plan (the “Employee Stock Purchase Plan”), based on their fair
values. SFAS 123(R) supersedes Accounting Principles Board Opinion No. 25,
Accounting
for Stock Issued to Employees
(“APB
25”), which the Company previously followed in accounting for stock-based
awards. In March 2005, the SEC issued
Staff
Accounting Bulletin No. 107
(“SAB
107”) to provide guidance on SFAS 123(R). The Company has applied SAB 107 in its
adoption of SFAS 123(R).
The
Company adopted SFAS 123(R) using the modified prospective transition method
as
of and for the nine months ended July 31, 2007 and 2006. In accordance with
the
modified prospective transition method, the Company’s financial statements for
prior periods have not been restated to reflect, and do not include, the impact
of SFAS 123(R). Share-based compensation expense recognized is based on the
value of the portion of share-based payment awards that is ultimately expected
to vest. Share-based compensation expense recognized in the Company’s
Consolidated Statement of Operations during the nine months ended July 31,
2007
and 2006 includes compensation expense for share-based payment awards granted
prior to, but not yet vested as of, October 31, 2005 based on the grant date
fair value estimated in accordance with the pro forma provisions of SFAS 123
and
new stock option grants made subsequent to October 31, 2005. A total of
1,850,000, and 1,303,000 stock option grants were awarded to employees during
the nine months ended July 31, 2007 and 2006, respectively, and a total of
115,000 and 150,000 stock option grants were awarded to directors during the
nine months ended July 31, 2007 and 2006, respectively.
In
conjunction with the adoption of SFAS 123(R), the Company elected to attribute
the value of share-based compensation to expense using the straight-line method,
which was previously used for its pro forma information required under SFAS
123
and SFAS 148. Note that the stock option grants on March 16, 2006 included
a total of 650,500 stock options that contain certain market condition
requirements (“2007 Premium Price Awards”) The 2007 Premium Price Awards are, to
the extent provided by law, incentive stock options that have an exercise price
of $3.35 per share, which is equal to 159% of the fair market value of the
Company’s common stock on the grant date. The 2007 Premium Price Awards also
include a market condition that provides that such stock options will only
vest
if the closing price of the Company's common stock is equal to or greater than
$3.35 on each day over any consecutive four month period beginning on any date
after the date of grant and ending no later than the third anniversary of the
date of grant. If the market condition is not satisfied by the third anniversary
of the date of grant, the 2007 Premium Price Awards will not vest. Subject
to
the attainment of the market condition by the Company’s common stock, the 2007
Premium Price Awards will vest, if at all, in equal annual installments over
a
four year period beginning on the second anniversary of the grant date of March
16, 2006. The 2007 Premium Price Awards have a term of 8 years from the date
of
grant. As of July 31, 2007 the market condition for the vesting of the 2007
Premium Price Awards has not been met. Share-based compensation expense related
to stock options and employee stock purchases, including the 2007 Premium Price
Awards, of $176,000 and $209,000 for the three months ended July 31, 2007 and
2006, respectively, and $490,000 and $645,000 for the nine months ended July
31,
2007 and 2006, respectively, was recorded in the financial statements as a
component of general and administrative expense. Share-based compensation
expense of $33,000 and $41,000 for the three months ended July 31, 2007 and
2006, respectively and $94,000 and $85,000 for the nine months ended July 31,
2007 and 2006, respectively, was recorded as part of the discontinued operations
of NOMOS Corporation.
The
Company uses the Black-Scholes option-pricing model for estimating the fair
value of options granted. The Black-Scholes option-pricing model was developed
for use in estimating the fair value of traded options that have no vesting
restrictions and are fully transferable. In addition, option valuation models
require the input of highly subjective assumptions, including the expected
stock
price volatility. The Company uses projected volatility rates, which are based
upon historical volatility rates, trended into future years. Because the
Company’s employee stock options have characteristics significantly different
from those of traded options, and because changes in the subjective input
assumptions can materially affect the fair value estimate, in management’s
opinion, the existing models do not necessarily provide a reliable single
measure of the fair value of the Company’s options. For purposes of financial
statement presentation and pro forma disclosures, the estimated fair values
of
the options are amortized over the options’ vesting periods.
Net
Loss per Share
Basic
loss per share is computed by dividing the loss by the weighted average number
of shares outstanding for the period.
Diluted
earnings (loss) per share is computed by dividing the net income (loss) by
the
sum of the weighted average number of common shares outstanding for the period
plus the assumed exercise of all dilutive securities by applying the treasury
stock method. Stock options for which the exercise price exceeds the average
market price over the period have an anti-dilutive effect on earnings per share
and, accordingly, are excluded from the calculation. The following table sets
forth the computation of basic and diluted loss per share:
|
|
Three
months ended July 31,
|
|
Nine
months ended July 31,
|
|
|
|
2007
|
|
2006
|
|
2007
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss from continuing operations
|
|
$
|
(2,970,000
|
)
|
$
|
(2,526,000
|
)
|
$
|
(7,393,000
|
)
|
$
|
(6,615,000
|
)
|
Net
loss from discontinued operations
|
|
$
|
(7,718,000
|
)
|
$
|
(2,107,000
|
)
|
$
|
(9,670,000
|
)
|
$
|
(4,388,000
|
)
|
Net
loss
|
|
$
|
(10,688,000
|
)
|
$
|
(4,633,000
|
)
|
$
|
(17,063,000
|
)
|
$
|
(11,003,000
|
)
|
Weighted
average shares outstanding - basic
|
|
|
29,317,056
|
|
|
23,954,948
|
|
|
29,327,062
|
|
|
19,327,230
|
|
Dilutive
effect of stock options and warrants
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Weighted
average shares outstanding -diluted
|
|
|
29,317,056
|
|
|
23,954,948
|
|
|
29,327,062
|
|
|
19,327,230
|
|
Basic
and diluted net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per share from continuing operation
|
|
$
|
(0.10
|
)
|
$
|
(0.10
|
)
|
$
|
(0.25
|
)
|
$
|
(0.34
|
)
|
Net
loss per share from continuing operations
|
|
$
|
(0.26
|
)
|
$
|
(0.09
|
)
|
$
|
(0.33
|
)
|
$
|
(0.23
|
)
|
Net
loss per share
|
|
$
|
(0.36
|
)
|
$
|
(0.19
|
)
|
$
|
(0.58
|
)
|
$
|
(0.57
|
)
|
Stock
options to purchase 4,629,600 and 3,594,588 common shares for the three months
ended July 31, 2007, and 2006, respectively, and 3,705,813 and 2,919,278 common
shares for the nine months ended July 31, 2007 and 2006, respectively, were
not
included in the computation of diluted earnings per share because their effect
would have been anti-dilutive.
Significant
Concentrations
As
of
July 31, 2007, there were two customers that made up more than 10% of revenues
and five customers that each made up more than 5% of accounts receivable, and
one supplier that made up more than 10% of purchases. No vendors represented
more than 5% of accounts payable.
Recent
Accounting Pronouncements
In
June
2006, the Financial Accounting Standards Board (“FASB”) issued Interpretation
No. 48, Accounting for Uncertainty in Income Taxes — An Interpretation
of FASB Statement No. 109, (FIN 48). FIN 48 clarifies the
accounting for uncertainty in income taxes recognized in an enterprise’s
financial statements in accordance with FASB Statement No. 109, Accounting
for Income Taxes. FIN 48 also prescribes a recognition threshold and
measurement attribute for the financial statement recognition and measurement
of
a tax position taken or expected to be taken in a tax return that results in
a
tax benefit. Additionally, FIN 48 provides guidance on de-recognition,
income statement classification of interest and penalties, accounting in interim
periods, disclosure, and transition. This interpretation is effective for fiscal
years beginning after December 15, 2006. The Company
is
currently evaluating the effect that the application of FIN 48 will have on
its
financial position, results of operations or cash flows.
In
September 2006, the FASB issued SFAS No. 157, “Fair Value
Measurements”,
(“SFAS No. 157”). SFAS No. 157 defines fair value, establishes a framework for
measuring fair value in generally accepted accounting principles (GAAP), and
expands disclosures about fair value measurements. This Statement applies under
other accounting pronouncements that require or permit fair value measurements,
and does not require any new fair value measurements. The application of SFAS
No. 157, however, may change current practice within an organization. SFAS
No.
157 is effective for all fiscal years beginning after November 15, 2007, with
earlier application encouraged.
The
Company is currently evaluating the effect that the application of SFAS No.
157
will have on its financial position, results of operations or cash
flows.
In
February 2007, the FASB issued SFAS No. 159,
“The
Fair Value Option for Financial Assets and Financial Liabilities.”
SFAS
159
provides companies with an option to report selected financial assets and
liabilities at fair value. The standard’s objective is to reduce both complexity
in accounting for financial instruments and the volatility in earnings caused
by
measuring related assets and liabilities differently. The standard requires
companies to provide additional information that will help investors and other
users of financial statements to more easily understand the effect of the
company’s choice to use fair value on its earnings. It also requires companies
to display the fair value of those assets and liabilities for which the company
has chosen to use fair value on the face of the balance sheet. The new standard
does not eliminate disclosure requirements included in other accounting
standards, including requirements for disclosures about fair value measurements
included in SFAS 157,
“Fair
Value Measurements,”
and
SFAS
107,
“Disclosures
about Fair Value of Financial Instruments.”
SFAS
159
is effective as of the start of fiscal years beginning after November 15,
2007. Early adoption is permitted. We are in the process of evaluating this
standard and therefore have not yet determined the impact that the adoption
of
SFAS 159 will have on our financial position, results of operations or cash
flows.
NOTE
2
—
DISCONTINUED OPERATIONS
On
August
3, 2007, the Company announced its intent to divest its NOMOS Radiation Oncology
business (“NOMOS”), which develops and markets IMRT/IGRT products used during
external beam radiation therapy for the treatment of cancer. The Company expects
that the divestiture of NOMOS will allow it to better utilize financial
resources to benefit the marketing and development of innovative brachytherapy
products for the treatment of cancer The Company has executed a purchase and
sale agreement with Best Medical International, Inc. (hereinafter referred
to as
the “Best”) to purchase certain assets and to assume certain liabilities of
NOMOS for $0.4 million, net of estimated closing costs. The closing was
completed on September 17, 2007.
In
connection with the divestiture of NOMOS, the Company determined that the
carrying value of the NOMOS assets held for sale at July 31, 2007 exceeded
their
fair value, as determined by estimated future cash flows, and therefore,
recorded a $6.7 million charge for the impairment of its net assets. These
amounts have been recorded as part of the loss from discontinued
operations.
Summarized
statement of earnings data for NOMOS:
|
|
Three
Months Ended July 31,
|
|
Nine
Months Ended July 31,
|
|
|
|
2007
|
|
2006
|
|
2007
|
|
2006
|
|
Net
revenue
|
|
$
|
3,065,000
|
|
$
|
3,931,000
|
|
$
|
9,136,000
|
|
$
|
13,437,000
|
|
Loss
from discontinued
operations
before income tax benefit
|
|
$
|
(7,718,000
|
)
|
$
|
(2,107,000
|
)
|
$
|
(9,670,000
|
)
|
$
|
(4,388,000
|
)
|
Income
tax benefit, net of reserve
|
|
|
---
|
|
|
---
|
|
|
---
|
|
|
---
|
|
Loss
from discontinued
operations
|
|
$
|
(7,718,000
|
)
|
$
|
(2,107,000
|
)
|
$
|
(9,670,000
|
)
|
$
|
(4,388,000
|
)
|
Summarized
balance sheet for NOMOS is as follows:
|
|
|
|
|
|
|
|
July
31, 2007
|
|
October
31, 2006
|
|
|
|
|
|
|
|
Assets
held for sale:
|
|
|
|
|
|
Accounts
receivable
|
|
$
|
1,492,000
|
|
$
|
2,093,000
|
|
Inventories
|
|
|
2,714,000
|
|
|
2,918,000
|
|
Prepaid
and other current assets
|
|
|
604,000
|
|
|
262,000
|
|
Equipment
and leasehold improvements
|
|
|
898,000
|
|
|
1,082,000
|
|
Goodwill
|
|
|
2,564,000
|
|
|
2,564,000
|
|
Intangible
assets
|
|
|
1,945,000
|
|
|
2,394,000
|
|
Other
assets
|
|
|
71,000
|
|
|
71,000
|
|
Impairment
charge
|
|
|
(6,654,000
|
)
|
|
---
|
|
Total
assets held for sale
|
|
$
|
3,634,000
|
|
$
|
11,384,000
|
|
Liabilities
held for sale:
|
|
|
|
|
|
|
|
Deferred
Revenue
|
|
|
3,110,000
|
|
|
3,664,000
|
|
Other
current liabilities
|
|
|
153,000
|
|
|
150,000
|
|
|
|
$
|
3,263,000
|
|
$
|
3,814,000
|
|
Upon
completion of the divestiture of the NOMOS related assets, the Company estimates
NOMOS will incur payments for the retained obligations to its vendors, customers
and former employees of approximately $1.9 million in accordance with their
terms, which are included in accounts payable and accrued liabilities at July
31, 2007.
During
the nine months ended July 31, 2006, the Company paid $0.1 million related
to
expenses accrued during the shut-down of its Theseus operation in 2004, and
this
amount is included in cash used in discontinued operations in the Consolidated
Statements of Cash Flows. No cash was paid, and no amounts remain outstanding
related to the Theseus discontinued operations as of July 31, 2007. There were
no revenues or expenses relating to the Theseus discontinued operations for
the
three months ended and the nine months ended July 31, 2007 and
2006.
NOTE
3
—
MARKETABLE SECURITIES
Marketable
securities consist of the following:
|
|
|
|
|
|
|
|
July
31, 2007
|
|
October
31, 2006
|
|
Securities
held to maturity:
|
|
|
|
|
|
Corporate
and government bonds
|
|
$
|
---
|
|
$
|
4,886,000
|
|
Commercial
paper
|
|
|
---
|
|
|
2,947,000
|
|
Certificate
of deposits and other
|
|
|
---
|
|
|
587,000
|
|
|
|
|
---
|
|
|
8,420,000
|
|
Less:
current portion
|
|
|
---
|
|
|
(8,420,000
|
)
|
Non-current
portion
|
|
$
|
---
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
The
amortized cost of all held to maturity securities approximates
fair value.
|
|
|
|
|
|
|
|
NOTE
4—ACCOUNTS RECEIVABLE
Accounts
receivable are recorded at the invoiced amount and do not bear interest. The
allowance for doubtful accounts is the Company’s best estimate of the amount of
probable credit losses in our existing accounts receivable. The Company
determines the allowance based on historical write-off experience and customer
economic data. We review our allowance for doubtful accounts monthly. Past
due
balances over 60 days and over a specified amount are reviewed individually
for
collectibility. Account balances are charged off against the allowance when
the
Company believes that it is probable the receivable will not be recovered.
The
Company does not have any off-balance-sheet credit exposure related to our
customers.
Accounts
receivable consist of the following:
|
|
July
31, 2007
|
|
October
31, 2006
|
|
Accounts
receivable - trade
|
|
$
|
2,135,000
|
|
$
|
3,392,000
|
|
Less:
allowance for doubtful accounts
|
|
|
(224,000
|
)
|
|
(774,000
|
)
|
|
|
$
|
1,911,000
|
|
$
|
2,618,000
|
|
The
provision for doubtful accounts was $(103,000) and $95,000 for the three months
ended July 31, 2007 and 2006, respectively, and $(213,000) and $281,000 for
the
nine months ended July 31, 2007 and 2006, respectively
NOTE
5—INVENTORIES
Inventories
consist of the following:
|
|
|
|
|
|
July
31, 2007
|
|
October
31, 2006
|
|
Raw
materials
|
|
$
|
1,457,000
|
|
$
|
1,059,000
|
|
Work
in process
|
|
|
128,000
|
|
|
140,000
|
|
Finished
goods
|
|
|
328,000
|
|
|
135,000
|
|
Reserve
for excess inventory
|
|
|
(138,000
|
)
|
|
(50,000
|
)
|
|
|
$
|
1,775,000
|
|
$
|
1,284,000
|
|
Adjustments
to the reserve for excess inventory included in cost of sales was $88,000 for
the three months ended July 31, 2007,and $88,000 and $(88,000) for the nine
months ended July 31, 2007 and 2006, respectively. No adjustments to the reserve
were recorded for the three months ended July 31, 2006.
NOTE
6—EQUIPMENT AND LEASEHOLD IMPROVEMENTS
Equipment
and leasehold improvements consist of the following:
|
|
|
|
|
|
July
31, 2007
|
|
October
31, 2006
|
|
Furniture,
fixtures and equipment
|
|
$
|
4,902,000
|
|
$
|
4,861,000
|
|
Leasehold
improvements
|
|
|
2,194,000
|
|
|
2,134,000
|
|
|
|
|
7,096,000
|
|
|
6,995,000
|
|
Less:
accumulated depreciation
|
|
|
(6,049,000
|
)
|
|
(5,677,000
|
)
|
|
|
$
|
1,047,000
|
|
$
|
1,318,000
|
|
Depreciation
expense was $114,000 and $151,000 for the three months ended July 31, 2007
and
2006, respectively, and $392,000 and $461,000 for the nine months ended July
31,
2007 and 2006, respectively.
NOTE
7—INTANGIBLE ASSETS
|
|
July
31, 2007
|
|
October
31, 2006
|
|
Amortizable
intangible assets
|
|
|
|
|
|
Purchased
technology
|
|
$
|
98,000
|
|
$
|
98,000
|
|
Existing
customer relationships
|
|
|
11,000
|
|
|
11,000
|
|
Trademark
|
|
|
19,000
|
|
|
19,000
|
|
Patents
and licenses
|
|
|
158,000
|
|
|
158,000
|
|
|
|
|
286,000
|
|
|
286,000
|
|
Less:
accumulated amortization
|
|
|
(169,000
|
)
|
|
(148,000
|
)
|
|
|
$
|
117,000
|
|
$
|
138,000
|
|
Amortization
expense was $7,000 for each three month period ended July 31, 2007 and 2006,
and
$21,000 for each nine month period ended July 31, 2007 and 2006. Estimated
amortization expense for the subsequent years is $28,000 annually through the
October, 2011.
NOTE
8
—
BORROWINGS
Line
of Credit
On
October 5, 2005, the Company entered into a Loan and Security Agreement (the
“Loan Agreement”)
with
Silicon Valley Bank (the “Bank”), for a secured, revolving line of credit of up
to $5,000,000. The line of credit had a term of one year and includes a letter
of credit sub-facility. Borrowings under the line of credit are subject to
a
borrowing base formula. The Company will pay interest on the borrowings under
the line of credit at the Bank’s prime rate, which was 8.25% on July 31, 2007,
or, if certain financial tests are not satisfied, at the Bank’s prime rate plus
1.5%. The line of credit is secured by all of the assets of the Company and
is
subject to customary financial and other covenants, including reporting
requirements.
On
January 12, 2006, the Company, entered into a First Amendment to Loan and
Security Agreement (the “Amendment”) with the Bank. The Amendment revised
certain terms of the Loan Agreement to provide an adjustment to the borrowing
base formula and to permit liens in favor of a holder of subordinated debt
that
are subordinated to the liens of the Bank. In addition, the Amendment
decreased the minimum tangible net worth that must be maintained by the Company
under the Asset Based Terms of the Loan Agreement from $5 million to $1.5
million and granted the Bank a warrant to purchase 39,683 shares of the
Company’s common stock at an exercise price of $1.89 per share. The
warrant will expire in five years unless previously exercised.
The
Company calculated the fair value of the warrant on the date of grant to be
$51,000 using the Black-Scholes model incorporating the following
assumptions:
Stock
price
|
|
$1.89
|
Dividend
yield
|
|
0%
|
Expected
volatility
|
|
63%
|
Risk-free
interest rate
|
|
4.9%
|
Expected
life
|
|
5
years
|
The
value
of the warrant is being amortized over the term of the line of credit at $5,100
per month, and is included in Interest and Other Expense on the Income
Statement.
On
October 31, 2006, the Company entered into a Second Amendment to Loan and
Security Agreement (the “Second Amendment”) with the Bank. The Second
Amendment extended the term of the line of credit to October 3, 2007 and revised
certain terms of the Loan Agreement. Specifically, the Second Amendment
decreased the amount available under the line of credit from $5 million to
$4
million, and increased the minimum tangible net worth that must be maintained
by
the Company from $1.5 million to $5 million. Borrowings under the line of credit
continue to be subject to a borrowing base formula. Borrowings now bear interest
at the prime rate until such time as the Company’s quick ratio, which is defined
as the ratio of unrestricted cash plus the Company’s net accounts receivable to
the Company’s current liabilities, falls below 1.00 to 1.00. At such time as the
Company’s quick ratio falls below 1.00 to 1.00, borrowings will bear interest at
the prime rate plus 1.50%, and the Company will pay a fee of 0.50% per annum
on
the unused portion of the line of credit, and a collateral handling fee in
an
amount equal to $2,000 per month. $1.4 million
was
outstanding against the Line of Credit as of July 31, 2007 at an interest rate
of 9.75% per annum.
Subordinated
Debt
On
March
28, 2006, the Company entered into a Loan and Security Agreement (the “Loan
Agreement”)
with
Partners for Growth, LLC (the “Debt Provider”), for a secured, revolving line of
credit of up to $4,000,000, which supplemented an existing line of credit
provided by Silicon Valley Bank. The line of credit had a term of eighteen
months. Borrowings under the Loan Agreement were subject to a borrowing base
formula. The Company has paid interest on the borrowings under the Loan
Agreement at prime rate as quoted in the
Wall
Street Journal,
which on
July 31, 2007 was 8.25%. Amounts owing under the Loan Agreement are secured
by
all of the assets of the Company and are subordinated to amounts owing under
the
line of credit with Silicon Valley Bank. The Loan Agreement does not contain
financial covenants; however the Company is subject to other customary
covenants, including reporting requirements, and events of default. In
connection with the Loan Agreement, the Company also granted the Debt Provider
a
warrant to purchase 395,000 shares of the Company’s common stock at an exercise
price of $1.89 per share. As a result of the private placement of the Company’s
common stock completed on June 7, 2006, and pursuant to the anti-dilution terms
of the warrant issued to the Debt Provider, the warrant was amended to increase
the number of shares of the Company’s common stock that the Debt Provider can
purchase from 395,000 shares to 555,039 shares, and the exercise price was
decreased from $1.89 per share to $1.35 per share. The warrant will expire
in
five years unless previously exercised.
The
Company calculated the fair value of the warrant on the date of grant to be
$475,000 using the Black-Scholes model incorporating the following
assumptions:
Stock
price
|
|
$2.05
|
Dividend
yield
|
|
0%
|
Expected
volatility
|
|
63%
|
Risk-free
interest rate
|
|
4.9%
|
Expected
life
|
|
5
years
|
The
issuance of the warrant has been accounted for as a loan origination fee. As
such, the value of the warrant has been deferred and is being amortized over
the
life of the loan at $26,500 per month and is included in Interest and Other
Expense on the Income Statement.
No
borrowings were outstanding against the Loan Agreement as of July 31,
2007.
NOTE
9—STOCKHOLDERS' EQUITY
Preferred
Stock
The
Company has authorized the issuance of 2,000,000 shares of preferred stock;
however, no shares have been issued. The designations, rights and preferences
of
any preferred stock that may be issued will be established by the Board of
Directors at or before the time of such issuance.
Authorized
Shares of Common Stock
Sale
of Common Stock and Warrants
On
June
7, 2006, we completed a private placement of
12,291,934
shares of the Company’s common stock at a purchase price of $1.95 per share as
well as warrants to purchase an additional 6,145,967 shares of the Company’s
common stock at an exercise price of $2.08 per share for an aggregate
consideration of approximately $24.0 million (before cash commissions and
expenses of approximately $2.0 million). The warrants are exercisable beginning
180 days after the date of closing until 7 years after the date of closing.
The
values of the warrants and common stock in excess of par value have been
classified as stockholders’ equity in additional paid-in capital in our
consolidated balance sheet as of January 31, 2007 and October 31, 2006. The
warrants were evaluated under SFAS 133 and EITF 00-19, and the Company
determined that the warrants have been correctly classified as
equity.
The
shares of common stock sold to the investors and the shares of common stock
issuable upon the exercise of the warrants are subject to certain registration
rights as set forth in the Securities Purchase Agreements. Under the Securities
Purchase Agreements, we agreed to file a registration statement with the
Securities and Exchange Commission within 45 days after the closing of the
transaction to register the resale of the shares of common stock and the shares
of common stock issuable upon the exercise of the warrants. If we failed to
file
a registration statement within such time period or such registration statement
was not declared effective within 90 days after the closing of the transaction,
we would have been liable for certain specified liquidated damages as set forth
in the Securities Purchase Agreements, except that the parties have agreed
that
the Company will not be liable for liquidated damages with respect to the
warrants or the warrant shares. We have agreed to maintain the effectiveness
of
this registration statement until the earlier of such time as the passage of
two
years from the closing date or all of the securities registered under the
registration statement may be sold under Rule 144(k) of the Securities Act
of
1933 or all of the securities registered under the registration statement have
been sold. We will pay all expenses incurred in connection with the
registration, except for underwriting discounts and commissions. Pursuant to
the
terms of the Securities Purchase Agreement, we filed a registration statement
on
Form S-3 with the Securities and Exchange Commission on July 21, 2006 to
register the shares of common stock sold to the investors and the shares of
common stock issuable upon the exercise of the warrants. The registration
statement was declared effective by the Securities and Exchange Commission
on
August 4, 2006.
The
Securities Purchase Agreements contain certain customary closing conditions,
as
well as the requirement that we increase the number of members of the Board
of
Directors of the Company (the “Board”) from seven members to nine members. Under
the Securities Purchase Agreements, Three Arch Partners, one of the investors,
has the right to designate two members to the Board so long as Three Arch
Partners beneficially owns greater than 3,500,000 shares of common stock
(including shares of common stock issuable upon exercise of the warrants, and
as
appropriately adjusted for stock splits, stock dividends and recapitalizations)
and the right to designate one member to the Board so long as Three Arch
Partners beneficially owns greater than 2,000,000 shares of common stock
(including shares of common stock issuable upon exercise of the warrants, and
as
appropriately adjusted for stock splits, stock dividends and recapitalizations).
In accordance with the terms of the Securities Purchase Agreements, we increased
the number of members of our Board from seven members to nine members and Three
Arch Partners designated Wilfred E. Jaeger, M.D. and Roderick A. Young to fill
the two vacancies. Our Board elected Dr. Jaeger and Mr. Young to serve as
members of the Board on June 13, 2006.
In
connection with the issuance of the warrants and upon closing of the
transaction, we entered into a Warrant Agreement with our transfer agent
relating to the warrant of Three Arch Partners and a different Warrant Agreement
with our transfer agent relating to the warrants of the investors other than
Three Arch Partners. The material differences between the two Warrant Agreements
are described below.
The
Three
Arch Partners Warrant Agreement includes a non-waivable provision that provides
that the number of shares issuable upon exercise of the warrants that may be
acquired by Three Arch Partners will be limited to the extent necessary to
assure that, following such exercise, the total number of shares of common
stock
then beneficially owned by Three Arch Partners and its affiliates does not
exceed 19.9% of the total number of issued and outstanding shares of common
stock as of the date of such exercise (including for such purpose the shares
of
common stock issuable upon such exercise of warrants), unless approved by our
stockholders prior to such exercise. The Warrant Agreement relating to the
warrants of the other investors does not include such a provision.
The
Warrant Agreement relating to the investors other than Three Arch Partners
includes a waivable provision that provides that the number of shares issuable
upon exercise of the warrants that may be acquired by a registered holder of
warrants upon an exercise of warrants will be limited to the extent necessary
to
assure that, following such exercise, the total number of shares of common
stock
then beneficially owned by its holder and its affiliates does not exceed 4.99%
of the total number of issued and outstanding shares of common stock (including
for such purpose the shares of common stock issuable upon such exercise of
warrants). This provision may be waived by a registered holder of warrants
upon,
at the election of such holder, upon not less than 61 days prior notice to
us.
This Warrant Agreement also contains a non-waivable provision that provides
that
the number of shares issuable upon exercise of the warrants that may be acquired
by a registered holder of warrants upon an exercise of warrants will be limited
to the extent necessary to assure that, following such exercise, the total
number of shares of common stock then beneficially owned by such holder and
its
affiliates does not exceed 9.99% of the total number of issued and outstanding
shares of common stock (including for such purpose the shares of common stock
issuable upon such exercise of warrants). The Warrant Agreement relating to
the
warrants of Three Arch Partners does not include such provisions.
Stock
Options
The
Company's 1996 Stock Option Plan ("1996 Plan"), as amended April 6, 2001,
provided for the issuance of incentive stock options to employees of the Company
and non-qualified options to employees, directors and consultants of the Company
with exercise prices equal to the fair market value of the Company's stock
on
the date of grant. Certain options are immediately exercisable while other
options vest over periods up to four years. The options expire ten years from
the date of grant. The 1996 Plan provided for the automatic increase on
January 1 of each year, beginning with calendar year 2002 and continuing
through calendar year 2004, by a number of shares equal to 3.5% of the total
number of shares of the Company's Common Stock outstanding on the last trading
day in the immediately preceding calendar year. In May 2004, the Company’s
shareholders approved proposals to amend the 1996 Plan to make an additional
600,000 shares available for issuance under the plan and to permit the issuance
of 1,362,589 replacement options in connection with the acquisition of NOMOS.
From November 1, 2005 through March 31, 2006, stock options for 1,303,000 shares
were granted to employees under the 1996 Plan. The 1996 Plan expired on April
1,
2006.
On
May 3,
2006, the Company’s shareholders approved the North American Scientific, Inc.
2006 Stock Plan (“2006 Plan”). Under the 2006 Plan, the Company may issue up to
1,700,000 shares, plus any shares from the 1996 Plan that are subsequently
terminated, expire unexercised or forfeited, to employees of the Company through
incentive stock options, non-qualified options, stock appreciation rights,
restricted stock and restricted stock units. The exercise price of an option
is
equal to the fair market value of the Company’s stock on the date of the grant.
As of July 31, 2007, 927,525 shares were terminated, expired unexercised or
forfeited in the 1996 Plan and were transferred to the 2006 Plan. During the
three months and nine months ended July 31, 2007, stock options for an aggregate
650,000 shares were granted to employees under the 2006 Plan, There were no
equity awards granted under the 2006 Plan during the three months and nine
months ended July 31, 2006. At July 31, 2007, there were 2,002,525 shares
available for grant under the 2006 Plan.
In
March 2003, the Company's shareholders approved the 2003 Non-Employee
Directors' Equity Compensation Plan ("Directors' Plan"). The Directors' Plan
supersedes prior provisions for grants of stock options to non-employee
directors contained in the 1996 Plan. Under the Directors' Plan, the Company
may
issue up to 500,000 shares to non-employee directors of the Company through
non-qualified options or restricted stock. The exercise price of an option
is
equal to the fair market value of the Company's stock on the date of grant.
Options and restricted stock vest equally over a three-year period on the
anniversary date of grant. The options expire ten years from the date of grant.
On June 5, 2007, the Board of Directors granted stock options underlying 115,000
shares of common stock to the elected non-employee Directors, of which 30,000
shares are pending approval of an increase in authorized shares for the
Directors’ Plan by the shareholders at the next annual meeting.
On
April
23, 2007 the Company granted stock options with respect to 1,800,000 shares
of
its common stock in connection with the employment by the Company of its new
CEO. (See Note 10 - Commitments and Contingencies). Options with respect to
600,000 shares of the Company’s common stock were issued under the 2006 Plan.
Options with respect to the remaining 1,200,000 shares of the Company’s common
stock were issued as a stand-alone grant outside the 2006 Plan as approved
by
written consent of a majority of shareholders on April 20, 2007. The stock
options have an exercise price of $1.16, which was equal to the fair market
value per share of the Company’s common stock on the grant date. All of the
options have a term of ten years and vest monthly over a four-year period.
The
options remain exercisable until the earlier of the expiration of the term
of
the option or (i) three months following Mr. Rush’s date of termination in the
case of termination for reasons other than cause, death or disability (as such
terms are defined in his employment agreement) or (ii) 12 months following
Mr.
Rush’s date of termination in the case of termination on account of death or
disability. In the event that Mr. Rush is terminated for cause, all outstanding
options, whether vested or not, will immediately lapse.
At
July
31, 2007, a total of 6,618,978 shares of the Company’s common stock were
reserved for issuance. The following table summarizes stock option activity
for
both plans:
|
|
|
|
Options
Outstanding
|
|
|
|
Options
Available
for
Grant
|
|
Number
Outstanding
|
|
Exercise
Price
|
|
Balance
at October 31, 2004
|
|
|
1,579,742
|
|
|
3,253,821
|
|
$
|
0.03
- $24.54
|
|
Granted
|
|
|
(275,000
|
)
|
|
275,000
|
|
$
|
2.25
- $3.66
|
|
Forfeited
and expired
|
|
|
427,699
|
|
|
(427,699
|
)
|
$
|
1.11
- $16.75
|
|
Exercised
|
|
|
—
|
|
|
(687,013
|
)
|
$
|
1.11
- $1.96
|
|
Balance
at October 31, 2005
|
|
|
1,732,441
|
|
|
2,414,109
|
|
$
|
0.03
- $24.54
|
|
Granted
|
|
|
(1,453,000
|
)
|
|
1,453,000
|
|
$
|
1.92
- $3.35
|
|
Forfeited
and expired
|
|
|
(
194,441
|
)
|
|
(426,618
|
)
|
$
|
1.11
- $16.75
|
|
Exercised
|
|
|
—
|
|
|
(2,186
|
)
|
$
|
1.11
- $1.12
|
|
Additional
shares reserved
|
|
|
1,700,000
|
|
|
—
|
|
|
|
|
Balance
at October 31, 2006
|
|
|
1,785,000
|
|
|
3,438,305
|
|
$
|
0.03
- $24.54
|
|
Granted
|
|
|
(1,965,000
|
)
|
|
1,965,000
|
|
$
|
0.93
- $1.50
|
|
Forfeited
and expired
|
|
|
972,525
|
|
|
(776,852
|
)
|
$
|
0.70
- $24.54
|
|
Exercised
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Additional
shares reserved
|
|
|
1,200,000
|
|
|
—
|
|
|
—
|
|
Balance
at July 31, 2007
|
|
|
1,992,525
|
|
|
4,626,453
|
|
$
|
0.03
- $23.50
|
|
There
were 1,649,187, 1,878,663 and 1,873,220 options exercisable with weighted
average exercise prices of $7.18, $8.57 and $8.79 at July 31, 2007, October
31,
2006 and 2005, respectively.
The
following table summarizes options outstanding at July 31, 2007 and the related
weighted average exercise price and remaining contractual life
information:
|
|
Employee
Options Outstanding
|
|
Employee
Options
Exercisable
|
|
Range
of
Exercise
Prices
|
|
Shares
|
|
Weighted
Avg.
Remaining
Contractual
Life
(Years)
|
|
Weighted
Avg.
Exercise
Price
|
|
Shares
|
|
Weighted
Avg.
Exercise
Price
|
|
$0.03
- $1.12
|
|
|
118,945
|
|
|
4.58
|
|
$
|
1.02
|
|
|
98,800
|
|
$
|
1.03
|
|
$1.13
- $1.16
|
|
|
1,800,000
|
|
|
9.73
|
|
|
1.16
|
|
|
112,500
|
|
|
1.16
|
|
$1.17
- $3.18
|
|
|
994,500
|
|
|
7.13
|
|
|
2.28
|
|
|
246,879
|
|
|
2.44
|
|
$3.19
- $7.60
|
|
|
1,126,566
|
|
|
5.45
|
|
|
5.36
|
|
|
604,566
|
|
|
7.01
|
|
$7.61
- $23.50
|
|
|
586,442
|
|
|
4.18
|
|
|
11.54
|
|
|
586,442
|
|
|
11.54
|
|
|
|
|
4,626,453
|
|
|
7.30
|
|
$
|
3.73
|
|
|
1,649,187
|
|
$
|
7.18
|
|
The
average fair value for accounting purposes of options granted was $1.17, $1.09
and $2.47 for the nine months ended July 31, 2007 and for the years ended
October 31, 2006 and 2005, respectively.
The
following table summarizes the weighted average price, weighted average
remaining contractual life and intrinsic value for granted and exercisable
options outstanding as of July 31, 2007 and October 31, 2006:
|
|
Number
of Shares
|
|
Weighted
Average Exercise Price
|
|
Weighted
Avg.
Remaining
Contractual
Life
(Years)
|
|
Intrinsic
Value
|
|
As
of October 31, 2006:
|
|
|
|
|
|
|
|
|
|
Employee
Options Outstanding
|
|
|
3,438,305
|
|
$
|
6.06
|
|
|
5.81
|
|
$
|
56,500
|
|
Employee
Options Expected to Vest
|
|
|
1,559,642
|
|
$
|
2.68
|
|
|
7.14
|
|
$
|
—
|
|
Employee
Options Exercisable
|
|
|
1,878,663
|
|
$
|
8.57
|
|
|
4.52
|
|
$
|
56,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As
of July 31, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee
Options Outstanding
|
|
|
4,626,453
|
|
$
|
3.73
|
|
|
7.30
|
|
$
|
24,640
|
|
Employee
Options Expected to Vest
|
|
|
2,977,266
|
|
$
|
0.65
|
|
|
1.65
|
|
$
|
17,250
|
|
Employee
Options Exercisable
|
|
|
1,649,187
|
|
$
|
7.18
|
|
|
5.05
|
|
$
|
7,840
|
|
|
|
|
|
|
|
|
|
|
|
Fair
Value Disclosures
The
Company calculated the fair value of each option grant on the respective date
of
grant using the Black-Scholes option-pricing model as prescribed by
SFAS 123(R) using the following assumptions:
|
|
Nine
months ended July 31
|
|
Year
Ended October 31,
|
|
|
|
2007
|
|
2006
|
|
2005
|
|
Dividend
yield
|
|
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
Expected
volatility
|
|
|
61
|
%
|
|
63
|
%
|
|
82
|
%
|
Risk-free
interest rate
|
|
|
4.8
|
%
|
|
4.9
|
%
|
|
3.9
|
%
|
Expected
life
|
|
|
5
years
|
|
|
5
years
|
|
|
5
years
|
|
Stockholders'
Rights Plan
In
October 1998, the Board of Directors of the Company implemented a rights
agreement to protect stockholders' rights in the event of a proposed takeover
of
the Company. In the case of a triggering event, each right entitles the
Company's stockholders to buy, for $80, $160 worth of common stock for each
share of common stock held. The rights will become exercisable only if a person
or group acquires, or commences a tender offer to acquire, 15% or more of the
Company's common stock. The rights, which expire in October 2008, are
redeemable at the Company's option for $0.001 per right. The Company also has
the ability to amend the rights, subject to certain limitations. On May 2,
2007,
the Company entered into a Third Amendment to Rights Agreement, which amended
the Rights Agreement to provide, among other things, that the Board of Directors
of the Company may determine that a person who would otherwise become an
Acquiring Person has become such inadvertently, and provided certain conditions
are satisfied, that such person is not an Acquiring Person for any purposes
of
the Rights Agreement.
Employee
Stock Purchase Plan
In
March
2000, the Board of Directors authorized an Employee Stock Purchase Plan ("the
ESPP") under which 300,000 shares of the Company's common stock are reserved
for
issuance. Eligible employees may authorize payroll deductions of up to 15%
of
their salary to purchase shares of the Company's common stock at a discount
of
up to 15% of the market value at certain plan-defined dates. In the nine months
ended July 31, 2007 and the years ended October 31, 2006 and 2005, the shares
issued under the ESPP were 154,082, 96,489 and 59,742 shares, respectively.
On
June 5, 2007, the Board of Directors approved a 300,000 share increase to
600,000 authorized shares for the ESPP. At July 31, 2007 and October 31,
2006, 219,757 and 73,839 shares were available for issuance under the ESPP,
respectively.
Common
Stock Repurchase Program
In
October 2001, the Board of Directors authorized a stock repurchase program
to acquire up to $10 million of the Company's common stock in the open
market at any time. The number of shares of common stock actually acquired
by
the Company will depend on subsequent developments and corporate needs, and
the
repurchase of shares may be interrupted or discontinued at any time. No shares
were repurchased by the Company during the three months ended July 31, 2007.
As
of July 31, 2007 and October 31, 2006, a cumulative total of 116,995 and
22,100 shares had been repurchased by the Company at a cost of $227,000 and
$133,000, respectively and are reflected as Treasury Stock on the Balance Sheet
at the respective dates.
NOTE
10—COMMITMENTS AND CONTINGENCIES
Contract
Commitments
The
Company has entered into purchase commitments of $112,000 to suppliers under
blanket purchase orders. The blanket purchase orders expire when the designated
quantities have been purchased.
Lease
Commitments
The
Company leases facilities and equipment under non-cancelable operating lease
agreements which renew annually at rates that are subject to annual adjustment
for increases in the Consumer Price Index. Future minimum lease payments under
these operating leases are $350,000 annually. Total rent expense was $87,000
and
$98,000 for the three months ended July 31, 2007 and 2006, respectively, and
$283,000 and $293,000, for the nine months ended July 31, 2007 and 2006,
respectively.
Third
Party License Agreements
We
license from third parties some of the technologies used in our core products.
The following are the minimum annual royalty amounts under each of the
agreements:
|
|
|
|
IdeaMatrix,
Inc.
|
$
|
125,000
|
|
University
of South Florida Research Foundation, Inc.
|
|
50,000
|
|
|
$
|
175,000
|
|
On
March
22, 2007, the Company entered into an employment agreement (the “Agreement”)
with John B. Rush in connection with his employment as the Company’s new
President and Chief Executive Officer. Mr. Rush’s base salary will be $350,000.
Mr. Rush will also be eligible to receive an annual bonus, if any, based upon
performance goals approved by the Board or the Compensation Committee of the
Board, in consultation with Mr. Rush, in an amount, not to exceed 60% of his
base salary, to be determined by the Compensation Committee. For the period
beginning on April 23,2007 and ending the last day of the Company’s fiscal year,
October 31, 2007, Mr. Rush will receive a guaranteed, minimum, pro-rated bonus
of 30% of his base salary.
On
April
23, 2007, the Company granted stock options to Mr. Rush with respect to
1,800,000 shares of our common stock. The stock options have an exercise price
of $1.16, which was equal to the fair market value per share of our common
stock
on the grant date. In addition, in the event that within 24 months of April
23,
2007, the Company issues additional shares of stock in connection with raising
capital in a private placement transaction, the Company is required to grant
options to Mr. Rush to acquire an additional number of shares of common stock
equal to 3% of the number of shares issued in connection with such transaction
(the “Additional Shares”).
All
of
the options have a term of ten years and vest monthly over a four-year period.
The options remain exercisable until the earlier of the expiration of the term
of the option or (i) three months following Mr. Rush’s date of termination in
the case of termination for reasons other than cause, death or disability (as
such terms are defined in his employment agreement) or (ii) 12 months following
Mr. Rush’s date of termination in the case of termination on account of death or
disability. In the event that Mr. Rush is terminated for cause, all outstanding
options, whether vested or not, will immediately lapse.
In
the
event (a) Mr. Rush’s employment is terminated by the Company at any time after
April 23, 2007 for any reason other than Mr. Rush’s death, disability or “cause”
(as defined in the Agreement) or (b) Mr. Rush resigns for a “good reason” (as
defined in the Agreement), Mr. Rush will receive his base salary in effect
on
the date of termination for a period ending 12 months following the date of
termination.
In
the
event of a “Control Termination” (as defined in the Agreement), Mr. Rush will be
entitled to receive his base salary in effect on the date of termination and
group health benefits for a period ending 12 months following the date of
termination and, in addition, Mr. Rush shall, as of the date of the Control
Termination, become fully vested in any unvested options previously granted
to
him.
Mr.
Rush’s employment agreement also provides that the Company will make a tax
gross-up payment to Mr. Rush in the event that payments to Mr. Rush on account
of a change in control constitute an excess parachute payment subject to an
excise tax under Section 4999 of the Code. Similarly, the Company will make
a
tax gross-up payment to Mr. Rush for any excise tax in the event that amounts
or
benefits payable to Mr. Rush are determined to be subject to the excise tax
on
nonqualified deferred compensation under Section 409A of the Code.
In
the
event that any amount payable upon Mr. Rush’s termination would be determined to
be “non-qualified deferred compensation” subject to Section 409A of the Code,
the Company may delay payment for six months, in order to comply with Section
409A of the Code.
On
November 2, 2006, the Company announced that Mr. Cutrer will transition from
the
position of President and Chief Executive Officer to become the Company’s
Executive Vice President and Chief Technology Officer upon his successor being
identified and joining the Company. As part of this transition process, on
December 21, 2006, the Company and Mr. Cutrer entered into a First Amended
and
Restated Employment Agreement (the “Amended Agreement”), which became effective
with the employment of Mr. Rush (the “Effective Date”). Under the Amended
Agreement, Mr. Cutrer’s annual base salary will be $280,000. In addition, Mr.
Cutrer will be eligible to receive an annual bonus, if any, based upon
performance goals approved by the Compensation Committee or the Board in an
amount to be determined in the sole discretion of the Compensation Committee
or
the Board. If Mr. Cutrer meets or exceeds the performance goals for a particular
measuring year, the annual bonus may not be less than 25% of his base
salary.
In
the
event Mr. Cutrer’s employment terminates on or before October 31, 2007 for (a)
any reason other than Mr. Cutrer ’s death, disability or “cause” (as defined in
the Amended Agreement) or (b) Mr. Cutrer resigns for “good reason” (as defined
in the Amended Agreement), Mr. Cutrer will continue to receive his base salary
in effect on the termination date through October 31, 2007.
In
the event Mr. Cutrer’s employment terminates at any time after the Effective
Date for any reason, except for a “Control Termination” (as defined in the
Amended Agreement), and in addition to any payment that may be due if he is
terminated on or before October 31, 2007 as noted above, Mr. Cutrer will be
entitled to receive (a) severance pay equal to three times (3x) his highest
base
salary during his employment by the Company payable over a three year period
in
accordance with the Company’s standard payroll practices for salaried employees,
and (b) any unvested stock options shall immediately vest as of the termination
date. In addition, the exercise date of all stock options that, on the
termination date, have an exercise price greater than the fair market value
of
the Company’s common stock will be extended to the later of (i) the last day of
the year in which the stock option would otherwise have expired or (ii) two
and
a half months after the date on which the stock option would otherwise have
expired (or such later date as may be permitted by final regulations issued
pursuant to Section 409A of the Internal Revenue Code of 1986, as amended (the
“Code”), but in no event later than the date on which the stock option would
have expired had Mr. Cutrer’s employment not been terminated).
In
the event of a “Control Termination” (as defined in the Amended Agreement), Mr.
Cutrer will be entitled to a “Control Severance Payment” in the gross amount
equal to the total of: (a) three (3) years’ base salary; (b) the highest annual
bonus paid to Mr. Cutrer in the three years prior to such termination multiplied
by three (3); (c) the Black/Scholes valuation of the stock options received
by
Mr. Cutrer during the one year prior to such termination multiplied by three
(3); and (d) a tax gross-up payment if any severance payment constitutes an
excess parachute payment subject to the excise tax imposed by Section 4999
of
the Code. The Control Severance Payment will be paid as salary continuation
ratably over a one year period. In addition, any unvested stock options will
immediately vest as of the termination date.
The
Company also maintains employment agreements with certain other key management.
The agreements provide for minimum base salaries, eligibility for stock options
and performance bonuses and severance payments.
Litigation
In
November 2005, the Company was served with a complaint filed in U.S. District
Court in Hartford, Connecticut by World Wide Medical Technologies (WWMT). WWMT’s
six count complaint alleges breach of a confidentiality agreement, fraud, patent
infringement, wrongful interference with contractual relations, violation of
the
Connecticut Uniform Trade Secrets Act, and violation of the Connecticut Unfair
Practices Act. WWMT alleges that the Company fraudulently obtained WWMT’s
confidential information during negotiations to purchase WWMT in 2004 and that
once the Company acquired that information, it purportedly learned that Richard
Terwilliger, (our former Vice President of New Product Development) owned
certain patent rights and that we began trying to inappropriately gain property
rights by hiring him away from WWMT. The Company was served with this matter
at
approximately the same time Mr. Terwilliger was served with a lawsuit in
state court and with an application seeking a preliminary
injunction declaring plaintiffs to be the sole owners of the intellectual
property at issue and preventing Mr. Terwilliger from effectively serving
as Vice President of New Product Development at the Company. The Company has
agreed to defend Mr. Terwilliger. We have moved the state court claim against
Mr. Terwilliger to federal court and the cases have been consolidated. The
defendants have answered both complaints and discovery has commenced
in each matter. In April 2006, WWMT had its hearing for a preliminary injunction
against Mr. Terwilliger heard in U.S. District Court. Plaintiffs abandoned
that portion of their application for preliminary injunction that was based on
an alleged misappropriation of trade secrets shortly before the hearing. On
August 30, 2006, Magistrate Judge Donna Martinez issued a ruling ordering
that what remained of plaintiffs' motion be denied. Specifically, the
Magistrate Judge found that plaintiffs do not have a reasonable likelihood
of
success on the merits of their claim for declaratory judgment that some or
all
of plaintiffs are the sole owners of the intellectual property at issues, and
she further found that there do not exist sufficiently serious questions
going to the merits of that claim to make them a fair ground for
litigation. The Company denies liability and intends to vigorously
defend itself in this litigation as it progresses. No trial date has
yet been set.
On
April
20, 2006, a lawsuit captioned
J.P.
Morgan Trust Company, N.A. v. John Alan Friede, et al.
was
filed in the U.S. District Court for the Southern District of New York against
John A. Friede, a current director and stockholder of the Company, Mr. Friede’s
wife, and NOMOS Corporation, a subsidiary of the Company. The plaintiff, J.P.
Morgan Trust Company, filed the lawsuit in its capacity as personal
representative of the Estate of Evelyn A.J. Hall, Mr. Friede’s deceased mother.
The complaint, as amended on August 8, 2006, asserts claims for reimbursement
and contribution, constructive fraud, breach of contract and other related
claims arising out of loans made by Mrs. Hall to, or for the benefit of, Mr.
and
Mrs. Friede and/or NOMOS, or acting as an accommodation party in additional
loans made to Mr. and Mrs. Friede by financial institutions that were not
subsequently repaid. During the time periods alleged in the complaint, Mr.
Friede was the Chairman, Chief Executive Officer and the largest stockholder
of
NOMOS. With respect to NOMOS, the complaint seeks at least approximately
$5,250,000 principal amount of loans allegedly made to and still outstanding
and
owed by NOMOS, and other related equitable remedies plus interest, costs and
expenses.
On
the
basis of copies of documents that have been made available to us, we believe
that the claims made against NOMOS in the lawsuit appear to be without merit
and
we intend to vigorously defend against them. However, in accordance with the
indemnification provisions of the merger agreement under which we acquired
NOMOS
on May 4, 2004, and the related indemnity escrow agreement, we have made a
claim
for indemnification against the escrow to preserve our right of indemnity.
Under
these provisions, an indemnifying party will not have any indemnification
obligations until such time as the aggregate indemnified losses for which we
are
entitled to indemnification equals or exceeds $400,000, at which point, the
indemnifying party will be liable for the full amount of all such indemnified
losses without regard to the $400,000 basket. As of the date hereof, the
indemnity escrow account holds approximately $1,225,000 of cash and 526,810
shares of our common stock. We also intend to review various other legal
remedies that may be available to us.
The
Company is also subject to other legal proceedings, claims and litigation
arising in the ordinary course of business. While the outcome of these matters
is currently not determinable, management does not expect that the ultimate
costs to resolve these matters will have a material adverse effect on the
Company's consolidated financial position, results of operations, or cash
flows.
As
of
this filing, the Company does not meet the $10 million stockholders’ equity
requirement
under
Maintenance Standard 1 for continued listing
on
the
Nasdaq Global Market
set
forth in Marketplace Rule 4450(a)(3).
As a
result of the Company’s non-compliance, The Nasdaq Stock Market may send the
Company a notice that the Company’s stock is subject to delisting from the The
Nasdaq Global Market
unless
the Company requests a hearing with a Nasdaq Listing Qualifications Panel to
appeal such delisting. A request for a hearing will stay the delisting action
pending the issuance of a written determination by a Nasdaq Listing
Qualifications Panel. While the Company is working diligently to meet the
minimum stockholders’ equity requirement as promptly as possible, the Company
can provide no assurances that a Nasdaq Listing Qualifications Panel will grant
the Company’s request for continued listing on The Nasdaq Global Market.
NOTE
11
—
SUBSEQUENT
EVENTS
On
August
24, 2007, North American Scientific, Inc. (“NASI”) and two of its subsidiaries,
NOMOS Corporation (“NOMOS”) and North American Scientific, Inc., a California
corporation (“NASI-California” and collectively, with NASI and NOMOS, the
“Company”), entered into a Third Amendment to Loan and Security Agreement (the
“Third Amendment”) with Silicon Valley Bank (“Silicon Valley”). The Third
Amendment amended that certain Loan and Security Agreement dated October 5,
2005
(the “Loan Agreement”).
The
Third
Amendment added a Bridge Loan Sub-limit to the Loan Agreement of up to
$1,500,000 at an interest rate of prime plus 4.0%, subject to a borrowing base
formula, and decreased the minimum tangible net worth that must be maintained
by
the Company from $5 million to $2 million. The maturity date of the Bridge
Loan
Sublimit shall be the earlier of October 3, 2007 or the date NASI closes a
private investment public equity transaction. Concurrent with the Third
Amendment, NASI issued Silicon Valley a warrant for 300,000 shares of NASI
common stock at an exercise price of $0.98, the closing price of NASI common
stock on August 24, 2007.
On
August
30, 2007 the Company terminated the Loan and Security Agreement (the “PFG Loan
Agreement”) with Partners For Growth II, L.P. (“PFG”) by mutual consent. The PFG
Loan Agreement was entered into on March 28, 2006 and was scheduled to expire
on
September 28, 2007. As a result of the termination, PFG released all liens
on
the Company’s assets. There were no outstanding borrowings under the PFG Loan
Agreement at the date of termination.
On
September 12, 2007 NASI announced that it had executed a purchase and sale
agreement with Best Medical International, Inc. to purchase certain assets
and
to assume certain liabilities of our NOMOS Radiation Oncology business, which
we
previously had reported as our IMRT/IGRT business segment (“NOMOS Transaction”).
The purchase price is $500,000 cash at closing, plus assumption of certain
obligations and liabilities, including approximately $3.1 million of liabilities
for warranty and maintenance agreements, $0.2 million of other accrued
liabilities, as well as the NOMOS facility lease in Cranberry Township,
Pennsylvania. NOMOS is retaining certain other liabilities, including certain
trade accounts payable and certain employee obligations. The closing was
completed on September 17, 2007. As a result, we have reported the results
of
the NOMOS Radiation Oncology business as a discontinued operation in our
financial statements for the three and nine months ended July 31, 2007 and
2006.
On
September 14, 2007, NASI and NASI-California entered into a Fourth Amendment
to
Loan and Security Agreement (the “Fourth Amendment”) with Silicon Valley. The
Fourth Amendment further amended the Loan Agreement.
The
Fourth Amendment included: (i) a forbearance by Silicon Valley from exercising
its rights and remedies against the Company, until such time as Silicon Valley
determines in its discretion to cease such forbearance, due to the default
under
the Loan Agreement resulting from the Company failing to comply with the
tangible net worth covenant in the Loan Agreement as of July 31, 2007 and August
31, 2007, and (ii) a consent to a subordinated debt facility of up to $750,000
with Agility Capital LLC. In connection with the Fourth Amendment, Silicon
Valley consented to the NOMOS Transaction and released its lien on the NOMOS
assets,
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of
Operations
The
following discussion and analysis provides information, which our management
believes is relevant to an assessment and understanding of our financial
condition and results of operations. The discussion should be read in
conjunction with the Consolidated Financial Statements contained herein and
the
notes thereto. Certain statements contained in this Form 10-Q, including,
without limitation, statements containing the words “believes”, “anticipates”,
“estimates”, “expects”, “projections”, and words of similar import are forward
looking as that term is defined by: (i) the Private Securities Litigation
Reform Act of 1995 (the "1995 Act") and (ii) releases issued by the
Securities and Exchange Commission (“SEC”). These statements are being made
pursuant to the provisions of the 1995 Act and with the intention of obtaining
the benefits of the "Safe Harbor" provisions of the 1995 Act. We caution that
any forward looking statements made herein are not guarantees of future
performance and that actual results may differ materially from those in such
forward looking statements as a result of various factors, including, but not
limited to, any risks detailed herein or detailed from time to time in our
other
filings with the SEC including our most recent report on Form 10-K. We are
not undertaking any obligation to update publicly any forward-looking
statements. Readers should not place undue reliance on these forward-looking
statements.
Subsequent
Events
On
August
24, 2007, North American Scientific, Inc. (“NASI”) and two of its subsidiaries,
NOMOS Corporation (“NOMOS”) and North American Scientific, Inc., a California
corporation (“NASI-California” and collectively, with NASI and NOMOS, the
“Company”), entered into a Third Amendment to Loan and Security Agreement (the
“Third Amendment”) with Silicon Valley Bank (“Silicon Valley”). The Third
Amendment amended that certain Loan and Security Agreement dated October 5,
2005
(the “Loan Agreement”).
The
Third
Amendment added a Bridge Loan Sub-limit to the Loan Agreement of up to
$1,500,000 at an interest rate of prime plus 4.0%, subject to a borrowing base
formula, and decreased the minimum tangible net worth that must be maintained
by
the Company from $5 million to $2 million. The maturity date of the Bridge
Loan
Sublimit shall be the earlier of October 3, 2007 or the date NASI closes a
private investment public equity transaction. Concurrent with the Third
Amendment, NASI issued Silicon Valley a warrant for 300,000 shares of NASI
common stock at an exercise price of $0.98, the closing price of NASI common
stock on August 24, 2007.
On
August
30, 2007 the Company terminated the Loan and Security Agreement (the “PFG Loan
Agreement”) with Partners For Growth II, L.P. (“PFG”) by mutual consent. The PFG
Loan Agreement was entered into on March 28, 2006 and was scheduled to expire
on
September 28, 2007. As a result of the termination, PFG released all liens
on
the Company’s assets. There were no outstanding borrowings under the PFG Loan
Agreement at the date of termination.
On
September 12, 2007 NASI announced that it had executed a purchase and sale
agreement with Best Medical International, Inc. to purchase certain assets
and
to assume certain liabilities of our NOMOS Radiation Oncology business, which
we
previously had reported as our IMRT/IGRT business segment (“NOMOS Transaction”).
The purchase price is $500,000 cash at closing, plus assumption of certain
obligations and liabilities, including approximately $3.1 million of liabilities
for warranty and maintenance agreements, $0.2 million of other accrued
liabilities, as well as the NOMOS facility lease in Cranberry Township,
Pennsylvania. NOMOS is retaining certain other liabilities, including certain
trade accounts payable and certain employee obligations. The closing was
completed on September 17, 2007. As a result, we have reported the results
of
the NOMOS Radiation Oncology business as a discontinued operation in our
financial statements for the three and nine months ended July 31, 2007 and
2006.
On
September 14, 2007, NASI and NASI-California entered into a Fourth Amendment
to
Loan and Security Agreement (the “Fourth Amendment”) with Silicon Valley. The
Fourth Amendment further amended the Loan Agreement.
The
Fourth Amendment included: (i) a forbearance by Silicon Valley from exercising
its rights and remedies against the Company, until such time as Silicon Valley
determines in its discretion to cease such forbearance, due to the default
under
the Loan Agreement resulting from the Company failing to comply with the
tangible net worth covenant in the Loan Agreement as of July 31, 2007 and August
31, 2007, and (ii) a consent to a subordinated debt facility of up to $750,000
with Agility Capital LLC. In connection with the Fourth Amendment, Silicon
Valley consented to the NOMOS Transaction and released its lien on the NOMOS
assets,
Overview
We
manufacture, market and sell products for the radiation oncology community,
including Prospera® brachytherapy seeds and SurTRAK™ needles and strands used
primarily in the treatment of prostate cancer. We also develop and market
brachytherapy accessories used in the treatment of disease and calibration
sources used in medical, environmental, research and industrial applications
On
November 7, 2006, we announced the introduction of ClearPath™, our unique
multicatheter breast brachytherapy device for Accelerated Partial Breast
Irradiation (APBI), at the American Society for Therapeutic Radiology and
Oncology (ASTRO) Annual Meeting in Philadelphia. The ClearPath systems are
placed through a single incision and are designed to conform to the resection
cavity, allowing for more conformal therapeutic radiation dose distribution
following lumpectomy compared to other methods of APBI. ClearPath is designed
to
accommodate either high-dose, ClearPath-HDR™, or low-dose rate, ClearPath-CR™,
treatment methods. The Company received 510k approval from the United States
Food and Drug Administration for a low-dose rate, or continuous release
treatment utilizing the Company’s Prospera® brachytherapy seeds in April 2006
and approval for the high-dose rate treatment in November 2006. We expect to
begin the commercial launch our ClearPath product during fiscal year 2007,
with
an initial focus on ClearPath-HDR, to be followed by release of our
ClearPath-CR.
As
stated
in Subsequent Events above, effective as of the end of our fiscal third quarter
ended July 31, 2007, our NOMOS Radiation Oncology business has been treated
as a
discontinued operation in our financial statements. This business was sold
on
September 17, 2007.
Based
on
the Company’s current operating plans, management believes that the Company’s
existing cash resources and cash forecasted by management to be generated by
operations, funds to be raised by the Company through an equity financing,
as
well as the Company’s anticipated available line of credit, will be sufficient
to meet working capital and capital requirements through at least the next
twelve months. In this regard, we must raise additional financing in fiscal
2007
to support launch and future development of ClearPath and fund our continuing
operations and other activities. However, there is no assurance that the Company
will be successful with its plans. If events and circumstances occur such
that the Company does not meet its current operating plans, the Company is
unable to raise sufficient additional financing, or the Company’s line of credit
(which presently expires on October 3, 2007) is insufficient or not
available, the Company will be required to further reduce expenses or take
other
steps which could have a material adverse effect on our future performance,
including but not limited to, the premature sale of some or all of our assets
or
product lines on undesirable terms, merger with or acquisition by another
company on unsatisfactory terms, or the cessation of operations.
Management
also expects that in future periods new products and services will provide
additional cash flow, although no assurances can be given that such cash flow
will be realized, and we are presently placing an emphasis on controlling
expenses.
Results
of Operations
Three
Months Ended July 31, 2007 Compared to Three Months Ended July 31,
2006
Total
Revenue
|
|
|
|
|
|
Three
Months Ended July 31
,
|
|
|
|
2007
|
|
2006
|
|
%
Change
|
|
($
millions)
|
|
|
|
|
|
|
|
Radiation
Sources
|
|
$
|
3.4
|
|
$
|
3.2
|
|
|
8.6
|
%
|
Total
revenue increased 9% to $3.4 million for the three months ended July 31, 2007
from $3.2 million for the three months ended July 31, 2006. The increase in
revenue is due to a 17% increase in sales of our brachytherapy seeds and
accessories, with increased product sales partially offset by a decline in
average selling prices, and a 14% decrease in sales of our non-therapeutic
products.
Gross
profit
|
|
Three
Months Ended July 31,
|
|
|
|
2007
|
|
2006
|
|
%
Change
|
|
($
millions)
|
|
|
|
|
|
|
|
Radiation
Sources
|
|
$
|
0.8
|
|
$
|
1.0
|
|
|
(24.5)
|
%
|
(%
of Revenue)
|
|
|
|
|
|
|
|
|
|
|
Radiation
Sources
|
|
|
21.8
|
%
|
|
31.4
|
%
|
|
(9.6)
|
%
|
Gross
profit decreased $0.2 million, or 25%, to $0.8 million for the three months
ended July 31, 2007 from $1.0 million for the three months ended July 31, 2006.
Gross profit as a percent of sales decreased from 31% in the three months ended
July 31, 2006 to 22% in three months ended July 31, 2007. The decrease in our
gross profit and gross profit as a percent of sales is primarily due to
increased material usage costs in brachytherapy seeds and non-therapeutic
products, partially offset by increased gross profit on higher product sales
and
reduced cost of outside stranding.
Selling
and marketing expenses
|
|
Three
Months Ended July 31,
|
|
|
|
2007
|
|
2006
|
|
%
Chang
e
|
|
($
millions)
|
|
|
|
|
|
|
|
Selling
and marketing expenses
|
|
$
|
1.1
|
|
$
|
0.7
|
|
|
62.1
|
%
|
As
a percent of total revenue
|
|
|
30.8
|
%
|
|
20.7
|
%
|
|
|
|
Selling
and marketing expenses, comprised primarily of salaries, commissions, and
marketing costs, increased $0.4 million, or 62%, to $1.1 million for the three
months ended July 31, 2007, from $0.7 million for the three months ended July
31, 2006. The increase in selling and marketing expenses is primarily attributed
to higher sales commissions related to the increased sales of brachytherapy
products, and increased marketing spending on our ClearPath device.
General
and administrative expenses ("G&A")
|
|
Three
Months Ended July 31
|
|
|
|
2007
|
|
2006
|
|
%
Change
|
|
($
millions)
|
|
|
|
|
|
|
|
General
and administrative expenses
|
|
$
|
2.1
|
|
$
|
2.6
|
|
|
(20.4
|
)%
|
As
a percent of total revenue
|
|
|
60.3
|
%
|
|
82.3
|
%
|
|
|
|
G&A
decreased $0.5 million, or 20%, to $2.1 million for the three months ended
July
31, 2007, from $2.6 million for the three months ended July 31, 2006. The
decrease in G&A is primarily attributed to a reduction in professional fees
and a decrease in the allowance for bad debts resulting from improved
collections of receivables.
Research
and development (“R&D”)
|
|
Three
Months Ended July 31
|
|
|
|
2007
|
|
2006
|
|
%
Change
|
|
($
millions)
|
|
|
|
|
|
|
|
Research
and development expenses
|
|
$
|
0.5
|
|
$
|
0.2
|
|
|
184.6
|
%
|
As
a percent of total revenue
|
|
|
15.1
|
%
|
|
5.7
|
%
|
|
|
|
R&D
increased $0.3 million or 185%, to $0.5 million for the three months ended
July
31, 2007, from $0.2 million for the three months ended July 31, 2006. The
increase in R&D spending is primarily due to increased spending on product
development for our ClearPath™ breast brachytherapy device.
Nine
Months Ended July 31, 2007 Compared to Nine Months Ended July 31,
2006
Total
Revenue
|
|
|
|
|
|
Nine
Months Ended July 31
|
|
|
|
2007
|
|
2006
|
|
%
Change
|
|
($
millions)
|
|
|
|
|
|
|
|
Radiation
Sources
|
|
$
|
11.1
|
|
$
|
9.2
|
|
|
20.5
|
%
|
Total
revenue increased 21% to $11.1 million for the nine months ended July 31, 2007
from $9.2 million for the nine months ended July 31, 2006. The increase in
our
Radiation Sources business reflects a 21% increase in sales of our brachytherapy
seeds and accessories, with increased product sales partially offset by a
decline in average selling prices, and a 18% increase in sales of our
non-therapeutic products.
Gross
profit
|
|
Nine
Months Ended July 31,
|
|
|
|
2007
|
|
2006
|
|
%
Change
|
|
($
millions)
|
|
|
|
|
|
|
|
Radiation
Sources
|
|
$
|
3.3
|
|
$
|
2.5
|
|
|
31.5
|
%
|
(%
of Revenue)
|
|
|
|
|
|
|
|
|
|
|
Radiation
Sources
|
|
|
30.0
|
%
|
|
27.5
|
%
|
|
2.5
|
%
|
Gross
profit increased $0.8 million, or 32%, to $3.3 million for the nine months
ended
July 31, 2007 from $2.5 million for the nine months ended July 31, 2006. Gross
profit as a percent of sales increased from 28% in the nine months ended July
31, 2006 to 30% in nine months ended July 31, 2007. The increase in our gross
profit and our gross profit as a percent of sales is primarily due to increased
product sales and reduced cost of outside stranding in our brachytherapy
business, and increased sales of our non-therapeutic products.
Selling
and marketing expenses
|
|
Nine
Months Ended July 31,
|
|
|
|
2007
|
|
2006
|
|
%
Change
|
|
($
millions)
|
|
|
|
|
|
|
|
Selling
and marketing expenses
|
|
$
|
2.8
|
|
$
|
2.0
|
|
|
44.3
|
%
|
As
a percent of total revenue
|
|
|
25.5
|
%
|
|
21.3
|
%
|
|
|
|
Selling
and marketing expenses, comprised primarily of salaries, commissions, and
marketing costs, increased $0.8 million, or 44%, to $2.8 million for the nine
months ended July 31, 2007, from $2.0 million for the nine months ended July
31,
2006. The increase in selling and marketing expenses is primarily attributed
to
higher sales commissions related to the increased sales of brachytherapy
products, and increased marketing expenses related to our ClearPath device
and
trade show expenses.
General
and administrative expenses ("G&A")
|
|
Nine
Months Ended July 31,
|
|
|
|
2007
|
|
2006
|
|
%
Change
|
|
($
millions)
|
|
|
|
|
|
|
|
General
and administrative expenses
|
|
$
|
6.5
|
|
$
|
6.3
|
|
|
3.4
|
%
|
As
a percent of total revenue
|
|
|
58.6
|
%
|
|
68.5
|
%
|
|
|
|
G&A
increased $0.2 million, or 3%, to $6.5 million for the nine months ended July
31, 2007, from $6.3 million for the nine months ended July 31, 2006. The
increase in G&A is primarily attributed to $0.7 million increase in
professional fees, partially offset by $0.5 million decrease in the allowance
for bad debts resulting from improved collections of accounts
receivable
Research
and development (“R&D”)
|
|
Nine
Months Ended July 31,
|
|
|
|
2007
|
|
2006
|
|
%
Change
|
|
($
millions)
|
|
|
|
|
|
|
|
Research
and development expenses
|
|
$
|
1.3
|
|
$
|
0.7
|
|
|
79.3
|
%
|
As
a percent of total revenue
|
|
|
11.5
|
%
|
|
7.7
|
%
|
|
|
|
R&D
increased $0.6 million or 79%, to $1.3 million for the nine months ended July
31, 2007, from $0.7 million for the nine months ended July 31, 2006. The
increase in R&D spending is primarily due to increased spending on product
development for our ClearPath™ breast brachytherapy device.
Liquidity
and Capital Resources
To
date,
our short-term liquidity needs have generally consisted of working capital
to
fund our ongoing operations and to finance growth in inventories, trade accounts
receivable, new product research and development, capital expenditures,
acquisitions and strategic investments in related businesses. We have
satisfied these needs primarily through a combination of cash generated by
operations, public offerings and private placements of our common stock and
borrowings from lenders. We expect that we will be able to
satisfy our longer term liquidity needs for research and development,
capital expenditures, and acquisitions through a combination of cash generated
by operations, issuance of our common stock, and our anticipated available
line
of credit.
The
accompanying financial statements have been prepared on a going concern basis,
which contemplates the realization of assets and liquidation of liabilities
in
the normal course of business. However, the Company has continued to incur
substantial net losses and used substantial amounts of cash. As of July 31,
2007, the Company has an accumulated deficit of $144.6 million; cash and cash
equivalents of $1.8 million,
borrowings under a line of credit of $1.4 million,
and no
long-term debt.
Based
on
the Company’s current operating plans, management believes that the Company’s
existing cash resources and cash forecasted by management to be generated by
operations, funds to be raised by the Company through an equity financing,
as
well as the Company’s anticipated available line of credit, will be sufficient
to meet working capital and capital requirements through at least the next
twelve months. In this regard, we expect that we will raise additional financing
in fiscal 2007 to fund our continuing operations, support the further
development and launch of ClearPath and other activities. However, there is
no
assurance that the Company will be successful with its plans. If events
and circumstances occur such that the Company does not meet its current
operating plans, the Company is unable to raise sufficient additional financing,
or the Company’s line of credit (which presently expires on October 3,
2007) is insufficient or not available, the Company may be required to
further reduce expenses or take other steps which could have a material adverse
effect on our future performance, including but not limited to, the premature
sale of some or all of our assets or product lines on undesirable terms, merger
with or acquisition by another company on unsatisfactory terms, or the cessation
of operations.
Management
also expects that in future periods new products and services will provide
additional cash flow, although no assurance can be given that such cash flow
will be realized, and we are presently placing an emphasis on controlling
expenses.
At
July
31, 2007, we had cash and cash equivalents aggregating approximately $1.8
million, a decrease of approximately $7.5 million from $9.3 million at October
31, 2006. The decrease was primarily attributed to $8.7 million used in
operations and $0.1 million used for capital expenditures, partially offset
by
borrowings under the line of credit of $1.4 million.
Cash
flows used in operating activities decreased $2.4 million, or 22%, to $8.7
million for the nine months ended July 31, 2007 from $11.1 million for the
nine
months ended July 31, 2006, primarily due to improved collections of accounts
receivable ($1.8 million), and a decrease in the allowance for doubtful accounts
of $0.2 million compared to an increase of $0.3 million in the prior year.
We
expect that cash used in operating activities may fluctuate in future periods
as
a result of a number of factors, including fluctuations in our operating
results, accounts receivable collections, inventory management, research and
development expenses, and the timing of payments.
Cash
flows provided by investing activities increased $17.5 million to $8.2 million
for the nine months ended July 31, 2007, from $9.3 million cash used in
investing activities for the nine months ended July 31, 2006. The increase
reflects the additional draw down of our balance of marketable securities to
fund operations in 2007 compared to investments in marketable securities in
2006.
Cash
provided by financing activities decreased $20.7 million to $1.4 million for
the
nine months ended July 31, 2007 from $22.1 million for the nine months ended
July 31, 2006. The decrease is due to a drawdown on the lines of credit of
$1.4
million in 2007 and proceeds from the sale of stock in 2006.
We
have
$0.3 million in operating lease obligations for facilities and equipment under
non-cancelable operating lease agreements. We have also entered into purchase
commitments to suppliers under blanket purchase orders in the amount of $0.1
million.
Critical
Accounting Policies
The
preparation of financial statements and related disclosures in conformity with
accounting principles generally accepted in the United States of America
requires management to make judgments, assumptions and estimates that affect
the
amounts reported in the Consolidated Financial Statements included in the
Company’s Form 10-K for the year ended October 31, 2006, and accompanying notes.
Note 1 to the Consolidated Financial Statements describes the significant
accounting policies and methods used in the preparation of the Consolidated
Financial Statements. Estimates are used for, but not limited to, the accounting
for revenue recognition, allowance for doubtful accounts, goodwill and
long-lived asset impairments, loss contingencies, and taxes. Estimates and
assumptions about future events and their effects cannot be determined with
certainty. We base our estimates on historical experience and on various other
assumptions believed to be applicable and reasonable under the circumstances.
These estimates may change as new events occur, as additional information is
obtained and as our operating environment changes. These changes have
historically been minor and have been included in the consolidated financial
statements as soon as they became known. The following critical accounting
policies are impacted significantly by judgments, assumptions and estimates
used
in the preparation of the Consolidated Financial Statements and actual results
could differ materially from the amounts reported based on these
policies.
Revenue
Recognition
The
Company sells products for radiation therapy treatment, including brachytherapy
seeds used in the treatment of cancer and non-therapuetic sources used in
calibration devices.
Product
revenue
The
Company applies the provisions of SEC Staff Accounting Bulletin (“SAB”) No. 104,
“Revenue Recognition” for the sale of non-software products. SAB No. 104,
which supercedes SAB No. 101, “Revenue Recognition in Financial Statements”,
provides guidance on the recognition, presentation and disclosure of revenue
in
financial statements. SAB No. 104 outlines the basic criteria that must be
met to recognize revenue and provides guidance for the disclosure of revenue
recognition policies. In general, the Company recognizes revenue related
to product sales when (i) persuasive evidence of an arrangement exists, (ii)
delivery has occurred, (iii) the fee is fixed or determinable, and (iv)
collectibility is reasonably assured.
Allowance
for Doubtful Accounts and Sales Returns
The
allowance for doubtful accounts is based on our assessment of the collectibility
of specific customer accounts and the aging of the accounts receivable. We
regularly review the allowance by considering factors such as historical
experience, age of the accounts receivable balances and current economic
conditions that may affect a customer's ability to pay. If there was a
deterioration of a major customer's credit worthiness or actual defaults are
higher than our historical experience, our estimates of the recoverability
of
amounts due us could be overstated which could have an adverse impact on our
financial results.
A
reserve
for sales returns is established based on historical trends in product return
rates and is recorded as a reduction of our accounts receivable. If the actual
future returns were to deviate from the historical data on which the reserve
had
been established, our revenue could be adversely affected. To date, product
returns have not been considered material to our results of
operations.
Inventory
Reserves
Inventories
are valued at the lower of cost or market as determined under the first-in,
first-out method. Costs include materials, labor and manufacturing
overhead.
The
Company's products are subject to shelf-life expiration periods, which are
carefully monitored by the Company. Provision is made for inventory items which
may not be sold because of expiring dates. The Company routinely reviews other
inventories for evidence of impairment of value and makes provision as such
impairments are identified.
Goodwill
and Other Intangible Assets
SFAS
142,
Goodwill and Other Intangible Assets, requires that goodwill be tested for
impairment at the reporting unit level (operating segment or one level below
an
operating segment) on an annual basis (September 30) and between annual tests
if
an event occurs or circumstances change that would more likely than not reduce
the fair value of a reporting unit below its carrying value. These events or
circumstances could include a significant change in the business climate, legal
factors, operating performance indicators, competition, sale or disposition
of a
significant portion of a reporting unit. Application of the goodwill impairment
test requires judgment, including the identification of reporting units,
assignment of assets and liabilities to reporting units, assignment of goodwill
to reporting units, and determination of the fair value of each reporting unit.
The fair value of each reporting unit is estimated using a discounted cash
flow
methodology. This requires significant judgments including estimation of future
cash flows, which is dependent on internal forecasts, estimation of the
long-term rate of growth for our business, the useful life over which cash
flows
will occur, and determination of our weighted average cost of capital. Changes
in these estimates and assumptions could materially affect the determination
of
fair value and/or goodwill impairment for each reporting unit.
Research
and Development Costs
We
account for research and development costs in accordance with several accounting
pronouncements, including SFAS 2, Accounting for Research and Development Costs,
and SFAS 86, Accounting for the Costs of Computer Software to be Sold, Leased,
or Otherwise Marketed. SFAS 86 specifies that costs incurred internally in
researching and developing a computer software product should be charged to
expense until technological feasibility has been established for the product.
Once technological feasibility is established, all software costs should be
capitalized until the product is available for general release to customers.
Judgment is required in determining when technological feasibility of a product
is established. We have determined that technological feasibility for our
software products is reached shortly before the products are released to
manufacturing. Costs incurred after technological feasibility is established
are
not material, and accordingly, we expense all research and development costs
when incurred.
Loss
Contingencies
We
record
liabilities related to pending litigation when an unfavorable outcome is
probable and we can reasonably estimate the amount of the loss. We are subject
to various legal proceedings and claims, either asserted or unasserted, that
arise in the ordinary course of business. We evaluate, among other factors,
the
degree of probability of an unfavorable outcome and an estimate of the amount
of
the loss. Significant judgment is required in both the determination of the
probability and as to whether an exposure can be reasonably estimated. When
we
determine that it is probable that a loss has been incurred, the effect is
recorded promptly in the consolidated financial statements. Although the outcome
of these claims cannot be predicted with certainty, we do not believe that
any
of our existing legal matters will have a material adverse effect on our
financial condition or results of operations.
Income
Taxes
We
account for income taxes using the liability method. Deferred taxes are
determined based on the differences between the financial statement and tax
bases of assets and liabilities, using enacted tax rates in effect for the
year
in which the differences are expected to reverse. Valuation allowances are
established when necessary to reduce deferred tax assets to the amounts expected
to be realized. In addition, we are subject to examination of our income tax
returns by the Internal Revenue Service and other tax authorities. We regularly
assess the likelihood of adverse outcomes resulting from these
examinations.
Recent
Accounting Pronouncements
In
June
2006, the Financial Accounting Standards Board (“FASB”) issued Interpretation
No. 48, Accounting for Uncertainty in Income Taxes — An Interpretation
of FASB Statement No. 109, (FIN 48). FIN 48 clarifies the
accounting for uncertainty in income taxes recognized in an enterprise’s
financial statements in accordance with FASB Statement No. 109, Accounting
for Income Taxes. FIN 48 also prescribes a recognition threshold and
measurement attribute for the financial statement recognition and measurement
of
a tax position taken or expected to be taken in a tax return that results in
a
tax benefit. Additionally, FIN 48 provides guidance on de-recognition,
income statement classification of interest and penalties, accounting in interim
periods, disclosure, and transition. This interpretation is effective for fiscal
years beginning after December 15, 2006.
The
Company is currently evaluating the effect that the application of FIN 48 will
have on its financial position, results of operations or cash
flows.
In
September 2006, the FASB issued SFAS No. 157, “Fair Value
Measurements”,
(“SFAS No. 157”). SFAS No. 157 defines fair value, establishes a framework for
measuring fair value in generally accepted accounting principles (GAAP), and
expands disclosures about fair value measurements. This Statement applies under
other accounting pronouncements that require or permit fair value measurements,
and does not require any new fair value measurements. The application of SFAS
No. 157, however, may change current practice within an organization. SFAS
No.
157 is effective for all fiscal years beginning after November 15, 2007, with
earlier application encouraged.
The
Company is currently evaluating the effect that the application of SFAS No.
157
will have on its financial position, results of operations or cash
flows.
In
February 2007, the FASB issued SFAS No. 159,
“The
Fair Value Option for Financial Assets and Financial Liabilities.”
SFAS
159
provides companies with an option to report selected financial assets and
liabilities at fair value. The standard’s objective is to reduce both complexity
in accounting for financial instruments and the volatility in earnings caused
by
measuring related assets and liabilities differently. The standard requires
companies to provide additional information that will help investors and other
users of financial statements to more easily understand the effect of the
company’s choice to use fair value on its earnings. It also requires companies
to display the fair value of those assets and liabilities for which the company
has chosen to use fair value on the face of the balance sheet. The new standard
does not eliminate disclosure requirements included in other accounting
standards, including requirements for disclosures about fair value measurements
included in SFAS 157,
“Fair
Value Measurements,”
and
SFAS
107,
“Disclosures
about Fair Value of Financial Instruments.”
SFAS
159
is effective as of the start of fiscal years beginning after November 15,
2007. Early adoption is permitted. We are in the process of evaluating this
standard and therefore have not yet determined the impact that the adoption
of
SFAS 159 will have on our financial position, results of operations or cash
flows.
Item
3.
Quantitative
and Qualitative Disclosures about Market Risk
Information
about market risks for the three months ended July 31, 2007, does not differ
materially from that discussed under Item 7A of the registrant's Annual Report
on Form 10-K for the fiscal year ended October 31, 2006.
Item
4.
Controls
and Procedures
(a)
Evaluation of Disclosure Controls and Procedures
As
required by Rule 13a-15(b) under the Securities Exchange Act of 1934 (the
“Exchange Act”), we have carried out an evaluation, under the supervision and
with the participation of our management, including our Chief Executive Officer
(“CEO”) and our Chief Financial Officer (“CFO”), of the effectiveness, as of the
end of the fiscal quarter covered by this report, of the design and operation
of
our “disclosure controls and procedures” as defined in Rule 13a-15(e)
promulgated by the SEC under the Exchange Act. Based upon that evaluation,
our
CEO and our CFO concluded that our disclosure controls and procedures, as of
the
end of such fiscal quarter, were adequate and effective to ensure that
information required to be disclosed by us in the reports that we file or submit
under the Exchange Act is recorded, processed, summarized and reported within
the time periods specified in the Commission’s rules and forms and that such
information is accumulated and communicated to our management, including our
CEO
and CFO, as appropriate to all timely decisions regarding required disclosure.
(b)
Changes in Internal Controls
There
has
been no change in our internal control over financial reporting during the
quarter ended July 31, 2007, that has materially affected or is reasonably
like
to materially affect our internal control over financial reporting.
PART
II - OTHER INFORMATION
The
Company was not required to report the information pursuant to Items 1 through
6
of Part II of Form 10-Q except as follows:
We
operate in a rapidly changing environment that involves a number of risks,
some
of which are beyond our control. In addition to other information in this Form
10-Q, you should carefully consider the risks described below before investing
in our securities. This discussion highlights some of the risks that may affect
future operating results. The risks described below are not the only ones facing
us. Additional risks and uncertainties not presently known to us, which we
currently deem immaterial or which are similar to those faced by other companies
in our industry or business in general, may also impair our business operations.
If any of the following risks or uncertainties actually occurs, our business,
financial condition and operating results would likely suffer.
Item
1A. Risk Factors
We
have experienced significant losses and may continue to incur such losses in
the
future. As a result, the amount of our cash, cash equivalents, and investments
in marketable securities has materially declined. We will need to raise
additional financing in fiscal 2007 to fund our continuing operations, support
the further development and launch of ClearPath and other activities. If we
continue to incur significant losses and are unable to access sufficient working
capital from our operations or through external financings, we will be unable
to
fund future operations and operate as a going concern.
We
have
incurred substantial net losses in each of the last six fiscal years. As
reflected in our financial statements, we have experienced net losses of $17.1
million in the nine months ended July 31, 2007, and $17.1 million, $55.5 million
and $36.3 million in our fiscal years ended October 31, 2006, 2005 and 2004,
respectively. As a result, the amount of our cash, cash equivalents, and
investments in marketable securities has significantly declined from
approximately
$15.0
million at October 31, 2004 to $1.8 million at July 31, 2007. In addition,
our
subordinated line of credit with Partners For Growth was teminated by mutual
consent on August 30, 2007, and although our line of credit with Silicon Valley
Bank was expanded by $1.5 million with a bridge loan sublimit on August 24,
2007, the line of credit expires on October 3, 2007, and there is no assurance
that it will be renewed.
The
negative cash flow we have sustained has materially reduced our working capital,
which in turn, could materially and negatively impact our ability to fund future
operations and continue to operate as a going concern. Management has taken
and
continues to take actions intended to improve our results. These actions include
reducing cash operating expenses, developing new technologies and products,
improving existing technologies and products, and expanding into new
geographical markets.
The
availability of necessary working capital, however, is subject to many factors
beyond our control, including our ability to obtain additional financing, our
ability to increase revenues and to reduce further our losses from operations,
economic cycles, market acceptance of our products, competitors’ responses to
our products, the intensity of competition in our markets, and the level of
demand for our products.
The
amount of
working capital that we will need in the future will also depend on our efforts
and many factors, including:
|
•
|
Our
ability to successfully develop, market and sell our products, including
the successful further development and launch of our new ClearPath
device
for treatment of breast cancer;
|
|
•
|
Continued
scientific progress in our discovery and research
programs;
|
|
•
|
Levels
of selling and marketing expenditures that will be required to launch
future products and achieve and maintain a competitive position in
the
marketplace for both existing and new
products;
|
|
•
|
Structuring
our businesses in alignment with their revenues to reduce operating
losses;
|
|
•
|
Levels
of inventory and accounts receivable that we
maintain;
|
|
•
|
Level
of capital expenditures;
|
|
•
|
Acquisition
or development of other businesses, technologies or
products;
|
|
•
|
The
time and costs involved in obtaining regulatory approvals;
|
|
•
|
The
costs involved in preparing, filing, prosecuting, maintaining, defending,
and enforcing patent claims; and
|
|
•
|
The
potential need to develop, acquire or license new technologies and
products.
|
We
will
need to raise additional equity financing, reduce operations and take other
steps to achieve positive cash flow. We also may be required to curtail our
expenses or to take steps that could hurt our future performance, including
but
not limited to, the termination of major portions of our research and
development activities, the premature sale of some or all of our assets or
product lines on undesirable terms, merger with or acquisition by another
company on unsatisfactory terms or the cessation of operations. We cannot assure
you that we will be successful in these efforts or that any or some of the
above
factors will not negatively impact us. We believe that we will be able to raise
sufficient cash to sustain us at least through the next twelve months.
Future
financing transactions will likely have dilutive and other negative effects
on
our existing shareholders.
In
June
2006, the Company completed a private placement of shares of its common stock
that also includes 6,145,967 shares of common stock issuable upon exercise
of
warrants. This financing resulted in significant dilution of the Company’s
current shareholders. In fiscal 2007, the Company will endeavor to issue and
sell additional equity or convertible securities to raise capital. If the
Company does so, the percentage ownership of the Company held by existing
shareholders would be further reduced, and existing shareholders may experience
significant dilution. In addition, new investors in the Company may demand
rights, preferences or privileges that differ from, or are senior to, those
of
our existing shareholders, such as warrants in addition to the securities
purchased and other protections against future dilutive transactions.
We
currently do not meet the continued listing requirements of the Nasdaq Global
Market. Our ability to publicly or privately sell equity securities and the
liquidity of our common stock could be adversely affected if we are delisted
from The Nasdaq Global Market.
As
of
this filing, the Company does not meet the $10 million stockholders’ equity
requirement
under
Maintenance Standard 1 for continued listing
on
the
Nasdaq Global Market
set
forth in Marketplace Rule 4450(a)(3).
As a
result of the Company’s non-compliance, The Nasdaq Stock Market may send the
Company a notice that the Company’s stock is subject to delisting from the The
Nasdaq Global Market
unless
the Company requests a hearing with a Nasdaq Listing Qualifications Panel to
appeal such delisting. A request for a hearing will stay the delisting action
pending the issuance of a written determination by a Nasdaq Listing
Qualifications Panel. While the Company is working diligently to meet the
minimum stockholders’ equity requirement as promptly as possible, the Company
can provide no assurances that a Nasdaq Listing Qualifications Panel will grant
the Company’s request for continued listing on The Nasdaq Global Market.
Alternatively,
if faced with such delisting, we may submit an application to transfer the
listing of our common stock to The Nasdaq Capital Market. Among other
requirements, The Nasdaq Capital Market has a minimum $2.5 million stockholders’
equity requirement and a $1.00 minimum bid price requirement for continued
listing. As of this filing, we do not meet the minimum $2.5 million
stockholders’ equity requirement or the $1.00 minimum bid price requirement for
listing on the Nasdaq Capital Market.
Alternatively,
if our
common stock is delisted by Nasdaq, our common stock may be eligible to trade
on
the American Stock Exchange, the OTC Bulletin Board maintained by Nasdaq,
another over-the-counter quotation system, or on the pink sheets where an
investor may find it more difficult to dispose of or obtain accurate quotations
as to the market value of our common stock, although there can be no assurance
that our common stock will be eligible for trading on any alternative exchanges
or markets. In addition, we would be subject to Rule 15c2-11 promulgated by
the
SEC. If we fail to meet criteria set forth in the rule (for example, by failing
to file periodic reports as required by the Exchange Act), various practice
requirements are imposed on broker-dealers who sell securities governed by
the
rule to persons other than established customers and accredited investors.
For
these types of transactions, the broker-dealer must make a special suitability
determination for the purchaser and have received the purchaser's written
consent to the transactions prior to sale. Consequently, such rule may deter
broker-dealers from recommending or selling our common stock, which may further
affect the liquidity and price of our common stock.
Delisting
from Nasdaq could adversely affect our ability to raise additional financing
through the public or private sale of equity securities. We need to raise
additional financing in fiscal 2007 to fund our continuing operations, support
the launch and further development of ClearPath, and other activities. Delisting
from Nasdaq also would make trading our common stock more difficult for
investors, potentially leading to further declines in our share price. It would
also make it more difficult for us to raise additional capital.
Success
of our announced plans to introduce a breast brachytherapy device will be
dependent upon a variety of factors.
We
previously have announced the introduction of ClearPath, a new brachytherapy
device for the treatment of breast cancer. Because we believe that our ClearPath
device has certain technical and market advantages, we expect that this device
may generate significant revenues in the future. There are a number of factors
which could adversely affect our ability to achieve this goal,
including:
|
·
|
Successful
further development of a commercially marketable
device;
|
|
·
|
Successful
launch of a marketing and sales program for this
device;
|
|
·
|
Our
ability to protect our intellectual property through patents and
licenses
and avoid infringement of intellectual property of
others;
|
|
·
|
Successful
completion of technical improvements to the
device;
|
|
·
|
Our
ability to successfully manufacture production quantities of the
device;
|
|
·
|
The
acceptance of the device by physicians and health professionals as
an
alternative to other approaches to delivering radiation to a cancer
patient’s breast tissue or to other products using a similar approach but
employing different competitive technologies;
and
|
|
·
|
Our
ability to hire and train a direct sales force to sell the
device;
|
We
may encounter insurmountable obstacles or incur substantially greater costs
and
delays than anticipated in the development process.
From
time
to time, we have experienced setbacks and delays in our research and development
efforts and may encounter further obstacles in the course of the development
of
additional technologies, products and services. We may not be able to overcome
these obstacles or may have to expend significant additional funds and time.
Technical obstacles and challenges we encounter in our research and development
process may result in delays in or abandonment of product commercialization,
may
substantially increase the costs of development, and may negatively affect
our
results of operations.
New
product
developments in the healthcare industry are inherently risky and unpredictable.
These risks include:
•
failure
to prove feasibility;
•
time
required from proof of feasibility to routine production;
•
timing
and cost of regulatory approvals and clearances;
•
competitors' response to new product developments;
•
manufacturing cost overruns;
•
failure
to obtain customer acceptance and payment; and
•
excess
inventory caused by phase-in of new products and phase-out of old products.
The
high cost
of technological innovation is coupled with rapid and significant change in
the
regulations governing the products that compete in our market, by industry
standards that could change on short notice, and by the introduction of new
products and technologies that could render existing products and technologies
uncompetitive. We cannot be sure that we will be able to successfully develop
new products or enhancements to our existing products. Without successful new
product introductions, our revenues likely will continue to suffer, as
competition erodes average selling prices. Even if customers accept new or
enhanced products, the costs associated with making these products available
to
customers, as well as our ability to obtain capital to finance such costs,
could
reduce or prevent us from increasing our operating margins.
All
of our product lines are subject to intense competition. Our most significant
competitors have greater resources than we do. As a result, we cannot be certain
that our competitors will not develop superior technologies, larger more
experienced sales forces or otherwise be able to compete against us more
effectively. If we fail to maintain our competitive position in key product
areas, we may lose significant sources of revenue.
We
believe that our Prospera brachytherapy seeds, our SurTRAK strands and needles
and our new ClearPath device can generate substantial revenues in the future.
We
will need to continue to develop enhancements to these products and improvements
on our core technologies in order to compete effectively. Rapid change and
technological innovation characterize the marketplace for medical products,
and
our competitors could develop technologies that are superior to our products
or
that render such products obsolete. We anticipate that expenditures for research
and development will continue to be significant. The domestic and foreign
markets for radiation therapy are highly competitive. Many of our competitors
and potential competitors have substantial installed bases of products and
significantly greater financial, research and development, marketing and other
resources than we do. Competition may increase as emerging and established
companies enter the field. In addition, the marketplace could conclude that
the
tasks our products were designed to perform are no longer elements of a
generally accepted treatment regimen. This could result in us having to reduce
production volumes or discontinue production of one or more of our products.
Our
primary
competitors in the brachytherapy seed business include: Nycomed Amersham PLC
(through its control of Oncura) and C.R Bard, Inc., both of whom
manufacture and sell Iodine-125 brachytherapy seeds, as well as distribute
Palladium-103 seeds manufactured by a third party (in the case of Oncura, we
currently manufacture a portion of its Palladium-103 seed requirements pursuant
to a distribution agreement reached in July, 2005); Core Oncology, which
manufactures and sells Iodine-125 brachytherapy seeds and currently distributes
third party manufactured Palladium-103 brachytherapy seeds; and Theragenics
Corporation, which manufacturers Palladium-103 seeds and sells Palladium-103
and
Iodine-125 brachytherapy seeds directly and its Palladium-103 brachytherapy
seeds through marketing relationships with third parties. Several additional
companies currently sell brachytherapy seeds as well. Our SurTRAK strands and
needles are subject to competition from a number of companies, including
Worldwide Medical Technologies, Inc.
Our
new
ClearPath-HDR device for treatment of breast cancer is, like its competitors,
designed to connect to a source of high-dose-rate (HDR) radiation which is
administered in a specially shielded room in a hospital. It faces competition
from Cytyc Corp. SenoRx, Inc. and Cianna Medical, (previously BioLucent, Inc.)
The MammoSite RTS device from Cytyc Corp., currently the market leader, uses
a
balloon and catheter system to place the radiation source directly into the
post-lumpectomy cavity. A device developed by SenoRx, Inc. also uses a balloon
and catheter system to deliver the radiation dose. The SAVI device manufactured
by Cianna Medical does not use a balloon and is comprised of an expandable
bundle of catheters.
Our
radiation reference source business also is subject to intense competition.
Competitors in this industry include AEA Technology PLC and Eckert &
Ziegler AG. We believe that these companies have a dominant position in the
market for radiation reference source products.
Because
we are a relatively small company, there is a risk that potential customers
will
purchase products from larger manufacturers, even if our products are
technically superior, based on the perception that a larger, more established
manufacturer may offer greater certainty of continued product improvements,
support and service, which could cause our revenues to decline. In addition,
many
of
our competitors are substantially larger and have greater sales, marketing
and
financial resources than we do. Developments by any of these or other companies
or advances by medical researchers at universities, government facilities or
private laboratories could render our products obsolete. Moreover, companies
with substantially greater financial resources, as well as more extensive
experience in research and development, the regulatory approval process,
manufacturing and marketing, may be in a better position to seize market
opportunities created by technological advances in our industry.
We
are highly dependent on our direct sales organization, which is small compared
to many of our competitors. Also, we will need to hire and train additional
sales representatives to sell our ClearPath device. Any failure to build, manage
and maintain our direct sales organization could negatively affect our revenues.
Our
current
domestic direct sales force is small relative to many of our competitors. There
is intense competition for skilled sales and marketing employees, particularly
for people who have experience in the radiation oncology market. Accordingly,
we
could find it difficult to hire or retain skilled individuals to sell our
products. Any failure to build our direct sales force could adversely affect
our
growth and our ability to meet our revenue goals.
As
a
result of our relatively small sales force the need to hire and train additional
sales representatives to sell our ClearPath device, and the intense competition
for skilled sales and marketing employees, there can be no assurance that our
direct sales and marketing efforts will be successful. If we are not successful
in our direct sales and marketing, our sales revenue and results of operations
are likely to be materially adversely affected.
We
depend partially on our relationships with distributors and other industry
participants to market some of our products, and if these relationships are
discontinued or if we are unable to develop new relationships, our revenues
could decline.
Our
2005
agreement with Oncura for distribution of our Palladium-103 brachytherapy seeds
is be an important component of that business. In addition, we do not have
a
direct sales force for our non-therapeutic radiation source products, and rely
entirely on the efforts of agents and distributors for sales of those
non-brachytherapy products. We cannot assure you that we will be able to
maintain our existing relationships with our agents and distributors for the
sale of our Palladium-103 brachytherapy seeds and our non-therapeutic radiation
source products.
If
we are sued for product-related liabilities, the cost could be prohibitive
to
us.
The
testing, marketing and sale of human healthcare products entail an inherent
exposure to product liability claims. Third parties may successfully assert
product liability claims against us. Although we currently have insurance
covering claims against our products, we may not be able to maintain this
insurance at acceptable cost in the future, if at all. In addition, our
insurance may not be sufficient to cover particularly large claims. Significant
product liability claims could result in large and unexpected expenses as well
as a costly distraction of management resources and potential negative publicity
and reduced demand for our products.
Currently,
our products are predominantly used in the treatment of tumors of the prostate.
If we do not obtain wider acceptance of our products to treat other types of
cancer, our sales could fail to increase and we could fail to achieve our
desired growth rate.
Currently,
our brachytherapy products are used almost exclusively for the treatment of
prostate cancer. Further research, clinical data and years of experience will
likely be required before there can be broad acceptance for the use of our
brachytherapy products for additional types of cancer. If our products do not
become more widely accepted in treating other types of cancer, our sales could
fail to increase or could decrease.
We
rely on several sole source suppliers and a limited number of other suppliers
to
provide raw materials and significant components used in our products. A
material interruption in supply could prevent or limit our ability to accept
and
fill orders for our products.
We
depend
upon a limited number of outside unaffiliated suppliers for our radioisotopes.
Our principal suppliers are Nordion International, Inc. and Eckert &
Ziegler AG. We also utilize other commercial isotope manufacturers located
in
the United States and overseas. To date, we have been able to obtain the
required radioisotopes for our products without any significant delays or
interruptions. Currently, we rely exclusively upon Nordion International for
our
supply of the Palladium-103 isotope; if Nordion International ceases to supply
isotopes in sufficient quantity to meet our needs, there may not be adequate
alternative sources of supply. If we lose any of these suppliers (including
any
single-source supplier), we would be required to find and enter into supply
arrangements with one or more replacement suppliers. Obtaining alternative
sources of supply could involve significant delays and other costs and these
supply sources may not be available to us on reasonable terms or at all. Any
disruption of supplies could delay delivery of our products that use
radioisotopes, which could adversely affect our business and financial results
and could result in lost or deferred sales.
If
we are unable to attract and retain qualified employees, we may be unable to
meet our growth and revenue needs.
Our
success is materially dependent on a limited number of key employees, and,
in
particular, the continued services of John B. Rush, our president and chief
executive officer, L. Michael Cutrer, our executive vice president and chief
technology officer, Troy A. Barring, our chief operating officer, and James
W.
Klingler, our chief financial officer. Our future business and financial results
could be adversely affected if the services of Messrs. Rush, Cutrer, Barring
or
Klingler or other key employees cease to be available. To our knowledge, none
of
our key employees have any plans to retire or leave in the near future.
Our
future success and ability to grow our business will depend in part on the
continued service of our skilled personnel and our ability to identify, hire
and
retain additional qualified personnel. Although some employees are bound by
a
limited non-competition agreement that they sign upon employment, few of our
employees are bound by employment contracts, and it is difficult to find
qualified personnel, particularly medical physicists and customer service
personnel, who are willing to travel extensively. We compete for qualified
personnel with medical equipment manufacturers, universities and research
institutions. Because the competition for these personnel is intense, costs
related to compensation may increase significantly.
Even
when
we are able to hire a qualified medical physicist, engineer or other technical
person, there is a significant training period of up to several months before
that person is fully capable of performing the functions we need. This could
limit our ability to expand our business.
The
medical device industry is characterized by competing intellectual property,
and
we could be sued for violating the intellectual property rights of others,
which
may require us to withdraw certain products from the market.
The
medical
device industry is characterized by a substantial amount of litigation over
patent and other intellectual property rights. Our competitors, like companies
in many high technology businesses, continually review other companies' products
for possible conflicts with their own intellectual property rights. Determining
whether a product infringes a patent involves complex legal and factual issues,
and the outcome of patent litigation actions is often uncertain. Our competitors
could assert that our products and the methods we employ in the use of our
products are covered by United States or foreign patent rights held by them.
In
addition, because patent applications can take many years to issue, there could
be applications now pending of which we are unaware, which could later result
in
issued patents that our products infringe. There could also be existing patents
that one or more of our products could inadvertently be infringing of which
we
are unaware.
While
we do
not believe that any of our products, services or technologies infringe any
valid intellectual property rights of third parties, we may be unaware of
third-party intellectual property rights that relate to our products, services
or technologies. As the number of competitors in the radiation oncology market
grows, and as the number of patents issued in this area grows, the possibility
of a patent infringement claim against us going forward increases. We could
incur substantial costs and diversion of management resources if we have to
assert our patent rights against others. An unfavorable outcome to any
litigation could harm us. In addition, we may not be able to detect infringement
or may lose competitive position in the market before we do so.
To
address
patent infringement or other intellectual property claims, we may have to enter
into license agreements and technology cross-licenses or agree to pay royalties
at a substantial cost to us. We may be unable to obtain necessary licenses.
A
valid claim against us and our failure to obtain a license for the technology
at
issue could prevent us from selling our products and materially adversely affect
our business, financial results and future prospects.
If
we fail to protect our intellectual property rights or if our intellectual
property rights do not adequately cover the technologies we employ, or if such
rights are declared to be invalid, other companies may take advantage of our
technology ideas and more effectively compete directly against us, or we might
be forced to discontinue selling certain products.
Our
success
depends in part on our ability to obtain and enforce patent protections for
our
products and operate without infringing on the proprietary rights of third
parties. We rely on U.S. and foreign patents to protect our intellectual
property. We also rely significantly on trade secrets and know-how that we
seek
to protect. We attempt to protect our intellectual property rights by filing
patent applications for new features and products we develop. We enter into
confidentiality or license agreements with our employees, consultants,
independent contractors and corporate partners, and we seek to control access
to
our intellectual property and the distribution of our products, documentation
and other proprietary information. We plan to continue these methods to protect
our intellectual property and our products. These measures may afford only
limited protection. In addition, the laws of some foreign countries may not
protect our intellectual property rights to the same extent as do the laws
of
the United States.
If
a
competitor infringes upon our patent or other intellectual property rights,
enforcing those rights could be difficult, expensive and time-consuming, making
the outcome uncertain. Competitors could also bring actions or counterclaims
attempting to invalidate our patents. Even if we are successful, litigation
to
enforce our intellectual property rights or to defend our patents against
challenge could be costly and could divert our management's attention.
In
2006,
we licensed intellectual property which was later the subject of litigation
brought by WorldWide Medical Technologies in U.S. District Court against both
the Company as well as their former employee, Richard Terwilliger, who was
previously our Vice-President of New Product Development. This intellectual
property relates to the Company’s brachytherapy business, specifically, certain
needle-loading and stranding technologies. While the Company does not believe
that it has any liability in this matter, and is vigorously defending itself
in
the litigation, we cannot predict what effect an adverse result from this
litigation would have on our future sales of the products at issue.
We
use radioactive materials which are subject to stringent regulation and which
may subject us to liability if accidents occur
.
We
manufacture and process radioactive materials which are subject to stringent
regulation. We operate under licenses issued by the California Department of
Health which are renewable every eight years. We received a renewal of our
licenses for our North Hollywood and Chatsworth facilities in 2007. California
is one of the "Agreement States," which are so named because the Nuclear
Regulatory Commission, or NRC, has granted such states regulatory authority
over
radioactive materials, provided such states have regulatory standards meeting
or
exceeding the standards imposed by the NRC. Most users of our products must
obtain licenses issued by the state in which they reside (if they are Agreement
States) or the NRC. Use licenses are also required by some of the foreign
jurisdictions in which we may seek to market our products.
Although
we believe that our safety procedures for handling and disposing of these
radioactive materials comply with the standards prescribed by state and federal
regulations, the risk of accidental contamination or injury from these materials
cannot be completely eliminated. In the event of such an accident, we could
be
held liable for any damages that result. We believe we carry reasonably adequate
insurance to cover us in the event of any damages resulting from the use of
hazardous materials.
Healthcare
reforms, changes in health-care policies and unfavorable changes to third-party
reimbursements for use of our products, could cause declines in the revenues
of
our products, and could hamper the introduction of new
products.
Hospitals
and freestanding clinics may be less likely to purchase our products if they
cannot be assured of receiving favorable reimbursement for treatments using
our
products from third-party payors, such as Medicare, Medicaid and private health
insurance plans. Generally speaking, Medicare pays hospitals, freestanding
clinics and physicians a fixed amount for services using our products,
regardless of the costs incurred by those providers in furnishing the services.
Such providers may perceive the set reimbursement amounts as inadequate to
compensate for the costs incurred and thus may be reluctant to furnish the
services for which our products are designed. Moreover, third-party payors
are
increasingly challenging the pricing of medical procedures or limiting or
prohibiting reimbursement for some services or devices, and we cannot be sure
that they will reimburse our customers at levels sufficient to enable us to
achieve or maintain sales and price levels for our products. There is no uniform
policy on reimbursement among third-party payors, and we can provide no
assurance that procedures using our products will qualify for reimbursement
from
third-party payors or that reimbursement rates will not be reduced or
eliminated. A reduction in or elimination of third-party payor reimbursement
for
treatments using our products would likely have a material adverse effect on
our
revenues.
Furthermore,
any federal and state efforts to reform government and private healthcare
insurance programs could significantly affect the purchase of healthcare
services and products in general and demand for our products in particular.
We
are unable to predict whether potential reforms will be enacted, whether other
healthcare legislation or regulation affecting the business may be proposed
or
enacted in the future or what effect any such legislation or regulation would
have on our business, financial condition or results of
operations.
The
federal
Medicare program currently reimburses hospitals and freestanding clinics for
brachytherapy treatments. Medicare reimbursement amounts typically are reviewed
and adjusted at least annually. Medicare reimbursement policies are reviewed
and
revised on an ad hoc basis. Adjustments could be made to these reimbursement
policies or amounts, which could result in reduced or no reimbursement for
brachytherapy services. Changes in Medicare reimbursement policies or amounts
affecting hospitals and freestanding clinics could negatively affect market
demand for our products.
Medicare
reimbursement amounts for seeding are currently significantly less than for
radical prostatectomy, or RP. Although seeding generally requires less physician
time than RP, lower reimbursement amounts, when combined with physician
familiarity with RP, may create disincentives for urologists to perform seeding.
Private
third-party payors often adopt Medicare reimbursement policies and payment
amounts. As such, Medicare reimbursement policy and payment amount changes
concerning our products also could be extended to private third-party payor
reimbursement policies and amounts and could affect demand for our products
in
those markets as well.
Acceptance
of
our products in foreign markets could be affected by the availability of
adequate reimbursement or funding, as the case may be, within prevailing
healthcare payment systems. Reimbursement, funding and healthcare payment
systems vary significantly by country and include both government-sponsored
healthcare and private insurance. We can provide no assurance that third-party
reimbursement will be made available with respect to treatments using our
products under any foreign reimbursement system.
Problems
with any of these reimbursement systems that adversely affect demand for our
products could cause our revenues from our products to decline and our business
to suffer.
Also,
we,
our distributors and healthcare providers performing radiation therapy
procedures are subject to state and federal fraud and abuse laws prohibiting
kickbacks and, in the case of physicians, patient self-referrals. We may be
subjected to civil and criminal penalties if we or our agents violate any of
these prohibitions.
We
are subject to extensive government regulation applicable to the manufacture
and
distribution of our products. Complying with the Food And Drug Administration
and other domestic and foreign regulatory bodies is an expensive and
time-consuming process, whose outcome can be difficult to predict. If we fail
or
are delayed in obtaining regulatory approvals or fail to comply with applicable
regulations, we may be unable to market and distribute our products or may
be
subject to civil or criminal penalties.
We
and
some of our suppliers and distributors are subject to extensive and rigorous
government regulation of the manufacture and distribution of our products,
both
in the United States and in foreign countries. Compliance with these laws and
regulations is expensive and time-consuming, and changes to or failure to comply
with these laws and regulations, or adoption of new laws and regulations, could
adversely affect our business.
In
the
United States, as a manufacturer and seller of medical devices and devices
utilizing radioactive by-product material, we and some of our suppliers and
distributors are subject to extensive regulation by federal governmental
authorities, such as the United States Food and Drug Administration, or FDA,
and
state and local regulatory agencies, such as the State of California, to ensure
such devices are safe and effective. Such regulations, which include the U.S.
Food, Drug and Cosmetic Act, or the FDC Act, and regulations promulgated by
the
FDA, govern the design, development, testing, manufacturing, packaging,
labeling, distribution, import/export, possession, marketing, disposal, clinical
investigations involving humans, sale and marketing of medical devices,
post-market surveillance, repairs, replacements, recalls and other matters
relating to medical devices, radiation producing devices and devices utilizing
radioactive by-product material. State regulations are extensive and vary from
state to state. Our brachytherapy seeds constitute medical devices subject
to
these regulations. Future products in any of our business segments may
constitute medical devices and be subject to regulation as such. These laws
require that manufacturers adhere to certain standards designed to ensure that
the medical devices are safe and effective. Under the FDC Act, each medical
device manufacturer must comply with requirements applicable to manufacturing
practices.
In
the
United States, medical devices are classified into three different categories,
over which the FDA applies increasing levels of regulation: Class I,
Class II, and Class III. The FDA has classified all of our
brachytherapy products as Class I devices. Before a new device can be introduced
into the United States market, the manufacturer must obtain FDA clearance or
approval through either a 510(k) premarket notification or a premarket approval,
unless the product is otherwise exempt from the requirements. Class I
devices are statutorily exempt from the 510(k) process, unless the device is
intended for a use which is of substantial importance in preventing impairment
of human health or it presents a potential unreasonable risk of illness or
injury.
A
510(k)
premarket notification clearance will typically be granted for a device that
is
substantially equivalent to a legally marketed Class I or Class II
medical device or a Class III medical device for which the FDA has not yet
required submission of a premarket approval. A 510(k) premarket notification
must contain information supporting the claim of substantial equivalence, which
may include laboratory results or the results of clinical studies. Following
submission of a 510(k) premarket notification, a company may not market the
device for clinical use until the FDA finds the product is substantially
equivalent for a specific or general intended use. FDA clearance generally
takes
from four to twelve months, but it may take longer, and there is no assurance
that the FDA will ultimately grant a clearance. The FDA may determine that
a
device is not substantially equivalent and require submission and approval
of a
premarket approval or require further information before it is able to make
a
determination regarding substantial equivalence.
Most
of
the products that we are currently marketing have received clearances from
the
FDA through the 510(k) premarket notification process. For any devices already
cleared through the 510(k) process, modifications or enhancements that could
significantly affect safety or effectiveness, or constitute a major change
in
intended use require a new 510(k) submission and a separate FDA determination
of
substantial equivalence. We have made minor modifications to our products and,
using the guidelines established by the FDA, have determined that these
modifications do not require us to file new 510(k) submissions. If the FDA
disagrees with our determinations, we may not be able to sell one or more of
our
products until the FDA has cleared new 510(k) submissions for these
modifications, and there is no assurance that the FDA will ultimately grant
a
clearance. In addition, the FDA may determine that future products require
the
more costly, lengthy and uncertain premarket approval process under
Section 515 of the FDC. The approval process under Section 515
generally takes from one to three years, but in many cases can take even longer,
and there can be no assurance that any approval will be granted on a timely
basis, if at all. Under the premarket approval process, an applicant must
generally conduct at least one clinical investigation and submit extensive
supporting data and clinical information establishing the safety and
effectiveness of the device, as well as extensive manufacturing information.
Clinical investigations themselves are typically lengthy and expensive, closely
regulated and frequently require prior FDA clearance. Even if clinical
investigations are conducted, there is no assurance that they will support
the
claims for the product. If the FDA requires us to submit a new pre-market
notification under Section 510(k) for modifications to our existing
products, or if the FDA requires us to go through the lengthier, more rigorous
Section 515 pre-market approval process, our product introductions or
modifications could be delayed or cancelled, which could cause our revenues
to
be below expectations.
In
addition to FDA-required market clearances and approvals, our manufacturing
operations are required to comply with the FDA's Quality System Regulation,
or
QSR, which addresses the quality program requirements, such as a company's
management responsibility for the company's quality systems, and good
manufacturing practices, product design, controls, methods, facilities and
quality assurance controls used in manufacturing, assembly, packing, storing
and
installing medical devices. Compliance with the QSR is necessary to receive
FDA
clearance or approval to market new products and is necessary for us to be
able
to continue to market cleared or approved product offerings.
There
can
be no assurance that we will not incur significant costs to comply with these
regulations in the future or that the regulations will not have a material
adverse effect on our business, financial condition and results of operations.
Our compliance and the compliance by some of our suppliers with applicable
regulatory requirements is and will continue to be monitored through periodic
inspections by the FDA.
The
FDA
makes announced and unannounced inspections to determine compliance with the
QSR's and may issue us 483 reports listing instances where we have failed to
comply with applicable regulations and/or procedures or Warning Letters which,
if not adequately responded to, could lead to enforcement actions against us,
including fines, the total shutdown of our production facilities and criminal
prosecution.
If
we or any
of our suppliers fail to comply with FDA requirements, the FDA can institute
a
wide variety of enforcement actions, ranging from a public warning letter
to
more severe sanctions such as:
•
fines,
injunctions and civil penalties;
•
the
recall or seizure of our products;
•
the
imposition of operating restrictions, partial suspension or total shutdown
of
production;
•
the
refusal of our requests for 510(k) clearance or pre-market approval of new
products;
•
the
withdrawal of 510(k) clearance or pre-market approvals already granted; and
•
criminal prosecution.
Similar
consequences could arise from our failure, or the failure by any of our
suppliers, to comply with applicable foreign laws and regulations. Foreign
regulatory requirements vary by country. In general, our products are regulated
outside the United States as medical devices by foreign governmental agencies
similar to the FDA. However, the time and cost required to obtain regulatory
approvals from foreign countries could be longer than that required for FDA
clearance and the requirements for licensing a product in another country may
differ significantly from the FDA requirements. We rely, in part, on our foreign
distributors to assist us in complying with foreign regulatory requirements.
We
may not be able to obtain these approvals without incurring significant expenses
or at all, and the failure to obtain these approvals would prevent us from
selling our products in the applicable countries. This could limit our sales
and
growth.
Our
future growth depends, in part, on our ability to penetrate foreign markets,
particularly in Asia and Europe. However, we have encountered difficulties
in
gaining acceptance of our products in foreign markets, where we have limited
experience marketing, servicing and distributing our products, and where we
will
be subject to additional regulatory burdens and other
risks.
Our
future
profitability will depend in part on our ability to establish, grow and
ultimately maintain our product sales in foreign markets, particularly in Asia
and Europe. However, we have limited experience in marketing, servicing and
distributing our products in other countries. In 2006, less than 5% of our
product revenues and less than 5% of our total revenues were derived from sales
to customers outside the United States and Canada. Our foreign operations
subject us to additional risks and uncertainties, including:
•
our
customers' ability to obtain reimbursement for procedures using our products
in
foreign markets;
•
the
burden of complying with complex and changing foreign regulatory requirements;
•
language barriers and other difficulties in providing long-range customer
support and service;
•
longer
accounts receivable collection times;
•
significant currency fluctuations, which could cause our distributors to reduce
the number of products they purchase from us because the cost of our products
to
them could fluctuate relative to the price they can charge their customers;
•
reduced
protection of intellectual property rights in some foreign countries; and
•
the
interpretation of contractual provisions governed by foreign laws in the event
of a contract dispute.
Our
foreign
sales of our products could also be adversely affected by export license
requirements, the imposition of governmental controls, political and economic
instability, trade restrictions, changes in tariffs and difficulties in staffing
and managing foreign operations. In addition, we are subject to the Foreign
Corrupt Practices Act, any violation of which could create a substantial
liability for us and also cause a loss of reputation in the market.
As
part of our business strategy, we intend to pursue transactions that may cause
us to experience significant charges to earnings that may adversely affect
our
stock price and financial condition
.
We
regularly review potential transactions related to technologies, product
candidates or product rights and businesses complementary to our business.
Such
transactions could include mergers, acquisitions, strategic alliances, licensing
agreements or co-promotion agreements. Our acquisition of Theseus Imaging
Corporation in October 2000 and the acquisition of NOMOS, in May 2004, are
examples of such transactions. In the future, if we have sufficient available
capital, we may choose to enter into such transactions. We may not be able
to
successfully integrate newly acquired organizations, products or technologies
into our business and the process could be expensive and time consuming and
may
strain our resources. Depending upon the nature of any transaction, we may
experience a charge to earnings which could be material.
Operating
results for a particular period may fluctuate and are difficult to
predict.
The
results of operations for any fiscal quarter or fiscal year are not necessarily
indicative of results to be expected in future periods. Our operating results
have in the past been, and will continue to be, subject to quarterly and annual
fluctuations as a result of a number of factors. As a consequence, operating
results for a particular future period are difficult to predict. Such factors
include the following:
|
·
|
Our
net sales may grow at a slower rate than experienced in previous
periods
and, in particular periods, may
decline;
|
|
·
|
Our
future sales growth is highly dependent on the successful introduction
of
our ClearPath device;
|
|
·
|
Our
brachytherapy product lines may experience some variability in revenue
due
to seasonality. This is primarily due to three major holidays occurring
in
our first fiscal quarter and the apparent reduction in the number
of
procedures performed during summer months, which could affect our
third
fiscal quarter results;
|
|
·
|
Estimates
with respect to the useful life and ultimate recoverability of our
carrying basis of assets, including goodwill and purchased intangible
assets, could change as a result of such assessments and
decisions;
|
|
·
|
As
a result of our growth in past periods, our fixed costs have increased.
With increased levels of spending and the impact of long-term commitments,
we may not be able to quickly reduce these fixed expenses in response
to
short-term business changes; and
|
|
·
|
Acquisitions
that result in in-process research and development expenses may be
charged
fully in an individual quarter.
|
|
·
|
Changes
or anticipated change in third-party reimbursement amounts or policies
applicable to treatments using our
products;
|
|
·
|
Timing
of the announcement, introduction and delivery of new products or
product
enhancements by us and by our competitors;
|
|
·
|
The
possibility that unexpected levels of cancellations of orders or
backlog
may affect certain assumptions upon which we base our forecasts and
predictions of future performance;
|
|
·
|
Changes
in the general economic conditions in the regions in which we do
business;
|
|
·
|
Unfavorable
outcome of any litigation; and
|
|
·
|
Accounting
adjustments such as those relating to reserves for product recalls,
stock
option expensing as required under SFAS No. 123R and changes in
interpretation of accounting
pronouncements
|
Being
a public company significantly increases our administrative
costs.
The
Sarbanes-Oxley Act of 2002, as well as rules subsequently implemented by the
SEC
and listing requirements subsequently adopted by NASDAQ in response to
Sarbanes-Oxley, have required changes in corporate governance practices,
internal control policies and audit committee practices of public companies.
These rules, regulations, and requirements have significantly increased our
legal, financial, compliance and administrative costs, and have made certain
other activities more time consuming and costly, as well as requiring
substantial time and attention of our senior management. The Company expects
its
continued compliance with these and future rules and regulations to continue
to
require significant resources. These new rules and regulations also may make
it
more difficult and more expensive for us to obtain director and officer
liability insurance in the future, and could make it more difficult for us
to
attract and retain qualified members for our Board of Directors, particularly
to
serve on our audit committee.
Our
publicly-filed SEC reports are reviewed by the SEC from time to time and any
significant changes required as a result of any such review may result in
material liability to us and have a material adverse impact on the trading
price
of our common stock.
The
reports of publicly-traded companies are subject to review by the SEC from
time
to time for the purpose of assisting companies in complying with applicable
disclosure requirements and to enhance the overall effectiveness of companies
public filings, and comprehensive reviews of such reports are now required
at
least every three years under the Sarbanes-Oxley Act of 2002. While we believe
that our previously filed SEC reports comply, and we intend that all future
reports will comply in all material respects with the published rules and
regulations of the SEC, we could be required to modify or reformulate
information contained in prior filings as a result of an SEC review. Any
modification or reformulation of information contained in such reports could
be
significant and result in material liability to us and have a material adverse
impact on the trading price of our common stock.
Market
volatility and fluctuations in our stock price and trading volume may cause
sudden decreases in the value of an investment in our common stock.
The
market price of our common stock has historically been, and we expect it to
continue to be, volatile. The price of our common stock has ranged between
$0.85
and $2.00 in the fifty-two week period ended July 31, 2007. The stock market
has
from time to time experienced extreme price and volume fluctuations,
particularly in the medical device sector, which have often been unrelated
to
the operating performance of particular companies. Factors such as announcements
of technological innovations or new products by our competitors or disappointing
results by third parties, as well as market conditions in our industry, may
significantly influence the market price of our common stock. Our stock price
has also been affected by our own public announcements regarding such things
as
quarterly sales and earnings. Consequently, events both within and beyond our
control may cause shares of our stock to lose their value rapidly.
In
addition, sales of a substantial number of shares of our common stock by
stockholders could adversely affect the market price of our shares. In
connection with our June 2006 sale of common stock and accompanying warrants,
we
filed resale registration statements covering an aggregate of up to 12,291,934
shares of common stock and 6,145,967 shares of common stock issuable to upon
exercise of warrants for the benefit of the selling security holders. The actual
or anticipated resale by such investors under these registration statements
may
depress the market price of our common stock. Bulk sales of shares of our common
stock in a short period of time could also cause the market price for our shares
to decline.
Item
2.
Unregistered
Sales of Equity Securities and Use of Proceeds
None.
Issuer
Purchases of Equity Securities
In
October 2001, the Board of Directors authorized a stock repurchase program
to acquire up to $10 million of the Company's common stock in the open
market at any time. The number of shares of common stock actually acquired
by
the Company will depend on subsequent developments and corporate needs, and
the
repurchase of shares may be interrupted or discontinued at any time. No shares
were repurchased by the Company for the three months ended July 31, 2007. As
of
July 31, 2007 and October 31, 2006, a cumulative total of 116,995 shares
and 22,100 shares had been repurchased by the Company at a cost of $227,000
and
$133,000, respectively and are reflected as Treasury Stock on the Balance Sheet
at the respective dates.
We
expect repurchases will be made in accordance with Rule 10b-18 and include
a
plan designed to satisfy the Rule 10b5-1 safe harbor.
Item
4. Submission of Matters to a Vote of Security Holders
On
June
5, 2007 the Company, at its Annual Meeting of Stockholders, elected nine
directors to hold office until the 2008 Annual Meeting.
The
following table includes those persons nominated and elected as directors to
hold office until the 2008 Annual Meeting of Stockholders, including the number
of shares cast for, withheld, abstained and broker non-votes with respect to
each of the nominees:
|
Description
|
|
For
|
|
Withheld
|
|
Abstained
|
|
Broker
Non-Votes
|
|
L.
Michael Cutrer
|
|
22,198,438
|
|
360,118
|
|
---
|
|
---
|
|
John
A. Friede
|
|
22,279,911
|
|
278,645
|
|
---
|
|
---
|
|
Dr.
Wilfred E. Jaeger
|
|
22,314,953
|
|
243,603
|
|
---
|
|
---
|
|
John
B. Rush
|
|
22,299,953
|
|
258,603
|
|
---
|
|
---
|
|
John
M. Sabin
|
|
22,291,879
|
|
266,677
|
|
---
|
|
---
|
|
Richard
A. Sandberg
|
|
22,116,899
|
|
441,657
|
|
---
|
|
---
|
|
Dr.
Gary N. Wilner
|
|
22,307,129
|
|
152,427
|
|
---
|
|
---
|
|
Nancy
J. Wysenski
|
|
22,120,903
|
|
437,653
|
|
---
|
|
---
|
|
Roderick
A. Young
|
|
22,305,929
|
|
252,627
|
|
---
|
|
---
|
|
|
|
|
|
|
|
|
|
|
Item
5. Other Information
Completion
of Disposition of Assets
On
September 17, 2007 North American Scientific, Inc. (“NASI”) completed the
disposition of its NOMOS Radiation Oncology business (the “NOMOS Transaction”).
In connection with the NOMOS Transaction, NOMOS Corporation (“NOMOS”) sold
substantially all of its assets, including accounts receivable, contract rights,
inventory, equipment and intellectual property, but excluding cash and certain
other assets, to Best Medical International, Inc. (“Best”). The purchase price
was $500,000 cash at closing, plus assumption of certain obligations and
liabilities of NOMOS by Best, including approximately $3.1 million of
liabilities for warranty and maintenance agreements, $0.2 million of other
accrued liabilities, as well as the NOMOS facility lease in Cranberry Township,
Pennsylvania. NOMOS retained certain other liabilities, including certain trade
accounts payable and certain employee obligations.
Entry
into a Material Definitive Agreement
On
September 14, 2007, NASI and its wholly-owned subsidiary, North American
Scientific, Inc., a California corporation (collectively, the “Company”),
entered into a Fourth Amendment to Loan and Security Agreement (the “Fourth
Amendment”) with Silicon Valley Bank (“Silicon Valley”). The Fourth Amendment
amended the Loan and Security Agreement dated October 5, 2005 (the “Loan
Agreement”). The Fourth Amendment included: (i) a forbearance by Silicon Valley
from exercising its rights and remedies against the Company, until such time
as
Silicon Valley determines in its discretion to cease such forbearance, due
to
the defaults under the Loan Agreement resulting from the Company failing to
comply with the tangible net worth covenant in the Loan Agreement as of July
31,
2007 and August 31, 2007, and (ii) a consent to a subordinated debt facility
of
up to $750,000 with Agility Capital LLC. In connection with the Fourth
Amendment, Silicon Valley consented to the NOMOS Transaction and released its
lien on the NOMOS assets. A copy of the Fourth Amendment is attached hereto
as
Exhibit 10.3.
Item
6.
Exhibits
(a)
Exhibits.
Exhibits
No.
|
Title
|
|
|
10.1
|
Third
Amendment to Loan and Security Agreement dated August 24, 2007,
between
Silicon Valley Bank, North American Scientific, Inc., a Delaware
corporation, North American Scientific, Inc., a California corporation,
and NOMOS Corporation.
|
|
|
10.2
|
Agreement
among North American Scientific, Inc., NOMOS corporation, and Best
Medical
International, Inc., dated as of September 11, 2007, incorporated
by
reference to Exhibit 10.1 to Registrant’s Form 8-K filed September 14,
2007.
|
|
|
10.3
|
Fourth
Amendment and Forbearance to Loan and Security Agreement dated
September
14, 2007, between Silicon Valley Bank, North American Scientific,
Inc., a
Delaware corporation, and North American Scientific, Inc., a California
corporation.
|
|
|
31.1
|
Certification
of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
|
|
|
31.2
|
Certification
of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
|
|
|
32.1
|
Certification
of Chief Executive Officer and Chief Financial Officer Pursuant
to Section
906 of the Sarbanes-Oxley Act of
2002.
|