UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
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þ
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Quarterly Report Pursuant to Section 13 or 15 (d) of the Securities Exchange Act of 1934
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For the quarterly period ended June 30, 2008.
OR
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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
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For the transition period from
to .
Commission file number 001-32629
AVALON PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Its Charter)
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Delaware
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52-2209310
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(State or Other Jurisdiction of
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(I.R.S. Employer Identification No.)
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Incorporation or Organization)
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20358 Seneca Meadows Parkway
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Germantown, Maryland
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20876
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(Address of Principal Executive Offices)
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(Zip Code)
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Registrants Telephone Number, Including Area Code:
(301) 556-9900
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
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No
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Indicate by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of
large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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Smaller reporting company
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(Do not check if a smaller reporting company)
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Indicate by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act). Yes
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No
þ
As of July 31, 2008, 17,033,441 shares of Avalon Pharmaceuticals, Inc. common stock, par
value $.01 per share, were outstanding.
AVALON PHARMACEUTICALS, INC.
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Page
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PART I. FINANCIAL INFORMATION
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Item 1. Financial Statements
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4
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Balance Sheets as of June 30, 2008 (unaudited) and December 31, 2007
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4
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Statements of Operations for the three and six months ended June 30, 2008 and 2007 (unaudited)
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5
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Statements of Cash Flows for the six months ended June 30, 2008 and 2007 (unaudited)
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6
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Notes to Financial Statements (unaudited)
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7
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Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
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12
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Item 3. Quantitative and Qualitative Disclosures About Market Risk
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16
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Item 4T. Controls and Procedures
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16
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PART II. OTHER INFORMATION
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Item 4. Submission of Matters to a Vote of Security Holders
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16
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Item 6. Exhibits
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17
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SIGNATURES
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18
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2
FORWARD-LOOKING STATEMENTS
From time to time in this interim quarterly report we may make statements that reflect
our current expectations regarding our future results of operations, economic performance, and
financial condition, as well as other matters that may affect our business. In general, we try to
identify these forward-looking statements by using words such as anticipate, believe, expect,
estimate, and similar expressions.
All of these items involve significant risks and uncertainties. These and any of the
other statements we make in this quarterly report that are forward-looking are made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We caution you that
our actual results may differ significantly from the results we discuss in the forward-looking
statements.
We discuss some factors that could cause or contribute to such differences in the Risk
Factors section of our Annual Report on
Form 10-K
for the fiscal year ended December 31, 2007. In
addition, any forward-looking statements we make in this document speak only as of the date of this
document, and we do not intend to update any such forward-looking statements to reflect events or
circumstances that occur after that date.
3
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
AVALON PHARMACEUTICALS, INC.
BALANCE SHEETS
(in thousands, except share amounts)
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June 30,
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December 31,
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2008
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2007
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(Unaudited)
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ASSETS
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Current assets:
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Cash and cash equivalents
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$
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4,806
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$
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6,276
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Short-term marketable securities
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6,855
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15,558
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Accounts receivable
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19
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200
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Interest receivable
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90
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190
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Prepaid expenses
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889
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743
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Deposits
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102
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Total current assets
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12,659
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23,069
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Restricted cash and marketable securities
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4,458
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5,275
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Property and equipment, net
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6,657
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7,325
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Long-term marketable securities
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535
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1,416
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Deferred financing costs, net
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265
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220
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Total assets
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$
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24,574
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$
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37,305
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LIABILITIES AND STOCKHOLDERS EQUITY
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Current liabilities:
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Accounts payable
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$
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1,932
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$
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1,063
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Accrued expenses and other current liabilities
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698
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1,207
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Deferred revenue and customer advances
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1,017
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1,204
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Current portion of long-term debt
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1,200
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1,211
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Total current liabilities
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4,847
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4,685
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Deferred rent
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428
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446
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Long-term debt, net of current portion
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4,800
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6,000
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Stockholders equity:
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Series C Junior Participating Preferred
stock, $0.01 par value, 300,000 shares
authorized, no shares issued and outstanding
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Common stock, $0.01 par value; 60,000,000
shares authorized; 17,033,441 and 17,026,462
shares issued and outstanding at June 30,
2008 and December 31, 2007, respectively
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170
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170
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Additional capital
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150,528
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150,331
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Other comprehensive income
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6
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50
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Accumulated deficit
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(136,205
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(124,377
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Total stockholders equity
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14,499
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26,174
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Total liabilities and stockholders equity
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$
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24,574
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$
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37,305
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See accompanying notes.
4
AVALON PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended
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Six Months Ended
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June 30,
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June 30,
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2008
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2007
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2008
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2007
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Revenues
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$
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137
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$
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78
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$
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187
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$
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809
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Costs and expenses:
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Research and development
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4,509
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4,066
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8,869
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8,178
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General and administrative
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1,281
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2,043
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3,413
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4,271
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Total costs and expenses
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5,790
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6,109
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12,282
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12,449
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Loss from operations
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(5,653
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(6,031
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(12,095
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(11,640
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Other income (expense):
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Interest income
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153
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378
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460
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717
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Interest expense
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(92
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(158
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(208
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(330
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Other
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14
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2
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16
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99
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Total other income (expense), net
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75
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222
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268
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486
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Net loss
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$
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(5,578
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$
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(5,809
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$
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(11,827
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$
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(11,154
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Net loss per share basic and diluted
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$
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(0.33
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$
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(0.40
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$
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(0.69
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$
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(0.82
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Weighted average number of shares
basic and diluted
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17,033,042
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14,672,577
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17,031,620
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13,547,779
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See accompanying notes.
5
AVALON PHARMACEUTICALS, INC.
STATEMENTS OF CASH FLOWS
(in thousands)
(Unaudited)
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Six Months Ended
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June 30,
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2008
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2007
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Operating activities
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Net loss
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$
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(11,827
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$
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(11,154
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Adjustments to reconcile net loss to net cash used in operating activities:
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Depreciation
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874
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1,061
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Non-cash interest expense
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106
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108
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Amortization of premium on investments
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(151
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(244
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Stock based compensation
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196
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1,002
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Changes in operating assets and liabilities:
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Prepaid expenses
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(146
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31
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Accounts receivable and other assets
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383
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215
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Accounts payable
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869
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(537
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Accrued expenses and other current liabilities
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(509
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(40
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Deferred revenue and customer advances
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(187
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340
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Deferred rent
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(18
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(10
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Net cash used in operating activities
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(10,410
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(9,228
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Investing activities
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Proceeds from the sale and maturities of marketable securities
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16,718
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15,640
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Purchases of marketable securities
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(6,210
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(25,317
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Purchases of property and equipment
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(206
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(309
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)
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Net cash provided by (used in) investing activities
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10,302
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(9,986
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Financing activities
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Principal payments on debt
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(1,200
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)
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(1,450
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Proceeds from issuance of common stock
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28,320
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Deferred financing costs
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(162
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)
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(148
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)
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Net cash provided by (used in) financing activities
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(1,362
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)
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26,722
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Net (decrease) increase in cash and cash equivalents
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(1,470
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)
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7,508
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Cash and cash equivalents at beginning of period
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6,276
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3,099
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Cash and cash equivalents at end of period
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$
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4,806
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$
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10,607
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See accompanying notes.
6
AVALON PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS
JUNE 30, 2008
(UNAUDITED)
1. Basis of Presentation
The financial statements included in this report have been prepared, without audit,
pursuant to the rules and regulations of the Securities and Exchange Commission. Certain
information and footnote disclosures, normally included in financial statements prepared in
accordance with U.S. generally accepted accounting principles, have been condensed or omitted
pursuant to such rules and regulations. These financial statements should be read in conjunction
with the audited financial statements and the related notes included in our Annual Report on Form
10-K for the fiscal year ended December 31, 2007.
In the opinion of our management, any adjustments contained in the accompanying unaudited
financial statements as of and for the three and six months ended June 30, 2008 and 2007 are of a
normal recurring nature and are necessary to present fairly our financial position, results of
operations and cash flows. Interim results are not necessarily indicative of results for the full
fiscal year.
2. Liquidity Risks and Managements Plans
The accompanying financial statements have been prepared on a going-concern basis, which
contemplates the realization of assets and satisfaction of liabilities in the normal course of
business. Since inception, the Company has incurred, and continues to incur, significant losses
from operations. On August 13, 2008 the Company announced that it was restructuring its
operations. As a result, the Company reduced its workforce by approximately one third. The
Company expects to incur restructuring charges related to this action of $0.9 million to $1.1
million. These charges will be included in the Companys statement of operations principally in
the third quarter of 2008. Company management estimates that its current capital resources will
not be sufficient to fund the Companys restructured operations significantly beyond December 31,
2008 without an additional curtailment of operating and capital expenditures, additional
partnership revenues, or new equity or debt financing.
The Companys ability to continue as a going concern is dependent on its success at
raising additional capital sufficient to meet its obligations on a timely basis, and to ultimately
attain profitability. Management is active in discussions to raise the necessary funds for the
Companys growth and development activities. However, there is no assurance that the Company will
raise capital sufficient to enable the Company to continue its restructured operations
significantly beyond December 31, 2008.
In the event the Company is unable to successfully raise additional capital, it is
unlikely that the Company will have sufficient cash flows and liquidity to finance its business
operations as currently contemplated. Accordingly, in the event new financing is not obtained, the
Company will likely reduce general and administrative expenses and delay research and development
projects as well as further acquisition of scientific equipment and supplies until it is able to
obtain sufficient financing to do so.
These factors could significantly limit the Companys ability to continue as a going
concern. The balance sheets do not include any adjustments relating to recoverability and
classification of recorded asset amounts or the amounts and classification of liabilities that
might be necessary should the Company be unable to continue in existence.
3. Organization
Avalon Pharmaceuticals, Inc. (Avalon, or the Company), was incorporated on
November 10, 1999, under the laws of the state of Delaware. Avalon is a biopharmaceutical company
using proprietary technology, AvalonRx
®
, to discover and develop novel therapeutics.
4. Recent Accounting Pronouncements
In September 2006, the FASB issued SFAS No. 157,
Fair Value Measurements
(SFAS 157).
SFAS 157 provides guidance for using fair value to measure assets and liabilities. It also responds
to investors requests for expanded information about the extent to which companies measure assets
and liabilities at fair value, the information used to measure fair value and the effect of fair
value measurements on earnings. SFAS 157 applies whenever other standards require (or permit)
assets or liabilities to be measured at fair value, and does not expand the use of fair value in
any new circumstances. SFAS 157 is effective for financial statements issued for fiscal years
beginning after November 15, 2007. The Company has adopted the provisions of SFAS 157 as of
January 1, 2008, for financial instruments. Although the adoption of SFAS 157 did not materially
impact its financial condition, results of operations or cash flow, the Company is now required to
provide additional disclosures as part of its financial statements. SFAS 157 establishes a
three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These
tiers include:
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Level 1, defined as observable inputs such as quoted prices in active markets for identical assets;
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Level 2, defined as observable inputs other than level 1 prices such as quoted prices for similar
assets; quoted prices in markets that are not active; or other inputs that are observable or can
be corroborated by observable market data for substantially the full term of the assets or
liabilities; and
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Level 3, defined as unobservable inputs in which little or no market data exists, therefore
requiring an entity to develop its own assumptions.
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7
The Companys cash equivalents, short-term, long-term and restricted marketable
securities are subject to fair value measurements. The inputs used in measuring the fair value of
these instruments are considered to be level 1 in accordance with the SFAS 157 hierarchy.
In February 2007, the FASB issued SFAS No. 159,
The Fair Value Option for Financial
Assets and Financial Liabilities Including an amendment of FASB Statement No. 115
(SFAS 159).
SFAS 159 expands the use of fair value accounting but does not affect existing standards that
require assets or liabilities to be carried at fair value. Under SFAS 159, a company may elect to
use fair value to measure accounts and loans receivable, available-for-sale and held-to-maturity
securities, equity method investments, accounts payable, guarantees and issued debt. Other eligible
items include firm commitments for financial instruments that otherwise would not be recognized at
inception and non-cash warranty obligations where a warrantor is permitted to pay a third party to
provide the warranty goods or services. If the use of fair value is elected, any upfront costs and
fees related to the item must be recognized in earnings and cannot be deferred, such as debt
issuance costs. The fair value election is irrevocable and generally made on an
instrument-by-instrument basis, even if a company has similar instruments that it elects not to
measure based on fair value. At the adoption date, unrealized gains and losses on existing items
for which fair value has been elected are reported as a cumulative adjustment to beginning retained
earnings. Subsequent to the adoption of SFAS 159, changes in fair value are recognized in earnings.
SFAS 159 is effective for financial statements issued for fiscal years beginning after November 15,
2007. The adoption of SFAS No. 159 did not have a material impact on our financial position or
results of operations.
In June 2007, the FASB ratified EITF 07-03,
Accounting for Nonrefundable Advance Payments
for Goods or Services Received for Use in Future Research and Development Activities
(EITF
07-03). EITF 07-03 requires that nonrefundable advance payments for goods or services that will be
used or rendered for future research and development activities be deferred and capitalized and
recognized as an expense as the goods are delivered or the related services are performed. EITF
07-03 is effective, on a prospective basis, for financial statements issued for fiscal years
beginning after December 15, 2007. The adoption of EITF 07-03 did not have a material impact on our
financial statements.
5. Summary of Significant Accounting Policies
Use of Estimates
The preparation of financial statements in conformity with accounting principles
generally accepted in the United States requires management to make estimates and assumptions that
affect the amounts reported in the financial statements and accompanying notes. Actual results
could differ from those estimates.
Reclassification
Certain reclassifications of prior period amounts have been made to conform with the
current year presentation.
Cash and Cash Equivalents
The Company considers all highly liquid investments with a maturity of three months or
less when purchased to be cash equivalents. Cash equivalents consist primarily of money market
funds and commercial paper. The Company maintains cash balances with financial institutions in
excess of insured limits. The Company does not anticipate any losses with such cash balances.
Marketable Securities
Marketable securities consist primarily of U.S. Treasury, agency and corporate debt
securities with various maturities. Management classifies the Companys marketable securities as
available-for-sale. Such securities are stated at market value, with the unrealized gains and
losses included as accumulated other comprehensive income (loss). Realized gains and losses and
declines in value judged to be other-than-temporary on securities available for sale, if any, are
included in operations. A decline in the market value of any available-for-sale security below cost
that is deemed to be other-than-temporary results in a reduction in fair value. The impairment is
charged to earnings, and a new cost basis for the security is established. Dividend and interest
income are recognized when earned. The cost of securities sold is calculated using the specific
identification method.
Revenue Recognition
Revenue is recognized when there is persuasive evidence that an agreement exists,
delivery has occurred, the price is fixed and determinable, and collection is reasonably assured.
Payments received in advance of work performed are recorded as deferred revenue and recognized
ratably over the performance period. Milestone payments are recognized as revenue when milestones,
as defined in the contract, are
achieved. During the first six months of 2008, the Company recognized revenue from work performed
on its collaboration agreement with Novartis, and recognized no revenue from its other
collaboration agreements.
8
Research and Development Costs
Expenditures, other than advance payments for research and development, subject to the
provisions of EITF 07-03, are expensed as incurred.
Restricted Cash and Investments
In accordance with the terms of a financing arrangement with the Maryland Industrial
Development Financing Authority (MIDFA) and Manufacturers and Traders Trust Company (M&T Bank), in
order to finance the build out of the Companys corporate headquarters and research facility
located in Germantown, Maryland, the Company established an investment account which is pledged as
collateral for a letter of credit. The issuer of the letter of credit, M&T Bank, maintains the
investment account. M&T Banks security interest in the account cannot exceed the minimum required
cash collateral amount, which as of June 30, 2008 was defined as an adjusted market value of $4.3
million. This collateral agreement defines adjusted market value as the product of the fair market
value of each permitted investment by a defined percentage ranging from 60% to 100%, depending on
the nature of the permitted investment. The minimum cash collateral amount automatically decreases
each April 1, as specified in the collateral agreement.
Comprehensive Income
SFAS No. 130,
Reporting Comprehensive Income,
requires the presentation of comprehensive
income or loss and its components as part of the financial statements. For the six months ended
June 30, 2008 and 2007, the Companys net loss plus its unrealized gains (losses) on
available-for-sale securities reflects comprehensive income (loss).
Stock-Based Compensation
The Company accounts for share-based payments in accordance with the provisions of FASB
Statement No. 123(R),
Share-Based Payment
.
The fair value of each option grant is estimated on the date of grant using the
Black-Scholes option-pricing fair value model and recognized as compensation expense over the
vesting period of the award using the accelerated attribution method. The following
weighted-average assumptions were used for options granted during the three months ended June 30,
2008 and 2007, and a discussion of our methodology for developing each of the assumptions used in
the valuation model follows:
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Three Months
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Three Months
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Ended
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Ended
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|
|
June 30, 2008
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June 30, 2007
|
Dividend yield
|
|
|
0.00
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%
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|
|
0.00
|
%
|
Expected volatility
|
|
|
72.8
|
%
|
|
|
67.0
|
%
|
Risk-free interest rate
|
|
|
3.27
|
%
|
|
|
4.83
|
%
|
Expected life of the option term (in years)
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|
5.3
|
|
|
|
6.0
|
|
Forfeiture rate
|
|
|
4.2
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%
|
|
|
4.2
|
%
|
Dividend Yield
The Company has never declared or paid dividends and has no plans to do so in the
foreseeable future.
Expected Volatility
Volatility is a measure of the amount by which a financial variable such as a
share price has fluctuated (historical volatility) or is expected to fluctuate (expected
volatility) during a period. Due to the Companys limited trading history, there had been
inadequate data to calculate historical volatility of our stock. Prior to June 30, 2007, the
Company used an average volatility of similar companies in the pharmaceutical industry. Since June
30, 2007, the Company uses an average of the volatility of its own stock and the average volatility
of similar companies in the pharmaceutical industry.
Risk-Free Interest Rate
This is the U.S. Treasury rate for the week of each option grant during
the quarter having a term that most closely resembles the expected life of the option term.
Expected Life of the Option Term
This is the period of time that the options granted are expected
to remain unexercised. The expected term is based upon managements consideration of the historical
life of options, the vesting period of the option granted and the contractual period of the option
granted.
Forfeiture Rate
This is the estimated number of stock options granted that are expected to be
forfeited or cancelled on an annual basis before becoming fully vested. The Company estimates the
forfeiture rate based on past turnover data.
9
Stock Compensation Plans
The Company adopted the Avalon Pharmaceuticals, Inc. 1999 Stock Incentive Plan (the 1999
Plan) to provide for the granting of stock awards, such as stock options, restricted common stock,
and stock appreciation rights to employees, directors and other individuals as determined by the
Board of Directors. The Company terminated the 1999 Plan as to future awards effective upon the
closing of the Companys initial public offering in October 2005. As of June 30, 2008, the Company
had reserved 449,964 shares of common stock to accommodate the exercise of outstanding options
granted under the 1999 Plan.
Effective upon the closing of the Companys initial public offering in October 2005, the
Company adopted the Avalon Pharmaceuticals, Inc. 2005 Omnibus Long-Term Incentive Plan (the 2005
Plan) to provide for the granting of stock awards, such as stock options, restricted common stock,
stock units, dividend equivalent rights, stock appreciation rights and unrestricted common stock,
and other performance and annual incentive awards to employees, directors and other individuals as
determined by the Board of Directors. At the inception of the 2005 Plan, 989,738 shares were
reserved for issuance under the 2005 Plan. The number of shares available for issuance under the
2005 Plan was increased from 989,738 shares to 1,581,582 shares in June 2006 and from 1,581,582
shares to 2,381,582 shares in June 2007. Additionally, shares that become available due to
forfeiture of outstanding awards under the 1999 Plan are available for awards under the 2005 Plan.
As of June 30, 2008, the Company had reserved 2,820,874 shares of common stock to accommodate the
exercise of outstanding option grants under the 1999 Plan and 2005 Plan and for future grants under
the 1999 Plan and 2005 Plan.
Generally, stock options are granted with an exercise price that equals the fair market
value of the Companys common stock on the grant date. Options typically have a life of ten years
and vest over periods ranging from six months to five years. Options generally expire 90 days after
an employee terminates employment with the Company.
Shares of common stock issued to non-employee directors as part of their annual director
compensation for the three and six month periods ended June 30, 2008 were 3,528 and 6,979 shares,
respectively. The fair market value of these shares, on the date of grant, was approximately $8,750
and $20,208, respectively.
The weighted-average grant-date fair value of equity awards granted during the three and
six month periods ended June 30, 2008 was $1.06 and $1.51, respectively. The total fair value of
stock options which vested during the three and six month periods ended June 30, 2008 was
approximately $334,000 and $607,000, respectively. There were 1,636,718 fully vested stock options
outstanding at June 30, 2008. These stock options had a weighted average remaining life of
6.66 years.
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Weighted-
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|
|
Weighted-
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
Remaining
|
|
|
Aggregate
|
|
|
|
|
|
|
|
Exercise
|
|
|
Contractual
|
|
|
Intrinsic Value
|
|
|
|
Shares
|
|
|
Price
|
|
|
Term
|
|
|
(in thousands)
|
|
Outstanding at March 31, 2008
|
|
|
2,182,121
|
|
|
$
|
4.04
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
19,200
|
|
|
|
1.68
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired
|
|
|
80,838
|
|
|
|
3.81
|
|
|
|
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|
|
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|
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|
|
|
|
|
|
|
|
Outstanding at June 30, 2008
|
|
|
2,120,483
|
|
|
|
4.02
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest at June 30, 2008
|
|
|
1,567,976
|
|
|
$
|
4.18
|
|
|
|
6.66
|
|
|
$
|
|
|
Exercisable at June 30, 2008
|
|
|
1,636,718
|
|
|
$
|
4.18
|
|
|
|
6.66
|
|
|
$
|
|
|
No stock options were exercised during the six months ended June 30, 2008. Due to the
valuation allowance on all deferred tax assets, the Company recorded no tax benefit for stock
compensation expense recognized during the three months ended June 30, 2008. As of June 30, 2008,
unamortized stock-based compensation expenses of approximately $567,000 remains to be recognized
over a weighted average period of 2.4 years.
Basic and Diluted Net Loss Attributable to Common Stockholders Per Common Share
Basic net loss attributable to common stockholders per common share excludes dilution for
potential common stock issuances and is computed by dividing net loss by the weighted-average
number of common shares outstanding for the period. Diluted net loss per common share reflects the
potential dilution that could occur if securities or other contracts to issue common stock were
exercised or converted into common stock. Stock options and warrants were not considered in the
computation of diluted net loss per common share for the periods presented, as their effect is
antidilutive.
6. Debt
In February 2008, the Company entered into an amendment to the letter of credit with M&T
Bank and the Maryland Industrial Development Financing Authority to extend the expiry of the letter
of credit agreement to April 8, 2013. In addition, the amendment removes the Companys
financial covenant obligations under the letter of credit regarding the maintenance of (i) a
minimum ratio of current assets to current liabilities and (ii) a minimum tangible net worth.
10
7. Stockholders Equity
Preferred Stock
In April 2007, the Company entered into a Rights Agreement (the Rights Agreement)
between the Company and American Stock Transfer & Trust Company, as Rights Agent. In connection
with the adoption of the Rights Agreement, the Board of Directors of the Company declared a
dividend distribution of one right (Right) for each outstanding share of common stock, par value
$0.01 per share of the Company, payable to stockholders of record on May 10, 2007. Each Right, when
exercisable, entitles the registered holder to purchase from the Company one one-thousandth of one
share of Series C Junior Participating Preferred Stock at a price of $60.00 per one one-thousandth
share, subject to adjustment. The description and terms of the Rights are set forth in the Rights
Agreement.
Initially, the Rights will be attached to all certificates representing shares of common
stock then outstanding, and no separate certificates evidencing the Rights will be distributed. The
Rights will separate from the common stock and a distribution of Rights Certificates will occur
upon the earlier to occur of (i) 10 days following a public announcement that a person or group of
affiliated or associated persons has acquired beneficial ownership of 20% or more of the
outstanding shares of common stock or (ii) 10 business days following the commencement of, or the
first public announcement of the intention to commence, a tender offer or exchange offer the
consummation of which would result in the beneficial ownership by a person of 20% or more of the
outstanding shares of common stock. (the earlier of such dates being called the Distribution
Date).
Until the Distribution Date, (i) the Rights will be evidenced by the common stock
certificates, and will be transferred with and only with the common stock certificates, (ii) new
common stock certificates issued after May 10, 2007 upon transfer or new issuance of the common
stock will contain a notation incorporating the Rights Agreement by reference, and (iii) the
surrender for transfer of any certificates for common stock outstanding will also constitute the
transfer of the Rights associated with the common stock represented by such certificate.
The Rights are not exercisable until the Distribution Date and will expire at the close
of business on May 10, 2017, unless such date is extended, the Rights Agreement is terminated, or
the Rights are earlier redeemed or exchanged by the Company as described below. The Rights will not
be exercisable by a holder in any jurisdiction where the requisite qualification to the issuance to
such holder, or the exercise by such holder, of the Rights has not been obtained or is not
obtainable.
As soon as practicable following the Distribution Date, separate certificates evidencing
the Rights will be mailed to holders of record of the common stock as of the close of business on
the Distribution Date and, thereafter, the separate Rights Certificates alone will evidence the
Rights. Except as otherwise determined by the Board of Directors of the Company, only shares of
common stock issued prior to the Distribution Date will be issued with Rights.
In the event that a person becomes the beneficial owner of 20% or more of the then
outstanding shares of common stock, except pursuant to an offer for all outstanding shares of
common stock which the Directors determine to be fair to and otherwise in the best interests of the
Company and its stockholders, each holder of a Right will have the right to exercise the Right by
purchasing, for an amount equal to the Purchase Price, common stock (or, in certain circumstances,
cash, property or other securities of the Company) having a value equal to two times such amount.
Notwithstanding any of the foregoing, following the occurrence of the events set forth in this
paragraph, all Rights that are beneficially owned by any acquiring person will be null and void.
7. Related Party Transactions
The Company paid one member of the board of directors consulting fees totaling $27,000
for the six months ended June 30, 2008.
8. Income Taxes
For the six month periods ended June 30, 2008, and 2007, there is no current provision
for income taxes and the deferred tax benefit has been entirely offset by valuation allowances. The
difference between the amounts of income tax benefit that would result from applying domestic
federal statutory income tax rates to the net loss and the net deferred tax assets is related to
certain nondeductible expenses, state income taxes, and the change in the valuation allowance.
11
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our results of operations, financial condition
and liquidity and capital resources should be read in conjunction with our unaudited consolidated
financial statements and related notes contained in this Quarterly Report on
Form 10-Q
, as well as
the audited financial statements and related notes for the fiscal year ended December 31, 2007 and
Managements Discussion and Analysis of Financial Condition and Results of Operations, contained
in our Annual Report on
Form 10-K
, for the fiscal year ended December 31, 2007.
Overview
We are a biopharmaceutical company focused on the discovery, development and
commercialization of first-in-class cancer therapeutics. We use AvalonRx®, our proprietary
platform, which is based on large-scale biomarker identification and monitoring, to discover and
develop therapeutics for pathways that have historically been characterized as undruggable.
Since our inception, our operations have consisted primarily of developing AvalonRx®,
utilizing our technology to seek to discover and develop novel cancer therapeutics, and the
in-license and development of AVN944. During that period, we have generated limited revenue from
collaborative partners, and have had no revenue from product sales. Our operations have been funded
principally through the offering of equity securities and debt financings.
We have never been profitable and, as of June 30, 2008, we had an accumulated deficit of
$136.2 million. We had net losses of $11.8 million for the six months ended June 30, 2008 and net
losses of $21.7 million for the year ended December 31, 2007. We expect to incur significant
operating losses for the foreseeable future as we advance our drug candidates from discovery
through preclinical testing and clinical trials and seek regulatory approval and eventual
commercialization. We will need to generate significant revenues to achieve profitability, and we
may never do so.
As of June 30, 2008, we had cash, cash equivalents and marketable securities of approximately
$16.7 million. Of this amount, $4.5 million is currently held in a restricted account to serve as
collateral for our long-term debt. We estimate that our existing capital resources will not be
sufficient to fund our planned operations significantly beyond December 31, 2008. Management
continues to pursue additional funding sources; however, there is no assurance that we will raise
capital sufficient to enable us to continue our operations past December 31, 2008. A failure to
raise additional funds in the near term will require us to reduce our operating and capital
expenditures, scale back or eliminate some or all of our research and development programs or
license to third parties products or technologies that we would otherwise seek to develop
ourselves. There is no assurance that we could continue as a going concern if this were the case.
Recent Developments
On August 13, 2008 the Company announced that it was restructuring its operations to focus on
the pre-clinical and clinical development of its Beta-catenin inhibitor program and on its existing
collaborations, such as with Merck. The Company is curtailing its other development programs and
is seeking a partner for its AVN944 development program. In connection with the restructuring of
its operations, the Company is reducing its workforce by approximately one third. The Company
expects to report restructuring charges related to these actions of $0.9 million to $1.1 million
for severance and related costs.
On June 13, 2008, the United States Patent Office granted a notice of allowance of claims to
Vertex Pharmaceuticals, Inc. for certain revised claims filed by Vertex on its United States patent
that covers AVN944. The revised claims correct a defect in the original claims filed by Vertex to
include AVN944 within the claims covered by the patent. AVN944 was in-licensed by us from Vertex
in February 2005.
Financial Operations Overview
Revenue
We have not generated any revenue from sales of commercial products and do not expect to
generate any product revenue for the foreseeable future. To date, our revenue has consisted of
collaboration revenue.
Collaboration Revenue.
Since inception, we have generated revenue solely in connection
with our collaboration and pilot study agreements. Our collaborations with Merck, AstraZeneca and
Novartis include upfront payments, research funding, and/or payments for the achievement of certain
discovery and development related milestones. During the first half of 2008, we recognized revenue
from work performed under our collaboration with Novartis and recognized no revenue from our other
collaborations.
Research and Development Expense
Research and development expense consists of expenses incurred in connection with
developing and advancing our drug discovery technology and identifying and developing our drug
candidates and supporting our collaborative relationships. These expenses consist primarily of
salaries and related expenses, the purchase of laboratory supplies, access to data sources,
facility costs, costs for preclinical development and expenses related to our in-license and
clinical trials of AVN944. Other than for advance payments for research and development costs,
subject to the provisions of EITF 07-03, we charge all research and development expenses to
operations as incurred.
12
We expect our research and development costs to be substantial as we advance AVN944
through clinical trials and move other drug candidates into preclinical testing and clinical
trials. Based on the results of our preclinical studies, we expect to selectively advance some drug
candidates into clinical trials. We anticipate that we will select drug candidates and research
projects for further development on an ongoing basis in response to their preclinical and clinical
success and commercial potential. In July 2007, we initiated U.S. Phase II clinical trials of
AVN944 in patients diagnosed with pancreatic cancer. We are currently conducting Phase I clinical
trials for AVN944 in patients with hematological cancer and Phase II clinical trials for patients
with pancreatic cancer.
General and Administrative
General and administrative expense consists primarily of salaries and related expenses
for personnel in administrative, finance, business development and human resource functions. Other
costs include legal costs of pursuing patent protection of our intellectual property and other fees
for legal services.
Critical Accounting Policies and Significant Judgments and Estimates
Stock-Based Compensation
We account for share-based payments in accordance with the provisions of FASB Statement
No. 123(R),
Share-Based Payment
. For the six months ended June 30, 2008, we recorded approximately
$176,000 of stock-based compensation expenses, of which $57,000 was included in research and
development expense and $119,000 was included in general and administrative expense. Since we
continue to operate in a net loss, stock-based compensation expense had no impact for tax-related
effects on cash flow from operations and cash flow from financing activities for the six months
ended June 30, 2008. As of June 30, 2008, unamortized stock-based compensation expenses of
approximately $567,000 remains to be recognized over a weighted-average period of approximately 2.4
years. We amortize stock-based compensation expenses on an accelerated basis over the vesting
period.
We estimated the fair value of stock options granted during the three months ended June
30, 2008 using the Black-Scholes option pricing model. The assumptions used under this model are as
follows: (i) expected term of 5.3 years based upon managements consideration of the historical
life of options, the vesting period of the option granted and the contractual period of the option
granted; (ii) expected volatility of 72.8% based on historical and peer volatility data; (iii)
weighted average risk-free interest rate of 3.27% based on the U.S. Treasury yield curve in effect
at the time of grant for periods corresponding with the expected term of the option; and (iv)
expected dividend yield of zero percent. In addition, under SFAS 123(R), the fair value of stock
options granted is recognized as expense over the service period, net of estimated forfeitures.
Based on historical data, we calculated a 4.20% annual forfeiture rate, which we believe is a
reasonable assumption. However, the estimation of forfeitures requires judgment, and to the extent
actual results or updated estimates differ from our current estimates, such amounts will be
recorded as a cumulative adjustment in the period estimates are revised.
The Black-Scholes option pricing model requires the input of highly subjective
assumptions. Because our employee stock options have characteristics significantly different from
those of traded options, and because changes in the subjective input assumptions can materially
affect the fair value estimate, in managements opinion, the existing models may not provide a
reliable single measure of the fair value of our employee stock. In addition, management will
continue to assess the assumptions and methodologies used to calculate estimated fair value of
share-based compensation. Circumstances may change and additional data may become available over
time, which result in changes to these assumptions and methodologies, and which could materially
impact our fair value determination.
Results of Operations
Three Months Ended June 30, 2008 and 2007
Revenue.
Total revenues for the three months ended June 30, 2008 were $137,000, an
increase of $59,000 from the same period in the prior year. All 2007 and 2008 revenues were
attributable to our collaboration agreement with Novartis.
Research and Development.
Research and development expenses increased by $442,000, or
11%, to $4.5 million for the three months ended June 30, 2008 from $4.1 million for the same period
in 2007. The increase in research and development expenses was primarily attributable to increases
in clinical trial and product costs related to our AVN944 drug candidate.
Research and development expenses consist of direct costs which include salaries and
related costs of research and development personnel, and the costs of consultants, materials and
supplies associated with research and development projects. Indirect research and development costs
include facilities, depreciation, patents and other indirect overhead costs.
General and Administrative.
General and administrative expenses decreased by $761,000 or
37%, to $1.3 million for the three months ended June 30, 2008, compared to $2.0 million for the
three months ended June 30, 2007. The decrease is primarily attributable to a decrease in
compensation expense related to stock options and reduction in costs related to personnel and
consultants.
Interest Income.
Interest income decreased by $225,000 or 60%, to $153,000 for the three
months ended June 30, 2008, compared to $378,000 for the three months ended June 30, 2007. The
decrease in interest income is primarily due to lower balances of cash and investments and lower
average interest rates.
13
Interest Expense.
Interest expense decreased by $65,000, or 41%, to $92,000 for the
three months ended June 30, 2008, compared to $158,000 for the three months ended June 30, 2007.
The decrease in interest expense was primarily related to lower debt balances and lower average
interest rates on debt.
Other Income.
Other income was $14,000 for the three months ended June 30, 2008,
compared to $2,000 for the three months ended June 30, 2007. The increase in other income was
primarily related to income from subletting part of our facility and the provision of shared
services to subtenants.
Six Months Ended June 30, 2008 and 2007
Revenue.
Total revenues for the six months ended June 30, 2008 were $187,000, a decrease
of $662,000 from the same period in the prior year. All 2007 and 2008 revenues were attributable
to our collaboration agreement with Novartis.
Research and Development.
Research and development expenses increased by $691,000, or
8%, to $8.9 million for the six months ended June 30, 2008 from $8.2 million for the same period in
2007. The increase in research and development expenses was primarily attributable to increases in
clinical trial and product costs related to our AVN944 drug candidate.
General and Administrative.
General and administrative expenses decreased by $857,000 or
20%, to $3.4 million for the six months ended June 30, 2008, compared to $4.3 million for the six
months ended June 30, 2007. The decrease is primarily attributable to a decrease in compensation
expense related to stock options and a reduction in consulting costs.
Interest Income.
Interest income decreased by $257,000 or 36%, to $460,000 for the six
months ended June 30, 2008, compared to $717,000 for the six months ended June 30, 2007. The
decrease in interest income is primarily due to lower balances of cash and investments and lower
average interest rates.
Interest Expense.
Interest expense decreased by $122,000, or 37%, to $208,000 for the
six months ended June 30, 2008, compared to $330,000 for the six months ended June 30, 2007. The
decrease in interest expense was primarily related to lower debt balances and lower average
interest rates on debt.
Other Income.
Other income was $16,000 for the six months ended June 30, 2008, compared
to $99,000 for the six months ended June 30, 2007. The decrease in other income was primarily
related to a reduction of income from subletting part of our facility and the provision of shared
services to subtenants.
Liquidity and Capital Resources
Our primary cash requirements are to:
|
|
|
fund our research and development and clinical programs;
|
|
|
|
|
obtain regulatory approvals;
|
|
|
|
|
prosecute, defend and enforce any patent claims and other intellectual property rights;
|
|
|
|
|
fund general corporate overhead; and
|
|
|
|
|
support our debt service requirements and contractual obligations.
|
Our cash requirements could change materially as a result of the progress of our research
and development and clinical programs, licensing activities, acquisitions, divestitures or other
corporate developments.
We have incurred operating losses since our inception and historically have financed our
operations principally through public stock offerings, debt financings, private placements of
equity securities, strategic collaborative agreements that include research and development funding
and development milestones, and investment income.
In evaluating alternative sources of financing we consider, among other things, the
dilutive impact, if any, on our stockholders, the ability to leverage stockholder returns through
debt financing, the particular terms and conditions of each alternative financing arrangement and
our ability to service our obligations under such financing arrangements.
As of June 30, 2008, we had cash, cash equivalents and marketable securities of
approximately $16.7 million. Of this amount, $4.5 million is currently held in a restricted account
to serve as collateral for our long-term debt. Our funds are currently invested in investment grade
commercial paper and United States government securities. We estimate that our existing capital
resources will not be sufficient to fund our planned operations significantly beyond December 31,
2008. Management continues to pursue additional funding sources; however, there is no assurance
that we will raise capital sufficient to enable us to continue our operations past year end. A
failure to raise additional funds in the near term will require us to reduce our operating and
capital expenditures, scale back or eliminate some or all of our research and development
programs or license to third parties products or technologies that we would otherwise seek to
develop ourselves. There is no assurance that we could continue as a going concern if this were the
case.
14
Sources and Uses of Cash
Operating Activities.
Net cash used in operating activities for the six months ended
June 30, 2008 was $10.4 million, compared to $9.2 million for the same period in fiscal 2007.
During the first six months of fiscal year 2008, our net loss of $11.8 million was reduced by
non-cash charges of $1.0 million, primarily for stock compensation, depreciation and amortization,
offset by changes in our net operating assets and liabilities.
Investing Activities.
Net cash provided by investing activities for the six months ended
June 30, 2008 was $10.3 million, compared to net cash used in investing activities of $10.0 million
for the same period in 2007. Proceeds from the sale and maturity of marketable securities were the
primary source of cash from investing activities, providing $16.7 million in the first six months
of 2008 and $15.6 million in the comparable period of 2007. Cash used in investing activities
principally represents the amount used to purchase marketable securities, net of proceeds from the
sale and maturity of marketable securities.
Financing Activities.
Net cash used by financing activities for the six months ended
June 30, 2008 was $1.4 million, compared to $26.7 million of net cash provided by financing
activities for the same period in 2007. Aggregate proceeds of $28.2 million from the issuance of
common stock in two private placements was the principal source of net cash provided by financing
activities during the first six months of 2007.
Credit Arrangements
In April 2003, we entered into a series of agreements with the Maryland Industrial
Development Financing Authority, or MIDFA, and Manufacturers and Traders Trust Company, or M&T
Bank, in order to finance improvements to our corporate office and research facility located in
Germantown, Maryland. MIDFA sold development bonds in the amount of $12.0 million. The proceeds of
the bond sale were put in trust to reimburse us for the costs we incurred for improvements to our
facility. We are required to repay the trust $1.2 million annually, on the first day of April, for
these borrowings. The borrowing bears interest at a variable rate and matures on April 8, 2013. The
weighted-average interest rate during the six months ended June 30, 2008 and 2007 was 3.09% and
5.36% respectively
In connection with the development bond financing, we entered into an agreement with M&T
Bank to issue the trustee an irrevocable letter of credit to provide payment of the principal and
interest of the bonds. The amount of the letter of credit changes annually, as principal payments
are made. As of June 30, 2008, that amount is $6,098,630, consisting of $6.0 million of principal
and $98,630 in interest, computed at 50 days at an assumed maximum rate of interest of 12% per
annum. The letter of credit expires the earlier of April 8, 2013, or the date the bonds have been
paid in full. In consideration of the letter of credit, we have granted M&T Bank a security
interest in certain facility improvements, equipment and cash collateral held as restricted cash.
Operating Capital and Capital Expenditure Requirements
Our future funding requirements will depend on many factors, including but not limited
to:
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the size and complexity of our research and development programs;
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the scope and results of our preclinical testing and clinical trials;
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continued scientific progress in our research and development programs;
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the time and expense involved in seeking regulatory approvals;
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competing technological and market developments;
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acquisition, licensing and protection of intellectual property rights; and
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the cost of establishing manufacturing capabilities and conducting commercialization activities.
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Until we can generate a sufficient amount of product revenue to finance our cash
requirements, which we may never do, we expect to finance future cash needs primarily through
public or private equity offerings, debt financings or strategic collaborations. If we are
successful in raising additional funds through the issuance of equity securities, investors likely
will experience dilution, or the equity securities may have rights, preferences or privileges
senior to those of the holders of our common stock. If we raise funds through the issuance of debt
securities, those securities would have rights, preferences and privileges senior to those of our
common stock. We do not know whether additional funding will be available on acceptable terms, or
at all. If we are not able to secure additional funding in the near term, we will have to
significantly reduce our operating and capital expenditures and delay, reduce the scope of, or
eliminate one or more of our clinical trials or research and development programs. In addition, we
may have to partner one or more of our drug candidate programs at an earlier stage of development,
which would lower the economic value of those programs to our Company. We may not be able to
continue as a going concern if this were to be the case.
15
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Not applicable pursuant to the rules of the Securities and Exchange Commission relating
to the disclosure requirements for a smaller reporting company.
Item 4T. Controls and Procedures
Disclosure Controls and Procedures:
Under the supervision and with the participation of
our management, including our Chief Executive Officer and our Chief Financial Officer, we have
evaluated the effectiveness of our disclosure controls and procedures, as of June 30, 2008 (the
Evaluation Date). Based on that evaluation, our Chief Executive Officer and Chief Financial
Officer have concluded that, as of the Evaluation Date, our disclosure controls and procedures were
effective.
Changes in Internal Control over Financial Reporting:
There have been no changes in our
internal control over financial reporting during the quarter ended on the Evaluation Date that has
materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
PART II. OTHER INFORMATION
Item 4. Submission of Matters to a Vote of Security Holders
Our stockholders voted on two items at the Annual Meeting of Stockholders held on June 4,
2008:
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1.
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To elect six directors to serve on our Board of Directors for a term
of one year and until their successors are elected and qualified:
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2.
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To ratify the appointment of Ernst & Young LLP as our independent
public accounting firm for the fiscal year ending December 31, 2008.
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The nominees for director were elected based on the following votes:
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Directors
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Votes For
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Votes Withheld
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% Votes For
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Kenneth C. Carter, Ph.D.
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11,245,350
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917,975
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66.02
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Philip Frost, M.D., Ph.D.
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11,986,603
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176,722
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70.37
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David S. Kabakoff, Ph.D.
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11,244,900
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918,425
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66.02
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Michael R. Kurman, M.D.
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11,245,850
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917.475
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66.02
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Bradley G. Lorimier
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11,242,600
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920,725
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66.00
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William H. Washecka
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11,241,800
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921,525
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66.00
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The proposal to ratify the appointment of Ernst & Young, LLP as our independent registered public
accounting firm for the fiscal year ending December 31, 2008 received the following votes:
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12,146,157 votes for approval;
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10,917 votes against;
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6,251 abstentions.
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There were zero (0) broker non-votes for this item.
16
Item 6. Exhibits
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Exhibit No.
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Description
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31.1
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Certification of Chief Executive Officer pursuant to
Rule 13a-14(a) under the Securities Exchange Act of 1934 as
adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002.
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31.2
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Certification of Chief Financial Officer pursuant to
Rule 13a-14(a) under the Securities Exchange Act of 1934 as
adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002.
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32.1
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Certification of Chief Executive Officer and Chief Financial
Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002.
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17
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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AVALON PHARMACEUTICALS, INC.
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Date: August 14, 2008
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By:
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/s/ Kenneth C. Carter
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Kenneth C. Carter, Ph.D.
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President, Chief Executive Officer and Director
(Principal Executive Officer)
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Date: August 14, 2008
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By:
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/s/ C. Eric Winzer
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C. Eric Winzer
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Executive Vice President and Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)
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18
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