Athersys, Inc. 10-Q
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 March 31, 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: 000-52108
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
of incorporation or organization)
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(I.R.S. Employer Identification No.) |
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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 þ
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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, $0.001 par value, as of May 1,
2008 was 18,927,988.
ATHERSYS INC.
TABLE OF CONTENTS
2
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements.
Athersys, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
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March 31, |
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December 31, |
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2008 |
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2007 |
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(Unaudited) |
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(Note) |
Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
17,548 |
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$ |
13,248 |
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Available-for-sale securities |
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21,883 |
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22,477 |
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Accounts receivable |
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676 |
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836 |
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Receivable from Angiotech |
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255 |
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63 |
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Investment interest receivable |
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272 |
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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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286 |
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394 |
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Total current assets |
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41,083 |
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37,443 |
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Available-for-sale securities |
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5,366 |
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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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68 |
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86 |
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Equipment, net |
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402 |
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387 |
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Accounts receivable, net |
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43 |
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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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$ |
47,388 |
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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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$ |
1,858 |
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$ |
1,011 |
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Accrued compensation and related benefits |
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162 |
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71 |
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Accrued clinical trial costs |
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230 |
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735 |
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Accrued expenses and other |
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632 |
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993 |
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Current portion of long-term debt, net |
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1,013 |
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1,784 |
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Total current liabilities |
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3,895 |
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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 March
31, 2008 and December 31, 2007 |
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Common stock, $0.001 par value;
100,000,000 shares authorized, and
18,927,988 shares issued and outstanding
at March 31, 2008 and December 31, 2007 |
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19 |
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19 |
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Additional paid-in capital |
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208,503 |
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208,039 |
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Accumulated other comprehensive income |
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114 |
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52 |
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Accumulated deficit |
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(165,143 |
) |
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(160,479 |
) |
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Total stockholders equity |
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43,493 |
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47,631 |
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Total liabilities and stockholders equity |
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$ |
47,388 |
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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
1
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.
2
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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March 31, |
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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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$ |
390 |
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$ |
310 |
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Grant revenue |
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402 |
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569 |
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Total revenues |
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792 |
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879 |
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Costs and expenses |
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Research and development |
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4,315 |
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2,365 |
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General and administrative |
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1,481 |
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608 |
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Depreciation |
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57 |
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80 |
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Total costs and expenses |
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5,853 |
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3,053 |
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Loss from operations |
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(5,061 |
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(2,174 |
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Interest income and other |
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459 |
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47 |
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Interest expense |
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(62 |
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(333 |
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Accretion of premium on convertible debt |
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(260 |
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Net loss |
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$ |
(4,664 |
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$ |
(2,720 |
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Preferred stock dividends |
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$ |
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$ |
(375 |
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Net loss attributable to common stockholders |
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$ |
(4,664 |
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$ |
(3,095 |
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Basic and diluted net loss per common share
attributable to common stockholders |
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$ |
(0.25 |
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$ |
(10.54 |
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Weighted average shares outstanding, basic
and diluted |
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18,927,988 |
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293,770 |
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See accompanying notes to unaudited condensed consolidated financial statements.
3
Athersys, Inc.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
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Three months ended |
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March 31, |
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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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$ |
(4,664 |
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$ |
(2,720 |
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Adjustments to reconcile net loss to net cash
used in operating activities: |
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Depreciation |
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57 |
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80 |
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Accretion of premium on convertible debt |
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260 |
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Stock-based compensation |
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464 |
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44 |
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Provision on note receivable |
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18 |
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Expense related to warrants issued to lenders |
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11 |
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Amortization of discount on
available-for-sale securities |
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(57 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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159 |
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572 |
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Receivable from Angiotech |
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(192 |
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Prepaid expenses and other assets |
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89 |
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(87 |
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Accounts payable and accrued expenses |
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72 |
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(229 |
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Net cash used in operating activities |
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(4,043 |
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(2,080 |
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Investing activities |
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Purchase of available-for-sale securities |
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(10,102 |
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Maturities of available-for-sale securities |
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19,299 |
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Purchases of equipment |
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(72 |
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(3 |
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Net cash provided by (used in) investing activities |
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9,125 |
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(3 |
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Financing activities |
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Principal payments on debt |
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(782 |
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(1,134 |
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Proceeds from convertible promissory note |
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5,000 |
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Net cash (used in) provided by financing activities |
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(782 |
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3,866 |
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Increase in cash and cash equivalents |
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4,300 |
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1,783 |
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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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$ |
17,548 |
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$ |
3,311 |
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See accompanying notes to unaudited condensed consolidated financial statements.
4
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.
5
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 Standard
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.
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 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) |
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Outstanding stock options to purchase 3,735,276 and 103,368 shares of common stock for the
three-month periods ended March 31, 2008 and 2007, respectively; |
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2) |
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Warrants to purchase 5,125,496 and 25,639 shares of common stock for the three-month periods
ended March 31, 2008 and 2007, respectively; |
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3) |
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Shares of common stock issuable upon the conversion of convertible preferred stock in the
amount of 364,524 for the three-month period ended March 31, 2007; and |
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Shares of common stock issuable upon the conversion of convertible promissory notes in the
approximate amount of 245,762 for the three-month period ended March 31, 2007. |
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.
6
Below is a reconciliation, in thousands, of net loss to comprehensive loss for all periods
presented.
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Three months ended March 31, |
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2008 |
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2007 |
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Net loss |
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$ |
(4,664 |
) |
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$ |
(2,720 |
) |
Unrealized gain on available-for-sale securities |
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62 |
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Comprehensive loss |
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$ |
(4,602 |
) |
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$ |
(2,720 |
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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:
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Level 1
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Unadjusted quoted prices in active markets for identical assets or liabilities. |
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Level 2
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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. |
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Level 3
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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):
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Fair Value Measurements at March 31, 2008 Using |
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Quoted Prices in Active |
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Significant Other |
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Balance as of |
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Markets for Identical |
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Observable Inputs |
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Significant Unobservable |
Description |
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March 31, 2008 |
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Assets (Level 1) |
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(Level 2) |
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Inputs (Level 3) |
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Available-for-sale
securities |
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$ |
27,249 |
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$ |
27,249 |
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$ |
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$ |
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Fair value is based upon quoted market prices in active markets. We had no level 2 or level 3
assets at March 31, 2008. We will 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.
7. Stock-based Compensation
In 2007, we adopted two incentive plans that authorized an aggregate of 4,500,000 shares of common
stock for awards to employees, directors and consultants. These equity incentive 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.
7
As of March 31, 2008, a total of 769,000 shares are available for issuance under our equity
compensation plans and 3,731,000 options to purchase shares of common stock were outstanding.
Also, options to purchase 4,276 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 March 31, 2008, stock
compensation expense was approximately $464,000. During the three-month period ended March 31,
2008, we issued options to purchase 103,000 shares of common stock to employees and a consultant.
At March 31, 2008, total unrecognized estimated compensation cost related to unvested stock options
was approximately $4.6 million, which is expected to be recognized by January 2012 using the
straight-line method.
8. Long-Term Debt
A summary of our long-term debt outstanding is as follows (in thousands):
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March 31, |
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December 31, |
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2008 |
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2007 |
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Notes payable to lenders |
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$ |
1,018 |
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$ |
1,800 |
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Discount related to warrant issuance |
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(5 |
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(16 |
) |
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Total, net |
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1,013 |
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1,784 |
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Less current portion |
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1,013 |
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1,784 |
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$ |
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$ |
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In November 2004, we issued $7.5 million of notes payable to lenders, the proceeds of which are
unrestricted and used for general corporate purposes. The notes are 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 lenders have the right to receive a milestone payment of $2.25 million upon the occurrence of
certain events. In October 2007, an amendment to the loan agreement was executed to clarify the
milestone events as follows: (1) cumulative equity financing proceeds in excess of $5 million,
whereby 10% of such proceeds that are not directly tied to the collaboration activities will be
used to pay the milestone; (2) our merger with or into another entity where our stockholders do not
hold at least a majority of the voting power of the surviving entity; (3) the sale of all or
substantially all of our assets; and (4) our liquidation or dissolution. The milestone payment is
payable in cash, except that if the milestone event is (1) 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 March 31, 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 has been recognized as a debt discount
over the remaining term of the loan.
9. Convertible Notes
Upon the closing of our equity offering in June 2007, convertible promissory notes issued to
Angiotech 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
8
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 March 31, 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. 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%.
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. 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 this 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 that will be 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. Following a detailed analysis of the results of the clinical trial, the completion of
certain required non-clinical studies and regulatory approval, we
9
intend to initiate a Phase II clinical trial in the United States that will examine safety and
effectiveness in clinically obese patients in the second half of 2008.
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 and peripheral vascular disease, is being developed
with our partner, Angiotech Pharmaceuticals, Inc. We intend to initiate both of these trials in
2008 and file an additional investigational new drug application, or IND, for treatment of ischemic
stroke in 2008. 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 addition to these drug development 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 $165 million at March 31, 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 provide revenues and capabilities to help
to further advance our product candidates, and we have also built a substantial portfolio of
intellectual property.
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.
10
The following tables set forth our revenues and expenses for the periods indicated. The following
tables are stated in thousands.
Revenues
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
|
|
2008 |
|
|
2007 |
|
License fees |
|
$ |
390 |
|
|
$ |
310 |
|
Grant revenue |
|
|
402 |
|
|
|
569 |
|
|
|
|
|
|
|
|
|
|
$ |
792 |
|
|
$ |
879 |
|
|
|
|
|
|
|
|
Research and development expenses
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
Type of expense |
|
2008 |
|
|
2007 |
|
Personnel costs |
|
$ |
765 |
|
|
$ |
597 |
|
Research supplies |
|
|
183 |
|
|
|
204 |
|
Facilities |
|
|
211 |
|
|
|
191 |
|
Clinical and preclinical development costs |
|
|
2,298 |
|
|
|
808 |
|
Sponsored research |
|
|
105 |
|
|
|
133 |
|
Patent legal fees |
|
|
230 |
|
|
|
276 |
|
Other |
|
|
333 |
|
|
|
125 |
|
Stock-based compensation |
|
|
190 |
|
|
|
31 |
|
|
|
|
|
|
|
|
|
|
$ |
4,315 |
|
|
$ |
2,365 |
|
|
|
|
|
|
|
|
General and administrative expenses
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
Type of expense |
|
2008 |
|
|
2007 |
|
Personnel costs |
|
$ |
489 |
|
|
$ |
358 |
|
Facilities |
|
|
87 |
|
|
|
77 |
|
Legal and professional fees |
|
|
296 |
|
|
|
82 |
|
Other |
|
|
335 |
|
|
|
78 |
|
Stock-based compensation |
|
|
274 |
|
|
|
13 |
|
|
|
|
|
|
|
|
|
|
$ |
1,481 |
|
|
$ |
608 |
|
|
|
|
|
|
|
|
Three Months Ended March 31, 2008 and 2007
Revenues. Revenues decreased to $792,000 for the three months ended March 31, 2008 from $879,000
in the comparable period in 2007. Grant revenue decreased $167,000 for the three months ended
March
11
31, 2008 compared to the three months ended March 31, 2007. The decrease in grant revenue was due
to the timing of expenditures that are reimbursed with grant proceeds. License fee revenues
increased $80,000 for the three months ended March 31, 2008 compared to the three months ended
March 31, 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 $4.3 million for
the three months ended March 31, 2008 from $2.4 million in the comparable period in 2007. The
increase of approximately $2.0 million related primarily to an increase in clinical and preclinical
development costs of $1.5 million, an increase in other expenses of $208,000, an increase in stock
compensation expense of $159,000 and an increase in personnel and facilities costs of $188,000 in
the three months ended March 31, 2008 compared to the comparable period in 2007. These increases
were partially offset by a decrease in patent legal fees of $46,000 and a decrease in sponsored
research and research supplies of $49,000 in the three months ended March 31, 2008 compared to the
comparable period in 2007. The $1.5 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 two or more MultiStem disease indications in 2008.
Our clinical costs for the three months ended March 31, 2008 are reflected net of a reimbursement
from Angiotech related to our MultiStem acute myocardial infarction collaboration in the amount of
$192,000. 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. The increase in other
expenses for the three-month period ended March 31, 2008 was primarily a result of increased
outside service costs and travel costs. 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 increased to $1.5 million
for the three months ended March 31, 2008 from $608,000 in the comparable period in 2007. The
increase of $873,000 relates primarily to a $261,000 increase in stock compensation expense, a
$257,000 increase in other expenses, a $214,000 increase in legal and professional fees and a
$141,000 increase in personnel and facilities costs. The increase in legal and professional fees
for the three months ended March 31, 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
three-month period ended March 31, 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 $57,000 for the three months ended March 31, 2008
from $80,000 for the comparable period in 2007. The decrease was due to more equipment becoming
fully depreciated.
Interest Income and Other. Interest income represents interest income earned on our cash and
available-for-sale securities and other income consists of foreign currency gains related to our
activities in Europe and certain contracts denominated in foreign currencies. Interest income and
other increased to $459,000 for the three months ended March 31, 2008 from $47,000 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 $62,000 for the three months ended March 31, 2008
from $333,000 for the comparable period in 2007. Interest expense in the three-month period ended
March 31, 2008 consists primarily of interest on our senior loan. Included in interest expense for
the three-month period ended March 31, 2007 is interest on our senior loan and subordinated
convertible
12
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 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 March 31, 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.
LIQUIDITY AND CAPITAL RESOURCES
Our sources of liquidity include our cash balances and available-for-sale securities. At March 31,
2008, we had $17.5 million in cash and cash equivalents and $27.3 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 $23 million to $25 million to fund our activities in 2008, which is an increase
in cash expenditures reflecting the impact of the ATHX-105 Phase II clinical trial. With the
anticipated completion of 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.
We expect to continue to incur substantial losses through at least the next several years and may
incur losses in subsequent periods. The amount and timing of our future losses are highly
uncertain. Our ability to achieve and thereafter sustain profitability will be dependent upon,
among other things, successfully developing, commercializing and obtaining regulatory approval or
clearances for our technologies and products resulting from these technologies.
Net cash used in operating activities was $4.0 million for the three months ended March 31, 2008
and $2.1 million for the three months ended March 31, 2007, and represented the use of cash in
funding preclinical and product development initiatives and administrative costs. We expect that
net cash used in operating activities will increase as we increase our clinical trial activity for
ATHX-105 and MultiStem and as we continue to advance our various research and product development
activities.
Net cash provided by (used in) investing activities was $9.1 million for the three months ended
March 31, 2008 and $(3,000) for the three months ended March 31, 2007. The fluctuations from period
to period were due to the timing of purchases and maturity dates of investments and purchases of
equipment.
13
Financing activities used cash of $(782,000) for the three months ended March 31, 2008
and provided cash of $3.9 million for the three months ended March 31, 2007. This fluctuation relates primarily to
the issuance of a convertible promissory note in the first quarter of 2007 to Angiotech.
Investors in our equity offering in June 2007 received five-year warrants to purchase an aggregate
of 3,250,000 shares of common stock with an exercise price of $6.00 per share. The lead investor in
the June offering, Radius Venture Partners, invested $10.0 million in the June offering and
received additional five-year warrants to purchase an aggregate of 500,000 shares of common stock
with a cash or cashless exercise price of $6.00 per share. The placement agents for the June
offering received five-year warrants to purchase an aggregate of 1,093,525 shares of common stock
with a cash or cashless exercise price of $6.00 per share. The exercise of such warrants could
provide us with cash proceeds.
Our senior loan, which had a balance of $1.0 million at March 31, 2008, will be repaid in full in
June 2008. The senior lenders have the right to receive a milestone payment of $2.25 million upon
the occurrence of certain events as clarified in the October 2007 amendment to the senior loan 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 milestone events occurred in the
three-month period ended March 31, 2008. The senior lenders also received warrants to purchase
149,026 shares of common stock with an exercise price of $5.00 upon the closing of our equity
offering in June 2007. We are considering entering into a new debt facility in 2008.
In connection with developing MultiStem for the treatment of the cardiovascular disorders of
myocardial infarction and peripheral vascular disease as part of a commercial collaboration with
Angiotech that was entered into in May 2006, in support of the collaboration, Angiotech purchased
subordinated convertible promissory notes in the aggregate principal amount of $10.0 million, which
were converted along with accrued interest into common stock upon the closing of our equity
offering in June 2007. Upon the successful achievement of specified clinical development and
commercialization milestones, we may also receive up to $3.75 million of additional equity
investments and $63.75 million of aggregate cash payments, though there can be no assurance that we
will achieve any milestones.
Under the terms of the collaboration, the parties plan to jointly fund clinical development
activity, whereby preclinical costs will be borne solely by us, costs for phase I and phase II
studies will be borne 50% by us and 50% by Angiotech, costs for the first phase III study will be
borne 33% by us and 67% by Angiotech, and costs for any phase III studies subsequent to the first
phase III study will be borne 25% by us and 75% by Angiotech. We have lead responsibility for
preclinical and early clinical development and manufacturing of the MultiStem product, and
Angiotech will take the lead on pivotal and later clinical trials and commercialization. Late in
2007, the parties began to share costs for phase I clinical development, of which $255,000 was due
from Angiotech at March 31, 2008. We will receive nearly half of the net profits from the sale of
any jointly developed, approved products. In addition, we will retain the commercial rights to
MultiStem for all other therapeutic applications, including treatment of stroke, bone marrow
transplantation and oncology support, blood and immune system disorders, autoimmune disease, and
other indications that we may elect to pursue. In December 2007, we achieved a clinical development
milestone upon the authorization of our IND by the FDA. This milestone event required Angiotech to
either purchase $5.0 million of our common stock, or forego the purchase and allow us to select
from two pre-defined milestone replacements. Angiotech opted to forego the purchase, and we
elected to increase our share of the net profits from the sale of approved products as the
milestone replacement.
14
We have an operating lease for our office and laboratory space with options to renew through March
2013 at the existing rental rate, which is approximately $267,000 per year. We exercised options to
renew the lease through March 2010. In February 2008, we entered into a three-year lease agreement
for office and laboratory space for our Belgian subsidiary, with an annual rent of approximately
$45,000, subject to annual adjustments based on an inflationary index. The lease includes an option
to renew for four additional years, through December 31, 2014.
We have no off-balance sheet arrangements.
CRITICAL ACCOUNTING POLICIES AND MANAGEMENT ESTIMATES
The SEC defines critical accounting policies as those that are, in managements view, important to
the portrayal of our financial condition and results of operations and demanding of managements
judgment. Our discussion and analysis of financial condition and results of operations are based on
our consolidated financial statements, which have been prepared in accordance with U.S. generally
accepted accounting principles (GAAP). The preparation of these financial statements requires us
to make estimates on experience and on various assumptions that we believe are reasonable under the
circumstances, the results of which form the basis for making judgments about the carrying values
of assets and liabilities that are not readily apparent from other sources. Actual results may
differ from those estimates. A description of these accounting policies and estimates is included
in Item 7 Managements Discussion and Analysis of Financial Condition and Results of Operations
in our Annual Report on Form 10-K for the year ended December 31, 2007. There have been no material
changes in our accounting polices and estimates as described in our Annual Report. For additional
information regarding our accounting policies, see Note B to the Consolidated Financial Statements
in our Annual Report on Form 10-K for the year ended December 31, 2007.
New Accounting Standard
In September 2006, the Financial Accounting Standards Board (FASB) issued 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, which did not have a material impact on our financial position
or results. See Note 6 to our condensed consolidated financial statements included in this
Quarterly Report on Form 10-Q.
CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These
forward-looking statements relate to, among other things, the expected timetable for development of
our product candidates, our growth strategy, and our future financial performance, including our
operations, economic performance, financial condition, prospects, and other future events. We have
attempted to identify forward-looking statements by using such words as anticipates, believes,
can, continue, could, estimates, expects, intends, may, plans, potential,
should, will, or other similar expressions. These forward-looking statements are only
predictions and are largely based on our current expectations. These forward-looking statements
appear in a number of places in this quarterly report on Form 10-Q.
In addition, a number of known and unknown risks, uncertainties, and other factors could affect the
accuracy of these statements. Some of the more significant known risks that we face are the risks
and
uncertainties inherent in the process of discovering, developing, and commercializing products that
are
15
safe and effective for use as human therapeutics, including the uncertainty regarding market
acceptance of our product candidates and our ability to generate revenues. These risks may cause
our actual results, levels of activity, performance, or achievements to differ materially from any
future results, levels of activity, performance, or achievements expressed or implied by these
forward-looking statements.
Other important factors to consider in evaluating our forward-looking statements include:
|
|
|
our ability to successfully complete clinical trials for our product
candidates; |
|
|
|
|
the possibility of delays in, adverse results of and excessive costs of the
development process; |
|
|
|
|
changes in external market factors; |
|
|
|
|
changes in our industrys overall performance; |
|
|
|
|
changes in our business strategy; |
|
|
|
|
our ability to protect our intellectual property portfolio; |
|
|
|
|
our possible inability to enter into licensing or co-development arrangements
for certain product candidates; |
|
|
|
|
our possible inability to execute our strategy due to changes in our industry
or the economy generally; |
|
|
|
|
changes in productivity and reliability of suppliers; and |
|
|
|
|
the success of our competitors and the emergence of new competitors. |
Although we currently believe that the expectations reflected in the forward-looking statements are
reasonable, we cannot guarantee our future results, levels of activity or performance. We
undertake no obligation to publicly update forward-looking statements, whether as a result of new
information, future events or otherwise, except as required by law. You are advised, however, to
consult any further disclosures we make on related subjects in our reports on Forms 10-Q, 8-K and
10-K furnished to the SEC. You should understand that it is not possible to predict or identify
all risk factors. Consequently, you should not consider any such list to be a complete set of all
potential risks or uncertainties.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Interest Rate Risk
Our exposure to interest rate risk is related to our investment portfolio and our borrowings. Fixed
rate investments and borrowings may have their fair market value adversely impacted from changes in
interest rates. Due in part to these factors, our future investment income may fall short of
expectations. Further, we may suffer losses in investment principal if we are forced to sell
securities that have declined in market value due to changes in interest rates. We invest our
excess cash primarily in debt instruments of the U.S. government and its agencies, corporate debt
securities, floating-rate notes and A1+/P1 commercial paper.
We enter into loan arrangements with financial institutions when needed. At March 31, 2008, we had
borrowings of approximately $1.0 million outstanding under our senior loan, which bears interest at
a fixed rate of approximately 13%.
Item 4. Controls and Procedures.
Disclosure controls and procedures
Our management, under the supervision of and with the participation of our Chief Executive Officer
and our Vice President of Finance, has evaluated the effectiveness of our disclosure controls and
procedures,
16
as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934,
as of the end of the period covered by this quarterly report on Form 10-Q. Based upon this
evaluation, our Chief Executive Officer and Vice President of Finance have concluded that, as of
the end of the period covered by this quarterly report on Form 10-Q, our disclosure controls and
procedures were effective.
Changes in internal control over financial reporting
During the first quarter of 2008, there has been no change in our internal control over financial
reporting (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934)
that has materially affected, or is reasonably likely to materially affect, our internal control
over financial reporting.
PART II. OTHER INFORMATION
Item 6. Exhibits.
|
|
|
Exhibit No. |
|
Description |
|
|
|
10.1
|
|
Summary of Athersys, Inc. 2008 Cash Bonus Incentive Plan |
|
|
|
31.1
|
|
Certification of Gil Van Bokkelen, Chairman and Chief Executive Officer,
pursuant to SEC Rules 13a-14(a) and 15d-14(a) adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. |
|
|
|
31.2
|
|
Certification of Laura K. Campbell, Vice President of Finance, pursuant to
SEC Rules 13a-14(a) and 15d-14(a) adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. |
|
|
|
32.1
|
|
Certification of Gil Van Bokkelen, Chairman and Chief
Executive Officer, and Laura Campbell, Vice President of Finance, pursuant to 18
U.S.C. Section 1350, adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002. |
17
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
ATHERSYS, INC.
|
|
|
/s/ Gil Van Bokkelen |
|
Date: May 8, 2008 |
Gil Van Bokkelen |
|
|
Chairman and Chief Executive Officer
(principal executive officer authorized to sign on
behalf of the registrant) |
|
|
|
|
|
|
/s/ Laura K. Campbell |
|
|
Laura K. Campbell |
|
|
Vice President, Finance
(principal financial and accounting officer
authorized to sign on behalf of the registrant) |
|
18
EXHIBIT INDEX
|
|
|
Exhibit No. |
|
Description |
|
|
|
10.1
|
|
Summary of Athersys, Inc. 2008 Cash Bonus Incentive Plan |
|
|
|
31.1
|
|
Certification of Gil Van Bokkelen, Chairman and Chief Executive Officer,
pursuant to SEC Rules 13a-14(a) and 15d-14(a) adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. |
|
|
|
31.2
|
|
Certification of Laura K. Campbell, Vice President of Finance, pursuant to
SEC Rules 13a-14(a) and 15d-14(a) adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. |
|
|
|
32.1
|
|
Certification of Gil Van Bokkelen, Chairman and Chief Executive Officer, and
Laura Campbell, Vice President of Finance, pursuant to 18 U.S.C. Section 1350, adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
19