e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
FORM 10-Q
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þ |
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Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of
1934 |
for the quarterly period ended December 31, 2008.
or
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Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
for the transition from to .
Commission File Number: 333-82900
ThermoGenesis Corp.
(Exact name of registrant as specified in its charter)
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Delaware
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94-3018487 |
(State of incorporation)
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(I.R.S. Employer Identification No.) |
2711 Citrus Road
Rancho Cordova, California 95742
(Address of principal executive offices) (Zip Code)
(916) 858-5100
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
a non-accelerated filer, or a smaller reporting company.
See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer o |
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Accelerated filer þ |
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Non-accelerated filer o
(Do not check if a smaller reporting company) |
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Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No þ
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of
the latest practicable date.
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Class
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Outstanding at February 3, 2009 |
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Common stock, $.001 par value
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56,092,960 |
ThermoGenesis Corp.
INDEX
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Page Number |
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3 |
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12 |
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18 |
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18 |
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19 |
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19 |
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19 |
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19 |
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19 |
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20 |
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20 |
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21 |
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EX-31.1 |
EX-32 |
i
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
ThermoGenesis Corp.
Condensed Consolidated Balance Sheets (Unaudited)
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December 31, |
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June 30, |
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2008 |
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2008 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
2,772,000 |
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$ |
4,384,000 |
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Short-term investments |
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16,014,000 |
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20,903,000 |
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Accounts receivable, net of allowance for
doubtful accounts of $12,000 ($31,000 at June 30, 2008) |
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5,824,000 |
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5,976,000 |
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Inventories |
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5,593,000 |
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5,131,000 |
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Other current assets |
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300,000 |
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367,000 |
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Total current assets |
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30,503,000 |
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36,761,000 |
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Equipment at cost less accumulated depreciation of $3,149,000
($2,950,000 at June 30, 2008) |
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1,355,000 |
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1,450,000 |
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Other assets |
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116,000 |
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71,000 |
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$ |
31,974,000 |
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$ |
38,282,000 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
2,064,000 |
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$ |
4,186,000 |
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Accrued payroll and related expenses |
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659,000 |
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564,000 |
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Deferred revenue |
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738,000 |
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801,000 |
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Other current liabilities |
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1,491,000 |
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1,232,000 |
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Total current liabilities |
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4,952,000 |
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6,783,000 |
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Deferred revenue |
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643,000 |
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974,000 |
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Commitments and contingencies |
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Stockholders equity: |
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Preferred stock, $0.001 par value; 2,000,000 shares authorized;
none outstanding |
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Common stock, $0.001 par value; 80,000,000 shares
authorized; 56,027,960 issued and outstanding
(56,027,960 at June 30, 2008) |
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56,000 |
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56,000 |
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Paid in capital in excess of par |
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120,506,000 |
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120,278,000 |
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Accumulated deficit |
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(94,183,000 |
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(89,809,000 |
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Total stockholders equity |
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26,379,000 |
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30,525,000 |
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$ |
31,974,000 |
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$ |
38,282,000 |
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See accompanying notes.
Page 3
ThermoGenesis Corp.
Condensed Consolidated Statements of Operations (Unaudited)
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Three Months Ended |
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Six Months Ended |
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December 31, |
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December 31, |
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2008 |
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2007 |
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2008 |
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2007 |
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Product and other revenues |
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$ |
6,126,000 |
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$ |
5,487,000 |
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$ |
10,628,000 |
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$ |
9,119,000 |
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Cost of product and other revenues |
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3,913,000 |
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3,577,000 |
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7,135,000 |
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6,000,000 |
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Gross profit |
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2,213,000 |
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1,910,000 |
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3,493,000 |
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3,119,000 |
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Expenses: |
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Selling, general and administrative |
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2,673,000 |
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2,357,000 |
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5,120,000 |
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4,777,000 |
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Research and development |
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1,298,000 |
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1,617,000 |
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2,898,000 |
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3,113,000 |
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Total operating expenses |
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3,971,000 |
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3,974,000 |
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8,018,000 |
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7,890,000 |
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Interest and other income, net |
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63,000 |
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347,000 |
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151,000 |
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754,000 |
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Net loss |
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$ |
(1,695,000 |
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$ |
(1,717,000 |
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$ |
(4,374,000 |
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$ |
(4,017,000 |
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Per share data: |
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Basic and diluted net loss per common
share |
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$ |
(0.03 |
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$ |
(0.03 |
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$ |
(0.08 |
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$ |
(0.07 |
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Shares used in computing per share data |
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56,027,960 |
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55,701,175 |
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56,027,960 |
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55,680,342 |
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See accompanying notes.
Page 4
ThermoGenesis Corp.
Condensed Consolidated Statements of Cash Flows (Unaudited)
Six Months Ended December 31, 2008 and 2007
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2008 |
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2007 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(4,374,000 |
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$ |
(4,017,000 |
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Adjustments to reconcile net loss to net cash used
in operating activities: |
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Depreciation and amortization |
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244,000 |
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265,000 |
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Stock based compensation expense |
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228,000 |
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1,121,000 |
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Accretion of discount on short-term investments |
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(130,000 |
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(564,000 |
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Net change in operating assets and liabilities: |
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Accounts receivable, net |
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152,000 |
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123,000 |
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Inventories |
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(462,000 |
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(191,000 |
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Other current assets |
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67,000 |
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204,000 |
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Other assets |
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6,000 |
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45,000 |
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Accounts payable |
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(2,122,000 |
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(434,000 |
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Accrued payroll and related expenses |
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95,000 |
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(9,000 |
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Deferred revenue |
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(394,000 |
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(332,000 |
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Other current liabilities |
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266,000 |
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304,000 |
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Net cash used in operating activities |
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(6,424,000 |
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(3,485,000 |
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Cash flows from investing activities: |
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Capital expenditures |
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(200,000 |
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(225,000 |
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Purchase of investments |
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(16,981,000 |
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(23,482,000 |
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Maturities of investments |
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22,000,000 |
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25,000,000 |
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Net cash provided by investing activities |
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4,819,000 |
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1,293,000 |
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Cash flows from financing activities: |
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Payments on capital lease obligations |
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(7,000 |
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(8,000 |
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Exercise of stock options and warrants |
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266,000 |
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Net cash (used in) provided by financing activities |
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(7,000 |
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258,000 |
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Net decrease in cash and cash equivalents |
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(1,612,000 |
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(1,934,000 |
) |
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Cash and cash equivalents at beginning of period |
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4,384,000 |
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5,730,000 |
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Cash and cash equivalents at end of period |
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$ |
2,772,000 |
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$ |
3,796,000 |
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Supplemental non-cash flow information: |
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Transfer of inventory to equipment |
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$ |
150,000 |
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Transfer of equipment to inventory |
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$ |
18,000 |
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Transfer of equipment to other assets |
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$ |
51,000 |
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See accompanying notes.
Page 5
ThermoGenesis Corp.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Basis of Presentation and Summary of Significant Accounting Policies
Organization and Basis of Presentation
ThermoGenesis Corp. (the Company) designs, manufactures and markets automated and semi-automated
devices and single-use processing disposables that enable hospitals and blood banks to manufacture
a therapeutic dose of stem cells, wound healing proteins or growth factors from a single unit of
cord blood or the patients bone marrow or peripheral blood in less than one hour. Initially, the
Company developed medical devices for ultra rapid freezing and thawing of blood components, which
the Company manufactures and distributes to blood banks and hospitals.
Principles of Consolidation
The accompanying unaudited condensed consolidated financial statements include the accounts of the
parent company, ThermoGenesis, and its wholly-owned subsidiary, Vantus. All significant
intercompany balances and transactions have been eliminated in consolidation.
Interim Reporting
The accompanying unaudited condensed consolidated financial statements have been prepared in
accordance with accounting principles generally accepted in the United States for interim financial
information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly,
certain information and footnote disclosures normally included in annual financial statements
prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such SEC rules and
regulations and accounting principles applicable for interim periods. All sales, domestic and
foreign, are denominated in U.S. dollars and therefore currency fluctuations are believed to have
no impact on the Companys net revenues. In the opinion of management, all adjustments (consisting
of normal recurring accruals) considered necessary for a fair presentation have been included.
Operating results for the six month period ended December 31, 2008 are not necessarily indicative
of the results that may be expected for the year ending June 30, 2009. These unaudited condensed
consolidated financial statements should be read in conjunction with the consolidated financial
statements and the notes thereto included in the Annual Report on Form 10-K for the fiscal year
ended June 30, 2008.
Revenue Recognition
The Company recognizes revenue including multiple element arrangements, in accordance with the
provisions of the Securities and Exchange Commissions (SEC) Staff Accounting Bulletin (SAB) No.
104, Revenue Recognition and the Financial Accounting Standards Boards (FASB) Emerging Issues Task
Force (EITF) 00-21, Revenue Agreements with Multiple Deliverables. Revenues from the sale of the
Companys products are recognized when persuasive evidence of an arrangement exists, delivery has
occurred (or services have been rendered), the price is fixed or determinable, and collectibility
is reasonably assured. The Company generally ships products F.O.B. shipping point. There is no
conditional evaluation on any product sold and recognized as revenue. All foreign sales are
denominated in U.S. dollars. Amounts billed in excess of revenue recognized are recorded as
deferred revenue on the balance sheet.
Page 6
The Companys foreign sales are generally through distributors. There is no right of return
provided for distributors. For sales of products made to distributors, the Company considers a
number of factors in determining whether revenue is recognized upon transfer of title to the
distributor, or when payment is received. These factors include, but are not limited to, whether
the payment terms offered to the distributor are considered to be non-standard, the distributor
history of adhering to the terms of its contractual arrangements with the Company, the level of
inventories maintained by the distributor, whether the Company has a pattern of granting
concessions for the benefit of the distributor, and whether there are other conditions that may
indicate that the sale to the distributor is not substantive. The Company currently recognizes
revenue primarily on the sell-in method with its distributors.
Revenue arrangements with multiple elements are divided into separate units of accounting if
certain criteria are met, including whether the delivered item has value to the customer on a
stand-alone basis and whether there is objective and reliable evidence of the fair value of any
undelivered items. Revenue is recognized as specific elements indicated in sales contracts are
executed. If an element is essential to the functionality of an arrangement, the entire
arrangements revenue is deferred until that essential element is delivered. The fair value of
each undelivered element that is not essential to the functionality of the system is deferred until
performance or delivery occurs. The fair value of an undelivered element is based on vendor
specific objective evidence or third party evidence of fair value as appropriate. Costs associated
with inconsequential or perfunctory elements in multiple element arrangements are accrued at the
time of revenue recognition. The Company accounts for training and installation as a separate
element of a multiple element arrangement. The Company therefore recognizes the fair value of
training and installation services upon their completion when the Company is obligated to perform
such services.
Service revenue generated from contracts for providing maintenance of equipment is amortized over
the life of the agreement. All other service revenue is recognized at the time the service is
completed.
Milestone payments the Company receives under research and development arrangements are recognized
as revenue upon achievement of the milestone events, which represent the culmination of the
earnings process, and when collectibility is reasonably assured. Milestone payments are triggered
by the results of the Companys development efforts. Accordingly, the milestone payments are
substantially at risk at the inception of the contract, and the amounts of the payments assigned
thereto are commensurate with the milestone achieved. Upon the achievement of a milestone event,
which may include acceptance by the counterparty, the Company has no future performance obligations
related to that milestone as the milestone payments received by the Company are nonrefundable.
For licensing agreements pursuant to which the Company receives up-front licensing fees for
products or technologies that will be provided by the Company over the term of the arrangements,
the Company defers the up-front fees and recognizes the fees as revenue on a straight-line method
over the term of the respective license. For license agreements that require no continuing
performance on the Companys part, license fee revenue is recognized immediately upon grant of the
license.
Shipping and handling fees billed to customers are included in product and other revenues, while
the related costs are included in cost of product and other revenues.
Fair Value of Financial Instruments
The Company adopted Statement of Financial Accounting Standard No. 157, Fair Value Measurements
(SFAS No. 157) effective July 1, 2008 for financial assets and liabilities measured on a recurring
basis. SFAS No. 157 applies to all financial assets and financial liabilities that are measured
and reported on a fair value basis and requires disclosure that established a framework for
measuring fair value and expands disclosure about fair value measurements. There was no impact for
adoption of SFAS No. 157 to the Companys consolidated financial statements.
Page 7
SFAS No. 157 establishes a valuation hierarchy for disclosure of the inputs to valuation used to
measure fair value. This hierarchy prioritizes the inputs into three broad levels as follows. Level
1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities.
Level 2 inputs are quoted prices for similar assets and liabilities in active markets or inputs
that are observable for the asset or liability, either directly or indirectly through market
corroboration, for substantially the full term of the financial instrument. Level 3 inputs are
unobservable inputs based on managements own assumptions used to measure assets and liabilities at
fair value. A financial asset or liabilitys classification within the hierarchy is determined
based on the lowest level input that is significant to the fair value measurement.
Level 1 money market funds are included in cash and cash equivalents on the Companys condensed
consolidated balance sheet.
Segment Reporting
The Company operates in a single segment providing medical devices and disposables to hospitals and
blood banks throughout the world which utilize the equipment to process blood components.
Net Loss per Share
Net loss per share is computed by dividing the net loss to common stockholders by the weighted
average number of common shares outstanding. The calculation of the basic and diluted earnings per
share is the same for all periods presented, as the effect of the potential common stock
equivalents is anti-dilutive due to the Companys net loss position for all periods presented.
Anti-dilutive securities, which consist of stock options and common stock restricted awards that
were not included in diluted net loss per common share were 2,737,831 and 3,492,232 as of December
31, 2008 and 2007, respectively.
Reclassifications
Certain amounts in the prior periods financial statements have been reclassified to conform with
the 2009 presentation.
Recent Accounting Pronouncements
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities (SFAS No. 159). SFAS No. 159 allows entities to voluntarily choose to
measure many financial assets and financial liabilities at fair value. The Company adopted SFAS
No. 159 effective July 1, 2008 and has not elected the fair value option for its financial
instruments. The adoption of SFAS No. 159 did not have an impact on the Companys consolidated
results or financial condition.
In June 2007, the FASB ratified a consensus opinion reached by the EITF on EITF Issue 07-3,
Accounting for Nonrefundable Advance Payments for Goods or Services Received for Use in Future
Research and Development Activities (EITF 07-3). The guidance in EITF 07-3 requires the Company to
defer and capitalize nonrefundable advance payments made for goods or services to be used in
research and development activities until the goods have been delivered or the related services
have been performed. If the goods are no longer expected to be delivered nor the services expected
to be performed, the Company would be required to expense the related capitalized advance payments.
The consensus in EITF 07-3 was effective for fiscal years, and interim periods within those fiscal
years, beginning after December 15, 2007 and is applied prospectively to new contracts entered into
on or after December 15, 2007. The Company adopted EITF 07-3 effective July 1, 2008. The adoption
of EITF 07-3 did not have a material impact on the Companys results of operations or financial
condition.
Page 8
In December 2007, the FASB ratified EITF Issue No. 07-1, Accounting for Collaborative
Arrangements (EITF 07-1). EITF 07-1 defines collaborative arrangements and establishes reporting
requirements for transactions between participants in a collaborative arrangement and between
participants in the arrangement and third parties. EITF 07-1 also establishes the appropriate
income statement presentation and classification for joint operating activities and payments
between participants, as well as the sufficiency of the disclosures related to these arrangements.
EITF 07-1 is effective for fiscal years beginning after December 15, 2008. EITF 07-1 shall be
applied retrospectively to all prior periods presented for all collaborative arrangements existing
as of the effective date. The Company is currently assessing the potential impact, if any, the
adoption of EITF 07-1 may have on its consolidated financial statements.
In December 2007, the FASB issued SFAS No. 141R, Business Combinations (SFAS No. 141R) which
replaces SFAS No. 141. The statement retains the purchase method of accounting for acquisitions,
but requires a number of changes, including changes in the way assets and liabilities are
recognized in the purchase accounting. It also changes the recognition of assets acquired and
liabilities assumed arising from contingencies, requires the capitalization of in-process research
and development at fair value and requires the expensing of acquisition-related costs as incurred.
SFAS No. 141R is effective for business combinations for which the acquisition date is on or after
the beginning of the first annual reporting period beginning on or after December 15, 2008. The
Company will assess the potential impact of the adoption of SFAS No. 141R if and when a future
acquisition occurs.
In May 2008, the FASB issued SFAS No. 162, The Hierarchy of Generally Accepted Accounting
Principles (SFAS No. 162). SFAS No. 162 identifies the sources of accounting principles to be used
in the preparation of financial statements that are presented in conformity with generally accepted
accounting principles in the United States for non-governmental entities. SFAS No 162 is effective
60 days following approval by the Securities and Exchange Commission of the Public Company
Accounting Oversight Boards amendments to AU Section 411, The Meaning of Present Fairly in
Conformity with Generally Accepted Accounting Principles. The Company does not expect SFAS No. 162
to have a material impact on its financial statements. The Company is currently assessing the
potential impact, if any, the adoption of SFAS No. 162 may have on its consolidated financial
statements.
2. Investments
The following is a summary of held-to-maturity securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Estimated |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificate of deposit |
|
$ |
4,000,000 |
|
|
|
|
|
|
|
|
|
|
$ |
4,000,000 |
|
U.S. Treasury obligations |
|
|
12,014,000 |
|
|
$ |
30,000 |
|
|
|
|
|
|
|
12,044,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
16,014,000 |
|
|
$ |
30,000 |
|
|
|
|
|
|
$ |
16,044,000 |
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
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|
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|
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|
|
Maturity Date: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less than 90 days |
|
$ |
4,996,000 |
|
|
|
|
|
|
|
|
|
|
$ |
5,000,000 |
|
Due in 91-365 days |
|
|
11,018,000 |
|
|
|
|
|
|
|
|
|
|
|
11,044,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
16,014,000 |
|
|
|
|
|
|
|
|
|
|
$ |
16,044,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury obligations |
|
$ |
20,903,000 |
|
|
|
|
|
|
$ |
13,000 |
|
|
$ |
20,890,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Page 9
3. Inventories
Inventories consisted of the following at:
|
|
|
|
|
|
|
|
|
|
|
December 31, 2008 |
|
|
June 30, 2008 |
|
Raw materials |
|
$ |
1,816,000 |
|
|
$ |
1,869,000 |
|
Work in process |
|
|
1,590,000 |
|
|
|
1,302,000 |
|
Finished goods |
|
|
2,187,000 |
|
|
|
1,960,000 |
|
|
|
|
|
|
|
|
|
|
$ |
5,593,000 |
|
|
$ |
5,131,000 |
|
|
|
|
|
|
|
|
4. Commitments and Contingencies
Import/Export Bonds
The Company imports and exports products and components as a routine part of its business, and must
comply with the rules and regulations of both the U.S. Food and Drug Administration (FDA) and the
U.S. Department of Homeland Security Bureau of Customs and Border Protection (CBP). With products
and components that require FDA approval, but prior to the receipt of such approval, the Company
enters the components into the U.S. under certain temporary import provisions and must provide
documentation of re-export of such product or its destruction within specified time periods. If
components or products have not been exported or destroyed within the period provided for by the
regulations, the Port Director may make a demand in writing under the bond for the payment of
defined damages. The Company has in the past used a continuous import bond (CIB) in the face
amount of $50,000 for these activities, which would provide payment of any damages up to the face
amount of the bond. The Company was notified by CBP at the Port of San Francisco that it is in
breach of the temporary import agreement for components sold within the U.S. to our strategic
partners who then export such components for use outside the U.S. The Company may be exposed to
damages up to a maximum of the face amount of our continuous import bond for each year the
non-compliant imports occurred, and the bond was in effect. For the quarter ended December 31,
2007, the Company recorded an estimated loss contingency in the amount of $100,000, which was based
on the face amounts of the bond described above. During the quarter ended December 31, 2008, the
Company paid $32,000 in penalties to settle the ten bonds issued for the first year of the CIB and
released the unused portion of $18,000. At December 31, 2008, the Company still had $50,000
accrued for the face amount of the second year of the bond.
Product Recalls
As part of its normal operations, the Company may conduct recalls of products or parts, some of
which may require in-field service or part replacements. Recalls may, depending on the
circumstances, interrupt a customers business, or require a customer to incur additional expenses.
Further, the Company may enlist certain customers to assist and facilitate the recalls and field
actions, and may try to compensate the customers for their expenses incurred. For the year ended
June 30, 2008, the Company accrued $185,000 for payments that may be paid in connection with
recalls the Company had during that fiscal year. The Company settled the matter
during the third quarter of fiscal 2009 for $160,000, which represents the accrual as of December 31, 2008.
Page 10
In the second quarter of fiscal 2009, the Company initiated a voluntary recall of certain lots of
the AXP disposable bag sets as they may contain particulates from a supplied component that may be
released into the sterile, non-pyrogenic fluid path. This recall was not a result of any reports
of patient safety issues. The Company accrued $520,000 in the cost of product and other
revenues line item for the quarter ended September 30, 2008 as its best estimate of the costs
associated with this voluntary recall. During the quarter ended December 31, 2008, the Company
shipped $252,000 of product replacements and completed its testing of the subject lots. Based on
the testing, it was determined that one lot previously reserved for did not have to be recalled.
Therefore, the Company reversed $115,000 during the quarter ended December 31, 2008. The Companys
plan as it relates to the recall is subject to the approval by the FDA. Therefore, the ultimate
scope and cost of the recall could be materially different than the estimated accrual the Company
has recorded in the December 31, 2008 financial statements.
Warranty
The Company offers a one-year warranty on all of its products. In addition, the Companys one-year
warranty for the BioArchive
® System includes labor and travel. The Company warrants
disposable products through their expiration date. The Company periodically assesses the adequacy
of its recorded warranty liabilities and adjusts the amounts as necessary.
Changes in the Companys product liability during the period are as follows:
|
|
|
|
|
July 1, 2008 balance |
|
$ |
507,000 |
|
Warranties issued during the period |
|
|
197,000 |
|
Settlements made during the period |
|
|
(476,000 |
) |
Changes in liability for pre-existing warranties during the
period, including expirations |
|
|
511,000 |
|
|
|
|
|
Balance at December 31, 2008 |
|
$ |
739,000 |
|
|
|
|
|
As a result of the voluntary recall of certain lots of the AXP disposable bag sets, the Company
made revisions to its estimated warranty liability. These changes in estimates increased and
decreased the Companys cost of product and other revenues and net loss by $520,000 and net loss
per share of $0.01 and $115,000 (no net loss per share impact), respectively, for the quarters
ended September 30 and December 31, 2008. In the prior fiscal year, as a result of various quality
issues experienced by high usage customers of the AXP devices and docking stations, the Company
made revisions to its estimated warranty liability for the six month period ended December 31,
2007. The Company recorded a change in estimate, which increased the Companys cost of product and
other revenues and net loss (no net loss per share impact) by $249,000. The Company did not record
any significant change in estimate during the quarter ended September 30, 2007.
Page 11
5. Stockholders Equity
Stock Based Compensation
The Company recorded stock-based compensation of $105,000 and $228,000 for the three and six months
ended December 31, 2008 and $493,000 and $1,121,000 for the three and six months ended December 31,
2007.
The following is a summary of option activity for the Companys stock option plans:
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Number of |
|
|
Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
Shares |
|
|
Price |
|
|
Life |
|
|
Value |
|
Outstanding at June 30, 2008 |
|
|
2,994,937 |
|
|
$ |
2.64 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
125,333 |
|
|
$ |
1.58 |
|
|
|
|
|
|
|
|
|
Forfeited or Expired |
|
|
(401,939 |
) |
|
$ |
2.80 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2008 |
|
|
2,718,331 |
|
|
$ |
2.57 |
|
|
|
1.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and Expected to Vest at
December 31, 2008 |
|
|
2,648,436 |
|
|
$ |
2.57 |
|
|
|
1.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2008 |
|
|
1,897,120 |
|
|
$ |
2.70 |
|
|
|
1.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate intrinsic value is calculated as the difference between the exercise price of the
underlying awards and the quoted price of the Companys common stock. There were no options that
were in-the-money at December 31, 2008. There were no options exercised during the six months
ended December 31, 2008. During the six months ended December 31, 2007, the aggregate intrinsic
value of options exercised under the Companys stock option plans was $248,000, determined as of
the date of option exercise.
6. Subsequent Event
Stock Options
On January 30, 2009, the Board of Directors granted a total of 1,081,000 stock options to all
current employees of the Company. The options have an exercise price of $0.77 per share, vest in
three equal installments over three years and expire on January 30, 2013.
Item 2. Managements Discussion and Analysis of Financial Condition and Results of
Operations
Forward-Looking Statements
This report contains forward-looking statements which are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements
involve risks and uncertainties that could cause actual results to differ materially from the
forward-looking statements. When used in this report, the words anticipate, believe,
estimate, expect and similar expressions as they relate to the Company or its management are
intended to identify such forward-looking statements. The Companys actual results, performance or
achievements could differ materially from the results expressed in, or implied by these
forward-looking statements. The Company wishes to caution readers of the important factors, among
others, that in some cases have affected, and in the future could
Page 12
affect the Companys actual results and could cause actual results for fiscal year 2009, and
beyond, to differ materially from those expressed in any forward-looking statements made by, or on
behalf of, the Company. These factors include without limitation, the ability to obtain capital
and other financing in the amounts and at the times needed to complete clinical trials and product
marketing for new products, market acceptance of new products, regulatory approval and time frames
for such approval of new products and new claims for existing products, realization of forecasted
income and expenses, initiatives by competitors, price pressures, the risks associated with
initiating manufacturing for new products, and the risk factors listed from time to time in the
Companys SEC reports, including, in particular, the factors and discussion in the Companys Form
10-K for its last fiscal year.
Overview
We are a leading supplier of innovative products and services that process and store adult stem
cells. Our products concentrate and store stem cells of a single donor which can be administered
to that donor or a matched patient. Our devices and disposables are intended for use by
physicians, researchers, hospitals and blood banks. These stem cells typically originate from the
blood or tissue from donated cord blood or the bone marrow of the patient to be treated. The Stem
Cell therapy market is a broad, rapidly growing field of medicine that involves the collection,
purification, manipulation and administration of stem cells, to treat serious injuries or diseases
such as malignant or genetic blood diseases, tailored to individual patients. This methodology of
personalized treatment is considerably different than practices with generic conventional
pharmaceutical drugs. Pharmaceutical drugs are produced in large quantities and are effective on
most patients with similar underlying medical conditions. Additionally, these drugs typically
consist of inert materials that can be stored in medicine cabinets at room temperature. In
contrast, personalized cell therapies are manufactured one at a time, are intended for a single
patient and must be used immediately or, if stored, require precision freezing and extremely low
storage temperatures (-196°C in some cases) in order to preserve the viability of the cells.
Our Products
The BioArchive System is an automated cryogenic system used in stem cell therapy to cryopreserve
and archive stem cells and tissue for future transplant and treatment. The BioArchive System,
which can store up to 3,626 units of stem cells, is the only fully automated system that integrates
controlled rate freezing, quarantine and long term cryogenic storage. The robotic storage and
retrieval of these stem cell units improves cell viability, provides precise inventory management
and minimizes the possibility of human error. We have sold more than 190 BioArchive Systems to
date to private and public cord blood banks and stem cell research institutes in more than 25
countries. The BioArchive System serves the human stem cell storage market.
The AutoXpress Platform or AXP is an innovative product which automates the isolation and
concentration of stem cells from cord blood in a functionally closed sterile disposable set in
preparation for cryopreservation and long term storage. The AXP Platform consists of a
microprocessor controlled electromechanical device which includes optical sensors and
accelerometers and a dedicated disposable bag set. During the centrifugation step, the AXP
automatically concentrates the stem cells in the cord blood by removing excess plasma and red blood
cells. The benefits of the AXP technology are its ability to efficiently isolate and concentrate
stem cells with minimal operator time and electronic documentation of the processing for Current
Good Manufacturing Practice (cGMP) compliance. As a result, cord blood banks are able to achieve
improved operating efficiency as compared to manual processing methods. In
Page 13
addition to labor savings, the AXP is also considerably faster than manual methods. At the end of
the centrifugation of the AXP, the concentrated stem cells are delivered into an integral freezing
container. After the cryopreservation solution is added to the AXP freezing bag using the integral
sterile filter, the concentrated stem cells are ready to be frozen and stored with the BioArchive
System until needed for a stem cell transplantation.
The MarrowXpress or MXP, an extension of the AXP, defines a new processing standard for isolating
and retrieving stem cells from bone marrow aspirate. It is an automated, closed, sterile system
that volume-reduces blood to a user-defined volume while retaining over 90% of the mononuclear
cells. Self-powered and microprocessor-controlled, the MarrowXpress Platform contains flow control
optical sensors which achieve precise separation. In June 2008, we received the CE-Mark, enabling
commercial sales in Europe. In July 2008, we received authorization from the FDA to begin
marketing the MXP for use in the clinical laboratory or intraoperatively at the point-of-care for
preparation of a cell concentrate from bone marrow. In September 2008, the Company announced an
agreement with Celling Technologies, a subsidiary of Spine-Smith, LLC, to distribute the MXP for
orthopedic applications. The product was launched in December 2008.
The CryoSeal® FS System (CryoSeal) produces a second-generation surgical sealant which
harvests the two interactive protein component solutions of a fibrin sealant: (1) the wound healing
proteins of fibrinogen, fibronectin, Factor VIII, von Willebrands Factor and Factor XIII and (2)
the activating enzyme, thrombin, from the patients own blood. When combined at the bleeding wound
site, the two components form an adhesive gel that stops bleeding and bonds tissue. This advanced
surgical sealant may be manufactured in either hospitals or blood centers and competes with
conventional fibrin sealants, sourced from pools of plasma purchased from up to ten thousand
individuals.
We believe that there is a market for our 100% autologous CryoSeal System due to its safety
advantages over conventional, non-autologous fibrin sealants that carry the risk of contamination
by blood-borne pathogens from other donors, and that this market may extend beyond the typical
wound care applications to include use of the technology in the delivery of stem cells for cell
therapeutics. Therefore, we are evaluating alternatives for commercialization of our CryoSeal
System including new strategic partnering and licensing, distribution channel partners, potential
acquirers of the technology and the potential use of the technology in the delivery of stem cells.
The following is Managements discussion and analysis of certain significant factors which have
affected the Companys financial condition and results of operations during the period included in
the accompanying consolidated financial statements.
Critical Accounting Policies
Managements discussion and analysis of its financial condition and results of operations are based
upon the Companys condensed consolidated financial statements, which have been prepared in
accordance with accounting principles generally accepted in the United States. The preparation of
these consolidated financial statements requires the Company to make estimates and judgments that
affect the reported amounts of assets, liabilities, revenues and expenses and related disclosure of
contingent assets and liabilities. On an on-going basis, the Company evaluates its estimates,
including those related to bad debts, inventories, warranties, contingencies and litigation. The
Company bases its estimates on historical experience and on various other assumptions that are
believed to be reasonable under the circumstances, the results of which form the basis for making
judgments about the carrying values of assets and liabilities that are not readily apparent from
other sources. Actual results may differ from these estimates under different assumptions or
conditions. For a full discussion of our accounting estimates and assumptions that the Company has
identified as critical in the preparation of our condensed consolidated financial statements,
please refer to our 2008 Annual Report on form 10-K.
Page 14
Results of Operations for the Three Months Ended December 31, 2008 as Compared to the Three Months
Ended December 31, 2007
Net Revenues:
Revenues for the three months ended December 31, 2008 were $6,126,000 compared to $5,487,000 for
the three months ended December 31, 2007, an increase of $639,000 or 12%. The increase in revenues
was driven by the AXP and BioArchive disposables. Revenues generated from AXP disposables
increased $814,000 due to higher volume and price increases. Additionally, revenues from
BioArchive disposables increased $388,000 over the quarter ended December 31, 2007 primarily due to
increased sales of manual processing bag sets in new accounts and competitive conversion in
Southeast Asia and Latin America. The increases were offset by a decrease in revenues from
CryoSeal disposables of $310,000. The Companys largest CryoSeal distributors are in countries
that have been affected by a decline in domestic currencies against the strengthening dollar.
Additionally in the second quarter of fiscal 2008, we had revenues
of $110,000 to our distributor in Brazil for an initial order for the
government production of fibrin sealant.
The following represents the Companys cumulative BioArchive devices sold into the following
geographies through the dates indicated:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2008 |
|
2007 |
United States |
|
|
49 |
|
|
|
37 |
|
Asia |
|
|
63 |
|
|
|
57 |
|
Europe |
|
|
49 |
|
|
|
45 |
|
Rest of World |
|
|
33 |
|
|
|
27 |
|
|
|
|
|
|
|
|
|
|
|
|
|
194 |
|
|
|
166 |
|
|
|
|
|
|
|
|
|
|
The following represents the Companys revenues for disposables by product line for the three
months ended:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
AXP |
|
$ |
2,198,000 |
|
|
$ |
1,384,000 |
|
BioArchive |
|
|
1,162,000 |
|
|
|
774,000 |
|
CryoSeal |
|
|
92,000 |
|
|
|
402,000 |
|
|
|
|
|
|
|
|
|
|
$ |
3,452,000 |
|
|
$ |
2,560,000 |
|
|
|
|
|
|
|
|
Percentage of total Company revenues |
|
|
56 |
% |
|
|
47 |
% |
|
|
|
|
|
|
|
Gross Profit:
The Companys gross profit was $2,213,000 or 36% of net revenues for the three months ended
December 31, 2008, as compared to $1,910,000 or 35% for the corresponding fiscal 2008 period. The
slight increase in gross profit percentage is primarily due to the reversal of $115,000 previously
accrued for the voluntary recall of the AXP bag sets.
Page 15
Selling, General and Administrative Expenses:
Selling, general and administrative expenses were $2,673,000 for the three months ended December
31, 2008, compared to $2,357,000 for the comparable fiscal 2008 period, an increase of $316,000 or
13%. The increase is primarily due to a severance accrual of $370,000 to the Companys former
Chief Executive Officer.
Research and Development Expenses:
Included in this line item are Engineering, Regulatory Affairs, Scientific and Clinical Affairs.
Research and development expenses for the three months ended December 31, 2008, were $1,298,000
compared to $1,617,000 for the corresponding fiscal 2008 period, a decrease of $319,000 or 20%.
The decrease is primarily due to a decrease in stock compensation expense of $400,000 as the
restricted stock awarded to the Companys former Chief Technology Architect fully vested in April
2008. This decrease was offset by an increase in expenses associated with the Vantus subsidiary of
$100,000, which was formed in February 2008.
Results of Operations for the Six Months Ended December 31, 2008 as Compared to the Six Months
Ended December 31, 2007
Net Revenues:
Revenues for the six months ended December 31, 2008 were $10,628,000 compared to $9,119,000 for the
six months ended December 31, 2007, an increase of $1,509,000 or 17%. As noted above, the increase
in revenues is primarily due to an increase in AXP and BioArchive disposable revenues of
$1,654,000, offset by a decrease in CryoSeal disposable revenues of $608,000.
The following represents the Companys revenues for disposables by product line for the six months
ended:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
AXP |
|
$ |
3,363,000 |
|
|
$ |
2,102,000 |
|
BioArchive |
|
|
1,976,000 |
|
|
|
1,583,000 |
|
CryoSeal |
|
|
175,000 |
|
|
|
783,000 |
|
|
|
|
|
|
|
|
|
|
$ |
5,514,000 |
|
|
$ |
4,468,000 |
|
|
|
|
|
|
|
|
Percentage of total Company revenues |
|
|
52 |
% |
|
|
49 |
% |
|
|
|
|
|
|
|
Gross Profit:
The Companys gross profit was $3,493,000 or 33% of net revenues for the six months ended December
31, 2008, as compared to $3,119,000 or 34% for the corresponding fiscal 2008 period. The decrease
in gross profit percentage is primarily due to the net $405,000 accrual for the voluntary recall of
AXP bag sets. Offsetting the decrease, as our production volume of devices increased, we absorbed
additional overhead costs of approximately $200,000.
Page 16
Selling, General and Administrative Expenses:
Selling, general and administrative expenses were $5,120,000 for the six months ended December 31,
2008, compared to $4,777,000 for the comparable fiscal 2008 period, an increase of $343,000 or 7%.
The increase is primarily due to a severance accrual of $370,000 to the Companys former Chief
Executive Officer and an increase in governance fees driven by an increase of two independent
directors over the prior year as well as having installed an independent Chairman of the Board of
$100,000 offset by a decrease in stock compensation expense of $200,000.
Research and Development Expenses:
Included in this line item are Engineering, Regulatory Affairs, Scientific and Clinical Affairs.
Research and development expenses for the six months ended December 31, 2008, were $2,898,000
compared to $3,113,000 for the corresponding fiscal 2008 period, a decrease of $215,000 or 7%. The
decrease is primarily due to a decrease in stock compensation expense of $680,000 as the restricted
stock awarded to the Companys former Chief Technology Architect fully vested in April 2008 and a
decrease of $130,000 in payments made to UC Davis in connection with a collaboration agreement to
develop stem cell treatments. This decrease was offset by an increase in expenses associated with
the Vantus subsidiary of $290,000 and an increase in salaries and benefits of $248,000 primarily
due to hiring a new Vice President of Research and Development in August 2008 and other personnel.
Liquidity and Capital Resources
At December 31, 2008, the Company had cash, cash equivalents and short-term investments of
$18,786,000 and working capital of $25,551,000. This compares to cash, cash equivalents and
short-term investments of $25,287,000 and working capital of $29,978,000 at June 30, 2008. The
cash was used to fund operations, capital expenditures and other strategic initiatives of the
Company. In addition to product revenues, the Company has primarily financed operations through
the private and public placement of equity securities and has raised approximately $108,000,000,
net of expenses, through common and preferred stock financings and option and warrant exercises.
Net cash used in operating activities for the six months ended December 31, 2008 was $6,424,000,
primarily due to the net loss of $4,374,000 which included the accretion of discount on short-term
investments of $130,000, offset by depreciation and stock based compensation expense of $244,000
and $228,000, respectively. Accounts payable used $2,122,000 of cash due to paying vendors for
purchases made late in the prior fiscal year, primarily for disposable products.
We believe that our currently available cash, cash equivalents and short-term investments, will be
sufficient to satisfy our operating and working capital requirements for at least the next twelve
months. Deterioration in credit markets and impacts on our customers spending could adversely
impact our revenue. Although we dont anticipate significant deterioration in our customers
markets, such an event could impact revenues resulting in increased losses that would require us to
alter development plans or to seek additional debt or equity capital to continue those development
programs. We believe that certain developmental projects are essential to sustained increased
revenues long term.
Off-Balance Sheet Arrangements
As of December 31, 2008, the Company has no off-balance sheet arrangements.
Backlog
The Companys cancelable backlog at December 31, 2008 was $1,675,000.
Page 17
Item 3. Quantitative and Qualitative Disclosures about Market Risk
All sales, domestic and foreign, are made in U.S. dollars and therefore material fluctuations in
foreign currency rates are believed to have no impact on the Companys net revenues. The Company
has no long-term investments or long-term debt, other than a capital lease, and therefore is not
subject to interest rate risk. Management does not believe that inflation has had or will have a
significant impact on the Companys results of operations. The Company is not exposed to any
market risk involving activities in derivative financial instruments, other financial instruments
or derivative commodity instruments.
Item 4. Controls and Procedures
The Company carried out an evaluation, under the supervision and with the participation of the
Companys management, including the Companys Principal Executive Officer along with the Companys
Principal Financial Officer (in this case the same person), of the effectiveness of the design and
operation of the Companys disclosure controls and procedures (as defined by Exchange Act Rule
13a-15(e) and 15d-15(e)) as of the end of our fiscal quarter pursuant to Exchange Act Rule 13a-15.
Based upon that evaluation, the Companys Chief Executive Officer/Chief Financial Officer concluded
that the Companys disclosure controls and procedures are effective.
There were no changes in the Companys internal controls over financial reporting that occurred
during the three months ended December 31, 2008 that have materially affected, or are reasonably
likely to materially affect, its internal controls over financial reporting. The Company believes
that a control system, no matter how well designed and operated, cannot provide absolute assurance
that the objectives of the control system are met, and no evaluation of controls can provide
absolute assurance that all control issues and instances of fraud, if any, within any company have
been detected.
Page 18
PART II OTHER INFORMATION
Item 1. Legal Proceedings.
In the normal course of operations, the Company may have disagreements or disputes
with distributors, vendors or employees. These disputes are seen by the Companys
management as a normal part of business, and there are no pending actions currently
or no threatened actions that management believes would have a significant material
impact on the Companys financial position, results of operations or cash flows.
Item 1A. Risk Factors.
In addition to the factors discussed below and other information set forth in this
report, you should carefully consider the factors discussed in Part I, Item 1A.
Risk Factors in our Annual Report on Form 10-K for the year ended June 30, 2008,
which could materially affect our business, financial condition or future results.
There have been no material changes from those risk factors, other
than the addition of any risk factors listed below. The risks described in
our Annual Report on Form 10-K are not the only risks facing our Company.
Additional risks and uncertainties not currently known to us or that we currently
deem to be immaterial also may materially adversely affect our business, financial
condition and/or operating results.
The Continuing Crisis in the U.S. and World Financial and Securities Markets Could
Have a Material Adverse Effect on our Customers Business and Effect our Operations
and Revenues.
The current economic crisis heightens the risk that our customers may lack the
funding or credit facilities that they may have previously used for acquiring our
products. Such credit or funding restrictions could delay or lower our revenues.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults upon Senior Securities.
None.
Item 4. Submission of Matters to a Vote of Security Holders.
An Annual Meeting of Stockholders was held on December 12, 2008. The following
matters were voted on:
Proposal 1: Election of five directors to serve until the next Annual Meeting of
Stockholders and until their successors are duly elected and qualified.
Proposal 2: Ratification to appoint Ernst & Young LLP as the Companys independent
registered public accounting firm for the 2009 fiscal year.
Page 19
A summary of the voting for each proposal submitted is as follows:
Proposal #1
|
|
|
|
|
|
|
|
|
Election of Directors |
|
For |
|
Withhold |
Hubert E. Huckel, M.D. |
|
|
41,774,194 |
|
|
|
6,258,317 |
|
Patrick McEnany |
|
|
47,068,154 |
|
|
|
964,357 |
|
Woodrow A. Myers, M.D. |
|
|
47,263,699 |
|
|
|
768,812 |
|
Tiffany Olson |
|
|
47,416,965 |
|
|
|
615,546 |
|
Mahendra Rao M.D., Ph.D. |
|
|
47,417,439 |
|
|
|
615,072 |
|
Proposal #2 Ratification of Auditors
|
|
|
|
|
|
|
|
|
|
|
For |
|
Against |
|
Abstain |
|
Not Voted |
47,712,613
|
|
|
198,159 |
|
|
|
121,739 |
|
|
|
Item 5. Other Information.
None.
Item 6. Exhibits:
|
31.1 |
|
Certification by the Principal Executive/Financial Officer
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
32 |
|
Certification of Principal Executive Officer and Principal
Financial Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002 |
Page 20
ThermoGenesis Corp.
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
ThermoGenesis Corp.
(Registrant)
|
|
Dated: February 4, 2009 |
/s/ Matthew T. Plavan
|
|
|
Matthew T. Plavan |
|
|
Interim Chief Executive Officer/Chief
Financial Officer
(Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer) |
|
|
Page 21