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 September 30, 2006.
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 |
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
(State of incorporation)
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94-3018487
(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,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act.
o
Large accelerated filer
þ Accelerated filer o Non-accelerated filer
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 1, 2006 |
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Common stock, $.001 par value
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54,940,675 |
ThermoGenesis Corp.
INDEX
Page 2
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
ThermoGenesis Corp.
Condensed Balance Sheets (Unaudited)
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September 30, |
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June 30, |
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(in thousands, except share and per share amounts) |
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2006 |
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2006 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
6,675 |
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$ |
3,527 |
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Short-term investments |
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31,697 |
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35,472 |
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Accounts receivable, net of allowance for
doubtful accounts of $33 ($17 at June 30, 2006) |
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3,349 |
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3,773 |
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Inventories |
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3,231 |
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2,792 |
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Other current assets |
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418 |
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462 |
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Total current assets |
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45,370 |
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46,026 |
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Equipment at cost less accumulated depreciation of $3,133
($3,024 at June 30, 2006) |
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1,446 |
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1,489 |
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Other assets |
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96 |
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88 |
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$ |
46,912 |
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$ |
47,603 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,918 |
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$ |
1,931 |
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Accrued payroll and related expenses |
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301 |
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417 |
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Deferred revenue |
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698 |
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718 |
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Other current liabilities |
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916 |
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618 |
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Total current liabilities |
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3,833 |
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3,684 |
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Deferred revenue |
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1,753 |
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1,921 |
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Long-term portion of capital lease obligations and note payable |
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22 |
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26 |
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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, $0.001 par value; 80,000,000 shares
authorized; 54,934,175 issued and outstanding
(54,882,952 at June 30, 2006) |
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55 |
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55 |
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Paid in capital in excess of par |
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116,197 |
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115,769 |
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Accumulated deficit |
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(74,948 |
) |
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(73,852 |
) |
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Total stockholders equity |
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41,304 |
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41,972 |
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$ |
46,912 |
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$ |
47,603 |
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See accompanying notes to financial statements.
Page 3
ThermoGenesis Corp.
Condensed 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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2006 |
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2005 |
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Product and other revenues |
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$ |
3,819 |
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$ |
2,086 |
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Milestone payments and license fees |
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486 |
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30 |
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Net revenues |
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4,305 |
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2,116 |
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Cost of product and other revenues |
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2,529 |
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1,529 |
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Cost of milestone payments and license fees |
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64 |
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Cost of revenues |
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2,593 |
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1,529 |
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Gross profit |
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1,712 |
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587 |
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Expenses: |
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Selling, general and administrative |
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2,312 |
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1,584 |
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Research and development |
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962 |
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1,073 |
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Total operating expenses |
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3,274 |
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2,657 |
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Interest and other income, net |
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466 |
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54 |
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Net loss |
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($ |
1,096 |
) |
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($ |
2,016 |
) |
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Per share data: |
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Basic and diluted net loss per common
share |
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($ |
0.02 |
) |
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($ |
0.04 |
) |
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Shares used in computing per share data |
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54,903,767 |
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45,917,502 |
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See accompanying notes to financial statements.
Page 4
ThermoGenesis Corp.
Condensed Statements of Cash Flows (Unaudited)
Three Months Ended September 30, 2006 and 2005
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(in thousands) |
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2006 |
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2005 |
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Cash flows from operating activities: |
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Net loss |
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($1,096 |
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($2,016 |
) |
Adjustments to reconcile net loss to net cash used
in operating activities: |
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Depreciation and amortization |
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111 |
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93 |
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Stock based compensation expense |
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342 |
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231 |
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Amortization of premium on short-term investments |
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(377 |
) |
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Net change in operating assets and liabilities: |
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Accounts receivable |
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424 |
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692 |
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Inventories |
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(455 |
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186 |
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Other current assets |
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44 |
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102 |
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Other assets |
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(8 |
) |
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Accounts payable |
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(13 |
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(624 |
) |
Accrued payroll and related expenses |
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(116 |
) |
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(99 |
) |
Deferred revenue |
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(188 |
) |
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(30 |
) |
Other current liabilities |
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298 |
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(77 |
) |
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Net cash used in operating activities |
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(1,034 |
) |
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(1,542 |
) |
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Cash flows from investing activities: |
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Capital expenditures |
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(52 |
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(40 |
) |
Purchase of short-term investments |
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(7,848 |
) |
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Maturities of short-term investments |
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12,000 |
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Net cash provided by (used in) investing activities |
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4,100 |
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(40 |
) |
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Cash flows from financing activities: |
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Payments on capital lease obligations and note payable |
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(4 |
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(36 |
) |
Exercise of stock options and warrants |
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86 |
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171 |
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Net cash provided by financing activities |
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82 |
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135 |
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Net increase (decrease) in cash and cash equivalents |
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3,148 |
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(1,447 |
) |
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Cash and cash equivalents at beginning of period |
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3,527 |
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9,568 |
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Cash and cash equivalents at end of period |
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$ |
6,675 |
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$ |
8,121 |
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Supplemental non-cash flow information: |
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Equipment acquired by capital lease |
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$ |
106 |
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Transfer of inventory to equipment |
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$ |
36 |
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$ |
22 |
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Transfer of equipment to inventory |
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$ |
20 |
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$ |
63 |
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See accompanying notes to financial statements
Page 5
ThermoGenesis Corp.
Notes to Condensed Financial Statements (Unaudited)
1. Summary of Significant Accounting Policies
Interim Reporting
The accompanying unaudited 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 made in U.S. dollars and therefore
currency fluctuations are believed to have no impact on ThermoGenesis Corps (the Company) 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, 2006 are not necessarily indicative of the results that may be
expected for the year ending June 30, 2007. These financial statements should be read in
conjunction with the financial statements and the notes thereto included in the Annual Report on
Form 10-K for the fiscal year ended June 30, 2006.
The balance sheet at June 30, 2006, 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. 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 the 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. If an undelivered element exists, the Company
will determine the fair value of the undelivered element and subtract the fair value of the
undelivered element from the total consideration under the arrangement. The residual amount is the
Companys estimate of the fair value of the delivered element. 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.
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.
Milestone payments the Company receives under collaborative arrangements are recognized as revenue upon
achievement of the milestone events, which represent the culmination of the earnings process, and when
collectability 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. The
direct costs, primarily labor, of product development contracts are
deferred until the development revenue is recognized.
Page 6
ThermoGenesis Corp.
Notes to Condensed Financial Statements (Unaudited) (Continued)
1. Summary of Significant Accounting Policies (Continued)
Revenue Recognition (Continued)
Revenues from the sale of the Companys products are recognized upon transfer of title. The
Company generally ships products F.O.B. shipping point at its office. There is no conditional
evaluation on any product sold and recognized as revenue. All foreign sales are denominated in
U.S. dollars. 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 the distributor places the product with an end-user. 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, or 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.
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. 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. Amounts billed in
excess of revenue recognized are recorded as deferred revenue on the balance sheet.
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, warrants and common stock restricted
awards that were not included in diluted net loss per common share were 2,953,633 and 2,883,816 as
of September 30, 2006 and 2005.
Page 7
ThermoGenesis Corp.
Notes to Condensed Financial Statements (Unaudited) (Continued)
1. Summary of Significant Accounting Policies (Continued)
Recent Accounting Pronouncements
In September 2006, the SEC issued SAB No. 108, Considering the Effects of Prior Year Misstatements
when Quantifying Misstatements in Current Year Financial Statements (SAB No. 108) to provide
guidance on the consideration of the effects of prior year misstatements in quantifying current
year misstatements for the purpose of a materiality assessment. Under SAB No. 108, companies
should evaluate a misstatement based on its impact on the current year income statement, as well as
the cumulative effect of correcting such misstatements that existed in prior years existing in the
current years ending balance sheet. SAB No. 108 will become effective for the Company in its
fiscal year ending June 30, 2007. We are currently evaluating the impact of the provisions
of SAB No. 108 on our financial statements.
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. SFAS No.
157 applies under other accounting standards that require or permit fair value measurements.
Accordingly, SFAS No. 157 does not require any new fair value measurement. SFAS No. 157 is
effective for financial statements issued for fiscal years beginning after November 15, 2007. We
are currently evaluating the impact of the provisions of SFAS No. 157 on our financial statements.
2. Short-term Investments
Short-term investments consisted of the following at September 30, 2006:
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Gross |
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Gross |
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Amortized |
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Unrealized |
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Unrealized |
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Estimated |
(in thousands) |
|
Cost |
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Gains |
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Losses |
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Fair Value |
September 30, 2006 |
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U.S. government and
agency securities |
|
$ |
31,697 |
|
|
$ |
10 |
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|
($9 |
) |
|
$ |
31,698 |
|
The aggregate amount of unrealized losses and fair value of U.S. government and agency securities,
which are not deemed to be other-than-temporarily impaired and less than twelve months, are $9 and
$7,955 respectively. The unrealized loss 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.
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Amortized |
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Estimated |
|
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Cost |
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Fair Value |
Maturity Date: |
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Less than 90 days |
|
$ |
23,789 |
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$ |
23,798 |
|
Due in 91-365 days |
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|
7,908 |
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|
7,900 |
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|
$ |
31,697 |
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|
$ |
31,698 |
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|
Page 8
ThermoGenesis Corp.
Notes to Condensed Financial Statements (Unaudited) (Continued)
3. Inventories
Inventories consisted of the following at:
|
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|
|
(in thousands) |
|
September 30, 2006 |
|
|
June 30, 2006 |
|
Raw materials |
|
$ |
1,983 |
|
|
$ |
1,603 |
|
Work in process |
|
|
1,385 |
|
|
|
1,433 |
|
Finished goods |
|
|
641 |
|
|
|
530 |
|
Reserve |
|
|
(778 |
) |
|
|
(774 |
) |
|
|
|
|
|
|
|
|
|
$ |
3,231 |
|
|
$ |
2,792 |
|
|
|
|
|
|
|
|
Included in the Companys inventory reserve at September 30, 2006 and June 30, 2006 were $464 and
$459, respectively, related to CryoSeal® FS System inventory products, which is based on
inventory levels in excess of forecasted demand for the product. The remainder of the reserve
relates to certain BioArchive® System and ThermoLine inventory which have been
identified as slow-moving or potentially obsolete.
4. Commitments and Contingencies
Warranty
The Company offers a one-year warranty for parts only on all of its non-disposable products. The
Company estimates the costs that may be incurred under its basic limited warranty and records a
liability in the amount of such costs at the time product revenue is recognized. Factors that
affect the Companys warranty liability include the number of installed units, historical and
anticipated rates of warranty claims, and cost per claim. 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:
|
|
|
|
|
(in thousands) |
|
|
|
|
July 1, 2006 balance |
|
$ |
74 |
|
Warranties issued during the period |
|
|
47 |
|
Settlements made during the period |
|
|
(7 |
) |
Changes in liability for pre-existing warranties during the period,
including expirations |
|
|
(24 |
) |
|
|
|
|
Balance at September 30, 2006 |
|
$ |
90 |
|
|
|
|
|
Page 9
ThermoGenesis Corp.
Notes to Condensed Financial Statements (Unaudited) (Continued)
5. Stockholders Equity
Stock Based Compensation
Effective July 1, 2005, the Company adopted the fair value recognition provisions of FASB Statement
No. 123(R), Share-Based Payment, using the modified-prospective-transition method. Under that
transition method, compensation cost recognized in fiscal year 2007 and 2006 includes: (a)
compensation cost for all share-based payments granted prior to, but not yet vested as of July 1,
2005, based on the grant date fair value estimated in accordance with the original provisions of
Statement 123, and (b) compensation cost for all share-based payments granted subsequent to July 1,
2005, based on the grant-date fair value estimated in accordance with the provisions of Statement
123(R). As a result, a non-cash charge of $339,000 and $195,000 was charged to compensation expense
during the first quarter of fiscal 2007 and 2006, respectively.
The following is a summary of option activity for the Companys stock option plans:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
Weighted- |
|
Average |
|
|
|
|
|
|
|
|
Average |
|
Remaining |
|
Aggregate |
(in thousands, except shares, |
|
Number of |
|
Exercise |
|
Contractual |
|
Intrinsic |
share price and term) |
|
Shares |
|
Price |
|
Life |
|
Value |
|
|
|
Outstanding at June 30, 2006 |
|
|
2,539,321 |
|
|
$ |
2.72 |
|
|
|
3.34 |
|
|
$ |
3,737 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
45,000 |
|
|
$ |
3.95 |
|
|
|
|
|
|
|
|
|
Forfeited or Expired |
|
|
(3,550 |
) |
|
$ |
3.85 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(40,000 |
) |
|
$ |
2.18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2006 |
|
|
2,540,771 |
|
|
$ |
2.75 |
|
|
|
3.2 |
|
|
$ |
3,131 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and Expected to Vest at
September
30, 2006 |
|
|
2,507,615 |
|
|
$ |
2.74 |
|
|
|
3.2 |
|
|
$ |
3,109 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at September 30, 2006 |
|
|
1,856,864 |
|
|
$ |
2.46 |
|
|
|
2.9 |
|
|
$ |
2,745 |
|
|
|
|
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 for the 2,034,574 options that
were in-the-money at September 30, 2006.
Page 10
ThermoGenesis Corp.
Managements Discussion and Analysis of
Financial Condition and Results of Operations
for the Three Months Ended September 30, 2006 and 2005
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 2007, 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 Securities and
Exchange Commission (SEC) reports, including, in particular, the factors and discussion in the
Companys Form 10-K for its last fiscal year.
Introduction
The Company designs and manufactures medical devices and disposables for the distributed
manufacturing of personalized cell therapy and surgical wound care products such as units of
umbilical cord blood stem cells, fibrin sealant and thrombin. These products typically originate
from the blood or tissue of the patient or a single human leukocyte antigen (HLA) typed and
pathogen screened placenta or living donor. Cell therapy and surgical wound care products are
broad, rapidly growing fields of medicine that involves the collection, purification, manipulation
and administration of somatic stem cells, wound healing proteins or growth factors to treat
malignant or genetic blood diseases or wounds incurred during surgery, 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 therapy and surgical wound care products are
manufactured one at a time, are intended for a single patient and require extremely low storage
temperatures (-196°C in some cases) in order to preserve the cells, blood proteins or growth
factors.
The Companys products can address a broad range of cell therapy and surgical wound care
treatments. Until the middle of the 1990s, researchers were familiar with only two major types of
stem cells, embryonic stem cells and adult stem cells. However, recent years have seen the
emergence of a category of stem cells called somatic stem cells that are found in umbilical cord
blood or bone marrow and other tissues of the body. Somatic stem cells are capable of a wide range
of differentiation into several highly diverse cell types such as nerve cells, muscle cells and
hematopoietic cells. Somatic stem cells have come into focus as fundamental units of development
and maintenance of the adult organism as well as an attractive tool for tissue regeneration.
Page 11
ThermoGenesis Corp.
Managements Discussion and Analysis of
Financial Condition and Results of Operations
for the Three Months Ended September 30, 2006 and 2005 (Continued)
Introduction (Continued)
The ability to obtain large quantities of somatic stem cells able to produce mature muscle, nerve
or pancreatic cells is useful in the development of clinical treatments for genetic diseases. This
clinical practice is personalized medicine which utilizes either an individuals own somatic stem
cells, thus circumventing problems of immune rejection associated with implantation of allogeneic
tissue or blood cells, or utilizes immunologically matched tissue or stem cells.
Cell therapy and surgical wound care products can be characterized by (1) the source of the somatic
stem cells (e.g., neonatal, adult, or perhaps, in the future, embryonic) (2) the source of blood
proteins or growth factors (e.g., from the patient or a matched single donor), (3) the cell progeny
in the final product (e.g., hematopoietic, mesenchymal, dendritic cells, chondrocytes, etc.), (4)
the disease targeted (e.g., bone marrow rescue, diabetes, myocardial infarction, Parkinsons), and
(5) the type of manipulation (e.g., cell isolation, capture, expansion, gene modification,
cryopreservation, cryoprecipitation or chemical fractionation). Critical factors in providing
acceptable personalized cell therapy and surgical wound care products are that they be precisely
identified and tracked from their source to the receiving patient and that every manufacturing
step, such as harvesting, processing, freezing, transporting, matching and administering, preserves
the potency of the product.
The Companys BioArchive and AXP products and intellectual property are designed to ensure that the
therapeutic cells are fully functional at time of transplant, which may be months or years after
production and storage. We believe that the Companys products, contain substantial advantages
over other products and practices in enabling the precision manufacturing of cell therapy and
surgical wound care products in a safe sterile environment which will reduce the loss of cells and
loss of cell viability at each step of the process from collection to administration.
Cell Therapy
The BioArchive System, an automated cryogenic device, is used by cord blood stem cell banks in more
than 25 countries for cryopreserving and archiving cord blood stem cell units for transplant. GE
Healthcare is the global distribution partner for the BioArchive System. The BioArchive System has
initially been configured to automate the cryopreservation and archiving in liquid nitrogen of
units of hematopoietic stem cells sourced from umbilical cord blood. Cord blood stem cell units
have been used more than 10,000 times to treat leukemias, lymphomas, diverse inherited anemias,
such as sickle cell anemia and thalassemia, and other life threatening genetic diseases.
The Company completed development of the AXP System in fiscal 2006, and initiated a Master File of
the product with the Food and Drug Administration (FDA). The AXP System is an innovative product
which semi-automates the isolation and concentration of hematopoietic stem cells from cord blood
into a fixed 20 ml volume in a functionally closed sterile environment. It includes a compact
battery powered device and a proprietary disposable bag set. The AXP System replaces the current
clinical process which is typically an 18-step manual method over a ninety (90) minute period with
a semi-automated process requiring only thirty (30) minutes. The manual process requires the
introduction of sedimentation agents or density gradient media into the cord blood and requires a
clean room along with trained technicians to accomplish. The AXP System completes its processing
without these agents or media with a higher cell recovery rate in a functionally closed bag set in
thirty (30) minutes. Included in the set is a 25 ml freezing bag which can be archived in the
BioArchive System.
Page 12
ThermoGenesis Corp.
Managements Discussion and Analysis of
Financial Condition and Results of Operations
for the Three Months Ended September 30, 2006 and 2005 (Continued)
Introduction (Continued)
To date, our BioArchive System and related products are purchased predominantly by specialized cord
blood stem cell banks and stem cell research facilities. The sales of BioArchive devices have been
dependent on start-up and ongoing funding costs associated with new stem cell banks as the science
evolved. In more recent periods governmental funding of cord blood banks, as well as more
recognized therapeutic benefits from this stem cell treatment appear to be increasing demand for
cord blood stem cell transplants.
Surgical Wound Care
The CryoSeal System 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.
The Company completed a 150 patient blinded, randomized multi-center U.S. clinical trial for the
CryoSeal System and sales in the U.S. are pending the required FDA approval following our Premarket
Approval (PMA), submitted December 28, 2005. The study reached its primary end point, which was
to demonstrate equivalency (i.e. that results obtained using the CryoSeal FS System were
non-inferior to results achieved with the control). The data in fact demonstrated that patients
treated with CryoSeal FS showed superiority (statistically significant quicker time to
hemostasis) versus the control group. The Company has received CE Mark approval for the system
enabling its sale and use in Europe, however sales into individual countries under cost
reimbursement structures often require the existence of supporting clinical usage within the
individual country. We have, through our distribution partners in Europe, initiated more aggressive
marketing including a number of clinical trials. In Japan, our distributor, Asahi, has completed
enrollment in their pivotal clinical trial and filed their PMA equivalent in March 2005 with
approval expected in first half of calendar 2007.
The TPD, a product line extension of the CryoSeal platform, is a small stand alone disposable that
isolates and captures activated autologous thrombin from approximately 11 ml of patient blood
plasma. Thrombin is used as a topical hemostatic agent for minor bleeding sites, to treat
pseudoaneurysms and to release growth factors from platelets.
The Companys legacy is in its ThermoLine products for ultra rapid freezing and thawing of blood
components, which the Company distributes to blood banks and hospitals. We are currently
evaluating continuation of the ThermoLine, or divestiture, consistent with our strategic direction
emphasizing the cell therapy and surgical wound care market. Beginning in late 1993, and with
accelerated research and development efforts from 1996 to present, the Company completed
development of the BioArchive, AXP and CryoSeal technology platforms.
Page 13
ThermoGenesis Corp.
Managements Discussion and Analysis of
Financial Condition and Results of Operations
for the Three Months Ended September 30, 2006 and 2005 (Continued)
Introduction (Continued)
In our early history, our revenue was derived principally from the sale of our blood plasma
freezers and thawers. With the launch of our BioArchive System in 1999, we realized revenue
increases due to the sale of that equipment. The installed base of our medical devices is designed
to drive increases in revenue due to the recurring sale of disposables. We anticipate similar
revenue increases from disposable sales related to the CryoSeal System and AXP System when the
installed base of units increases, however there is no assurance that this will occur. With our
efforts increasingly directed at both the cell therapy and tissue therapy markets, and our
re-evaluation of the strategic relevance of our ThermoLine business, we will continue to assess our
internal resources needs and operational structure. As part of those efforts, and with additional
products staging to come on the market, we plan to significantly increase our staffing levels in
engineering, scientific research, sales and marketing and management during fiscal 2007 in an
effort to accelerate product launches and product development, as we pursue increased revenue.
The Company has announced a number of important agreements, summarized as follows:
In March of 2005, the Company entered into a Supply Agreement with Biomet Biologicals, formerly
Cell Factors Technologies, Inc., an Indiana corporation and an affiliate of Biomet, Inc.
(Biomet). Under the agreement, the Company will manufacture a thrombin disposable and reagent for
the Clotalyst System. The Clotalyst System is Biomets autologous clotting factor device and blood
processing disposables. The Company assumes the role of manufacturer for Biomet of the Clotalyst
device and blood processing disposals for a term of five years. The agreement requires Biomet,
upon FDA clearance, to purchase a minimum quantity of 20,000 devices per year. Biomet has paid a
one time advance fee for engineering and development of the product.
In July 2005, the Company entered into a non-exclusive, five-year distribution agreement with
Biomet to supply Biomet with the Companys existing CE marked TPD for sale in Europe for all
applications and worldwide for spinal applications in order to allow them to immediately begin
marketing their platelet gel product. Previously, Biomet had been selling bovine thrombin with
their platelet gel product.
In October 2005, the Company entered into a five-year agreement with GE Healthcare (formerly
Amersham Biosciences AB), which outlined the terms of a strategic relationship between the Company
and GE Healthcare. Pursuant to this agreement, (i) GE Healthcare becomes the exclusive worldwide
distributor and service provider for the Companys BioArchive and AXP products, (ii) GE Healthcare
agreed to provide the Company with certain funds upon execution of the agreement and over the
ensuing 15 months and (iii) GE Healthcare and the Company agreed to collaborate on certain future
improvements to these product lines.
In November 2005, the Company entered into a non-exclusive, five-year distribution and product
modification agreement with Medtronic to supply the CE marked TPD for sale with Medtronics
Magellan Platelet Separation Device. This agreement intends to allow the sale of an all autologous
platelet gel. Initially, Medtronic will sell the TPD-enabled Magellan product in Europe and
Canada.
Page 14
ThermoGenesis Corp.
Managements Discussion and Analysis of
Financial Condition and Results of Operations
for the Three Months Ended September 30, 2006 and 2005 (Continued)
Introduction (Continued)
In July 2006, the Company entered into a Product Development and Supply Agreement with Biomet.
Under the development phase of this agreement, Biomet will pay the Company $1.1 million in
milestone payments to develop a fibrinogen concentration kit containing the Companys CryoSeal II
kit. The Company will grant intellectual property license rights to Biomet and its affiliates to
manufacture, use and sell the product for use in surgical hemostats, graft delivery systems and
surgeries. The Company has the right of first offer to manufacture the product; and if the Company
does not manufacture the product, Biomet will pay a royalty. The agreement has a term of 5 years.
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 financial statements.
Critical Accounting Policies
The Companys discussion and analysis of its financial condition and results of operations are
based upon the Companys financial statements, which have been prepared in accordance with
accounting principles generally accepted in the United States. The preparation of these 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.
The Company believes the following critical accounting policies affect its more significant
judgments and estimates used in the preparation of its financial statements.
Stock-Based Compensation:
The Company accounts for stock-based employee compensation arrangements in accordance with the
provisions of Statement of Financial Accounting Standards No. 123(R), Shared-Based Payments (FAS
123(R)). Under FAS 123(R), compensation cost is calculated on the date of the grant using the
Black Scholes-Merton option-pricing formula. The compensation expense is then amortized over the
vesting period. The Company uses the Black-Scholes-Merton option-pricing formula in determining the
fair value of the Companys options at the grant date and applies judgment in estimating the key
assumptions that are critical to the model such as the expected term, volatility and forfeiture
rate of an option. The Companys estimate of these key assumptions is based on historical
information and judgment regarding market factors and trends. If actual results are not consistent
with the Companys assumptions and judgments used in estimating the key assumptions, the Company
may be required to record additional compensation or income tax expense, which could have a
material impact on the Companys financial position and results of operations.
Page 15
ThermoGenesis Corp.
Managements Discussion and Analysis of
Financial Condition and Results of Operations
for the Three Months Ended September 30, 2006 and 2005 (Continued)
Critical Accounting Policies (Continued)
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. 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 the 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. If an undelivered element exists, the Company
will determine the fair value of the undelivered element and subtract the fair value of the
undelivered element from the total consideration under the arrangement. The residual amount is the
Companys estimate of the fair value of the delivered element. 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.
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.
Milestone payments the Company receives under collaborative arrangements are recognized as revenue upon
achievement of the milestone events, which represent the culmination of the earnings process, and when
collectability 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. The
direct costs, primarily labor, of product development contracts are
deferred until the development revenue is recognized.
Allowance for Doubtful Accounts:
The Company maintains allowances for doubtful accounts for estimated losses resulting from the
inability of its customers to make required payments. If the financial condition of the Companys
customers were to deteriorate, resulting in an impairment of their ability to make payments,
additional allowances may be required, which would be charged against earnings.
Warranty:
The Company provides for the estimated cost of product warranties at the time revenue is
recognized. While the Company engages in extensive product quality programs and processes,
including actively monitoring and evaluating the quality of its component suppliers, the Companys
warranty obligation is affected by product failure rates, material usage and service delivery costs
incurred in correcting a product failure. Should actual product failure rates, material usage or
service delivery costs differ from the Companys estimates, revisions to the estimated warranty
liability would be required.
Page 16
ThermoGenesis Corp.
Managements Discussion and Analysis of
Financial Condition and Results of Operations
for the Three Months Ended September 30, 2006 and 2005 (Continued)
Critical Accounting Policies (Continued)
Inventory Reserve:
The Company plans inventory procurement and production based on orders received, forecasted demand
and supplier requirements. The Company writes down its inventories for estimated obsolescence or
unmarketable inventories equal to the difference between the cost of inventories and its net
realizable value based upon estimates about future demand from our customers and distributors and
market conditions. Because some of the Companys products are highly dependent on government and
third-party funding, current customer use and validation, and completion of regulatory and field
trials, there is a risk that we will forecast incorrectly and purchase or produce excess inventory.
As a result, actual demand may differ from forecasts, and such a difference may have a material
adverse effect on future results of operations due to required write-offs of excess or obsolete
inventory. This inventory risk may be further compounded for the CryoSeal family of products
because they are at initial market introduction and market acceptance will depend upon the customer
accepting the products as clinically useful, reliable, accurate and cost effective compared to
existing and future products and completion of required clinical or field acceptance trials.
Results of Operations
Results of Operations for the Three Months Ended September 30, 2006 as Compared to the Three Months
Ended September 30, 2005
Net Revenues:
Revenues for the three months ended
September 30, 2006 were $4,305,000, compared to $2,116,000 for the three months ended September 30, 2005,
an increase of $2,189,000 or 103%. Cell Therapy revenues were $3,198,000 for the three months ended September 30,
2006, compared to $1,454,000 for the corresponding fiscal 2006 period, an increase of $1,744,000 or 120%.
The increase in revenues was primarily due to sales of seven BioArchives during the first quarter of fiscal 2007, compared
to three sold during the first quarter of fiscal 2006. The AXP product line revenues were $493,000 of Cell Therapy revenues for
the quarter ended September 30, 2006, as compared to zero for the corresponding period of the prior year. Sales of Cell Therapy
spare parts were $320,000 for the first quarter of fiscal 2007, an increase of $311,000. Cell Therapy revenues also increased
due to the amortization of the distribution and license fees paid by GE Healthcare in accordance with the International Distribution
Agreement. Included in the Cell Therapy revenues noted was $787,000 generated from the sales of BioArchive disposables for the quarter
ended September 30, 2006, an increase of $113,000 or 17%.
The following represents the Companys cumulative BioArchive devices sold into the following
geographies through the dates indicated:
|
|
|
|
|
|
|
|
|
|
|
September 30 |
|
|
2006 |
|
2005 |
United States |
|
|
29 |
|
|
|
24 |
|
Asia |
|
|
52 |
|
|
|
46 |
|
Europe |
|
|
36 |
|
|
|
26 |
|
Rest of World |
|
|
25 |
|
|
|
21 |
|
|
|
|
|
|
|
|
|
|
|
|
|
142 |
|
|
|
117 |
|
|
|
|
|
|
|
|
|
|
Page 17
ThermoGenesis Corp.
Managements Discussion and Analysis of
Financial Condition and Results of Operations
for the Three Months Ended September 30, 2006 and 2005 (Continued)
Results of Operations (Continued)
Surgical
Wound Care revenues were $639,000 for the quarter ended
September 30, 2006, compared to $150,000 for the quarter ended September 30, 2005. The increase is
primarily due to $300,000 in development milestone payments, the sale of three CryoSeal devices during the quarter ended September 30, 2006, versus none
during the quarter ended September 30, 2005 and an increase in sales of the TPD and CryoSeal
processing disposable.
The
revenue increases noted above were offset by a decrease in revenues
of $44,000 from our legacy
product line, the ThermoLine.
Cost of Revenues:
Total cost of
revenues as a percent of revenues was 60% for the three months ended September 30, 2006, as
compared to 72% for the corresponding fiscal 2006 period. The improvement in gross margin is due
to the increase in volume of Cell Therapy devices, both BioArchive and AXP and the increase in
revenues from licenses, milestone payments and royalties.
Selling, General and Administrative Expenses:
Selling, general and administrative expenses were $2,312,000 for the three months ended September
30, 2006, compared to $1,584,000 for the fiscal 2006 period, an increase of $728,000 or 46%. The
increase is primarily due to recruiting expenses associated with the hiring of sales and marketing
personnel for the Surgical Wound Care product line and initiating searches for senior management of
Cell Therapy and general operations. Also, there was an increase in stock compensation expense due
to options granted and vested during the quarter.
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, 2006, were $962,000
compared to $1,073,000 for the corresponding fiscal 2006 period, a decrease of $111,000 or 10%.
The decrease is primarily due to a reduction in the costs associated with the design and
development services for the AXP System, which was launched during fiscal 2006 and a decrease in
clinical trial costs related to the completed CryoSeal FS human clinical trial.
Liquidity and Capital Resources
At September 30, 2006, the Company had cash and short-term investments of $38,372,000 and working
capital of $41,537,000. This compares to cash and short-term investments of $38,999,000 and
working capital of $42,342,000 at June 30, 2006. The cash was used to fund operations and other
cash needs 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 $106 million, net of expenses, through common and preferred stock financings and
option and warrant exercises. As of September 30, 2006, the Company has no off-balance sheet
arrangements.
Page 18
ThermoGenesis Corp.
Managements Discussion and Analysis of
Financial Condition and Results of Operations
for the Three Months Ended September 30, 2006 and 2005 (Continued)
Liquidity and Capital Resources (Continued)
Net cash used in operating activities for the quarter ended
September 30, 2006 was $1,034,000,
primarily due to the net loss of $1,096,000, offset by depreciation and stock based compensation
expense of $111,000 and $342,000, respectively. Accounts receivable generated $424,000 of cash as
a result of the timing of sales and payments from customers. Inventories utilized $455,000 of cash
as a result of increasing our inventories to support our anticipated revenue growth.
We believe that our currently available cash, cash equivalents and short-term investments, and cash
generated from operations will be sufficient to satisfy our operating and working capital
requirements for at least the next twelve months. However, if we experience significant growth in
the future, we may be required to raise additional cash through the issuance of new debt or
additional equity.
Backlog
The Companys cancelable backlog at September 30, 2006 was $844,000.
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 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 Chief Executive Officer along with the Companys
Chief 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 in ensuring that information
required to be disclosed by us in reports that we file or submit under the Exchange Act is
recorded, processed, summarized and reported within the time periods specified in the Securities
and Exchange Commissions rules and forms.
There were no changes in the Companys internal controls over financial reporting that occurred
during the three months ended September 30, 2006 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 19
PART II OTHER INFORMATION
Item 1. Legal.
In the normal course of operations, the Company may have disagreements or disputes
with 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 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, 2006, which could materially affect
our business, financial condition or future results. 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.
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:
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31.1 |
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Certification by the Principal Executive Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002. |
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31.2 |
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Certification by the Principal Financial Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002. |
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32 |
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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.
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ThermoGenesis Corp. |
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(Registrant) |
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Dated: November 7, 2006
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/s/ Philip H. Coelho
Philip H. Coelho
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Chief Executive Office |
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(Principal Executive Officer) |
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/s/ Matthew T. Plavan |
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Matthew T. Plavan |
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Chief Financial Officer |
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(Principal Financial Officer and Principal |
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Accounting Officer) |
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Page 21
Exhibit Index
Exhibit:
31.1 |
|
Certification by the Principal Executive Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002. |
|
31.2 |
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Certification by the Principal Financial Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002. |
|
32 |
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Certification of Principal Executive Officer and Principal
Financial Officer pursuant to Section 906 of the Sarbanes |