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, 2010
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 has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files). Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check one):
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o
(Do not check if a smaller reporting company)
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Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
At
November 1, 2010, there were 127,029,870 shares of Common Stock, $.01 par value, issued and
outstanding.
STEMCELLS, INC.
INDEX
NOTE REGARDING REFERENCES TO US AND OUR COMMON STOCK
Throughout this Form 10-Q, the words we, us, our, and StemCells refer to StemCells, Inc.,
including our directly and indirectly wholly-owned subsidiaries. Common stock refers to the
common stock, $.01 par value, of StemCells, Inc.
2
PART I-FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
STEMCELLS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
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September 30, 2010 |
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December 31, 2009 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
24,554,574 |
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$ |
38,617,977 |
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Marketable securities |
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145,423 |
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196,995 |
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Trade receivables |
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28,954 |
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87,019 |
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Other receivables |
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143,633 |
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679,034 |
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Prepaid assets |
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776,909 |
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560,144 |
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Total current assets |
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25,649,493 |
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40,141,169 |
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Property, plant and equipment, net |
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2,711,838 |
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2,856,695 |
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Other assets, non-current |
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2,491,792 |
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2,525,185 |
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Goodwill |
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1,918,661 |
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2,019,679 |
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Other intangible assets, net |
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3,187,293 |
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3,647,596 |
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Total assets |
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$ |
35,959,077 |
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$ |
51,190,324 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,235,820 |
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$ |
890,582 |
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Accrued expenses and other current liabilities |
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1,691,517 |
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3,760,438 |
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Accrued wind-down expenses, current |
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1,410,677 |
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1,449,810 |
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Deferred revenue, current |
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59,656 |
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119,542 |
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Capital lease obligation, current |
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66,176 |
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68,000 |
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Deferred rent, current |
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80,392 |
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Bonds payable, current |
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172,500 |
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161,250 |
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Total current liabilities |
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4,636,346 |
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6,530,014 |
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Capital lease obligation, non-current |
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35,581 |
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85,826 |
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Bonds payable, non-current |
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568,750 |
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698,750 |
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Fair value of warrant liability |
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4,492,664 |
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9,676,968 |
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Deposits and other long-term liabilities |
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458,032 |
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466,211 |
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Accrued wind-down expenses, non-current |
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2,331,041 |
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3,056,675 |
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Deferred rent, non-current |
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3,579 |
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50,600 |
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Deferred revenue, non-current |
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117,594 |
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130,213 |
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Total liabilities |
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12,643,587 |
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20,695,257 |
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Commitments and contingencies (Note 8) |
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Stockholders equity: |
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Common stock, $0.01 par value; 250,000,000
shares authorized; issued and outstanding
126,969,469 at September 30, 2010 and
118,349,587 at December 31, 2009 |
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1,269,694 |
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1,183,495 |
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Additional paid-in capital |
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324,156,169 |
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314,944,784 |
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Accumulated deficit |
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(302,314,613 |
) |
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(286,027,935 |
) |
Accumulated other comprehensive income |
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204,240 |
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394,723 |
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Total stockholders equity |
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23,315,490 |
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30,495,067 |
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Total liabilities and stockholders equity |
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$ |
35,959,077 |
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$ |
51,190,324 |
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See 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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2010 |
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2009 |
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2010 |
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2009 |
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Revenue: |
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Revenue from licensing agreements and grants |
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$ |
123,693 |
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$ |
98,806 |
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$ |
409,092 |
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$ |
300,260 |
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Revenue from product sales |
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129,826 |
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154,362 |
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318,831 |
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274,961 |
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Total revenue |
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253,519 |
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253,168 |
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727,923 |
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575,221 |
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Cost of product sales |
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35,914 |
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141,453 |
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104,538 |
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200,979 |
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Gross profit |
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217,605 |
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111,715 |
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623,385 |
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374,242 |
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Operating expenses: |
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Research and development |
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5,200,612 |
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4,988,569 |
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15,096,354 |
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14,278,958 |
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Selling, general and administrative |
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2,017,872 |
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2,111,838 |
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6,889,292 |
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6,852,724 |
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Wind-down expenses |
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(5,679 |
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291,168 |
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539,821 |
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Total operating expenses |
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7,218,484 |
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7,094,728 |
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22,276,814 |
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21,671,503 |
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Loss from operations |
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(7,000,879 |
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(6,983,013 |
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(21,653,429 |
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(21,297,261 |
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Other income (expense): |
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Realized gain on sale of marketable securities |
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397,866 |
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Change in fair value of warrant liability |
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1,227,585 |
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1,830,414 |
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5,184,304 |
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(822,517 |
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Interest income |
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10,911 |
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5,531 |
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24,814 |
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55,816 |
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Interest expense |
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(22,221 |
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(27,613 |
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(72,775 |
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(84,863 |
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Other income (expense) |
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232,348 |
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29,940 |
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230,408 |
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(41,694 |
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Total other income (expense), net |
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1,448,623 |
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1,838,272 |
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5,366,751 |
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(495,392 |
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Net loss |
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$ |
(5,552,256 |
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$ |
(5,144,741 |
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$ |
(16,286,678 |
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$ |
(21,792,653 |
) |
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Basic and diluted net loss per share |
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$ |
(0.04 |
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$ |
(0.05 |
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$ |
(0.13 |
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$ |
(0.21 |
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Shares used to compute basic and diluted loss per share |
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127,091,721 |
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108,257,345 |
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122,015,319 |
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103,071,957 |
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See 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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2010 |
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2009 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(16,286,678 |
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$ |
(21,792,653 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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1,169,054 |
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1,220,813 |
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Stock-based compensation |
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2,987,883 |
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3,174,945 |
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Gain on sale of marketable securities |
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(397,866 |
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Gain from settlement agreement, net |
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(226,580 |
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Loss on disposal of fixed assets |
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1,854 |
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Write-down of fixed assets |
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62,807 |
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Write-down of intangible assets |
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35,684 |
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Change in fair value of warrant liability |
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(5,184,304 |
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822,517 |
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Changes in operating assets and liabilities: |
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Other receivables |
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558,709 |
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398,742 |
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Trade receivables |
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54,309 |
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Prepaid and other current assets |
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(209,259 |
) |
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196,778 |
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Other assets, non-current |
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42,482 |
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(269,393 |
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Accounts payable and accrued expenses |
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(1,706,687 |
) |
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(509,958 |
) |
Accrued wind-down expenses |
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(762,474 |
) |
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(775,547 |
) |
Deferred revenue |
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(61,289 |
) |
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(303,027 |
) |
Deferred rent |
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(130,768 |
) |
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(256,715 |
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Net cash used in operating activities |
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(19,655,257 |
) |
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(18,491,364 |
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Cash flows from investing activities: |
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Proceeds from the sale of marketable securities |
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4,510,213 |
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Purchase of marketable securities |
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(4,977,982 |
) |
Payment of advances under notes receivable |
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(79,829 |
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Purchases of property, plant and equipment |
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(766,907 |
) |
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(485,750 |
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Acquisition of other assets |
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(15,000 |
) |
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Net cash used in investing activities |
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(766,907 |
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(1,048,348 |
) |
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Cash flows from financing activities: |
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Proceeds from issuance of common stock, net of issuance costs |
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7,015,322 |
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17,694,812 |
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Proceeds from the exercise of stock options |
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18,936 |
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252,984 |
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Proceeds from the exercise of warrants |
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331,501 |
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Payments related to net share issuance of stock based awards |
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(483,406 |
) |
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(380,548 |
) |
Proceeds from (repayment of) capital lease obligations |
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(52,069 |
) |
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147,825 |
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Repayment of bonds payable |
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(118,750 |
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(110,417 |
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Net cash provided by financing activities |
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6,380,033 |
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17,936,157 |
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Decrease in cash and cash equivalents |
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(14,042,131 |
) |
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(1,603,555 |
) |
Effects of foreign exchange rate changes on cash |
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(21,272 |
) |
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(212,916 |
) |
Cash and cash equivalents, beginning of period |
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38,617,977 |
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30,042,986 |
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Cash and cash equivalents, end of period |
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$ |
24,554,574 |
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$ |
28,226,515 |
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Supplemental disclosure of cash flow information: |
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Interest paid |
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$ |
72,775 |
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$ |
84,863 |
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Supplemental schedule of non-cash investing and financing activities: |
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Stock issued as part of our acquisition of the operations of SCS Plc (1) |
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$ |
4,425,500 |
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Forgiveness of principal and accrued interest on notes receivable (1) |
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$ |
709,076 |
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Stock retired from settlement agreement (1) |
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$ |
241,150 |
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Stock issue for licensing agreement(2) |
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$ |
10,000 |
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(1) |
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On April 1, 2009, we acquired the operations of Stem Cell Sciences Plc (SCS, now known as
Asset Realisation Company Limited). As consideration, we issued 2,650,000 shares of our common
stock with a closing price of $1.67 per share and waived certain commitments of SCS to repay
approximately $709,000 in principal and accrued interest owed to us. Pursuant to the
acquisition agreement, 20% of the 2,650,000 shares were placed into an escrow for a twelve
month period to satisfy any indemnification obligations owed to us by SCS. On August 19,
2010, we entered into a settlement agreement with SCS in which the parties agreed to the
release of half the escrowed shares to SCS and half to us in full satisfaction of our claims
for indemnification, and both parties waived all other claims, known and unknown, against the
other. The 265,000 shares returned to us are being treated as retired and no longer
outstanding. We have recorded approximately $227,000 as other income, which was the value of
these shares based on the closing price of $0.91 per share on August 19, 2010, and net of
amounts already accrued for potential claims against the escrowed shares. |
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(2) |
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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 we hold a license from Cal
Tech, payable in cash or common stock at our choice. We elected to pay the fees in stock and
issued 5,900 shares of our common stock in 2009. In September 2010, we terminated all our
licensing agreements with Cal Tech. |
See Notes to Condensed Consolidated Financial Statements.
5
Notes to Condensed Consolidated Financial Statements (Unaudited)
September 30, 2010 and 2009
Note 1. Summary of Significant Accounting Policies
Nature of Business
StemCells, Inc., a Delaware corporation, is a biopharmaceutical company that operates in one
segment, the research, development, and commercialization of stem cell therapeutics and related
technologies.
The accompanying financial data as of and for the three and nine months ended September 30,
2010 and 2009 have been prepared by us, without audit, pursuant to the rules and regulations of the
Securities and Exchange Commission (SEC). Certain information and footnote disclosures normally
included in financial statements prepared in accordance with accounting principles generally
accepted in the United States (U.S. GAAP) have been condensed or omitted pursuant to these rules
and regulations. The December 31, 2009 condensed consolidated balance sheet was derived from
audited financial statements, but does not include all disclosures required by U.S. GAAP. However,
we believe that the disclosures are adequate to make the information presented not misleading.
These condensed consolidated financial statements should be read in conjunction with the
consolidated financial statements and the notes thereto included in our Annual Report on Form 10-K
for the fiscal year ended December 31, 2009.
We have incurred significant operating losses since inception. We expect to incur additional
operating losses over the foreseeable future. We have very limited liquidity and capital resources
and must obtain significant additional capital and other resources in order to provide funding for
our product development efforts, the acquisition of technologies, businesses and intellectual
property rights, preclinical and clinical testing of our products, pursuit of regulatory approvals,
acquisition of capital equipment, laboratory and office facilities, establishment of production
capabilities, selling, general and administrative expenses and other working capital requirements.
We rely on our cash reserves, proceeds from equity and debt offerings, proceeds from the transfer
or sale of intellectual property rights, equipment, facilities or investments, government grants
and funding from collaborative arrangements, to fund our operations. If we exhaust our cash
reserves and are unable to obtain adequate financing, we may be unable to meet our operating
obligations and we may be required to initiate bankruptcy proceedings. 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.
6
Principles of Consolidation
The condensed consolidated financial statements include the accounts of StemCells, Inc., and
our wholly-owned subsidiaries, StemCells California, Inc., StemCells Property Holding LLC, Stem
Cell Sciences Holdings Ltd; Stem Cell Sciences (UK) Ltd; and Stem Cell Sciences (Australia) Pty
Ltd. All significant intercompany accounts and transactions have been eliminated.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to
make judgments, assumptions and estimates that affect the amounts reported in our condensed
consolidated financial statements and accompanying notes. Actual results could differ materially
from these estimates.
Significant estimates include the following:
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the grant date fair value of stock-based awards recognized as compensation
expense (see Note 6, Stock-Based Compensation); |
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accrued wind-down expenses (see Note 7, Wind-Down Expenses); |
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the fair value of warrants recorded as a liability (see Note 9, Warrant
Liability); and |
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|
|
the fair value of goodwill and other intangible assets (see Note 5, Goodwill
and Other Intangible Assets). |
Financial Instruments
Cash and Cash Equivalents
Cash equivalents are money market accounts, money market funds and investments with an average
maturity of 90 days or less from the date of purchase.
Marketable Securities
Our existing marketable securities are designated as available-for-sale securities. These
securities are carried at fair value (see Note 2, Financial Instruments), with the unrealized
gains and losses reported as a component of stockholders equity. Management determines the
appropriate designation of its investments (current or non-current) in marketable securities at the
time of purchase and reevaluates such designation as of each balance sheet date. The cost of
securities sold is based upon the specific identification method.
If the estimated fair value of a security is below its carrying value, we evaluate whether we
have the intent and ability to retain our investment for a period of time sufficient to allow for
any anticipated recovery to the cost of the investment, and whether evidence indicating that the
cost of the investment is recoverable within a reasonable period of time outweighs evidence to the
contrary. Other-than-temporary declines in estimated fair value of all marketable securities are
charged to Other income (expense), net. No such impairment was recognized during the nine months
ended September 30, 2010 or 2009.
Trade and Other Receivables
Our receivables generally consist of interest income on our financial instruments, revenue
from licensing agreements and grants, revenue from product sales, and rent from our sub-lease
tenants.
Warrant Liability
Authoritative accounting guidance prescribes that warrants issued under contracts that could
require net-cash settlement should be classified as liabilities and contracts that only provide for
settlement in shares should be classified as equity. In order for a contract to
7
be classified as equity, specific conditions must be met. These conditions are intended to
identify situations in which net cash settlement could be forced upon the issuer. We issued
warrants as part of both our November 2008 and November 2009 financings (see Note 9, Warrant
Liability). As the contracts include the possibility of net-cash settlement, we are required to
classify the fair value of the warrants issued as a liability, with subsequent changes in fair
value to be recorded as income (loss) on change in fair value of warrant liability. We use the
Black-Scholes-Merton (Black-Scholes) option pricing model to estimate fair value of warrants
issued. In using this model, we make certain assumptions about risk-free interest rates, dividend
yields, volatility and expected term of the warrants. Risk-free interest rates are derived from the
yield on U.S. Treasury debt securities. Dividend yields are based on our historical dividend
payments, which have been zero to date. Volatility is derived from the historical volatility of our
common stock as traded on Nasdaq. The expected term of the warrants is based on the time to
expiration of the warrants from the date of measurement.
Goodwill and Other Intangible Assets
Goodwill and intangible assets are primarily from a business acquisition accounted for under
the purchase method. Goodwill and intangible assets deemed to have indefinite lives are not
amortized but are subject to annual impairment tests. We test goodwill for impairment on an annual
basis or more frequently if we believe indicators of impairment exist. Intangible assets with
finite useful lives are amortized generally on a straight-line basis over the periods benefited.
Intangible assets with finite useful lives are reviewed for impairment whenever events or changes
in circumstances indicate the carrying amount of an asset may not be recoverable. Prior to fiscal
year 2001, we capitalized certain patent costs, which are being amortized over the estimated lives
of the patents and would be expensed at the time such patents are deemed to have no continuing
value. Since 2001, all patent costs are expensed as incurred. License costs are capitalized and
amortized over the estimated life of the license agreement.
Revenue Recognition
We currently recognize revenue resulting from the licensing and use of our technology and
intellectual property, from government grants, and from product sales. 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 generally 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. Revenue from licensing agreements are recognized net
of a fixed percentage due to licensors as royalties. Grant revenue from government agencies are
funds received to cover specific expenses and 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 relevant collaborative agreement or
grant. Revenue from product sales are recognized when the product is shipped and the order
fulfilled.
Stock-Based Compensation
Compensation expense for stock-based payment awards to employees is based on their grant date
fair value as calculated and amortized over their vesting period. See Note 6, Stock-Based
Compensation for further information.
We use the Black-Scholes model to calculate the fair value of stock-based awards.
Net Loss per Share
Basic net loss per share is computed by dividing net loss by the weighted-average number of
shares of common stock outstanding during the period. Diluted net loss per share is computed based
on the weighted-average number of shares of common stock and other dilutive securities. To the
extent these securities are anti-dilutive, they are excluded from the calculation of diluted
earnings per share.
8
The following is a reconciliation of the numerators and denominators of the basic and diluted
earnings per share computations:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
|
Nine months ended September 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Net loss |
|
$ |
(5,552,256 |
) |
|
$ |
(5,144,741 |
) |
|
$ |
(16,286,678 |
) |
|
$ |
(21,792,653 |
) |
Weighted average shares outstanding
used to compute basic and diluted
net loss per share |
|
|
127,091,721 |
|
|
|
108,257,345 |
|
|
|
122,015,319 |
|
|
|
103,071,957 |
|
Basic and diluted net loss per share |
|
$ |
(0.04 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.21 |
) |
The following outstanding potentially dilutive common stock equivalents were excluded from the
computation of diluted net loss per share because the effect would have been anti-dilutive as of
September 30:
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
Options |
|
|
11,427,099 |
|
|
|
9,293,703 |
|
Restricted stock units |
|
|
4,660,055 |
|
|
|
2,367,901 |
|
Warrants |
|
|
14,344,828 |
|
|
|
10,344,828 |
|
|
|
|
|
|
|
|
Total |
|
|
30,431,982 |
|
|
|
22,006,432 |
|
|
|
|
|
|
|
|
Comprehensive Loss
Comprehensive loss is comprised of net losses and other comprehensive loss or income (OCL).
OCL includes certain changes in stockholders equity that are excluded from net losses.
Specifically, we include in OCL changes in unrealized gains and losses on our marketable securities
and unrealized gains and losses on foreign currency translations. Accumulated other comprehensive
income was $204,240 as of September 30, 2010 and $394,723 as of December 31, 2009.
The activity in OCL was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
|
Nine months ended September 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Net loss |
|
$ |
(5,552,256 |
) |
|
$ |
(5,144,741 |
) |
|
$ |
(16,286,678 |
) |
|
$ |
(21,792,653 |
) |
Net change in
unrealized gains
and losses on
marketable
securities |
|
|
20,462 |
|
|
|
(5,248 |
) |
|
|
(51,572 |
) |
|
|
128,512 |
|
Net change in
unrealized gains
and losses on
foreign currency
translations |
|
|
267,769 |
|
|
|
(208,537 |
) |
|
|
(138,911 |
) |
|
|
(434,175 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(5,264,025 |
) |
|
$ |
(5,358,526 |
) |
|
$ |
(16,477,161 |
) |
|
$ |
(22,098,316 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Recent Accounting Pronouncements
In January 2010, the Financial Accounting Standards Board (FASB), issued new standards to
update and amend existing standards on Fair Value Measurements and Disclosures. These standards
require new disclosures on the amount and reason for transfers in and out of Level 1 and Level 2
fair value measurements. The standards also require disclosure of activities in Level 3 fair value
measurements that use significant unobservable inputs, including purchases, sales, issuances, and
settlements. The standards also clarify existing disclosure requirements on levels of
disaggregation, which requires fair value measurement disclosure for each class of assets and
liabilities, and disclosures about valuation techniques and inputs used to measure fair value of
recurring and non recurring fair value measurements that fall in ether Level 2 or Level 3. The new
disclosures and clarifications of existing disclosures are effective for our interim and annual
reporting periods beginning January 1, 2010, except for the disclosures about purchases, sales,
issuances and settlements in the roll forward activity in Level 3 fair value measurements. Those
disclosures are effective for our fiscal year beginning January 1, 2011. We do not expect the
adoption of the new standards related to Level 3 fair value measurements on January 1, 2011 to have
a material effect on our consolidated financial condition and results of operations.
In April 2010, FASB issued Accounting Standards Update (ASU) No. 2010-17, Revenue
RecognitionMilestone Method, which provides guidance on defining a milestone and determining when
it may be appropriate to apply the milestone method of revenue recognition for research or
development transactions. Research or development arrangements frequently include payment
provisions whereby a portion or all of the consideration is contingent upon milestone events such
as successful completion of phases in a study or achieving a specific result from the research or
development efforts. The amendments in this ASU provide guidance on the criteria that should be met
for determining whether the milestone method of revenue recognition is appropriate. The ASU is
effective for fiscal years and interim periods within those years beginning on or after June 15,
2010, with early adoption permitted. This ASU is
9
effective for our interim and annual reporting periods beginning January 1, 2011. We are
currently evaluating the impact of this new standard, if any, on our financial condition and
results of operations.
Note 2. Financial Instruments
The following table summarizes the fair value of our cash, cash equivalents and
available-for-sale marketable securities held in our current investment portfolio:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
|
|
|
|
Cost |
|
|
Gains |
|
|
(Losses) |
|
|
Fair Value |
|
September 30, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash |
|
$ |
250,209 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
250,209 |
|
Cash equivalents |
|
|
24,304,365 |
|
|
|
|
|
|
|
|
|
|
|
24,304,365 |
|
Marketable equity securities, current |
|
|
74,456 |
|
|
|
70,967 |
|
|
|
|
|
|
|
145,423 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cash, cash equivalents, and marketable securities |
|
$ |
24,629,030 |
|
|
$ |
70,967 |
|
|
$ |
|
|
|
$ |
24,699,997 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash |
|
$ |
1,064,148 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
1,064,148 |
|
Cash equivalents |
|
|
37,553,829 |
|
|
|
|
|
|
|
|
|
|
|
37,553,829 |
|
Marketable equity securities, current |
|
|
74,456 |
|
|
|
122,539 |
|
|
|
|
|
|
|
196,995 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cash, cash equivalents, and marketable securities |
|
$ |
38,692,433 |
|
|
$ |
122,539 |
|
|
$ |
|
|
|
$ |
38,814,972 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross unrealized gains and losses on cash equivalents were not material at September 30, 2010
and December 31, 2009. At September 30, 2010, our cash equivalents were primarily money market
funds consisting mainly of U.S. Treasury debt securities.
Our investment in marketable equity securities consists of ordinary shares of ReNeuron Group
Plc (ReNeuron), a publicly listed U.K. corporation. In July 2005, we entered into an agreement with
ReNeuron under which we 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.
We received shares of ReNeuron common stock, as well as 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 we 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. In July and August 2005, we received approximately 8,836,000
ordinary shares of ReNeuron common stock, net of approximately 104,000 shares that were transferred
to NeuroSpheres, Ltd., an Alberta corporation (NeuroSpheres), and subsequently, as a result of
certain anti-dilution provisions in the agreement, we received approximately 1,261,000 more shares,
net of approximately 18,000 shares that were transferred to NeuroSpheres. In February 2007, we sold
5,275,000 shares for net proceeds of approximately $3,075,000. We recognized approximately $716,000
as realized gain from this transaction. In the first quarter of 2009, we sold 2,900,000 shares of
ReNeuron and received net proceeds of approximately $510,000 for a realized gain of approximately
$398,000. At September 30, 2010 and December 31, 2009, we owned 1,921,924 shares of ReNeuron with a
carrying and fair market value of approximately $145,000 and $197,000 respectively.
Changes in the fair market value of our ReNeuron shares as a result of changes in market price
per share or the exchange rate between the U.S. dollar and the British pound are accounted for as
an unrealized gain or loss under other comprehensive income (loss) if deemed temporary and are
not recorded as other income (expense), net until the shares are disposed of and a gain or loss
realized. If the fair value of a security is below its carrying value, we evaluate whether we have
the intent and ability to retain our investment for a period of time sufficient to allow for any
anticipated recovery to the cost of the investment, and whether evidence indicating that the cost
of the investment is recoverable within a reasonable period of time outweighs evidence to the
contrary. Other-than-temporary declines in estimated fair value of all marketable securities are
charged to other income (expense), net. For the nine months ended September 30, 2010, we recorded
an unrealized loss of approximately $52,000.
10
Note 3. Fair Value Measurement
The following tables present our assets and liabilities that are measured at fair value
on a recurring basis and are categorized using the fair value hierarchy. The fair value hierarchy
has three levels based on the reliability of the inputs used to determine fair value.
Level 1 Observable inputs that reflect quoted prices (unadjusted) for identical assets or
liabilities in active markets.
Level 2 Directly or indirectly observable inputs other than in Level 1, that include quoted
prices for similar assets or liabilities in active markets or quoted prices for identical or
similar assets or liabilities in markets that are not active.
Level 3 Unobservable inputs which are supported by little or no market activity that reflects
the reporting entitys own assumptions about the assumptions that market participants would use in
pricing the asset or liability.
The fair value hierarchy also requires an entity to maximize the use of observable inputs and
minimize the use of unobservable inputs when measuring fair value.
Our cash equivalents, marketable securities, bonds payable and warrant liability are
classified within Level 1 or Level 2. This is because our cash equivalents and marketable
securities are valued primarily using quoted market prices, our bonds payable are valued using
alternative pricing sources and models utilizing market observable inputs and our warrant liability
is valued using an option pricing model that uses assumptions with observable inputs such as
risk-free interest rates that are derived from the yield on U.S. Treasury debt securities,
volatility and price based on our common stock as traded on Nasdaq.
We currently do not have any Level 3 financial assets or liabilities.
The following table presents financial assets and liabilities measured at fair value:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurement |
|
|
|
|
|
|
at Reporting Date Using |
|
|
|
|
|
|
Quoted Prices |
|
|
Significant |
|
|
|
|
|
|
in Active Markets |
|
|
Other |
|
|
|
|
|
|
for |
|
|
Observable |
|
|
As of |
|
|
|
Identical Assets |
|
|
Inputs |
|
|
September 30, |
|
|
|
(Level 1) |
|
|
(Level 2) |
|
|
2010 |
|
Financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
24,304,365 |
|
|
$ |
|
|
|
$ |
24,304,365 |
|
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
Equity securities |
|
|
145,423 |
|
|
|
|
|
|
|
145,423 |
|
|
|
|
|
|
|
|
|
|
|
Total financial assets |
|
$ |
24,449,788 |
|
|
|
|
|
|
|
24,449,788 |
|
|
|
|
|
|
|
|
|
|
|
Financial liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
Bond payable |
|
$ |
|
|
|
$ |
741,250 |
|
|
$ |
741,250 |
|
Warrant liability |
|
$ |
|
|
|
|
4,492,664 |
|
|
|
4,492,664 |
|
|
|
|
|
|
|
|
|
|
|
Total financial liabilities |
|
$ |
|
|
|
$ |
5,233,914 |
|
|
$ |
5,233,914 |
|
|
|
|
|
|
|
|
|
|
|
Note 4. Acquisition of Stem Cell Sciences Plc (SCS) Operations
On April 1, 2009, we acquired the operations of SCS for an aggregate purchase price of
approximately $5,135,000. The acquired operations includes proprietary cell technologies relating
to embryonic stem cells, induced pluripotent stem (iPS) cells, and tissue-derived (adult) stem
cells; expertise and infrastructure for providing cell-based assays for drug discovery; a cell
culture products business; and an intellectual property portfolio with claims relevant to cell
processing, reprogramming and manipulation, as well as to gene targeting and insertion.
11
The purchase price has been allocated as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated life of |
|
|
|
Allocated purchase |
|
|
intangible assets |
|
|
|
Price |
|
|
in years |
|
Net tangible assets |
|
$ |
36,000 |
|
|
|
|
|
Intangible assets: |
|
|
|
|
|
|
|
|
Customer relationships and developed technology |
|
|
1,310,000 |
|
|
|
6 to 9 |
|
In-process research and development |
|
|
1,340,000 |
|
|
|
13 to 19 |
|
Trade name |
|
|
310,000 |
|
|
|
15 |
|
Goodwill |
|
|
2,139,000 |
|
|
|
N/A |
|
|
|
|
|
|
|
|
|
Total |
|
$ |
5,135,000 |
|
|
|
|
|
In-process research and development assets relate to: 1) the acquisition of certain intellectual property rights
not expected to expire until 2027 related to our program focused on developing genetically
engineered rat models of human disease (our Transgenic Rat Program); and 2) the acquisition of
certain technology related to the commercialization of our SC Proven cell culture products and the
development and commercialization of cell-based assay platforms for use in drug discovery and
development (our Assay Development Program).
At the time of valuation (April 2009), the technology related to our Transgenic Rat Program
was in its nascent stage, and therefore we concluded that the remaining 19 years of legal life of
the intellectual property was appropriate as the remaining useful life for this technology.
As for our Assay Development Program, at the time of valuation (April 2009), we expected to
achieve proof of concept by 2012. Due to the foundational nature of our Assay Development Program
patents and technologies, we expect the technologies to remain useful and relevant within the
industry for at least 10 years following commercial launch of a product or service under our Assay
Development Program. Because these technologies are not expected to begin generating revenue until
2011-2012, we estimated the remaining useful life for these technologies to be approximately 13
years from the valuation date.
Trade name relates to the SC Proven trademark of our cell culture products which we expect
to market for 15 years from the date of acquisition, based on which, we estimated a remaining
useful life of 15 years from the valuation date.
Note 5. Goodwill and Other Intangible Assets
In March 2010, we received approximately $47,000 for an R&D tax credit due to our wholly-owned
subsidiary Stem Cell Sciences (Australia) Pty Ltd. The R&D tax credit was due for the year 2007.
Accordingly, the purchase price allocation for the SCS acquisition was adjusted and the gross
carrying amount of goodwill recorded at the date of acquisition was reduced by that amount.
The following table represents changes in goodwill:
|
|
|
|
|
Balance as of December 31, 2009 |
|
$ |
2,019,679 |
|
Reductions (R&D credit as described above) |
|
|
(47,374 |
) |
Foreign currency translation |
|
|
(53,644 |
) |
|
|
|
|
Balance as of September 30, 2010 |
|
$ |
1,918,661 |
|
|
|
|
|
The components of our other intangible assets at September 30, 2010 are summarized below:
|
|
|
|
|
|
|
Net Carrying |
|
Other Intangible Asset Class |
|
Amount |
|
Customer relationships and developed technology |
|
$ |
1,155,995 |
|
In-process research and development |
|
|
1,317,456 |
|
Trade name |
|
|
304,746 |
|
Patents |
|
|
366,702 |
|
License agreements |
|
|
42,394 |
|
|
|
|
|
Total other intangible assets |
|
$ |
3,187,293 |
|
|
|
|
|
12
Amortization expense was approximately $93,000 in the third quarter of 2010.
Note 6. Stock-Based Compensation
We currently grant stock-based awards under three equity incentive plans. As of September 30,
2010, we had 23,759,050 shares authorized to be granted under the three plans. Under these plans we
may grant various types of equity awards to our employees, directors and consultants, at prices
determined by our Board of Directors, including incentive stock options, nonqualified stock
options, stock appreciation rights, restricted stock, restricted stock units, and performance-based
shares. Incentive stock options may only be granted to employees under these plans with a grant
price not less than the fair market value of the stock on the date of grant. We use these plans to
grant shares to employees for the employer match of employee 401(k) plan contributions.
Our stock-based compensation expense for the three and nine months ended September 30 was as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Research and development expense |
|
$ |
371,694 |
|
|
$ |
551,210 |
|
|
$ |
1,531,632 |
|
|
$ |
1,629,551 |
|
Selling, general and administrative expense |
|
|
493,675 |
|
|
|
584,978 |
|
|
|
1,456,251 |
|
|
|
1,545,394 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total employee stock-based compensation
expense and effect on net loss |
|
$ |
865,369 |
|
|
$ |
1,136,188 |
|
|
$ |
2,987,883 |
|
|
$ |
3,174,945 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect on basic and diluted net loss per share |
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.03 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2010, we had approximately $7,595,000 of total unrecognized compensation
expense related to unvested awards of stock options and restricted stock units granted under our
various equity incentive plans that we expect to recognize over a weighted-average vesting period
of 2.8 years.
Stock Options
Generally, stock options granted to employees have a maximum term of ten years, and vest over
a four year period from the date of grant; 25% vest at the end of one year, and 75% vest monthly
over the remaining three-year service period. We may grant options with different vesting terms
from time to time. Upon employee termination of service, any unexercised vested option will be
forfeited three months following termination or the expiration of the option, whichever is earlier.
Unvested options are forfeited on termination.
A summary of our stock option activity for the three months ended September 30, 2010 is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average |
|
|
|
Number of options |
|
|
exercise price ($) |
|
Balance at June 30, 2010 |
|
|
11,498,991 |
|
|
|
2.02 |
|
Granted |
|
|
3,000 |
|
|
|
0.89 |
|
Exercised |
|
|
|
|
|
|
|
|
Cancelled |
|
|
(74,892 |
) |
|
|
3.74 |
|
|
|
|
|
|
|
|
Outstanding options at
September 30, 2010 |
|
|
11,427,099 |
|
|
|
2.00 |
|
|
|
|
|
|
|
|
The estimated weighted-average fair value of options granted in the three months ended
September 30, 2010 and 2009 was approximately $0.73 and $1.38 per option, respectively. The fair
value of options granted is estimated as of the date of grant using the
Black-Scholes option pricing model, which requires certain assumptions as of the date of
grant. The weighted-average assumptions used as of September 30, 2010 and 2009 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
Expected life (years)(1)
|
|
|
7.6 |
|
|
|
7.6 |
|
|
|
7.2 |
|
|
|
7.4 |
|
Risk-free interest rate(2)
|
|
|
2.2 |
% |
|
|
3.2 |
% |
|
|
2.9 |
% |
|
|
2.8 |
% |
Expected volatility(3)
|
|
|
88.0 |
% |
|
|
91.8 |
% |
|
|
88.4 |
% |
|
|
93.6 |
% |
Expected dividend yield(4)
|
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
13
|
|
|
(1) |
|
The expected term represents our estimated period during which our stock-based awards remain
outstanding. We estimated this period based on historical experience of similar awards, giving
consideration to the contractual terms of the awards, vesting requirements, and expectation of
future employee behavior, including post-vesting terminations. |
|
(2) |
|
The risk-free interest rate is based on U.S. Treasury debt securities with maturities close
to the expected term of the option as of the date of grant. |
|
(3) |
|
Expected volatility is based on historical volatility over the most recent historical period
equal to the length of the expected term of the option as of the date of grant. |
|
(4) |
|
We have not historically issued any dividends, and we do not expect to in the foreseeable
future. |
At the end of each reporting period, we estimate forfeiture rates based on our historical
experience within separate groups of employees and adjust the stock-based compensation expense
accordingly.
A summary of changes in unvested options for the three months ended September 30, 2010 is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average grant |
|
|
|
Number of options |
|
|
date fair value ($) |
|
Unvested options at June 30, 2010 |
|
|
4,254,807 |
|
|
|
1.09 |
|
Granted |
|
|
3,000 |
|
|
|
0.73 |
|
Vested |
|
|
(254,651 |
) |
|
|
1.65 |
|
Cancelled |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unvested options at September 30, 2010 |
|
|
4,003,156 |
|
|
|
1.06 |
|
|
|
|
|
|
|
|
The estimated fair value of shares vested were approximately $420,000 in the three months
ended September 30, 2010.
Restricted Stock Units
We have granted restricted stock units (RSUs) to certain employees which entitle the holders
to receive shares of our common stock upon vesting of the RSUs. The fair value of restricted stock
units granted are based upon the market price of the underlying common stock as if it were vested
and issued on the date of grant.
A summary of our restricted stock unit activity for the three months ended September 30, 2010
is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average grant |
|
|
|
Number of RSUs |
|
|
date fair value ($) |
|
Balance at June 30, 2010 |
|
|
4,888,388 |
|
|
|
1.23 |
|
Granted |
|
|
10,000 |
|
|
|
1.03 |
|
Vested and converted to common shares |
|
|
(33,333 |
) |
|
|
1.09 |
|
Cancelled |
|
|
(200,000 |
) |
|
|
1.05 |
|
|
|
|
|
|
|
|
Balance unvested at September 30, 2010 (1) |
|
|
4,665,055 |
|
|
|
1.23 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
55,000 of these restricted stock units vest and convert into shares of our common stock after
one year from the date of grant. 2,380,754 of these restricted stock units vest and convert
into shares of our common stock over a three year period from the date of grant: one-third of
the award will vest on each grant date anniversary following the grant. 2,069,301 of these
restricted stock units vest and convert into shares of our common stock over a four year
period from the date of grant: one-fourth of the award will vest on each grant date
anniversary following the grant. 160,000 of these restricted stock units will vest and convert
into shares of our common stock subject to attainment of certain performance criteria and will
be forfeited if not met. |
14
Stock Appreciation Rights
In July 2006, we granted cash-settled Stock Appreciation Rights (SARs) to certain employees
that give the holder the right, upon exercise, to the difference between the price per share of our
common stock at the time of exercise and the exercise price of the SARs.
The SARs have a maximum term of ten years with an exercise price of $2.00, which is equal to
the market price of our common stock at the date of grant. The SARs vest 25% on the first
anniversary of the grant date and 75% vest monthly over the remaining three-year service period.
Compensation expense is based on the fair value of SARs which is calculated using the Black-Scholes
option pricing model. The stock-based compensation expense and liability are re-measured at each
reporting date through the earlier date of settlement or forfeiture of the SARs.
A summary of the changes in SARs for the three months ended September 30, 2010 is as follows:
|
|
|
|
|
|
|
Number of SARs |
|
Outstanding at June 30, 2010 |
|
|
1,354,088 |
|
Granted |
|
|
|
|
Exercised |
|
|
|
|
Forfeited and expired |
|
|
|
|
Outstanding SARs at September 30, 2010 |
|
|
1,354,088 |
|
|
|
|
|
SARs exercisable at September 30, 2010 |
|
|
1,354,088 |
|
|
|
|
|
For the three months ended September 30, 2010, we re-measured the liability related to the
SARs and reduced compensation expense by approximately $97,000. For the same period in 2009, we
reduced compensation expense by approximately $5,000.
The compensation expense recognized for the three months ended September 30, 2010 may not be
representative of compensation expense for future periods and its resulting effect on net loss and
net loss per share attributable to common stockholders, 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. We will continue to recognize compensation
cost each period, which will be the change in fair value from the previous period through the
earlier date of settlement or forfeiture of the SARs.
Note 7. Wind-Down Expenses
Rhode Island
In October 1999, we relocated to California from Rhode Island and established a wind down
reserve for the estimated lease payments and operating costs of our scientific and administrative
facility in Rhode Island. Even though we intend to dispose of the facility at the earliest possible
time, we cannot determine with certainty a fixed date by which such disposal will occur. In light
of this uncertainty, we periodically re-evaluate and adjust the reserve. We consider various
factors such as our 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.
The summary of the changes to our wind-down reserve related to this facility for 2010 and 2009
were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
January 1 to |
|
|
April 1 to |
|
|
July 1 to |
|
|
January 1 to |
|
|
January 1 to |
|
|
|
March 31, |
|
|
June 30, |
|
|
September 30, |
|
|
September 30, |
|
|
December 31, |
|
|
|
2010 |
|
|
2010 |
|
|
2010 |
|
|
2010 |
|
|
2009 |
|
Accrued wind-down reserve at beginning of period |
|
$ |
3,572,000 |
|
|
$ |
3,422,000 |
|
|
$ |
3,268,000 |
|
|
$ |
3,572,000 |
|
|
$ |
4,448,000 |
|
Less actual expenses recorded against estimated
reserve during the period |
|
|
(315,000 |
) |
|
|
(280,000 |
) |
|
|
(303,000 |
) |
|
|
(898,000 |
) |
|
|
(1,216,000 |
) |
Additional expense recorded to revise estimated
reserve at period-end |
|
|
165,000 |
|
|
|
126,000 |
|
|
|
|
|
|
|
291,000 |
|
|
|
340,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revised reserve at period-end |
|
|
3,422,000 |
|
|
|
3,268,000 |
|
|
|
2,965,000 |
|
|
|
2,965,000 |
|
|
|
3,572,000 |
|
Add deferred rent at period-end |
|
|
809,000 |
|
|
|
758,000 |
|
|
|
708,000 |
|
|
|
708,000 |
|
|
|
861,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total accrued wind-down expenses at period-end
(current and non-current) |
|
$ |
4,231,000 |
|
|
$ |
4,026,000 |
|
|
$ |
3,673,000 |
|
|
$ |
3,673,000 |
|
|
$ |
4,433,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued wind-down expenses, current |
|
$ |
1,443,000 |
|
|
$ |
1,510,000 |
|
|
$ |
1,342,000 |
|
|
$ |
1,342,000 |
|
|
$ |
1,376,000 |
|
Accrued wind-down expenses, non-current |
|
|
2,788,000 |
|
|
|
2,516,000 |
|
|
|
2,331,000 |
|
|
|
2,331,000 |
|
|
|
3,057,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total accrued wind-down expenses |
|
$ |
4,231,000 |
|
|
$ |
4,026,000 |
|
|
$ |
3,673,000 |
|
|
$ |
3,673,000 |
|
|
$ |
4,433,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15
Australia
On April 1, 2009, as part of our acquisition of the SCS operations, we acquired operations
near Melbourne, Australia. In order to reduce operating complexity and expenses, we made the
decision to close our site in Australia and consolidate personnel and programs to our Cambridge,
U.K. and Palo Alto, California sites. U.S. GAAP requires that a liability for a cost associated
with an exit or disposal activity be recognized when the liability is incurred. In accordance with
U.S. GAAP requirements, at June 30, 2009, we established a short-term reserve of approximately
$310,000 for the estimated costs to close down and exit our Australia operations. The reserve
reflects the estimated cost to terminate our facility lease in Australia (with an original
termination date of December 31, 2010), employee termination benefits and other liabilities
associated with the wind-down and relocation of our operations in Australia. The facility lease
agreement was terminated effective July 2009 and our operations in Australia have been relocated to
Cambridge, U.K. and Palo Alto, California. We recorded actual expenses of approximately $10,000 and
$236,000 in 2010 and 2009, respectively, against this reserve. We believe that the estimated
remaining balance of approximately $69,000 in our reserve will be sufficient to cover any remaining
exit costs.
|
|
|
|
|
|
|
July 1 to |
|
|
|
September 30, |
|
|
|
2010 |
|
Accrued wind-down reserve at June 30, 2010 |
|
$ |
61,000 |
|
Less actual expenses recorded against estimated reserve during the period |
|
|
(1,000 |
) |
Foreign currency translation |
|
|
9,000 |
|
|
|
|
|
Accrued wind-down reserve at September 30, 2010 |
|
$ |
69,000 |
|
|
|
|
|
Note 8. Commitments and Contingencies
Leases
Capital Leases
We entered into 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 our pilot manufacturing facility in Rhode Island. The related lease agreements are
structured such that lease payments fully fund all semiannual interest payments and annual
principal payments through maturity in August 2014. The interest rate for the remaining bond series
is 9.5%. The bond contains certain restrictive covenants
which limit, among other things, the payment of cash dividends and the sale of the related
assets. The outstanding principal was approximately $741,000 at September 30, 2010 and $860,000 at
December 31, 2009.
Operating Leases
We lease various real properties under operating leases that generally require us to pay
taxes, insurance, maintenance, and minimum lease payments. Some of our leases have options to
renew.
Operating Leases California
We currently lease space in an approximately 68,000 square foot facility located at the
Stanford Research Park in Palo Alto, California. The facility includes space for animals,
laboratories, offices, and a GMP (Good Manufacturing Practices) suite. Prior to
16
September 2010, we leased approximately 68,000 square feet of the facility, and were required to
provide a letter of credit for approximately $778,000, which served as a security deposit for the
duration of the lease term. The letter of credit issued by our financial institution is
collateralized by a certificate of deposit for the same amount, which was reflected as restricted
cash in other assets, non-current on our condensed consolidated balance sheets. In September 2010,
we amended our lease to reduce the area leased to approximately 51,200 square feet, to change the expiry date of
the lease term from August 31, 2011 to June 30, 2011, and to reduce the letter of credit that
serves as a security deposit to approximately $389,000 from approximately $778,000. The difference
of approximately $389,000 will be transferred from our restricted cash account to our cash and cash
equivalents account. In connection with this September 2010 lease amendment, we terminated a
space-sharing agreement covering approximately 10,451 square feet of this facility. At September
30, 2010, the aggregate remaining rent payment under the amended lease is approximately $1,233,000.
We recognize operating lease expense on a straight-line basis. At September 30, 2010, we had
prepaid rent balance of approximately $70,000. At December 31, 2009, we had a deferred rent
balance of approximately $131,000.
In September 2010, we entered into a two-year sublease agreement with Caliper Life Sciences,
Inc., for approximately 13,200 square feet in a facility located in Mountain View, California. We will pay
approximately $695,000 in aggregate as rent over the term of the lease. The lease contains
escalating rent payments, which we recognize as operating lease expense on a straight-line basis.
Deferred rent was approximately $4,000 as of September 30, 2010.
Operating Leases Rhode Island
We entered into a fifteen-year lease agreement for a scientific and administrative facility in
Rhode Island in connection with a sale and leaseback arrangement in 1997. The lease term expires
June 30, 2013. The lease contains escalating rent payments, which we recognize on a straight-line
basis. Deferred rent expense for this facility was approximately $707,000 at September 30, 2010 and
$861,000 at December 31, 2009, and is included as part of the wind-down accrual on the accompanying
condensed consolidated balance sheets.
Operating Leases United Kingdom
On April 1, 2009, as part of our acquisition of the operations of SCS, we acquired operations
in Cambridge, U.K. As of April 2009, our wholly-owned subsidiary, Stem Cell Sciences (UK) Ltd, had
two lease agreements for approximately 3,900 square feet of office and lab space in aggregate in
two buildings of the Babraham Research Campus in Cambridge, U.K. One of these two leases, for
approximately 2,000 square feet, expired by its terms on February 28, 2010. The second, for
approximately 1,900 square feet, has an initial term until March 2011, with an option, at our
election, to extend the term for an additional five years. In February 2010, we entered into a new
lease agreement effective March 1, 2010, for approximately 3,240 square feet. The initial term of
this new lease will continue until March 2011, with an option, at our election, to extend the term
for an additional two years. The two currently effective Cambridge leases cover in aggregate
approximately 5,000 square feet. We expect to pay approximately 134,000 GBP as rental payments for
2010 in aggregate for the Cambridge leases. StemCells, Inc. is the guarantor of Stem Cell Sciences
(UK) Ltds obligations under both leases.
Contingencies
In July 2006, we filed suit against Neuralstem, Inc. in the Federal District Court for the District
of Maryland, alleging that Neuralstems activities violate claims in four of the patents we
exclusively license from NeuroSpheres. In December 2006, Neuralstem petitioned the U.S. Patent and
Trademark Office (PTO) to reexamine two of the patents in our infringement action against
Neuralstem, namely U.S. Patent No. 6,294,346 (claiming the use of human neural stem cells for drug
screening) and U.S. Patent No. 7,101,709 (claiming the use of human neural stem cells for screening
biological agents). In April 2007, Neuralstem petitioned the PTO to reexamine the remaining two
patents in the suit, namely U.S. Patent No. 5,851,832 (claiming methods for proliferating human
neural stem cells) and U.S. Patent No. 6,497,872 (claiming methods for transplanting human neural
stem cells). These requests were granted by the PTO and, in June 2007, the parties voluntarily
agreed to stay the pending litigation while the PTO considered these reexamination requests. In
April 2008, the PTO upheld the 832 and 872 patents, as amended, and issued Notices of Intent to
Issue an Ex Parte Reexamination Certificate for both. In May 2009, the PTO upheld the 346 and 709
patents, as amended, and issued Notices of Intent to Issue an Ex Parte Reexamination Certificate
for both.
17
In May 2008, we filed a second patent infringement suit against Neuralstem and its two
founders, Karl Johe and Richard Garr. In this suit, which we filed in the Federal District Court
for the Northern District of California, we allege that Neuralstems activities infringe claims in
two patents we exclusively license from NeuroSpheres, specifically U.S. Patent No. 7,361,505
(claiming composition of matter of human neural stem cells derived from any source material) and
U.S. Patent No. 7,115,418 (claiming methods for proliferating human neural stem cells). In
addition, we allege various state law causes of action against Neuralstem arising out of its
repeated derogatory statements to the public about our patent portfolio. Also in May 2008,
Neuralstem filed suit against us and NeuroSpheres in the Federal District Court for the District of
Maryland seeking a declaratory judgment that the 505 and 418 patents are either invalid or are
not infringed by Neuralstem and that Neuralstem has not violated California state law. In August
2008, the California court transferred our lawsuit against Neuralstem to Maryland for resolution on
the merits. In July 2009, the Maryland District Court granted our motion to consolidate these two
cases with the litigation we initiated against Neuralstem in 2006. In August 2009, the Maryland
District Court approved a scheduling order submitted by the parties for discovery and trial.
Effective 2008, as part of an indemnification agreement with NeuroSpheres, we are entitled to
offset all litigation costs incurred in this patent infringement suit, against amounts that would
otherwise be owed to NeuroSpheres under our exclusive license agreements with NeuroSpheres, such as
annual maintenance fees, milestones and royalty payments. Under the terms of our license
agreements, we are required to make annual payments of $50,000 to NeuroSpheres, and we expect to
make these annual payments through the remaining life of the patent which, at December 31, 2009,
was approximately 15 years. We have therefore capitalized $750,000 (15 years at $50,000 per year)
to offset litigation costs. The amount capitalized is not dependent on the achievement of any
milestones or related to any other contingent payments which may become due under the arrangement.
We will reduce this asset by $50,000 per year in lieu of the cash payments due to NeuroSpheres. As
the $50,000 annual payments are fully creditable against royalties due to Neurospheres, we have
classified the $750,000 as prepaid royalties under Other assets, non-current on our accompanying
condensed consolidated balance sheets. We have concluded that the estimated balance of $750,000, as
of September 30, 2010, is a fair estimate and realizable against future milestone and royalty
payments to NeuroSpheres, and that litigation costs incurred above this amount will be expensed as
incurred. Management will reevaluate this estimate on a quarterly basis based on actual costs and
other relevant factors.
Note 9. Warrant Liability
We use the Black-Scholes option pricing model to estimate fair value of warrants issued. In
using this model, we make certain assumptions about risk-free interest rates, dividend yields,
volatility and expected term of the warrants. Risk-free interest rates are derived from the yield
on U.S. Treasury debt securities. Dividend yields are based on our historical dividend payments,
which have been zero to date. Volatility is derived from the historical volatility of our common
stock as traded on Nasdaq. The expected term of the warrants is based on the time to expiration of
the warrants from the date of measurement.
In November 2008, we sold 13,793,104 units to institutional investors at a price of $1.45 per
unit, for gross proceeds of $20,000,000. The units, each of which consisted of one share of common
stock and a warrant to purchase 0.75 shares of common stock at an exercise price of $2.30 per
share, were offered as a registered direct offering under a shelf registration statement previously
filed with, and declared effective by, the SEC. We received total proceeds, net of offering expenses
and placement agency fees, of approximately $18,637,000. We recorded the fair value of the warrants
to purchase 10,344,828 shares of our common stock as a liability. The fair value of the warrant
liability will be revalued at the end of each reporting period, with the change in fair value of
the warrant liability recorded as a gain or loss in our condensed consolidated statements of
operations. The fair value of the warrants will continue to be classified as a liability until such
time as the warrants are exercised, expire or an amendment of the warrant agreement renders these
warrants to be no longer classified as a liability.
The assumptions used for the Black-Scholes option pricing model are as follows:
18
|
|
|
|
|
|
|
|
|
|
|
To Calculate |
|
|
|
Fair Value of Warrant |
|
|
|
Liability at |
|
|
|
September 30, 2010 |
|
|
June 30, 2010 |
|
Expected life (years) |
|
|
3.6 |
|
|
|
3.9 |
|
Risk-free interest rate |
|
|
1.0 |
% |
|
|
1.7 |
% |
Expected volatility |
|
|
80.8 |
% |
|
|
80.0 |
% |
Expected dividend yield |
|
|
0 |
% |
|
|
0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At September 30, |
|
|
At June 30, |
|
|
Change in Fair Value |
|
|
|
2010 |
|
|
2010 |
|
|
of Warrant Liability |
|
Fair value of warrant liability |
|
$ |
2,908,344 |
|
|
$ |
3,755,689 |
|
|
$ |
(847,345 |
) |
In November 2009, we sold 10,000,000 units to institutional investors at a price of $1.25 per
unit, for gross proceeds of $12,500,000. The units, each of which consisted of one share of common
stock and a warrant to purchase 0.4 shares of common stock at an exercise price of $1.50 per share,
were offered as a registered direct offering under a shelf registration statement previously filed
with, and declared effective by, the SEC. We received total proceeds, net of offering expenses and
placement agency fees, of approximately $11,985,000. We recorded the fair value of the warrants to
purchase 4,000,000 shares of our common stock as a liability. The fair value of the warrant
liability will be revalued at the end of each reporting period, with the change in fair value of
the warrant liability recorded as a gain or loss in our condensed consolidated statements of
operations. The fair value of the warrants will continue to be classified as a liability until such
time as the warrants are exercised, expire or an amendment of the warrant agreement renders these
warrants to be no longer classified as a liability.
The assumptions used for the Black-Scholes option pricing model are as follows:
|
|
|
|
|
|
|
|
|
|
|
To Calculate |
|
|
|
Fair Value of Warrant Liability at |
|
|
|
September 30, |
|
|
June 30, |
|
|
|
2010 |
|
|
2010 |
|
Expected life (years) |
|
|
4.6 |
|
|
|
4.8 |
|
Risk-free interest rate |
|
|
1.3 |
% |
|
|
2.1 |
% |
Expected volatility |
|
|
77.0 |
% |
|
|
76.2 |
% |
Expected dividend yield |
|
|
0 |
% |
|
|
0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At September 30, |
|
|
At June 30, |
|
|
Change in Fair Value |
|
|
|
2010 |
|
|
2010 |
|
|
of Warrant Liability |
|
Fair value of warrant liability |
|
$ |
1,584,320 |
|
|
$ |
1,964,560 |
|
|
$ |
(380,240 |
) |
Note 10. Common Stock
On June 8, 2009, we filed a prospectus supplement that relates to the issuance and sale, from
time to time, of up to $30,000,000 of our common stock. These sales will be made pursuant to the
terms of a sales agreement with a sales agent. The prospectus is a part of a shelf registration
statement that we filed with the SEC on June 25, 2008. Under this shelf registration process, we
may offer to sell in one or more offerings equity or debt securities up to a total dollar amount of
$100,000,000. Under our above mentioned sales agreement, in the nine-month period ended September
30, 2010, we sold 1,192,200 shares of common stock at an average price of approximately $1.16 per
share for gross proceeds of approximately $1,381,000.
On June 29, 2010, under our effective shelf registration statement previously filed with the
SEC, we sold seven million shares of our common stock to an institutional investor, at a price of
$0.865 per share. We received net proceeds, after deducting offering expenses and fees, of
approximately $5,700,000. No warrants were issued in this transaction. As part of the purchase
agreement, the institutional investor agreed to purchase an additional five million shares of
common stock approximately 12 weeks after the initial sale, at a purchase price to be calculated
using the then-current trading price. We decided not to sell these additional shares and on
September 20, 2010, we terminated the purchase agreement. We have not incurred any early
termination penalties in connection with our voluntary termination of this agreement.
19
|
|
|
ITEM 2. |
|
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
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
the fact that additional trials will be required to confirm the safety and demonstrate the efficacy
of our HuCNS-SC cells for the treatment of neuronal ceroid lipofuscinosis (NCL, also known as
Batten disease), Pelizeaus-Merzbacher disease (PMD), or any other disease; uncertainty as to
whether the U.S. Food and Drug Administration (FDA) or other regulatory authorities will permit us
to proceed or continue with clinical testing of proposed products despite the novel and unproven nature of our
technologies; the risk that our clinical trials or studies could be substantially delayed beyond
their expected dates or cause us to incur substantial unanticipated costs; uncertainties in 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; uncertainty regarding our ability to obtain a corporate partner or partners,
if needed, to support the development and commercialization of our potential cell-based
therapeutics products; uncertainty regarding the outcome of our clinical trials or studies we may
conduct in the future; uncertainty regarding the validity and enforceability of our issued patents;
risks relating to the maunfacutre of our products, much of which must comply with Good
Manufacturing Practices and exacting release testing; uncertainty whether any products that may be
generated in our cell-based therapeutics programs will prove clinically safe and effective;
uncertainty whether we will achieve significant revenue from product sales or become profitable;
uncertainties regarding our obligations with respect to our former facilities in Rhode Island;
obsolescence of our technologies; competition from third parties; intellectual property rights of
third parties; litigation risks; 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 Risk Factors in Part II, Item
1A of this report and Part I, Item 1A included in our Annual Report on Form 10-K for the fiscal
year ended December 31, 2009.
Overview
The Company
We are engaged in researching, developing, and commercializing stem cell therapeutics and
technologies for stem cell-based research, drug discovery and development. Our research and
development (R&D) efforts primarily support our therapeutic product programs, where we are engaged
in identifying and developing potential cell-based therapeutics which can either restore or support
organ function. In particular, since we relocated our corporate headquarters to California in 1999,
our R&D efforts have been directed at refining our methods for identifying, isolating, culturing,
and purifying the human neural stem cell and human liver engrafting cells (hLEC) and developing
these as potential cell-based therapeutics for the central nervous system (CNS) and the liver,
respectively. In our CNS Program, our HuCNS-SC® product candidate (purified human neural
stem cells) is currently in clinical development for two neurodegenerative brain disorders, and our
goal is to initiate clinical testing of our HuCNS-SC cells for spinal cord injury and degenerative
retinal disorders in 2011 and 2012, respectively. We have completed a six patient Phase I clinical
trial in infantile and late infantile neuronal ceroid lipofuscinosis (NCL), a lysomal storage
disorder often referred to as Batten disease. The data from this trial showed that the HuCNS-SC
cells were well tolerated and there was evidence of engraftment and long-term survival of the
cells. In October 2010, we initiated a second clinical trial in NCL to further assess the safety of
HuCNS-SC cells and to examine their ability to affect the progression of the disease. We are also
currently conducting a Phase I clinical trial to assess the safety and preliminary effectiveness of
HuCNS-SC cells as a treatment for Pelizeaus-Merzbacher Disease (PMD), a myelination disorder in the
brain. Two of the four planned patients for this trial have been enrolled and transplanted with our
HuCNS-SC cells, and we anticipate completing enrollment in early 2011. In our Liver Program, we
have identified a subset of our human liver engrafting cells which we believe may be a candidate
for product development, and we are working to purify and characterize this subset. We have also
conducted research on several other cell types and in other areas, which could lead to other
possible product candidates, process improvements or further research activities. For a brief
description of our significant therapeutic research and development programs, see Overview
Research
20
and Development Programs in the Business Section of Part I, Item 1 included in our Annual
Report on Form 10-K for the fiscal year ended December 31, 2009.
We are also engaged in developing and commercializing applications of our technologies to
enable stem cell-based research, which we believe represent nearer-term commercial opportunities.
Our portfolio of technologies includes cell technologies relating to embryonic stem cells, induced
pluripotent stem (iPS) cells, and tissue-derived (adult) stem cells; expertise and infrastructure
for providing cell-based assays for drug discovery; a cell culture products business; and an
intellectual property portfolio with claims relevant to cell processing, reprogramming and
manipulation, as well as to gene targeting and insertion. Many of our enabling technologies were
acquired in April 2009 as part of our acquisition of the operations of Stem Cell Sciences Plc
(SCS). See Note 4, Acquisition of SCS Operations, in the Notes to Consolidated Financial
Statements in Part I, Item 1 of this Form 10-Q for further information.
We have not derived any revenue or cash flows from the sale or commercialization of any
products except for license revenue for certain of our patents and revenue from the sale of
proprietary cell culture products for use in research. As a result, we have incurred annual
operating losses since inception and expect to incur substantial operating losses in the future.
Therefore, we are dependent upon external financing from equity and debt offerings and revenue from
collaborative research arrangements with corporate sponsors to finance our operations. We have no
such collaborative research arrangements at this time and there can be no assurance that such
financing or partnering revenue will be available when needed or on terms acceptable to us.
Before we can derive revenue or cash inflows from the commercialization of any of our
therapeutic product candidates, we will need to: (i) conduct substantial in vitro testing and
characterization of our proprietary cell types, (ii) undertake preclinical and clinical testing for
specific disease indications; (iii) develop, validate and scale-up manufacturing processes to
produce these cell-based therapeutics, and (iv) obtain required regulatory approvals. These steps
are risky, expensive and time consuming.
Overall, we expect our R&D expenses to be substantial and to increase for the foreseeable
future as we continue the development and clinical investigation of our current and future product
candidates. However, expenditures on R&D programs are subject to many uncertainties, including
whether we develop our product candidates with a partner or independently. We cannot forecast with
any degree of certainty whether our current product candidates will be subject to future
collaboration, when such collaboration agreements will be secured, if at all, and to what degree
such arrangements would affect our development plans and capital requirements. In addition, there
are numerous factors associated with the successful commercialization of any of our cell-based
therapeutics, including future trial design and regulatory requirements, many of which cannot be
determined with accuracy at this time given the stage of our development and the novel nature of
stem cell technologies. The regulatory pathways, both in the United States and internationally, are
complex and fluid given the novel and, in general, clinically unproven nature of stem cell
technologies. At this time, due to such uncertainties and inherent risks, we cannot estimate in a
meaningful way the duration of, or the costs to complete, our R&D programs or whether, when or to
what extent we will generate revenues or cash inflows from the commercialization and sale of any of
our therapeutic product candidates. While we are currently focused on advancing each of our product
development programs, our future R&D expenses will depend on the determinations we make as to the
scientific and clinical prospects of each product candidate, as well as our ongoing assessment of
the regulatory requirements and each product candidates commercial potential.
Given the early stage of development of our therapeutic product candidates, any estimates of
when we may be able to commercialize one or more of these products would not be meaningful.
Moreover, any estimate of the time and investment required to develop potential products based upon
our proprietary HuCNS-SC and hLEC technologies will change depending on the ultimate approach or
approaches we take to pursue them, the results of preclinical and clinical studies, and the content
and timing of decisions made by the FDA and other regulatory authorities. There can be no assurance
that we will be able to develop any product successfully, or that we will be able to recover our
development costs, whether upon commercialization of a developed product or otherwise. We cannot
provide assurance that any of these programs will result in products that can be marketed or
marketed profitably. If certain of our development-stage programs do not result in commercially
viable products, our results of operations could be materially adversely affected.
The research markets served by our enabling technologies are highly competitive, complex and
dynamic. Technological advances and scientific discoveries have accelerated the pace of change in
biological research, and stem cell technologies have been evolving
21
particularly fast. We compete mainly by focusing on specialty cell culture products and
cell-based assays, which are custom designed for use in stem cell-based research, where we believe
our expertise, intellectual property and reputation give us competitive advantage. We believe that,
in this particular market niche, our products and technologies offer customers specific advantages
over those offered by our competitors. We compete by offering innovative, quality-controlled
products, consistently made and designed to produce reproducible results. We continue to make
investments in research and development, quality management, quality improvement, and product
innovation. There can be no assurance that we will have sufficient resources to continue to make
such investments. For the nine-month period ended September 30, 2010, we generated revenues from
the sale of specialty cell culture products of approximately $318,000. There can be no assurance
that we will be able to continue to generate such revenues in the future.
Significant Events
In August 2010, we published new preclinical data demonstrating that our proprietary human
neural stem cells restore lost motor function in mice with chronic spinal cord injury. This was
the first published study to show that human neural stem cells can restore mobility even when
administered at time points beyond the acute phase of trauma, suggesting the prospect of treating a
much broader population of injured patients than previously demonstrated. This study, entitled
Human Neural Stem Cells Differentiate and Promote Locomotor Recovery in an Early Chronic Spinal
Cord Injury NOD-scid Mouse Model, was published in the international peer-reviewed journal PLoS
ONE.
In August 2010, we were notified by Nasdaq that the closing bid price of our common stock had
been below $1.00 per share for 30 consecutive business days, and therefore we did not meet the
requirements for continued listing on the Nasdaq Global Market. In accordance with Nasdaq rules, we
have 180 calendar days, or until February 8, 2011, to regain compliance with this requirement. To
do so, the closing bid price of our common stock must be $1.00 per share or higher for a minimum of
ten consecutive business days. If compliance is not achieved by February 8, 2011, Nasdaq will
notify us that our shares are subject to delisting from the Nasdaq Global Market. At that point,
our options include applying for an extension of the compliance period or an appeal to a Nasdaq
Listing Qualifications Panel. There can be no assurance that we will be able to regain or maintain
compliance with the minimum bid price rule or other listing criteria or that an appeal, if taken,
would be successful.
In August 2010, independent researchers used our technology to achieve the first-ever
genetically engineered rat derived from rat embryonic stem (ES) cells. This study, published in the
international peer-reviewed journal Nature, creates the potential for the types of genetic
manipulations previously only possible in mice, and for modeling a broader range of human diseases
with the rat. While both mice and rats are used as models of human disease, the rat is the
preferred species because certain aspects of its physiology, behavior and metabolism are closer to
the human. This work validates intellectual property owned by us, including patents covering both
rat ES and rat induced pluripotent stem cells as well as genetically engineered rats derived from
these cells.
In October 2010, we announced that two
of four planned patients in our Phase I clinical trial in PMD had been enrolled and transplanted with our HuCNS-SC cells. PMD
is a fatal myelination disorder that afflicts male children and this trial is the first to evaluate purified neural stem cells
as a potential treatment for a myelination disorder. This trial is
being conducted at UCSF Benioff Childrens Hospital.
In October 2010, we initiated a second clinical trial of our HuCNS-SC cells in infantile and
late infantile NCL. The trial is designed to evaluate the safety and preliminary efficacy of the
cells, and is expected to enroll six patients with less advanced stages of the disease than those
who enrolled in our Phase I NCL trial. The trial is being conducted at Oregon Health & Science
University Doernbecher Childrens Hospital, a leading medical center with nationally recognized
programs in pediatric neurology and neurosurgery.
In
October 2010, we were approved to receive four cash grants of
approximately $978,000, in aggregate, for work related
to both our CNS and Liver Programs. These grants were certified under the federal governments Qualifying Therapeutic Discovery Projects Program.
Critical Accounting Policies and the Use of Estimates
The accompanying discussion and analysis of our financial condition and results of operations
are based on our condensed consolidated financial statements and the related disclosures, which
have been prepared in accordance with U.S. GAAP. The preparation of these condensed consolidated
financial statements requires management to make estimates, assumptions, and judgments that affect
the reported amounts in our condensed consolidated financial statements and accompanying notes.
These estimates form the basis for making judgments about the carrying values of assets and
liabilities. We base our estimates and judgments on historical experience and on various other
assumptions that we believe to be reasonable under the circumstances, and we have established
internal controls related to the preparation of these estimates. Actual results and the timing of
the results could differ materially from these estimates.
22
Stock-Based Compensation
U.S. GAAP requires us to recognize expense related to the fair value of our stock-based
payment awards, including employee stock options and restricted stock units. Under the provisions
of U.S. GAAP, employee stock-based payment is estimated at the date of grant based on the awards
fair value using the Black-Scholes-Merton (Black-Scholes) option-pricing model and is recognized as
expense ratably over the requisite service period. The Black-Scholes option-pricing model requires
the use of certain assumptions, the most significant of which are our estimates of the expected
volatility of the market price of our stock and the expected term of the award. Our estimate of the
expected volatility is based on historical volatility. The expected term represents our estimated
period during which our stock-based awards remain outstanding. We estimate the expected term based
on historical experience of similar awards, giving consideration to the contractual terms of the
awards, vesting requirements, and expectation of future employee behavior, including post-vesting
terminations.
We review our valuation assumptions at each grant date and, as a result, our assumptions in
future periods may change. As of September 30, 2010, we expect to recognize approximately
$7,595,000 of compensation expense related to unvested stock-based awards over a weighted-average
period of 2.8 years. See also Note 6, Stock-Based Compensation, in the notes to condensed
consolidated financial statements of Part I, Item 1 of this Form 10-Q for further information.
Wind-down expenses Rhode Island
In connection with exiting our research and manufacturing operations in Lincoln, Rhode Island,
and the relocation of our corporate headquarters and remaining research laboratories to California
in October 1999, we provided a reserve for our estimate of the exit cost obligation. The reserve
reflects estimates of the ongoing costs of our former scientific 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 our 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 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 over the last seven years (2003 through 2009) was approximately 74%, varying from 62% to
89%. As of September 30, 2010, based on current information available to management, the vacancy
rate is projected to be approximately 74% for 2010 and 2011, and approximately 70% from 2011
through the end of the lease. These estimates are based on actual occupancy as of September 30,
2010, 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 the remainder of the lease had been 5% higher or lower at September 30, 2010, then the
reserve would have increased or decreased by approximately $90,000. Similarly, a 5% increase or
decrease in the operating expenses for the facility would have increased or decreased the reserve
by approximately $77,000, and a 5% increase or decrease in the assumed average rental charge per
square foot would have decreased or increased the reserve by approximately $27,000. Management does
not wait for specific events to change its estimate, but instead uses its best efforts to
anticipate them on a quarterly
23
basis. See Note 7 Wind-Down Expenses, in the notes to condensed consolidated financial
statements of Part I, Item 1 of this Form 10-Q for further information.
Wind-down expenses Australia
On April 1, 2009, as part of our acquisition of the SCS operations, we acquired operations
near Melbourne, Australia. In order to reduce operating complexity and expenses, we made the
decision to close our site in Australia and consolidate personnel and programs to our Cambridge,
U.K. and Palo Alto, California sites. U.S. GAAP requires that a liability for a cost associated
with an exit or disposal activity be recognized when the liability is incurred. In accordance with
U.S. GAAP requirements, at June 30, 2009, we established a short-term reserve of approximately
$310,000 for the estimated costs to close down and exit our Australia operations. The reserve
reflects the estimated cost for an early termination of our facility lease in Australia (with an
original termination date of December 31, 2010), employee termination benefits and other
liabilities associated with the wind-down and relocation of our operations in Australia. The
facility lease agreement has been terminated and our operations in Australia have been relocated to
Cambridge, U.K. and Palo Alto, California. We recorded actual expenses of approximately $10,000 and
$236,000 against this reserve in the nine-month periods ended September 30, 2010 and 2009,
respectively. As of September 30, 2010, we believe that the estimated remaining balance of
approximately $69,000 in our reserve will be sufficient to cover any remaining exit costs.
Business Combinations
The operating results of acquired companies or operations are included in our consolidated
financial statements starting on the date of acquisition. Goodwill is recorded at the time of an
acquisition and is calculated as the difference between the aggregate consideration paid for an
acquisition and the fair value of the net tangible and intangible assets acquired. Accounting for
acquisitions requires extensive use of accounting estimates and judgments to allocate the purchase
price to the fair value of the net tangible and intangible assets acquired, including in-process
research and development. Goodwill and intangible assets deemed to have indefinite lives are not
amortized but are subject to annual impairment tests. If the assumptions and estimates used to
allocate the purchase price are not correct, or if business conditions change, purchase price
adjustments or future asset impairment charges could be required. We test goodwill for impairment
on an annual basis or more frequently if we believe indicators of impairment exist. Impairment
evaluations involve management estimates of asset useful lives and future cash flows. Significant
management judgment is required in the forecasts of future operating results that are used in the
evaluations. It is possible, however, that the plans and estimates used may be incorrect. If our
actual results, or the plans and estimates used in future impairment analysis, are lower than the
original estimates used to assess the recoverability of these assets, we could incur impairment
charges in a future period.
Results of Operations
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 clinical studies, research
collaborations and development programs for both cell-based therapeutic products and research
tools, unpredictable or unanticipated manufacturing and supply costs, unanticipated capital
expenditures necessary to support our business, expenses arising out of the integration of the
acquired SCS operations, developments in on-going patent protection and litigation, the on-going
expenses to lease and maintain our Rhode Island facilities, and the increasing costs associated
with operating our California and Cambridge, U.K. facilities.
We acquired the operations of SCS on April 1, 2009, and have consolidated such operations
since that date (See Note 4. Acquisition of Stem Cell Sciences Plc (SCS) Operations, in the notes
to condensed consolidated financial statements of Part I, Item1 of this Form 10-Q for further
information). Consequently, our results of operations for the nine-month period ended September 30,
2010 will include the acquired operations for the full nine months, but will only include them in
the second quarter and third quarter of 2009 for the nine-month period in 2009.
24
Revenue and Cost of Product Sales
Revenue for the three and nine-month periods ended September 30, 2010, as compared with the
same periods in 2009, is summarized in the table below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended, |
|
|
|
|
|
|
|
|
|
|
Nine months ended, |
|
|
|
|
|
|
September 30 |
|
|
Change in 2010 versus 2009 |
|
|
September 30 |
|
|
Change in 2010 versus 2009 |
|
|
|
2010 |
|
|
2009 |
|
|
$ |
|
|
% |
|
|
2010 |
|
|
2009 |
|
|
$ |
|
|
% |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing agreements and grants |
|
$ |
123,693 |
|
|
$ |
98,806 |
|
|
$ |
24,887 |
|
|
|
25 |
% |
|
$ |
409,092 |
|
|
$ |
300,260 |
|
|
$ |
108,832 |
|
|
|
36 |
% |
Product sales |
|
|
129,826 |
|
|
|
154,362 |
|
|
|
(24,536 |
) |
|
|
(16 |
)% |
|
|
318,831 |
|
|
|
274,961 |
|
|
|
43,870 |
|
|
|
16 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
|
253,519 |
|
|
|
253,168 |
|
|
|
351 |
|
|
|
0 |
% |
|
|
727,923 |
|
|
|
575,221 |
|
|
|
152,702 |
|
|
|
27 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales |
|
|
35,914 |
|
|
|
141,453 |
|
|
|
(105,539 |
) |
|
|
(75 |
)% |
|
|
104,538 |
|
|
|
200,979 |
|
|
|
(96,441 |
) |
|
|
(48 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Profit |
|
$ |
217,605 |
|
|
$ |
111,715 |
|
|
$ |
105,890 |
|
|
|
95 |
% |
|
$ |
623,385 |
|
|
$ |
374,242 |
|
|
$ |
249,143 |
|
|
|
67 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue in the third quarter of 2010 was approximately $254,000, which was flat compared
to the total revenue of approximately $253,000 in the third quarter of 2009..
Third quarter ended September 30, 2010 versus third quarter ended September 30, 2009.
Licensing and grant revenue increased approximately $25,000, or 25%, in 2010 compared to 2009,
which was primarily attributable to higher grant revenue at our acquired operations. In the third
quarter of 2010, revenue from product sales was approximately $25,000, or 16%, lower as compared to
the same period in 2009. This decrease was primarily attributable to large orders for certain
products in the third quarter of 2009 that have not recurred in the third quarter of 2010.
Total revenue in the nine-month period ended September 30, 2010 was approximately $728,000,
which was 27% higher than total revenue of approximately $575,000 in the similar period of 2009.
Nine-month period ended September 30, 2010 versus nine-month period ended September 30, 2009.
Licensing and grant revenue for the nine-month period ended September 30, 2010, was approximately
$109,000, or 36%, higher compared to the same period in 2009. This increase was primarily
attributable to the nine-month period of 2010 including three quarters of revenue recognized and
consolidated in connection with our acquired operations, as compared to only two quarters for the
same period in 2009. In the nine-month period ended September 30, 2010, we recognized approximately
$319,000 as revenue from product sales and $105,000 as cost of product sales, compared to
approximately $275,000 as revenue from product sales and $201,000 as cost of products sales, for
the same period in 2009. The increase in the first nine months of 2010 compared to the similar
period in 2009 was primarily attributable to the consolidation of three quarters of product sales
from our acquired operations in the U.K. in the nine-month period of 2010 compared to two quarters
for the same period in 2009.
Operating Expenses
Operating expenses for the three and nine-month periods ended September 30, 2010, as compared
with the same periods in 2009, are summarized in the table below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended, |
|
|
Change in 2010 versus |
|
|
Nine months ended, |
|
|
Change in 2010 versus |
|
|
|
September 30 |
|
|
2009 |
|
|
September 30 |
|
|
2009 |
|
|
|
2010 |
|
|
2009 |
|
|
$ |
|
|
% |
|
|
2010 |
|
|
2009 |
|
|
$ |
|
|
% |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research & development |
|
$ |
5,200,612 |
|
|
$ |
4,988,569 |
|
|
$ |
212,043 |
|
|
|
4 |
% |
|
$ |
15,096,354 |
|
|
$ |
14,278,958 |
|
|
$ |
817,396 |
|
|
|
6 |
% |
Selling, general & administrative |
|
|
2,017,872 |
|
|
|
2,111,838 |
|
|
|
(93,966 |
) |
|
|
(4 |
)% |
|
|
6,889,292 |
|
|
|
6,852,724 |
|
|
|
36,568 |
|
|
|
1 |
% |
Wind-down expenses |
|
|
|
|
|
|
(5,679 |
) |
|
|
5,679 |
|
|
|
(100 |
)% |
|
|
291,168 |
|
|
|
539,821 |
|
|
|
(248,653 |
) |
|
|
(46 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
$ |
7,218,484 |
|
|
$ |
7,094,728 |
|
|
$ |
123,756 |
|
|
|
2 |
% |
|
$ |
22,276,814 |
|
|
$ |
21,671,503 |
|
|
$ |
605,311 |
|
|
|
3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25
Research and Development Expenses
Our R&D expenses consist primarily of salaries and related personnel expenses, costs
associated with clinical trials and regulatory submissions; costs associated with preclinical
activities such as toxicology studies; costs associated with cell processing and process
development; certain patent-related costs such as licensing; facilities related costs such as
depreciation; lab equipment and supplies. Clinical trial expenses include payments to vendors such
as clinical research organizations, contract manufacturers, clinical trial sites, laboratories for
testing clinical samples and consultants. Cumulative R&D costs incurred since we refocused our
activities on developing cell-based therapeutics (fiscal years 2000 through the three months ended
September 30, 2010) were approximately $121 million. Over this period, the majority of these
cumulative costs were related to: (i) characterization of our proprietary HuCNS-SC cells, (ii)
expenditures for toxicology and other preclinical studies, preparation and submission of
applications to regulatory agencies to conduct clinical trials and obtaining regulatory clearance
to initiate such trials, all with respect to our HuCNS-SC cells, (iii) preclinical studies and
development of our human liver engrafting cells, (iv) costs associated with cell processing and
process development, and (v) costs associated with our clinical studies.
We use and manage our R&D resources, including our employees and facilities, across various
projects rather than on a project-by-project basis for the following reasons. The allocations of
time and resources change as the needs and priorities of individual projects and programs change,
and many of our researchers are assigned to more than one project at any given time. Furthermore,
we are exploring multiple possible uses for each of our proprietary cell types, so much of our R&D
effort is complementary to and supportive of each of these projects. Lastly, much of our R&D effort
is focused on manufacturing processes, which can result in process improvements useful across cell
types. We also use external service providers to assist in the conduct of our clinical trials, to
manufacture certain of our product candidates and to provide various other R&D related products and
services. Many of these costs and expenses are complementary to and supportive of each of our
programs. Because we do not have a development collaborator for any of our product programs, we are
currently responsible for all costs incurred with respect to our product candidates.
R&D expenses totaled approximately $5,201,000 in the third quarter of 2010 compared with
$4,989,000 in the third quarter of 2009.
Third quarter ended September 30, 2010 versus third quarter ended September 30, 2009. R&D
expenses increased approximately $212,000, or 4%, in 2010 compared to 2009. This increase was
primarily attributable to (i) an increase of approximately $94,000 in R&D expenses related to
developing applications of our cell technologies for stem cell based research and drug discovery,
(ii) an increase of approximately $63,000 in expenses related to our clinical trials, and (iii) an
increase of approximately $206,000 in expenses related to continuing preclinical studies of our
HuCNS-SC cells for spinal cord injury, retinal disorders and other potential indications, testing
and characterization of our proprietary cells, and process development. These increased expenses
were partially offset by a decrease in personnel expenses of approximately $151,000, primarily
attributable to lower stock-based compensation expense.
R&D expenses totaled approximately $15,096,000 in the nine-month period ended September 30,
2010, compared with $14,279,000 for the same period in 2009.
Nine-month period ended September 30, 2010 versus nine-month period ended September 30, 2009.
R&D expenses increased approximately $817,000, or 6%, in 2010 compared to 2009. This increase was
primarily attributable to (i) an increase of approximately $563,000 in R&D expenses related to
consolidation of three quarters of our acquired operations in the nine-month period of 2010
compared to two quarters for the same period in 2009, (ii) an increase of approximately $316,000
in expenses related to our clinical trials, and (iii) an increase of approximately $115,000 in
expenses related to our continuing preclinical studies of our HuCNS-SC cells as a potential
treatment for spinal cord injury, retinal disorders and other potential indications. These
increased expenses were partially offset by (i) a decrease in personnel expenses of approximately
$129,000, primarily attributable to lower stock-based compensation expense, and (ii) a decrease in
other expenses of approximately $48,000.
26
Selling, General and Administrative Expenses
Selling, general and administrative (SG&A) expenses are primarily comprised of salaries,
benefits and other staff related costs associated with sales and marketing, finance, legal, human
resources, information technology, and other administrative personnel, facilities and overhead
costs, external legal and other external general and administrative services.
SG&A expenses totaled approximately $2,018,000 in the third quarter of 2010 compared with
approximately $2,112,000 in the third quarter of 2009.
Third quarter ended September 30, 2010 versus third quarter ended September 30, 2009. SG&A
expenses decreased approximately $94,000, or 4%, in 2010 compared to 2009. This decrease was
primarily attributable to (i) a decrease of approximately $170,000 in legal and consulting expenses
at our U.K. operations as we consolidated our activities at the site, and (ii) a decrease of
approximately $89,000 in personnel expenses primarily attributable to a decrease in stock-based
compensation expense. These decreased expenses were partially offset by (i) an increase in
external service expenses of approximately $139,000, primarily legal fees for our litigation
against Neuralstem (see also Note 8, Commitments and Contingencies, in the notes to condensed
consolidated financial statements of Part I, Item 1 of this Form 10-Q for further information), and
(ii) an increase of approximately $26,000 in other expenses.
SG&A expenses totaled approximately $6,889,000 in the nine-month period ended September 30,
2010, compared with $6,853,000 for the same period in 2009.
Nine-month period ended September 30, 2010 versus nine-month period ended September 30, 2009.
SG&A expenses increased approximately $36,000, or 1%, from 2009 to 2010. This was primarily
attributable to (i) an increase of approximately $224,000 in SG&A expense related to consolidation
of acquired operations for three quarters in the nine-month period in 2010 compared to two quarters
for the same period in 2009, (ii) an increase in external services of approximately $179,000,
mainly due to an increase in recruiting and investor relations expenses, and (iii) an increase of
approximately $51,000 in other expenses. These increased expenses were partially offset by (i) a
decrease in personnel expenses of approximately $249,000, primarily attributable to lower
stock-based compensation expense, and (ii) a decrease of approximately $169,000 in legal and
consulting expenses at our U.K. operations as we consolidated our activities at the site.
Wind-down Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended, |
|
|
Nine months ended, |
|
|
|
September 30 |
|
|
September 30 |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Rhode Island |
|
$ |
|
|
|
$ |
(5,679 |
) |
|
$ |
291,168 |
|
|
$ |
229,552 |
|
Australia |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
310,269 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total wind-down expenses |
|
$ |
|
|
|
$ |
(5,679 |
) |
|
$ |
291,168 |
|
|
$ |
539,821 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rhode Island
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. The reserve was approximately $4,433,000 at December 31, 2009. Payments net of subtenant
income of approximately $303,000 for the third quarter and $898,000 for the nine-month period ended
September 30, 2010, were recorded against this reserve. At September 30, 2010, we re-evaluated the
estimate and did not make an adjustment to the reserve of approximately $3,673,000 by recording any
additional wind-down expenses. For the similar period in 2009, payments recorded against the
reserve were approximately $286,000 in the third quarter of 2009, and $910,000 for the nine-month
period ended September 30, 2009, and to adjust the reserve, we recorded a credit of approximately
$6,000 in the third quarter of 2009. 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
27
the reserve, as necessary. See Note 7 Wind-down expenses, in the notes to condensed
consolidated financial statements of Part I, Item 1 of this Form 10-Q for further information.
Australia
On April 1, 2009, as part of our acquisition of the SCS operations, we acquired operations
near Melbourne, Australia. In order to reduce operating complexity and expenses, we made the
decision to close our site in Australia and consolidate personnel and programs to our Cambridge,
U.K. and Palo Alto, California sites. U.S. GAAP requires that a liability for a cost associated
with an exit or disposal activity be recognized when the liability is incurred. In accordance with
U.S. GAAP requirements, at September 30, 2009, we established a short-term reserve of approximately
$310,000 for the estimated costs to close down and exit our Australia operations. The reserve
reflects the estimated cost to terminate our facility lease in Australia (with an original
termination date of December 31, 2010), employee termination benefits and other liabilities
associated with the wind-down and relocation of our operations in Australia. The facility lease
agreement has been terminated and our operations in Australia have been relocated to Cambridge,
U.K. and Palo Alto, California. We recorded actual expenses of approximately $10,000 and $236,000
against this reserve in 2010 and 2009 respectively. No further adjustments were made to the reserve
balance as we believe that the estimated remaining balance of approximately $69,000 in our reserve
at September 30, 2010, will be sufficient to cover any remaining exit costs.
Other Income (Expense)
Other income totaled approximately $1,449,000 in the third quarter of 2010 compared with other
income of $1,830,000 in the same period of 2009, and other income of $5,367,000 for the nine-month
period ended September 30, 2010 compared with other expense of approximately $495,000 for the
nine-month period ended September 30, 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended, |
|
|
Change in 2010 versus |
|
|
Nine months ended, |
|
|
Change in 2010 versus |
|
|
|
September 30 |
|
|
2009 |
|
|
September 30 |
|
|
2009 |
|
|
|
2010 |
|
|
2009 |
|
|
$ |
|
|
% |
|
|
2010 |
|
|
2009 |
|
|
$ |
|
|
% |
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on sale of marketable securities |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
397,866 |
|
|
$ |
(397,866 |
) |
|
|
(100 |
)% |
Change in fair value of warrant liability |
|
|
1,227,585 |
|
|
|
1,830,414 |
|
|
|
(602,829 |
) |
|
|
(33 |
)% |
|
|
5,184,304 |
|
|
|
(822,517 |
) |
|
|
6,006,821 |
|
|
|
(730 |
)% |
Interest income |
|
|
10,911 |
|
|
|
5,531 |
|
|
|
5,380 |
|
|
|
97 |
% |
|
|
24,814 |
|
|
|
55,816 |
|
|
|
(31,002 |
) |
|
|
(56 |
)% |
Interest expense |
|
|
(22,221 |
) |
|
|
(27,613 |
) |
|
|
5,392 |
|
|
|
(20 |
)% |
|
|
(72,775 |
) |
|
|
(84,863 |
) |
|
|
12,088 |
|
|
|
(14 |
)% |
Other income (expense), net |
|
|
232,348 |
|
|
|
29,940 |
|
|
|
202,408 |
|
|
|
676 |
% |
|
|
230,408 |
|
|
|
(41,694 |
) |
|
|
272,102 |
|
|
|
653 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income |
|
$ |
1,448,623 |
|
|
$ |
1,838,272 |
|
|
$ |
(389,649 |
) |
|
|
(21 |
)% |
|
$ |
5,366,751 |
|
|
$ |
(495,392 |
) |
|
$ |
5,862,143 |
|
|
|
(1,183 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on Sale of Marketable Equity Securities
In the first quarter of 2009, we sold in aggregate 2,900,000 shares of ReNeuron and received
proceeds of approximately $510,000. We recognized a realized gain of approximately $398,000 for
that quarter. We did not sell any ReNeuron shares during the nine-month period ended September 30,
2010. We owned 1,921,924 ordinary shares of ReNeuron at September 30, 2010. See Note 2 Financial
Instruments in the notes to condensed consolidated financial statements of Part I, Item 1 of this
Form 10-Q for further information.
28
Change in Fair Value of Warrant Liability
As part of both our November 2008 and November 2009 financings, we issued warrants with five year
terms to purchase 10,344,828 and 4,000,000 shares of our common stock at $2.30 and $1.50 per share,
respectively. As the contracts include the possibility of net-cash settlement, we are required to
classify the fair value of the warrants issued as a liability, with subsequent changes in fair
value to be recorded as income (loss) on change in fair value of warrant liability. The fair value
of the warrants is determined using the Black-Scholes option pricing model and is affected by
changes in inputs to that model including our stock price, expected stock price volatility, the
contractual term, and the risk-free interest rate. Our estimate of the expected volatility is based
on historical volatility. The expected term of the warrants is based on the time to expiration of
the warrants from the date of measurement. Risk-free interest rates are derived from the yield on
U.S. Treasury debt securities. We will continue to classify the fair value of the warrants as a
liability until the warrants are exercised, expire or are amended in a way that would no longer
require these warrants to be classified as a liability. See Note 9 Warrant Liability in the notes
to condensed consolidated financial statements of Part I, Item 1 of this Form 10-Q for further
information.
Interest Income
Interest income in the three and nine-month periods ended September 30, 2010 and 2009 were not
significant due to low average yields.
Interest Expense
Interest expense in the third quarter of 2010 decreased by approximately $5,000 or 20% when
compared to the same period in 2009. Interest expense for the nine-month period ended September 30,
2010 decreased by approximately $12,000, or 14%, when compared to the same period in 2009.
Interest expense is primarily for outstanding debt and capital lease balances. See Note 8
Commitment and Contingencies, in the notes to condensed consolidated financial statements of Part
I, Item 1 of this Form 10-Q for further information.
Other income (expense), net
Other income for the three and nine month periods in 2010 includes approximately $227,000 from
final settlement of various claims related to the SCS acquisition. On April 1, 2009, we acquired
the operations of Stem Cell Sciences Plc (SCS, now known as Asset Realization Company Ltd.) As
consideration, we issued 2,650,000 shares of our common stock with a closing price of $1.67 per
share and waived certain commitments of SCS to repay approximately $709,000 in principal and
accrued interest owed to us. Pursuant to the acquisition agreement, 20% of the 2,650,000 shares
were placed into an escrow for a twelve month period to satisfy any indemnification obligations
owed to us by SCS. On August 19, 2010, we entered into a settlement agreement with SCS in which
the parties agreed to the release of half the escrowed shares to SCS and half to us in full
satisfaction of our claims for indemnification, and both parties waived all other claims, known and
unknown, against the other. The 265,000 shares returned to us are being treated as retired and no
longer outstanding. We have recorded approximately $227,000 as other income, which was the value
of these shares based on the closing price of $0.91 per share on August 19, 2010, and net of
amounts already accrued for potential claims against the escrowed shares.
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, revenue from collaborative
agreements, research grants, license fees, and interest income.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
Change |
|
|
2010 |
|
2009 |
|
$ |
|
% |
Cash and cash equivalents |
|
$ |
24,554,574 |
|
|
$ |
38,617,977 |
|
|
$ |
(14,063,403 |
) |
|
|
(36 |
)% |
29
In summary, our cash flows were:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended September 30, |
|
Change in 2010 versus 2009 |
|
|
2010 |
|
2009 |
|
$ |
|
% |
Net cash used in operating activities |
|
$ |
(19,655,257 |
) |
|
$ |
(18,491,364 |
) |
|
$ |
(1,163,893 |
) |
|
|
6 |
% |
Net cash used in investing activities |
|
$ |
(766,907 |
) |
|
$ |
(1,048,348 |
) |
|
$ |
281,441 |
|
|
|
(27 |
)% |
Net cash provided by financing activities |
|
$ |
6,380,033 |
|
|
$ |
17,936,157 |
|
|
$ |
(11,556,124 |
) |
|
|
(64 |
)% |
Net Cash Used in Operating Activities
Net cash used in operating activities in the first nine months of 2010 increased by
approximately $1,164,000, or 6%, when compared to the same period of 2009. Cash used in operating
activities is primarily driven by our net loss as adjusted for non-cash charges and differences in
the timing of operating cash flows.
Net Cash Provided by (Used in) Investing Activities
The decrease of approximately $281,000, or 27%, from 2009 to 2010 for net cash used in
investing activities, was primarily attributable to a net purchase of marketable debt securities of
approximately$468,000 in the first nine months of 2009 as compared to
none in 2010, the decrease was partially offset by an increase in capital expenditures of
approximately $266,000 in the first nine months of 2010 as compared to a similar period in 2009.
Net Cash Provided by Financing Activities
Net cash provided by financing activities in the first nine months of 2010 decreased
approximately $11,556,000, or 64%, compared to the same period in 2009 primarily due to lower net
proceeds from sales of common stock. In the first nine months of 2010, we received aggregate net
proceeds of approximately $7,015,000 from the sale of 1,192,200 shares of common stock at an
average price of $1.16 per share under various sales agreements and the sale of 7,000,000 shares at
$0.865 per share to an institutional investor. In the first nine months of 2009, we received net
proceeds of approximately $17,695,000 from the sale of 9,817,400 shares of common stock at an
average price of $1.88 per share under a sales agreement. See Note 10 Common Stock in the notes
to condensed consolidated financial statements of Part I, Item 1 of this Form 10-Q for further
information on the financing activities in 2010.
Listed below are key financing transactions entered into by us in the prior three years:
|
|
|
In November 2009, we sold 10,000,000 units to institutional investors at a price of
$1.25 per unit, for gross proceeds of $12,500,000. The units, each of which consisted of
one share of common stock and a warrant to purchase 0.4 shares of common stock at an
exercise price of $1.50 per share, were offered as a registered direct offering under a
shelf registration statement previously filed with and declared effective by the
Securities and Exchange Commission. We received total proceeds net of offering expenses
and placement agency fees of approximately $11,985,000. |
|
|
|
|
In June 2009, we filed a prospectus supplement that relates to the issuance and sale
of up to $30,000,000 of our common stock, from time to time through a sales agreement with
a sales agent. The prospectus is a part of a shelf registration statement that we filed
with the SEC on June 25, 2008. Under this shelf registration process, we may offer to sell
in one or more offerings equity or debt securities up to a total dollar amount of
$100,000,000. In 2009, we sold a total of 1,830,000 shares of our common stock under a
June 2009 sales agreement with a sales agent at an average price per share of $1.80 for
gross proceeds of approximately $3,291,000. |
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In November 2008, we sold 13,793,104 units to institutional investors at a price of
$1.45 per unit, for gross proceeds of $20,000,000. The units, each of which consisted of
one share of common stock and a warrant to purchase 0.75 shares of common stock at an
exercise price of $2.30 per share, were offered as a registered direct offering under a
shelf registration statement previously filed with and declared effective by the
Securities and Exchange Commission. We received total proceeds net of offering expenses
and placement agency fees of approximately $18,637,000. |
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In 2007, 2008 and 2009, we sold a total of 10,000,000 shares of our common stock at
an average price per share of $2.06 for gross proceeds of approximately $20,555,000. These
shares were sold under a sales agreement entered into in December 2006, under which up to
10,000,000 shares may be sold from time to time under a shelf registration statement. |
30
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 revenue to achieve or sustain
profitability in the 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 selling, 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. On June 25, 2008 we filed with
the SEC a universal shelf registration statement, declared
effective July 18, 2008, which permits us to issue up to $100 million worth of registered debt
and equity securities. Under this effective shelf registration, we have the flexibility to issue
registered securities, from time to time, in one or more separate offerings or other transactions
with the size, price and terms to be determined at the time of issuance. Registered securities
issued using this shelf may be used to raise additional capital to fund our working capital and
other corporate needs, for future acquisitions of assets, programs or businesses, and for other
corporate purposes. As of November 1, 2010, we had approximately $41 million under our universal
shelf registration statement available for issuing debt or equity securities; approximately $30
million of this $41 million has been reserved for the potential exercise of the warrants issued in
connection with our November 2008 and November 2009 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 needed
at all, or on terms acceptable to us. Lack of necessary funds may require us, among other things,
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. In addition, the decline in economic activity, together with the
deterioration of the credit and capital markets, could have an adverse impact on potential sources
of future financing.
In August 2010, we were notified by Nasdaq that the closing bid price of our common stock had
been below $1.00 per share for 30 consecutive business days, and therefore we did not meet the
requirements for continued listing on the Nasdaq Global Market. In accordance with Nasdaq rules, we
have 180 calendar days, or until February 8, 2011, to regain compliance with this requirement. To
do so, the closing bid price of our common stock must be $1.00 per share or higher for a minimum of
ten consecutive business days. If compliance is not achieved by February 8, 2011, Nasdaq will
notify us that our shares are subject to delisting from the Nasdaq Global Market. At that point,
our options include applying for an extension of the compliance period or an appeal to a Nasdaq
Listing Qualifications Panel. There can be no assurance that we will be able to regain or maintain
compliance with the minimum bid price rule or other listing criteria or that an appeal, if taken,
would be successful.
Commitments
See Note 8, Commitments and Contingencies in the notes to condensed consolidated financial
statements of Part I, Item 1 of this Form 10-Q for further information.
Off-Balance Sheet Arrangements
We have certain contractual arrangements that create potential risk for us and are not
recognized in our Consolidated Balance Sheets. Discussed below are those off-balance sheet
arrangements that have or are reasonably likely to have a material current or future effect on our
financial condition, changes in financial condition, revenue or expenses, results of operations,
liquidity, capital expenditures or capital resources.
31
Operating Leases
We lease various real properties under operating leases that generally require us to pay
taxes, insurance, maintenance, and minimum lease payments. Some of our leases have options to
renew.
Operating Leases California
We currently lease space in an approximately 68,000 square foot facility located at the
Stanford Research Park in Palo Alto, California. The facility includes space for animals,
laboratories, offices, and a GMP (Good Manufacturing Practices) suite. Prior to September 2010, we
leased approximately 68,000 square feet of the facility, and were required to provide a letter of
credit for approximately $778,000, which served as a security deposit for the duration of the lease
term. The letter of credit issued by our financial institution is collateralized by a certificate
of deposit for the same amount, which was reflected as restricted cash in other assets, non-current
on our condensed consolidated balance sheets. In September 2010, we amended our lease to reduce the
area leased to 51,200 square feet, to change the expiry date of the lease term from August 31, 2011
to June 30, 2011, and to reduce the letter of credit that serves as a security deposit to
approximately $389,000 from approximately $778,000. The difference of approximately
$389,000 will be transferred from our restricted cash account to our cash and cash equivalents
account. In connection with this September 2010 lease amendment, we terminated a space-sharing
agreement covering approximately 10,451 square feet of this facility. At September 30, 2010, the
aggregate remaining rent payment under the amended lease is approximately $1,233,000. We recognize
operating lease expense on a straight-line basis. At September 30, 2010, we had prepaid rent
balance of approximately $70,000. At December 31, 2009, we had a deferred rent balance of
approximately $131,000.
In September 2010, we entered into a two-year sublease agreement with Caliper Life Sciences,
Inc., for approximately 13,200 square feet in a facility located in Mountain View, California. We
will pay approximately $695,000 in aggregate as rent over the term of the lease. The lease
contains escalating rent payments, which we recognize as operating lease expense on a straight-line
basis. Deferred rent was approximately $4,000 as of September 30, 2010.
Operating Leases Rhode Island
We continue to have outstanding obligations in regard to our former facilities in Lincoln,
Rhode Island. In 1997, we had entered into a fifteen-year lease for a scientific and administrative
facility in a sale and leaseback arrangement. The lease includes escalating rent payments. At
September 30, 2010, we expect to pay in aggregate, approximately $458,000 in rent and estimated
operating expenses before receipt of sub-tenant income, for the remainder of 2010. At September 30,
2010, we expect to receive, in aggregate, approximately $96,000 in sub-tenant rent and operating
expenses for the remainder of 2010. As a result of the above transactions, our estimated cash
outlay net of sub-tenant rent for the facility will be approximately $362,000 for the remainder of
2010.
Operating Leases United Kingdom
On April 1, 2009, as part of our acquisition of the operations of SCS, we acquired operations
in Cambridge, U.K.. As of April 2009, our wholly-owned subsidiary, Stem Cell Sciences (UK) Ltd, had
two lease agreements for approximately 3,900 square feet of office and lab space in aggregate in
two buildings of the Babraham Research Campus in Cambridge, U.K. One of these two leases, for
approximately 2,000 square feet, expired by its terms on February 28, 2010. The third, for
approximately 1,900 square feet, had an initial term until March 2011, with an option, at our
election, to extend the term for an additional five years. In February 2010, in order to
consolidate our operations into a single building at the research campus, we entered into a new
lease agreement effective March 1, 2010, for approximately 3,240 square feet. The initial term of
this new lease will continue until March 2011, with an option, at our election, to extend the term
for an additional two years. The two currently effective Cambridge leases cover in aggregate
approximately 5,000 square feet. At September 30, 2010, we expect to pay approximately 35,000 GBP
as rental payments for the remainder of 2010 in aggregate for the Cambridge leases. StemCells, Inc.
is a guarantor of Stem Cell Sciences (UK) Ltds obligations under both leases.
With the exception of leases discussed above, 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.
32
Contractual Obligations
In the table below, we set forth our legally binding and enforceable contractual cash
obligations at September 30, 2010:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payable in |
|
|
|
Obligations |
|
|
Payable in (October to |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2015 |
|
|
|
at September |
|
|
December) |
|
|
Payable in |
|
|
Payable in |
|
|
Payable in |
|
|
Payable in |
|
|
and |
|
|
|
30, 2010 |
|
|
2010 |
|
|
2011 |
|
|
2012 |
|
|
2013 |
|
|
2014 |
|
|
Beyond |
|
Operating lease payments(1) |
|
$ |
5,376,184 |
|
|
$ |
841,760 |
|
|
$ |
2,392,527 |
|
|
$ |
1,409,475 |
|
|
$ |
732,422 |
|
|
$ |
|
|
|
$ |
|
|
Capital lease (equipment) |
|
|
110,068 |
|
|
|
18,348 |
|
|
|
73,391 |
|
|
|
18,329 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Bonds Payable (principal & interest)(2) |
|
|
919,344 |
|
|
|
61,912 |
|
|
|
242,321 |
|
|
|
240,666 |
|
|
|
237,593 |
|
|
|
136,852 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual cash obligations |
|
$ |
6,405,596 |
|
|
$ |
922,020 |
|
|
$ |
2,708,239 |
|
|
$ |
1,668,470 |
|
|
$ |
970,015 |
|
|
$ |
136,852 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
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Operating lease payments exclude space-sharing and sub-lease income (see Off-Balance Sheet
Arrangements Operating Leases above for further information), but include rent payments
for our Rhode Island facility that are included as part of our Accrued wind-down expenses in
our condensed consolidated financial statements. See Note 7, Wind-down expenses and Note
8, Commitments and Contingencies in the notes to condensed consolidated financial statements of
Part I, Item 1 of this Form 10-Q for further information. |
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(2) |
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See Note 8, Commitments and Contingencies in the notes to condensed consolidated financial
statements of Part I, Item 1 of this Form 10-Q for further information. |
Under license agreements with NeuroSpheres, Ltd., we obtained an exclusive patent license
covering all uses of certain neural stem cell technology. We made up-front payments to NeuroSpheres
of 65,000 shares of our common stock and $50,000, and will make additional cash payments as stated
milestones are achieved. Effective in 2004, we were obligated to pay annual payments of $50,000,
creditable against certain royalties. Effective in 2008, as part of the indemnification agreement
with NeuroSpheres described above, we offset the annual $50,000 obligation against litigation costs
incurred under that agreement.
We periodically enter into licensing agreements with third parties to obtain exclusive or
non-exclusive licenses for certain technologies. The terms of certain of these agreements require
us to pay future milestone payments based upon achievement of certain developmental, regulatory or
commercial milestones. We do not anticipate making any milestone payments under any of our
licensing agreements for 2010. Milestone payments beyond fiscal year 2010 cannot be predicted or
estimated, due to the uncertainty of achieving the required developmental, regulatory or commercial
milestones.
We do not have any material unconditional purchase obligations or commercial commitments
related to capital expenditures, clinical development, clinical manufacturing, or other external
services contracts at September 30, 2010.
Recent Accounting Pronouncements
In January 2010, the Financial Accounting Standards Board (FASB), issued new standards to
update and amend existing standards on Fair Value Measurements and Disclosures. These standards
require new disclosures on the amount and reason for transfers in and out of Level 1 and Level 2
fair value measurements. The standards also require disclosure of activities in Level 3 fair value
measurements that use significant unobservable inputs, including purchases, sales, issuances, and
settlements. The standards also clarify existing disclosure requirements on levels of
disaggregation, which requires fair value measurement disclosure for each class of assets and
liabilities, and disclosures about valuation techniques and inputs used to measure fair value of
recurring and non recurring fair value measurements that fall in ether Level 2 or Level 3. The new
disclosures and clarifications of existing disclosures are effective for our interim and annual
reporting periods beginning January 1, 2010, except for the disclosures about purchases, sales,
issuances and settlements in the roll forward activity in Level 3 fair value measurements. Those
disclosures are effective for our fiscal year beginning January 1, 2011. We do not expect the
adoption of the new standards related to Level 3 fair value measurements on January 1, 2011 to have
a material effect on our consolidated financial condition and results of operations.
33
In April 2010, FASB issued Accounting Standards Update (ASU) No. 2010-17, Revenue
RecognitionMilestone Method, which provides guidance on defining a milestone and determining when
it may be appropriate to apply the milestone method of revenue recognition for research or
development transactions. Research or development arrangements frequently include payment
provisions whereby a portion or all of the consideration is contingent upon milestone events such
as successful completion of phases in a study or achieving a specific result from the research or
development efforts. The amendments in this ASU provide guidance on the criteria that should be met
for determining whether the milestone method of revenue recognition is appropriate. The ASU is
effective for fiscal years and interim periods within those years beginning on or after June 15,
2010, with early adoption permitted. This ASU is effective for our interim and annual reporting
periods beginning January 1, 2011. We are currently evaluating the impact of this new standard, if
any on our financial condition and results of operations.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our market risks at September 30, 2010 have not changed materially from those discussed in
Item 7A of our Form 10-K for the year ended December 31, 2009 on file with the U.S. Securities and
Exchange Commission.
See also Note 2, Financial Assets, in the notes to condensed consolidated financial
statements in Part I, Item 1 of this Form 10-Q.
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 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 II-OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
In July 2006, we filed suit against Neuralstem, Inc. in the Federal District Court for the
District of Maryland, alleging that Neuralstems activities violate claims in four of the patents
we exclusively licensed from NeuroSpheres. In December 2006, Neuralstem petitioned the U.S. Patent
and Trademark Office (PTO) to reexamine two of the patents in our infringement action against
Neuralstem, namely U.S. Patent No. 6,294,346 (claiming the use of human neural stem cells for drug
screening) and U.S. Patent No. 7,101,709 (claiming the use of human neural stem cells for screening
biological agents). In April 2007, Neuralstem petitioned the PTO to reexamine the remaining two
patents in the suit, namely U.S. Patent No. 5,851,832 (claiming methods for proliferating human
neural stem cells) and U.S. Patent No. 6,497,872 (claiming methods for transplanting human neural
stem cells). These requests were granted by the PTO and, in June 2007, the parties voluntarily
agreed to stay the pending litigation while the PTO considered these reexamination requests. In
April 2008, the PTO upheld the 832 and 872 patents, as amended, and issued Notices of Intent to
Issue an Ex Parte Reexamination Certificate for both. In May 2009, the PTO upheld the 346 and 709
patents, as amended, and issued Notices of Intent to Issue an Ex Parte Reexamination Certificate
for both.
In May 2008, we filed a second patent infringement suit against Neuralstem and its two
founders, Karl Johe and Richard Garr. In this suit, which we filed in the Federal District Court
for the Northern District of California, we allege that Neuralstems activities
34
infringe claims in two patents we exclusively license from NeuroSpheres, specifically U.S. Patent No. 7,361,505
(claiming composition of matter of human neural stem cells derived from any source material) and
U.S. Patent No. 7,115,418 (claiming methods for proliferating human neural stem cells). In
addition, we allege various state law causes of action against Neuralstem arising out of its
repeated derogatory statements to the public about our patent portfolio. Also in May 2008,
Neuralstem filed suit against us and NeuroSpheres in the Federal District Court for the District of
Maryland seeking a declaratory judgment that the 505 and 418 patents are either invalid or are
not infringed by Neuralstem and that Neuralstem has not violated California state law. In August
2008, the California court transferred our lawsuit against Neuralstem to Maryland for resolution on
the merits. In July 2009, the Maryland District Court granted our motion to consolidate these two
cases with the litigation we initiated against Neuralstem in 2006. In August 2009, the Maryland
District Court approved a scheduling order submitted by the parties for discovery and trial.
In addition to the actions described above, in April 2008, we filed an opposition to
Neuralstems European Patent No. 0 915 968 (methods of isolating, propagating and differentiating
CNS stem cells), because the claimed invention is believed by us to be unpatentable over prior art,
including patents exclusively licensed by us from NeuroSpheres. Neuralstem has responded to this
opposition and the parties are currently awaiting a hearing, expected to be held in 2010.
ITEM 1A. RISK FACTORS
There have been no material change from the risk factors disclosed in Part I, Item 1A, of our
Annual Report on Form 10-K for the fiscal year ended December 31, 2009.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
ITEM 5. OTHER INFORMATION
None.
ITEM 6. EXHIBITS
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Exhibit 10.1 |
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Amendment to lease, dated August 25, 2010, between the Board of Trustees of the
Leland Stanford Junior University and the Registrant |
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Exhibit 31.1 |
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Certification of Martin McGlynn under Section 302 of the Sarbanes-Oxley Act of 2002 |
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Exhibit 31.2 |
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Certification of Rodney K. B. Young under Section 302 of the Sarbanes-Oxley Act of
2002
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Exhibit 32.1 |
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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
|
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Exhibit 32.2 |
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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
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35
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.
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STEMCELLS, INC.
(name of Registrant)
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November 2, 2010 |
/s/ Rodney K. B. Young
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Rodney K. B. Young |
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Chief Financial Officer |
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36
Exhibit Index
|
|
|
Exhibit 10.1 |
|
Amendment to lease, dated August 25, 2010, between the Board of Trustees of the
Leland Stanford Junior University and the Registrant
|
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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
|
37