ATHERSYS, INC. 10-Q/A
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q/A
(Amendment No. 1)
(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, 2007
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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
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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,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer o Non-accelerated filer 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, 2007, was 18,927,988.
ATHERSYS, INC.
TABLE OF CONTENTS
EXPLANATORY NOTE
Athersys, Inc. (the Company) is filing this Amendment No. 1 on Form 10-Q/A (this
Amendment) to amend and restate the consolidated statements of operations and the related
financial information of the Company that were included in its original Quarterly Report on Form
10-Q for the three and six months ended June 30, 2007 (the Original Form 10-Q).
In June 2007, a wholly-owned subsidiary of the Company merged with and into Athersys, Inc.
(Old Athersys), whereby Old Athersys became a wholly-owned subsidiary of the Company, which was
named BTHC VI, Inc. at the time of such merger (the Merger). Prior to the consummation of the
Merger, Old Athersys negotiated with holders of its convertible preferred stock a planned
restructuring of its capital stock, which included the conversion of the preferred stock into
shares of Old Athersys common stock, the termination of the warrants issued to the former holders
of Class C convertible preferred stock and the termination of rights to preferred dividends,
including the elimination of the accrued dividends payable to the former holders of Class C
convertible preferred stock. As a result, immediately prior to the consummation of the Merger, all
shares of Old Athersys convertible preferred stock (including termination of warrants and
elimination of accrued dividends) were converted into 53,341,747 shares of Old Athersys common
stock. Upon closing of the Merger, the 53,341,747 shares of Old Athersys common stock were
exchanged for 1,912,356 shares of Company common stock using the Merger exchange rate. Old Athersys
also retired the shares of its preferred and common stock held in treasury. Immediately following
the Merger, the Company issued and sold 13,000,000 shares of common stock and warrants to purchase
3,250,000 shares of common stock to new investors for gross proceeds of $65.0 million (the
Financing).
In July 2007, the Company filed a registration statement with the SEC to register the resale
of the shares of common stock issued in the Financing, including the shares issuable upon the
exercise of warrants. In late September 2007, in response to the Companys filing of an amended
registration statement, the SEC issued a comment about the accounting for the change to the
conversion ratios of the convertible preferred stock in connection with the Merger. In
consultation with its independent registered public accounting firm and the Audit Committee of the
Companys Board of Directors, the Company determined that the change to the conversion ratios of
the convertible preferred stock effected as part of the restructuring of the Old Athersys capital
stock should have been accounted for as an induced conversion, resulting in a $4.8 million deemed
dividend that would increase the net loss attributable to common stockholders.
The Companys previously reported consolidated statements of operations for the three and six
months ended June 30, 2007 included in the Original Form 10-Q did not include the $4.8 million
amount in the net loss attributable to common stockholders, and the basic and diluted net loss per
common share were understated as a result. The amended and restated consolidated statements of
operations included in this Amendment now reflect this $4.8 million deemed dividend in the
calculation of basic and diluted net loss per common share. Additionally, in light of the amendment
and restatement of our consolidated statements of operations included in this Amendment, we have
re-evaluated our disclosure controls and procedures as of June 30, 2007.
This Amendment amends and restates only Items 1, 2 and 4 of Part I of the Original Form 10-Q.
Except as described in this Explanatory Note, this Amendment does not modify or update the
disclosures in our Form 10-Q for the three and six months ended June 30, 2007. Therefore,
this Amendment does not reflect any other events that occurred after the original August 17, 2007
filing date of the Original Form 10-Q. Forward-looking statements in this Amendment have also not
been updated from the Original Form 10-Q.
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements.
BTHC VI, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
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June 30, |
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December 31, |
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2007 |
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2006 |
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(Unaudited) |
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(Note) |
Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
58,939 |
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$ |
1,528 |
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Accounts receivable |
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384 |
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872 |
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Prepaid expenses and other |
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433 |
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361 |
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Total current assets |
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59,756 |
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2,761 |
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Notes receivable from related parties |
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562 |
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562 |
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Equipment, net |
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355 |
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509 |
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Accounts receivable, net |
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75 |
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117 |
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Equity investment and other assets |
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317 |
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317 |
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Total assets |
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$ |
61,065 |
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$ |
4,266 |
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Liabilities and stockholders equity (deficit) |
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Current liabilities: |
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Accounts payable |
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$ |
1,008 |
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$ |
898 |
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Accrued compensation and related benefits |
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65 |
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423 |
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Accrued expenses and other |
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1,047 |
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1,214 |
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Current
portion of long-term debt, net |
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3,235 |
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3,332 |
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Total current liabilities |
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5,355 |
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5,867 |
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Long-term debt |
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1,800 |
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Convertible promissory notes, net |
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7,510 |
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Accrued interest |
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214 |
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Accrued dividends |
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8,882 |
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Stockholders equity: |
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Convertible preferred stock, at stated value; no
shares authorized, issued or outstanding at June
30, 2007; 13,432,350 shares authorized and
10,168,231 shares issued and outstanding at
December 31, 2006 |
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68,301 |
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Preferred stock, 10,000,000 shares authorized
and no shares issued and outstanding at June 30,
2007; no shares authorized, issued or
outstanding at December 31, 2006 |
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Common stock, $0.001 par value;100,000,000
shares authorized and 18,927,988 shares issued
and outstanding at June 30, 2007; 40,000,000
shares authorized and 293,770 shares issued and
outstanding at December 31, 2006 |
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19 |
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Additional paid-in capital |
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207,033 |
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53,495 |
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Treasury stock |
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(250 |
) |
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Accumulated deficit |
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(151,342 |
) |
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(141,553 |
) |
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Total stockholders equity (deficit) |
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55,710 |
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(20,007 |
) |
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Total liabilities and stockholders equity (deficit) |
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$ |
61,065 |
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$ |
4,266 |
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Note: The balance sheet at December 31, 2006 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
BTHC VI, 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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2007 |
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2006 |
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2007 |
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2006 |
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Revenues |
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License fees |
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$ |
313 |
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$ |
261 |
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$ |
623 |
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$ |
481 |
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Grant revenue |
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410 |
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229 |
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979 |
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638 |
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Total revenues |
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723 |
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490 |
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1,602 |
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1,119 |
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Costs and expenses |
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Research and development (including stock
compensation expense of $2,000 and
$72 in the three months ended June
30, 2007 and 2006, respectively; and $2,031 and $159 in the six months ended
June 30, 2007 and 2006, respectively) |
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4,989 |
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2,361 |
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7,354 |
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4,945 |
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General and administrative (including stock
compensation expense of $2,089 and
$46 in the three months ended
June 30, 2007 and 2006, respectively; and
$2,102 and $91 in the six months
ended June 30, 2007 and 2006, respectively) |
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3,497 |
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1,066 |
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4,105 |
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1,754 |
|
Depreciation |
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|
75 |
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|
138 |
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|
155 |
|
|
|
293 |
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|
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Total costs and expenses |
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8,561 |
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|
|
3,565 |
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11,614 |
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6,992 |
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|
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Loss from operations |
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|
(7,838 |
) |
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|
(3,075 |
) |
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|
(10,012 |
) |
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|
(5,873 |
) |
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Other income (loss) |
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1,500 |
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(3 |
) |
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1,500 |
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208 |
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Interest income |
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175 |
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38 |
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222 |
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67 |
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Interest expense see Note 7 |
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(710 |
) |
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|
(255 |
) |
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(1,043 |
) |
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(490 |
) |
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Accretion of premium on convertible debt |
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(196 |
) |
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(456 |
) |
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Loss before cumulative effect of change
in accounting principle |
|
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(7,069 |
) |
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|
(3,295 |
) |
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|
(9,789 |
) |
|
|
(6,088 |
) |
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|
|
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Cumulative effect of change in accounting
principle |
|
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|
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|
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306 |
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Net loss |
|
$ |
(7,069 |
) |
|
$ |
(3,295 |
) |
|
$ |
(9,789 |
) |
|
$ |
(5,782 |
) |
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|
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|
Preferred stock dividends |
|
$ |
(284 |
) |
|
$ |
(347 |
) |
|
$ |
(659 |
) |
|
$ |
(695 |
) |
|
|
|
|
|
|
|
|
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|
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|
Deemed dividend resulting from induced conversion of convertible preferred stock |
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(4,800 |
) |
|
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|
|
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(4,800 |
) |
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|
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|
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Net loss attributable to common stockholders 2007 restated |
|
$ |
(12,153 |
) |
|
$ |
(3,642 |
) |
|
$ |
(15,248 |
) |
|
$ |
(6,477 |
) |
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|
Dividends declared per common share |
|
$ |
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|
|
$ |
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|
|
$ |
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|
|
$ |
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Basic and diluted net loss per common share 2007 restated: |
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|
|
|
|
|
|
|
|
|
|
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Net loss before cumulative effect of change
in accounting principle |
|
$ |
(2.53 |
) |
|
$ |
(12.40 |
) |
|
$ |
(5.99 |
) |
|
$ |
(23.19 |
) |
Cumulative effect of change in accounting
principle |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1.05 |
|
|
|
|
Net loss |
|
$ |
(2.53 |
) |
|
$ |
(12.40 |
) |
|
$ |
(5.99 |
) |
|
$ |
(22.14 |
) |
|
|
|
|
|
|
|
|
|
|
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|
|
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|
|
|
|
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|
Weighted average shares outstanding, basic
and diluted |
|
|
4,800,760 |
|
|
|
293,770 |
|
|
|
2,547,265 |
|
|
|
292,513 |
|
|
|
|
See accompanying notes to unaudited condensed consolidated financial statements.
2
BTHC VI, Inc.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
|
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|
|
|
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|
|
Six Months ended |
|
|
June 30, |
|
|
2007 |
|
2006 |
|
|
|
Operating activities |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(9,789 |
) |
|
$ |
(5,782 |
) |
Adjustments to reconcile net loss to net cash
used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
155 |
|
|
|
293 |
|
Equity in earnings of unconsolidated affiliate |
|
|
|
|
|
|
(117 |
) |
Accretion of premium on convertible debt |
|
|
456 |
|
|
|
|
|
Forgiveness of note receivable from related party |
|
|
|
|
|
|
122 |
|
Compensation common stock options |
|
|
4,133 |
|
|
|
250 |
|
Expense related to warrants issued to lenders |
|
|
438 |
|
|
|
|
|
Income from cumulative effect of change in
accounting principle |
|
|
|
|
|
|
(306 |
) |
Amortization of premium on
available for sale securities and other |
|
|
7 |
|
|
|
24 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
530 |
|
|
|
239 |
|
Prepaid expenses and other assets |
|
|
(72 |
) |
|
|
143 |
|
Accounts payable and accrued expenses |
|
|
(95 |
) |
|
|
819 |
|
|
|
|
Net cash used in operating activities |
|
|
(4,237 |
) |
|
|
(4,315 |
) |
|
|
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
|
|
|
Purchase of available for sale securities |
|
|
|
|
|
|
(3,024 |
) |
|
|
|
|
|
|
|
|
|
Maturities of available for sale securities |
|
|
|
|
|
|
3,804 |
|
|
|
|
|
|
|
|
|
|
Purchases of equipment |
|
|
(3 |
) |
|
|
(67 |
) |
|
|
|
Net cash (used in) provided by investing activities |
|
|
(3 |
) |
|
|
713 |
|
|
|
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
|
|
Principal payments on debt |
|
|
(1,843 |
) |
|
|
(1,222 |
) |
Proceeds from convertible promissory note |
|
|
5,000 |
|
|
|
5,000 |
|
Proceeds from issuance of common stock, net |
|
|
58,494 |
|
|
|
6 |
|
|
|
|
Net cash provided by financing activities |
|
|
61,651 |
|
|
|
3,784 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase in cash and cash equivalents |
|
|
57,411 |
|
|
|
182 |
|
Cash and cash equivalents at beginning of the period |
|
|
1,528 |
|
|
|
1,080 |
|
|
|
|
Cash and cash equivalents at end of the period |
|
$ |
58,939 |
|
|
$ |
1,262 |
|
|
|
|
See accompanying notes to unaudited condensed consolidated financial statements.
3
BTHC VI, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
1. Background; Recent Merger and Offering Restated
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. (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 Athersys on June 8, 2007, with Athersys continuing as the surviving entity in the merger (the
Merger). As a result of the Merger, Athersys became our wholly-owned subsidiary, and the
business of Athersys became our sole operations. Unless otherwise indicated, all references to
the Company are to BTHC VI, together with its wholly-owned subsidiary, Athersys.
Prior to the consummation of the Merger, the
Company negotiated with holders of its convertible preferred
stock a planned restructuring of its capital stock, which
included the conversion of the preferred stock into shares of
the Companys common stock, the termination of the warrants
issued to the former holders of Class C Convertible
Preferred Stock and the termination of rights to preferred dividends, including the
elimination of the accrued dividends payable to the former
holders of Class C Convertible Preferred Stock. As a
result, immediately prior to the consummation of the Merger, all
convertible preferred stock (including termination of warrants
and elimination of accrued dividends) was converted into
53,341,747 shares of common stock. The change to the conversion
ratios of the convertible preferred stock was deemed to be an
induced conversion, which resulted in a $4.8 million deemed dividend and an increase to
the net loss attributable to common stockholders in June 2007.
Upon closing of the Merger, the 53,341,747 shares of common
stock were exchanged for 1,912,356 shares of BTHC VI common
stock using the Merger exchange rate. The Company also retired
the shares of preferred and common stock held in treasury.
At the time the Merger was deemed effective, each share of common stock of Athersys was converted
into 0.0358493 shares of BTHC VI common stock, par value $0.001 per share. Prior to the Merger,
BTHC VI effected a 1-for-1.67 reverse stock split of its shares of common stock and increased the
number of authorized shares of common stock to 100,000,000.
BTHC VIs acquisition of Athersys on June 8, 2007 effected a change in control and was accounted
for as a reverse acquisition whereby Athersys is the accounting acquirer for financial statement
purposes. Accordingly, the financial statements of the Company presented reflect the historical
results of 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 stock have been
retroactively restated for all periods present to reflect the shares of BTHC VI common stock after
giving effect to the Merger. Basic and diluted net loss per share attributable to common
stockholders has been computed using the retroactively restated common stock.
Immediately after the Merger, BTHC VI completed an offering of 13,000,000 shares of common stock
for aggregate gross proceeds of $65.0 million (the Offering). Offering costs in the amount of
approximately $6.5 million were netted against the proceeds of the Offering, resulting in net
proceeds from the Offering of approximately $58.5 million. The Offering 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. BTHC VI 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. The placement agents
also received cash fees in an amount equal to 8.5% of the gross proceeds, excluding proceeds from
existing investors in the Company. In consideration for certain advisory services, the Company
paid an affiliate and largest stockholder of BTHC VI a one-time fee of $350,000 in cash upon
consummation of the Merger.
Athersys is a biopharmaceutical company engaged in the development and commercialization of
therapeutic products in one business segment. Operations consist primarily of research and product
development activities.
4
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 registration
statement on Form S-1 as filed with the SEC on July 10, 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.
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. The Companys 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. Net Loss per Share Restated
The Company has revised its accounting for the change in conversion ratios of its convertible
preferred stock in response to comments from the staff of the Securities and Exchange Commission in
the course of its review of the Companys registration statement. The change to the
conversion ratios of the convertible preferred stock represents an induced conversion which resulted
in a deemed dividend in the amount of $4.8 million which was previously not included in determining
the net loss attributable to common stockholders. In reporting the deemed dividend, the Company has
increased the net loss attributable to common stockholders for the three and six months ended June
30, 2007 to $12,153,000 and $15,248,000, respectively, as compared to $7,353,000 and $10,448,000,
as originally reported and increased the basic and diluted net loss per common share for the three
and six months ended June 30, 2007 to $2.53 and $5.99, respectively, as compared to $1.53 and
$4.10, as originally reported.
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.
The Company has outstanding certain options and warrants, and prior to June 8, 2007, had
outstanding certain 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. As such,
the numerator and the denominator used in computing both basic and diluted net loss per share
attributable to common stock holders are equal.
Outstanding stock options to purchase 3,629,814 and 127,686 shares of common stock for each of the
three and six-month periods ended June 30, 2007 and June 30, 2006, respectively, were not included
in the calculation of diluted net loss per share attributable to common stockholders because their
effects were antidilutive.
Warrants to purchase 5,125,496 and 25,639 shares of common stock for each of the three and
six-month periods ended June 30, 2007 and June 30, 2006, respectively, were not included in the
calculation of diluted net loss per share attributable to common stockholders because their effects
were antidilutive.
Shares of
common stock issuable upon the conversion of convertible preferred stock
in the amount of 276,071 and 319,839 on a historical basis
(1,450,028 and 1,679,915 taking
into consideration the restructuring of Athersys stock that occurred
in 2007 at the time of the Merger) for the three and
six-month periods ended June 30, 2007, respectively, and 364,093 on a historical basis
(1,912,356 taking into consideration the restructuring of Athersys stock
that occurred in 2007 at the time of the Merger) for each of the three and
six-month periods ended June 30, 2006 were not included in the
calculation of diluted net loss per share attributable to common stockholders
because their effects were antidilutive.
Shares of common stock issuable upon the conversion of convertible promissory notes in the
amount of 202,631 and 224,197 on a historical basis (1,833,179 and 2,028,281 taking
into consideration the closing of the Offering in 2007) for the three and six-month
periods ended June 30, 2007, respectively, and 62,312 and 31,156 on a historical
basis (563,732 and 281,866 taking
into consideration the closing of the Offering in 2007) for the three
and six-month periods ended June 30, 2006, respectively, were
not included in the calculation of diluted net loss per share attributable to common stockholders
because their effects were antidilutive.
5
4. 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 the
reconciliation, in thousands, of net loss to comprehensive loss for all periods presented.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
Net loss |
|
$ |
(7,069 |
) |
|
$ |
(3,295 |
) |
|
$ |
(9,789 |
) |
|
$ |
(5,782 |
) |
Unrealized gain on
available-for-sale
securities |
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
13 |
|
|
|
|
Comprehensive loss |
|
$ |
(7,069 |
) |
|
$ |
(3,293 |
) |
|
$ |
(9,789 |
) |
|
$ |
(5,769 |
) |
|
|
|
5. Equity Restructuring
Immediately prior to the Merger (see Note 1), all shares of Athersys preferred stock were converted
into shares of Athersys common stock. The preferred stock on the balance sheet was eliminated and
accounted for as common stock issued and additional paid-in capital. Also, $250,000 of treasury
stock held by Athersys was retired in connection with the Merger and reversed to additional paid-in
capital. Accrued dividends on Athersys convertible preferred stock were eliminated and reversed
to additional paid-in capital. Additionally, warrants that were issued to the former holders of
convertible preferred stock were terminated.
6. Share-based Compensation
Equity Compensation Plans
BTHC VI adopted an incentive plan prior to closing the Merger that made available 3,035,000 shares
of common stock for awards to employees, directors and consultants. Upon closing the Merger,
another similar incentive plan was adopted that made available 1,465,000 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. Total awards under these plans are
limited to 4,500,000 shares of common stock in the aggregate.
In May 2007, the majority of Athersys outstanding options were terminated. New option awards to
purchase 3,625,000 shares of common stock with an exercise price of $5.00 were granted to
employees, directors and certain consultants in June 2007 upon the closing of the Merger. The
options that were granted to employees vest approximately 40% on the date of grant, and ratably
over three years thereafter. The option awards granted to non-employees and board members
generally vest at varying percentages over three years. Upon the closing of the Merger, BTHC VI
assumed 5,052 options granted to former employees and consultants of Athersys, which will be
governed by the former Athersys equity plans until the awards expire.
6
Impact of Adoption of SFAS No. 123R
In December 2004, SFAS No. 123 (revised 2004), Share-Based Payment (SFAS No. 123R), was issued as
a revision to SFAS No. 123, Accounting for Stock Options (SFAS No. 123). The new statement was
adopted by the Company on January 1, 2006. Prior to January 1, 2006, the Company elected to account
for its stock-based compensation in accordance with the intrinsic value method as described in the
provisions of Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees,
and related interpretations, as permitted by SFAS No. 123. As such, compensation was determined
prior to 2006 on the date of issuance or grant as the excess of the current estimated market value
of the underlying stock over the purchase or exercise price of the stock option. Compensation
expense was recognized over the respective vesting periods of the equity instruments, if any, using
the graded vesting method as prescribed by Financial Accounting Standards Board Interpretation No. 28.
On January 1, 2006, the Company adopted the fair value recognition provisions of SFAS No. 123R
using the modified-prospective-transition method. Under that transition method, compensation cost
recognized subsequent to adoption includes: (a) compensation cost for all share-based payments
granted prior to, but not yet vested as of January 1, 2006, based on the grant date fair value
estimated in accordance with the original provisions of SFAS No. 123, and (b) compensation cost for
all share-based payments granted subsequent to January 1, 2006, based on the grant-date fair value
estimated in accordance with the provisions of SFAS No. 123R. For some of the awards granted prior
to the adoption of SFAS No. 123R, the Company recognized compensation expense on the accelerated
method. For awards granted subsequent to adoption of SFAS No. 123R, the Company recognizes expense
on the straight-line method. Upon adoption of SFAS 123R, Athersys estimated forfeitures in
calculating the expense relating to share-based compensation, while previously Athersys was
permitted to recognize forfeitures as an expense reduction upon occurrence. The adjustment to apply
estimated forfeitures to previously recognized share-based compensation was accounted for as a
cumulative effect of a change in accounting principle at January 1, 2006 and reduced net loss by
$306,000 for the six months ended June 30, 2006.
Valuation of Share-based Compensation under SFAS No. 123R
The Company uses a Black-Scholes option pricing model to estimate the grant-date fair value of
share-based awards under SFAS No. 123R. The expected term of options granted represents the period of time
that option grants are expected to be outstanding. The Company used the simplified method under SAB No. 107 to calculate the expected life of option grants in 2007 given its limited history. We determine volatility by using the historical stock
volatility of other companies with similar characteristics. Estimates
of fair value are not intended to predict actual future events or the
value ultimately realized by persons who receive equity awards.
SFAS No. 123R requires forfeitures to be estimated at the time of grant and revised, if necessary,
in subsequent periods if actual forfeitures differ from those estimates. If actual forfeitures vary from the estimate, the
Company will recognize the difference in compensation expense in the period the actual forfeitures occur or when options vest.
In May 2007, Athersys terminated the majority of stock option awards to its officers, employees,
directors and consultants. Only a nominal number of option awards (5,052 option shares) held by
former employees and consultants were assumed by BTHC VI. Upon closing the Merger, options for
3,625,000 shares of stock were issued under the BTHC VI equity incentive plans to employees,
directors and consultants at an exercise price of $5.00 per share.
The Company accounted for the termination of the Athersys options to employees, directors, and
consultants as a settlement and any previously unrecognized
compensation expense ($385,000) was
recognized on the termination date in May 2007. The options for 5,052 shares that were assumed by
BTHC VI were fully vested when they were assumed, and no additional compensation was recognized.
The fair
value of unvested stock options granted to consultants is measured
on a quarterly basis using the
Black-Scholes method and the related expense is recognized over the period that services are
provided. The key assumptions used in the computation of expense at
June 30, 2007 included the fair value of the Companys
stock of $7.75 at June 30, 2007, volatility of 75.3%, risk-free
interest rate of 5.5%, and an expected life represented by the
contractual term of 5 years.
The weighted-average estimated fair value of stock options
granted
7
under the
equity compensation plans during the six months ended June 30,
2007 was $2.91 per share for employees and directors using the following assumptions:
|
|
|
Expected volatility |
|
75.9% |
Risk-free interest rate |
|
5.5% |
Weighted average expected life (years) |
|
5.75 years |
Dividend yield |
|
0.0% |
Share-based Award Activity
The following table summarizes the Companys stock option activity during the six months ended June
30, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average |
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
|
|
|
|
Weighted-Average |
|
Contractual Term |
|
|
Options |
|
Exercise Price |
|
(in years) |
Outstanding at January 1, 2007 |
|
|
116,083 |
|
|
$ |
80.61 |
|
|
|
2.86 |
|
Granted |
|
|
3,625,000 |
|
|
|
5.00 |
|
|
|
9.68 |
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited/cancelled/expired |
|
|
(111,269 |
) |
|
|
78.66 |
|
|
|
2.88 |
|
|
|
|
Outstanding at June 30, 2007 |
|
|
3,629,814 |
|
|
$ |
5.21 |
|
|
|
9.67 |
|
|
|
|
Vested and exercisable at June 30, 2007 |
|
|
1,225,814 |
|
|
$ |
5.61 |
|
|
|
9.67 |
|
|
|
|
As of June 30, 2007, a total of 875,000 shares are available for issuance under the Companys
equity compensation plans. For the six-month period ended June 30, 2007, stock compensation
expense was approximately $4.1 million. At June 30, 2007, total unrecognized estimated
compensation cost related to unvested stock options was approximately
$6.6 million, which is
expected to be recognized by June 30, 2010 using the straight-line method.
8
7. Long-Term Debt
A summary of the Companys long-term debt outstanding is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2007 |
|
2006 |
|
|
|
Notes payable to lenders |
|
$ |
3,235 |
|
|
$ |
5,132 |
|
Less current portion |
|
|
3,235 |
|
|
|
3,332 |
|
|
|
|
|
|
$ |
|
|
|
$ |
1,800 |
|
|
|
|
In November 2004, the Company 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 first to occur
of the following milestone events: (1) a firmly underwritten initial public offering of common
stock; (2) a merger with or into another entity where the
Companys 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
the Companys assets; and (4) the liquidation or
dissolution of the Company. The milestone payment is payable in cash,
except that if the milestone event is an initial public offering,
the Company may elect to pay 75% of the
milestone in shares of common stock at the per share offering price to the public. No amounts have
been recorded in relation to the milestone as of June 30, 2007.
Upon the closing of the Offering, 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 the Companys 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, of which $438,000 was recognized in June 2007
as additional interest expense and the remaining $54,000 will be recognized over
the remaining term of the loan.
8. Convertible Notes
Collaboration Convertible Notes
In 2006, the Company entered into a collaboration with a pharmaceutical company. The Company issued
a $5.0 million convertible promissory note to the collaborator at the inception of the program,
which was followed by the issuance of an additional convertible promissory note in the aggregate
principal amount of $5.0 million in January 2007 upon the achievement of certain milestones. Upon
the closing of the Offering, the convertible notes aggregating $10.0 million were converted along
with accrued interest into 1,885,890 shares of common stock at a conversion price of $5.50 per
share, which was 110% of the price per share in the Offering in accordance with the terms of the
notes.
Bridge Notes and Warrants
Also in 2006, the Company completed a bridge financing of $2.5 million in the form of convertible
promissory notes. The notes were issued primarily to existing stockholders of the Company. The
notes
9
bore interest at 10%, had a three-year term, and were secured by a lien on substantially all of the
assets of the Company. The notes, if not converted, were repayable with accrued interest
at maturity, plus a repayment fee of 200% of the outstanding principal. The Company 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 bridge noteholders also received warrants to purchase common stock, which were exercisable only
upon a restructuring of the Companys capital stock in connection with a financing. The exercise
price was $0.01 per share and the number of shares issuable was based on a formula tied to the
pre-money value of the Company. The Company recognized a $250,000 discount on the notes, which was
allocated to the fair value of the warrants in 2006.
Upon the closing of the Offering, the bridge notes were converted along with accrued interest into
531,781 shares of common stock at a conversion price of $5.00 per share, which was the price per
share in the Offering. The notes were reversed and the related premium and discount were
eliminated and recorded as additional paid-in capital. The bridge
noteholders also exercised their warrants upon the closing of the
Offering for 999,977
shares of common stock at an aggregate exercise price of $10,000. Upon the conversion of the bridge notes,
the bridge noteholders also received warrants to purchase 132,945 shares of common stock at $6.00
per share with a five-year term, which was consistent with the warrants issued to new investors in
the Offering.
9. Warrants
As of June 30, 2007, the Company 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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10. Other Recent Events
In May 2007, Athersys sold certain non-core assets related to its asthma discovery program to a
pharmaceutical company for $2.0 million, of which $1.5 million was received at closing. The
remaining $0.5 million was received in August 2007 upon Athersys delivery of certain ancillary assets
related to the program. Athersys recognized a gain on the sale (other income) of these assets in
the amount of $2.0 million, of which $1.5 million was recognized in May 2007 and $0.5 million will
be recognized in August 2007.
Upon the closing of the Offering, the Company achieved a milestone related to its stem cell
technology and issued 1,379 shares of common stock and paid $500,000 cash to the former holders of
the technology. The issued shares were recorded at fair value on the date the milestone
was achieved. The consideration paid under this arrangement has been recorded as research and
development expense. The Company may be required to pay cash of
$0.5 million to the former holders of
the technology upon the
10
achievement
of an additional milestone in connection with the Companys filing of an investigational new drug
application with the FDA.
The Company filed a resale registration statement with the SEC in July 2007 covering 18,508,251
shares of common stock, which includes all shares of common stock issued in the Offering 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). Subject to certain exceptions, if the resale registration statement is not declared
effective (within 90 days of the filing date) by the SEC or ceases to remain effective, a cash
penalty will be assessed representing 1% of the amount invested in
the Offering for each 30-day period (capped at 10%) until the registration statement is either declared
effective or becomes effective again, as applicable.
11. Taxes
Athersys has net operating loss and research and development credit carryforwards that result in
deferred tax assets that have been fully offset by a valuation allowance. Athersys use of its
current net operating loss and research and development credit
carryforwards will be significantly
limited under Section 382 of the Internal Revenue Code as a result of the change in ownership related to the Merger and the Offering.
In July 2006, the Financial Accounting Standards Board issued FASB Interpretation No. 48 (FIN
48), Accounting for Uncertainty in Income Taxes, which is applicable for fiscal years beginning
after December 15, 2006. FIN 48 clarifies the accounting for uncertainty in income taxes recognized
in an enterprises financial statements in accordance with SFAS No. 109, Accounting for Income
Taxes. FIN 48 prescribes a recognition threshold and measurement attribute for financial statement
recognition and measurement of a tax position reported or expected to be reported on a tax return.
FIN 48 also provides guidance on derecognition, classification, interest and penalties, accounting
in interim periods, disclosure, and transition. Athersys adopted the provisions of FIN 48 on
January 1, 2007. Upon adoption of FIN 48 and through June 30, 2007, Athersys determined that it had
no liability for uncertain income taxes as prescribed by FIN 48. Athersys policy is to recognize
potential accrued interest and penalties related to the liability for uncertain tax benefits, if
applicable, in income tax expense. Net operating loss and credit carryforwards since inception
remain open to examination until the statute expires for the period
in which the carryforwards are utilized, and will for a period post utilization. Athersys
does not anticipate any events during 2007 that would require it to record a liability related to
any uncertain income taxes.
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 registration statement on Form S-1 as filed with the SEC on July 10,
2007. Operating results are not necessarily indicative of results that may occur in future
periods.
Overview and Recent Developments
Athersys is 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 its proprietary technologies, Athersys has established a pipeline of therapeutic
product development programs in multiple disease areas that it intends to advance into clinical
trials in 2007 and 2008. Athersys lead product candidate is ATHX-105, which is a treatment for
obesity that is currently in a phase I clinical trial. Athersys is also developing novel
pharmaceutical products for the treatment of
11
cognitive disorders, such as ADHD and narcolepsy, which is excessive sleepiness. In addition to
these drug development programs, Athersys entered into a collaboration with Angiotech to jointly
develop a novel, proprietary non-embryonic stem cell product, MultiStem, for the treatment of
myocardial infarction and peripheral vascular disease. Athersys is also developing MultiStem for
stroke, oncology support, and certain other disease indications.
Athersys has incurred losses since inception of operations in December 1995 and had an accumulated
deficit of $151.3 million at June 30, 2007. Athersys losses have resulted principally from costs
incurred in research and development, acquisition and licensing costs, and general and
administrative costs associated with its operations. Athersys has used the financing proceeds from
private equity and debt offerings and other sources of capital to develop its technologies, such as
random activation of gene expression, or RAGE, and to acquire its stem cell technology. Athersys has also built its drug development
capabilities to allow it to begin a phase I clinical trial of its lead product candidate, ATHX-105.
Athersys has established strategic collaborations that provide revenues and capabilities to help to
further advance its product candidates. Athersys has a pipeline of product candidates that includes
potential small molecule products to treat obesity and cognitive disorders. Athersys stem cell
product candidates may be used in the areas of cardiovascular disease, oncology support and stroke,
and may have utility in treating other disease indications. Athersys has also built a substantial
portfolio of intellectual property.
In connection with the merger of B-VI Acquisition Corp., a wholly-owned subsidiary of BTHC VI, with
and into Athersys on June 8, 2007 (the Merger), all of Athersys shares of preferred stock were
converted into common stock of Athersys and exchanged for shares of BTHC VI common stock. Also,
all accrued dividends related to the preferred stock were eliminated, warrants issued to preferred
stockholders were terminated, and shares of stock held in treasury were retired.
On June 8, 2007, we also completed the offering of 13,000,000 shares of our common stock and
received gross proceeds of $65.0 million (the Offering). Investors in the Offering also 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 Offering invested $10.0 million and received
additional five-year warrants to purchase an aggregate of 500,000 shares of common stock with an
exercise price of $6.00 per share. The placement agents received five-year warrants to purchase
and aggregate of 1,093,525 shares of common stock with an exercise price of $6.00 per share. The
placement agents also received cash fees in an amount equal to approximately $5.5 million, which
was based on 8.5% of the gross proceeds, excluding proceeds from existing investors in the Company.
In consideration for certain advisory services, the Company paid an affiliate and largest
stockholder of BTHC VI a one-time fee of $350,000 in cash upon consummation of the merger. In
connection with the Offering, all of Athersys convertible notes were converted into shares of BTHC
VI common stock.
In May 2007, Athersys terminated the majority of stock option awards to its officers, employees,
directors and consultants. Only a nominal number of option awards (5,052 option shares) held by
former employees and consultants were assumed by BTHC VI. Upon closing the Merger, options for
3,625,000 shares of common stock were issued under the BTHC VI equity incentive plans to employees,
directors and consultants at $5.00 per share. For the six month period ended June 30, 2007, stock
compensation expense was approximately $4.1 million, of which
$2.0 million was recorded as research and development expense
and $2.1 million was recorded as general and administrative
expense. At June 30, 2007, total unrecognized
estimated compensation cost related to unvested stock options was
approximately $6.6 million, which
is expected to be recognized by June 2010 using the straight-line method.
12
In May 2007, Athersys sold certain non-core assets related to its asthma discovery program to a
pharmaceutical company for $2.0 million, of which $1.5 million was received at closing. The
remaining $0.5 million was received in August 2007 upon Athersys delivery of certain ancillary assets
related to the program.
Results of Operations
Since Athersys inception, its revenues have consisted of license fees from its collaborators and
grant proceeds from federal and state grants. Athersys has derived no revenue on the sale of
FDA-approved products to date. Research and development expenses consist primarily of salaries and
related personnel costs, legal expenses resulting from intellectual property application processes,
contracted service costs, and laboratory supply and reagent costs. Athersys expenses research and
development costs as they are incurred. We expect to continue to make significant investments in
research and development to enhance our technologies, conduct preclinical studies and clinical
trials of our products, and manufacture our products. General and administrative expenses consist
primarily of: salaries and related expenses for executive, business development, finance, and other
administrative personnel; professional fees; and other corporate expenses. Our general and
administrative expenses are expected to increase as we expand our regulatory affairs and product
development capabilities, as well as expand our business development and assume the obligations of
a public reporting company. Athersys depreciates its fixed assets on a straight-line basis. To
date, Athersys has financed its 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. We expect our development costs to increase as we initiate
clinical trials of our product candidates in 2007 and 2008.
13
The following table sets forth Athersys revenues and expenses for the periods indicated. The
following tables are stated in thousands.
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
License fees |
|
$ |
313 |
|
|
$ |
261 |
|
|
$ |
623 |
|
|
$ |
481 |
|
Grant revenue |
|
|
410 |
|
|
|
229 |
|
|
|
979 |
|
|
|
638 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
723 |
|
|
$ |
490 |
|
|
$ |
1,602 |
|
|
$ |
1,119 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
Type of expense |
|
2007 |
|
2006 |
|
2007 |
|
2006 |
Personnel costs |
|
$ |
849 |
|
|
$ |
747 |
|
|
$ |
1,446 |
|
|
$ |
1,430 |
|
Research supplies |
|
|
155 |
|
|
|
346 |
|
|
|
359 |
|
|
|
663 |
|
Facilities |
|
|
184 |
|
|
|
219 |
|
|
|
375 |
|
|
|
463 |
|
Sponsored research,
preclinical and clinical
costs |
|
|
673 |
|
|
|
732 |
|
|
|
1,614 |
|
|
|
1,596 |
|
Patent legal fees |
|
|
385 |
|
|
|
95 |
|
|
|
661 |
|
|
|
230 |
|
Other |
|
|
743 |
|
|
|
150 |
|
|
|
868 |
|
|
|
404 |
|
Stock compensation expense |
|
|
2,000 |
|
|
|
72 |
|
|
|
2,031 |
|
|
|
159 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
4,989 |
|
|
$ |
2,361 |
|
|
$ |
7,354 |
|
|
$ |
4,945 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
Type of expense |
|
2007 |
|
2006 |
|
2007 |
|
2006 |
Personnel costs |
|
$ |
641 |
|
|
$ |
610 |
|
|
$ |
999 |
|
|
$ |
999 |
|
Facilities |
|
|
74 |
|
|
|
70 |
|
|
|
151 |
|
|
|
140 |
|
Legal and professional fees |
|
|
197 |
|
|
|
240 |
|
|
|
279 |
|
|
|
340 |
|
Other |
|
|
496 |
|
|
|
100 |
|
|
|
574 |
|
|
|
184 |
|
Stock compensation expense |
|
|
2,089 |
|
|
|
46 |
|
|
|
2,102 |
|
|
|
91 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3,497 |
|
|
$ |
1,066 |
|
|
$ |
4,105 |
|
|
$ |
1,754 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2007 and 2006
Revenues. Revenues increased to $723,000 for the three months ended June 30, 2007 from $490,000 in
the comparable period in 2006. License fee revenues increased $52,000 for the three months ended
June 30, 2007 compared to the three months ended June 30, 2006. The increase in license fee revenue
over this
period was a result of the nature and timing of target acceptances
and milestone payments under Athersys collaboration
14
agreements with Bristol-Myers Squibb and Pfizer. Grant revenue increased $181,000 for the three
months ended June 30, 2007 compared to the three months ended June 30, 2006. In July 2003, Athersys
was awarded a $5.0 million state grant that spanned three years and was completed in February 2006.
This grant was renewed in May 2006 for approximately $3.5 million and will also span three years.
The increase in grant revenue for the three months ended June 30, 2007 compared to the three months
ended June 30, 2006 was principally the result of recognizing three months of revenue under this
state grant in the second quarter of 2007 versus only one and a half months of revenue in the
comparable period of 2006.
Research
and Development Expenses. Research and development expenses
increased to $5.0 million
for the three months ended June 30, 2007 from $2.4 million in the comparable period in 2006. The
increase of approximately $2.6 million relates primarily to an
increase of $1.9 million in stock
compensation expense, an increase of $593,000 in other expenses, an increase of $290,000 in patent
legal fees, and an increase of $102,000 in personnel costs, partially offset by a decrease in
research supplies and facilities costs of $226,000 related to the restructuring and reduction in
force effected in late 2005 that carried over into early 2006, and a decrease in sponsored
research, preclinical and clinical costs of $59,000. Included in other expenses in 2007 was a
milestone payment related to our stem cell technology in the amount of $507,000, of which $500,000
was paid in cash and 1,379 shares of common stock were issued to the former holders of our stem
cell technology in connection with a collaboration milestone. The increase in patent legal fees for the
three months ended June 30, 2007 was a result of maintaining Athersys growing and maturing
portfolio of patent applications and the performance of patent legal work related to the May 2007
asthma asset sale. Included in personnel costs for the three months
ended June 30, 2007 and 2006 was
approximately $262,000 and $121,000, respectively, of expense related to the Athersys cash incentive plan that resulted in bonus payments upon the achievement of
certain milestones. We generally do not track our early stage 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 $3.5 million
for the three months ended June 30, 2007 from $1.1 million in the comparable period in 2006. The
increase of $2.4 million relates primarily to a $2.0 million increase in stock compensation
expense, a $396,000 increase in other expenses, and a $35,000 increase in personnel and facilities
costs, partially offset by a $43,000 decrease in legal and professional fees. Included in other
expenses for the three months ended June 30, 2007 was a one-time advisory fee of $350,000 related
to the Merger and approximately $50,000 of other costs related to being a public company. Included in personnel
costs for the three months ended June 30, 2007 and 2006 was
approximately $308,000 and $89,000, respectively,
of expense related to the Athersys cash incentive plan that resulted in bonus payments upon the achievement of
milestones. Also included in personnel costs in May 2006 was
approximately $122,000 ($146,000 including taxes) in connection with the
forgiveness of a 2002 loan made to Gil Van Bokkelen.
Depreciation. Depreciation expense decreased to $75,000 for the three months ended June 30, 2007
from $138,000 for the comparable period in 2006. The decrease was due to more laboratory equipment,
computer equipment, furniture, and leasehold improvements becoming fully depreciated, combined with
fewer purchases of new equipment during the three months ended June 30, 2007 compared with the
comparable period of 2006.
Other Income. In May 2007, Athersys sold certain non-core assets related to its asthma 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 $0.5 million was
received and recognized as other income in
August 2007 upon Athersys delivery of certain ancillary assets related to the program.
Interest Income. Interest income represents interest earned on Athersys cash and available for
sale securities. Interest income increased to $175,000 for the three months ended June 30, 2007
from $38,000 for the comparable period in 2006 due to the increase in Athersys average cash
balances during those periods. Athersys obtained $5.0 million in each of January 2007 and May 2006
as a result of issuing convertible promissory notes to Angiotech related to its co-development
collaboration agreement, which
15
were converted into common stock in connection with the Offering. In addition, we received net
proceeds of $58.5 million from the Offering in June 2007.
Interest Expense. Interest expense on Athersys debt outstanding under its Senior Loan (as defined
below) and its subordinated convertible promissory notes increased to
$710,000 for the three months
ended June 30, 2007 from $255,000 for the comparable period in 2006. The increase in interest
expense was due to the convertible promissory notes issued by Athersys in May 2006, October 2006
and January 2007, and the recording of $438,000 of interest expense associated with the issuance of
warrants to the Senior Lenders (as defined below) in connection with the Offering.
Accretion of Premium on Convertible Debt. The accretion of premium on convertible debt in the
amount of $196,000 for the three months ended June 30, 2007 was a result of the $2.5 million
convertible promissory notes issued 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.
Athersys 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. This accretion
was reversed in June 2007 when the notes were converted into common stock upon the closing of the
Offering.
Deemed Dividend. In connection with the Merger, 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 in June 2007.
Six Months Ended June 30, 2007 and 2006
Revenues. Revenues increased to $1.6 million for the six months ended June 30, 2007 from $1.1
million in the comparable period in 2006. License fee revenues increased $142,000 for the six
months ended June 30, 2007 compared to the six months ended June 30, 2006. The increase in license
fee revenue over this period was a result of the nature and timing of
target acceptances and milestone payments under
Athersys collaboration agreements with Bristol-Myers Squibb and Pfizer. Grant revenue increased
$341,000 for the six months ended June 30, 2007 compared to the six months ended June 30, 2006. In
July 2003, Athersys was awarded a $5.0 million state grant that spanned three years and was
completed in February 2006. This grant was renewed in May 2006 for approximately $3.5 million that
will also span three years. The increase in grant revenue for the six months ended June 30, 2007
compared to the six months ended June 30, 2006 was principally the result of recognizing six months
of revenue under this state grant in the six months ended June 30, 2007 versus only three and a
half months of revenue in the comparable period of 2006.
Research
and Development Expenses. Research and development expenses
increased to $7.4 million for
the six months ended June 30, 2007 from $4.9 million in the comparable period in 2006. The increase
of approximately $2.5 million relates primarily to an increase
of $1.9 million in stock
compensation expense, an increase of $464,000 in other expenses, an increase of $431,000 in patent
legal fees, an increase of $18,000 in sponsored research, preclinical and clinical costs and an
increase of $16,000 in personnel costs, partially offset by a decrease in research supplies and
facilities costs of $392,000, related to the restructuring and reduction in force effected in late
2005 that carried over into early 2006. Included in other expenses for the six months ended June
30, 2007 was a milestone payment related to our stem cell technology of $507,000 paid in cash and
stock to the former holders of the technology in connection with a collaboration milestone. Included in
other expenses in for the six months ended June 30, 2006 was a milestone payment related to our
stem cell technology of $125,000 paid in stock to the former holders
of the technology, in connection with the
issuance of a patent. The increase in patent legal fees for the six months ended June 30, 2007 was
a result of maintaining Athersys growing and maturing portfolio of patent applications and the
performance of patent legal work related to the May 2007 asthma
asset sale. Included in
personnel costs for the six months ended June 30, 2007 and 2006
was approximately $262,000 and $121,000, respectively, of expense related
the Athersys cash incentive plan
that resulted in bonus payments upon the achievement of certain milestones. We generally do not
track our early stage research expenses by project; rather, we track such expenses by the type of
cost incurred.
16
General
and Administrative Expenses. General and administrative expenses
increased to $4.1 million
for the six months ended June 30, 2007 from $1.8 million in the comparable period in 2006. The
increase of approximately $2.3 million relates primarily to a $2.0 million increase in stock compensation
expense, a $390,000 increase in other expenses, and an $11,000 increase in personnel and facilities
costs, partially offset by a $61,000 decrease in legal and professional fees. Included in other
expenses for the six months ended June 30, 2007 was a one-time advisory fee of $350,000 related to
the Merger and approximately $50,000 of other costs related to being
a public company. Included in personnel costs for the six months ended June 30, 2007 and 2006
was approximately $308,000 and $89,000, respectively, of expense related to the Athersys cash
incentive plan that resulted in bonus payments upon the achievement of milestones. Also included in
personnel costs in May 2006 was approximately $122,000 ($146,000
including taxes) in connection with the forgiveness of a 2002 loan made to Gil Van Bokkelen.
Depreciation. Depreciation expense decreased to $155,000 in the six months ended June 30, 2007 from
$293,000 in the six months ended June 30, 2006. The decrease in depreciation expense was due to
more laboratory equipment, computer equipment, furniture, and leasehold improvements becoming fully
depreciated, combined with fewer purchases of new equipment.
Other Income. In May 2007, Athersys sold certain
non-core assets related to its asthma 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
$0.5 million was received and recognized as other income in August 2007 upon Athersys delivery of certain
ancillary assets related to the program. In January 2006, a milestone was achieved related to
Athersys joint venture with Oculus Pharmaceuticals, Inc. (Oculus). As a result, Athersys
received $100,000 of stock-based proceeds from Oculus, which was recorded in other income.
Similarly, Oculus also received stock-based proceeds in another company in the amount of $260,000.
Athersys recorded its share of Oculus net income (after recapturing past losses) of $117,000 in
equity in earnings of unconsolidated affiliate on the statement of operations. No additional
milestones were achieved related to this joint venture in the six months ended June 30, 2007.
Interest Income. Interest income represents interest earned on Athersys cash and available for
sale securities. Interest income increased to $222,000 for the six months ended June 30, 2007 from
$67,000 for the comparable period in 2006 due to the increase in Athersys average cash balances
during those periods. Athersys obtained $5.0 million in each of January 2007 and May 2006 as a
result of issuing convertible promissory notes to Angiotech related to its co-development
collaboration agreement. In addition, in June 2007, we received net proceeds of $58.5 million from
the Offering.
Interest Expense. Interest expense on Athersys debt outstanding under its Senior Loan (as defined
below) and its convertible promissory notes increased to $1,043,000 for the six months ended June 30,
2007 from $490,000 for the comparable period in 2006. The increase in interest expense was due to
the convertible promissory notes issued by Athersys in May 2006, October 2006 and January 2007, and
the recording $438,000 of interest expense associated with the issuance of warrants to the Senior
Lenders (as defined below) in connection with the Offering.
Accretion of Premium on Convertible Debt. The accretion of premium on convertible debt in the
amount of $456,000 for the six months ended June 30, 2007 was a result of the $2.5 million
convertible promissory notes issued 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.
Athersys 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. This accretion
was reversed in June 2007 when the notes were converted into common stock upon the closing of the
Offering.
Cumulative Effect of Change in Accounting Principle. Effective January 1, 2006, Athersys adopted
the fair value recognition provisions of SFAS No. 123R, using the modified-prospective-transition
method. SFAS No. 123R requires Athersys to estimate forfeitures in calculating the expense relating
to share-
17
based compensation, while previously Athersys was permitted to recognize forfeitures as an expense
reduction upon occurrence. The adjustment to apply estimated forfeitures to previously recognized
share-based compensation was accounted for as a cumulative effect of a change in accounting
principle at January 1, 2006 and reduced net loss by $306,000 for the six months ended June 30,
2006.
Deemed Dividend. In connection with the Merger, 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 in June 2007.
LIQUIDITY AND CAPITAL RESOURCES
Athersys has primarily financed its operations through private equity and debt financings that have
resulted in aggregate cumulative proceeds of approximately $200 million, which includes gross
proceeds of $65.0 million received in June 2007 from the Offering. We received net proceeds of
approximately $58.5 million from the Offering. The placement agents received approximately $5.5
million in cash fees from the gross proceeds.
In November 2004, Athersys entered into a Loan and Security Agreement (the Senior Loan) with
Venture Lending & Leasing IV, Inc. and Costella Kirsch IV, L.P. (the Senior Lenders), pursuant to
which it borrowed $7.5 million that matures on June 1, 2008. Amounts outstanding under the Senior
Loan are payable in 30 monthly installments following an initial interest-only period that expired
on December 1, 2005. The Senior Loan has a fixed interest rate of approximately 13%. A
final payment of $487,500 is due on June 1, 2008. As of June 30, 2007, the outstanding balance of
the Senior Loan was approximately $3.2 million. Athersys obligations under the Senior Loan are
secured by a lien on substantially all of its assets other than its intellectual property.
However, a lien on our intellectual property could attach at any time if the ratio of our
unrestricted cash to four months expenses is less than one-to-one. The agreement governing the
Senior Loan contains affirmative and negative covenants customary for such financings and customary
events of default. As of June 30, 2007, Athersys was in compliance with these covenants.
The Senior Lenders have the right to receive a milestone payment of $2.25 million upon the first to
occur of the following milestone events: (1) a firmly underwritten initial public offering of
common stock; (2) Athersys merger with or into another entity where its 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 Athersys assets; and (4) Athersys liquidation or dissolution. The milestone
payment is payable in cash, except that if the milestone event is an initial public offering,
Athersys may elect to pay 75% of the milestone in shares of common stock at the per share offering
price to the public. Although the Offering did not constitute a milestone event under the Senior
Loan, we are discussing an amendment with the Senior Lenders to include the occurrence of an
additional significant financing or financings as a milestone event
that would obligate us to make
such milestone payment or otherwise restructure the milestone payment since an initial public
offering technically can no longer occur. 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 the Offering,
the fair value of which was
$492,000. Of this amount, $438,000 was recorded as interest expense in June 2007
and the remaining $54,000 will be recognized over the remaining term
of the loan. We are evaluating
the potential restructuring or prepayment of the Senior Loan.
In October 2006, Athersys completed a bridge financing in the amount of $2.5 million in the form of
10% secured convertible promissory notes. The notes and accrued interest were converted into common
stock at a conversion price of $5.00 upon the closing of the Offering. The noteholders also
received warrants to purchase 999,977 shares of common stock, which
were exercised upon the closing of the Offering.
In connection with developing MultiStem for the treatment of myocardial infarction and peripheral
vascular disease, Angiotech purchased subordinated convertible promissory notes in the aggregate
principal amount of $10.0 million as part of a commercial collaboration that was formed in May
2006. The notes were converted along with accrued interest into common stock upon the closing of
the Offering at a conversion price of $5.50, which was 110% of the price per share paid in the
Offering. Athersys may
18
also receive additional equity investments and cash payments based upon the successful achievement
of specified clinical development and commercialization milestones.
Athersys contractual payment obligations as of June 30, 2007 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less than 1 |
|
1 3 |
|
3 5 |
|
More than |
Contractual Obligations |
|
Total |
|
year |
|
years |
|
years |
|
5 years |
Operating lease for facilities |
|
$ |
201,000 |
|
|
$ |
201,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term debt (principal) |
|
$ |
3,235,000 |
|
|
$ |
3,235,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term
debt (discount) |
|
$ |
54,000 |
|
|
$ |
54,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term debt (interest) |
|
$ |
252,000 |
|
|
$ |
252,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
3,742,000 |
|
|
$ |
3,742,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Athersys has an operating lease for its office and laboratory space that expires in March 2009.
Athersys has an option to renew the lease in six-month intervals during the term at the existing
rental rate. Athersys has exercised options to renew the lease through March 2008. Athersys has
never paid dividends on its capital stock, and all accrued cumulative dividends were eliminated in
June 2007 in connection with the Merger.
The Company filed a resale registration statement with the SEC in July 2007 covering 18,508,251
shares, which includes all shares of common stock issued in the Offering and shares of common stock
issuable upon exercise of the warrants issued in the Offering (as well as the 531,781 shares of
common stock issued to the bridge investors and their 132,945 shares underlying warrants). Subject
to certain exceptions, if the resale registration statement is not declared effective (within 90
days of the filing date) by the SEC or ceases to remain effective, a
cash penalty will be assessed representing 1% of the amount invested
in the Offering for each 30-day period (capped at 10%) until the registration statement is either declared effective or
becomes effective again, as applicable.
At June 30, 2007, Athersys had $58.9 million in cash and cash equivalents.
Net cash used in operating activities was $4.2 million in the six months ended June 30, 2007 and
$4.3 million for the six months ended June 30, 2006, and was primarily attributed to expenditures
used to fund Athersys research and product development activities. Net cash used in investing
activities was $(3,000) in the six months ended June 30, 2007
and net cash provided was $713,000 in the six months ended
June 30, 2006. The fluctuations from period to period are due to the timing of purchases and
maturity dates of investments, and the purchase of equipment. Purchases of equipment were $3,000 in
the six months ended June 30, 2007 and $67,000 in the six-month period ended June 30, 2006.
Financing activities provided cash of $61.7 million in the six months ended June 30, 2007 and $3.8
million in the six months ended June 30, 2006. The Offering proceeds were received in the second
quarter of 2007. Also, proceeds from the issuance of convertible notes to Angiotech were received
in January 2007 in the amount of $5.0 million, and in May 2006 also in the amount of $5.0 million.
The financing proceeds have been offset by the repayment of debt in each period.
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.
19
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.
While we believe that the net proceeds from the Offering, combined with current capital resources
and anticipated cash flows from licensing activities, will be sufficient to meet our capital and
operating requirements through at least December 2009, we cannot assure that we will not require
additional financing before that time. Our funding requirements may change at any time due to
technological advances or competition from other companies. 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 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.
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 operation 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.
Our critical accounting polices include:
Revenue Recognition
Our revenue recognition policies are in accordance with the SEC Staff Accounting Bulletin No. 104,
Revenue Recognition, and Emerging Issues Task Force No. 00-21, Revenue Arrangements with Multiple
Deliverables, which provide guidance on revenue recognition in financial statements and are based
on the interpretations and practices developed by the SEC. Some of our agreements contain multiple
elements, including technology access and development fees, research funding, milestones and
royalty obligations.
Revenue is recognized over the period that we perform the required activities under the terms of
various agreements. Revenues from transactions that do not require future performance obligations
from us are recognized as contemplated in the agreements, typically upon acceptance and when
collectibility is reasonably assured. We defer nonrefundable upfront fees under our collaborations
and recognize them over the period in which we have significant involvement or perform services,
using various factors specific to the collaboration. Amounts we receive for research funding are
recognized as revenue as the services are performed. Revenue resulting from the achievement of
milestone events stipulated in the agreements is recognized when the milestone is achieved.
Revenue from grants consists primarily of funding under cost reimbursement programs from federal
and state sources for qualified research and development activities performed by us. Revenue from
grants is recorded when earned under the terms of the agreements.
20
Research and Development
Research and development expenditures, including direct and allocated overhead expenses, are
charged to expense as incurred.
Royalties
We may be required to remit royalty payments based on product sales to certain parties under
license agreements. We have not paid any such royalties for the six-month periods ended June 30,
2007 and 2006.
Long-Lived Assets
Equipment is stated at acquired cost less accumulated depreciation. Laboratory and office equipment
are depreciated on the straight-line basis over the estimated useful lives (three to seven years).
Impairment of long-lived assets is recognized when events or changes in circumstances indicate that
the carrying amount of the asset or related group of assets may not be recoverable. If the expected
future undiscounted cash flows are less than the carrying amount of the asset, an impairment loss
is recognized at that time. Measurement of impairment may be based upon appraisal, market value of
similar assets or discounted cash flows.
Patent Costs and Rights
Patent costs and rights are expensed as incurred. We have filed for broad intellectual property
protection on our technologies. We currently haves numerous U.S. patent applications and
corresponding international patent applications related to our technologies, as well as many issued
U.S. and international patents.
Stock-Based Compensation
In December 2004, SFAS No. 123R was issued as a revision to SFAS No. 123, Accounting for Stock
Options. SFAS No. 123R was required to be adopted by the Company in January 2006. Prior to January
1, 2006, we elected to account for our stock-based compensation in accordance with the intrinsic
value method as described in the provisions of Accounting Principles Board Opinion No. 25,
Accounting for Stock Issued to Employees, and related interpretations, as permitted by SFAS No.
123. As such, compensation was recorded prior to 2006 on the date of issuance or grant as the
excess of the current estimated market value of the underlying stock over the purchase or exercise
price of the stock option. Any unearned compensation was recognized over the respective vesting
periods of the equity instruments, if any, using the graded vesting method as prescribed by
Financial Accounting Standards Board Interpretation No. 28.
Effective January 1, 2006, we adopted the fair value recognition provisions of SFAS No. 123R using
the modified-prospective-transition method. Under that transition method, compensation cost
recognized in 2006 includes: (1) compensation cost for all share-based payments granted prior to,
but not yet vested as of January 1, 2006, based on the grant date fair value estimated in
accordance with the original provisions SFAS No. 123; and (2) compensation cost for all share-based
payments granted subsequent to January 1, 2006, based on the grant-date fair value estimated in
accordance with the provisions of SFAS No. 123R. For some of the awards granted prior to the
adoption of SFAS No. 123R, Athersys recognized compensation expense on the accelerated method. For
awards granted subsequent to adoption of SFAS No. 123R, we recognize expense on the straight-line
method.
21
The computation of the expense associated with share-based compensation requires the use of a
valuation model. The Company currently uses a Black-Scholes option pricing model to calculate the
fair value of its stock options. The Black-Scholes model requires the use of subjective
assumptions, including estimating the expected term of stock options and expected stock price
volatility. Changes in the assumptions to reflect future stock price volatility and actual
forfeiture experience could result in a change in the assumptions used to value awards in the
future and may result in a material change to the fair value calculation of share-based awards. The
fair value of share-based compensation awards less estimated forfeitures is recognized on a
straight line basis over the vesting period.
SFAS No. 123R requires forfeitures to be estimated at the time of grant and revised, if
necessary, in subsequent periods if actual forfeitures differ from those estimates. If actual
forfeitures vary from our estimates, we will recognize the difference in compensation cost in the
period the actual forfeitures occur or when options vest.
Income Taxes
As of December 31, 2006, we had net operating loss and research and development credit
carryforwards of approximately $109.9 million and $5.8 million, respectively. These carryforwards
may be used to reduce future tax liabilities and expire at various dates between 2013 and 2027.
Our use of these net operating loss and research and development credit carryforwards will be
significantly limited under Section 382 of the Internal Revenue Code as a result of the change in ownership related to the Merger and Offering.
Recently Issued Accounting Standards
In July 2006, the Financial Accounting Standards Board issued FASB Interpretation No. 48 (FIN
48), Accounting for Uncertainty in Income Taxes, which is applicable for fiscal years beginning
after December 15, 2006. FIN 48 clarifies the accounting for uncertainty in income taxes recognized
in an enterprises financial statements in accordance with SFAS No. 109, Accounting for Income
Taxes. FIN 48 prescribes a recognition threshold and measurement attribute for financial statement
recognition and measurement of a tax position reported or expected to be reported on a tax return.
FIN 48 also provides guidance on derecognition, classification, interest and penalties, accounting
in interim periods, disclosure, and transition. Athersys adopted the provisions of FIN 48 on
January 1, 2007. Upon adoption of FIN 48 and through June 30, 2007, Athersys determined that it had
no liability for uncertain income taxes as prescribed by FIN 48. Athersys policy is to recognize
potential accrued interest and penalties related to the liability for uncertain tax benefits, if
applicable, in income tax expense. Net operating loss and credit carryforwards since inception
remain open to examination by taxing authorities, and will for a period post utilization. We do not
anticipate any events during 2007 that would require Athersys to record a liability related to any
uncertain income taxes.
The above listing is not intended to be a comprehensive list of all of our accounting policies. In
many cases, the accounting treatment of a particular transaction is specifically dictated by GAAP.
See our audited consolidated financial statements and notes thereto included in our registration
statement on Form S-1 as filed with the SEC on July 10, 2007, which contains accounting policies
and other disclosures required by GAAP.
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,
22
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 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:
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our ability to successfully complete clinical trials for our product
candidates, including our phase I clinical trial for ATHX-105; |
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the possibility of delays in, adverse results of, and excessive costs of the
development process; |
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changes in external market factors; |
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changes in our industrys overall performance; |
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changes in our business strategy; |
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our ability to protect our intellectual property portfolio; |
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our possible inability to enter into licensing or co-development arrangements
for certain product candidates; |
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our possible inability to execute our strategy due to changes in our industry
or the economy generally; |
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changes in productivity and reliability of suppliers; and |
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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. 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.
23
Item 4. Controls and Procedures.
Restatement
On October 8, 2007, in response to a comment raised by the staff of the Securities and
Exchange Commission concerning the accounting for the change in the conversion ratios of our
convertible preferred stock in connection with the Merger, our management, in consultation with our
independent registered public accounting firm and the Audit Committee of our Board of Directors,
concluded that our consolidated statements of operations for the three and six months ended June
30, 2007 should be amended and restated to reflect a $4.8 million deemed dividend that increased the
net loss attributable to common stockholders and the impact of this deemed dividend on the basic
and diluted net loss per common share.
Disclosure controls and procedures
In connection with the restatement, our management, under the supervision of and with the participation of our Chief Executive Officer
and our Vice President of Finance, has re-evaluated the effectiveness of our disclosure controls and
procedures, as defined in Rules 13a-15(e) and 15d-15(e) 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, as a result of the restatement, 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 not effective.
Changes in internal control over financial reporting
During the closing of the December 31, 2006 financial statements audit in March 2007, a material
weakness in Athersys internal control over financial reporting was identified related to an over-accrued
dividend that resulted in a restatement to the 2005 audited financial statements. During the
quarter ended June 30, 2007, we have made improvements to our controls around our review of
contractual obligations and the accounting thereof. As of June 30, 2007, we have remediated this
material weakness based on such improvements.
Since Athersys public company reporting obligations began on June 8, 2007 in connection with the
Merger, we will be required to comply with Section 404 of the Sarbanes-Oxley Act of 2002 for the
first time in 2007, and will be required to provide a management report on internal control over
financial reporting in connection with our annual report on Form 10-K for the year ending December
31, 2007. We are preparing for compliance with Section 404 by strengthening, assessing and testing
our system of internal controls to provide the basis for our report, and have not completed this
process as of the date of this quarterly report on Form 10-Q.
24
Item 6. Exhibits.
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Exhibit |
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Number |
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Description of Document |
3.1
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Certificate of Incorporation of BTHC VI, Inc., last amended June 1, 2007 (incorporated herein
by reference to Exhibit 3.1 to the registrants Current Report on Form 8-K (Commission No.
000-52108) filed with the Commission on June 14, 2007) |
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3.2
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Bylaws of BTHC VI, Inc., dated as of June 8, 2007 (incorporated herein by reference to
Exhibit 3.2 to the registrants Current Report on Form 8-K (Commission No. 000-52108) filed
with the Commission on June 14, 2007) |
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10.1
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Amendment No. 3 to Amended and Restated Registration Rights Agreement, dated as of May 15,
2007, by and among Athersys, Inc. and the Existing Stockholders (as defined therein)
(incorporated herein by reference to Exhibit 10.9 to the registrants Current Report on Form
8-K (Commission No. 000-52108) filed with the Commission on June 14, 2007) |
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10.2
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BTHC VI, Inc. Long-Term Incentive Plan (incorporated herein by reference to Exhibit 10.10 to
the registrants Current Report on Form 8-K (Commission No. 000-52108) filed with the
Commission on June 14, 2007) |
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10.3
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BTHC VI, Inc. Equity Incentive Compensation Plan (incorporated herein by reference to Exhibit
10.11 to the registrants Current Report on Form 8-K (Commission No. 000-52108) filed with the
Commission on June 14, 2007) |
25
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Exhibit |
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Number |
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Description of Document |
10.4
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Amendment No. 1 to Amended and Restated Employment Agreement, dated as of May 31, 2007, by
and between Advanced Biotherapeutics, Inc. and Gil Van Bokkelen (incorporated herein by
reference to Exhibit 10.15 to the registrants Current Report on Form 8-K (Commission No.
000-52108) filed with the Commission on June 14, 2007) |
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10.5
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Amendment No. 1 to Amended and Restated Employment Agreement, dated as of May 31, 2007, by
and between Advanced Biotherapeutics, Inc. and John Harrington (incorporated herein by
reference to Exhibit 10.18 to the registrants Current Report on Form 8-K (Commission No.
000-52108) filed with the Commission on June 14, 2007) |
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10.6
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Amendment No. 1 to Employment Agreement, dated as of May 31, 2007, by and between Advanced
Biotherapeutics, Inc. and Laura Campbell (incorporated herein by reference to Exhibit 10.21 to
the registrants Current Report on Form 8-K (Commission No. 000-52108) filed with the
Commission on June 14, 2007) |
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10.7
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Amendment No. 1 to Employment Agreement, dated as of May 31, 2007, by and between Advanced
Biotherapeutics, Inc. and Kurt Brunden (incorporated herein by reference to Exhibit 10.23 to
the registrants Current Report on Form 8-K (Commission No. 000-52108) filed with the
Commission on June 14, 2007) |
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10.8
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Amendment No. 1 to Employment Agreement, dated as of May 31, 2007, by and between Advanced
Biotherapeutics, Inc. and Robert Deans (incorporated herein by reference to Exhibit 10.26 to
the registrants Current Report on Form 8-K (Commission No. 000-52108) filed with the
Commission on June 14, 2007) |
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10.9
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Amendment No. 1 to Employment Agreement, dated as of May 31, 2007, by and between Advanced
Biotherapeutics, Inc. and William Lehmann (incorporated herein by reference to Exhibit 10.29
to the registrants Current Report on Form 8-K (Commission No. 000-52108) filed with the
Commission on June 14, 2007) |
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10.10
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Form Amendment No. 1 to Incentive Agreement by and between Advanced Biotherapeutics, Inc.
and named executive officers, and acknowledged by Athersys, Inc. and ReGenesys, LLC
(incorporated herein by reference to Exhibit 10.32 to the registrants Current Report on Form
8-K (Commission No. 000-52108) filed with the Commission on June 14, 2007) |
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10.11
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Securities Purchase Agreement, dated as of June 8, 2007, by and among Athersys, BTHC VI,
Inc. and Investors (as defined therein) (incorporated herein by reference to Exhibit 10.33 to
the registrants Current Report on Form 8-K (Commission No. 000-52108) filed with the
Commission on June 14, 2007) |
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10.12
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Form Indemnification Agreement for Directors, Officers, and Directors and Officers
(incorporated herein by reference to Exhibit 10.1 to the registrants Current Report on Form
8-K (Commission No. 000-52108) filed with the Commission on
August 6, 2007) |
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10.13*
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Consulting Agreement, by and among Athersys, Inc., Advanced Biotherapeutics, Inc. and Dr.
Kurt Brunden, dated as of July 23, 2007 |
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31.1
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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. |
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31.2
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Certification of Laura 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. |
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32.1
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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. |
* Previously filed.
26
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.
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ATHERSYS, INC. |
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Date:
October 9, 2007
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/s/ Gil Van Bokkelen
Gil Van Bokkelen
Chairman and Chief Executive Officer
(principal executive officer authorized to sign on
behalf of the registrant)
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/s/ Laura K. Campbell
Laura K. Campbell
Vice President of Finance
(principal financial and accounting officer
authorized to sign on behalf of the registrant)
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27
EXHIBIT INDEX
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Exhibit |
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Number |
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Description of Document |
3.1
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Certificate of Incorporation of BTHC VI, Inc., last amended June 1, 2007 (incorporated herein
by reference to Exhibit 3.1 to the registrants Current Report on Form 8-K (Commission No.
000-52108) filed with the Commission on June 14, 2007) |
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3.2
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Bylaws of BTHC VI, Inc., dated as of June 8, 2007 (incorporated herein by reference to
Exhibit 3.2 to the registrants Current Report on Form 8-K (Commission No. 000-52108) filed
with the Commission on June 14, 2007) |
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10.1
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Amendment No. 3 to Amended and Restated Registration Rights Agreement, dated as of May 15,
2007, by and among Athersys, Inc. and the Existing Stockholders (as defined therein)
(incorporated herein by reference to Exhibit 10.9 to the registrants Current Report on Form
8-K (Commission No. 000-52108) filed with the Commission on June 14, 2007) |
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10.2
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BTHC VI, Inc. Long-Term Incentive Plan (incorporated herein by reference to Exhibit 10.10 to
the registrants Current Report on Form 8-K (Commission No. 000-52108) filed with the
Commission on June 14, 2007) |
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10.3
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BTHC VI, Inc. Equity Incentive Compensation Plan (incorporated herein by reference to Exhibit
10.11 to the registrants Current Report on Form 8-K (Commission No. 000-52108) filed with the
Commission on June 14, 2007) |
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10.4
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Amendment No. 1 to Amended and Restated Employment Agreement, dated as of May 31, 2007, by
and between Advanced Biotherapeutics, Inc. and Gil Van Bokkelen (incorporated herein by
reference to Exhibit 10.15 to the registrants Current Report on Form 8-K (Commission No.
000-52108) filed with the Commission on June 14, 2007) |
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10.5
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Amendment No. 1 to Amended and Restated Employment Agreement, dated as of May 31, 2007, by
and between Advanced Biotherapeutics, Inc. and John Harrington (incorporated herein by
reference to Exhibit 10.18 to the registrants Current Report on Form 8-K (Commission No.
000-52108) filed with the Commission on June 14, 2007) |
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10.6
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Amendment No. 1 to Employment Agreement, dated as of May 31, 2007, by and between Advanced
Biotherapeutics, Inc. and Laura Campbell (incorporated herein by reference to Exhibit 10.21 to
the registrants Current Report on Form 8-K (Commission No. 000-52108) filed with the
Commission on June 14, 2007) |
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10.7
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Amendment No. 1 to Employment Agreement, dated as of May 31, 2007, by and between Advanced
Biotherapeutics, Inc. and Kurt Brunden (incorporated herein by reference to Exhibit 10.23 to
the registrants Current Report on Form 8-K (Commission No. 000-52108) filed with the
Commission on June 14, 2007) |
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10.8
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Amendment No. 1 to Employment Agreement, dated as of May 31, 2007, by and between Advanced
Biotherapeutics, Inc. and Robert Deans (incorporated herein by reference to Exhibit 10.26 to
the registrants Current Report on Form 8-K (Commission No. 000-52108) filed with the
Commission on June 14, 2007) |
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10.9
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Amendment No. 1 to Employment Agreement, dated as of May 31, 2007, by and between Advanced
Biotherapeutics, Inc. and William Lehmann (incorporated herein by reference to Exhibit 10.29
to the registrants Current Report on Form 8-K (Commission No. 000-52108) filed with the
Commission on June 14, 2007) |
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Exhibit |
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Number |
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Description of Document |
10.10
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Form Amendment No. 1 to Incentive Agreement by and between Advanced Biotherapeutics, Inc.
and named executive officers, and acknowledged by Athersys, Inc. and ReGenesys, LLC
(incorporated herein by reference to Exhibit 10.32 to the registrants
Current Report on Form 8-K (Commission No. 000-52108) filed with the Commission on
June 14, 2007) |
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10.11
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Securities Purchase Agreement, dated as of June 8, 2007, by and among Athersys, BTHC VI,
Inc. and Investors (as defined therein) (incorporated herein by reference to Exhibit 10.33 to
the registrants Current Report on Form 8-K (Commission No. 000-52108) filed with the
Commission on June 14, 2007) |
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10.12
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Form Indemnification Agreement for Directors, Officers, and Directors and Officers
(incorporated herein by reference to Exhibit 10.1 to the registrants Current Report on Form
8-K (Commission No. 000-52108) filed with the Commission on
August 6, 2007) |
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10.13*
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Consulting Agreement, by and among Athersys, Inc., Advanced Biotherapeutics, Inc. and Dr.
Kurt Brunden, dated as of July 23, 2007 |
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31.1
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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. |
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31.2
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Certification of Laura 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. |
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32.1
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|
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. |
* Previously filed.