e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For the quarter ended: September 30, 2006 Commission File Number: 0-19871
STEMCELLS, INC.
(Exact name of registrant as specified in its charter)
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DELAWARE
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94-3078125 |
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
identification No) |
3155 PORTER DRIVE
PALO ALTO, CA 94304
(Address of principal executive offices including zip code)
(650) 475-3100
(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 twelve months (or
for such shorter periods that the registrant was required to file such reports) and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check One):
Large accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
At October 30, 2006, there were 77,809,096 shares of Common Stock, $.01 par value, issued and
outstanding.
PART IFINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
STEMCELLS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
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September 30, 2006 |
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December 31, 2005 |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
55,440,550 |
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$ |
34,540,908 |
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Receivables |
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445,368 |
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201,919 |
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Other current assets |
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1,107,032 |
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386,966 |
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Total current assets |
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56,992,950 |
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35,129,793 |
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Marketable securities |
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1,041,527 |
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3,720,794 |
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Property, plant and equipment, net |
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3,803,441 |
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3,282,588 |
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Other assets, net |
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2,615,172 |
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2,705,513 |
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Total assets |
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$ |
64,453,090 |
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$ |
44,838,688 |
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Liabilities and stockholders equity |
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Current liabilities: |
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Accounts payable |
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$ |
592,476 |
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$ |
637,122 |
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Accrued expenses |
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906,830 |
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1,483,300 |
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Accrued wind-down expenses, current portion |
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950,079 |
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1,118,796 |
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Deferred revenue, current portion |
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20,709 |
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Capital lease obligations, current portion |
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54,676 |
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Bonds payable, current portion |
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238,333 |
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254,167 |
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Total current liabilities |
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2,708,427 |
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3,548,061 |
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Bonds payable, less current maturities |
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1,177,915 |
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1,351,250 |
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Deposits and other long-term liabilities |
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495,242 |
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522,866 |
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Accrued wind-down expenses, non-current portion |
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5,926,763 |
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6,186,930 |
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Deferred rent |
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1,007,336 |
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853,997 |
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Deferred revenue, non-current portion |
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227,565 |
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Total liabilities |
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11,543,248 |
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12,463,104 |
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Stockholders equity: |
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Common stock, $.01 par value; 125,000,000
shares authorized; 77,803,368 and 65,396,022
shares issued and outstanding at September
30, 2006 and December 31, 2005, respectively |
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778,033 |
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653,960 |
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Additional paid in capital |
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254,157,840 |
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217,919,336 |
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Accumulated deficit |
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(198,989,259 |
) |
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(185,943,565 |
) |
Accumulated other comprehensive loss |
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(3,036,772 |
) |
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(254,147 |
) |
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Total stockholders equity |
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52,909,842 |
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32,375,584 |
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Total liabilities and stockholders equity |
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$ |
64,453,090 |
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$ |
44,838,688 |
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See accompanying notes to condensed consolidated financial statements.
3
STEMCELLS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
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Three months ended |
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Nine months ended |
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September 30, |
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September 30, |
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2006 |
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2005 |
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2006 |
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2005 |
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Revenue: |
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Revenue from grants and licensing agreements |
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$ |
18,321 |
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$ |
91,255 |
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$ |
80,406 |
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$ |
163,345 |
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Total revenue |
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18,321 |
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91,255 |
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80,406 |
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163,345 |
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Operating expenses: |
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Research and development |
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3,523,078 |
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2,336,562 |
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9,402,472 |
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5,924,591 |
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General and administrative |
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1,889,512 |
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1,549,443 |
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4,979,349 |
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4,009,187 |
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Wind-down expenses |
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168,168 |
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297,184 |
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499,186 |
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2,015,384 |
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Total operating expenses |
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5,580,758 |
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4,183,189 |
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14,881,007 |
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11,949,162 |
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Loss from operations |
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(5,562,437 |
) |
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(4,091,934 |
) |
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(14,800,601 |
) |
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(11,785,817 |
) |
Other income (expense): |
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License and settlement agreement, net |
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3,747,601 |
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103,359 |
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3,747,601 |
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Interest income |
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735,652 |
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301,255 |
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1,779,016 |
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790,407 |
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Interest expense |
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(34,062 |
) |
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(42,021 |
) |
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(111,159 |
) |
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(133,777 |
) |
Other income (expense) |
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(2,362 |
) |
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(8,594 |
) |
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(16,309 |
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(29,226 |
) |
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Total other income (expense) |
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699,228 |
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3,998,241 |
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1,754,907 |
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4,375,005 |
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Net loss |
( |
$ |
4,863,209 |
) |
( |
$ |
93,693 |
) |
( |
$ |
13,045,694 |
) |
( |
$ |
7,410,812 |
) |
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Net loss per share basic and diluted |
( |
$ |
0.06 |
) |
( |
$ |
0.00 |
) |
( |
$ |
0.18 |
) |
( |
$ |
0.12 |
) |
Weighted average shares used to compute net
loss per share basic and diluted |
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77,779,257 |
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64,179,563 |
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73,487,670 |
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63,226,214 |
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See accompanying notes to condensed consolidated financial statements.
4
STEMCELLS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
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Nine months ended |
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September 30, |
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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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($13,045,694 |
) |
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($7,410,812 |
) |
Adjustments to reconcile net loss to net cash
used in operating activities: |
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Depreciation and amortization |
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790,949 |
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|
834,135 |
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Amortization of deferred compensation |
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354,624 |
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Stock-based compensation expense |
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1,812,962 |
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|
550,649 |
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Loss on disposal of fixed assets |
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|
1,197 |
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|
1,377 |
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Income from license and settlement agreement |
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(103,359 |
) |
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(3,974,883 |
) |
Changes in operating assets and liabilities: |
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Accrued interest receivable |
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(119,147 |
) |
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(31,215 |
) |
Receivables |
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(124,302 |
) |
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|
60,517 |
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Other current assets |
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(720,066 |
) |
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(237,840 |
) |
Other assets |
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|
106,271 |
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|
52,947 |
|
Accounts payable and accrued expenses |
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(621,116 |
) |
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(670,512 |
) |
Accrued wind-down expenses |
|
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(428,884 |
) |
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|
1,192,125 |
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Deposits received (refunded) |
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(27,624 |
) |
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|
(95,173 |
) |
Deferred rent |
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|
153,339 |
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|
186,517 |
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Deferred revenue |
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248,274 |
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Net cash used in operating activities |
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(12,077,200 |
) |
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(9,187,544 |
) |
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Cash flows from investing activities: |
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Purchase of property, plant and equipment |
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(1,230,554 |
) |
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(696,793 |
) |
Acquisition of other assets |
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(88,375 |
) |
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(80,000 |
) |
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Net cash used in investing activities |
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(1,318,929 |
) |
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|
(776,793 |
) |
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Cash flows from financing activities: |
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Proceeds from the exercise of stock options |
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|
123,186 |
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|
343,165 |
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Proceeds from the exercise of warrants |
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|
994,896 |
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|
3,753,123 |
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Proceeds from issuance of common stock |
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33,421,534 |
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Repayments of capital lease obligations |
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(54,676 |
) |
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|
(39,232 |
) |
Repayment of debt obligations |
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|
(189,169 |
) |
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|
(181,667 |
) |
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Net cash provided by financing activities |
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|
34,295,771 |
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|
|
3,875,389 |
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Increase (decrease) in cash and cash equivalents |
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|
20,899,642 |
|
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|
(6,088,948 |
) |
Cash and cash equivalents, beginning of period |
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|
34,540,908 |
|
|
|
41,059,532 |
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Cash and cash equivalents, end of period |
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$ |
55,440,550 |
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$ |
34,970,584 |
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Supplemental disclosure of cash flow information: |
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Interest paid |
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$ |
111,159 |
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$ |
133,777 |
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Stock issued for licensing agreements |
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$ |
10,000 |
(1) |
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(1) |
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Under terms of a license agreement with the
California Institute of Technology (Cal Tech),
annual fees of $5,000 were due on each of two
patents to which StemCells holds a license from
Cal Tech, payable in cash or stock at the
Companys choice. The Company elected to pay
the fees in stock and issued 3,848 unregistered
shares to Cal Tech. |
See accompanying notes to condensed consolidated financial statements
5
Notes to Condensed Consolidated Financial Statements
(Unaudited) September 30, 2006 and 2005
NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The terms StemCells, the Company, our, we and us as used in this report refer to
StemCells, Inc. The accompanying unaudited, condensed consolidated financial statements have been
prepared by the Company in accordance with generally accepted accounting principles 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. In the opinion of management,
the accompanying financial statements include all adjustments, consisting of normal recurring
accruals, considered necessary for a fair presentation of the financial position, results of
operations and cash flows for the periods presented. Results of operations for the nine months
ended September 30, 2006, are not necessarily indicative of the results that may be expected for
the entire fiscal year ending December 31, 2006.
The balance sheet at December 31, 2005 has been derived from the audited financial statements
at that date but does not include all of the information and footnotes required for complete
financial statements in accordance with accounting principles generally accepted in the United
States of America. For the complete financial statements, refer to the audited financial
statements and footnotes thereto as of December 31, 2005, included on Form 10-K.
The Company has incurred significant operating losses and negative cash flows since inception.
It has not achieved profitability and may not be able to realize sufficient revenues to achieve or
sustain profitability in the future. The Company has limited capital resources and it will need to
raise additional capital from time to time to sustain its product development efforts, acquisition
of technologies and intellectual property rights, preclinical and clinical testing of anticipated
products, pursuit of regulatory approvals, acquisition of capital equipment, laboratory and office
facilities, establishment of production capabilities, general and administrative expenses and other
working capital requirements. To fund its operations, the Company relies on cash balances,
proceeds from equity and debt offerings, proceeds from the transfer or sale of intellectual
property rights, equipment, facilities or investments, and on government grants and collaborative
arrangements. The Company cannot be certain that such funding will be available when needed. The
financial statements do not include any adjustments to reflect the possible future effects on the
recoverability and classification of assets or the amounts and classification of liabilities that
may result from the outcome of this uncertainty.
Use of Estimates
The preparation of consolidated financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make estimates and
assumptions that affect the amounts reported in the consolidated financial statements. Actual
results could differ from these estimates. Significant estimates include the following:
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Accrued wind-down expenses (Note 4). |
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The grant date fair value of share-based awards recognized as compensation expense in
accordance with the provisions of Statement of Financial Accounting Standards No. 123
(Revised 2004) Share-Based Payment (SFAS 123R). See Stock-Based Compensation below. |
Marketable securities
In accordance with Statement of Financial Accounting Standards (SFAS) No. 115 Accounting
for Certain Investments in Debt and Equity Securities, the Company has classified the Companys
short-term investments as available-for-sale marketable securities in the accompanying consolidated
financial statements. The marketable securities are stated at fair market value, with unrealized
gains and losses reported in other comprehensive income. Management
6
reviews securities with unrealized losses for other than temporary impairment. A decline in
the fair value of securities that is deemed other than temporary is charged to earnings when so
deemed.
Reclassification
Certain reclassifications of prior year amounts have been made to conform to current year
presentation. Patent related expenses of $189,980 and $529,244 for the three and nine-month period
ended September 30, 2005 have been reclassified from research and development expense to general
and administrative expense on the consolidated statements of operations for that period to conform
with current year presentation.
Net Loss Per Share
The Company has computed net loss per common share according to the Statement of Financial
Accounting Standards No. 128 Earnings Per Share, which requires disclosure of basic and diluted
earnings per share. Basic earnings per share excludes any dilutive effects of options, warrants
and convertible securities, and is computed using the weighted average number of common shares
outstanding during the period. Diluted earnings per share includes the impact of potentially
dilutive securities and is computed using the weighted average of common and diluted equivalent
stock options, warrants and convertible securities outstanding during the period. Stock options,
warrants and convertible securities that are anti-dilutive are excluded from the calculation of
diluted loss per common share.
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Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Net loss applicable
to common
stockholders |
|
|
($4,863,209 |
) |
|
|
($93,693 |
) |
|
|
($13,045,694 |
) |
|
|
($7,410,812 |
) |
Weighted average
shares used in
computing net loss
per share
applicable to
common
stockholders, basic
and diluted. |
|
|
77,779,257 |
|
|
|
64,179,563 |
|
|
|
73,487,670 |
|
|
|
63,226,214 |
|
Net loss per share
applicable to
common
stockholders, basic
and diluted. |
|
|
($0.06 |
) |
|
|
($0.00 |
) |
|
|
($0.18 |
) |
|
|
($0.12 |
) |
The Company has excluded outstanding stock options and warrants from the calculation of
diluted loss per common share because all such securities are anti-dilutive for all applicable
periods presented. These outstanding securities consist of the following potential common shares:
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|
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|
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Outstanding at September 30, |
|
|
|
2006 |
|
|
2005 |
|
Outstanding options |
|
|
8,989,671 |
|
|
|
6,641,401 |
|
Outstanding warrants |
|
|
1,930,658 |
|
|
|
3,341,212 |
|
|
|
|
|
|
|
|
Total |
|
|
10,920,329 |
|
|
|
9,982,613 |
|
|
|
|
|
|
|
|
Stock-Based Compensation
In December 2004, the Financial Accounting Standards Board (FASB) issued SFAS 123R. SFAS 123R
requires all share-based payments to employees, or to non-employee directors as compensation for
service on the Board of Directors, to be recognized as compensation expense in the consolidated
financial statements based on the fair values of such payments. The Company maintains shareholder
approved stock-based compensation plans, pursuant to which it grants stock-based compensation to
its employees, and to non-employee directors for Board service. These grants are primarily in the
form of options that allow a grantee to purchase a fixed number of shares of the Companys common
stock at a fixed exercise price equal to the market price of the shares at the date of the grant
(qualified stock option grants). The options may vest on a single date or in tranches over a
period of time,
7
but normally they do not vest unless the grantee is still employed by or a director of the Company
on the vesting date. The compensation expense for these grants will be recognized over the
requisite service period which is typically the period over which the stock-based compensation
awards vest. The Company made no modifications to outstanding options with respect to vesting
periods or exercise prices prior to adopting SFAS 123R. In March 2005, the Securities and Exchange
Commission (SEC) issued Staff Accounting Bulletin No. 107 (SAB 107), which provides guidance on the
implementation of SFAS 123R. The Company applied the principles of SAB 107 in conjunction with its
adoption of SFAS 123R.
The Company adopted SFAS 123R effective January 1, 2006, using the modified-prospective
transition method. Under this transition method, compensation expense will be recognized based on
the grant date fair value estimated in accordance with the provisions of SFAS 123R for all new
grants effective January 1, 2006, and for options granted prior to but not vested as of December
31, 2005. Prior periods were not restated to reflect the impact of adopting the new standard and
therefore do not include compensation expense related to qualified stock option grants for those
periods. In accordance with SFAS 123R, the Company recognized stock option related compensation
expense of approximately $696,000 and $1,604,000 for the three and nine month periods ended
September 30, 2006. All options granted in the three and nine month period ended September 30,
2006 were qualified stock options and the related compensation expense was recognized on a straight
line basis over the vesting period of each grant net of estimated forfeitures. The Companys
estimated forfeiture rates are based on its historical experience within separate groups of
employees. The estimated fair value of the options granted during 2006 and prior years was
calculated using a Black Scholes Merton option pricing model (Black Scholes model). The following
summarizes the assumptions used in the Black Scholes model as applied in the first three quarters
of 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
Second Quarter |
|
Third Quarter |
|
|
2006 |
|
2006 |
|
2006 |
Risk free interest rate(1) |
|
|
4.72 |
% |
|
|
5.08 |
% |
|
|
4.68 |
% |
Volatility(2) |
|
|
119.5 |
% |
|
|
110.8 |
% |
|
|
106.6 |
% |
Dividend yield(3) |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
Expected term (years until
exercise)(4) |
|
|
6.25 |
|
|
|
6.25 |
|
|
|
6.25 |
|
|
|
|
(1) |
|
The risk-free interest rate is based on US Treasury debt securities with
maturities close to the expected term of the option. |
|
(2) |
|
Expected volatility is based on historical volatility of the Companys stock
factoring in daily share price observations. In computing expected volatility, the
length of the historical period used is equal to the length of the expected term of the
option. |
|
(3) |
|
No cash dividends have been declared on the Companys common stock since the
Companys inception, and the Company currently does not anticipate paying cash
dividends over the expected term of the option. |
|
(4) |
|
The expected term is equal to the average of the contractual life of the stock
option and its vesting period. |
At September 30, 2006, approximately $7,310,000 of unrecognized compensation expense related
to stock options is expected to be recognized over a weighted average period of approximately 1.7
years. The resulting effect on net loss and net loss per share attributable to common stockholders
is not likely to be representative of the effects in future periods, due to changes in forfeiture
rates, additional grants and subsequent periods of vesting.
8
Prior to January 1, 2006, the Company accounted for its stock-based compensation plans under
Accounting Principles Board Opinion No. 25 (APB 25), Accounting for Stock Issued to Employees.
In accordance with APB 25, the Company recognized no compensation expense for qualified stock
option grants, as the options were granted at fair market price of the underlying shares on the
date of the grant. For options issued with an exercise price less than the fair market value of the
shares at the date of grant, the Company recognized the difference between the exercise price and
fair market value as compensation expense in accordance with APB 25. Prior to January 1, 2006, the
Company provided pro forma disclosure amounts in accordance with Statement of Financial Accounting
Standards No. 123 Accounting for Stock-Based Compensation, (SFAS 123) as amended by Statement of
Financial Accounting Standards No. 148 Accounting for Stock-Based Compensation Transition and
Disclosure, (SFAS 148). As compensation expense was disclosed but not recognized in periods prior
to January 1, 2006, no cumulative adjustment for forfeitures was recorded in 2006. The following
table illustrates the effect on net loss and net loss per share if the Company had applied the fair
value recognition provisions of SFAS 123 to stock-based employee compensation in the prior three
and nine-month periods ended September 30, 2005:
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
September 30, 2005 |
|
September 30, 2005 |
Net loss as reported |
|
|
($93,693 |
) |
|
|
($7,410,812 |
) |
Add: Stock-based employee/director compensation
expense included in reported net loss |
|
|
|
|
|
|
|
|
Deduct: Total stock-based employee/director
compensation expense under the fair value based method
for all awards |
|
|
(507,833 |
) |
|
|
(746,525 |
) |
Net loss pro forma |
|
|
($601,526 |
) |
|
|
($8,157,337 |
) |
Basic and diluted net loss per share as reported |
|
|
($0.00 |
) |
|
|
($0.12 |
) |
Basic and diluted net loss per share pro forma |
|
|
($0.01 |
) |
|
|
($0.13 |
) |
Shares used in basic and diluted loss per share amounts |
|
|
64,179,563 |
|
|
|
63,226,214 |
|
The Company accounts for stock options granted to non-employees in accordance with SFAS 123
and Emerging Issues Task Force (EITF) 96-18 Accounting For Equity Instruments That Are Issued To
Other Than Employees For Acquiring, Or In Conjunction With Selling, Goods Or Services, and
accordingly, recognizes as expense the estimated fair value of such options as calculated using the
Black Scholes model. The fair value is re-measured at each reporting date during the service
period and is amortized over the vesting period of each option or the recipients contractual
arrangement, if shorter. No stock options were issued to non-employees during the three and nine
month period ending September 30, 2006, other than options granted to non-employee members of the
Board of Directors for service as Board members.
Stock
Appreciation Rights
In July 2006, the Company, pursuant to the 2006 Equity Incentive Plan, granted cash-settled
Stock Appreciation Rights (SARs) to certain employees. The SARs give the holder the right, upon
exercise, to the difference between the price per share of the Companys common stock at the time
of exercise and the exercise price of the SAR. The exercise price of the SARs is equal to the
market price of the Companys common shares at the date of grant. The SARs will vest on the same
schedule as the Companys qualified options issued to employees, i.e., 25% on the first anniversary
of the grant date and then 1/48th every month thereafter. The Company will recognize
compensation expense for the SARs over the requisite service period which is typically the period
over which the awards vest. Since the vesting schedule of the SARs is identical to the vesting
schedule of options granted this period, the Companys fair value calculation of the SARs issued
using the Black Scholes model were based on the same assumptions used in calculating compensation
expense for stock options granted this period. The
9
fair value of the share-based compensation liability for the cost of the requisite service
that has been rendered at the reporting date is re-measured at each reporting date through the date
of settlement. The following table presents the activity of the Companys SARs awards for the nine
month periods ended September 30, 2006 and 2005.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
|
|
|
|
|
|
Weighted |
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Average Exercise |
|
|
|
|
|
Average Exercise |
|
|
SARs |
|
Price |
|
SARs |
|
Price |
|
|
2006 |
|
2005 |
Outstanding at January 1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
1,564,599 |
|
|
$ |
2.00 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canceled |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30 |
|
|
1,564,599 |
|
|
$ |
2.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SARs exercisable at September 30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At September 30, 2006, approximately $2,100,000 of unrecognized compensation expense
related to SARs is expected to be recognized over a weighted average period of approximately 2
years. The resulting effect on net loss and net loss per share attributable to common stockholders
is not likely to be representative of the effects in future periods, due to changes in the fair
value calculation which is dependent on the stock price, volatility, interest and forfeiture rates,
additional grants and subsequent periods of vesting.
Revenue Recognition
Revenues from collaborative agreements and grants are recognized as earned upon either the
incurring of reimbursable expenses directly related to the particular research plan or the
completion of certain development milestones as defined within the terms of the collaborative
agreement. The Company currently recognizes revenues resulting from the licensing and use of our
technology and intellectual property. Such licensing agreements may contain multiple elements,
such as upfront fees, payments related to the achievement of particular milestones and royalties.
Revenue from upfront fees for licensing agreements that contain multiple elements are deferred and
recognized on a straight-line basis over the term of the agreement, fees associated with
substantive at risk performance-based milestones are recognized as revenue upon completion of the
scientific or regulatory event specified in the agreement, and royalties received are recognized as
earned.
Recent Accounting Pronouncements
The Company is currently evaluating the following recent accounting pronouncements:
In June 2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty in Income
Taxesan Interpretation of FASB Statement No. 109 (FIN 48). FIN 48 clarifies the accounting for
uncertainty in income taxes recognized in an entitys financial statements in accordance with SFAS
No. 109, Accounting for Income Taxes, and prescribes a recognition threshold and measurement
attribute for the financial statement recognition and measurement of a tax position taken or
expected to be taken in a tax return. Additionally, FIN 48 provides guidance on subsequent
derecognition of tax positions, financial statement classification, recognition of interest and
penalties, accounting in interim periods, and disclosure and transition requirements. FIN 48 is
effective for the Companys fiscal year beginning January 1, 2007, with early adoption permitted.
The Company is currently evaluating the impact, if any, of the adoption of FIN 48 on its
consolidated financial statements.
In September 2006, the FASB issued FASB Statement No. 157, Fair Value Measurements (SFAS
157), which defines fair value, establishes a framework for measuring fair value under GAAP, and
expands disclosures about fair value measurements. SFAS 157 applies to other accounting
pronouncements that require or permit fair value measurements. The new guidance is effective for
financial statements issued for fiscal years beginning after November 15, 2007, and for interim
periods within those fiscal years. The Company is currently evaluating the
10
requirements of SFAS 157; however, it does not believe that its adoption will have a material
effect on its consolidated financial statements.
In September 2006, the Staff of the SEC issued Staff Accounting Bulletin No. 108, Considering
the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial
Statements (SAB No.108). SAB No. 108 provides guidance on the consideration of the effects of
prior year misstatements in quantifying current year misstatements for the purpose of determining
whether the current years financial statements are materially misstated. SAB No. 108 is effective
for the Companys fiscal year beginning January 1, 2007. The Company is currently evaluating the
requirements of SAB No. 108; however, it does not believe that its adoption will have a material
effect on its consolidated financial statements.
NOTE 2. RENEURON LICENSE AND SETTLEMENT AGREEMENT
In July 2005, the Company entered into a license and settlement agreement with ReNeuron
Limited, a wholly owned subsidiary of ReNeuron Group plc, a publicly listed UK corporation
(collectively referred to as ReNeuron). As part of the agreement, the Company granted ReNeuron a
license that allows ReNeuron to exploit their c-mycER conditionally immortalized adult human
neural stem cell technology for therapy and other purposes. In return for the license, StemCells
received a 7.5% fully-diluted equity interest in ReNeuron, subject to certain anti-dilution
provisions, and a cross-license to the exclusive use of ReNeurons technology for certain diseases
and conditions, including lysosomal storage diseases, spinal cord injury, cerebral palsy and
multiple sclerosis. The agreement also provides for full settlement of any potential claims that
either StemCells or ReNeuron might have had against the other in connection with any putative
infringement of certain of each partys patent rights prior to the effective date of the agreement.
The agreement is Exhibit 10.71 to the Companys Quarterly Report on Form 10-Q for the quarter
ended June 30, 2005. An amendment to the agreement was entered on April 3, 2006, a copy of which
was attached as Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q for the quarter ended
March 31, 2006. On June 29, 2006, ReNeuron issued additional shares of common stock, of which
StemCells was entitled to 439,071 shares because of the anti-dilution provisions within the
agreement and net of shares due to Neurospheres Ltd., an Alberta corporation from which StemCells
has licensed some of the patent rights that are the subject of the agreement with ReNeuron. The
Company recorded approximately $103,000 as other income for the additional shares. The fair market
value of the Companys holdings in ReNeuron common stock as of December 31, 2005 (8,835,766 shares)
and September 30, 2006 (9,274,837 shares) was approximately $3,721,000 and $1,042,000 respectively.
Changes in market value as a result of changes in market price per share or the exchange rate
between the US dollar and the British pound are accounted for under other comprehensive loss if
deemed temporary, as in this case, and are not recorded as other income or loss until the shares
are disposed of and a gain or loss realized. The unrealized loss as of September 30, 2006, is
approximately $3,037,000. A decline in the fair value of securities that is deemed other than
temporary would be charged to earnings.
NOTE 3. LEASES
The Company had undertaken direct financing transactions with the State of Rhode Island
and received proceeds from the issuance of industrial revenue bonds totaling $5,000,000 to finance
the construction of a pilot manufacturing facility related to its former encapsulated cell
technology. The related leases are structured such that lease payments will fully fund all
semiannual interest payments and annual principal payments through maturity in August 2014.
Interest rates vary with the respective bonds maturities, ranging currently from 8.1% to 9.5%.
The outstanding principal at September 30, 2006 was approximately $1,416,000. The bonds contain
certain restrictive covenants, which limit among other things, the payment of cash dividends and
the sale of the related assets.
The Company entered into a fifteen-year lease for a laboratory facility in connection with a
sale and leaseback arrangement in 1997. The lease has escalating rent payments and accordingly,
the Company is recognizing rent expense on a straight-line basis. At December 31, 2005 and
September 30, 2006, the Company had deferred rent liability for this facility of approximately
$1,208,000 and $1,231,000 respectively; the deferred rent liability is presented as part of the
wind-down accrual.
11
Although the Company previously discontinued activities relating to encapsulated cell
technology, the Company remains obligated under the leases for the pilot manufacturing facility and
the laboratory facility. The Company has succeeded in subleasing the pilot manufacturing facility
and part of the laboratory facility. The aggregate income received by the Company is significantly
less than the Companys aggregate obligations under the leases, and the Companys continued receipt
of rental income is dependent on the financial ability of the occupants to comply with their
obligations under the subleases. The Company continues to seek to sublet the vacant portions of
the Rhode Island facilities, to assign or sell its interests in all of these properties, or to
otherwise arrange for the termination of its obligations under the lease obligations on these
facilities. There can be no assurance, however, that the Company will be able to dispose of these
properties in a reasonable time, if at all, or to terminate its lease obligations without the
payment of substantial consideration
As of February 1, 2001, the Company entered into a 5-year lease for 40,000 square feet of an
approximately 68,000 square foot facility located in the Stanford Research Park in Palo Alto, CA.
The facility includes space for animals, laboratories and offices. On December 19, 2002 the
Company negotiated an amendment to the lease, which resulted in reducing the average annual rent
over the remaining term of the lease from approximately $3.7 million to $2.0 million. As part of
the amendment the Company issued a letter of credit on January 2, 2003 for $503,079, which was an
addition to the letter of credit in the amount of $275,000 issued at commencement of the lease, to
serve as a deposit for the duration of the lease. The Company negotiated an amendment to the lease
effective April 1, 2005, which extends the term of the lease through March 31, 2010, includes an
immediate reduction in the rent per square foot, and provides for an expansion of the leased
premises by approximately 28,000 additional square feet effective July 1, 2006. In addition, the
Company sublet some of the additional space for the period from April 1, 2005 through June 30,
2006. The average annual rent due from the Company under its lease for the period commencing April
1, 2005 to March 31, 2010 is approximately $2 million before subtenant income. The lease has
escalating rent payments, which the Company is recognizing on a straight-line basis. At September
30, 2006, the Company had deferred rent liability for this facility of approximately $1,007,000.
At September 30, 2006 the Company has a space-sharing agreement covering in total approximately
11,000 square feet of this facility. The Company receives the amount of base rent plus the
proportionate share of the operating expenses that it pays for such space over the term of these
agreements.
NOTE 4. RELOCATION TO CALIFORNIA FROM RHODE ISLAND
In October 1999, the Company relocated to California from Rhode Island and established a wind
down reserve for the estimated lease payments and operating costs of the Rhode Island facilities
through an expected disposal date of June 30, 2000. The Company did not fully sublet the Rhode
Island facilities in 2000. Even though the Company intends to dispose of the facility at the
earliest possible time, the Companys management cannot determine with certainty a fixed date by
which such disposal will occur. In light of this uncertainty, the Company periodically
re-evaluates and adjusts the reserve. The Company considers various factors such as the Companys
lease payments through to the end of the lease, operating expenses, the current real estate market
in Rhode Island, and estimated subtenant income based on actual and projected occupancy. At
December 31, 2005 the reserve was approximately $6,098,000. For the three and nine-month period
ended September 30, 2006, the Company incurred approximately $368,000 and $950,000 respectively in
operating expenses, which was recorded against the reserve. After evaluating the afore-mentioned
factors the Company re-valued the reserve to $5,647,000 at September 30, 2006 by recording an
additional $156,000, $175,100 and $168,000 at March 31, 2006, June 30, 2006 and September 30, 2006
respectively, as wind-down expenses.
Wind-down reserve
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
July to |
|
January to |
|
January to |
|
|
January to |
|
April to June |
|
September |
|
September 30, |
|
December 31, |
|
|
March 31, 2006 |
|
30, 2006 |
|
30, 2006 |
|
2006 |
|
2005 |
|
|
|
Accrued wind-down
reserve at beginning
of period |
|
$ |
6,098,000 |
|
|
|
5,970,000 |
|
|
|
5,847,000 |
|
|
$ |
6,098,000 |
|
|
$ |
4,350,000 |
|
Less actual expenses
recorded against
estimated reserve
during the period |
|
|
(284,000 |
) |
|
|
(298,000 |
) |
|
|
(368,000 |
) |
|
|
(950,000 |
) |
|
|
(1,079,000 |
) |
12
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
July to |
|
January to |
|
January to |
|
|
January to |
|
April to June |
|
September |
|
September 30, |
|
December 31, |
|
|
March 31, 2006 |
|
30, 2006 |
|
30, 2006 |
|
2006 |
|
2005 |
|
|
|
Additional expense
recorded to revise
estimated reserve at
period-end |
|
|
156,000 |
|
|
|
175,000 |
|
|
|
168,000 |
|
|
|
499,000 |
|
|
|
2,827,000 |
|
|
|
|
Revised reserve at
period-end |
|
|
5,970,000 |
|
|
|
5,847,000 |
|
|
|
5,647,000 |
|
|
|
5,647,000 |
|
|
|
6,098,000 |
|
Add deferred rent at
period end (See Note
3) |
|
|
1,215,000 |
|
|
|
1,223,000 |
|
|
|
1,230,000 |
|
|
|
1,230,000 |
|
|
|
1,208,000 |
|
|
|
|
Total accrued
wind-down expenses at
period-end (current
and non current
portion) |
|
$ |
7,185,000 |
|
|
$ |
7,070,000 |
|
|
$ |
6,877,000 |
|
|
$ |
6,877,000 |
|
|
$ |
7,306,000 |
|
|
|
|
Accrued wind-down
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current portion |
|
$ |
1,182,000 |
|
|
$ |
1,255,000 |
|
|
$ |
950,000 |
|
|
$ |
950,000 |
|
|
$ |
1,119,000 |
|
|
|
|
Non current portion |
|
|
6,003,000 |
|
|
|
5,815,000 |
|
|
|
5,927,000 |
|
|
|
5,927,000 |
|
|
|
6,187,000 |
|
|
|
|
Total Accrued
wind-down expenses |
|
$ |
7,185,000 |
|
|
$ |
7,070,000 |
|
|
$ |
6,877,000 |
|
|
$ |
6,877,000 |
|
|
$ |
7,306,000 |
|
|
|
|
NOTE 5. GRANTS
In September 2004, the National Institutes of Health (NIH) awarded the Company a Small
Business Technology Transfer grant of $464,000 for studies in Alzheimers disease, consisting of
approximately $308,000 for the first year and approximately $156,000 for the remainder of the grant
term, September 30, 2005 through March 31, 2006. The studies have been conducted by Dr. George A.
Carlson of the McLaughlin Research Institute (MRI) in Great Falls, Montana, which will receive
approximately $222,000 of the total award. The remaining $242,000 has been recognized by the
Company as grant revenue as and when resources were expended for this study. For the nine month
period ended September 30, 2006, the Company recognized approximately $38,000; the Company has now
drawn down in full its share of the grant.
NOTE 6. STOCKHOLDERS EQUITY
In March 2006, a warrant issued as part of the June 16, 2004 financing arrangement was
exercised to purchase an aggregate of 526,400 shares of the Companys common stock at $1.89 per
share. The Company issued 526,400 shares of its common stock and received proceeds of
approximately $995,000. On April 6, 2006, the Company sold 11,750,820 shares of its common stock
to a limited number of institutional investors at a price of $3.05 per share, for gross proceeds of
approximately $35,840,000. The shares were offered as a registered direct placement under the
Companys effective shelf registration statement previously filed with the Securities and Exchange
Commission. For the three and nine month period ended September 30, 2006, the Company issued
22,346 and 126,278 shares from activity related to its stock option plans. The following table
presents the activity of the Companys stock option plans for the nine month periods ended
September 30, 2006 and 2005.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
|
|
|
|
|
|
Weighted |
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Average Exercise |
|
|
|
|
|
Average Exercise |
|
|
Options |
|
Price |
|
Options |
|
Price |
|
|
2006 |
|
2005 |
Outstanding at January 1 |
|
|
6,608,109 |
|
|
$ |
3.02 |
|
|
|
6,682,201 |
|
|
$ |
2.67 |
|
Granted |
|
|
2,755,684 |
|
|
$ |
2.37 |
|
|
|
963,057 |
|
|
$ |
4.84 |
|
Exercised |
|
|
(126,278 |
) |
|
$ |
1.95 |
|
|
|
(278,273 |
) |
|
$ |
1.26 |
|
Canceled |
|
|
(247,844 |
) |
|
$ |
2.48 |
|
|
|
(725,584 |
) |
|
$ |
3.11 |
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30 |
|
|
8,989,671 |
|
|
$ |
2.85 |
|
|
|
6,641,401 |
|
|
$ |
3.00 |
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at September 30 |
|
|
4,885,216 |
|
|
$ |
3.02 |
|
|
|
4,204,398 |
|
|
$ |
3.09 |
|
|
|
|
|
|
|
|
|
|
|
|
13
Stock Issued for Technology Licenses
Pursuant to the terms of a license agreement, the Company in August 2006 issued 3,848 shares
of common stock with a market value of $10,000 to Cal Tech, in payment of annual fees of $5,000
due on each of two patents licensed to StemCells. The fees are payable in cash or stock at the
Companys option, and the Company elected to pay them in stock.
14
|
|
|
ITEM 2. |
|
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
The following discussion of our financial condition and the results of our operations for
the three and nine month periods ended September 30, 2006 and 2005 should be read in conjunction
with the accompanying unaudited condensed consolidated financial statements and the related
footnotes thereto.
This report contains forward looking statements within the meaning of Section 27A of the
Securities Act and Section 21E of the Securities Exchange Act that involve substantial risks and
uncertainties. Such statements include, without limitation, all statements as to expectation or
belief and statements as to our future results of operations, the progress of our research, product
development and clinical programs, the need for, and timing of, additional capital and capital
expenditures, partnering prospects, costs of manufacture of products, the protection of and the
need for additional intellectual property rights, effects of regulations, the need for additional
facilities and potential market opportunities. Our actual results may vary materially from those
contained in such forward-looking statements because of risks to which we are subject, including
uncertainty as to whether the U.S. Food and Drug Administration (FDA) will permit us to proceed
with clinical testing of proposed products despite the novel and unproven nature of our technology;
the risk that our initial clinical trial could be substantially delayed beyond its expected dates
or cause us to incur substantial unanticipated costs; uncertainties regarding our ability to obtain
the capital resources needed to continue our current research and development operations and to
conduct the research, preclinical development and clinical trials necessary for regulatory
approvals; the uncertainty regarding our ability to obtain a corporate partner or partners if
needed to support the development and commercialization of our cell-based therapeutics programs;
the uncertainty regarding the outcome of the Companys Phase I clinical trial in NCL and any other
trials we may conduct in the future; the uncertainty regarding the validity and enforceability of
our issued patents; the uncertainty whether any products that may be generated in our cell-based
therapeutics programs will prove clinically effective and not cause tumors or other side effects;
the uncertainty whether we will achieve revenues from product sales or become profitable;
uncertainties regarding our obligations in regard to our former encapsulated cell therapy
facilities in Rhode Island; obsolescence of our technology; competition from third parties;
intellectual property rights of third parties; litigation and other risks to which we are subject.
All forward-looking statements attributable to us or to persons acting on our behalf are expressly
qualified in their entirety by the cautionary statements and risk factors set forth in Item 1A
(Risk Factors) and elsewhere in our Form 10-K for the year ended December 31, 2005 and the risk
factors set forth in Part II, Item 1A (Risk Factors) and elsewhere in this Form 10-Q.
Overview
Since our inception in 1988, we have been primarily engaged in research and development
of human therapeutic products. Since the second half of 1999, our sole focus has been on our stem
cell technology. In March 2006, we initiated a Phase I clinical trial of our human neural stem
cells as a treatment for the infantile and late infantile forms of neuronal ceroid lipofuscinosis
(NCL) at Doernbecher Childrens Hospital at Oregon Health & Science University (OHSU) in Portland,
Oregon. NCL, which is often referred to as Batten disease, is a rare, fatal neurodegenerative
disease afflicting infants and young children. We expect to dose the first patient in this trial
later this year.
We have not derived any revenues from the sale of any products apart from license revenue for
the research use of our human neural stem cells and other patented cells and media, and we do not
expect to receive revenues from product sales for at least several years. We have not
commercialized any product and in order to do so we must, among other things, substantially
increase our research and development expenditures as research and product development efforts
accelerate and clinical trials are initiated. We incurred significant costs for toxicology and
other studies in preparation for submitting the NCL IND to, and getting it cleared by, the FDA, and
will incur more such costs for any future INDs. We have incurred annual operating losses since
inception and expect to incur substantial operating losses in the future. As a result, we are
dependent upon external financing from equity and debt offerings and revenues from collaborative
research arrangements with corporate partners to finance our operations. There are no such
collaborative research arrangements at this time and there can be no assurance that financing or
partnering revenues will be available when needed or on terms acceptable to us.
15
Our results of operations have varied significantly from year to year and quarter to quarter
and may vary significantly in the future due to the occurrence of material recurring and
nonrecurring events, including without limitation the receipt and payment of recurring and
nonrecurring licensing payments, the initiation or termination of research collaborations, the
on-going expenses of leasing and maintaining our facilities in Rhode Island and the increasing
costs associated with our facility in California. To expand and support our Research and
Development programs, we will need to hire more personnel, which will lead to higher operating
expenses.
Our program in neural stem and progenitor cells includes preclinical research and development
directed toward a range of target diseases and conditions as well as the NCL clinical trial
described above. In our liver cell program, we are engaged in evaluating our proprietary human
liver engrafting cell in various in vivo assays. We plan to advance our liver cell program into
product development as rapidly as we can. Our pancreas program is still in the discovery stage and
further evaluation of the therapeutic potential of the candidate human pancreatic stem/progenitor
cell will be required.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
We believe the following critical accounting policies affect our more significant judgments
and estimates used in the preparation of our consolidated financial statements:
Use of Estimates
The preparation of consolidated financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make estimates and
assumptions that affect the amounts reported in the consolidated financial statements. Actual
results could differ from these estimates. The significant estimates include the accrued wind-down
expenses related to our Rhode Island facilities and the grant date fair value of share based awards
recognized as compensation expense in accordance with the provisions of SFAS 123R.
Stock-Based Compensation
In December 2004, FASB issued SFAS 123R Share-Based Payment, which is a revision of SFAS 123
Accounting for Stock-Based Compensation and amends SFAS No. 95 Statement of Cash Flows. SFAS
123R supersedes APB Opinion No. 25 Accounting for Stock Issued to Employees and its related
implementation guidance. SFAS 123R covers a wide range of share-based compensation arrangements
including stock options, restricted share plans, performance-based awards, share appreciation
rights, and employee share purchase plans. The new standard is effective as of the beginning of
the first interim or annual reporting period that begins after December 15, 2005. We adopted SFAS
123R effective January 1, 2006. Adoption of the expensing requirements will reduce our reported
earnings.
Research and Development Costs
We expense all research and development costs as incurred. Research and development costs
include costs of personnel, external services, supplies, facilities and miscellaneous other costs.
Wind-down and Exit Costs
In connection with the wind-down of our former encapsulated cell technology operations, our
research and manufacturing operations in Lincoln, Rhode Island, and the relocation of our remaining
research and development activities and corporate headquarters to California in October 1999, we
provided a reserve for our estimate of the exit cost obligation in accordance with EITF 94-3 Other
Cost to Exit an Activity. The reserve reflects estimates of the ongoing costs of our former
research and administrative facility in Lincoln, which we hold on a lease that terminates on June
30, 2013. We are seeking to sublease, assign, sell or otherwise divest ourselves of our interest
in the facility at the earliest possible time, but we cannot determine with certainty a fixed date
by which such events will occur, if at all.
In determining the facility exit cost reserve amount, we are required to consider the
Companys lease payments through to the end of the lease term and estimate other relevant factors
such as facility operating expenses, real estate market conditions in Rhode Island for similar
facilities, occupancy rates and sublease rental rates
16
projected over the course of the leasehold. We re-evaluate the estimate each quarter, taking
account of changes, if any, in each underlying factor. The process is inherently subjective
because it involves projections over time from the date of the estimate through the end of the
lease and it is not possible to determine any of the factors except the lease payments with
certainty over that period.
Management forms its best estimate on a quarterly basis, after considering actual sublease
activity, reports from our broker/realtor about current and predicted real estate market conditions
in Rhode Island, the likelihood of new subleases in the foreseeable future for the specific
facility and significant changes in the actual or projected operating expenses of the property. We
discount the projected net outflow over the term of the leasehold to arrive at the present value,
and adjust the reserve to that figure. The estimated vacancy rate for the facility is an important
assumption in determining the reserve because changes in this assumption have the greatest effect
on estimated sublease income. In addition, the vacancy rate estimate is the variable most subject
to change, while at the same time it involves the greatest judgment and uncertainty due to the
absence of highly predictive information concerning the future of the local economy and future
demand for specialized laboratory and office space in that area. The average vacancy rate of the
facility for years 2001 through 2005 was approximately 64%, varying from 49% to 80%. As of
September 30, 2006, based on current information available to management, the vacancy rate is
projected to be 91% for the remainder of 2006, 84% for 2007, and approximately 70% from 2008
through the end of the lease. These estimates are based on actual occupancy in 2006, expiration of
subleases in 2006 and 2008, predicted lead time for acquiring new subtenants, historical vacancy
rates for the area and assessments by our broker/realtor of future real estate market conditions.
If the assumed vacancy rate for 2008 to the end of the Lease had been five percentage points higher
or lower at September 30, 2006, then the reserve would have increased or decreased by approximately
$235,000. Similarly, a 5% increase or decrease in the operating expenses for the facility from
2006 would have increased or decreased the reserve by approximately $120,000, and a 5% increase or
decrease in the assumed average rental charge per square foot would have increased or decreased the
reserve by approximately $68,000. Management does not wait for specific events to change its
estimate, but instead uses its best efforts to anticipate them on a quarterly basis.
The wind-down reserve at the end of December 31, 2005 was $6,098,000. For the three and
nine-month period ended September 30, 2006, we recorded actual expenses against this reserve of
approximately $368,000 and $950,000 respectively. Based on managements evaluation of the factors
mentioned, and particularly the projected vacancy rates described above, we adjusted the reserve to
$5,647,000 by recording an additional $499,000 for the nine month period ended September 30, 2006.
See Note 4 for a breakdown of these figures by quarter.
RESULTS OF OPERATIONS
Three months ended September 30, 2006 and 2005
Revenue
Revenue in the third quarter of 2006, as compared with the same quarter in 2005, is summarized
in the table below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
|
Change from previous year |
|
|
|
|
|
|
|
|
|
|
$ |
|
% |
|
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from
grants and
licensing
agreements |
|
$ |
18,321 |
|
|
$ |
91,255 |
|
|
|
($72,934 |
) |
|
|
(80 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
18,321 |
|
|
$ |
91,255 |
|
|
|
($72,934 |
) |
|
|
(80 |
%) |
For the three months ended September 30, 2006 and 2005, revenue from grants and licensing
agreements totaled approximately $18,000 and $91,000 respectively. The decrease in revenue from
2005 to 2006 was primarily attributable to the completed draw down by March 31, 2006 of a September
2004 Small Business Technology Transfer grant for studies in Alzheimers disease. The grant of
$464,000 for studies in Alzheimers disease consisted of approximately $308,000 for the first year
and approximately $156,000 for the remainder of the grant term, September 30, 2005 through March
31, 2006.
17
Operating Expenses
Operating expenses in the third quarter of 2006, as compared with the same quarter in 2005, is
summarized in the table below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
|
Change from previous year |
|
|
|
|
|
|
|
|
|
|
$ |
|
% |
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
3,523,078 |
|
|
$ |
2,336,562 |
|
|
$ |
1,186,516 |
|
|
|
51 |
% |
General and administrative |
|
|
1,889,512 |
|
|
|
1,549,443 |
|
|
|
340,069 |
|
|
|
22 |
% |
Wind-down expenses |
|
|
168,168 |
|
|
|
297,184 |
|
|
|
(129,016 |
) |
|
|
(43 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
$ |
5,580,758 |
|
|
$ |
4,183,189 |
|
|
$ |
1,397,569 |
|
|
|
33 |
% |
Research and development expenses totaled approximately $3,523,000 for the three months ended
September 30, 2006, compared with approximately $2,336,000 for the same period in 2005. The
increase of $1,187,000, or approximately 51%, from 2005 to 2006 was primarily attributable to
expansion of our operations in cell processing and clinical development, which consisted of an
increase in personnel costs of approximately $655,000 and an increase in external services of
approximately $267,000 with the remainder due to increases in supplies, rent and other operating
expenses. Of the approximately $655,000 increase in personnel costs, approximately $281,000 was
attributable to the expensing of stock based compensation as required by the new accounting
pronouncement SFAS 123R (see Stock Based Compensation under Note 1 above), with the balance
attributable to an increase in head count. At September 30, 2006, we had 37 full-time employees
working in research and development and laboratory support services as compared to 32 at September
30, 2005.
General and administrative expenses were approximately $1,889,000 for the three months ended
September 30, 2006, compared with approximately $1,549,000 for the same period in 2005. The
increase of $340,000, or approximately 22%, from 2005 to 2006 was primarily attributable to an
increase in personnel costs of approximately $527,000, of which approximately $411,000 was
attributable to the expensing of stock based compensation as required by the new accounting
pronouncement SFAS 123R (see Stock Based Compensation under Note 1 above) with the balance
attributable to an increase in head count. The increase in personnel costs was partially offset by
a net decrease in other costs primarily attributable to the expensing of the fair value of options
granted to a consultant in 2005 and a decrease in listing fees in 2006 as compared to 2005. The
listing fees were higher in 2005 than in 2006, primarily due to the initial cost of moving our
shares in 2005 from the Nasdaq Capital Market to the Nasdaq Global Market.
In 1999, in connection with exiting our former research facility in Rhode Island, we created a
reserve for the estimated lease payments and operating expenses related to it. The reserve has
been re-evaluated and adjusted based on assumptions relevant to real estate market conditions and
the estimated time until we could either fully sublease, assign or sell our remaining interests in
the property. At June 30, 2006, the reserve was approximately $5,847,000. For the three months
ended September 30, 2006, expenses of $368,000 net of subtenant income were recorded against this
reserve (see Note 4 for a breakdown of these figures by quarter). At September 30, 2006, we
re-evaluated the estimate and adjusted the reserve to approximately $5,647,000 by recording an
additional $168,000 as wind-down expenses. Wind-down expenses recorded for the same period in 2006
were approximately $297,000. Expenses for this facility will fluctuate based on changes in tenant
occupancy rates and other operating expenses related to the lease. Even though it is our intent to
sublease, assign, sell or otherwise divest ourselves of our interests in the facility at the
earliest possible time, we cannot determine with certainty a fixed date by which such events will
occur. In light of this uncertainty, based on estimates, we will periodically re-evaluate and
adjust the reserve, as necessary.
18
Other Income
Other income in the third quarter of 2006, as compared with the same quarter in 2005, is
summarized in the table below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
|
Change from previous year |
|
|
|
|
|
|
|
|
|
|
$ |
|
% |
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License and settlement agreement, net |
|
$ |
|
|
|
$ |
3,747,601 |
|
|
|
($3,747,601 |
) |
|
|
(100 |
)% |
Interest income |
|
|
735,652 |
|
|
|
301,255 |
|
|
|
434,397 |
|
|
|
144 |
% |
Interest expense |
|
|
(34,062 |
) |
|
|
(42,021 |
) |
|
|
7,959 |
|
|
|
(19 |
)% |
Other income (expense) |
|
|
(2,362 |
) |
|
|
(8,594 |
) |
|
|
6,232 |
|
|
|
(73 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense) |
|
$ |
699,228 |
|
|
$ |
3,998,241 |
|
|
|
($3,299,013 |
) |
|
|
(83 |
)% |
The license and settlement agreement in 2005 was a one-time event resulting in income in the
form of stock in ReNeuron, our licensee.
Interest income for the three months ended September 30, 2006 and 2005 was approximately
$736,000 and $301,000, respectively. The increase in interest income in 2006 was primarily
attributable to a higher yield on a higher investment balance.
Interest expense for the three months ended September 30, 2006 and 2005 was approximately
$34,000 and $42,000 respectively. The decrease in interest expense in 2006 was attributable to
lower outstanding debt and capital lease balances in 2006 compared to 2005. Other income (expense)
includes state franchise tax paid and gain or loss on disposal of equipment.
Nine months ended September 30, 2006 and 2005
Revenue
Revenue for the nine months ended September 30, 2006, as compared with the same period in
2005, is summarized in the table below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
|
Change from previous year |
|
|
|
|
|
|
|
|
|
|
$ |
|
% |
|
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from grants |
|
$ |
80,406 |
|
|
$ |
163,345 |
|
|
|
($82,939 |
) |
|
|
(51 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
80,406 |
|
|
$ |
163,345 |
|
|
|
($82,939 |
) |
|
|
(51 |
)% |
For the nine months ended September 30, 2006 and 2005, revenue from grants and licensing
agreements totaled approximately $80,000 and $163,000 respectively. The decrease in revenue from
2005 to 2006 was primarily attributable to the completed draw down by March 31, 2006 of a September
2004 Small Business Technology Transfer grant for studies in Alzheimers disease. The grant of
$464,000 for studies in Alzheimers disease consisted of approximately $308,000 for the first year
and approximately $156,000 for the remainder of the grant term, September 30, 2005 through March
31, 2006.
19
Operating Expenses
Operating expenses for the nine months ended September 30, 2006, as compared with the same
period in 2005, is summarized in the table below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
|
Change from previous year |
|
|
|
|
|
|
|
|
|
|
$ |
|
% |
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
9,402,472 |
|
|
$ |
5,924,591 |
|
|
$ |
3,477,881 |
|
|
|
59 |
% |
General and administrative |
|
|
4,979,349 |
|
|
|
4,009,187 |
|
|
|
970,162 |
|
|
|
24 |
% |
Wind-down expenses |
|
|
499,186 |
|
|
|
2,015,384 |
|
|
|
(1,516,198 |
) |
|
|
(75 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
$ |
14,881,007 |
|
|
$ |
11,949,162 |
|
|
$ |
2,931,845 |
|
|
|
25 |
% |
Research and development expenses totaled approximately $9,402,000 for the nine months ended
September 30, 2006, compared with approximately $5,924,000 for the same period in 2005. The
increase of $3,477,000, or approximately 59%, from 2005 to 2006 was primarily attributable to
expansion of our operations in cell processing and clinical development, which consisted of an
increase in personnel costs of approximately $1,782,000 and an increase in external services of
approximately $814,000, with the remainder attributable to increases in supplies, rent and other
operating expenses. Of the approximately $1,782,000 increase in personnel costs, approximately
$734,000 was attributable to the expensing of stock based compensation as required by the new
accounting pronouncement SFAS 123R (see Stock Based Compensation under Note 1 above), with the
balance attributable to an increase in head count. At September 30, 2006, we had 37 full-time
employees working in research and development and laboratory support services as compared to 32 at
September 30, 2005.
General and administrative expenses were approximately $4,979,000 for the nine months ended
September 30, 2006, compared with approximately $4,009,000 for the same period in 2005. The
increase of $970,000, or approximately 24%, from 2005 to 2006 was primarily attributable to an
increase in personnel costs of approximately $1,240,000, of which approximately $870,000 was
attributable to the expensing of stock based compensation as required by the new accounting
pronouncement SFAS 123R (see Stock Based Compensation under Note 1 above) with the balance
attributable to an increase in head count. The increase in personnel costs was partially offset by
a net decrease in other costs primarily attributable to the expensing of the fair value of options
granted to a consultant in 2005 and a decrease in listing fees in 2006 as compared to 2005. The
listing fees were higher in 2005 than in 2006, primarily due to the initial cost of moving our
shares in 2005 from the Nasdaq Capital Market to the Nasdaq Global Market.
In 1999, in connection with exiting our former research facility in Rhode Island, we created a
reserve for the estimated lease payments and operating expenses related to it. The reserve has
been re-evaluated and adjusted based on assumptions relevant to real estate market conditions and
the estimated time until we could either fully sublease, assign or sell our remaining interests in
the property. At December 31, 2005 the reserve was approximately $6,098,000. At September 30,
2006 we re-evaluated the estimate and adjusted the reserve to approximately $5,647,000 by recording
an additional $499,000 (which includes the March 31 and June 30, 2006 adjustment of $156,000 and
$175,000 respectively) as wind-down expenses (see Note 4 for a breakdown of these figures by
quarter). Wind-down expenses recorded for the same period in 2005 were $2,015,000. Expenses for
this facility will fluctuate based on changes in tenant occupancy rates and other operating
expenses related to the lease. Even though it is our intent to sublease, assign, sell or otherwise
divest ourselves of our interests in the facility at the earliest possible time, we cannot
determine with certainty a fixed date by which such events will occur. In light of this
uncertainty, based on estimates, we will periodically re-evaluate and adjust the reserve, as
necessary.
Other Income
Other income for the nine months ended September 30, 2006, as compared with the same period in
2005, is summarized in the table below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
|
Change from previous year |
|
|
|
|
|
|
|
|
|
|
$ |
|
% |
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License and settlement agreement, net |
|
$ |
103,359 |
|
|
$ |
3,747,601 |
|
|
|
($3,644,242 |
) |
|
|
(97 |
)% |
Interest income |
|
|
1,779,016 |
|
|
|
790,407 |
|
|
|
988,609 |
|
|
|
125 |
% |
Interest expense |
|
|
(111,159 |
) |
|
|
(133,777 |
) |
|
|
22,618 |
|
|
|
(17 |
)% |
Other income (expense) |
|
|
(16,309 |
) |
|
|
(29,226 |
) |
|
|
12,917 |
|
|
|
(44 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense) |
|
$ |
1,754,907 |
|
|
$ |
4,375,005 |
|
|
|
($2,620,098 |
) |
|
|
(60 |
%) |
20
For the nine months ended September 30, 2006, as part of a license and settlement agreement
with ReNeuron (see Note 2 for details), we recorded approximately $103,000 as other income for
additional shares of ReNeuron common stock due to us because of an anti-dilution provision in the
agreement.
Interest income for the nine months ended September 30, 2006 and 2005 was approximately
$1,779,000 and $790,000 respectively. The increase in interest income in 2006 was primarily
attributable to a higher yield on a higher investment balance..
Interest expense for the nine months ended September 30, 2006 and 2005 was approximately
$111,000 and $134,000 respectively. The decrease in interest expense in 2006 was attributable to
lower outstanding debt and capital lease balances in 2006 compared to 2005. Other income (expense)
includes state franchise tax paid and gain or loss on acquisition or disposal of equipment.
LIQUIDITY AND CAPITAL RESOURCES
Since our inception, we have financed our operations through the sale of common and preferred
stock, the issuance of long-term debt and capitalized lease obligations, revenues from
collaborative agreements, research grants and interest income.
We had cash and cash equivalents totaling $55,440,550 at September 30, 2006. Cash equivalents
are invested in US Treasury debt securities with maturities of less than 90 days. The table below
summarizes our cash flows for the respective nine month periods.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
|
Change from previous year |
|
|
|
|
|
|
|
|
|
|
$ |
|
% |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
( |
$ |
12,077,200 |
) |
( |
$ |
9,187,544 |
) |
( |
$ |
2,889,656 |
) |
|
|
31 |
% |
Net cash used in investing activities |
|
|
(1,318,929 |
) |
|
|
(776,793 |
) |
|
|
(542,136 |
) |
|
|
70 |
% |
Net cash provided (used) by financing activities |
|
|
34,295,771 |
|
|
|
3,875,389 |
|
|
|
30,420,382 |
|
|
|
785 |
% |
|
|
|
Increase (decrease) in cash and cash equivalents |
|
$ |
20,899,642 |
|
( |
$ |
6,088,948 |
) |
|
$ |
26,988,590 |
|
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
Percentage change cannot be calculated |
The increase from 2005 to 2006 of approximately $2,890,000, or 31%, in cash used in operating
activities was primarily attributable to an increase in personnel costs and external services, and
the increase of $542,000, or 70%, in cash used in investing activities was primarily attributable
to an increase in equipment costs, all resulting from the expansion of our operations in cell
processing and clinical development.
The increase from 2005 to 2006 of $30,420,000 for net cash provided by financing activities
was primarily attributable to the sale on April 6, 2006, of 11,750,820 shares of our common stock
to a limited number of institutional investors at a price of $3.05 per share, for gross proceeds of
approximately $35,840,000. The shares were offered as a registered direct placement under the
Companys effective shelf registration statement previously filed with the U.S. Securities and
Exchange Commission (SEC). We received total proceeds, net of offering expenses and placement
agency fees, of approximately $33,200,000. UBS Investment Bank (UBS) acted as placement agent in
this offering. For acting as our placement agent, UBS received fees of approximately $2,150,000 and
expense reimbursement of approximately $50,000. No warrants were issued as part of this financing
transaction.
21
Other financing arrangements in the previous three years include the following:
|
|
|
On October 26, 2004, we entered into an agreement with institutional investors
with respect to the registered direct placement of 7,500,000 shares of our common
stock at a purchase price of $3.00 per share, for gross proceeds of $22,500,000.
C.E. Unterberg, Towbin LLC (Unterberg) and Shoreline Pacific, LLC (Shoreline)
served as placement agents for the transaction. We sold these shares under a shelf
registration statement previously filed with and declared effective by the SEC.
For acting as our placement agent Unterberg and Shoreline received fees of
approximately $1,350,000 and expense reimbursement of approximately $40,000. No
warrants were issued as part of this financing transaction. |
|
|
|
|
On June 16, 2004, we entered into a definitive agreement with
institutional and other accredited investors with respect to the private placement
of approximately 13,160,000 shares of our common stock at a purchase price of $1.52
per share, for gross proceeds of approximately $20,000,000. Investors also received
warrants exercisable for five years to purchase approximately 3,290,000 shares of
common stock at an exercise price of $1.90 per share. Unterberg served as placement
agent for the transaction. For acting as our placement agent, Unterberg received
fees totaling $1,200,192, expense reimbursement of approximately $25,000 and a five
year warrant to purchase 526,400 shares of our common stock at an exercise price of
$1.89 per share. |
|
|
|
|
On December 10, 2003 we completed a $9.5 million financing transaction with
Riverview Group L.L.C. (Riverview), through the sale of 5,000,000 shares of common
stock at a price of $1.90 per share. The closing price of our common stock on that
date was $2.00 per share. |
|
|
|
|
Pursuant to a Stock Purchase Agreement dated May 7, 2003, we issued
4,000,000 shares of our common stock to Riverview for $6.5 million, or $1.625 per
share. On the date of the agreement, the price was above the trading price of our
common stock, which closed at $1.43 per share on that date. We also agreed to
issue a 2-year warrant to Riverview to purchase 1,898,000 shares of common stock at
$1.50 per share. In November 2003 and May 2005, Riverview exercised this warrant,
resulting in gross proceeds to us of $2,847,000. |
Future Contractual Cash Obligations
We continue to have outstanding obligations in regard to our former facilities in Lincoln,
Rhode Island, and expect to pay in 2006, based on past experience and current assumptions,
approximately $1,100,000 in lease payments and other operating expenses net of sub-tenant income.
We have subleased a portion of these facilities and are actively seeking to sublease, assign or
sell our remaining interests in these facilities. Failure to do so within a reasonable period of
time will have a material adverse effect on our liquidity and capital resources.
The following table summarizes our future contractual cash obligations (including both Rhode
Island and California leases, but excluding interest income and sub-lease income):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
October to |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payable in |
|
|
|
|
|
|
December |
|
Payable in |
|
Payable in |
|
Payable in |
|
Payable in |
|
2011 and |
|
|
Total |
|
2006 |
|
2007 |
|
2008 |
|
2009 |
|
2010 |
|
beyond |
|
|
|
Capital lease
payments |
|
$ |
2,020,694 |
|
|
$ |
99,055 |
|
|
$ |
332,545 |
|
|
$ |
244,531 |
|
|
$ |
244,572 |
|
|
$ |
242,560 |
|
|
$ |
857,431 |
|
Operating lease
payments |
|
|
15,793,226 |
|
|
|
778,728 |
|
|
|
3,165,162 |
|
|
|
3,469,017 |
|
|
|
3,536,843 |
|
|
|
1,767,304 |
|
|
|
3,076,172 |
|
|
|
|
Total contractual
cash obligations |
|
$ |
17,813,920 |
|
|
$ |
877,783 |
|
|
$ |
3,497,707 |
|
|
$ |
3,713,548 |
|
|
$ |
3,781,415 |
|
|
$ |
2,009,864 |
|
|
$ |
3,933,603 |
|
|
|
|
We have incurred significant operating losses and negative cash flows since inception. We
have not achieved profitability and may not be able to realize sufficient revenues to achieve or
sustain profitability in the
22
future. We do not expect to be profitable in the next several years, but rather expect to
incur additional operating losses. We have limited liquidity and capital resources and must obtain
significant additional capital resources in order to sustain our product development efforts, for
acquisition of technologies and intellectual property rights, for preclinical and clinical testing
of our anticipated products, pursuit of regulatory approvals, acquisition of capital equipment,
laboratory and office facilities, establishment of production capabilities, for general and
administrative expenses and other working capital requirements. We rely on cash balances and
proceeds from equity and debt offerings, proceeds from the transfer or sale of our intellectual
property rights, equipment, facilities or investments, and government grants and funding from
collaborative arrangements, if obtainable, to fund our operations.
We intend to pursue opportunities to obtain additional financing in the future through equity
and debt financings, grants and collaborative research arrangements. We have a shelf registration
covering shares of our common stock up to a value of approximately $64 million that could be
available for financings. The source, timing and availability of any future financing will depend
principally upon market conditions, interest rates and, more specifically, on our progress in our
exploratory, preclinical and future clinical development programs. Funding may not be available
when neededat all, or on terms acceptable to us. Lack of necessary funds may require us to
delay, scale back or eliminate some or all of our research and product development programs,
planned clinical trials, and/or our capital expenditures, or to license our potential products or
technologies to third parties.
With the exception of operating leases for facilities, we have not entered into any
off-balance sheet financial arrangements and have not established any special purpose entities. We
have not guaranteed any debts or commitments of other entities or entered into any options on
non-financial assets.
23
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
In July 2005, the Company entered into a license and settlement agreement with ReNeuron.
As part of the agreement, the Company granted ReNeuron a license that allows ReNeuron to exploit
its c-mycER conditionally immortalized adult human neural stem cell technology for therapy and
other purposes. In return for the license, StemCells received a 7.5% fully-diluted equity interest
in ReNeuron, subject to certain anti-dilution provisions, and a cross-license to the exclusive use
of ReNeurons technology for certain diseases and conditions, including lysosomal storage diseases,
spinal cord injury, cerebral palsy and multiple sclerosis. The agreement also provides for full
settlement of any potential claims that either StemCells or ReNeuron might have had against the
other in connection with any putative infringement of certain of each partys patent rights prior
to the effective date of the agreement. The agreement is Exhibit 10.71 to the Companys Quarterly
Report on Form 10-Q for the quarter ended June 30, 2005. An amendment to the agreement was entered
on April 3, 2006, a copy of which was attached as an exhibit to the Companys Quarterly Report on
Form 10-Q for the quarter ended June 30, 2006. On June 29, 2006, ReNeuron issued additional shares
of common stock, of which StemCells was entitled to 439,071 shares because of the anti-dilution
provisions within the agreement and net of shares due to Neurospheres Ltd., an Alberta corporation
from which StemCells has licensed some of the patent rights that are the subject of the agreement
with ReNeuron. The Company recorded approximately $103,000 as other income for the additional
shares. The fair market value of the StemCells holdings in ReNeurons common stock as of December
31, 2005 (8,835,766 shares) and September 30, 2006 (9,274,837 shares) was approximately $3,721,000
and $1,042,000 respectively. Changes in market value as a result of changes in market price per
share or the exchange rate between the US dollar and the British pound are accounted for under
other comprehensive loss if deemed temporary, and are not recorded as other income or loss
until the shares are disposed of and a gain or loss realized. The unrealized loss as of September
30, 2006, is approximately $3,037,000. A decline in the fair value of securities that is deemed
other than temporary would be charged to earnings.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exchange Rate at |
|
Market Value in |
|
Expected |
|
|
|
|
|
|
No. of Shares at |
|
Share price at |
|
September 30, |
|
USD at |
|
Future |
Company/Stock |
|
|
|
|
|
September 30, |
|
September 30, |
|
2006 |
|
September 30, |
|
Cash |
Symbol |
|
Exchange |
|
Associated Risks |
|
2006 |
|
2006 in GBP (£) |
|
1 GBP = USD |
|
2006 |
|
Flows |
ReNeuron Group |
|
AIM (AIM is the |
|
- Lower share price |
|
|
9,274,837 |
|
|
|
0.0600 |
|
|
|
1.8716 |
|
|
$ |
1,041,527 |
|
|
|
(1 |
) |
plc/RENE |
|
London Stock |
|
- Foreign currency |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exchanges |
|
translation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alternative |
|
- Liquidity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment Market) |
|
- Bankruptcy |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
We have not formally adopted a liquidation plan for this investment. Liquidation may be
necessary in the future to meet operating cash flow requirements. Although we are not legally
restricted from selling the stock, the share price is subject to change and the volume traded
has been very small since the stock was listed on the AIM on August 12, 2005. The performance
of ReNeuron Group plc stock since its listing does not predict its future value. |
Other than the above, no significant changes have occurred in our quantitative and qualitative
information about market risks disclosed in our Annual Report on Form 10-K for the fiscal year
ending December 31, 2005.
ITEM 4. CONTROLS AND PROCEDURES
In response to the requirement of the Sarbanes-Oxley Act of 2002, as of the end of the
period covered by this report, our chief executive officer and chief financial officer, along with
other members of management, reviewed the effectiveness of the design and operation of our
disclosure controls and procedures. Such controls and procedures are designed to ensure that
information required to be disclosed in the Companys Exchange Act reports is recorded, processed,
summarized and reported within the time periods specified in the SECs rules and forms, and that
such information is accumulated and communicated to management, including the chief executive
officer and the chief financial officer, as appropriate, to allow timely decisions regarding
required disclosure. Based on this
24
evaluation, the chief executive officer and chief financial officer have concluded that the
Companys disclosure controls and procedures are effective.
During the most recent quarter, there were no changes in internal controls over financial
reporting that occurred during the period covered by this report that have materially affected, or
are reasonably likely to materially affect, these controls of the Company.
PART IIOTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Geron Corporation has opposed two of our European patents that relate to neural stem
cells and their uses, alleging that each patent should be revoked on multiple grounds. The
oppositions were filed with the European Patent Office on December 11, 2003 (Patent No.
EP-B-0594669) and February 13, 2004 (Patent No. EP-B-0669973). We filed responses to both
oppositions on September 23, 2004. Both oppositions were heard in 2005, and the patents were
maintained in somewhat altered form by the Opposition Division of the European Patent Office. The
written opinion was issued on May 24, 2006 in the case concerning Patent No. EP-B-0669973, and the
time for appeal has expired. The written opinion has not yet been issued in the case concerning
Patent No. EP-B-0594669; the time for appeal will begin to run in that case when the Opposition
Division opinion issues; there can be no assurance that Geron will not appeal in this case. While
we are confident that, should the decision be appealed by Geron, it will be upheld, there can be no
guarantee of this. If we were ultimately unsuccessful in our defense of this patent, all claimed
rights in it would be lost in Europe. U.S. counterparts to both of these patents are part of our
issued patent portfolio; they are not subject to opposition, since that procedure does not exist
under U.S. patent law, but other types of proceedings may be available to third parties to contest
our U.S. patents.
In July 2006, we filed suit against Neuralstem, Inc., in the Federal District Court alleging
that its activities violate claims in four of our patents. Neuralstem has filed a motion for
dismissal or summary judgment, citing Title 35, Section 271(e)(1) of the United States Code, which
says that it is not an act of patent infringement to make, use or sell a patented invention solely
for uses reasonably related to the development and submission of information to the FDA.
Neuralstem argues that since it does not have any therapeutic products on the market yet, the
activities complained of fall within the protection of Section 271(e)(1) that is, basically, that
the suit is premature. This issue will be decided after discovery is taken.
ITEM 1A. RISK FACTORS
There have been no material changes from the risk factors disclosed in Part 1, Item 1A,
of our Annual Report on Form 10-K for the fiscal year ending December 31, 2005.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Under terms of a license agreement with Cal Tech, annual fees of $5,000 were due on each
of two patents to which StemCells holds a license from Cal Tech, payable in cash or stock at the
Companys choice. The Company elected to pay the fees in stock and issued 3,848 unregistered
shares to Cal Tech.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None
PART II ITEM 5
OTHER INFORMATION
There were no matters required to be disclosed in a current report on Form 8-K during the
fiscal quarter covered by this report that were not so disclosed.
25
PART II ITEM 6
EXHIBITS
Exhibit 31.1 Certification of Martin McGlynn under Section 302 of the Sarbanes-Oxley Act of 2002
Exhibit 31.2 Certification of Rodney K. B. Young under Section 302 of the Sarbanes-Oxley Act of
2002
Exhibit 32.1 Certification of Martin McGlynn Pursuant to 18 U.S.C. Section 1350, As Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Exhibit 32.2 Certification of Rodney K. B. Young Pursuant to 18 U.S.C. Section 1350, As Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
26
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
|
|
|
|
|
|
|
|
|
|
|
|
STEMCELLS, INC. |
|
|
|
|
(name of Registrant) |
|
|
|
|
|
|
|
October 30, 2006
|
|
/s/ Rodney K. B. Young |
|
|
|
|
|
|
|
|
|
Rodney K. B. Young |
|
|
|
|
Chief Financial Officer |
|
|
27
Exhibit Index
Exhibit 31.1 Certification of Martin McGlynn under Section 302 of the Sarbanes-Oxley Act of 2002
Exhibit 31.2 Certification of Rodney K. B. Young under Section 302 of the Sarbanes-Oxley Act of 2002
Exhibit 32.1 Certification of Martin McGlynn Pursuant to 18 U.S.C. Section 1350, As Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Exhibit 32.2 Certification of Rodney K. B. Young Pursuant to 18 U.S.C. Section 1350, As Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
exv31w1
Exhibit 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
UNDER SECTION 302 OF THE SARBANES-OXLEY ACT
I, Martin McGlynn, certify that:
|
(1) |
|
I have reviewed this quarterly report on Form 10-Q of StemCells, Inc.; |
|
|
(2) |
|
Based on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in light of
the circumstances under which such statements were made, not misleading with respect to the
period covered by this report; |
|
|
(3) |
|
Based on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the registrant as of, and for, the periods
presented in this quarterly report; |
|
|
(4) |
|
The registrants other certifying officer(s) and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) designed such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure that
material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly
during the period in which this report is being prepared;
(b) designed such internal control over financial reporting, or caused such
internal control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial reporting and
the preparation of financial statements for external purposes in accordance with
generally accepted accounting principles;
(c) evaluated the effectiveness of the registrants disclosure controls and
procedures and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period covered by this
report based on such evaluation; and
(d) disclosed in this report any change in the registrants internal control
over financial reporting that occurred during the registrants most recent fiscal
quarter (the registrants fourth fiscal quarter in the case of an annual report)
that has materially affected, or is reasonably likely to materially affect, the
registrants internal control over financial reporting; and
|
(5) |
|
The registrants other certifying officer(s) and I have disclosed, based on our most
recent evaluation of internal control over financial reporting, to the registrants
auditors and the audit committee of the registrants board of directors (or persons
performing the equivalent functions): |
(a) all significant deficiencies and material weaknesses in the design or operation
of internal control over financial reporting which are reasonably likely to
adversely affect the registrants ability to record, process, summarize and report
financial information; and
(b) any fraud, whether or not material, that involves management or other employees
who have a significant role in the registrants internal control over financial
reporting.
Date: October 30, 2006
|
|
|
/s/ Martin McGlynn
Martin McGlynn
|
|
|
President and Chief Executive Officer |
|
|
exv31w2
Exhibit 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER
UNDER SECTION 302 OF THE SARBANES-OXLEY ACT
I, Rodney K. B. Young, certify that:
|
(1) |
|
I have reviewed this quarterly report on Form 10-Q of StemCells, Inc.; |
|
|
(2) |
|
Based on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in light of
the circumstances under which such statements were made, not misleading with respect to the
period covered by this report; |
|
|
(3) |
|
Based on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the registrant as of, and for, the periods
presented in this quarterly report; |
|
|
(4) |
|
The registrants other certifying officer(s) and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) designed such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure that
material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly
during the period in which this report is being prepared;
(b) designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with
generally accepted accounting principles;
(c) evaluated the effectiveness of the registrants disclosure controls and
procedures and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period covered by this
report based on such evaluation; and
(d) disclosed in this report any change in the registrants internal control
over financial reporting that occurred during the registrants most recent fiscal
quarter (the registrants fourth fiscal quarter in the case of an annual report)
that has materially affected, or is reasonably likely to materially affect, the
registrants internal control over financial reporting; and
|
(5) |
|
The registrants other certifying officer(s) and I have disclosed, based on our most
recent evaluation of internal control over financial reporting, to the registrants
auditors and the audit committee of the registrants board of directors (or persons
performing the equivalent functions): |
(a) all significant deficiencies and material weaknesses in the design or operation
of internal control over financial reporting which are reasonably likely to
adversely affect the registrants ability to record, process, summarize and report
financial information; and
(b) any fraud, whether or not material, that involves management or other employees
who have a significant role in the registrants internal control over financial
reporting.
Date: October 30, 2006
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/s/ Rodney K. B. Young
Rodney K. B. Young
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Chief Financial Officer |
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exv32w1
Exhibit 32.1
Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
In connection with the StemCells, Inc. (the Company) Quarterly on Form 10-Q for the period
ending September 30, 2006 as filed with the Securities and Exchange Commission on the date hereof
(the Report), I, Martin McGlynn, President and Chief Executive Officer of the Company, certify
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002, that, to the best of my knowledge:
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(1). The Report fully complies with the requirements of Section 13(a) or 15(d) of
the Securities Exchange Act of 1934, as amended; and |
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(2). The information contained in the Report fairly presents, in all material
respects, the financial condition and results of operations of the Company. |
A signed original of this written statement required by Section 906 has been provided to StemCells,
Inc. and will be retained by StemCells, Inc. and furnished to the Securities and Exchange
Commission or its staff upon request.
Date: October 30, 2006
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/s/ Martin McGlynn
Martin McGlynn
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President and Chief Executive Officer |
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exv32w2
Exhibit 32.2
Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
In connection with the StemCells, Inc. (the Company) Quarterly on Form 10-Q for the period
ending September 30, 2006 as filed with the Securities and Exchange Commission on the date hereof
(the Report), I, Rodney K. B. Young, Chief Financial Officer of the Company, certify pursuant to
18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that,
to the best of my knowledge:
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(1). The Report fully complies with the requirements of Section 13(a) or 15(d) of
the Securities Exchange Act of 1934, as amended; and |
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(2). The information contained in the Report fairly presents, in all material
respects, the financial condition and results of operations of the Company. |
A signed original of this written statement required by Section 906 has been provided to StemCells,
Inc. and will be retained by StemCells, Inc. and furnished to the Securities and Exchange
Commission or its staff upon request.
Date: October 30, 2006
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/s/ Rodney K. B. Young
Rodney K. B. Young
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Chief Financial Officer |
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