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: March 31, 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
April 30, 2010, there were 119,673,325 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, $.01 par value, of StemCells, Inc.
2
PART I-FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
STEMCELLS,
INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
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March 31, 2010 |
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December 31, 2009 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
31,336,987 |
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$ |
38,617,977 |
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Marketable securities, current |
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156,730 |
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196,995 |
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Trade receivables |
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41,522 |
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87,019 |
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Other receivables |
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406,702 |
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679,034 |
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Prepaid assets |
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695,446 |
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560,144 |
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Total current assets |
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32,637,387 |
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40,141,169 |
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Property, plant and equipment, net |
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2,637,181 |
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2,856,695 |
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Other assets, non-current |
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2,541,086 |
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2,525,185 |
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Goodwill |
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1,852,189 |
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2,019,679 |
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Other intangible assets, net |
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3,330,750 |
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3,647,596 |
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Total assets |
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$ |
42,998,593 |
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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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$ |
1,017,848 |
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$ |
890,582 |
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Accrued expenses and other current liabilities |
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1,979,764 |
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3,760,438 |
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Accrued wind-down expenses, current |
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1,512,062 |
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1,449,810 |
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Deferred revenue, current |
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186,119 |
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119,542 |
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Capital lease obligation, current |
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64,620 |
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68,000 |
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Deferred rent, current |
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41,273 |
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80,392 |
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Bonds payable, current |
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165,000 |
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161,250 |
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Total current liabilities |
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4,966,686 |
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6,530,014 |
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Capital lease obligation, non-current |
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69,494 |
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85,826 |
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Bonds payable, non-current |
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656,250 |
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698,750 |
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Fair value of warrant liability |
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8,160,619 |
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9,676,968 |
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Deposits and other long-term liabilities |
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466,211 |
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466,211 |
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Accrued wind-down expenses, non-current |
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2,788,815 |
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3,056,675 |
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Deferred rent, non-current |
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40,281 |
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50,600 |
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Deferred revenue, non-current |
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126,007 |
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130,213 |
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Total liabilities |
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17,274,363 |
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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, $0.01 par value;
250,000,000 shares authorized; issued and
outstanding 119,622,033 at March 31, 2010 and
118,349,587 at December 31, 2009 |
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1,196,219 |
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1,183,495 |
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Additional paid-in capital |
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316,635,781 |
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314,944,784 |
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Accumulated deficit |
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(292,152,010 |
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(286,027,935 |
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Accumulated other comprehensive income |
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44,240 |
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394,723 |
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Total stockholders equity |
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25,724,230 |
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30,495,067 |
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Total liabilities and stockholders equity |
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$ |
42,998,593 |
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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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March 31, |
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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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$ |
113,849 |
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$ |
56,603 |
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Revenue from product
sales |
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116,424 |
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Total revenue |
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230,273 |
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56,603 |
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Cost of product sales |
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(43,762 |
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Gross profit |
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186,511 |
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56,603 |
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Operating expenses: |
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Research and development |
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5,037,514 |
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4,235,788 |
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Selling, general and
administrative |
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2,584,742 |
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2,538,913 |
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Wind-down expenses |
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165,335 |
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205,436 |
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Total operating expenses |
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7,787,591 |
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6,980,137 |
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Loss from operations |
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(7,601,080 |
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(6,923,534 |
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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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1,516,349 |
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(2,755,448 |
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Interest income |
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594 |
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41,947 |
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Interest expense |
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(25,500 |
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(28,175 |
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Other expense |
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(14,438 |
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(14,210 |
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Total other income (expense), net |
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1,477,005 |
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(2,358,020 |
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Net loss |
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$ |
(6,124,075 |
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$ |
(9,281,554 |
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Basic and diluted net loss per share |
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$ |
(0.05 |
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$ |
(0.10 |
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Shares used to compute basic and diluted loss per
share |
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118,959,136 |
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96,048,288 |
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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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Three months ended |
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March 31, |
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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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$ |
(6,124,075 |
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$ |
(9,281,554 |
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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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418,307 |
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298,347 |
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Stock-based compensation |
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1,018,972 |
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981,015 |
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Gain on sale of marketable securities |
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(397,868 |
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Change in fair value of warrant liability |
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(1,516,349 |
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2,755,448 |
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Changes in operating assets and liabilities: |
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Trade receivables |
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41,568 |
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Other receivables |
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300,765 |
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54,976 |
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Prepaid and other current assets |
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(138,508 |
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250,236 |
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Other assets, non-current |
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(17,588 |
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6,020 |
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Accounts payable and accrued expenses |
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(1,614,964 |
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(180,823 |
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Accrued wind-down expenses |
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(201,175 |
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(176,779 |
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Deferred revenue |
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74,198 |
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(14,362 |
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Deferred rent |
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(49,437 |
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(76,287 |
) |
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Net cash used in operating activities |
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(7,808,286 |
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(5,781,631 |
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Cash flows from investing activities: |
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Proceeds from the sale of marketable securities |
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3,612,750 |
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Payment of advances under notes receivable |
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(415,000 |
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Purchases of property, plant and equipment |
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(78,871 |
) |
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(277,436 |
) |
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Net cash provided by (used in) investing activities |
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(78,871 |
) |
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2,920,314 |
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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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1,044,907 |
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6,744,958 |
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Proceeds from the exercise of stock options |
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636 |
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75,064 |
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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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(360,793 |
) |
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(380,548 |
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Proceeds from (repayment of) capital lease
obligations |
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(19,713 |
) |
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140,658 |
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Repayment of bonds payable |
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(38,750 |
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(36,250 |
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Net cash provided by financing activities |
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626,287 |
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6,875,383 |
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Increase (decrease) in cash and cash equivalents |
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(7,260,870 |
) |
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4,014,066 |
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Effects of foreign exchange rate changes on cash |
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(20,120 |
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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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$ |
31,336,987 |
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$ |
34,057,052 |
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Supplemental disclosure of cash flow information: |
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Interest paid |
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$ |
25,500 |
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$ |
28,175 |
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See Notes to Condensed Consolidated Financial Statements.
5
Notes to Condensed Consolidated Financial Statements (Unaudited)
March 31, 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 months ended March 31, 2010 and 2009
has 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 such 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 sustain our product
development efforts, to provide funding for the acquisition of technologies, businesses and
intellectual property rights, preclinical and clinical testing of our investigative 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.
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). |
6
Financial Instruments
Cash and Cash Equivalents
We consider money market accounts, money market funds and investments with an average maturity
of 90 days or less from the date of purchase to be cash equivalents.
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 three months
ended March 31, 2010 or 2009.
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.
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. 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. 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. Such licensing agreements may contain multiple elements, such as upfront
fees, payments related to the achievement of particular milestones and royalties. Revenue from
upfront fees for licensing agreements that contain multiple elements are 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 collaborative agreements and grants are recognized as earned upon either the
incurring of reimbursable expenses directly related to the particular research plan or the
completion of certain development milestones as defined within the terms of the 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.
Compensation expense for stock-based awards granted to non-employees is based on the estimated
fair value of the award which is re-measured at each reporting date and is amortized over the
remaining vesting period.
7
We use the Black-Scholes-Merton (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.
The following is a reconciliation of the numerators and denominators of the basic and diluted
earnings per share computations:
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Three months ended March 31, |
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|
2010 |
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|
2009 |
|
Net
loss |
|
$ |
(6,124,075 |
) |
|
$ |
(9,281,554 |
) |
Weighted average shares outstanding used to
compute basic and diluted net loss per
share |
|
|
118,959,136 |
|
|
|
96,048,288 |
|
Basic and diluted net loss per
share |
|
$ |
(0.05 |
) |
|
$ |
(0.10 |
) |
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
March 31:
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2010 |
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2009 |
|
Options |
|
|
9,830,870 |
|
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|
8,355,287 |
|
Restricted stock
units |
|
|
1,777,151 |
|
|
|
1,350,000 |
|
Warrants |
|
|
14,344,828 |
|
|
|
11,425,354 |
|
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Total |
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25,952,849 |
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21,130,641 |
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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 $44,240 as of March 31, 2010 and $394,723 as of December 31, 2009.
The activity in OCL was as follows:
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2010 |
|
|
2009 |
|
Net
loss |
|
$ |
(6,124,075 |
) |
|
$ |
(9,281,554 |
) |
Net change in unrealized gains and losses
on marketable securities |
|
|
(40,265 |
) |
|
|
50,484 |
|
Net change in unrealized gains and losses
on foreign currency translations |
|
|
(310,218 |
) |
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss |
|
$ |
(6,474,558 |
) |
|
$ |
(9,231,070 |
) |
|
|
|
|
|
|
|
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 these new standards 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), 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, if any on our financial condition
and results of operations.
8
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 |
|
March 31, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash |
|
$ |
383,733 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
383,733 |
|
Cash equivalents |
|
|
30,953,254 |
|
|
|
|
|
|
|
|
|
|
|
30,953,254 |
|
Marketable equity securities, current |
|
|
74,456 |
|
|
|
82,274 |
|
|
|
|
|
|
|
156,730 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cash, cash equivalents, and marketable securities |
|
$ |
31,411,443 |
|
|
$ |
82,274 |
|
|
$ |
|
|
|
$ |
31,493,717 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 March 31, 2010 and
December 31, 2009. At March 31, 2010, our cash equivalents were primarily money market
funds consisting mainly of U.S. Treasury securities.
Our investment in marketable 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 March 31, 2010 and December 31, 2009, we owned 1,921,924 shares of ReNeuron with a
carrying and fair market value of approximately $157,000 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 three months ended March 31, 2010, we recorded an
unrealized gain of approximately $40,000.
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.
9
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 and bonds payable are classified within Level 1 or Level 2. This
is because our cash equivalents and marketable securities are valued primarily using quoted market
prices and our bonds payable are valued using alternative pricing sources and models utilizing market observable inputs. 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 |
|
|
March 31, |
|
|
|
(Level 1) |
|
|
(Level 2) |
|
|
2010 |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
Cash Equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
30,953,254 |
|
|
$ |
|
|
|
$ |
30,953,254 |
|
Marketable Securities: |
|
|
|
|
|
|
|
|
|
|
|
|
Equity securities |
|
|
156,730 |
|
|
|
|
|
|
|
156,730 |
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
31,109,984 |
|
|
|
|
|
|
|
31,109,984 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
Bond payable |
|
$ |
|
|
|
$ |
821,250 |
|
|
$ |
821,250 |
|
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 media
formulation and reagent business; and an intellectual property portfolio with claims relevant to
cell processing, reprogramming and manipulation, as well as to gene targeting and insertion.
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 |
|
|
|
|
|
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.
10
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 |
|
|
(120,116 |
) |
|
|
|
|
Balance as of March 31, 2010 |
|
$ |
1,852,189 |
|
|
|
|
|
The components of our other intangible assets at March 31, 2010 are summarized below:
|
|
|
|
|
|
|
Net Carrying |
|
Other Intangible Asset Class |
|
Amount |
|
Customer
relationships and developed technology |
|
$ |
1,204,401 |
|
In-process
research and development |
|
|
1,318,857 |
|
Trade name |
|
|
305,084 |
|
Patents |
|
|
394,604 |
|
License agreements |
|
|
107,804 |
|
|
|
|
|
Total other intangible assets |
|
$ |
3,330,750 |
|
|
|
|
|
Amortization
expense was approximately $131,000 in the first quarter of 2010.
Note 6. Stock-Based Compensation
We currently grant stock-based awards under three
equity incentive plans. We had 23,759,050 shares authorized to be granted under the three plans as of March 31, 2010. 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 months ended March 31 was as follows:
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
|
|
2010 |
|
|
2009 |
|
Research and development expense |
|
$ |
546,608 |
|
|
$ |
492,587 |
|
General and administrative expense |
|
|
472,364 |
|
|
|
488,428 |
|
|
|
|
|
|
|
|
Total employee stock-based compensation expense and effect on net loss |
|
$ |
1,018,972 |
|
|
$ |
981,015 |
|
|
|
|
|
|
|
|
Effect on basic and diluted net loss per common share |
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
|
|
|
|
|
|
As of March 31, 2010, we had approximately $4,991,000 of total unrecognized compensation
expense related to unvested awards of stock options and restricted stock units granted under our
various stock-based plans that we expect to recognize over a weighted-average vesting period of 2.4
years.
Stock Options
Generally, stock options granted to employees have a maximum term of ten years, and vest over
a four year period from the date of grant; 25% vest at the end of one year, and 75% vest monthly
over the remaining three-year service period. We may grant options with different vesting terms
from time to time. Upon employee termination of service, any unexercised vested option will be
forfeited three months following termination or the expiration of the option, whichever is earlier.
Unvested options are forfeited on termination.
A summary of our stock option activity for the three months ended March 31, 2010 is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average |
|
|
|
Number of options |
|
|
exercise price ($) |
|
Balance at December 31, 2009 |
|
|
9,260,812 |
|
|
|
2.28 |
|
Granted |
|
|
692,500 |
|
|
|
1.20 |
|
Exercised |
|
|
(1,042 |
) |
|
|
0.61 |
|
Cancelled |
|
|
(121,400 |
) |
|
|
2.02 |
|
|
|
|
|
|
|
|
Outstanding options at March 31, 2010 |
|
|
9,830,870 |
|
|
|
2.20 |
|
|
|
|
|
|
|
|
The estimated weighted-average fair value of options granted in the three months ended March
31, 2010 and 2009 was approximately $0.93 and $1.40 per option, respectively. The fair value of
options granted is estimated as of the date of grant using the Black-Scholes option pricing model,
which requires certain assumptions as of the date of grant. The weighted-average assumptions used
as of March 31, 2010 and 2009 were as follows:
11
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
2010 |
|
2009 |
Expected life(years)(1) |
|
|
6.9 |
|
|
|
7.6 |
|
Risk-free interest rate(2) |
|
|
3.1 |
% |
|
|
2.4 |
% |
Expected volatility(3) |
|
|
88.8 |
% |
|
|
96.5 |
% |
Expected dividend yield(4) |
|
|
0 |
% |
|
|
0 |
% |
|
|
|
(1) |
|
The expected term represents the period during which our stock-based awards are expected to
be outstanding. We estimated this amount based on historical experience of similar awards,
giving consideration to the contractual terms of the awards, vesting requirements, and
expectation of future employee behavior, including post-vesting terminations. |
|
(2) |
|
The risk-free interest rate is based on U.S. Treasury debt securities with maturities close
to the expected term of the option as of the date of grant. |
|
(3) |
|
Expected volatility is based on historical volatility over the most recent historical period
equal to the length of the expected term of the option as of the date of grant. |
|
(4) |
|
We have not historically issued any dividends, and we do not expect to in the foreseeable
future. |
At the end of each reporting period, we estimate forfeiture rates based on our historical
experience within separate groups of employees and adjust the stock-based compensation expense
accordingly.
A summary of changes in unvested options for the three months ended March 31, 2010 is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average grant |
|
|
|
Number of options |
|
|
date fair value ($) |
|
Unvested options at December 31, 2009 |
|
|
2,613,057 |
|
|
|
1.53 |
|
Granted |
|
|
692,500 |
|
|
|
0.93 |
|
Vested |
|
|
(298,246 |
) |
|
|
1.78 |
|
Cancelled |
|
|
(85,568 |
) |
|
|
1.53 |
|
|
|
|
|
|
|
|
Unvested options at March 31, 2010 |
|
|
2,921,743 |
|
|
|
1.36 |
|
|
|
|
|
|
|
|
The estimated fair value of shares vested were approximately $531,000 in the three months
ended March 31, 2010.
Restricted Stock Units
We have granted restricted stock units (RSUs) to certain employees which entitle the holders
to receive shares of our common stock upon vesting of the RSUs. The fair value of restricted stock
units granted are based upon the market price of the underlying common stock as if it were vested
and issued on the date of grant.
A summary of our restricted stock unit activity for the three months ended March 31, 2010 is
as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average grant |
|
|
|
Number of RSUs |
|
|
date fair value ($) |
|
Balance at December 31, 2009 (1) |
|
|
2,437,901 |
|
|
|
1.49 |
|
Granted (2) |
|
|
30,667 |
|
|
|
1.18 |
|
Vested and converted to common shares |
|
|
(650,750 |
) |
|
|
1.22 |
|
Cancelled |
|
|
(40,667 |
) |
|
|
1.63 |
|
|
|
|
|
|
|
|
Balance unvested at March 31, 2010 |
|
|
1,777,151 |
|
|
|
1.58 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
1,061,500 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. 1,046,401 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. 30,000 of these restricted
stock units vest and convert into shares of our common stock after one
year from the date of grant. 300,000 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. |
12
|
|
|
(2) |
|
20,667 of these restricted stock units vest and convert into shares of
our common stock in May 2010. 10,000 of these restricted stock units
vest and convert into shares of our common stock after one year from
the date of grant. |
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 date of settlement.
A summary of the changes in SARs for the three months ended March 31, 2010 is as follows:
|
|
|
|
|
|
|
Number of SARs |
|
Outstanding at December 31, 2009 |
|
|
1,430,849 |
|
Granted |
|
|
|
|
Exercised |
|
|
|
|
Forfeited and expired |
|
|
(7,996 |
) |
|
|
|
|
Outstanding SARs at March 31, 2010 |
|
|
1,422,853 |
|
|
|
|
|
SARs exercisable at March 31, 2010 |
|
|
1,310,008 |
|
|
|
|
|
For the three months ended March 31, 2010, we re-measured the liability related to the SARs
and due to a decrease in the price per share of our common stock and forfeiture, the re-measured
fair value of the liability reduced compensation expense by approximately $51,000. For the same
period in 2009, we recorded compensation expense of approximately $242,000.
At March 31, 2010, approximately $46,000 of unrecognized compensation expense related to SARs
is expected to be recognized over the next four months. The resulting effect on net loss and net
loss per share attributable to common stockholders is not likely to be representative of the
effects in future periods, due to changes in the fair value calculation which is dependent on the
stock price, volatility, interest and forfeiture rates, additional grants and subsequent periods of
vesting.
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 the 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 as of March 31,
2010 and December 31, 2009 were as follows:
|
|
|
|
|
|
|
|
|
|
|
January to |
|
|
January to |
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
Accrued wind-down reserve at beginning of period |
|
$ |
3,572,000 |
|
|
$ |
4,448,000 |
|
Less actual expenses recorded against estimated reserve during the period |
|
|
(315,000 |
) |
|
|
(1,216,000 |
) |
Additional expense recorded to revise estimated reserve at period-end |
|
|
165,000 |
|
|
|
340,000 |
|
|
|
|
|
|
|
|
Revised reserve at period-end |
|
|
3,422,000 |
|
|
|
3,572,000 |
|
Add deferred rent at period-end |
|
|
809,000 |
|
|
|
861,000 |
|
|
|
|
|
|
|
|
Total accrued wind-down expenses at period-end (current and non current) |
|
$ |
4,231,000 |
|
|
$ |
4,433,000 |
|
|
|
|
|
|
|
|
Accrued wind-down expenses, current |
|
$ |
1,443,000 |
|
|
$ |
1,376,000 |
|
Accrued wind-down expenses, non-current |
|
|
2,788,000 |
|
|
|
3,057,000 |
|
|
|
|
|
|
|
|
Total accrued wind-down expenses |
|
$ |
4,231,000 |
|
|
$ |
4,433,000 |
|
|
|
|
|
|
|
|
13
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 $6,000 and $236,000 in 2010 and 2009, respectively,
against this reserve. We believe that the estimated remaining balance of approximately $70,000 in
our reserve will be sufficient to cover any remaining exit costs.
|
|
|
|
|
|
|
January to |
|
|
|
March 31, |
|
|
|
2010 |
|
Accrued wind-down reserve at December 31, 2009 |
|
$ |
74,000 |
|
Less actual expenses recorded against estimated reserve during the period |
|
|
(6,000 |
) |
Additional expense recorded to revise estimated reserve at period-end |
|
|
2,000 |
|
|
|
|
|
Accrued wind-down reserve at March 31, 2010 |
|
$ |
70,000 |
|
|
|
|
|
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 $821,000 at March 31, 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 have leased 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. GMP facilities can be used to manufacture materials for
clinical trials. Under the term of the agreement we were required to provide a letter of credit for
a total of approximately $778,000, which serves 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 is reflected as restricted cash in other assets, non-current
on our condensed consolidated balance sheets. In October 2009, we amended the lease to extend the
expiry date of the lease term from March 31, 2010 to August 31, 2011. The aggregate rent payment
for the extended lease term is approximately $3,100,000. The lease contains escalating rent
payments, which we recognize as operating lease expense on a straight-line basis. Deferred rent was
approximately $82,000 as of March 31, 2010 and $131,000 as of December 31, 2009, and is reflected
as deferred rent on our accompanying Consolidated Balance Sheets. As of March 31, 2010, we had a
space-sharing agreement covering
14
approximately
10,451 square feet of this facility.
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 $809,000 at March 31, 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 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 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 the 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. In
September 2009, we also filed a request with the PTO to reexamine Neuralstems U.S. Patent
No. 5,753,506 (methods of isolating, propagating and differentiating CNS stem cells), which is the
U.S. counterpart of Neuralstems 968 patent in Europe. In January 2010, we filed a request with
the PTO to reexamine
15
Neuralstems U.S. Patent No. 7,544,511 (methods for immortalizing neural stem cells using a
c-myc construct), which is a continuation in part of the 506 patent. The PTO granted the first
reexamination request in October 2009 and the second in April 2010.
Effective 2008, as part of an indemnification agreement with NeuroSpheres, we offset the
annual $50,000 obligation against litigation costs incurred under that agreement. The estimated
balance for future offsets is included under Other assets, non-current on our accompanying
Consolidated Balance Sheets. We have concluded that the estimated balance of $750,000 as of
March 31, 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 an effective 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.
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
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 |
|
|
|
March 31, 2010 |
|
|
December 31, 2009 |
|
Expected life (years) |
|
|
4.1 |
|
|
|
4.4 |
|
Risk-free interest rate |
|
|
1.9 |
% |
|
|
2.0 |
% |
Expected volatility |
|
|
79.9 |
% |
|
|
79.1 |
% |
Expected dividend yield |
|
|
0 |
% |
|
|
0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At March 31, |
|
|
At December 31, |
|
|
Change in Fair Value |
|
|
|
2010 |
|
|
2009 |
|
|
of Warrant Liability |
|
Fair value of warrant liability |
|
$ |
5,441,379 |
|
|
$ |
6,295,448 |
|
|
$ |
(854,069 |
) |
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 an effective 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.
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
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:
16
|
|
|
|
|
|
|
|
|
|
|
To Calculate |
|
|
|
Fair Value of Warrant Liability at |
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
Expected life (years) |
|
|
5.1 |
|
|
|
5.3 |
|
Risk-free interest rate |
|
|
2.4 |
% |
|
|
2.5 |
% |
Expected volatility |
|
|
76.7 |
% |
|
|
85.9 |
% |
Expected dividend yield |
|
|
0 |
% |
|
|
0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At March 31, |
|
|
At December 31, |
|
|
Change in Fair Value |
|
|
|
2010 |
|
|
2009 |
|
|
of Warrant Liability |
|
Fair value of warrant liability |
|
$ |
2,719,240 |
|
|
$ |
3,381,520 |
|
|
$ |
(662,280 |
) |
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, through our sales agent Cantor Fitzgerald &
Co (Cantor). These sales will be made pursuant to the terms of a sales agreement with Cantor, under
which we will pay Cantor a fee of 3.0% of the gross proceeds. The prospectus is a part of a
registration statement that we filed with the SEC on June 25, 2008, using a shelf registration
process. Under this shelf registration process, we may offer to sell in one or more offerings up to
a total dollar amount of $100,000,000. Under our sales agreement with Cantor, in the three-month
period ended March 31, 2010, we sold 882,200 shares of common stock at a price of approximately
$1.23 per share for gross proceeds of approximately $1,088,000.
|
|
|
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 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; the 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; the uncertainty regarding the outcome of our clinical trials or studies we
may conduct in the future; the uncertainty regarding the validity and enforceability of our issued
patents; the risk that we may not be able to manufacture additional master and working cell banks
when needed; the uncertainty whether any products that may be generated in our cell-based
therapeutics programs will prove clinically safe and effective; the uncertainty whether we will
achieve significant revenue from product sales or become profitable; uncertainties regarding our
obligations with respect to our former encapsulated cell therapy 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.
17
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 cellular medicine 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 indications: neuronal ceroid
lipofuscinosis (NCL), a lysomal storage disorder often referred to as Batten disease, and
Pelizeaus-Merzbacher Disease (PMD), a myelination disorder in the brain. We have completed a six
patient Phase I clinical trial in infantile and late infantile NCL. 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 HuCNS-SC cells. In April 2010, we submitted a protocol to the FDA for a second
clinical trial in NCL, which is designed to further assess the safety of HuCNS-SC cells, while also
examining the ability of the cells to affect the progression of the disease. There can be no
assurance when or if such a trial will be initiated. 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 PMD. We enrolled and treated the first patient in this trial in February 2010, and we expect it
will take 12-18 months to complete enrollment. In addition to these clinical development
activities, our HuCNS-SC cells are in preclinical development for spinal cord injury and retinal
disorders. In our Liver Program, we are in preclinical development with our human liver engrafting
cells. We have decided to defer initiating a clinical study of hLEC pending additional improvements
to our process of isolating and purifying hLEC. 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 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 5, Acquisition of SCS Operations, in the Notes to Consolidated Financial
Statements in Part II, Item 8 of this Form 10-K 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 patented cells and sales of 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 which of 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
18
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 particularly fast. We compete
mainly by focusing on specialty media 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 year
ended December 31, 2009, we generated revenues from the sale of specialty cell culture products of
approximately $385,000. There can be no assurance that we will be able to continue to generate such
revenues in the future.
Significant Events
In January 2010, we launched GS1-R, the first commercially available medium to enable the
derivation, maintenance and growth of true (germline competent) rat embryonic stem cells. GS1-R is
expected to have significant utility in the creation of genetically engineered rat models of human
disease for use in academic, medical and pharmaceutical research.
In February 2010, we enrolled and treated the first patient in our PMD trial at UCSF, marking
the first time that neural stem cells have been transplanted as a potential treatment for a
myelination disorder. We expect it will take 12-18 months to complete enrollment in this trial.
In February 2010, we launched GS2-M, a new cell culture medium that enables the derivation and
long-term maintenance of true mouse iPS cells. GS2-M has been shown to increase the efficiency of
reprogramming pre-iPS cells to derive fully pluripotent stem cells, and to maintain mouse iPS
cells in a pluripotent state in long-term culture.
In March 2010, we announced that the United Kingdom (UK) Intellectual Property Office has
granted patent number GB2451523 with broad claims covering true (germline competent) rat stem cells
and genetically engineered rats derived from these cells. The patented technology is expected to
have significant utility to academic and pharmaceutical industry researchers by enabling them to
create novel rat models for the study of human diseases. Both mice and rats are used by scientists
to model various human diseases. However, rat models are more frequently used by pharmaceutical
companies because the physiological characteristics of rats make them better suited for assessing
drug efficacy and toxicity. We hold an exclusive license to commercialize this technology and are
globally prosecuting the patent family that claims it. The patent family is based upon
groundbreaking research led by prominent academic researchers at the University of Edinburgh.
In April 2010, we submitted a protocol to the FDA for a second clinical trial of our
proprietary HuCNS-® human neural stem cells in NCL. The proposed new trial is designed to
further assess the safety of HuCNS-SC cells in NCL, while also examining the ability of the cells
to affect the progression of the disease.
19
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.
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 the period
during which our stock-based awards are expected to be 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 March 31, 2010, total compensation cost related to unvested
stock-based awards not yet recognized was approximately $4,991,000, which is expected to be
recognized as expense over a weighted-average period of 2.4 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 March 31, 2010, based on current information available to management, the vacancy rate
is projected to be approximately 76% for 2010 and approximately 70% from 2011 through the end of
the lease. These estimates are based on actual occupancy as of March 31, 2010, predicted lead time
for
20
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 March 31, 2010, then the reserve would have
increased or decreased by approximately $125,000. Similarly, a 5% increase or decrease in the
operating expenses for the facility would have increased or decreased the reserve by approximately
$89,000, and a 5% increase or decrease in the assumed average rental charge per square foot would
have increased or decreased the reserve by approximately $38,000. Management does not wait for
specific events to change its estimate, but instead uses its best efforts to anticipate them on a
quarterly basis. 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 $6,000 and
$236,000 against this reserve in 2010 and 2009 respectively. As of March 31, 2010, we believe that
the estimated remaining balance of approximately $70,000 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 (IPR&D). 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 additional
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.
Revenue and Cost of Product Sales
Revenue for the first quarter of 2010, as compared with the same period in 2009, is summarized
in the table below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended, |
|
|
|
|
|
|
March 31 |
|
|
Change in 2010 versus 2009 |
|
|
|
2010 |
|
|
2009 |
|
|
$ |
|
|
% |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing agreements and
grants |
|
$ |
113,849 |
|
|
$ |
56,603 |
|
|
$ |
57,246 |
|
|
|
101 |
% |
Product
sales |
|
|
116,424 |
|
|
|
|
|
|
|
116,424 |
|
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
revenues |
|
|
230,273 |
|
|
|
56,603 |
|
|
|
173,670 |
|
|
|
307 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product
sales |
|
|
(43,762 |
) |
|
|
|
|
|
|
(43,762 |
) |
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
Profit |
|
$ |
186,511 |
|
|
$ |
56,603 |
|
|
$ |
129,908 |
|
|
|
230 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
Calculation is not meaningful |
21
Total revenue in the first quarter of 2010 was approximately $230,000, which was 307% higher
than total revenue in the first quarter of 2009. The increase in 2010 compared to 2009 was
primarily attributable to consolidation of revenues from the acquired SCS operations in the first
quarter of 2010, which were not part of our operations in the same period in 2009.
First quarter ended March 31, 2010 versus first quarter ended March 31, 2009. Licensing and
grant revenue for the first quarter of 2010 were approximately $57,000, or 101%, higher as compared
to the same period in 2009. This increase was primarily attributable to approximately $72,000 in
grant and licensing revenue recognized and consolidated as part of our acquisition of the SCS
operations, and an increase of approximately $3,000 in licensing revenue from existing licensing
agreements. These increases were offset by a decrease in revenue of approximately $18,000 from an
existing grant which we were awarded in October 2008 from the National Institute of Diabetes and
Digestive and Kidney Diseases to research and develop a potential cell-based therapeutic for liver
disease. In the first quarter of 2010, we recognized approximately $116,000 and $44,000 as revenue
from product sales and cost of product sales, respectively, in connection with our acquisition of
the SCS operations, compared to none in the same period of 2009.
Operating Expenses
Operating expenses for the first quarter of 2010, as compared with the same period in 2009, is
summarized in the table below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended, |
|
|
Change in 2010 versus |
|
|
|
March 31 |
|
|
2009 |
|
|
|
2010 |
|
|
2009 |
|
|
$ |
|
|
% |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research & development |
|
$ |
5,037,514 |
|
|
$ |
4,235,788 |
|
|
$ |
801,726 |
|
|
|
19 |
% |
Selling, general & administrative |
|
|
2,584,742 |
|
|
|
2,538,913 |
|
|
|
45,829 |
|
|
|
2 |
% |
Wind-down expenses |
|
|
165,335 |
|
|
|
205,436 |
|
|
|
(40,101 |
) |
|
|
(20 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
$ |
7,787,591 |
|
|
$ |
6,980,137 |
|
|
$ |
807,454 |
|
|
|
12 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
March 31, 2010) were approximately $117 million. Over this period, the majority of these cumulative
costs were related to: (i) characterization of our proprietary HuCNS-SC cell, (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 $5,038,000 in the first quarter of 2010 compared with
$4,236,000 in the first quarter of 2009.
22
First
quarter ended March 31, 2010 versus first quarter ended
March 31, 2009. The increase of approximately $802,000, or 19%, from 2009 to 2010 was
primarily attributable to (i) increased R&D operations of approximately $566,000 from our
acquisition of the SCS operations; R&D activity associated with the SCS operations is primarily
focused on developing cell technologies for non-therapeutic applications, such as use in cell-based
assays for drug discovery, (ii) an increase in clinical study expenses of approximately $180,000
attributable to the initiation of our phase I clinical trial to assess the safety and preliminary
effectiveness of HuCNS-SC cells as a treatment for PMD, (iii) a net increase in personnel expenses
of approximately $101,000 resulting from an increased head count at our California site to support
expanded operations in our cell processing and product development
programs, and (iv) an increase in other expenses of
approximately $32,000. These increased expenses were partially offset by a decrease in stock-based
compensation expenses of approximately $77,000.
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 $2,585,000 in the first quarter of 2010 compared with
$2,539,000 in the first quarter of 2009.
First quarter ended March 31, 2010 versus first quarter ended March 31, 2009. The increase of
approximately $46,000, or 2%, in SG&A expenses from 2009 to 2010 was primarily attributable to (i)
increased SG&A expenses of approximately $224,000 at our acquired SCS operations, (ii) an increase
in external services of approximately $180,000 mainly due to an increase in consultant, recruiting
and investor relations expenses, and (iii) an increase of approximately $31,000 in other expenses.
These increased expenses were partially offset by a decrease in legal fees of approximately
$333,000, primarily attributable to the legal fees incurred in 2009 for our acquisition of the SCS
operations and a decrease in stock-based compensation expense of approximately $56,000.
Wind-down Expenses
|
|
|
|
|
|
|
|
|
|
|
Three months ended, |
|
|
|
March 31 |
|
|
|
2010 |
|
|
2009 |
|
Rhode
Island |
|
$ |
165,335 |
|
|
$ |
205,436 |
|
Australia |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total wind-down
expenses |
|
$ |
165,335 |
|
|
$ |
205,436 |
|
|
|
|
|
|
|
|
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 $315,000 for the first quarter of 2010 were recorded against this reserve.
At March 31, 2010, we re-evaluated the estimate and adjusted the reserve to approximately
$4,231,000 by recording additional wind-down expenses of approximately $165,000. For the similar
period in 2009, payments recorded against the reserve were approximately $331,000, and additional
expenses recorded to adjust the reserve were approximately $206,000. Expenses for this facility
will fluctuate based on changes in tenant occupancy rates and other operating expenses related to
the lease. Even though it is our intent to sublease, assign, sell, or otherwise divest ourselves of
our interests in the facility at the earliest possible time, we cannot determine with certainty a
fixed date by which such events will occur. In light of this uncertainty, based on estimates, we
will periodically re-evaluate and adjust the reserve, as necessary. 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.
23
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 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 $6,000 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 $70,000 in our reserve
at March 31, 2010, will be sufficient to cover any remaining exit costs.
Other Income (Expense)
Other income totaled approximately $1,477,000 in the first quarter of 2010 compared with other
expense of $2,358,000 in the same period of 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended, |
|
|
Change in 2010 versus |
|
|
|
March 31 |
|
|
2009 |
|
|
|
2010 |
|
|
2009 |
|
|
$ |
|
|
% |
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on sale of marketable
securities |
|
$ |
|
|
|
$ |
397,866 |
|
|
$ |
(397,866 |
) |
|
|
(100 |
)% |
Change in fair value of warrant
liability |
|
|
1,516,349 |
|
|
|
(2,755,448 |
) |
|
|
4,271,797 |
|
|
|
(155 |
)% |
Interest
income |
|
|
594 |
|
|
|
41,947 |
|
|
|
(41,353 |
) |
|
|
(99 |
)% |
Interest expense |
|
|
(25,500 |
) |
|
|
(28,175 |
) |
|
|
2,675 |
|
|
|
(9 |
)% |
Other
expense, net |
|
|
(14,438 |
) |
|
|
(14,210 |
) |
|
|
(228 |
) |
|
|
2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense),
net |
|
$ |
1,477,005 |
|
|
$ |
(2,358,020 |
) |
|
$ |
3,835,025 |
|
|
|
(163 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
Calculation is not meaningful. |
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 in the first quarter of 2010. We owned 1,921,924
ordinary shares of ReNeuron at March 31, 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.
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-Merton (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 first quarter of 2010 decreased by approximately $41,000, or 99% when
compared to the same period in 2009. The decrease was primarily due to a lower average yield.
24
Interest Expense
Interest expense for the first quarter of 2010, was relatively flat when compared to the
similar 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.
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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
Change |
|
|
|
2010 |
|
|
2009 |
|
|
$ |
|
|
% |
|
Cash and cash equivalents |
|
$ |
31,336,987 |
|
|
$ |
38,617,977 |
|
|
$ |
(7,280,990 |
) |
|
|
(19 |
)% |
In summary, our cash flows were:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
Change in 2010 versus 2009 |
|
|
|
2010 |
|
|
2009 |
|
|
$ |
|
|
% |
|
Net cash used in operating activities |
|
$ |
(7,808,286 |
) |
|
$ |
(5,781,631 |
) |
|
$ |
(2,026,655 |
) |
|
|
35 |
% |
Net cash provided by (used in) investing activities |
|
$ |
(78,871 |
) |
|
$ |
2,920,314 |
|
|
$ |
(2,999,185 |
) |
|
|
(103 |
)% |
Net cash provided by financing activities |
|
$ |
626,287 |
|
|
$ |
6,875,383 |
|
|
$ |
(6,249,096 |
) |
|
|
(91 |
)% |
Net Cash Used in Operating Activities
Net cash used in operating activities in the first three months of 2010 increased by
approximately $2,027,000 or 35% when compared to the same period of 2009. Cash used in operating
activities is primarily driven by our net loss but operating cash flows differ from net loss due to
non-cash charges or differences in the timing of cash flows.
Net Cash Provided by (Used in) Investing Activities
The decrease of approximately $2,999,000 or 103% from 2009 to 2010 for net cash provided by
(used in) investing activities, was primarily attributable to a higher number of marketable debt
securities maturing in the first three months of 2009 as compared to the similar period in 2010 and
the sale of 2,900,000 shares of ReNeuron for net proceeds of approximately $510,000 in the first
quarter of 2009.
Net Cash Provided by Financing Activities
The decrease from 2009 to 2010 of approximately $6,249,000 for net cash provided by financing
activities was primarily attributable to gross proceeds of approximately $6,999,000 from the sale
of 3,325,000 shares of common stock at an average price of $2.10 per share in the first quarter of
2009, compared to gross proceeds of approximately $1,088,000 from the sale of approximately 882,200 shares of common stock at an average price of
$1.23 per share in the first quarter of 2010. These shares were sold under sales agreements with
Cantor Fitzgerald & Co. (Cantor).
Listed below are key financing transactions entered into by us in the last three years:
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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 an effective 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. |
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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 our
sales agent Cantor. The prospectus is a part of a registration statement that we filed with
the SEC on June 25, 2008, using a shelf registration process. Under this shelf
registration process, we may offer to sell in one or more offerings 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 this June 2009 sales agreement with Cantor at an average price per share of $1.80 for
gross proceeds of |
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approximately $3,291,000. Cantor is paid compensation equal to 3.0% of the
gross proceeds pursuant to the terms of the agreement. |
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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 an effective 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 December 2006, we filed a prospectus supplement announcing the entry of a sales
agreement with Cantor under which up to 10,000,000 shares may be sold from time to time
under a shelf registration statement. In 2007, 2008 and 2009, we sold a total of
10,000,000 shares of our common stock under this agreement at an average price per share of
$2.06 for gross proceeds of approximately $20,555,000. Cantor is paid compensation equal to
5.0% of the gross proceeds pursuant to the terms of the agreement. |
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 April 20,
2010, we had approximately $47 million under our universal shelf registration statement available
for issuing debt or equity securities; approximately $30 million of this $47 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.
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.
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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 entered into and amended a lease agreement for an approximately 68,000 square foot facility
located at the Stanford Research Park in Palo Alto, California. At March 31, 2010, we expect to pay
in aggregate, approximately $2,622,000 in rent and estimated operating expenses, before receipt of
sub-tenant income, for the remainder of 2010. At March 31, 2010, we had a space-sharing agreement
covering approximately 10,451 square feet of this facility.
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 March
31, 2010, we expect to pay in aggregate, approximately $1,374,000 in rent and estimated operating
expenses before receipt of sub-tenant income, for the remainder of 2010. At March 31, 2010, we
expect to receive, in aggregate, approximately $214,000 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 $1,160,000 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 second, 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 March 31, 2010, we expect to pay approximately 104,000 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.
Contractual Obligations
During the first three months of 2010, we believe that there have been no significant changes
in our payments due under contractual obligations, as disclosed in our Annual Report on Form 10-K
for the year ended December 31, 2009.
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 these new standards 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), 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, if any on our financial condition
and results of operations.
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ITEM 3. |
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QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Our market risks at March 31, 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.
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ITEM 4. |
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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 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 the 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. In
September 2009, we also filed a request with the PTO to reexamine Neuralstems U.S. Patent
No. 5,753,506 (methods of isolating, propagating and differentiating CNS stem cells), which is the
U.S. counterpart of Neuralstems 968 patent in Europe. In January 2010, we filed a request with
the PTO to
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reexamine Neuralstems U.S. Patent No. 7,544,511 (methods for immortalizing neural stem
cells using a c-myc construct), which is a continuation in part of the 506 patent. The PTO
granted the first reexamination request in October 2009 and the second in April 2010.
Effective 2008, as part of an indemnification agreement with NeuroSpheres, we offset the
annual $50,000 obligation against litigation costs incurred under that agreement. The estimated
balance for future offsets is included under Other assets, non-current on our accompanying
Consolidated Balance Sheets. We have concluded that the estimated balance of $750,000 as of
March 31, 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.
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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.
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ITEM 2. |
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UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
None.
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ITEM 3. |
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DEFAULTS UPON SENIOR SECURITIES |
None.
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ITEM 4. |
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SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS |
None.
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ITEM 5. |
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OTHER INFORMATION |
None.
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
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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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May 3, 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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Exhibit Index
Exhibit 31.1 Certification of Martin McGlynn under Section 302 of the Sarbanes-Oxley Act of 2002
Exhibit 31.2 Certification of Rodney K. B. Young under Section 302 of the Sarbanes-Oxley Act of
2002
Exhibit 32.1 Certification of Martin McGlynn Pursuant to 18 U.S.C. Section 1350, As Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Exhibit 32.2 Certification of Rodney K. B. Young Pursuant to 18 U.S.C. Section 1350, As Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
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