Filed by Bowne Pure Compliance
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2008
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934 |
For the transition period from to .
Commission
file number: 001-33876
Athersys, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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20-4864095 |
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(State or other jurisdiction
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(I.R.S. Employer Identification No.) |
of incorporation or organization) |
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3201 Carnegie Avenue, Cleveland, Ohio
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44115-2634 |
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(Address of principal executive offices)
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(Zip Code) |
Registrants telephone number, including area code: (216) 431-9900
Former name, former address and former fiscal year, if changed since last report: Not Applicable
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days: Yes þ 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
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Non-accelerated filer o
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Small reporting
company þ |
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
The number of outstanding shares of the registrants common stock, $0.001 par value, as of August
1, 2008 was 18,927,988.
ATHERSYS INC.
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements.
Athersys, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
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June 30, |
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December 31, |
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2008 |
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2007 |
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(Unaudited) |
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(Note) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
17,651 |
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$ |
13,248 |
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Available-for-sale securities |
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19,037 |
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22,477 |
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Accounts receivable |
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697 |
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836 |
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Receivable from Angiotech |
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269 |
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63 |
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Investment interest receivable |
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163 |
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262 |
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Deposit |
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163 |
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163 |
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Prepaid expenses and other |
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970 |
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394 |
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Total current assets |
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38,950 |
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37,443 |
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Available-for-sale securities |
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3,028 |
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13,850 |
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Deposits |
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109 |
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100 |
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Note receivable, net |
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48 |
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86 |
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Equipment, net |
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434 |
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387 |
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Accounts receivable, net |
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42 |
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Equity investments |
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317 |
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317 |
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Total assets |
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$ |
42,886 |
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$ |
52,225 |
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Liabilities and stockholders equity |
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Current liabilities: |
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Accounts payable |
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$ |
2,125 |
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$ |
1,011 |
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Accrued compensation and related benefits |
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263 |
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71 |
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Accrued clinical trial costs |
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18 |
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735 |
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Accrued expenses and other |
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793 |
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993 |
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Current portion of long-term debt, net |
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1,784 |
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Total current liabilities |
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3,199 |
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4,594 |
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Stockholders equity: |
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Preferred stock, at stated value;
10,000,000 shares authorized, and no shares
issued and outstanding at June 30, 2008 and
December 31, 2007 |
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Common stock, $0.001 par value; 100,000,000
shares authorized, and 18,927,988 shares
issued and outstanding at June 30, 2008 and
December 31, 2007 |
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19 |
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19 |
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Additional paid-in capital |
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208,942 |
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208,039 |
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Accumulated other comprehensive (loss) income |
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(9 |
) |
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52 |
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Accumulated deficit |
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(169,265 |
) |
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(160,479 |
) |
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Total stockholders equity |
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39,687 |
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47,631 |
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Total liabilities and stockholders equity |
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$ |
42,886 |
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$ |
52,225 |
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Note: The balance sheet at December 31, 2007 has been derived from audited financial statements at that date.
It does not include, however, all of the information and notes required by U.S. generally accepted accounting
principles for complete financial statements.
See accompanying notes to unaudited condensed consolidated financial statements.
1
Athersys, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
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Three months ended |
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Six months ended |
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June 30, |
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June 30, |
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2008 |
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2007 |
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2008 |
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2007 |
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Revenues |
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License fees |
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$ |
453 |
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$ |
313 |
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$ |
843 |
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$ |
623 |
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Grant revenue |
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323 |
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410 |
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725 |
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979 |
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Total revenues |
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776 |
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723 |
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1,568 |
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1,602 |
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Costs and expenses |
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Research and development |
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3,737 |
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4,989 |
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8,052 |
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7,354 |
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General and administrative |
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1,381 |
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3,497 |
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2,862 |
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4,105 |
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Depreciation |
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52 |
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75 |
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109 |
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155 |
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Total costs and expenses |
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5,170 |
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8,561 |
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11,023 |
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11,614 |
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Loss from operations |
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(4,394 |
) |
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(7,838 |
) |
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(9,455 |
) |
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(10,012 |
) |
Other income |
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17 |
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1,500 |
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20 |
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1,500 |
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Interest income |
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286 |
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175 |
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742 |
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222 |
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Interest expense |
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(31 |
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(710 |
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(93 |
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(1,043 |
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Accretion of premium on convertible debt |
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(196 |
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(456 |
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Net loss |
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$ |
(4,122 |
) |
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$ |
(7,069 |
) |
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$ |
(8,786 |
) |
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$ |
(9,789 |
) |
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Preferred stock dividends |
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$ |
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$ |
(284 |
) |
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$ |
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$ |
(659 |
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Deemed dividend resulting from induced
conversion of convertible preferred stock |
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$ |
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$ |
(4,800 |
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$ |
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$ |
(4,800 |
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Net loss attributable to common stockholders |
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$ |
(4,122 |
) |
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$ |
(12,153 |
) |
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$ |
(8,786 |
) |
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$ |
(15,248 |
) |
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Basic and diluted net loss per common share
attributable to common stockholders |
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$ |
(0.22 |
) |
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$ |
(2.53 |
) |
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$ |
(0.46 |
) |
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$ |
(5.99 |
) |
Weighted average shares outstanding, basic
and diluted |
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18,927,988 |
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4,800,760 |
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18,927,988 |
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2,547,265 |
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See accompanying notes to unaudited condensed consolidated financial statements.
2
Athersys,
Inc.
Condensed Consolidated Statements of Cash Flows
(In
thousands)
(Unaudited)
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Six months ended |
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June 30, |
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2008 |
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2007 |
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Operating activities |
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Net loss |
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$ |
(8,786 |
) |
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$ |
(9,789 |
) |
Adjustments to reconcile net loss to net cash
used in operating activities: |
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Depreciation |
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109 |
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155 |
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Gain on sale of fixed assets |
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(17 |
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Accretion of premium on convertible debt |
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456 |
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Stock-based compensation |
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903 |
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4,133 |
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Provision on note receivable |
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38 |
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Expense related to warrants issued to lenders |
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16 |
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438 |
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Amortization of discount on
available-for-sale securities and other |
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(75 |
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7 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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181 |
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530 |
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Receivable from Angiotech |
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(206 |
) |
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Prepaid expenses and other assets |
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(486 |
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(72 |
) |
Accounts payable and accrued expenses |
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389 |
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(95 |
) |
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Net cash used in operating activities |
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(7,934 |
) |
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(4,237 |
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Investing activities |
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Purchase of available-for-sale securities |
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(15,423 |
) |
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Maturities of available-for-sale securities |
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29,699 |
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Proceeds from sale of fixed assets |
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17 |
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Purchases of equipment |
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(156 |
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(3 |
) |
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Net cash provided by (used in) investing activities |
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14,137 |
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(3 |
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Financing activities |
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Principal payments on debt |
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(1,800 |
) |
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(1,844 |
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Proceeds from convertible promissory note |
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5,000 |
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Proceeds from issuance of common stock, net |
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58,495 |
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Net cash (used in) provided by financing activities |
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(1,800 |
) |
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61,651 |
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Increase in cash and cash equivalents |
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4,403 |
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57,411 |
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Cash and cash equivalents at beginning of the period |
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13,248 |
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1,528 |
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Cash and cash equivalents at end of the period |
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$ |
17,651 |
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$ |
58,939 |
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3
Athersys,
Inc.
Notes
to Unaudited Condensed Consolidated Financial Statements
1. Background
We are a biopharmaceutical company engaged in the development and commercialization of therapeutic
products in one business segment. Our operations consist primarily of research and product
development activities.
On May 24, 2007, BTHC VI, Inc. (BTHC VI) and its wholly owned subsidiary, B-VI Acquisition Corp.,
entered into an Agreement and Plan of Merger with Athersys, Inc. (Old Athersys). Pursuant to the
terms of the Agreement and Plan of Merger, B-VI Acquisition Corp., which BTHC VI recently had
incorporated for the purpose of completing the merger transaction described herein, merged with and
into Old Athersys on June 8, 2007, with Old Athersys continuing as the surviving entity in the
merger (the Merger). BTHC VI was a shell corporation with substantially no assets, liabilities
or operations as of the date of the Merger, and had 299,622 shares of common stock outstanding. As
a result of the Merger, Old Athersys became our wholly-owned subsidiary, and the business of Old
Athersys became our sole operations. On August 31, 2007, Old Athersys changed its name to ABT
Holding Company and BTHC VI changed its name to Athersys, Inc. Unless otherwise indicated, all
references in this quarterly report to the Company or Athersys are (a) prior to the Merger, to
ABT Holding Company (i.e., Old
Athersys) and its subsidiaries and (b) following the Merger, to
Athersys, Inc. and its subsidiaries, including ABT Holding Company.
BTHC VIs acquisition of Old Athersys on June 8, 2007 effected a change in control and was
accounted for as a reverse acquisition whereby Old Athersys is the accounting acquirer for
financial statement purposes. Accordingly, the financial statements of the Company presented
reflect the historical results of Old Athersys and do not include the historical financial results
of BTHC VI prior to the consummation of the Merger. The Companys authorized and issued shares of
common and preferred stock have been retroactively restated for all historical periods presented to
reflect the Merger exchange rate of 0.0358493. Basic and diluted net loss per share attributable
to common stockholders have been computed using the retroactively restated common stock.
Immediately after the Merger, we completed an offering of 13,000,000 shares of common stock for
aggregate gross proceeds of $65.0 million in June 2007, which included the issuance of warrants to
purchase 3,250,000 shares of common stock to the investors with an exercise price of $6.00 and a
five-year term. We also issued warrants to purchase 500,000 shares of common stock to the lead
investor and warrants to purchase 1,093,525 shares of common stock to the placement agents, each
with an exercise price of $6.00 and a five-year term.
2. Basis of Presentation
The accompanying unaudited condensed consolidated financial statements should be read in
conjunction with the audited financial statements and notes thereto included in our Annual Report
on Form 10-K for the year ended December 31, 2007. The accompanying financial statements have been
prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim
financial information and Article 10 of Regulation S-X. Accordingly, since they are interim
statements, the accompanying financial statements do not include all of the information and notes
required by GAAP for complete financial statements. The accompanying financial statements reflect
all adjustments, consisting of normal recurring adjustments, that are, in the opinion of
management, necessary for a fair presentation of financial position and results of operations for
the interim periods presented. Interim results are not necessarily indicative of results for a
full year.
4
The preparation of financial statements in conformity with GAAP requires management to make
estimates and assumptions that affect the amounts reported in the financial statements and
accompanying notes. Our critical accounting policies, estimates and assumptions are described in
Managements Discussion and Analysis of Financial Condition and Results of Operations, which is
included below in this Quarterly Report on Form 10-Q.
3. New Accounting Standards
In September 2006, the Financial Accounting Standards Board (FASB) issued Statement of Accounting
Standards (SFAS) No. 157, Fair Value Measurements. SFAS No. 157 defines fair value, establishes a
framework for measuring fair value in generally accepted accounting principles and expands
disclosures about fair value measurements. SFAS No. 157 does not require any new fair value
measurements. The FASB delayed the effective date of SFAS No. 157 for non-financial assets and
liabilities to fiscal years beginning after November 15, 2008. We adopted the provisions of SFAS
No. 157 related to our financial assets and liabilities on January 1, 2008. See Note 6.
In May 2008, the FASB issued FASB Staff Position APB 14-1 (FSP 14-1), Accounting for Convertible
Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).
FSP 14-1 requires the issuer of certain convertible debt instruments that may be settled in cash on
conversion to separately account for the liability and equity components in a manner that reflects
the issuers nonconvertible debt borrowing rate. The effective date of FSP 14-1 is January 1, 2009
for calendar year companies with retrospective application required for all periods presented for
instruments that were outstanding during any period presented in the annual financial statements.
We are currently evaluating the effect that FSP 14-1 will have on our financial statements.
4. Net Loss per Share
Basic and diluted net loss per share attributable to common stockholders are presented in
conformity with SFAS No. 128, Earnings per Share, for all periods presented. In accordance with
SFAS No. 128, basic and diluted net loss per share has been computed using the weighted-average
number of shares of common stock outstanding during the period.
We have outstanding options and warrants, and prior to June 8, 2007, also had outstanding
convertible debt and convertible preferred stock, which have not been used in the calculation of
diluted net loss per share because to do so would be anti-dilutive. The following instruments were
excluded from the calculation of diluted net loss per share attributable to common stockholders
because their effects would be antidilutive:
1) |
|
Outstanding stock options to purchase 3,776,240 shares of common stock for both the
three-month and six-month periods ended June 30, 2008 and 3,629,814 shares of common stock for
both the three-month and six-month periods ended June 30, 2007; |
|
2) |
|
Warrants to purchase 5,125,496 shares of common stock for each of the three-month and
six-month periods ended June 30, 2008 and each of the three-month and six-month periods ended
June 30, 2007; |
|
3) |
|
Shares of common stock issuable upon the conversion of convertible preferred stock in the
amount of 276,071 and 319,839 for the three-month and six-month periods ended June 30, 2007,
respectively; and |
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4) |
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Shares of common stock issuable upon the conversion of convertible promissory notes in the
approximate amount of 202,631 and 224,197 for the three-month and six-month periods ended June
30, 2007, respectively. |
5
5. Comprehensive Loss
In accordance with SFAS No. 130, Reporting Comprehensive Loss, all components of comprehensive
loss, including net loss, are reported in the financial statements in the period in which they are
recognized. Comprehensive loss is defined as the change in equity during a period from
transactions and other events and circumstances from non-owner sources.
Below is a reconciliation, in thousands, of net loss to comprehensive loss for all periods
presented.
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Net loss |
|
$ |
(4,122 |
) |
|
$ |
(7,069 |
) |
|
$ |
(8,786 |
) |
|
$ |
(9,789 |
) |
Unrealized loss on
available-for-sale
securities |
|
|
(123 |
) |
|
|
|
|
|
|
(61 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(4,245 |
) |
|
$ |
(7,069 |
) |
|
$ |
(8,847 |
) |
|
$ |
(9,789 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
6. Fair Value of Financial Instruments
On January 1, 2008, we adopted SFAS No. 157 related to our financial assets and liabilities and the
methods to measure fair value of assets and liabilities as set forth therein. Our
available-for-sale securities include U.S. government obligations, corporate debt securities,
floating rate notes and commercial paper.
SFAS No. 157 classifies the inputs used to measure fair value into the following hierarchy:
|
|
|
Level 1
|
|
Unadjusted quoted prices in active markets for identical assets or liabilities. |
|
|
|
Level 2
|
|
Unadjusted quoted prices in active markets for similar assets or liabilities,
or unadjusted quoted prices for identical or similar assets or liabilities in
markets that are not active, or inputs other than quoted prices that are
observable for the asset or liability. |
|
|
|
Level 3
|
|
Unobservable inputs for the asset or liability. |
The following table provides a summary of the fair values of our assets and liabilities under SFAS
No. 157 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at June 30, 2008 Using |
|
|
|
|
|
|
|
Quoted Prices in Active |
|
|
Significant Other |
|
|
|
|
|
|
Balance as of |
|
|
Markets for Identical |
|
|
Observable Inputs |
|
|
Significant Unobservable |
|
Description |
|
June 30, 2008 |
|
|
Assets (Level 1) |
|
|
(Level 2) |
|
|
Inputs (Level 3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale
securities |
|
$ |
22,065 |
|
|
$ |
22,065 |
|
|
$ |
|
|
|
$ |
|
|
Fair value is based upon quoted market prices in active markets. We had no level 2 or level 3
assets at June 30, 2008. We review and reassess the fair value hierarchy classifications on a
quarterly basis. Changes from one quarter to the next related to the observability of inputs to a
fair value measurement may result in a reclassification between hierarchy levels.
6
7. Stock-based Compensation
In 2007, we adopted two equity incentive plans that authorized an aggregate of 4,500,000 shares of
common stock for awards to employees, directors and consultants. These plans authorize the
issuance of equity-based compensation in the form of stock options, stock appreciation rights,
restricted stock, restricted stock units, performance shares and units, and other stock-based
awards to qualified employees, directors and consultants.
As of June 30, 2008, a total of 728,000 shares are available for issuance under our equity
compensation plans and 3,772,000 options to purchase shares of common stock were outstanding.
Also, options to purchase 4,240 shares of common stock are outstanding related to our old option
plans prior to the Merger in June 2007. For the three-month period ended June 30, 2008, stock
compensation expense was approximately $439,000. During the three-month period ended June 30,
2008, we issued options to purchase 90,000 shares of common stock to employees and directors. At
June 30, 2008, total unrecognized estimated compensation cost related to unvested stock options was
approximately $4.0 million, which is expected to be recognized by March 31, 2012 using the
straight-line method.
8. Long-Term Debt
A summary of our long-term debt outstanding is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
Notes payable to lenders |
|
$ |
|
|
|
$ |
1,800 |
|
Discount related to warrant issuance |
|
|
|
|
|
|
(16 |
) |
|
|
|
|
|
|
|
Total, net |
|
|
|
|
|
|
1,784 |
|
Less current portion |
|
|
|
|
|
|
1,784 |
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
In November 2004, we issued $7.5 million of notes payable to lenders, the proceeds of which were
unrestricted and used for general corporate purposes. The notes were payable in 30 monthly payments
after the initial interest-only period that expired December 1, 2005, with a fixed interest rate of
13% and a maturity date of June 1, 2008. The notes were repaid in full in June 2008.
The lenders retain a right to receive a milestone payment of $2.25 million upon the occurrence of
certain events as follows: (1) the entire amount upon (a) the merger with or into another entity
where our stockholders do not hold at least a majority of the voting power of the surviving entity,
(b) the sale of all or substantially all of our assets, and (c) our liquidation or dissolution; or
(2) a portion of the amount from proceeds of equity financings not tied to specific research and
development activities that are part of a research or development collaboration, in which case, the
senior lenders will receive an amount equal to 10% of proceeds above $5.0 million in cumulative
gross proceeds until the milestone amount is paid in full. The milestone payment is payable in
cash, except that if the milestone event is (2) above, we may elect to pay 75% of the milestone in
shares of common stock at the per-share offering price. No amounts have been recorded in relation
to the milestone as of June 30, 2008.
Upon the closing of our equity offering in June 2007, warrants to purchase 149,026 shares of common
stock with an exercise price of $5.00 per share and a seven-year term were issued to our lenders in
accordance with the loan agreement. The value of the warrants was $492,000 based on the
Black-Scholes valuation of the underlying security, which was recognized as a debt discount over
the remaining term of the loan.
7
9. Convertible Notes
Upon the closing of our equity offering in June 2007, convertible promissory notes issued to
Angiotech Pharmaceuticals, Inc. pursuant to a collaboration, and to our bridge financing investors
in 2006, were converted along with accrued interest into shares of common stock. The bridge notes,
if not converted, were repayable with accrued interest at maturity, plus a repayment fee of 200% of
the outstanding principal. We computed a premium on the debt in the amount of $5.25 million due
upon redemption, which was being accreted over the term of the notes using the effective interest
method. The unamortized premium was reversed and recorded in additional paid-in-capital when the
notes were converted into common stock upon the closing of our equity offering in June 2007.
10. Warrants
As of June 30, 2008, we had the following outstanding warrants to purchase shares of common stock:
|
|
|
|
|
|
|
|
Number of underlying shares |
|
|
Exercise Price |
|
Expiration |
|
|
|
|
|
|
|
4,976,470 |
|
|
$ |
6.00 |
|
June 8, 2012 |
|
149,026 |
|
|
$ |
5.00 |
|
June 8, 2014 |
|
|
|
|
|
|
|
|
5,125,496 |
|
|
|
|
|
|
|
|
|
|
|
|
|
11. Income Taxes
We have net operating loss and research and development tax credit carryforwards that may be used
to reduce future taxable income and tax liabilities. However, as a result of the change in
ownership related to our capital restructuring and equity offering in June 2007, we lost the use of
a significant portion of our pre-Merger net operating loss carryforwards under Section 382 of the
Internal Revenue Code. Our deferred tax assets have been fully offset by a valuation allowance due
to our cumulative losses.
12. Contingency
We initially filed a shelf registration statement with the SEC in July 2007 covering the resale of
18,508,251 shares of common stock, which includes all shares of common stock issued in our equity
offering in June 2007 and shares of common stock issuable upon exercise of warrants issued in the
offering (as well as the 531,781 shares of common stock issued to the bridge noteholders and the
132,945 shares underlying their warrants). The registration statement was declared effective by
the SEC on October 18, 2007. Under the registration rights agreement entered into in connection
with our June 2007 equity offering, subject to certain exceptions, if the registration statement
ceases to remain effective, a 1% cash penalty will be assessed for each 30-day period until the
registration statement becomes effective again, capped at 10%. Because the penalty is based on the
number of unregistered shares of common stock held by the investors in our June 2007 equity
offering, our maximum penalty exposure will decline over time as investors sell their shares of
common stock that were included in the registration statement.
8
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations.
This discussion and analysis should be read in conjunction with our financial statements and notes
thereto included in this Quarterly Report on Form 10-Q and the audited financial statement and
notes thereto included in our Annual Report
on Form 10-K for the year ended December 31, 2007.
Operating results are not necessarily indicative of results that may occur in future periods.
Overview and Recent Developments
We are a biopharmaceutical company engaged in the discovery and development of therapeutic product
candidates designed to extend and enhance the quality of human life. Through the application of our
proprietary technologies, we have established a pipeline of therapeutic product development
programs in multiple diseases and conditions. In July 2007, we initiated a Phase I clinical trial in the United
Kingdom with our lead candidate in clinical development (ATHX-105 for the treatment of obesity) and
completed the trial in January 2008. The primary objective of the Phase I clinical trial was to
assess the short-term safety of ATHX-105 and to establish an appropriate dose range for subsequent
clinical studies conducted in order to assess safety and effectiveness. There were
no severe or serious adverse events observed in the clinical trial, no negative effects on
cardiovascular, hematology or other clinical parameters, and no discontinuations due to adverse
events. Upon regulatory approval which we anticipate in the second
half of 2008, we intend to initiate a Phase II clinical trial in the United
States that will examine safety and effectiveness in clinically obese
patients. We are also developing pharmaceutical products for the treatment of certain
conditions affecting the central nervous system, such as ADHD, narcolepsy and other cognitive or
attention disorders.
In the fourth quarter of 2007, we received FDA authorization to advance two MultiStem® product
development programs into clinical trials, in the areas of transplant support and for treatment of
damage from myocardial infarction. The application of MultiStem for certain cardiovascular
applications, including myocardial infarction, is being developed with our partner, Angiotech
Pharmaceuticals, Inc. We have recently initiated both of these trials and intend to file an
additional investigational new drug application, or IND, for treatment of ischemic stroke in the
second half of 2008. In addition to these programs, we are also developing
MultiStem for certain other disease indications.
In June 2007, we completed a merger with BTHC VI, Inc. and its wholly-owned subsidiary that was
formed for the purpose of completing the merger. BTHC VI was a public shell corporation with
substantially no assets, liabilities or operations. We continued as the surviving entity in the
merger and our business became the sole operations of BTHC VI after the merger. BTHC VIs
acquisition of us effected a change in control and was accounted for as a reverse acquisition
whereby we were the accounting acquirer for financial statement purposes. Accordingly, our
financial statements present our historical results and do not include the historical financial
results of BTHC VI prior to the merger.
Immediately after the merger, we completed an offering of 13,000,000 shares of common stock for
aggregate gross proceeds of $65.0 million in June 2007, which included the issuance of warrants to
purchase 3,250,000 shares of common stock to the investors. We also issued warrants to purchase
500,000 shares of common stock to the lead investor and warrants to purchase 1,093,525 shares of
common stock to the placement agents.
We have incurred losses since inception of operations in December 1995 and had an accumulated
deficit of $169 million at June 30, 2008. Our losses have resulted principally from costs incurred
in research and development, clinical and preclinical product development, acquisition and
licensing costs, and general and administrative costs associated with our operations. We have used
the financing proceeds from private equity and debt offerings and other sources of capital to
develop our technologies, such as RAGE, and to acquire our stem cell technology. We have also built
drug development capabilities that have enabled us to advance product candidates into clinical
trials. We have established strategic collaborations that have provided revenues and capabilities
to help further advance our product candidates, and we have also built a substantial portfolio of
intellectual property.
9
Results of Operations
Since our inception, our revenues have consisted of license fees from our collaborators and grant
proceeds from federal and state grants. We have derived no revenue on the sale of FDA-approved
products to date. Research and development expenses consist primarily of costs associated with
external clinical and preclinical study fees, manufacturing costs, salaries and related personnel
costs, legal expenses resulting from intellectual property application processes, and laboratory
supply and reagent costs. We expense research and development costs as they are incurred. We expect
to continue to make significant investments in research and development to enhance our
technologies, advance clinical trials of our product candidates, expand our regulatory affairs and
product development capabilities, conduct preclinical studies of our products and manufacture our
products. General and administrative expenses consist primarily of salaries and related personnel
costs, professional fees and other corporate expenses. Our expenses are expected to increase as we
expand our business development activities and support our operating activities. To date, we have
financed our operations through private equity and debt financing and investments by strategic
collaborators. We expect to continue to incur substantial losses through at least the next several
years.
The following tables set forth our revenues and expenses for the periods indicated. The following
tables are stated in thousands.
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
License fees |
|
$ |
453 |
|
|
$ |
313 |
|
|
$ |
843 |
|
|
$ |
623 |
|
Grant revenue |
|
|
323 |
|
|
|
410 |
|
|
|
725 |
|
|
|
979 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
776 |
|
|
$ |
723 |
|
|
$ |
1,568 |
|
|
$ |
1,602 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
Type of expense |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Personnel costs |
|
$ |
801 |
|
|
$ |
849 |
|
|
$ |
1,566 |
|
|
$ |
1,446 |
|
Research supplies |
|
|
199 |
|
|
|
155 |
|
|
|
382 |
|
|
|
359 |
|
Facilities |
|
|
201 |
|
|
|
184 |
|
|
|
412 |
|
|
|
375 |
|
Clinical and preclinical
development costs |
|
|
1,534 |
|
|
|
625 |
|
|
|
3,832 |
|
|
|
1,433 |
|
Sponsored research |
|
|
106 |
|
|
|
48 |
|
|
|
211 |
|
|
|
181 |
|
Patent legal fees |
|
|
395 |
|
|
|
385 |
|
|
|
625 |
|
|
|
661 |
|
Other |
|
|
331 |
|
|
|
743 |
|
|
|
664 |
|
|
|
868 |
|
Stock-based compensation |
|
|
170 |
|
|
|
2,000 |
|
|
|
360 |
|
|
|
2,031 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3,737 |
|
|
$ |
4,989 |
|
|
$ |
8,052 |
|
|
$ |
7,354 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10
General and administrative expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
| |
June 30, |
|
|
June 30, |
|
Type of expense |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Personnel costs |
|
$ |
476 |
|
|
$ |
641 |
|
|
$ |
965 |
|
|
$ |
999 |
|
Facilities |
|
|
86 |
|
|
|
74 |
|
|
|
173 |
|
|
|
151 |
|
Legal and
professional fees |
|
|
210 |
|
|
|
197 |
|
|
|
506 |
|
|
|
279 |
|
Other |
|
|
340 |
|
|
|
496 |
|
|
|
675 |
|
|
|
574 |
|
Stock-based compensation |
|
|
269 |
|
|
|
2,089 |
|
|
|
543 |
|
|
|
2,102 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,381 |
|
|
$ |
3,497 |
|
|
$ |
2,862 |
|
|
$ |
4,105 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2008 and 2007
Revenues. Revenues increased to $776,000 for the three months ended June 30, 2008 from $723,000 in
the comparable period in 2007. License fee revenue increased $140,000 for the three months ended
June 30, 2008 compared to the three months ended June 30, 2007. The increase in license fee
revenue was a result of the nature and timing of target acceptances under our collaboration
agreement with Bristol-Myers Squibb. Grant revenue decreased $87,000 for the three months ended
June 30, 2008 compared to the three months ended June 30, 2007. The decrease in grant revenue was
due to the timing of expenditures that are reimbursed with grant proceeds.
Research and Development Expenses. Research and development expenses decreased to $3.7 million for
the three months ended June 30, 2008 from $5.0 million in the comparable period in 2007. The
decrease of approximately $1.3 million related primarily to a decrease in stock compensation
expense of $1.8 million and a decrease in other expenses of $412,000 in the three months ended June
30, 2008 compared to the comparable period in 2007. The decrease in other expenses for the three
months ended June 30, 2008 was primarily a result of milestone payment in the comparable period in
2007 in the amount of $507,000 associated with a collaboration related to our stem cell technology.
These decreases were partially offset primarily by an increase in clinical and preclinical
development costs of $909,000 related to preparations for a Phase II clinical trial of ATHX-105 and
two Phase I clinical trials related to MultiStem. Our clinical costs for the three months ended
June 30, 2008 are reflected net of Angiotechs cost-sharing amount related to our MultiStem acute
myocardial infarction collaboration in the amount of $269,500. We expect these expenses to continue
to increase in 2008 as we expect to initiate our ATHX-105 Phase II clinical trial and two or more
MultiStem clinical trials. Other than external expenses for our clinical and preclinical programs,
we do not track our research expenses by project; rather, we track such expenses by the type of
cost incurred.
11
General and Administrative Expenses. General and administrative expenses decreased to $1.4 million
for the three months ended June 30, 2008 from $3.5 million in the comparable period in 2007. The
decrease of $2.1 million relates primarily to a $1.8 million decrease in stock compensation
expense, a $156,000 decrease in other expenses and a $153,000 decrease in personnel and facilities
costs. Included in other expenses for the three-month period ended June 30, 2007 was a one-time
advisory fee of $350,000 related to the merger, which is the primary reason for the decrease in
other expenses. Included in personnel costs in the three months ended June 30, 2007 was
approximately $308,000 of bonus expenses that were tied to the achievement of certain milestones
and is the primary reason for the decrease in personnel costs.
Depreciation. Depreciation expense decreased to $52,000 for the three months ended June 30, 2008
from $75,000 for the comparable period in 2007. The decrease was due to more equipment becoming
fully depreciated.
Other Income. In May 2007, we sold certain non-core assets related to its asthma drug discovery
program to a pharmaceutical company for $2.0 million, of which $1.5 million was received at closing
and recorded in other income. The remaining $500,000 was received and recognized as other income in
August 2007 upon our delivery of certain ancillary assets related to the program.
Interest Income. Interest income represents interest income earned on our cash and
available-for-sale securities. Interest income increased to $286,000 for the three months ended
June 30, 2008 from $175,000 for the comparable period in 2007 due to the increase in our average
cash balances as a result of our equity offering in June 2007. Due to declining interest rates and
lower cash balances as a result of our ongoing and planned clinical and preclinical development, we
expect our 2008 interest income to decline over the remaining quarters of 2008.
Interest Expense. Interest expense decreased to $31,000 for the three months ended June 30, 2008
from $710,000 for the comparable period in 2007. Interest expense in the three-month period ended
June 30, 2008 consists primarily of interest on our senior loan. Included in interest expense for
the three-month period ended June 30, 2007 is interest on our senior loan and subordinated
convertible promissory notes issued to our bridge investors in October 2006 and to Angiotech, which
were converted into common stock upon the closing of our equity offering in June 2007. Unless we
enter into a new debt arrangement, we expect our interest expense to decrease in the second half of
2008 as a result of the repayment at maturity of our senior loan in June 2008.
Accretion of Premium on Convertible Debt. The accretion of premium on convertible debt for the
three months ended June 30, 2007 relates to the subordinated convertible promissory notes issued to
bridge investors in October 2006. The notes, if not converted, were repayable with accrued interest
at maturity, plus a repayment fee of 200% of the outstanding principal. We computed a premium on
the debt in the amount of $5.25 million due upon redemption, which was being accreted over the term
of the notes using the effective interest method. The unamortized premium was reversed and recorded
in additional paid-in-capital when the notes were converted into common stock upon the closing of
our equity offering in June 2007.
Deemed Dividend. In connection with the merger in 2007, all shares of Athersys convertible
preferred stock were converted into common stock, which resulted in a deemed dividend in the amount
of $4.8 million from the induced conversion associated with the change in the conversion ratios.
This amount is reflected as an increase to the net loss attributable to common stockholders for the
three months ended June 30, 2007.
12
Six Months Ended June 30, 2008 and 2007
Revenues. Total revenues were comparable for the six months ended June 30, 2008 and 2007. Grant
revenue decreased $254,000 for the six months ended June 30, 2008 compared to the six months ended
June 30, 2007. The decrease in grant revenue was due to the timing of expenditures that are
reimbursed with grant proceeds. License fee revenue increased $220,000 for the six months ended
June 30, 2008 compared to the six months ended June 30, 2007. The increase in license fee revenue
over this period was a result of the nature and timing of target acceptances under our
collaboration agreement with Bristol-Myers Squibb.
Research and Development Expenses. Research and development expenses increased to $8.1 million for
the six months ended June 30, 2008 from $7.4 million in the comparable period in 2007. The
increase of approximately $700,000 related primarily to an increase in clinical and preclinical
development costs of $2.4 million, an increase in personnel, research supplies and facilities costs
of $180,000 and an increase in sponsored research of $30,000 in the six months ended June 30, 2008
compared to the comparable period in 2007. These increases were partially offset by a decrease in
stock compensation expense of $1.7 million, a decrease in other expenses of $204,000 and a decrease
in patent legal fees of $36,000 in the six months ended June 30, 2008 compared to the comparable
period in 2007. The $2.4 million increase in preclinical and clinical costs was a result of the
continuation of the ATHX-105 clinical trial, which was completed in January 2008, preparation for a
Phase II clinical trial of ATHX-105, which includes certain non-clinical studies, and preparation
for Phase I clinical trials for MultiStem in 2008. Our clinical costs for the six months ended June
30, 2008 are reflected net of Angiotechs cost-sharing amount related to our MultiStem acute
myocardial infarction collaboration in the amount of $462,000. We expect these expenses to continue
to increase in 2008 as we expect to initiate our ATHX-105 Phase II clinical trial and continue two
MultiStem clinical trials that were recently initiated. The decrease in other expenses for the six
months ended June 30, 2008 was primarily a result of milestone payment in 2007 in the amount of
$507,000 associated with a collaboration related to our stem cell technology. Other than external
expenses for our clinical and preclinical programs, we do not track our research expenses by
project; rather, we track such expenses by the type of cost incurred.
General and Administrative Expenses. General and administrative expenses decreased to $2.9 million
for the six months ended June 30, 2008 from $4.1 million in the comparable period in 2007. The
decrease of $1.2 million relates primarily to a $1.6 million decrease in stock compensation
expense. This decrease was partially offset by an increase in legal, professional and consulting
fees of $227,000 and an increase in other expenses of $101,000. The increase in legal and
professional fees for the six months ended June 30, 2008 was primarily a result of accounting and
auditing fees incurred in connection with our annual audit and annual report, legal fees incurred
in connection with our annual report and fees for our board of directors. The increase in other
expenses for the six-month period ended June 30, 2008 was primarily a result of costs such as
printing costs for SEC filings, Nasdaq listing fees, directors and officers insurance costs,
investor and public relations costs and costs related to compliance with Section 404 of the
Sarbanes-Oxley Act of 2002.
Depreciation. Depreciation expense decreased to $109,000 for the six months ended June 30, 2008
from $155,000 for the comparable period in 2007. The decrease was due to more equipment becoming
fully depreciated.
Other Income. In May 2007, we sold certain non-core assets related to its asthma drug discovery
program to a pharmaceutical company for $2.0 million, of which $1.5 million was received at closing
and recorded in other income. The remaining $500,000 was received and recognized as other income in
August 2007 upon our delivery of certain ancillary assets related to the program.
Interest Income. Interest income represents interest income earned on our cash and
available-for-sale securities. Interest income increased to $742,000 for the six months ended June
30, 2008 from $222,000 for the comparable period in 2007 due to the increase in our average cash
balances as a result of our equity offering in June 2007. Due to declining interest rates and
lower cash balances as a result of our ongoing and planned clinical and preclinical development, we
expect our 2008 interest income to decline over the remaining quarters of 2008.
Interest Expense. Interest expense decreased to $93,000 for the six months ended June 30, 2008
from $1.0 million for the comparable period in 2007. Interest expense in the six-month period
ended June 30, 2008 consists primarily of interest on our senior loan. Included in interest
expense for the six-month period ended June 30, 2007 is interest on our senior loan and
subordinated convertible promissory notes issued to our bridge investors in October 2006 and to
Angiotech, which were converted into common stock upon the closing of our equity offering in June
2007. Unless we enter into a new debt arrangement, we expect our interest expense to decrease in
the second half of 2008 as a result of the repayment at maturity of our senior loan in June 2008.
Accretion of Premium on Convertible Debt. The accretion of premium on convertible debt for the six
months ended June 30, 2007 relates to the subordinated convertible promissory notes issued to
bridge investors in October 2006. The notes, if not converted, were repayable with accrued interest
at maturity, plus a repayment fee of 200% of the outstanding principal. We computed a premium on
the debt in the amount of $5.25 million due upon redemption, which was being accreted over the term
of the notes using the effective interest method. The unamortized premium was reversed and recorded
in additional paid-in-capital when the notes were converted into common stock upon the closing of
our equity offering in June 2007.
Deemed Dividend. In connection with the merger in 2007, all shares of Athersys convertible
preferred stock were converted into common stock, which resulted in a deemed dividend in the amount
of $4.8 million from the induced conversion associated with the change in the conversion ratios.
This amount is reflected as an increase to the net loss attributable to common stockholders for the
six months ended June 30, 2007.
LIQUIDITY AND CAPITAL RESOURCES
Our sources of liquidity include our cash balances and available-for-sale securities. At June 30,
2008, we had $17.7 million in cash and cash equivalents and $22.0 million in available-for-sale
securities. We have primarily financed our operations through private equity and debt financings
that have resulted in aggregate cumulative proceeds of approximately $200 million.
We will require substantial additional funding in order to continue our research and product
development programs, including preclinical testing and clinical trials of our product candidates.
We anticipate using approximately $25 million to fund our activities in 2008, which would represent
an increase in cash expenditures as compared to 2007 and reflects the impact of the ATHX-105 Phase
II clinical trial that we intend to initiate in the second half of 2008. When we complete the
ATHX-105 Phase II clinical trial, we expect lower clinical development costs in 2009, and as a
result, expect to have available cash to fund our operations into 2010 based on our current
business and operational plans and assuming no new financings. Our funding requirements may change
at any time due to technological advances, competition from other companies or for other reasons.
Our future capital requirements will also depend on numerous other factors, including scientific
progress in our research and development programs, additional personnel costs, progress in
preclinical testing and clinical trials, the time and cost related to proposed regulatory
approvals, if any, and the costs in filing and prosecuting patent applications and enforcing patent
claims. We cannot assure you that adequate funding will be available to us or, if available, that
it will be available on acceptable terms. Any shortfall in funding could result in our having to
curtail our research and development efforts.
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