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
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for the quarterly period ended September 30, 2008. |
or
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o |
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Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of
1934 |
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for the transition 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.
þ Yes o No
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 definition 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).
o Yes þ No
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 November 3, 2008 |
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Common stock, $.001 par value
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56,027,960 |
ThermoGenesis Corp.
INDEX
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PART I FINANCIAL INFORMATION
Item 1. Consolidated Financial Statements
ThermoGenesis Corp.
Condensed Consolidated Balance Sheets (Unaudited)
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September 30, |
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June 30, |
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(in thousands, except share and per share amounts) |
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2008 |
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2008 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
6,358 |
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$ |
4,384 |
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Short-term investments |
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15,961 |
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20,903 |
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Accounts receivable, net of allowance for
doubtful accounts of $13 ($31 at June 30, 2008) |
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4,176 |
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5,976 |
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Inventories |
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5,987 |
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5,131 |
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Other current assets |
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366 |
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367 |
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Total current assets |
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32,848 |
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36,761 |
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Equipment at cost less accumulated depreciation of $3,063
($2,950 at June 30, 2008) |
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1,435 |
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1,450 |
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Other assets |
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65 |
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71 |
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$ |
34,348 |
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$ |
38,282 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
2,631 |
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$ |
4,186 |
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Accrued payroll and related expenses |
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415 |
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564 |
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Deferred revenue |
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730 |
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801 |
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Other current liabilities |
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1,791 |
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1,224 |
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Total current liabilities |
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5,567 |
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6,775 |
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Deferred revenue |
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805 |
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974 |
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Long-term portion of capital lease obligations |
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7 |
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8 |
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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, $0.001 par value; 80,000,000 shares
authorized; 56,027,960 issued and outstanding
(56,027,960 at June 30, 2008) |
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56 |
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56 |
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Paid in capital in excess of par |
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120,401 |
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120,278 |
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Accumulated deficit |
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(92,488 |
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(89,809 |
) |
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Total stockholders equity |
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27,969 |
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30,525 |
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$ |
34,348 |
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$ |
38,282 |
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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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September 30, |
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(in thousands, except share and per share amounts) |
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2008 |
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2007 |
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Product and other revenues |
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$ |
4,502 |
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$ |
3,632 |
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Cost of product and other revenues |
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3,222 |
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2,423 |
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Gross profit |
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1,280 |
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1,209 |
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Expenses: |
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Selling, general and administrative |
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2,447 |
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2,420 |
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Research and development |
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1,600 |
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1,496 |
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Total operating expenses |
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4,047 |
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3,916 |
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Interest and other income, net |
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88 |
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407 |
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Net loss |
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($ |
2,679 |
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($ |
2,300 |
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Per share data: |
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Basic and diluted net loss per common share |
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($ |
0.05 |
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($ |
0.04 |
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Shares used in computing per share data |
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56,027,960 |
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55,659,508 |
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See accompanying notes.
Page 4
ThermoGenesis Corp.
Condensed Consolidated Statements of Cash Flows (Unaudited)
Three Months Ended September 30, 2008 and 2007
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(in thousands) |
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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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($ |
2,679 |
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($ |
2,300 |
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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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120 |
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136 |
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Stock based compensation expense |
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123 |
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628 |
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Accretion of discount on short-term investments |
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(76 |
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(295 |
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Net change in operating assets and liabilities: |
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Accounts receivable, net |
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1,800 |
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259 |
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Inventories |
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(856 |
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(716 |
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Other current assets |
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1 |
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34 |
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Other assets |
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6 |
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13 |
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Accounts payable |
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(1,555 |
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(74 |
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Accrued payroll and related expenses |
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(149 |
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(162 |
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Deferred revenue |
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(240 |
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(162 |
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Other current liabilities |
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569 |
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227 |
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Net cash used in operating activities |
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(2,936 |
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(2,412 |
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Cash flows from investing activities: |
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Capital expenditures |
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(105 |
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(173 |
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Purchase of investments |
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(3,982 |
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(9,766 |
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Maturities of investments |
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9,000 |
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13,000 |
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Net cash provided by investing activities |
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4,913 |
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3,061 |
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Cash flows from financing activities: |
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Payments on capital lease obligations |
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(3 |
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(5 |
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Exercise of stock options and warrants |
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266 |
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Net cash
(used in) provided by financing activities |
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(3 |
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261 |
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Net increase in cash and cash equivalents |
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1,974 |
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910 |
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Cash and cash equivalents at beginning of period |
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4,384 |
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5,730 |
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Cash and cash equivalents at end of period |
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$ |
6,358 |
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$ |
6,640 |
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Supplemental non-cash flow information: |
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Transfer of equipment to inventory |
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$ |
18 |
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See
accompanying notes.
Page 5
ThermoGenesis Corp.
Notes to Condensed Consolidated Financial Statements
(Unaudited; Amounts in thousands, except share and per share amounts)
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, they do not
include all of the information and footnotes required by generally accepted accounting principles
for complete financial statements. 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 three
month period ended September 30, 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.
The balance sheet at June 30, 2008, has been derived from the audited financial statements at that
date but does not include all the information and footnotes required by U.S. generally accepted
accounting principles for complete financial statements.
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.
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
Page 6
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 SFAS 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.
There was no impact for adoption of SFAS No. 157 to the Companys consolidated financial
statements. SFAS No. 157 requires disclosure that establishes a framework for measuring fair value
and expands disclosure about fair value measurements.
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
Page 7
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 3,124,437 and 3,557,270 as of September
30, 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 September 2006, the FASB issued Statement of Financial Accounting Standard (SFAS) No. 157, Fair
Value Measurements (SFAS No. 157). SFAS No. 157 defines fair value, establishes a framework for
measuring fair value under GAAP and expands disclosure about fair value measurements. In February
2008, the FASB issued FASB Staff Position (FSP) SFAS No. 157-2 Effective Date of FASB Statement
No. 157 (FSP 157-2) which delays the effective date of SFAS 157 for all non-financial assets and
non-financial liabilities, except those that are recognized or disclosed at fair value in the
financial statement on a recurring basis (at least annually). FSP 157-2 partially defers the
effective date of SFAS 157 to fiscal years beginning after November 15, 2008, and interim periods
within those fiscal years for items within the scope of FSP 157-2. The Company adopted SFAS No.
157, except as it applies to those non-financial assets and non-financial liabilities as noted in
FSP SFAS No. 157-2. The partial adoption of SFAS No. 157 did not have an impact on our
consolidated results or financial condition.
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 our 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
Page 8
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.
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.
Page 9
2. Investments
The following is a summary of held-to-maturity securities:
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|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Estimated |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
September 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury obligations |
|
$ |
15,961 |
|
|
$ |
18 |
|
|
$ |
9 |
|
|
$ |
15,970 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maturity Date: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less than 90 days |
|
$ |
12,970 |
|
|
|
|
|
|
|
|
|
|
$ |
12,988 |
|
Due in 91-365 days |
|
|
2,991 |
|
|
|
|
|
|
|
|
|
|
|
2,982 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
15,961 |
|
|
|
|
|
|
|
|
|
|
$ |
15,970 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury obligations |
|
$ |
20,903 |
|
|
|
|
|
|
$ |
13 |
|
|
$ |
20,890 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate amount of unrealized losses and fair value of short term investments, which are not
deemed to be other-than-temporarily impaired and less than twelve months are:
|
|
|
|
|
|
|
|
|
|
|
Aggregate
Fair Value |
|
|
Unrealized
Loss |
|
September 30, 2008 |
|
|
|
|
|
|
|
|
U.S. Treasury obligations |
|
$ |
2,982 |
|
|
$ |
9 |
|
|
|
|
|
|
|
|
Management has concluded that the unrealized losses on these investments are temporary, as the
duration of the decline in the value of the investments has been short; the extent of the decline,
both in dollars and percentage of cost is not considered significant; and the Company has the
ability and intent to hold the investments until at least substantially all of the cost of the
investments is recovered.
3. Inventories
Inventories consisted of the following at:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2008 |
|
|
June 30, 2008 |
|
Raw materials |
|
$ |
1,452 |
|
|
$ |
1,869 |
|
Work in process |
|
|
1,506 |
|
|
|
1,302 |
|
Finished goods |
|
|
3,029 |
|
|
|
1,960 |
|
|
|
|
|
|
|
|
|
|
$ |
5,987 |
|
|
$ |
5,131 |
|
|
|
|
|
|
|
|
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
US 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
Page 10
components into the United States 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 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 US to our strategic
partners who then export such components for use outside the United States. The matter is
currently under review. However, 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, which was based on the face amounts of the bond described above.
The CBP has issued penalty letters totaling $109 for ten of the 17 temporary bonds issued. This
penalty is capped at $50 under the first year of the CIB. The Company
has not made any significant payments during the three months ended
September 30, 2008. Therefore, the Company still considers
$100 the best estimate of the loss contingency and thus has made no adjustments to the accrual for
the quarter ended September 30, 2008.
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 for payments that may be paid in connection with recalls
the Company had during that fiscal year. The Company anticipates settling this matter in fiscal
2009.
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 has accrued $520 in the cost of product and other revenues line item for the quarter
ended September 30, 3008 as its best estimate of the costs associated with this voluntary recall.
The Companys plan as it relates to the recall is subject to
the Companys ongoing investigations and
approval by the FDA. Therefore, the ultimate scope and cost of the recall could be materially different than the estimated cost the Company has recorded in the September 30, 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 |
|
Warranties issued during the period |
|
|
84 |
|
Settlements made during the period |
|
|
(56 |
) |
Changes in liability for pre-existing warranties during the
period, including expirations |
|
|
526 |
|
|
|
|
|
Balance at September 30, 2008 |
|
$ |
1,061 |
|
|
|
|
|
Page 11
As a result of the product recall in the second quarter of fiscal 2009, the Company made revisions
to its estimated warranty liability for the three months ended September 30, 2008. The Company
recorded a
change in estimate, which increased the Companys cost of product and other revenues and net loss
by $520 and net loss per share of $0.01. The Company did not record any significant change in
estimate during the quarter ended September 30, 2007.
5. Stockholders Equity
Stock Based Compensation
The Company recorded stock-based compensation of $123 and $628 for the three months ended September
30, 2008 and 2007, respectively.
The following is a summary of option activity for the Companys stock option plans:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
(65,333 |
) |
|
$ |
2.37 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2008 |
|
|
3,054,937 |
|
|
$ |
2.60 |
|
|
|
2.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and Expected to Vest at
September 30, 2008 |
|
|
2,856,003 |
|
|
$ |
2.60 |
|
|
|
2.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at September 30, 2008 |
|
|
1,889,951 |
|
|
$ |
2.68 |
|
|
|
1.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 September 30, 2008. There were no options exercised during the three months
ended September 30, 2008. During the three months ended September 30, 2007, the aggregate
intrinsic value of options exercised under the Companys stock option plans was $248, determined as
of the date of option exercise.
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 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
Page 12
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.
In February 2008, the Company formed a wholly-owned subsidiary, Vantus Veterinary Stem Cell
Laboratories (Vantus). Vantus involves a formal collaboration with the Center for Equine Health and
Stem Cell Regenerative Medicine Group at the University of California, Davis, School of Veterinary
Medicine. Its initial focus will be to provide point-of-care products for use in treatment of
orthopedic injuries in the performance equine market.
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 180 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 and veterinary markets.
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 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.
Page 13
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 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 September 30, 2008 as Compared to the Three Months
Ended September 30, 2007
Net Revenues:
Revenues for the three months ended September 30, 2008 were $4,502,000 compared to $3,632,000 for
the three months ended September 30, 2007, an increase of $870,000 or 24%. This is primarily due
to an increase in sales of BioArchive devices. We recognized revenue on six BioArchive devices
during the quarter ended September 30, 2008 versus three in the corresponding quarter of the prior
year. This contributed $420,000 to the increase in revenues. Additionally, we had increased
shipments in the AXP product line, both devices and disposables, which contributed to an increase
in revenues of approximately $680,000. Shipments of AXP devices increased, 23 in the current
quarter versus none as the device was on hold in the corresponding period of the prior year until
certain quality enhancements could be completed.
The following represents the Companys cumulative BioArchive devices sold into the following
geographies through the dates indicated:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
United States |
|
|
48 |
|
|
|
34 |
|
Asia |
|
|
62 |
|
|
|
56 |
|
Europe |
|
|
47 |
|
|
|
42 |
|
Rest of World |
|
|
30 |
|
|
|
26 |
|
|
|
|
|
|
|
|
|
|
|
187 |
|
|
|
158 |
|
|
|
|
|
|
|
|
The following represents the Companys revenues for disposables by product line for the three
months ended:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
AXP |
|
$ |
1,166,000 |
|
|
$ |
718,000 |
|
BioArchive |
|
|
850,000 |
|
|
|
809,000 |
|
CryoSeal |
|
|
83,000 |
|
|
|
382,000 |
|
|
|
|
|
|
|
|
|
|
$ |
2,099,000 |
|
|
$ |
1,909,000 |
|
|
|
|
|
|
|
|
Percentage of total
Company revenues |
|
|
47 |
% |
|
|
53 |
% |
|
|
|
|
|
|
|
Gross Profit:
The Companys gross profit was $1,280,000 or 28% of net revenues for the three months ended
September 30, 2008, as compared to $1,209,000 or 33% for the corresponding fiscal 2008 period. The
decrease in gross profit percentage is primarily due to the $520,000 accrual for the voluntary recall of AXP
bag sets.
Selling, General and Administrative Expenses:
Selling, general and administrative expenses were $2,447,000 for the three months ended September
30, 2008, compared to $2,420,000 for the comparable fiscal 2008 period, an increase of $27,000.
The increase is primarily due to 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 offset by a decrease in stock compensation expense.
Page 15
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 September 30, 2008, were $1,600,000
compared to $1,496,000 for the corresponding fiscal 2008 period, an increase of $104,000 or 7%.
The increase is primarily due to expenses associated with the Vantus subsidiary, which was formed
in February 2008, of $190,000, increase of $115,000 in development of the MXP and Res-Q products and higher salary and benefit expenses of approximately $150,000
primarily due to hiring a new Vice President of Research and Development in August 2008 and other
personnel. These increases were offset by a decrease in stock compensation expense of $262,000
primarily due to the restricted stock awarded to the Companys former Chief Technology Architect
fully vesting 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.
Liquidity and Capital Resources
At September 30, 2008, the Company had cash, cash equivalents and short-term investments of
$22,319,000 and working capital of $27,281,000. This compares to cash, cash equivalents and
short-term investments of $25,287,000 and working capital of $29,986,000 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 three months ended September 30, 2008 was $2,936,000,
primarily due to the net loss of $2,679,000 which included the accretion of discount on short-term
investments of $76,000, offset by depreciation and stock based compensation expense of $120,000 and
$123,000, respectively. Accounts receivable generated $1,800,000 of cash as a result of collecting
payments from sales made in the prior quarter. Accounts payable used
$1,555,000 of cash due to
paying vendors for purchases made late in the prior quarter, 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 September 30, 2008, the Company has no off-balance sheet arrangements.
Backlog
The Companys cancelable backlog at September 30, 2008 was $1,822,000.
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
Page 16
Principal Financial Officer, 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 along with the Companys 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 September 30, 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.
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. 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.
None.
Item 5. Other Information.
None.
Item 6. Exhibits:
|
31.1 |
|
Certification by the Principal Executive Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
31.2 |
|
Certification by the Principal 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 17
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: November 5, 2008 |
/s/ William R. Osgood
|
|
|
William R. Osgood |
|
|
Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
|
Dated: November 5, 2008 |
/s/ Matthew T. Plavan
|
|
|
Matthew T. Plavan |
|
|
Chief Financial Officer
(Principal Financial Officer and Principal
Accounting Officer) |
|
Page 18
Exhibit Index
|
31.1 |
|
Certification by the Principal Executive Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
31.2 |
|
Certification by the Principal 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 |