UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
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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 MARCH 31, 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: 001-33054
TRUBION PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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DELAWARE
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52-2385898
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(State or other jurisdiction of incorporation or organization)
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(IRS Employer Identification No.)
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2401 FOURTH AVENUE, SUITE 1050
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SEATTLE, WASHINGTON
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98121
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(Address of registrants principal executive offices)
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(Zip Code)
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(206) 838-0500
(Telephone number, including area code)
N/A
(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)
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.
þ
Yes
o
No
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 definitions of large
accelerated filer, accelerated filer, and smaller reporting company in Rule 12b-2 of the
Exchange Act.
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Large accelerated filer
o
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Accelerated filer
þ
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Non-accelerated filer
o
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Smaller reporting company
o
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act).
o
Yes
No
þ
The number of shares of the registrants common stock, $0.001 par value, outstanding as of May
2, 2008 was 17,851,589.
TRUBION PHARMACEUTICALS, INC.
INDEX
2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
TRUBION PHARMACEUTICALS, INC.
BALANCE SHEETS
(In thousands, except share and par value)
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March 31, 2008
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December 31, 2007
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(unaudited)
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ASSETS
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Current assets:
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Cash and cash equivalents
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$
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19,233
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$
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41,827
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Investments
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52,851
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36,688
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Receivable from collaboration
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2,876
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4,237
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Prepaid expenses
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942
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1,224
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Total current assets
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75,902
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83,974
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Property and equipment, net
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10,985
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11,163
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Other assets
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27
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35
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Total assets
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$
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86,914
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$
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95,174
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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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483
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$
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1,031
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Accrued liabilities
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3,525
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3,337
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Accrued compensation
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1,265
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2,022
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Current portion of notes payable
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2,325
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2,426
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Current portion of deferred rent
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180
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180
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Current portion of deferred revenue
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5,848
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5,848
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Total current liabilities
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13,626
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14,844
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Non-current portion of notes payable
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7,024
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7,567
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Non-current portion of deferred rent
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270
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315
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Non-current portion of deferred revenue
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17,544
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19,006
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Interest rate swap liability
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363
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129
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Commitments and contingencies
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Stockholders equity :
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Preferred stock, $0.001 par value per share;
shares authorized 5,000,000 at March 31,
2008 and December 31, 2007; issued and
outstanding none at March 31, 2008 and
December 31, 2007
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Common stock, $0.001 par value per share;
shares authorized 150,000,000 at March
31, 2008 and December 31, 2007; issued and
outstanding 17,834,226 at March 31, 2008
and 17,792,170 at December 31, 2007
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18
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18
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Additional paid-in capital
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121,253
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120,471
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Deferred stock-based compensation
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(189
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)
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(294
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)
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Accumulated other comprehensive income (loss)
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(117
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)
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28
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Accumulated deficit
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(72,878
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)
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(66,910
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)
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Total stockholders equity
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48,087
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53,313
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Total liabilities and stockholders equity
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$
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86,914
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$
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95,174
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See accompanying notes
3
TRUBION PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS
(In thousands, except per share data)
(unaudited)
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Three Months Ended
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March 31,
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2008
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2007
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Revenue:
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Collaboration revenue
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$
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3,963
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$
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4,835
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Operating expenses:
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Research and development
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7,515
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8,591
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General and administrative
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2,973
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2,355
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Total operating expenses
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10,488
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10,946
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Loss from operations
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(6,525
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)
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(6,111
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Interest income
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735
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1,257
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Interest expense
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(178
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)
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(165
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Net loss
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$
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(5,968
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$
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(5,019
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Basic and diluted net loss per share
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$
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(0.33
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$
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(0.29
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Shares used in computation of basic and diluted net loss per share
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17,831
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17,566
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See accompanying notes
4
TRUBION PHARMACEUTICALS, INC.
STATEMENTS OF CASH FLOWS
(In thousands)
(unaudited)
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Three Months Ended
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March 31,
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2008
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2007
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Operating activities:
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Net loss
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$
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(5,968
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$
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(5,019
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Adjustments to reconcile net loss to net cash used in operating activities:
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Non-cash stock-based compensation expense
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862
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803
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Net amortization of discount on investments
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(139
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)
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(186
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Depreciation and amortization expense
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810
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671
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Amortization of debt discount
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4
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6
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Changes in operating assets and liabilities:
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Receivable from collaboration
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1,361
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911
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Prepaid expenses and other assets
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290
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37
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Accounts payable
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(548
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)
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(639
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Accrued liabilities and compensation
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(569
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(1,159
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)
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Deferred revenue
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(1,462
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)
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(2,000
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Deferred rent
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(45
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)
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(45
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Net cash used in operating activities
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(5,404
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)
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(6,620
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)
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Investing activities:
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Purchases of property and equipment
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(632
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)
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(2,263
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)
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Purchases of investments
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(29,021
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)
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(10,017
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Maturities of investments
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13,086
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16,183
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Net cash provided by (used in) investing activities
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(16,567
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)
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3,903
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Financing activities:
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Proceeds from issuance of notes payable
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1,516
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Payments on notes payable
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(648
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)
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(236
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)
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Proceeds from exercise of stock options
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25
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26
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Net cash provided by (used in) financing activities
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(623
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)
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1,306
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Net decrease in cash and cash equivalents
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(22,594
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)
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(1,411
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)
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Cash and cash equivalents at beginning of period
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41,827
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56,414
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Cash and cash equivalents at end of period
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$
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19,233
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$
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55,003
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Supplemental disclosure information:
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Cash paid for interest
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$
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140
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$
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158
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See accompanying notes
5
TRUBION PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS
(unaudited)
1. Summary of Significant Accounting Policies
Basis of Presentation
The balance sheet at December 31, 2007 has been derived from the audited financial statements
at that date, but does not include all of the information and footnotes required by U.S. generally
accepted accounting principles, or GAAP, for complete financial statements. The accompanying
unaudited financial statements have been prepared in accordance with accounting principles
generally accepted in the United States of America for interim financial information and with the
instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not contain all of
the information and footnotes required for complete financial statements. In the opinion of
management, the accompanying unaudited financial statements reflect all adjustments, which include
only normal recurring adjustments, necessary to present fairly our interim financial information.
The accompanying unaudited financial statements and notes to financial statements should be
read in conjunction with the audited financial statements and related notes thereto, which are
included in our annual report on Form 10-K for the year ended December 31, 2007, or the 2007 Form
10-K.
Use of Estimates
Our financial statements have been prepared in accordance with U.S. GAAP. The preparation of
these financial statements requires us to make estimates and judgments in certain circumstances
that affect the reported amounts of assets, liabilities, revenues and expenses, and related
disclosure of contingent assets and liabilities. In preparing these financial statements,
management has made its best estimates and judgments of certain amounts included in the financial
statements, giving due consideration to materiality. On an ongoing basis, we evaluate our
estimates, including those related to revenue recognition, classification of investments, fair
values of assets, income taxes, clinical trial, manufacturing and legal accruals, and other
contingencies. Management bases its estimates on historical experience and on various other
assumptions that it believes to be reasonable under the circumstances. Actual results could differ
from these estimates.
Reclassifications
We have made certain reclassifications to the prior years financial statements and notes to
conform to the current year presentation. These reclassifications related to the non-cash
amortization of discount on investments from investing activities and operating activities and the
presentation of cash flows from the purchase and maturity on investments within investing
activities. For the quarter ended March 31, 2007 this reclassification had an immaterial impact on
cash used in operating activities and cash used in investing activities and also reduced both
purchases and maturities of investments. These reclassifications did not affect our financial
position, net loss or net cash flows for the periods presented.
Adoption of Standards
In September 2006 the Financial Accounting Standards Board, or FASB, released Statement of
Financial Accounting Standards No. 157,
Fair Value Measurements,
or SFAS 157, which is effective
for fiscal years beginning after November 15, 2007. We adopted the provisions of SFAS 157 as of
January 1, 2008, with respect to our financial assets and liabilities only. The adoption of SFAS
157 did not have a material impact on our financial position, results of operations and cash flows.
SFAS 157 defines fair value, establishes a framework for measuring fair value under GAAP, and
expands disclosures about fair value measurements. In November 2007, the FASB agreed to a one-year
deferral of the effective date for non-financial assets and liabilities that are recognized or
disclosed at fair value on a nonrecurring basis. We are currently assessing the portion of the
pronouncement covered by the deferral.
In February 2007 the FASB issued SFAS No. 159,
The Fair Value Option for Financial Assets and
Financial Liabilities,
or SFAS 159. SFAS 159 allows an entity the irrevocable option to elect fair
value for the initial and subsequent measurement for specified financial assets and liabilities on
a contract-by-contract basis. We adopted the provisions of SFAS 159 effective January 1, 2008
without choosing to elect to measure certain financial assets or liabilities at fair value that
were not previously measured at fair value. Thus there was no impact to our results or operations
or financial condition upon adoption.
6
In June 2007 the Emerging Issues Task Force, or EITF, reach a final consensus on EITF issue
No. 07-3,
Accounting for Nonrefundable Advance Payments for Goods or Services Received for Use in
Future Research and Development Activities
, or EITF 07-3. EITF 07-3 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. Effective January 1, 2008, we adopted EITF 07-3.
The adoption did not have a material impact on our results or operations or financial condition.
2. Fair Value Measurements
We currently measure and record equivalents, investment securities considered
available-for-sale and an interest rate swap at fair value in the accompanying financial statements
cash. Fair value is defined under SFAS 157 as the exchange price that would be received for an
asset or paid to transfer a liability, an exit price, in the principal or most advantageous market
for the asset or liability in an orderly transaction between market participants on the measurement
date. Valuation techniques used to measure fair value under SFAS 157 must maximize the use of
observable inputs and minimize the use of unobservable inputs. SFAS 157 establishes a three-tier
fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers
include:
Level 1 Observable inputs for identical assets or liabilities such as quoted prices in
active markets;
Level 2 Inputs other than quoted prices in active markets that are either directly or
indirectly observable; and
Level 3 Unobservable inputs in which little or no market data exists, therefore developed
using estimates and assumptions developed by us, which reflect those that a market participant would use.
In accordance with SFAS 157, the following table represents our fair value hierarchy for our
financial assets and liabilities measured at fair value on a recurring basis as of March 31, 2008
(in thousands):
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Level 1
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Level 2
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Level 3
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Total
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Assets:
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Money market funds
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$
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15,586
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$
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$
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$
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15,586
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U.S. Treasury securities
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1,249
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1,249
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Corporate debt securities
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|
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54,848
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|
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54,848
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|
|
|
|
|
|
|
|
|
|
|
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Total
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$
|
16,835
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|
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$
|
54,848
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|
|
$
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$
|
71,683
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|
|
|
|
|
|
|
|
|
|
|
|
|
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Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate swap
|
|
|
|
|
|
|
363
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|
|
|
|
|
|
|
363
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|
|
|
|
|
|
|
|
|
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|
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Total
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$
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|
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$
|
363
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|
|
$
|
|
|
|
$
|
363
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|
|
|
|
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|
|
|
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Unrealized gains and losses on cash equivalents, available for sale securities, and our
interest rate swap are included in accumulated other comprehensive income (loss) in the
accompanying balance sheets. There were no realized gains or losses on cash equivalents, available
for sale securities, or our interest rate swap during the three months ended March 31, 2008 and
2007.
SFAS 157 requires separate disclosure of assets and liabilities measured at fair value on a
recurring basis, as documented above, from those measured at fair value on a nonrecurring basis.
As of March 31, 2008, no assets or liabilities are currently measured at fair value on a
nonrecurring basis.
3. Net Loss per Share
Basic net loss per share is calculated by dividing net loss by the weighted-average number of
common shares outstanding. Because we report a net loss for the three months ended March 31, 2008
and 2007, diluted net loss per share is the same as basic net loss per share. We have excluded all
outstanding stock options, warrants, and unvested restricted stock from the calculation of diluted
net loss per common share because all such securities are antidilutive to the computation of net
loss per share. Potentially dilutive securities include the following (in thousands):
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|
|
|
|
|
|
|
|
As of March 31,
|
|
|
2008
|
|
2007
|
Stock options
|
|
|
2,115
|
|
|
|
1,588
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|
Common shares subject to repurchase
|
|
|
|
|
|
|
1
|
|
|
|
|
|
|
|
2,115
|
|
|
|
1,589
|
|
|
|
|
7
4. Collaboration Agreement
In December 2005 we entered into a collaboration agreement with Wyeth for the development and
worldwide commercialization of TRU-015 and other CD20-directed therapeutics. We are also
collaborating with Wyeth on the development and worldwide commercialization of certain other
product candidates directed to a small number of targets other than CD20 that have been established
pursuant to the agreement. During the remaining term of our research and development services for
Wyeth, Wyeth has the right to replace a limited number of these targets. These replacement targets
are subject to our consent, which we may not unreasonably withhold. In addition, we have the option
to co-promote with Wyeth, on customary terms to be agreed, CD20-directed therapies in the United
States for niche indications. We retain the right to develop and commercialize, on our own or with
others, product candidates directed to all targets not included within the agreement, including
CD37. Unless earlier terminated, the agreement will remain in effect on a product-by-product basis
and on a country-by-country basis until the later of the date that any such product shall no longer
be covered by a valid claim of a U.S. or foreign patent or application and, generally, ten years
after the first commercial sale of any product licensed under the agreement. Wyeth may terminate
the agreement without cause at any time upon 90 days prior written notice.
In connection with the agreement Wyeth paid us a $40 million non-refundable, non-creditable
up-front fee in January 2006 and purchased directly from us in a private placement, concurrent with
our initial public offering, 800,000 shares of our common stock at the initial public offering
price of $13.00 per share, resulting in net proceeds of $10.4 million. Under the agreement we are
to provide research and development services for the three-year period ending December 22, 2008
with the option for Wyeth to extend the service period for two additional one-year periods. Wyeths
financial obligations to us include collaborative research funding commitments of $9 million in
exchange for such committed research and development services. This $9 million is subject to an
increase if the service period is extended beyond three years as well as annual increases pursuant
to percentage changes in the Consumer Price Index, or CPI.
In addition, Wyeths financial obligations include additional amounts for reimbursement of
agreed-upon external research and development costs and patent costs. Wyeths financial obligations
also include payments of up to $250 million based on regulatory and sales milestones for
CD20-directed therapies and payments of up to $535 million based on regulatory and sales milestones
for therapies directed to the small number of targets other than CD20 that have been established
pursuant to the agreement. In addition, we will receive royalty payments in the event of future
licensed product sales. The $40 million up-front fee is being recognized ratably over the estimated
term of our substantive contractual obligations under the agreement and the related research and
development service period. The estimated term of the research and development service period is
reviewed and adjusted as additional information becomes available. During the third quarter of
2007, the estimated term of the research and development service period was adjusted from five
years to six years and three months. The change in the estimated research and development service
period was primarily due to a change in the estimated service period for our obligations to conduct
clinical activities under our agreement with Wyeth. Revenue is expected to decrease in future
periods due to the revised recognition period for the up-front fee.
During the three months ended March 31, 2008 and 2007, we recognized as revenue $4.0 million
and $4.8 million, respectively, for research and development services pursuant to our Wyeth
collaboration. The $4.0 million recognized in the three months ended March 31, 2008 is comprised of
$1.5 million for amortization of the $40 million up-front fee received from Wyeth and $2.5 million
for collaborative research funding from the Wyeth collaboration. The $4.8 million recognized in
the three months ended March 31, 2007 is comprised of $2.0 million for amortization of the $40
million up-front fee received from Wyeth and $2.8 million for collaborative research funding from
the Wyeth collaboration.
8
5. Property and Equipment
Property and equipment consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
Lab equipment
|
|
$
|
9,964
|
|
|
$
|
8,874
|
|
Leasehold improvements
|
|
|
6,607
|
|
|
|
6,528
|
|
Computer equipment and software
|
|
|
1,045
|
|
|
|
990
|
|
Furniture and fixtures
|
|
|
447
|
|
|
|
447
|
|
Construction in progress
|
|
|
46
|
|
|
|
638
|
|
|
|
|
|
|
|
|
|
|
|
18,109
|
|
|
|
17,477
|
|
Accumulated depreciation and amortization
|
|
|
(7,124
|
)
|
|
|
(6,314
|
)
|
|
|
|
|
|
|
|
|
|
$
|
10,985
|
|
|
$
|
11,163
|
|
|
|
|
|
|
|
|
6. Accrued Liabilities
Accrued liabilities consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
Accrued clinical trials
|
|
$
|
1,773
|
|
|
$
|
1,553
|
|
Accrued professional fees
|
|
|
1,194
|
|
|
|
941
|
|
Other
|
|
|
558
|
|
|
|
843
|
|
|
|
|
|
|
|
|
|
|
$
|
3,525
|
|
|
$
|
3,337
|
|
|
|
|
|
|
|
|
7. Comprehensive Income (Loss)
Comprehensive loss is comprised of net loss and unrealized gains (losses) on marketable
securities and derivatives. The components of comprehensive loss at March 31, 2008 and 2007 were
as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three
months ended
March 31,
|
|
|
|
2008
|
|
|
2007
|
|
Net loss
|
|
$
|
(5,968
|
)
|
|
$
|
(5,019
|
)
|
Net unrealized gains (losses) on
securities available-for-sale
|
|
|
89
|
|
|
|
(8
|
)
|
Net unrealized losses on cash flow hedges
|
|
|
(234
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
$
|
(6,113
|
)
|
|
$
|
(5,027
|
)
|
|
|
|
|
|
|
|
8. Commitments
We have entered into agreements with Lonza Biologics, or Lonza, and related entities for
certain license rights related to Lonzas manufacturing technology, and research and development
services. We have reserved future manufacturing capacity from Lonza under pre-specified terms and
conditions. As of March 31, 2008, we had committed to purchase $1.8 million of manufacturing
services from Lonza in 2009. If we terminate our agreement with Lonza without providing adequate
notice to Lonza under the agreement, we may incur cancellation fees.
|
|
|
ITEM 2.
|
|
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
This quarterly report on
Form 10-Q
contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended, which are subject to the safe harbor created by those sections.
Forward-looking statements are based on our managements beliefs and assumptions and on information
currently available to them. In some cases you can identify forward-looking statements by terms
such as may, will, should, could, would, expect, plans, anticipates, believes,
estimates, projects, predicts, potential, and similar expressions intended to identify
forward-looking statements. Examples of these statements include, but are not limited to,
statements regarding: the implications of interim or final results of our
9
clinical trials, the progress of our research programs, including clinical testing, the extent
to which our issued and pending patents may protect our products and technology, our ability to
identify new product candidates, the potential of such product candidates to lead to the
development of commercial products, our anticipated timing for initiation or completion of our
clinical trials for any of our product candidates, our future operating expenses, our future
losses, our future expenditures for research and development, and the sufficiency of our cash
resources. Our actual results could differ materially from those anticipated in these
forward-looking statements for many reasons, including the risks faced by us and described in Part
II, Item 1A of this quarterly report on
Form 10-Q
and our other filings with the SEC. You should
not place undue reliance on these forward-looking statements, which apply only as of the date of
this quarterly report on
Form 10-Q
. You should read this quarterly report on
Form 10-Q
completely
and with the understanding that our actual future results may be materially different from what we
expect. Except as required by law, we assume no obligation to update these forward-looking
statements, whether as a result of new information, future events, or otherwise.
The following discussion and analysis should be read in conjunction with the unaudited
financial statements and notes thereto included in Part I, Item 1 of this quarterly report on Form
10-Q.
Overview
We are a biopharmaceutical company creating a pipeline of novel protein therapeutic product
candidates to treat autoimmune and inflammatory diseases and cancer. Our mission is to develop a
variety of first-in-class and best-in-class product candidates customized in an effort to optimize
safety, efficacy, and convenience that we believe may offer improved patient experiences. Our
current product candidates are novel small modular immunopharmaceutical, or
SMIP
tm
, therapeutics, that target specific antigens on B cells such as CD20 and
CD37, and are designed using our custom drug assembly technology.
Our lead product candidate, TRU-015, has completed a Phase 2b clinical trial for the treatment
of rheumatoid arthritis, or RA. In December 2005 we entered into a collaboration agreement with
Wyeth for the development and worldwide commercialization of certain therapeutics, including
TRU-015. We and our partner, Wyeth, have agreed on the design of the next clinical trial and
patient dosing has commenced. The randomized, parallel, double-blind, placebo-controlled,
dose-regimen finding study will evaluate the safety and efficacy of two dosing regimens
administered to patients with active seropositive RA on a background of methotrexate. This study
has been designed in a way that we believe could be supportive of a registration package with the
Federal Drug Administration, or FDA.
In collaboration with us, Wyeth is also developing SBI-087 and other CD20-directed products.
Our next generation CD20-directed product candidate, SBI-087 for RA builds on our and Wyeths
clinical experience with our lead compound, TRU-015, and is based on our SMIP
tm
technology. Our partner, Wyeth, has filed an investigational new drug, or IND, application for a
Phase I study of SBI-087 for RA, and patient dosing has commenced. In addition to RA, Wyeth
intends to pursue clinical evaluation of SBI-087 in Systemic Lupus Erythematosus, or SLE, and an
IND filing is expected in the second half of 2008.
Our proprietary product candidate, TRU-016, is a novel CD37-targeted therapy for the treatment
of B-cell malignancies, such as chronic lymphocytic leukemia, or CLL, and non-Hodgkins lymphoma,
or NHL. Patient dosing has commenced in a Phase 1/2 clinical trial for patients with CLL. TRU-016
uses a different mechanism of action than CD20-directed therapies. As a result, we believe its
novel design may provide patients with improved therapeutic options and enhance efficacy when used
alone or in combination with chemotherapy and/or CD20-directed therapeutics.
In December 2005 we entered into a collaboration agreement with Wyeth for the development and
worldwide commercialization of TRU-015 and other CD20-directed therapeutics. We are also
collaborating with Wyeth on the development and worldwide commercialization of certain other
product candidates directed to a small number of targets other than CD20 that have been established
pursuant to the agreement. During the remaining term of our research and development services for
Wyeth, Wyeth has the right to replace a limited number of these targets. These replacement targets
are subject to our consent, which we may not unreasonably withhold. In addition, we have the option
to co-promote with Wyeth, on customary terms to be agreed, CD20-directed therapies in the United
States for niche indications. We retain the right to develop and commercialize, on our own or with
others, product candidates directed to all targets not included within the agreement, including
CD37. Unless earlier terminated, our agreement with Wyeth will remain in effect on a
product-by-product basis and on a country-by-country basis until the later of the date that any
such product shall no longer be covered by a valid claim of a United States or foreign patent or
application and, generally, ten years after the first commercial sale of any product licensed under
the agreement.
10
In connection with the agreement, Wyeth paid us a $40 million non-refundable, non-creditable,
up-front fee in January 2006 and purchased directly from us in a private placement, concurrent with
our initial public offering, 800,000 shares of our common stock at the initial public offering
price of $13.00 per share, resulting in net proceeds to us of $10.4 million. Under the agreement we
are to provide research and development services for the three-year period ending December 22, 2008
with the option for Wyeth to extend the service period for two additional one-year periods. Wyeths
financial obligations include collaborative research funding commitments of $9 million in exchange
for such committed research and development services. This $9 million is subject to an increase if
the service period is extended beyond three years as well as annual increases pursuant to
percentage changes in the Consumer Price Index, or CPI.
In addition, Wyeths financial obligations include additional amounts for reimbursement of
agreed-upon external research and development costs and patent costs. Wyeth is also obligated to
make payments of up to $250 million based on the achievement of regulatory and sales milestones for
CD20-directed therapies and payments of up to $535 million based on the achievement of regulatory
and sales milestones for therapies directed to the small number of targets other than CD20 that
have been established pursuant to the agreement. In addition, we will receive royalty payments in
the event of future licensed product sales. Wyeth may terminate the agreement without cause at any
time upon 90 days prior written notice.
Assuming TRU-015 and other product candidates under the collaboration with Wyeth continue to
progress in development, expenses for future clinical trials may be higher than those incurred in
prior clinical trials. These expenses will, however, likely be incurred by Wyeth and expenses
incurred by us, if any, will be substantially offset by reimbursement revenue from Wyeth. In
addition, Wyeth is responsible for a substantial portion of costs related to patent prosecution and
patent litigation, if any, for products directed to targets selected by Wyeth pursuant to the
collaboration agreement.
The continued research and development of our product candidates will require significant
additional expenditures, including preclinical studies, clinical trials, manufacturing costs, and
the expenses of seeking regulatory approval. We rely on third parties to conduct a portion of our
preclinical studies, all of our clinical trials and all of the manufacturing of current Good
Manufacturing Process, or cGMP, material. We expect expenditures associated with these activities
to increase in future years as we continue developing our product candidates. Expenditures
associated with our product candidates included in the Wyeth collaboration will be substantially
offset by reimbursement revenue from Wyeth.
We have incurred significant losses since our inception. As of March 31, 2008, our accumulated
deficit was $72.9 million and total stockholders equity was $48.1 million. During the three months
ended March 31, 2008 and 2007, we recognized net losses of $6.0 million and $5.0 million,
respectively. We expect our net losses to increase as we continue our existing preclinical studies,
manufacturing, and clinical trials and expand our research and development efforts. In addition,
revenue may decrease in the future due to the successful transfer of the majority of clinical
development efforts and related costs to Wyeth, resulting in a decline in the associated
collaborative research revenue, and a decline in revenue associated with the amortization of the
up-front fee paid by Wyeth over a longer service period.
We were founded as a limited liability company in the state of Washington in March 1999, and
reincorporated in the state of Delaware in October 2002. To date, we have funded our operations
primarily through the sale of equity securities, strategic alliances, equipment financings, and
government grants.
Critical Accounting Policies and Significant Judgments and Estimates
Our managements discussion and analysis of our financial condition and results of operations
are based on our unaudited financial statements, which have been prepared in accordance with U.S.
generally accepted accounting principles. . The preparation of these financial statements requires
us to make estimates and judgments that affect the reported amounts of assets and liabilities and
the disclosure of contingent assets and liabilities at the date of the financial statements, as
well as reported revenues and expenses during the reporting periods. We base our estimates on
historical experience and on various other factors that we believe are reasonable under the
circumstances. The SEC considers an accounting policy to be critical if it is important to a
companys financial condition and results of operations, and if it requires the exercise of
significant judgment and the use of estimates on the part of management in its application. We have
discussed the selection and development of the critical accounting policies with the audit
committee of our board of directors, and the audit committee has reviewed our related disclosures
in this quarterly report. Although we believe that our judgments and estimates are appropriate,
actual results may differ from those estimates.
Our significant accounting policies are described in Note 1 to our audited financial
statements for the year ended December 31, 2007 in our annual report on Form 10-K. Of our
significant accounting policies, we believe that the following
accounting policies relating to revenue recognition, preclinical study and clinical trial
accruals, and stock-based compensation are the most critical to understanding and evaluating our
reported financial results.
11
Revenue Recognition
Revenue is recognized when there is persuasive evidence that an arrangement exists, delivery
has occurred, the price is fixed or determinable, and collection is reasonably assured. Revenue
arrangements with multiple elements are divided into separate units of accounting if certain
criteria are met, including whether the delivered element has stand-alone value to the customer and
whether there is objective and reliable evidence of the fair value of the undelivered items. The
consideration received is allocated among the separate units of accounting based on their
respective fair values when there is reliable evidence of fair value for the undelivered elements
of the arrangement. If separable, the applicable revenue recognition criteria are then applied to
each of the separate units. For combined units of accounting, the revenue is generally recognized
in the same manner as the final deliverable. Generally, revenue related to licensing activity and
our research and development services under collaboration agreements is recognized ratably over the
estimated term of the research and development service period. Payments received in advance of work
performed are recorded as deferred revenue and recognized when earned.
We recognize revenue from our collaboration agreement with Wyeth, which consists of
non-refundable, non-creditable up-front fees and license fees, collaborative research funding,
regulatory and sales milestones, and future product royalties. Revenue related to the Wyeth
collaboration is recognized as follows:
Up-Front Fees and License Fees:
Non-refundable, non-creditable up-front fees and license fees
received in connection with collaborative research and development agreements are deferred and
recognized on a straight-line basis over the estimated term of the research and development service
period. The estimated term of the research and development service period is reviewed and adjusted
based on the status of the project against the estimated timeline as additional information becomes
available. We also consider the time frame of our substantive contractual obligations related to
research and development agreements when estimating the term of the research and development
period. Revenue may fluctuate in the future due to adjustments to the estimated term of the
research and development service period. During the third quarter of 2007 the estimated term of
the research and development service period was adjusted from five years to six years and three
months. The change in the estimated research and development service period was primarily due a
change in the estimated service period for our obligations to conduct clinical activities under our
agreement with Wyeth.
Collaborative Research Funding:
Certain internal and external research and development costs
and patent costs are reimbursed in connection with collaboration agreements. Reimbursed costs are
recognized as revenue in the same period the costs are incurred. Reimbursed costs are subject to
the estimation processes described in the preclinical study, clinical trial and manufacturing
accruals processes described below and are subject to change in future periods when actual activity
is known. To date we have not made any material adjustments to these estimates.
Milestones:
Payments for milestones that are based on the achievement of substantive and
at-risk performance criteria are recognized in full at such time as the specified milestone has
been achieved according to the terms of the agreement. When payments are not for substantive and
at-risk milestones, revenue will be recognized immediately for the proportionate amount of the
payment that correlates to services that have already been rendered, with the balance recognized on
a straight-line basis over the remaining estimated term of the research and development service
period. The basis of the research and development service period is reviewed and adjusted based on
the status of the project against the estimated timeline as additional information becomes
available.
Royalties:
Royalties that are based on reported sales of licensed products and revenues will
be calculated based on contract terms when reported sales are reliably measurable and
collectibility is reasonably assured.
Preclinical Study, Clinical Trial, and Manufacturing Accruals
In accordance with SFAS No. 2,
Accounting for Research and Development Costs
, our research and
development costs are expensed as the related goods are delivered or the related services are
performed. In accordance with Emerging Issues Task Force, or EITF, Issue No. 07-3
Accounting for
Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research and Development
Activities
, nonrefundable advance payments for goods or services that will be used or rendered for
future research and development activities are deferred. Such amounts are recognized as an expense
as the related goods are delivered or the related services are performed. Research and development
costs include, but are not
limited to, salaries and benefits, lab supplies, preclinical fees, clinical trial and related
clinical manufacturing costs, allocated overhead costs, and professional service providers.
12
We estimate our preclinical study, clinical trial and manufacturing accrued expenses based on
our estimates of the services received pursuant to contracts with multiple research organizations
and contract manufacturers that conduct, manage, and provide materials for preclinical studies and
clinical trials on our behalf. The financial terms of these agreements vary from contract to
contract and may result in uneven payment flows. Our research and development costs are expensed as
the related goods are delivered or the related services are performed. Preclinical study, clinical
trial, and manufacturing expenses include the following:
|
|
|
fees paid to contract research organizations in connection with preclinical studies;
|
|
|
|
|
fees paid to clinical research organizations and other clinical sites in connection with clinical trials; and
|
|
|
|
|
fees paid to contract manufacturers in connection with the production of components and drug materials for
preclinical studies and clinical trials.
|
We record accruals for these preclinical study, clinical trial, and manufacturing expenses
based on the estimated amount of work completed. All such costs are included in research and
development expenses based on these estimates. Costs of setting up a preclinical study or clinical
trial are expensed as the related services are performed. Costs related to patient enrollment in
clinical trials are accrued as patients are enrolled in the trial. We monitor patient enrollment
levels and related activities to the extent possible through internal reviews, correspondence, and
discussions with research organizations. If we have incomplete or inaccurate information, we may,
however, underestimate or overestimate activity levels associated with various preclinical studies
and clinical trials at a given point in time. In the event we underestimate, we could record
significant research and development expenses in future periods when the actual activity level
becomes known. To the extent any of these expenses are reimbursable under our collaboration
agreement with Wyeth, we could also record significant adjustments to revenue when the actual
activity becomes known. To date, we have not made any material adjustments to our estimates of
preclinical study and clinical trial expenses. We make good-faith estimates that we believe to be
accurate, but the actual costs and timing of preclinical studies and clinical trials are highly
uncertain, subject to risks, and may change depending on a number of factors, including our
clinical development plan. If any of our product candidates enter Phase 3 clinical trials, the
process of estimating clinical trial costs will become more difficult because the trials will
involve larger numbers of patients and clinical sites.
Stock-Based Compensation
On January 1, 2006 we adopted the fair value recognition provisions of SFAS 123R,
Share-Based
Payment
, which requires the measurement and recognition of compensation expenses for all future
share-based payments made to employees and directors be based on estimated fair values. SFAS 123R
supersedes our previous accounting for employee stock options using the minimum-value method in
accordance with the Opinion of the Accounting Principles Board, or APB,
Accounting for Stock Issued
to Employees
, 25, FIN 44,
Accounting for Certain Transactions Involving Stock Compensation, an
Interpretation of APB 25
, and related interpretations, and the disclosure-only provisions of SFAS
No. 123,
Accounting for Stock-Based Compensation,
as amended by SFAS No. 148,
Accounting for
Stock-Based Compensation Transition and Disclosure.
Compensation costs for employee stock
options granted prior to January 1, 2006 were accounted for using the options intrinsic value or
the difference, if any, between the fair market value of our common stock and the exercise price of
the option.
We adopted SFAS 123R using the prospective transition method, under which compensation costs
recognized during the three months ended March 31, 2008 and March 31, 2007 include: (a)
compensation costs for all share-based payment awards granted prior to, but not yet vested as of,
January 1, 2006, based on the intrinsic value in accordance with the original provisions of APB 25
and (b) compensation costs for all share-based payment awards granted subsequent to January 1,
2006, based on the grant-date fair value estimated in accordance with the provisions of SFAS 123R.
In accordance with the prospective transition method, our financial statements for prior periods
have not been restated to reflect, and do not include, the impact of SFAS 123R. Total employee
stock-based compensation expense recognized under SFAS 123R for the three months ended March 31,
2008 and 2007 was $741,000 and $645,000, respectively. Of the $741,000 recognized in the three
months ended March 31, 2008, $269,000 was included in research and development expense and $472,000
was included in general and administrative expense. Of the $645,000 recognized in the three months
ended March 31, 2007, $253,000 was included in research and development expense and $392,000 was
included in general and administrative expense.
13
The fair value of each employee option grant in the three months ended March 31, 2008 and
2007, respectively, was estimated on the date of grant using the Black-Scholes option pricing model
with the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
Three months ended
|
|
|
March 31, 2008
|
|
March 31, 2007
|
Risk-free interest rate
|
|
|
2.80
|
%
|
|
|
4.62
|
%
|
Weighted-average expected life (in years)
|
|
|
6.03
|
|
|
|
6.25
|
|
Expected dividend yield
|
|
|
0
|
%
|
|
|
0
|
%
|
Expected volatility rate
|
|
|
70
|
%
|
|
|
75
|
%
|
Weighted-average estimated fair value of employee options
|
|
$
|
5.71
|
|
|
$
|
14.34
|
|
For stock options granted to non-employees, the fair value of the stock options is estimated
using the Black-Scholes valuation model. This model utilizes the estimated fair value of common
stock and requires that, at the date of grant, we make assumptions with respect to the expected
life of the option, the volatility of the fair value of our common stock, risk-free interest rates,
and expected dividend yields of our common stock. We have assumed that non-employee stock options
have an expected life of one to ten years and assumed common stock volatility between 65% and 100%.
Different estimates of volatility and expected life of the option could materially change the value
of an option and the resulting expense.
Stock-based compensation expense is recognized over the period of expected service by the
non-employee. As the service is performed, we are required to update these assumptions and
periodically revalue unvested options and make adjustments to the stock-based compensation expense
using the new valuation. These adjustments may result in higher or lower stock-based compensation
expense in the statement of operations than originally estimated or recorded. Ultimately, the final
compensation charge for each option grant to non-employees is unknown until those options have
vested or the performance of services is completed. Stock-based compensation expense associated
with these non-employee options was $23,000 and $24,000 for the three months ended March 31, 2008
and 2007, respectively. We expect stock-based compensation expense associated with non-employee
options to fluctuate in the future based on the volatility of our future stock price.
Results of Operations for the Three Months Ended March 31, 2008 and 2007
Revenue
Revenue decreased to $4.0 million in the three months ended March 31, 2008 from $4.8 million
in the three months ended March 31, 2007. The decrease was primarily due to an extension of the
recognition of the up-front fee and a slight decrease in reimbursement revenue from the Wyeth
collaboration related to the Phase 2b clinical trial for our lead product candidate, TRU-015 in the
treatment of RA. Revenue in the three months ended March 31, 2008 and 2007 included $1.5 million
and $2 million, respectively, for amortization of the $40 million up-front fee. This up-front fee
is being deferred and recognized on a straight-line basis over the estimated term of the research
and development service period of six years and three months. We expect revenue to fluctuate in the
future due to the timing of reimbursed legal and clinical development costs, and the recognition of
the associated collaborative research revenue.
Research and Development Expenses
Research and development expenses decreased to $7.5 million in the three months ended March
31, 2008 from $8.6 million in the three months ended March 31, 2007. The decrease was primarily
due to lower outside manufacturing costs for TRU-016 partially offset by increased
personnel-related expenses. We expect research and development expenses to increase in the future
due to increased manufacturing and clinical development costs primarily related to our TRU-016
product candidate, as well as the related expansion of our research and development organization,
advancement of our preclinical programs, and product candidate manufacturing costs. Our actual
research and development expenses, however, could differ materially from those anticipated.
At any time, we have many ongoing research projects. Our internal resources, employees, and
infrastructure are not directly tied to any individual research project and are typically deployed
across multiple projects. Through our clinical development programs, we are developing each of our
product candidates in parallel for multiple disease indications, and through our basic research
activities, we are seeking to design potential drug candidates for multiple new disease
indications. Due to the number of ongoing projects and our ability to utilize resources across
several projects, we do not record or maintain information regarding the costs incurred for our
research and development programs on a program-specific basis. In
addition, we believe that allocating costs on the basis of time incurred by our employees does
not accurately reflect the actual costs of a project.
14
Our research and development activities can be divided into research and preclinical programs
and clinical development programs. The costs associated with research and preclinical programs and
clinical development programs approximate the following (in thousands):
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|
|
|
|
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|
Three months ended
|
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|
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March 31,
|
|
|
|
2008
|
|
|
2007
|
|
Research and preclinical programs
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|
$
|
5,020
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|
|
$
|
4,869
|
|
Clinical development programs
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|
|
2,495
|
|
|
|
3,722
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|
|
|
|
|
|
|
|
Total research and development
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|
$
|
7,515
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|
|
$
|
8,591
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|
|
|
|
|
|
|
|
Research and preclinical program costs consist of costs associated with our product
development efforts, conducting preclinical studies, personnel costs, animal studies, lab supplies,
and indirect costs such as rent, utilities and depreciation. Clinical development costs consist of
clinical manufacturing costs, clinical trial site and investigator fees, personnel costs and
indirect costs such as rent, utilities, and depreciation. Clinical development program costs
decreased in the three months ended March 31, 2008 compared to the three months ended March 31,
2007 due to lower outside manufacturing costs for TRU-016.
The majority of our research and development programs is at an early stage and may not result
in any approved products. Product candidates that may appear promising at early stages of
development may not reach the market for a variety of reasons. Product candidates may be found to
be ineffective or to cause harmful side effects during clinical trials, may take longer to pass
through clinical trials than had been anticipated, may fail to receive necessary regulatory
approvals, and may prove impracticable to manufacture in commercial quantities at reasonable cost
and with acceptable quality. As part of our business strategy, we may enter into collaborative
arrangements with third parties to complete the development and commercialization of our product
candidates and it is uncertain which of our product candidates may be subject to future
collaborative arrangements. The participation of a collaborative partner may accelerate the time to
completion and reduce the cost to us of a product candidate or it may delay the time to completion
and increase the cost to us due to the alteration of our existing strategy.
As a result of the uncertainties discussed above, the uncertainty associated with clinical
trial enrollments, and the risks inherent in the development process, we are unable to determine
the duration and completion costs of the current or future clinical stages of our product
candidates or when, or to what extent, we will generate revenue from the commercialization and sale
of any of our product candidates. Development timelines, probability of success, and development
costs vary widely. Under our collaboration with Wyeth, we are responsible for completing the Phase
2a and 2b clinical trials of TRU-015 for RA. In addition, we are responsible for conducting
clinical studies for TRU-015 niche indications. While we are currently focused on developing
TRU-015 and other product candidates with Wyeth and our TRU-016 product candidate, together with
other product candidates that are outside our collaboration with Wyeth, we will make determinations
as to which programs to pursue and how much funding to direct to each program on an ongoing basis
in response to the scientific and clinical success of each product candidate, as well as an ongoing
assessment as to the product candidates commercial potential. We anticipate developing additional
product candidates, which will also increase our research and development expenses in future
periods. We do not expect any of our current product candidates to be commercially available in
major markets before 2012, if at all.
General and Administrative Expenses
General and administrative expenses increased to $3.0 million in the three months ended March
31, 2008 from $2.4 million in the three months ended March 31, 2007. The increase was primarily
due to increased fees related to filings for the protection of our intellectual property and
increased personnel costs. We expect our general and administrative expenses to remain relatively
stable in 2008. Our actual general and administrative expenses, however, could differ materially
from those anticipated.
Net Interest Income
Net interest income decreased to $557,000 in the three months ended March 31, 2008 from $1.1
million in the three months ended March 31, 2007. The decrease was primarily the result of a
decline in interest rates and a decrease in our
average cash and investment balance in the first three months of 2008 compared to the same
period in 2007. We expect net interest income to decrease in the future as a result of a declining
cash and investment balance.
15
Liquidity and Capital Resources
To date we have financed our operations primarily through public and private placements of
equity securities, raising net proceeds of $109.2 million through March 31, 2008. In January 2006
we received $40 million from Wyeth for the payment of the up-front fee. In October 2006 we
completed our initial public offering of 4,600,000 shares of common stock at a public offering
price of $13.00 per share for gross proceeds of $59.8 million. Net proceeds from the initial public
offering were approximately $52.8 million, after deducting underwriting discounts and commissions
and offering expenses payable by us. We also received proceeds of $10.4 million from the sale of
800,000 shares of common stock at $13.00 per share in private placement to Wyeth concurrent with
our initial public offering. We have received additional funding from asset-based lease financings
and interest earned on investments.
As of March 31, 2008 we had $72.1 million in cash, cash equivalents, and short-term
investments, and a $2.9 million receivable from Wyeth for collaborative research funding. Our cash
and investment balances are held in a variety of interest bearing instruments, including
obligations of United States government agencies, high credit rating corporate borrowers, and money
market accounts. We do not hold auction rate securities within our investment portfolio. Cash in
excess of immediate requirements is invested with regard to liquidity and capital preservation.
Operating Activities:
Net cash used in operating activities in the three months ended March
31, 2008 was $5.4 million compared to $6.6 million in the three months ended March 31, 2007. Net
cash used in operations in the three months ended March 31, 2008 and 2007 was primarily due to
personnel-related costs, clinical trial costs, lab supplies to support our research activities,
legal and professional fees, facilities costs and administrative costs incurred as a result of
being a publicly traded company. Net cash used in operations in the three months ended March 31,
2007 also included outside manufacturing costs. We expect net cash used in operating expenses to
increase in 2008 as we continue to expand our research and clinical activities.
Investing Activities:
Net cash used in investing activities in the three months ended March
31, 2008 was $16.6 million compared to net cash provided by investing activities of $3.9 million in
the three months ended March 31, 2007. Investing activities consist primarily of purchases and
maturities of marketable securities and capital purchases. Purchases of property and equipment
were $0.6 million and $2.3 million in the three months ended March 31, 2008 and 2007, respectively.
We expect to continue to make investments in property and equipment in 2008 as we expand our
operations, however, we expect to do so to a lesser extent than in 2007.
Financing Activities:
Net cash used in financing activities was $623,000 in the three months
ended March 31, 2008 compared to net cash provided by financing activities of $1.3 million in the
three months ended March 31, 2007. In the three months ended March 31, 2008 financing activities
consisted primarily of payments on an equipment financing arrangement of $648,000. In the three
months ended March 31, 2007 financing activities consisted primarily of proceeds from an equipment
financing arrangement of $1.5 million.
We entered into a loan and security agreement with Comerica Bank effective September 12, 2006,
the terms of which provide for an $8 million debt facility secured by a security interest in our
assets, other than intellectual property. Interest accrues from the date of each equipment advance
and is payable monthly. All equipment advances that were outstanding on September 12, 2007 were
payable in 60 equal installments of principal plus all accrued interest, beginning on October 12,
2007. The outstanding balances under the loan bear interest on a monthly basis at a variety of
interest rates to be elected by us at the time of each advance, ranging from a floating rate of
prime to a fixed rate of 8.50%, depending on the amount of our deposits with Comerica Bank. On July
24, 2007 we and Comerica Bank modified the loan and security agreement by entering into a first
amendment to loan and security agreement, which increased the debt facility by $2 million, for a
total debt facility of $10 million. As of March 31, 2008, we had drawn the full $10 million
available on the loan.
The loan and security agreement contains representations and warranties and affirmative and
negative covenants that are customary for credit facilities of this type. The loan and security
agreement could restrict our ability to, among other things, sell certain assets, engage in a
merger or change in control transaction, incur debt, pay cash dividends, and make investments. The
loan and security agreement also contains events of default that are customary for credit
facilities of this type, including payment defaults, covenant defaults, insolvency type defaults,
and events of default relating to liens, judgments, material misrepresentations, and the occurrence
of certain material adverse events.
16
An interest rate swap was entered into with Comerica Bank effective November 15, 2007, which
fixed the interest rate on the outstanding principal balance of the Comerica loan at 6.97%. We
receive the variable interest rate amount monthly, which is subsequently reclassified into interest
expense as a yield adjustment in the same period in which the related interest on the floating-rate
debt obligation affects earnings. Our objective of holding derivatives is to minimize the risks of
interest rate fluctuation by using the most effective methods to eliminate or reduce the impact of
this exposure. At March 31, 2008 the fair market value of the interest rate swap was valued as a
liability of approximately $363,000, which is included as a non-current liability on our balance
sheet.
Based on our current operating plans, we believe that our existing capital resources, together
with interest thereon, will be sufficient to meet our financial obligations for at least the next
12 months. The key assumptions underlying this estimate include:
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expenditures related to continued preclinical and clinical development of our product candidates
during this period will be within budgeted levels;
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unexpected costs related to the development of our manufacturing capability will not be material; and
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the hiring of a number of new employees at salary levels consistent with our estimates to support
our continued growth during this period.
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Our forecast of the period of time that our financial resources will be adequate to support
operations is a forward-looking statement and involves risks and uncertainties, and actual results
could vary as a result of a number of factors, including the factors discussed in the section of
Item 1A entitled Risk Factors. In light of the numerous risks and uncertainties associated with
the development and commercialization of our product candidates and the extent to which we enter
into collaborations with third parties to participate in their development and commercialization,
we are unable to estimate the amounts of increased capital outlays and operating expenditures
associated with product development. Our future funding requirements will depend on many factors,
including:
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milestone payments projected to be received under the Wyeth collaboration agreement;
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the scope, rate of progress, results and costs of our preclinical testing, clinical trials, and
other research and development activities;
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the terms and timing of any additional collaborative or licensing agreements that we may establish;
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the number and characteristics of product candidates that we pursue;
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the cost of preparing, filing, prosecuting, defending, and enforcing any patent claims and other
intellectual property rights;
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the hiring of a number of new employees will be at salary levels consistent with our estimates to support our continued growth during this period;
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the cost of establishing clinical and commercial supplies of our product candidates;
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the cost, timing, and outcomes of regulatory approvals; and
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the extent to which we acquire or invest in businesses, products, or technologies.
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We will need to raise additional funds to support our operations, and such funding may not be
available to us on acceptable terms, or at all. If we are unable to raise additional funds when
needed, we may not be able to continue development of our product candidates or we could be
required to delay, scale back, or eliminate some or all of our development programs and other
operations. We may seek to raise additional funds through public or private financing, strategic
partnerships, or other arrangements. Any additional equity financing may be dilutive to
stockholders and debt financing, if available, may involve restrictive covenants. If we raise funds
through collaborative or licensing arrangements we may be required to relinquish, on terms that are
not favorable to us, rights to some of our technologies or product candidates that we would
otherwise seek to develop or commercialize ourselves. Our failure to raise capital when needed may
harm our business and operating results.
As of March 31, 2008 the incremental costs of contractual commitments related to reservation
fees for future manufacturing capacity at Lonza were $1.8 million, all of which are due within the
next 12 months.
17
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our exposure to market risk is primarily confined to our investment securities and changes in
interest rates. The primary objective of our investment activities is to preserve our capital to
fund operations. We also seek to maximize income from our investments without assuming significant
risk. To achieve our objectives, we maintain a portfolio of investments in a variety of securities
of high credit quality. We have no exposure to auction rate securities within our investment
portfolio. The securities in our investment portfolio are not leveraged, are classified as
available for sale and, due to their very short-term nature, are subject to minimal interest rate
risk. We currently do not hedge interest rate exposure on our investment securities. We are also
exposed to potential loss on our interest rate swap agreement due to changes in U.S. interest
rates. We actively monitor changes in interest rates.
We are exposed to potential loss due to changes in interest rates. Our principal interest rate
exposure is due to changes in U.S. interest rates. Instruments with interest rate risk include
investment securities and our interest rate swap instrument. To estimate the potential loss due to
changes in interest rates, we performed a sensitivity analysis using the instantaneous adverse
change in interest rates of 100 basis points across the yield curve. On this basis, we estimate the
potential loss in fair value that would result from a hypothetical 1% (100 basis points) decrease
in interest rates to be $20,000 as of March 31, 2008.
ITEM 4. CONTROLS AND PROCEDURES
(a)
Evaluation of disclosure controls and procedures.
The Chief Executive Officer and the
Chief Financial Officer have reviewed the Companys disclosure controls and procedures prior to the
filing of this quarterly report. Based on that review, they have concluded that, as of the end of
the period covered by this quarterly report, these disclosure controls and procedures were, in
design and operation, effective to assure that the required information has been properly recorded,
processed, summarized, and reported to those responsible in order that it may be included in this
quarterly report.
(b)
Changes in internal control over financial reporting.
There have not been any changes in
the Companys internal control over financial reporting during the quarter ended March 31, 2008
which have materially affected, or are reasonably likely to materially affect, the Companys
internal control over financial reporting.
18
PART II. OTHER INFORMATION
Item 1A. Risk Factors
You should carefully consider the risks described below together with all of the other
information included in this quarterly report on Form 10-Q and in our annual report on Form 10-K
for the year ended December 31, 2007. The risks and uncertainties described below are not the only
ones facing our company. If any of the following risks actually occurs, our business, financial
condition, or operating results could be harmed. In such case, the trading price of our common
stock could decline, and investors in our common stock could lose all or part of their investment.
Risks Related to Our Business
Our success depends on the success of our lead product candidate, TRU-015, and we cannot be certain
that it will be safe or effective, complete clinical trials, receive regulatory approval, or be
successfully commercialized.
Although our lead product candidate, TRU-015, has completed a Phase 2b clinical trial for the
treatment of RA, additional clinical trials would be required before we are able to submit a
Biologic License Application, or BLA, to the FDA for approval. The regulatory approval process can
take many years and require the expenditure of substantial resources. In December 2005 we entered
into a collaboration agreement with Wyeth pursuant to which Wyeth is responsible for the regulatory
approval process regarding, and any subsequent commercialization of, TRU-015. In addition to the
risks and uncertainties inherent in the regulatory approval process, Wyeth may not advance the
development and commercialization of TRU-015 as quickly as we would like, if at all. For example,
Wyeth has recently determined not to pursue TRU-015 for any oncology indications and has
discontinued the TRU-015 Phase 1/2 clinical trial for the treatment of NHL that it had initiated in
December 2007. Clinical trials involving the number of sites and patients required for FDA approval
of TRU-015 for RA may not be successfully completed. If these clinical trials are not completed or
their results do not meet safety and efficacy thresholds required by the FDA, TRU-015 will likely
not receive regulatory approval. Even if TRU-015 receives regulatory approval, it may never be
successfully commercialized. If TRU-015 does not receive regulatory approval or is not successfully
commercialized, we may not be able to generate revenue, become profitable, or continue our
operations.
We depend on our collaborative relationship with Wyeth to develop, manufacture, and commercialize
our lead product candidate,
TRU-015,
and other selected product candidates.
In December 2005 we entered into a collaboration agreement with Wyeth for the development and
worldwide commercialization of TRU-015 and other therapeutics directed to CD20. We are also
collaborating with Wyeth on the development and worldwide commercialization of certain other
product candidates directed to a small number of targets other than CD20 that have been established
pursuant to the agreement. In addition, we have the option to co-promote with Wyeth, on customary
terms to be agreed, CD20-directed therapies in the United States for niche indications. The right
to develop and commercialize, on our own or with others, product candidates directed to all targets
not included within the agreement, including CD37, however, remains entirely with us. Although
Wyeth is responsible for developing, manufacturing, and commercializing product candidates directed
to collaboration targets, including CD20, and for the costs associated with such activities, we
were obligated to complete the Phase 2b clinical trial, and are obligated to conduct retreatment
studies in RA, and may be obligated to conduct niche indication registration studies for
CD20-directed therapies. Any future payments, including royalties to us, will depend on the extent
to which we and Wyeth advance product candidates through development and commercialization. Wyeth
may terminate the collaboration relationship, in whole or in part, without cause, by giving 90
days written notice to us. Wyeth also has the right to terminate the agreement, on a
target-by-target basis, upon 60 days written notice, if any safety or regulatory issue arises that
would have a material adverse effect on Wyeths ability to develop, manufacture or commercialize
one or more product candidates.
Our ability to receive any significant revenue from our product candidates covered by the
collaboration agreement depends on the efforts of Wyeth and on our ability to collaborate
effectively. With respect to control over decisions and responsibilities, the collaboration
agreement provides for a research committee and a CD20-directed therapy development committee
consisting of representatives of Wyeth and us. Ultimate decision-making authority as to most
matters within the collaboration, including development plans and timelines, however, is vested in
Wyeth. On March 27, 2008, we announced that Wyeth has determined not to proceed with CD20-directed
therapies for oncology indications, and, as a result, has discontinued clinical development of
TRU-015 for NHL. We also announced that Wyeth no longer intends to evaluate TRU-015 in a Phase 1
study in patients with kidney disease caused by lupus.
19
Wyeth has the right to develop multiple product candidates against the targets licensed to it
under our collaboration. Wyeth has begun clinical development of SBI-087, another CD20-directed
therapy, for RA and intends to file an IND for the evaluation of SBI-087 for SLE by the end of
2008. If Wyeth later determines not to continue developing two CD20-directed therapies, Wyeth
could decide to discontinue efforts to further develop TRU-015. SBI-087 is at an earlier stage in
clinical development than TRU-015 and as a result the time until potential commercialization of a
product resulting from our collaboration with Wyeth would likely be delayed by a decision by Wyeth
to develop SBI-087 instead of TRU-015, which could adversely affect our business and cause the
price of our common stock to fall.
On January 31, 2008, Wyeth announced that in 2008 it will begin a company-wide program
designed to redefine Wyeths business model to facilitate Wyeths long-term growth, as well as to
address Wyeths short-term fiscal challenges. We cannot assure you that Wyeth will continue the
collaboration agreement with us, will fulfill its obligations under the agreement, or will develop
and commercialize our product candidates as quickly as we would like. If Wyeth terminates the
agreement or fails to fulfill its obligations under the agreement, we would need to obtain the
capital necessary to fund the development and commercialization of our product candidates or enter
into alternative arrangements with a third party. We could also become involved in disputes with
Wyeth, which could lead to delays in or termination of our development and commercialization
programs and time-consuming and expensive litigation or arbitration. If Wyeth terminates or
breaches its agreement with us, or otherwise fails to complete its obligations in a timely manner,
our product development programs would be substantially delayed and the chances of successfully
developing or commercializing our product candidates would be materially and adversely affected.
We cannot assure you any of our product candidates will be safe or effective, or receive regulatory
approval.
The clinical trials and the manufacturing of our product candidates are, and marketing of our
products will be, subject to extensive and rigorous review and regulation by numerous government
authorities in the United States and in other countries where we intend to test and market our
product candidates. Before obtaining regulatory approvals for the commercial sale of any product
candidate, we must demonstrate through preclinical testing and clinical trials that the product
candidate is safe and effective for use in each target indication. This process can take many years
and require the expenditure of substantial resources, and may include post-marketing studies and
surveillance. To date, we have not successfully demonstrated in clinical trials safety or efficacy
sufficient for regulatory approval. Although our lead product candidate, TRU-015, has completed a
Phase 2b clinical trial for the treatment of RA, additional clinical trials would be required
before we are able to submit a BLA to the FDA for approval. In addition, our proprietary clinical
candidate TRU-016 and our Wyeth collaboration clinical candidate SBI-087 commenced initial clinical
testing in 2008 and as a result we do not yet have any clinical trial results regarding the safety
or efficacy of either of these product candidates. Even if, based on the results of the initial
clinical trials for TRU-016 and SBI-087, we determine to proceed with further clinical testing of
TRU-016 or Wyeth determines to proceed with further clinical testing of SBI-087, a number of
additional clinical trials will be required before we would be able to submit a BLA to the FDA for
approval of TRU-016 or before Wyeth would be able to submit a BLA to the FDA for approval of
SBI-087. The results from preclinical testing and clinical trials that we have completed may not
be predictive of results in future preclinical tests and clinical trials, and we cannot assure you
we will demonstrate sufficient safety and efficacy to seek or obtain the requisite regulatory
approvals. A number of companies in the biotechnology and pharmaceutical industries have suffered
significant setbacks in advanced clinical trials, even after promising results in earlier trials.
All of our other product candidates remain in the discovery and pre-clinical testing stages. We may
also encounter delays or rejections due to additional government regulation from future
legislation, administrative action, or changes in FDA policy. We cannot assure you regulatory
approval will be obtained for any of our product candidates, and even if the FDA approves a
product, the approval will be limited to those indications covered in the approval. If our current
product candidates are not shown to be safe and effective in clinical trials, the resulting delays
in developing other product candidates and conducting related preclinical testing and clinical
trials, as well as the potential need for additional financing, would have a material adverse
effect on our business, financial condition, and operating results. If we are unable to discover or
successfully develop drugs that are effective and safe in humans and receive regulatory approval,
we will not have a viable business. We do not expect any of our current product candidates to be
commercially available in major markets before 2012, if at all.
We have incurred operating losses in each year since our inception and expect to continue to incur
substantial and increasing losses for the foreseeable future.
We have been engaged in designing and developing compounds and product candidates since 1999
and have not generated any product revenue to date. Our net losses were $6.0 million and $5.0
million in the three months ended March 31, 2008 and 2007, respectively. As of March 31, 2008 we
had an accumulated deficit of $72.9 million. Since inception through March 31, 2008 we have
incurred $107.9
million of research and development expenses. We expect our research and development expenses
to further increase as we continue to design and develop compounds and product candidates. As a
20
result, we expect to continue to incur substantial and increasing losses for the foreseeable
future. We are uncertain when or if we will be able to achieve or sustain profitability. Failure to
become and remain profitable would adversely affect the price of our common stock and our ability
to raise capital and continue operations. In addition, our net operating loss carryforwards and
credits were substantially exhausted as a result of the payments we received from Wyeth in January
2006 pursuant to our collaboration agreement, and any remaining net operating loss carryforwards
and credits may be subject to an annual limitation due to the change in ownership provisions of
the Internal Revenue Code of 1986, as amended, and similar state law provisions, which would have
an adverse effect on our ability to reduce future tax expenses.
If we fail to obtain the capital necessary to fund our operations, we may be unable to develop our
product candidates and we could be forced to share our rights to these product candidates with
third parties on terms that may not be favorable to us.
We need large amounts of capital to support our research and development efforts. If we are
unable to secure capital to fund our operations we will not be able to continue our design and
development efforts, and we might have to enter into collaborations that could require us to share
rights to our product candidates to a greater extent than we currently intend. Based on our current
operating plans, we believe that our existing capital resources, together with interest thereon,
will be sufficient to meet our financial obligations for at least the next 12 months.
In addition, we may need to raise additional funds if we choose to expand more rapidly than we
presently anticipate. We may seek to sell additional equity or debt securities, or both, or incur
other indebtedness. The sale of additional equity or debt securities, if convertible, could result
in the issuance of additional shares of our capital stock and could result in dilution to our
stockholders. The incurrence of indebtedness would result in increased fixed payment obligations
and could also result in certain restrictive covenants, such as limitations on our ability to incur
additional debt, limitations on our ability to acquire or license intellectual property rights, and
other operating restrictions that could adversely impact our ability to conduct our business. In
addition, we cannot guarantee that future financing will be available in sufficient amounts or on
terms acceptable to us, if at all. If we are unable to raise additional capital in sufficient
amounts or on terms acceptable to us we will be prevented from pursuing research and development
efforts. This could harm our business prospects and financial condition and cause the price of our
common stock to fall.
Any failure or delay in commencing or completing clinical trials for product candidates could
severely harm our business.
Each of our product candidates must undergo extensive preclinical studies and clinical trials
as a condition to regulatory approval. Preclinical studies and clinical trials are expensive and
take many years to complete. To date we have not initiated any Phase 3 clinical trials of any
product candidate. The commencement and completion of clinical trials for our product candidates
may be delayed by many factors, including:
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our or our collaborators ability to obtain regulatory approval to commence a clinical trial;
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our or our collaborators ability to manufacture or obtain from third parties materials sufficient for use in
preclinical studies and clinical trials;
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delays in patient enrollment and variability in the number and types of patients available for clinical trials;
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poor effectiveness of product candidates during clinical trials;
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unforeseen safety issues or side effects;
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governmental or regulatory delays and changes in regulatory requirements, policy, and guidelines; and
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varying interpretation of data by us, any or all of our collaborators, the FDA, and similar foreign regulatory
agencies.
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It is possible that none of our product candidates will complete the required clinical trials
in any of the markets in which we or our collaborators intend to sell those product candidates.
Accordingly, we or our collaborators may not seek or receive the regulatory approvals necessary to
market our product candidates. Any failure or delay in commencing or completing clinical trials or
obtaining regulatory approvals for product candidates would prevent or delay their
commercialization and severely harm our business and financial condition.
21
If our SMIP
tm
technology or our product candidates, including TRU-015, conflict
with the rights of others, including Genentech intellectual property rights of which we are aware,
we may not be able to manufacture or market our product candidates, which could have a material
adverse effect on us and on our collaboration agreement with Wyeth.
Our commercial success will depend in part on not infringing the patents or violating the
proprietary rights of third parties. We are aware of intellectual property, including European
patent No. EP-B-1176981, in which Genentech has an ownership interest with claims directed to the
second medical use of an anti-CD20 antibody for treatment of RA. On August 8, 2006 we filed an
opposition to this patent raising objections as to its validity.
We cannot assure you we will be successful in opposing the grant of Genentechs patent.
Subsequent to the submission of our opposition, other parties filed oppositions to the Genentech
patent prior to August 30, 2006, including MedImmune, Inc., Genmab A/S, Centocor, Inc., Glaxo Group
Limited, Serono S.A., and Wyeth. We believe these additional opposition filings will not have a
negative effect on our opposition. Final resolution of the opposition proceedings will likely take
a number of years. In the meantime, the existence of opposition proceedings does not preclude
Genentech from attempting to enforce its patent against third parties, including us and Wyeth. In
addition to its opposition, Glaxo Group Limited filed an action in the United Kingdom to revoke the
U.K. counterpart of EP-B-1176981. Wyeth also initiated a revocation action.
If the Genentech patent is not held invalid or limited in scope, and if our activities are
determined to be covered by the patent, we cannot assure you Genentech would be willing to grant us
or Wyeth a license on terms we or they would consider commercially reasonable, if at all. As a
consequence, we and Wyeth could be prevented from manufacturing and marketing TRU-015 or SBI-087
for the treatment of RA in the designated and extended states of the European Patent Convention
where the patent is validated, which could have a material adverse effect on our business,
financial condition, and operating results. The Genentech European patent claims the benefit of
priority to two U.S. provisional patent applications that are unpublished and the status of which
will remain confidential unless a U.S. patent or patent application claiming priority to the
provisional patent applications publishes. In the event any such corresponding U.S. patent issues,
and if our activities are determined to be covered by such a patent, we cannot assure you Genentech
would be willing to grant us or Wyeth a license on terms we or they would consider commercially
reasonable, if at all, which could prevent us from manufacturing and marketing TRU-015 or SBI-087
for the treatment of RA in the United States, and have a material adverse effect on our business,
financial condition, operating results, and our collaboration with Wyeth.
Issued patents held by others may limit our ability to develop commercial products. All issued
patents are entitled to a presumption of validity under U.S. laws. If we need licenses to such
patents to permit us to manufacture, develop, or market our product candidates we may be required
to pay significant fees or royalties, and we cannot be certain that we would be able to obtain such
licenses. Competitors or third parties may obtain patents that may cover subject matter we use in
(a) developing the technology required to bring our products to market, (b) producing our products,
or (c) treating patients with our products. We know that others have filed patent applications in
various jurisdictions that relate to several areas in which we are developing products. Some of
these patent applications have already resulted in patents and some are still pending. We may be
required to alter our processes or product candidates, pay licensing fees, or cease activities.
Certain parts of our SMIP
tm
product technology, including the current
expression system responsible for the production of the recombinant proteins used in our product
candidates and certain nucleic acids, originated from third-party sources. These third-party
sources include academic, government, and other research laboratories, as well as the public
domain. If use of technology incorporated into or used to produce our product candidates is
challenged, or if our processes or product candidates conflict with patent rights of others, third
parties could bring legal actions against us in Europe, the United States, and elsewhere claiming
damages and seeking to enjoin manufacturing and marketing of the affected products. Additionally,
it is not possible to predict with certainty what patent claims may issue from pending
applications. In the United States, for example, patent prosecution can proceed in secret prior to
issuance of a patent. As a result, third parties may be able to obtain patents with claims relating
to our product candidates which they could attempt to assert against us. Further, as we develop our
products, third parties may assert that we infringe the patents currently held or licensed by them
and we cannot predict the outcome of any such action.
There has been significant litigation in the biotechnology industry over patents and other
proprietary rights, and if we become involved in any litigation it could consume a substantial
portion of our resources, regardless of the outcome of the litigation. If these legal actions are
successful, in addition to any potential liability for damages, we could be required to obtain a
license, grant cross-licenses, and pay substantial royalties in order to continue to manufacture or
market the affected products. We cannot assure you we would prevail in any legal action or that any
license required under a third-party patent would be made available on acceptable terms, if at all.
Ultimately, we could be prevented from commercializing a product or be forced to cease some aspect
of our business operations as a result of claims of patent infringement or violation of other
intellectual property rights, which could have a material adverse effect on our business,
financial condition, and operating results.
22
If we are unable to obtain, maintain, and enforce our proprietary rights, we may not be able to
compete effectively or operate profitably.
Our success depends in part on obtaining, maintaining, and enforcing our patents and other
proprietary rights, and will depend in large part on our ability to:
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obtain and maintain patent and other proprietary protection for our technology, processes, and product candidates;
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enforce patents once issued and defend those patents if their enforceability is challenged;
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preserve trade secrets; and
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operate without infringing the patents and proprietary rights of third parties.
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We currently have four issued patents, one in the United States, and one each in China, New
Zealand, and Australia. In addition, we have one allowed foreign patent, 30 U.S., and 174 foreign
pending patent applications, although there is no guarantee that any of these patent applications
will issue or grant. The degree of future protection for our proprietary rights is uncertain. For
example:
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we might not have been the first to make the inventions covered by any of our patents, if issued, or our
pending patent applications;
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we might not have been the first to file patent applications for these inventions;
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others may independently develop similar or alternative technologies or duplicate any of our technologies;
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it is possible that none of our pending patent applications will result in issued patents or, if issued,
these patents may not be sufficient to protect our technology or provide us with a basis for commercially
viable products, and may not provide us with any competitive advantages;
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if our pending applications issue as patents, they may be challenged by third parties as not infringed,
invalid, or unenforceable under U.S. or foreign laws;
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if issued, the patents under which we hold rights may not be valid or enforceable; or
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we may develop additional proprietary technologies that are not patentable and that may not be adequately
protected through trade secrets, if, for example, a competitor were to independently develop duplicative,
similar, or alternative technologies.
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The patent position of biotechnology and pharmaceutical firms is highly uncertain and involves
many complex legal and technical issues. There is no clear policy involving the breadth of claims
allowed in patents or the degree of protection afforded under patents. Although we believe our
potential rights under patent applications provide a competitive advantage, we cannot assure you
that patent applications owned by or licensed to us will result in patents being issued or that, if
issued, the patents will give us an advantage over competitors with similar technology, nor can we
assure you we can obtain, maintain, and enforce all ownership and other proprietary rights
necessary to develop and commercialize our product candidates.
Even if any or all of our patent applications issue as patents, others may challenge the
validity, inventorship, ownership, enforceability, or scope of our patents or other technology used
in or otherwise necessary for the development and commercialization of our product candidates.
Further, we cannot assure you any such challenge would not be successful. Moreover, the cost of
litigation to uphold the validity of patents to prevent infringement or to otherwise protect our
proprietary rights can be substantial. If the outcome of litigation is adverse to us, third parties
may be able to use the challenged technologies without payment to us. We cannot assure you our
patents, if issued, will not be infringed or successfully avoided through design innovation.
Intellectual property lawsuits are expensive and would consume time and other resources, even if
the outcome were successful. In addition, there is a risk that a court would decide that our
patents, if
23
issued, are not valid and that we do not have the right to stop the other party from using the
inventions. There is also the risk that, even if the validity of a patent were upheld, a court
would refuse to stop the other party from using the inventions, including on the ground that its
activities do not infringe that patent. If any of these events were to occur, our business,
financial condition, and operating results would be materially adversely affected.
In addition to the intellectual property and other rights described above, we also rely on
unpatented technology, trade secrets, trademarks, and confidential information, particularly when
we do not believe that patent protection is appropriate or available. Trade secrets are difficult
to protect and we cannot assure you others will not independently develop substantially equivalent
information and techniques or otherwise gain access to or disclose our unpatented technology, trade
secrets, and confidential information. In addition, we cannot assure you the steps we take with
employees, consultants, and advisors will provide effective protection of our confidential
information or, in the event of unauthorized use of our intellectual property or the intellectual
property of third parties, provide adequate or effective remedies or protection. We also will rely
on current and future trademarks to establish and maintain recognized brands. If we fail to acquire
and protect such trademarks, our ability to market and sell our products, and therefore our
business, financial condition and operating results, would be materially adversely affected. For
example, in November 2005 Merck KGaA filed a proceeding with the Office of Harmonisation of the
Internal Market opposing our European registration of the trademark TRUBION and seeking to place
certain restrictions on the identification of goods, services, and channels of trade description in
our European trademark registration. Merck claims rights resulting from its prior trademark
registration of TRIBION HARMONIS. We filed a response to the opposition and have commenced
negotiations with Merck regarding the matter. We intend to pursue the opposition vigorously if
negotiations are unsuccessful; however, if we are unable to effectively defend against the
opposition, we may be prohibited from using the TRUBION trademark in certain European Union
jurisdictions, which could have an adverse effect on our ability to promote the Trubion brand in
those jurisdictions.
We rely on third parties to conduct our clinical trials. If these third parties do not perform as
contractually required or otherwise expected, we may not be able to obtain regulatory approval for
or commercialize our product candidates.
We do not currently have the ability to conduct clinical trials and we must rely on third
parties, such as contract research organizations, medical institutions, clinical investigators, and
contract laboratories, to conduct our clinical trials. We have, in the ordinary course of business,
entered into agreements with these third parties. Nonetheless, we are responsible for confirming
that each of our clinical trials is conducted in accordance with its general investigational plan
and protocol. Moreover, the FDA requires us to comply with regulations and standards, commonly
referred to as good clinical practices, for conducting, recording, and reporting the results of
clinical trials to assure that data and reported results are credible and accurate and that the
trial participants are adequately protected. Our reliance on third parties does not relieve us of
these responsibilities and requirements. If these third parties do not successfully carry out their
contractual duties or regulatory obligations or meet expected deadlines, if the third parties need
to be replaced or if the quality or accuracy of the data they obtain is compromised due to the
failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our
clinical trials may be extended, delayed, suspended, or terminated, and we may not be able to
obtain regulatory approval for our product candidates.
We currently rely on third-party manufacturers to supply our product candidates and will rely on
third-party manufacturers to manufacture our product candidates in commercial quantities, which
could delay or prevent the clinical development and commercialization of our product candidates.
We currently depend on Wyeth for the supply of TRU-015 and SBI-087. We also currently depend
on contract manufacturers for certain biopharmaceutical development and manufacturing services for
TRU-016, our other current product candidate. Any disruption in production, inability of these
third-party manufacturers to produce adequate quantities to meet our needs, or other impediments
with respect to development or manufacturing could adversely affect our ability to successfully
complete clinical trials, delay submissions of our regulatory applications, or adversely affect our
ability to commercialize our product candidates in a timely manner, if at all.
Our product candidates have not yet been manufactured for commercial use. If any of our
product candidates becomes a product approved for commercial sale, in order to supply our or our
collaborators commercial requirements for such an approved product, the third-party manufacturer
may need to increase its manufacturing capacity, which may require the manufacturer to fund capital
improvements to support the scale-up of manufacturing and related activities. The third-party
manufacturer may not be able to successfully increase its manufacturing capacity for such an
approved product in a timely or economic manner, if at all. If any manufacturer is unable to
provide commercial quantities of such an approved product, we will have to successfully transfer
manufacturing technology to a new manufacturer. Engaging a new manufacturer for such an approved
product could require us to conduct comparative studies or utilize other means to determine
bioequivalence of the
24
new and prior manufacturers products, which could delay or prevent our ability to
commercialize such an approved product. If any of these manufacturers is unable or unwilling to
increase its manufacturing capacity or if we are unable to establish alternative arrangements on a
timely basis or on acceptable terms, the development and commercialization of such an approved
product may be delayed or there may be a shortage in supply. Any inability to manufacture our
products in sufficient quantities would seriously harm our business.
Any manufacturer of our product candidates and approved products, if any, must comply with
cGMP requirements enforced by the FDA through its facilities inspection program. These requirements
include quality control, quality assurance, and the maintenance of records and documentation.
Manufacturers of our product candidates and approved products, if any, may be unable to comply with
these cGMP requirements and with other FDA, state, and foreign regulatory requirements. We have
little control over our manufacturers compliance with these regulations and standards. A failure
to comply with these requirements may result in fines and civil penalties, suspension of
production, suspension, or delay in product approval, product seizure or recall, or withdrawal of
product approval. If the safety of any quantities supplied is compromised due to our manufacturers
failure to adhere to applicable laws or for other reasons, we may not be able to obtain regulatory
approval for or successfully commercialize our products, which would seriously harm our business.
If we enter into additional strategic partnerships, such as our relationship with Wyeth, we may be
required to relinquish important rights to and control over the development of our product
candidates or otherwise be subject to terms unfavorable to us.
If we enter into any strategic partnerships, we will be subject to a number of risks,
including:
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we may not be able to control the amount and timing of resources that
our strategic partners devote to the development or commercialization
of product candidates;
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strategic partners may delay clinical trials, provide insufficient
funding, terminate a clinical trial or abandon a product candidate,
repeat or conduct new clinical trials, or require a new version of a
product candidate for clinical testing;
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strategic partners may not pursue further development and
commercialization of products resulting from the strategic partnering
arrangement or may elect to discontinue research and development
programs;
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strategic partners may not commit adequate resources to the marketing
and distribution of any future products, limiting our potential
revenues from these products;
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disputes may arise between us and our strategic partners that result
in the delay or termination of the research, development, or
commercialization of our product candidates or that result in costly
litigation or arbitration that diverts managements attention and
consumes resources;
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strategic partners may experience financial difficulties;
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strategic partners may not properly maintain or defend our
intellectual property rights or may use our proprietary information in
a manner that could jeopardize or invalidate our proprietary
information or expose us to potential litigation;
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business combinations or significant changes in a strategic partners
business strategy may also adversely affect a strategic partners
willingness or ability to complete its obligations under any
arrangement;
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strategic partners could independently move forward with a competing
product candidate developed either independently or in collaboration
with others, including our competitors; and
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strategic partners could terminate the arrangement or allow it to
expire, which would delay the development and may increase the cost of
developing our product candidates.
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Our relationship with Wyeth may have a negative effect on our ability to enter into beneficial
relationships with third parties.
In December 2005 we entered into a collaboration agreement with Wyeth for the development and
worldwide commercialization of TRU-015 and other CD20-directed therapeutics. We are also
collaborating with Wyeth on the
25
development and worldwide commercialization of certain other product candidates directed to a
small number of targets other than CD20 that have been established pursuant to the agreement.
Companies other than Wyeth that may be interested in developing products with us are likely to be
less inclined to do so because of our relationship with Wyeth, or because of the perception that
development programs that Wyeth does not participate in are less promising programs. If our ability
to work with present or future strategic partners or collaborators is adversely affected as a
result of our collaboration agreement with Wyeth, our business prospects may be limited and our
financial condition may be adversely affected.
Even if our product candidates receive regulatory approval, they could be subject to restrictions
or withdrawal from the market and we may be subject to penalties if we fail to comply with
regulatory requirements or if we experience unanticipated problems with our products.
Any product candidate for which we receive regulatory approval, together with the
manufacturing processes, post-approval clinical data, and advertising and promotional activities
for such product, will be subject to continued review and regulation by the FDA and other
regulatory agencies. Even if regulatory approval of a product candidate is granted, the approval
may be subject to limitations on the indicated uses for which the product candidate may be marketed
or on the conditions of approval, or contain requirements for costly post-marketing testing and
surveillance to monitor the safety or efficacy of the product candidate. Later discovery of
previously unknown problems with our products or their manufacture, or failure to comply with
regulatory requirements, may result in:
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restrictions on the products or manufacturing processes;
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withdrawal of the products from the market;
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voluntary or mandatory recalls;
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fines;
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suspension of regulatory approvals;
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product seizures; or
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injunctions or the imposition of civil or criminal penalties.
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If we are slow or otherwise unable to adapt to changes in existing regulatory requirements, we
may lose marketing approval for any products that may be approved in the future.
Our product candidates may never achieve market acceptance even if we obtain regulatory approvals.
Even if we obtain regulatory approvals for the commercial sale of our product candidates, the
commercial success of these product candidates will depend on, among other things, their acceptance
by physicians, patients, third-party payors, and other members of the medical community as a
therapeutic and cost-effective alternative to competing products and treatments. If our product
candidates fail to gain market acceptance, we may be unable to earn sufficient revenue to continue
our business. Market acceptance of, and demand for, any product that we may develop and
commercialize will depend on many factors, including:
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our ability to provide acceptable evidence of safety and efficacy;
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the prevalence and severity of adverse side effects;
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availability, relative cost, and relative efficacy of alternative and competing treatments;
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the effectiveness of our marketing and distribution strategy;
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publicity concerning our products or competing products and treatments; and
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our ability to obtain sufficient third-party insurance coverage or reimbursement.
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26
If our product candidates do not become widely accepted by physicians, patients, third-party
payors, and other members of the medical community, our business, financial condition, and
operating results would be materially adversely affected.
Failure to obtain regulatory approval in foreign jurisdictions would prevent us from marketing our
products internationally.
We intend to have our product candidates marketed outside the United States. In order to
market our products in the European Union and many other non-U.S. jurisdictions, we must obtain
separate regulatory approvals and comply with numerous and varying regulatory requirements. To
date, we have not filed for marketing approval of any of our product candidates and may not receive
the approvals necessary to commercialize our product candidates in any market. The approval
procedure varies among countries and can involve additional testing and data review. The time
required to obtain foreign regulatory approval may differ from that required to obtain FDA
approval. The foreign regulatory approval process may include all of the risks associated with
obtaining FDA approval, or may include different or additional risks. We may not obtain foreign
regulatory approvals on a timely basis, if at all. Approval by the FDA does not ensure approval by
regulatory agencies in other countries, and approval by one foreign regulatory authority does not
ensure approval by regulatory agencies in other foreign countries or by the FDA. A failure or delay
in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory
approval process in other jurisdictions, including approval by the FDA. The failure to obtain
regulatory approval in foreign jurisdictions could seriously harm our business.
We may incur substantial costs as a result of litigation or other proceedings relating to patent
and other intellectual property rights.
The cost to us of any litigation or other proceedings relating to intellectual property
rights, even if resolved in our favor, could be substantial. Some of our competitors may be better
able to sustain the costs of complex patent litigation because they have substantially greater
resources. Uncertainties resulting from the initiation and continuation of any litigation could
have a material adverse effect on our ability to continue our operations. Should third parties file
patent applications, or be issued patents claiming technology also claimed by us in pending
applications, we may be required to participate in interference proceedings in the United States
Patent and Trademark Office to determine priority of invention, which could result in substantial
costs to us and an adverse decision as to the priority of our inventions. An unfavorable outcome in
an interference proceeding could require us to cease using the technology or to license rights from
prevailing third parties. We cannot assure you that any prevailing party would offer us a license
or that we could acquire any license made available to us on commercially acceptable terms.
If any products we develop become subject to unfavorable pricing regulations, third-party
reimbursement practices, or healthcare reform initiatives, our business could be harmed.
Our ability to commercialize any product candidate profitably will depend in part on the
extent to which reimbursement for such product candidate and related treatments will be available
from government health administration authorities, private health insurers, or private payors, and
other organizations in the United States and internationally. Even if we succeed in bringing one or
more product candidates to market, these products may not be considered cost-effective, and the
amount reimbursed for any product may be insufficient to allow us to sell it profitably. Because
our product candidates are in the early stages of development, we are unable at this time to
determine their cost-effectiveness and the level or method of reimbursement. There may be
significant delays in obtaining coverage for newly approved products, and coverage may be more
limited than the purposes for which the product candidate is approved by the FDA or foreign
regulatory agencies. Moreover, eligibility for coverage does not mean that any product will be
reimbursed in all cases or at a rate that covers our costs, including research, development,
manufacture, sale, and distribution. Increasingly, the third-party payors who reimburse patients,
such as government and private payors, are requiring that companies provide them with predetermined
discounts from list prices and are challenging the prices charged for medical products. If the
reimbursement we are able to obtain for any product we develop is inadequate in light of our
development and other costs, our business could be harmed.
We face potential product liability exposure, and if successful claims are brought against us, we
may incur substantial liability for a product candidate and may have to limit its
commercialization.
The use of our product candidates in clinical trials and the sale of any products for which we
obtain marketing approval expose us to the risk of product liability claims. Product liability
claims might be brought against us by consumers, health-care providers, pharmaceutical companies,
or others selling our products. If we cannot successfully defend ourselves against
27
these claims, we will incur substantial liabilities. Regardless of merit or eventual outcome,
product liability claims may result in:
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decreased demand for our product candidates;
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impairment of our business reputation;
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withdrawal of clinical trial participants;
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costs of related litigation;
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substantial monetary awards to patients or other claimants;
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loss of revenues; and
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the inability to commercialize our product candidates.
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Although we currently have product liability insurance coverage for our clinical trials for
expenses or losses, our insurance coverage may not reimburse us or may not be sufficient to
reimburse us for any or all expenses or losses we may suffer. Moreover, insurance coverage is
becoming increasingly expensive and, in the future, we may not be able to maintain insurance
coverage at a reasonable cost or in sufficient amounts to protect us against losses due to
liability. We intend to expand our insurance coverage to include the sale of commercial products if
we obtain marketing approval for our product candidates in development, but we may be unable to
obtain commercially reasonable product liability insurance for any products approved for marketing.
On occasion, large judgments have been awarded in class action lawsuits based on products that had
unanticipated side effects. A successful product liability claim or series of claims brought
against us could cause our stock price to fall and, if judgments exceed our insurance coverage,
could decrease our cash and adversely affect our business.
We face substantial competition, which may result in others discovering, developing, or
commercializing products before, or more successfully, than we do.
Our future success depends on our ability to demonstrate and maintain a competitive advantage
with respect to the design, development, and commercialization of our product candidates. We expect
any product candidate that we commercialize with our collaborative partners, or on our own, will
compete with other products.
Product Candidates for Autoimmune and Inflammatory Diseases.
If approved for the
treatment of RA, we anticipate that our product candidates would compete with other
marketed protein therapeutics for the treatment of RA including: Rituxan
®
(Genentech,
Biogen Idec, and Roche), Enbrel
®
(Amgen and Wyeth), Remicade
®
(JNJ and Schering-Plough),
Humira
®
(Abbott), and Orencia
®
(BMS).
Product Candidates for Systemic Lupus Erythematosus.
If approved for the treatment
of SLE, we anticipate that our product candidates would have to compete with other B-cell
depleting therapies. We are not aware of any CD37-directed therapeutics in development or
on the market for the treatment of SLE.
Product Candidates for B-cell Malignancies.
If approved for the treatment of CLL,
NHL, or other B-cell malignancies, we anticipate that our product candidates would compete
with other B-cell depleting therapies. While we are not aware of any CD37-directed
therapeutics in development or on the market, other biologic therapies are marketed for the
treatment of NHL or CLL or both, such as Rituxan
®
/Mabthera
®
(Genentech, Biogen Idec, and
Roche), Zevalin
®
(Biogen Idec and Schering AG), Bexxar
®
(GSK), and Campath
®
(Genzyme and
Schering AG).
Many of our potential competitors have substantially greater financial, technical,
manufacturing, marketing and personnel resources than we have. In addition, many of these
competitors have significantly greater commercial infrastructures than we have. Our ability to
compete successfully will depend largely on our ability to:
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design and develop products that are superior to other products in the market;
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attract and retain qualified scientific, medical, product development, commercial and sales and marketing
personnel;
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obtain patent and/or other proprietary protection for our processes, product candidates, and technologies;
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operate without infringing the patents and proprietary rights of third parties;
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obtain required regulatory approvals; and
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successfully collaborate with others in the design, development, and commercialization of new products.
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Established competitors may invest heavily to quickly discover and develop novel compounds
that could make our product candidates obsolete. In addition, any new product that competes with a
generic market-leading product must demonstrate compelling advantages in efficacy, convenience,
tolerability, and safety in order to overcome severe price competition and to be commercially
successful. If we are not able to compete effectively against our current and future competitors,
our business will not grow, and our financial condition and operating results will suffer.
If we are unable to establish a sales and marketing infrastructure or enter into collaborations
with partners to perform these functions, we will not be able to commercialize our product
candidates.
We currently do not have any internal sales, marketing, or distribution capabilities. In order
to commercialize any of our product candidates that are approved for commercial sale, we must
either acquire or internally develop a sales, marketing, and distribution infrastructure or enter
into collaborations with partners able to perform these services for us. In December 2005 we
entered into a collaboration agreement with Wyeth to develop and commercialize therapeutics
directed to the CD20 protein and other targets. If we do not enter into collaborations with respect
to product candidates not covered by the Wyeth collaboration, or if any of our product candidates
are the subject of collaborations with partners that are not able to commercialize such product
candidates, we will need to acquire or internally develop a sales, marketing, and distribution
infrastructure. Factors that may inhibit our efforts to commercialize our product candidates
without partners that are able to commercialize the product candidates include:
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our inability to recruit and retain adequate numbers of effective sales and marketing personnel;
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the inability of sales personnel to obtain access to or persuade adequate numbers of physicians
to prescribe our products;
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the lack of complementary products to be offered by sales personnel, which may put us at a
competitive disadvantage relative to companies with more extensive product lines; and
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unforeseen costs and expenses associated with creating a sales and marketing organization.
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If we are not able to partner with a third party able to commercialize our product candidates,
or are not successful in recruiting sales and marketing personnel or in building a sales,
marketing, and distribution infrastructure, we will have difficulty commercializing our product
candidates, which would adversely affect our business and financial condition.
We rely on highly skilled personnel, and if we are unable to retain or motivate key personnel or
hire qualified personnel, we may not be able to maintain our operations or grow effectively.
Our performance largely depends on the talents and efforts of highly skilled individuals. Our
future success depends on our continuing ability to develop, motivate, and retain qualified
management, clinical, and scientific personnel for all areas of our organization. If we are unable
to effectively train our newly enlarged workforce for any reason, we may not be able to implement
our development and commercialization activities. If we do not succeed in retaining and motivating
our personnel, our existing operations may suffer and we may be unable to grow effectively.
We may fail to select or capitalize on the most scientifically, clinically, or commercially
promising or profitable product candidates.
We have limited technical, managerial, and financial resources to determine which of our
product candidates should proceed to initial clinical trials, later-stage clinical development, and
potential commercialization. We may make incorrect determinations. Our decisions to allocate our
research and development, management, and financial resources toward particular product candidates
or therapeutic areas may not lead to the development of viable commercial products and may
divert resources from better opportunities. Similarly, our decisions to delay or terminate
drug development programs may also be incorrect and could cause us to miss valuable opportunities.
29
If we use biological and hazardous materials in a manner that causes contamination or injury or
violates laws, we may be liable for damages.
Our research and development activities involve the use of potentially harmful biological
materials, as well as hazardous materials, chemicals, and various radioactive compounds. We cannot
completely eliminate the risk of accidental contamination or injury from the use, storage,
handling, or disposal of these materials. In the event of contamination or injury, we could be held
liable for damages that result, and any liability could exceed our resources. We do not maintain
liability insurance coverage for our handling of biological or hazardous materials. We, the third
parties that conduct clinical trials on our behalf, and the third parties that manufacture our
product candidates are subject to federal, state, and local laws and regulations governing the use,
storage, handling, and disposal of these materials and waste products. The cost of compliance with
these laws and regulations could be significant. The failure to comply with any of these laws and
regulations could result in significant fines and work stoppages and may harm our business.
Risks Related to Our Common Stock
The trading price of our common stock may be subject to significant fluctuations and volatility,
and our stockholders may be unable to resell their shares at a profit.
The trading prices of many newly publicly traded companies are highly volatile, particularly
companies such as ours that have limited operating histories. Accordingly, the trading price of our
common stock has been subject to significant fluctuations and may continue to fluctuate or decline.
Since our initial public offering, which was completed in October 2006, the price of our common
stock has ranged from an intra-day low of $5.84 to an intra-day high of $22.50. Factors that could
cause fluctuations in the trading price of our common stock include the following:
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our ability to develop and market new and enhanced product candidates on a timely basis;
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announcements by us or our collaborators or competitors of new commercial products,
clinical progress or the lack thereof, changes in or terminations of relationships,
significant contracts, commercial relationships, or capital commitments;
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commencement of, or our involvement in, litigation;
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changes in earnings estimates or recommendations by securities analysts;
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changes in governmental regulations or in the status of our regulatory approvals;
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any major change in our board or management;
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quarterly variations in our operating results or those of our collaborators or competitors;
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general economic conditions and slow or negative growth of our markets; and
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political instability, natural disasters, war, and/or events of terrorism.
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In addition, the U.S. stock market has experienced extreme price and volume fluctuations that
have often been unrelated or disproportionate to the operating performance of trading companies.
Broad market and industry factors may seriously affect the market price of companies stock,
including ours, regardless of actual operating performance. In addition, in the past, following
periods of volatility in the overall market and the market price of a particular companys
securities, securities class action litigation has often been instituted against these companies.
This litigation, if instituted against us, could result in substantial costs and a diversion of our
managements attention and resources.
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If securities analysts do not publish research or reports about our business, or if they downgrade
our stock, the price of our stock could decline.
The trading market for our common stock will rely in part on the availability of research and
reports that third-party industry or financial analysts publish about us. There are many large,
publicly traded companies active in the biopharmaceutical industry, which may mean it will be less
likely that we receive widespread analyst coverage. Furthermore, if one or more of the analysts who
do cover us downgrade our stock, our stock price would likely decline. If one or more of these
analysts cease coverage of us, we could lose visibility in the market, which in turn could cause
our stock price to decline.
The concentration of our capital stock ownership with insiders will likely limit your ability to
influence corporate matters.
As of March 31, 2008, our executive officers, directors, current five percent or greater
stockholders, and affiliated entities together beneficially owned approximately 88% of our
outstanding common stock. As a result, these stockholders, acting together, have control over most
matters that require approval by our stockholders, including the election of directors and approval
of significant corporate transactions. Corporate action might be taken even if other stockholders
oppose them. This concentration of ownership might also have the effect of delaying or preventing a
change of control of us that other stockholders may view as beneficial.
Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition
of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our
stockholders to replace or remove our current management.
Provisions in our certificate of incorporation and bylaws may delay or prevent an acquisition
of us or a change in our management. These provisions include a classified board of directors, a
prohibition on actions by written consent of our stockholders and the ability of our board of
directors to issue preferred stock without stockholder approval. In addition, because we are
incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General
Corporation Law, which prohibits stockholders owning in excess of 15% of our outstanding voting
stock from merging or combining with us. Although we believe these provisions collectively provide
for an opportunity to receive higher bids by requiring potential acquirers to negotiate with our
board of directors, they would apply even if the offer may be considered beneficial by some
stockholders. In addition, these provisions may frustrate or prevent any attempts by our
stockholders to replace or remove our current management by making it more difficult for
stockholders to replace members of our board of directors, which is responsible for appointing the
members of our management.
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ITEM 6. EXHIBITS
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Exhibit
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Number
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Description
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3.1
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Amended and Restated Certificate of Incorporation (Exhibit 3.1)(A)
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3.2
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Amended and Restated Bylaws (Exhibit 3.2)(A)
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3.3
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Amendment to Amended and Restated Bylaws (Exhibit 3.1)(B)
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4.1
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Form of common stock certificate (Exhibit 4.1)(C)
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4.2
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Amended and Restated Investor Rights Agreement, dated July 13, 2004 (Exhibit 4.2)(A)
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4.3
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Amendment No. 1 to Amended and Restated Investor Rights Agreement, dated December 19, 2005
(Exhibit 4.3)(A)
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10.1
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Employment Agreement, dated as of March 21, 2008, between Trubion Pharmaceuticals, Inc. and Peter
A. Thompson (Exhibit 10.1)(D)
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10.2
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Employment Agreement, dated as of March 21, 2008, between Trubion Pharmaceuticals, Inc. and
Michelle G. Burris (Exhibit 10.2)(D)
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10.3
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Employment Agreement, dated as of March 21, 2008, between Trubion Pharmaceuticals, Inc. and
Daniel J. Burge (Exhibit 10.3)(D)
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10.4
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Employment Agreement, dated as of March 21, 2008, between Trubion Pharmaceuticals, Inc. and
Kathleen McKereghan Deeley (Exhibit 10.4)(D)
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10.5
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Employment Agreement, dated as of March 21, 2008, between Trubion Pharmaceuticals, Inc. and
Kendall M. Mohler, Ph.D. (Exhibit 10.5)(D)
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10.6
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Form of Amendment No. 1 to Employment Agreement between Trubion Pharmaceuticals, Inc. and
Executive
(Exhibit 10.1)(E)
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31.1*
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Certification of Chief Executive Officer 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 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 § 1350
as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
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(A)
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Incorporated by reference to the designated exhibit to the
registrants Registration Statement on Form S-1 filed with the SEC on
June 2, 2006 (File No. 333-134709).
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(B)
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Incorporated by reference to the designated exhibit to the
registrants Current Report on Form 8-K filed with the SEC on April 4,
2007 (File No. 001-33054).
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(C)
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Incorporated by reference to the designated exhibit to the
registrants Registration Statement on Form S-1 filed with the SEC on
October 2, 2006 (File No. 333-134709).
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(D)
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Incorporated by reference to the designated exhibit to the
registrants Current Report on Form 8-K (File No. 001-33054) filed
with the SEC on March 25, 2008.
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(E)
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Incorporated by reference to the designated exhibit to the
registrants Current Report on Form 8-K (File No. 001-33054) filed
with the SEC on April 8, 2008.
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*
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Filed herewith.
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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.
Date: May 8, 2008
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TRUBION PHARMACEUTICALS, INC.
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By:
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/s/ Michelle G. Burris
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Michelle G. Burris
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Senior Vice President and
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Chief Financial Officer
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(Principal Accounting and Financial Officer)
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33
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