IDERA PHARMACEUTICALS, INC. FORM 10-Q
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 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 |
For the quarterly period ended September 30, 2005, 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 |
For transition period from .
Commission File Number 001-31918
IDERA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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04-3072298 |
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(State or other jurisdiction of
Incorporation or organization)
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(I.R.S. Employer Identification
Number) |
345 Vassar Street
Cambridge, Massachusetts 02139
(Address of principal executive offices)
(617) 679-5500
(Registrants telephone number, including area code)
Formerly Hybridon, Inc.
(Former name, 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.
Yes þ No o
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of
the Exchange Act).
Yes o No þ
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No þ
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of
the latest practicable date.
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Common Stock, par value $.001 per share
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111,150,126 |
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Class
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Outstanding as of November 1, 2005 |
IDERA PHARMACEUTICALS, INC.
FORM 10-Q
INDEX
Amplivax®, Hybridon® and IMOxine® are our registered trademarks. IMO and Idera are also our
trademarks. Other trademarks appearing in this quarterly report are the property of their
respective owners.
2
PART I FINANCIAL STATEMENTS
ITEM 1 UNAUDITED FINANCIAL STATEMENTS
IDERA PHARMACEUTICALS, INC.
CONSOLIDATED CONDENSED BALANCE SHEETS
(UNAUDITED)
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SEPTEMBER 30, |
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DECEMBER 31, |
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2005 |
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2004 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
5,440,473 |
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$ |
5,021,860 |
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Short-term investments |
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6,704,392 |
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9,391,140 |
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Receivables |
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175,280 |
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293,113 |
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Prepaid expenses and other current assets |
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745,484 |
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333,316 |
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Total current assets |
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13,065,629 |
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15,039,429 |
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Property and equipment, net |
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462,054 |
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351,791 |
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Deferred financing costs |
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576,480 |
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Total Assets |
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$ |
14,104,163 |
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$ |
15,391,220 |
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Accounts payable |
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$ |
556,604 |
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$ |
354,736 |
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Accrued expenses |
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1,110,181 |
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1,332,150 |
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Current portion of deferred revenue |
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2,190,037 |
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171,287 |
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Total current liabilities |
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3,856,822 |
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1,858,173 |
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Non-current portion of accrued expenses |
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240,000 |
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Long term notes payable |
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5,032,750 |
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Capital lease |
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11,408 |
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Deferred revenue, net of current portion |
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1,761,335 |
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523,655 |
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Stockholders equity: |
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Preferred stock, $0.01 par value |
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Authorized 5,000,000 shares |
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Series A convertible preferred stock |
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Designated 1,500,000 shares |
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Issued and outstanding 655 at
September 30, 2005 and December 31, 2004 |
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7 |
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7 |
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Common stock, $0.001 par value |
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Authorized200,000,000 and 185,000,000
shares at September 30, 2005 and
December 31, 2004, respectively
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Issued and outstanding - 111,137,356 and
110,931,529 shares at September 30, 2005
and December 31, 2004, respectively |
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111,138 |
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110,932 |
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Additional paid-in capital |
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312,529,075 |
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311,988,467 |
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Accumulated deficit |
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(309,119,454 |
) |
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(299,293,785 |
) |
Accumulated other comprehensive loss |
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(2,007 |
) |
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(14,989 |
) |
Deferred compensation |
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(76,911 |
) |
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(21,240 |
) |
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Total stockholders equity |
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3,441,848 |
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12,769,392 |
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Total Liabilities and Stockholders Equity |
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$ |
14,104,163 |
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$ |
15,391,220 |
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The accompanying notes are an integral part of these consolidated condensed financial statements.
3
IDERA PHARMACEUTICALS, INC.
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(UNAUDITED)
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THREE MONTHS ENDED |
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NINE MONTHS ENDED |
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SEPTEMBER 30, |
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SEPTEMBER 30, |
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2005 |
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2004 |
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2005 |
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2004 |
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Alliance revenue |
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$ |
544,778 |
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$ |
77,967 |
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$ |
1,027,528 |
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$ |
811,342 |
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Operating expenses: |
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Research and development |
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2,579,654 |
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2,610,184 |
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8,230,400 |
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7,956,290 |
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General and administrative |
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792,652 |
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1,550,875 |
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2,584,624 |
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3,472,410 |
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Stock-based compensation
from repriced options (*) |
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121,198 |
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(18,574 |
) |
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149,236 |
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(592,358 |
) |
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Total operating expenses |
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3,493,504 |
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4,142,485 |
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10,964,260 |
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10,836,342 |
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Loss from operations |
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(2,948,726 |
) |
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(4,064,518 |
) |
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(9,936,732 |
) |
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(10,025,000 |
) |
Other income (expense): |
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Investment income, net |
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106,793 |
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57,296 |
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257,088 |
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143,522 |
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Interest expense |
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(107,816 |
) |
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(145,533 |
) |
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(29,385 |
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Net loss |
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(2,949,749 |
) |
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(4,007,222 |
) |
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(9,825,177 |
) |
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(9,910,863 |
) |
Accretion of preferred stock
dividends (Note 7) |
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(164 |
) |
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(158 |
) |
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(492 |
) |
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(2,675,836 |
) |
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Net loss applicable to common
stockholders |
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$ |
(2,949,913 |
) |
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$ |
(4,007,380 |
) |
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$ |
(9,825,669 |
) |
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$ |
(12,586,699 |
) |
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Basic and diluted net loss
per share (Note 3) |
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$ |
(0.03 |
) |
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$ |
(0.04 |
) |
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$ |
(0.09 |
) |
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$ |
(0.10 |
) |
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Basic and diluted net loss
per share applicable to
common stockholders (Note 3) |
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$ |
(0.03 |
) |
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$ |
(0.04 |
) |
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$ |
(0.09 |
) |
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$ |
(0.13 |
) |
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Shares used in computing
basic and diluted loss per
common share |
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111,115,039 |
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105,301,234 |
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111,042,768 |
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94,885,691 |
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(*) |
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The following summarizes the allocation of stock-based compensation from repriced options: |
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Research and development |
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$ |
83,757 |
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$ |
(13,439 |
) |
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$ |
106,308 |
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$ |
(429,505 |
) |
General and administrative |
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37,441 |
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(5,135 |
) |
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42,928 |
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(162,853 |
) |
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Total |
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$ |
121,198 |
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$ |
(18,574 |
) |
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$ |
149,236 |
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$ |
(592,358 |
) |
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The accompanying notes are an integral part of these consolidated condensed financial statements.
4
IDERA PHARMACEUTICALS, INC.
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(UNAUDITED)
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NINE MONTHS ENDED |
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SEPTEMBER 30, |
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2005 |
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2004 |
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Cash Flows From Operating Activities: |
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Net loss |
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$ |
(9,825,177 |
) |
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$ |
(9,910,863 |
) |
Adjustments to reconcile net loss to net cash used in operating activities |
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Loss on disposal of property and equipment |
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2,134 |
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Stock-based compensation |
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149,236 |
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(554,983 |
) |
Depreciation and amortization expense |
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212,652 |
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|
236,679 |
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Issuance of common stock for services rendered |
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27,352 |
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92,874 |
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Non-cash interest expense |
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71,148 |
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Changes in operating assets and liabilities |
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Accounts receivable |
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117,833 |
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|
6,877 |
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Prepaid expenses and other current assets |
|
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(412,168 |
) |
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|
(499,307 |
) |
Accounts payable and accrued expenses |
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(382,767 |
) |
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281,241 |
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Deferred revenue |
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3,256,430 |
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(33,153 |
) |
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Net cash used in operating activities |
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(6,783,327 |
) |
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(10,380,635 |
) |
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Cash Flows From Investing Activities: |
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Purchase of available for sale securities |
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(9,908,536 |
) |
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(15,735,747 |
) |
Proceeds from sale of available-for-sale securities |
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7,600,000 |
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10,000,000 |
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Proceeds from maturity of available-for-sale securities |
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5,000,000 |
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2,500,000 |
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Purchase of property and equipment |
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(206,512 |
) |
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(28,611 |
) |
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Net cash provided by (used in) investing activities |
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2,484,952 |
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(3,264,358 |
) |
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Cash Flow From Financing Activities: |
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Proceeds from issuance of convertible notes payable |
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5,032,750 |
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Sale of common stock and warrants, net of issuance costs |
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15,418,864 |
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Payment on debt |
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(1,306,000 |
) |
Issuance costs from financing |
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(386,480 |
) |
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Proceeds from exercise of common stock options and warrants |
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72,348 |
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|
141,521 |
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Payments on capital lease |
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(1,630 |
) |
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Net cash provided by financing activities |
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4,716,988 |
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14,254,385 |
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Net increase in cash and cash equivalents |
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418,613 |
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609,392 |
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Cash and cash equivalents, beginning of period |
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5,021,860 |
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7,607,655 |
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Cash and cash equivalents, end of period |
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$ |
5,440,473 |
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$ |
8,217,047 |
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Cash paid for interest |
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$ |
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$ |
58,770 |
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Supplemental disclosure of non-cash financing and investing activities: |
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Issuance of warrants for financing |
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$ |
219,385 |
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$ |
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Deferred compensation relating to issuance of stock options |
|
$ |
72,000 |
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$ |
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Accretion of Series A convertible preferred stock dividends (Note 7) |
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$ |
(492 |
) |
|
$ |
(569,524 |
) |
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Dividend from induced conversion of Series A preferred stock (Note 7) |
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$ |
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$ |
3,245,360 |
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Conversion of Series A preferred stock into common stock |
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$ |
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$ |
14,370 |
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Issuance of stock for services |
|
$ |
27,352 |
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$ |
92,874 |
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Equipment acquired under capital lease |
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$ |
19,556 |
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$ |
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|
The accompanying notes are an integral part of these consolidated condensed financial statements.
5
IDERA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
SEPTEMBER 30, 2005
(UNAUDITED)
(1) Organization
Idera Pharmaceuticals, Inc. (Idera or the Company) (AMEX: IDP) is a biotechnology company
engaged in the discovery and development of novel therapeutics that modulate immune responses
through Toll-like Receptors (TLRs) for the treatment of multiple diseases. The Company has
identified proprietary DNA-based structures that modulate TLRs. The Company believes that these
immune modulatory oligonucleotide (IMO) compounds are broadly applicable to large and growing
markets where significant unmet medical needs exist, including oncology, asthma/allergy, and
infectious diseases. Idera intends to continue identifying new drug candidates specific to various
diseases, based on the differentiated biological activities of its IMO compounds. The Companys
lead candidate is IMO-2055 (also known as HYB2055), a TLR9 agonist currently in Phase 2 clinical
testing as a monotherapy in renal cell carcinoma and in combination with the chemotherapy agents
gemcitabine and carboplatin in a Phase 1/2 oncology trial. The Company is also collaborating with
Novartis International Pharmaceuticals, Ltd., or Novartis, to develop treatments for asthma and
allergies.
Based on its current operating plan, the Company believes that its current cash, cash
equivalents and short-term investments will be sufficient to fund operations through mid 2006. The
Companys actual cash requirements will depend on many factors, including particularly the scope
and pace of its research and development efforts and its success in entering into strategic
alliances.
The Company does not expect to generate significant additional funds internally until it
successfully completes development and obtains marketing approval for products, either alone or in
collaborations with third parties, which the Company expects will take a number of years. In
addition, it has no committed external sources of funds. As a result, in order for the Company to
continue to pursue its clinical and preclinical development programs and continue its operations
beyond mid 2006, the Company must raise additional funds from debt or equity financings or from
collaborative arrangements with biotechnology or pharmaceutical companies. There can be no
assurance that the requisite funds will be available in the necessary time frame or on terms
acceptable to the Company. If the Company is unable to raise sufficient funds, the Company may be
required to delay, scale back or significantly curtail its operating plans and possibly relinquish
rights to portions of the Companys technology or products. In addition, increases in expenses or
delays in clinical development may adversely impact the Companys cash position and require further
cost reductions. No assurance can be given that the Company will be able to operate profitably on a
consistent basis, or at all, in the future.
On September 12, 2005, the Company changed its name from Hybridon, Inc. to Idera
Pharmaceuticals, Inc. On September 13, 2005, Ideras American Stock Exchange ticker symbol changed
from HBY to IDP.
(2) Unaudited Interim Financial Statements
The accompanying unaudited consolidated condensed financial statements included herein have
been prepared by the Company in accordance with generally accepted accounting principles for
interim financial information and pursuant to the rules and regulations of the Securities and
Exchange Commission. Accordingly, certain information and footnote disclosures normally included in
financial statements prepared in accordance with generally accepted accounting principles have been
condensed or omitted pursuant to such rules and regulations. In the opinion of management, all
adjustments, consisting of normal recurring adjustments, considered necessary for a fair
presentation of interim period results have been included. The Company believes that its
disclosures are adequate to make the information presented not misleading. Interim results for the
three and nine-month periods ended September 30, 2005 are not necessarily indicative of results
that may be expected for the year ended December 31, 2005. For further information, refer to the
financial statements and footnotes thereto included in the Companys
6
Annual Report on Form 10-K for the fiscal year ended December 31, 2004, which was filed with
the Securities and Exchange Commission on March 25, 2005.
(3) Net Loss per Common Share
The following table sets forth the computation of basic and diluted loss per share:
|
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|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
Numerator: |
|
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|
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|
|
|
Net loss |
|
$ |
(2,949,749 |
) |
|
$ |
(4,007,222 |
) |
|
$ |
(9,825,177 |
) |
|
$ |
(9,910,863 |
) |
Accretion of preferred stock dividends |
|
|
(164 |
) |
|
|
(158 |
) |
|
|
(492 |
) |
|
|
(2,675,836 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Numerator for basic and diluted loss
per share applicable to common
stockholders |
|
$ |
(2,949,913 |
) |
|
$ |
(4,007,380 |
) |
|
$ |
(9,825,669 |
) |
|
$ |
(12,586,699 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator for basic and diluted
loss per share |
|
|
111,115,039 |
|
|
|
105,301,234 |
|
|
|
111,042,768 |
|
|
|
94,885,691 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share basic and diluted: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share |
|
$ |
(0.03 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.10 |
) |
Accretion of preferred stock
dividends |
|
|
(0.00 |
) |
|
|
(0.00 |
) |
|
|
(0.00 |
) |
|
|
(0.03 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share applicable to
common stockholders |
|
$ |
(0.03 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.13 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net loss per common share is computed using the weighted average number of shares of
common stock outstanding during the period. For the three and nine months ended September 30, 2005
and 2004, diluted net loss per share of common stock was the same as basic net loss per share of
common stock, as the effects of the Companys common stock equivalents are antidilutive. Total
antidilutive securities were 39,441,957 and 30,201,511 at September 30, 2005 and 2004,
respectively. These antidilutive securities, including stock options, warrants, convertible
preferred stock and convertible debt instruments, are not included in the Companys calculation of
diluted net loss per common share.
(4) Cash Equivalents and Investments
The Company considers all highly liquid investments with maturities of 90 days or less when
purchased to be cash equivalents. Cash and cash equivalents at September 30, 2005 and December 31,
2004 consisted of cash and money market funds.
The Company accounts for investments in accordance with Statement of Financial Accounting
Standards (SFAS) No. 115, Accounting for Certain Investments in Debt and Equity Securities.
Management determines the appropriate classification of marketable securities at the time of
purchase. In accordance with SFAS No. 115, investments that the Company does not have the positive
intent to hold to maturity are classified as available-for-sale and reported at fair market
value. Unrealized gains and losses associated with available-for-sale investments are recorded in
Accumulated other comprehensive loss on the accompanying consolidated balance sheet. The
amortization of premiums and accretion of discounts, and any realized gains and losses and declines
in value judged to be other than temporary, and interest and dividends are included in Investment
income, net on the accompanying consolidated statement of operations for all available-for-sale
securities. The Company had no held-to-maturity investments, as defined by SFAS No. 115, at
September 30, 2005 and December 31, 2004. The cost of securities sold is based on the specific
identification method. The Company had no realized gains or losses on its investments for the three
and nine months ended September 30, 2005 and 2004, respectively. There were no losses or permanent
declines in value included in investment income for any securities in the three and nine months
ended September 30, 2005 and 2004.
7
The Company had no long-term investments as of September 30, 2005 and December 31, 2004.
Available-for-sale securities are classified as short-term regardless of their maturity date if the
Company has them available to fund operations within one year of the balance sheet date. Auction
securities are highly liquid securities that have floating interest or dividend rates that reset
periodically through an auctioning process that sets rates based on bids. Issuers include
municipalities, closed-end bond funds and corporations. These securities can either be debt or
preferred shares. The Companys short-term investments consisted of the following at September 30,
2005 and December 31, 2004:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Short-term available-for-sale investments at market value: |
|
|
|
|
|
|
|
|
Corporate bonds |
|
$ |
1,304,392 |
|
|
$ |
2,004,150 |
|
Government bonds |
|
|
|
|
|
|
2,986,990 |
|
Auction securities |
|
|
5,400,000 |
|
|
|
4,400,000 |
|
|
|
|
|
|
|
|
Total |
|
$ |
6,704,392 |
|
|
$ |
9,391,140 |
|
|
|
|
|
|
|
|
(5) Property and Equipment
At September 30, 2005 and December 31, 2004, net property and equipment at cost consists of
the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Leasehold improvements |
|
$ |
424,500 |
|
|
$ |
424,500 |
|
Laboratory equipment and other |
|
|
1,921,754 |
|
|
|
1,804,799 |
|
|
|
|
|
|
|
|
Total property and equipment, at cost |
|
|
2,346,254 |
|
|
|
2,229,299 |
|
Less: Accumulated depreciation and amortization |
|
|
1,884,200 |
|
|
|
1,877,508 |
|
|
|
|
|
|
|
|
Property and equipment, net |
|
$ |
462,054 |
|
|
$ |
351,791 |
|
|
|
|
|
|
|
|
In the first quarter of 2005, the Company wrote off unused property and equipment that had a
cost of approximately $109,000 resulting in a loss of approximately $2,000.
As of September 30, 2005, laboratory equipment includes approximately $20,000 of office
equipment financed under a capital lease.
(6) Stock-Based Compensation Related to Repriced Options
In September 1999, the Companys Board of Directors authorized the repricing of options to
purchase 5,251,827 shares of common stock to an exercise price of $0.50 per share, which
represented the market value of the common stock on the date of the repricing. These options are
subject to variable plan accounting which requires the Company to remeasure the intrinsic value of
the repriced options, through the earlier of the date of exercise, cancellation or expiration, at
each reporting date. For the three months and nine months ended September 30, 2005, the Company
recognized an expense of approximately $121,000 and $149,000, respectively, as stock compensation
relating to these repriced options as a result of an increase in the intrinsic value of these
options between December 31, 2004 and September 30, 2005. For the three and nine months ended
September 30, 2004, the Company recognized a credit of approximately $19,000 and $592,000,
respectively, for stock compensation from repriced options as a result of a decrease in the
intrinsic value of these options between December 31, 2003 and September 30, 2004. As of September
30, 2005, options to purchase 2,088,802 shares remained subject to variable plan accounting.
(7) Series A Convertible Preferred Stock
On December 4, 2003, the Companys stockholders approved amendments to the Companys Restated
Certificate of Incorporation that:
|
|
|
reduced the liquidation preference of the Companys Series A convertible preferred
stock from $100 per share to $1 per share; |
8
|
|
|
reduced the annual dividend on the Companys Series A convertible preferred stock from
6.5% to 1%; and |
|
|
|
|
increased the number of shares of the Companys common stock issuable upon conversion
of the Companys Series A convertible preferred stock by 25% over the number of shares that
would otherwise be issuable for a 60-day conversion period between December 4, 2003 and
February 2, 2004 inclusive. |
During the 60-day conversion period, the conversion ratio was increased so that the Series A
convertible preferred stockholders could receive approximately 29.41 shares of common stock for
each share of Series A convertible preferred stock converted instead of the stated conversion rate
of 23.53 shares. The value of the additional shares issued during the 60-day conversion period was
recorded as an addition to dividends in the statement of operations at the time of conversion. For
the nine months ended September 30, 2004 the Company recorded $3.2 million of preferred stock
dividends related to the additional shares issued in 2004.
From January 1, 2004 through February 2, 2004, 488,570 shares of Series A convertible
preferred stock were converted into 14,369,740 shares of the Companys common stock at the adjusted
conversion ratio. As a result of these conversions, $570,000 of dividends accreted during the year
ended December 31, 2003 were reversed during the nine month period ended September 30, 2004 because
the former holders of these shares of Series A convertible preferred stock were no longer entitled
to such dividends once their shares of series A convertible preferred stock were converted into
common stock.
(8) Stock-Based Compensation
The Company applies the disclosure-only provisions of SFAS No. 123, Accounting for Stock-Based
Compensation. The Company continues to account for employee stock compensation at intrinsic value,
in accordance with Accounting Principles Board (APB) Opinion No. 25, Accounting for Stock Issued to
Employees and related interpretations, with disclosure of the effects of fair value accounting on
net income or net loss and related per share amounts on a pro forma basis.
The pro forma effect of applying SFAS No. 123 for the three and nine months ended September
30, 2005 and 2004 would be as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
|
Nine months ended September 30, |
|
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
Net loss
applicable to
common
stockholders, as
reported |
|
$ |
(2,949,913 |
) |
|
$ |
(4,007,380 |
) |
|
$ |
(9,825,669 |
) |
|
$ |
(12,586,699 |
) |
Less: stock-based
compensation
expense (income)
included in
reported net loss |
|
|
121,198 |
|
|
|
(18,574 |
) |
|
|
149,236 |
|
|
|
(592,358 |
) |
Add: stock-based
employee
compensation
expense determined
under fair value
based method for
all awards |
|
|
(266,851 |
) |
|
|
(1,053,845 |
) |
|
|
(719,595 |
) |
|
|
(1,533,593 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma net loss
applicable to
common
stockholders, as
adjusted for the
effect of applying
SFAS No. 123 |
|
$ |
(3,095,566 |
) |
|
$ |
(5,079,799 |
) |
|
$ |
(10,396,028 |
) |
|
$ |
(14,712,650 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
net loss per share
applicable to
common stockholders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As reported |
|
$ |
(0.03 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.13 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma |
|
$ |
(0.03 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.16 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
The effects on the three and nine months ended September 30, 2005 and 2004 pro forma net loss
and net loss per share of expensing the estimated fair value of stock options are not necessarily
representative of the effects on reported net loss for the years ended December 31, 2005 and 2004
and future years because of the vesting periods of stock options and the potential for issuance of
additional stock options in future periods.
9
(9) Related Party Transactions
In the nine months ended September 30, 2005, the Company paid Pillar Investment Limited, which
is controlled by a director of the Company, approximately $264,000 in cash and issued warrants to
purchase 565,478 shares of common stock at an exercise price of $0.89 per share as fees in
connection with Pillar Investment Limited acting as placement agent for the sale of the 4%
convertible subordinated notes in May 2005 (Note 11). The warrants are exercisable on or prior to
May 24, 2010 and have a Black-Scholes value of approximately
$219,000 based on the following assumptions:
(1) volatility 75%, (2) discount
rate 3.8%, (3) term 5 years and (4)
no dividends.
In the three and nine months ended September 30, 2005, the Company paid directors of the
Company $15,000 and $25,000, respectively, for consulting services.
(10) Comprehensive Income
The following table includes the components of comprehensive income for the three and nine
months ended September 30, 2005 and 2004.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
|
Nine months ended September 30, |
|
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
Net loss |
|
$ |
(2,949,749 |
) |
|
$ |
(4,007,222 |
) |
|
$ |
(9,825,177 |
) |
|
$ |
(9,910,863 |
) |
Other comprehensive income (loss) |
|
|
173 |
|
|
|
12,815 |
|
|
|
12,982 |
|
|
|
(8,908 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
$ |
(2,949,576 |
) |
|
$ |
(3,994,407 |
) |
|
$ |
(9,812,195 |
) |
|
$ |
(9,919,771 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income represents the net unrealized losses on available-for-sale investments.
(11) Notes Payable
On May 24, 2005, Idera sold approximately $5.0 million in principal amount of 4% convertible
subordinated notes due April 30, 2008 (the 4% Notes). The Company has agreed to pay interest on the
4% Notes in arrears on December 15, 2005 for the period from the issuance to that date, and
thereafter semi-annually in arrears on April 30 and October 30 and at maturity or conversion. The
Company has the option to pay interest on the 4% Notes in cash or in shares of the Companys common
stock at the then current market value of the Companys common stock. Holders of the 4% Notes may
convert, at any time prior to maturity, the principal amount of the 4% Notes (or any portion
thereof) into shares of the Companys common stock at a conversion price of $0.89 per share. The
Company may cause the principal amount of the 4% Notes to be converted into shares of the Companys
common stock at the then current conversion price at any time prior to May 24, 2006 if the volume
weighted average of the closing sales prices of the Companys common stock for 10 consecutive
trading days is equal to at least $1.78 per share or at any time on or after May 24, 2006 if the
volume weighted average of the closing sales prices of the Companys common stock for 10
consecutive trading days is equal to at least $1.12 per share. If the Company conducts a financing
resulting in greater than $10.0 million in gross proceeds, the Company may elect to convert the 4%
Notes into shares of the Companys common stock at the then current conversion price if the
purchase price paid by the new investors in the financing (on a common stock equivalent basis) is
greater than the then current conversion price of the 4% Notes. Holders of the 4% Notes may demand
that the Company redeem the 4% Notes upon a change in control, a merger with an independent
company, or a change in the Companys listing status.
The Company capitalized its financing costs associated with the sale of the 4% Notes and is
amortizing them over the term of the 4% Notes. These costs include the Black-Scholes value of the
warrants, legal expenses and miscellaneous costs related to the placement agent.
On April 1, 2004, the Companys 9% convertible subordinated notes matured. As a result, the
Company paid $1,306,000 to the note holders in payment of the principal amount outstanding under
the notes plus accrued interest through the maturity date of $58,770. Upon payment, these notes
were cancelled.
10
(12) Financing
In April 2004, the Company raised approximately $11.8 million in gross proceeds through a
registered direct offering. In the offering, the Company sold 16,899,800 shares of common stock and
warrants to purchase 3,041,964 shares of common stock to institutional and other investors. The
warrants to purchase common stock have an exercise price of $1.14 per share and are exercisable on
or prior to April 20, 2009. The warrants may be exercised by cash payment only. On or after October
21, 2005, the Company may redeem the warrants if the closing sales price of the common stock for
each day of any 20 consecutive trading day period ending within 30 days prior to providing notice
of redemption is greater than or equal to $2.60 per share. The redemption price will be $0.01 per
share of common stock underlying the warrants. The redemption criteria have not been met as of
November 1, 2005. The Company may exercise its right to redeem the warrants by providing 30 days
prior written notice to the holders of the warrants. The net proceeds to the Company from the
offering, excluding the proceeds of any future exercise of the warrants, totaled approximately
$10.7 million.
In August 2004, the Company raised approximately $5.1 million in gross proceeds from a private
placement to institutional and overseas investors. In the private placement, the Company sold
8,823,400 shares of common stock and warrants to purchase 1,764,680 shares of common stock. The
warrants to purchase common stock have an exercise price of $0.67 per share and will expire if not
exercised on or prior to August 27, 2009. The warrants may be exercised by cash payment only. On or
after February 27, 2005, the Company may redeem the warrants if the closing sales price of the
common stock for each day of any 20 consecutive trading day period is greater than or equal to
$1.34 per share. The redemption price will be $0.01 per share of common stock underlying the
warrants. The Company may exercise its right to redeem the warrants by providing 30 days prior
written notice to the holders of the warrants. The redemption criteria have not been met as of
November 1, 2005. The net proceeds to the Company from the offering, excluding the proceeds of any
future exercise of the warrants, totaled approximately $4.7 million.
(13) Option Awards
On May 12, 2005, Ideras Compensation Committee of the Board of Directors approved a grant of
1,000,000 stock options to the Companys Chief Executive Officer. These options vest quarterly over
a three-year period. In addition, on May 12, 2005, the Compensation Committee agreed to grant
additional stock options to the CEO to purchase an aggregate of 1,000,000 shares of the Companys
common stock upon the achievement of specified milestones. Any options granted as a result of the
achievement of these milestones will vest over a three-year period commencing on the date the
specified milestone was achieved.
On June 1, 2005, options to purchase 400,000 of the additional 1,000,000 shares mentioned
above were granted upon the achievement of a milestone. Unlike the balance of the option shares
which will be granted with an exercise price equal to the fair market value on the date of grant,
this grant was made with an exercise price equal to the fair market value on May 12, 2005. As a
result, the Company recorded a charge to deferred compensation of $72,000, which represents the
difference between the option exercise price and the market price on the date that the milestone
was achieved.
(14) Novartis Collaboration
On May 31, 2005, the Company entered into a research collaboration and option agreement and a license, development and commercialization agreement with Novartis International Pharmaceutical Ltd. to discover, develop and potentially commercialize immune-modulatory oligonucleotides that are toll-like receptor 9 agonists and that are identified as potential treatments for human allergy and respiratory
diseases. Under the terms of the agreements, Novartis paid the Company a $4,000,000 license fee in
July 2005. In addition to the $4,000,000 upfront payment, Novartis agreed to fund substantially
all research activities and make milestone payments to Idera upon the achievement of clinical
development, regulatory approval and cumulative net sales milestones.
If Novartis elects to exercise its option to develop and commercialize licensed IMOs in the
initial collaboration disease areas, Novartis is potentially obligated to pay the Company up to
$132,000,000 in milestone payments. Novartis is also obligated to pay the Company a royalty on
net sales of all products, if any, commercialized by Novartis, its affiliates and sublicensees.
The Company is recognizing the $4,000,000 upfront payment as revenue over the two-year term of the
research collaboration.
Beginning on May 31, 2007, if specified
conditions are satisfied, Novartis may expand the collaboration to include additional human
disease areas, other than oncology and infectious diseases. Novartis is potentially obligated to
pay the Company additional milestone payments if Novartis elects to expand the collaboration to
include additional disease areas and then develops and commercializes licensed IMOs in the
additional disease areas based on the achievement of clinical development and regulatory approval
milestones.
11
(15) New Accounting Pronouncement
In December 2004, the FASB issued SFAS No. 123 (revised 2004), Share-Based Payment, which is
a revision of SFAS No. 123, Accounting for Stock-Based Compensation. SFAS No. 123(R) supersedes
APB Opinion No. 25, Accounting for Stock Issued to Employees, and amends SFAS No. 95, Statement
of Cash Flows. Generally, the approach in SFAS No. 123(R) is similar to the approach described in
SFAS No. 123. However, SFAS No. 123(R) requires all share-based payments to employees, including
grants of employee stock options, to be recognized in the income statement based on their fair
values. Pro forma disclosure will no longer be an alternative. The new standard will be effective
for the Company in the quarter beginning January 1, 2006.
As permitted by SFAS 123, the Company currently accounts for share-based payments to employees
using APB 25s intrinsic value method and, as such, generally, except for marking to market the
repriced options discussed in Note 6, the Company recognizes no compensation cost for employee
stock options. Accordingly, the adoption of SFAS 123(R)s fair value method may have a material
impact on the Companys results of operations, although it will have no impact on the Companys
overall financial position. The impact of adopting SFAS 123(R) cannot be predicted at this time
because it will depend on levels of share-based payments granted in the future. However, had the
company adopted SFAS 123(R) in a prior period, the impact of applying that standard would have
approximated the impact of SFAS 123 as described in the disclosure of pro forma net loss and net
loss per share in Note 8 to these financial statements. The Company is currently evaluating the
impact of adopting SFAS 123(R) on its financial position and results of operations, including the
valuation methods and support for the assumptions that underlie the valuation of the awards.
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
GENERAL
We are engaged in the discovery and development of novel therapeutics that modulate immune
responses through Toll-like Receptors, or TLRs, for the treatment of multiple diseases. We have
identified proprietary DNA-based structures that modulate TLRs. We believe that these immune
modulatory oligonucleotides, or IMOTM, compounds are broadly applicable to large and
growing markets where significant unmet medical needs exist, including oncology, asthma/allergy,
and infectious diseases. We intend to continue identifying new drug candidates specific to various
diseases, based on the differentiated biological activities of our IMOTM compounds.
IMO-2055, our lead candidate, is a synthetic DNA-based sequence designed to mimic bacterial DNA and
be recognized by a specific protein receptor called TLR9, which triggers the activation and
modulation of the immune system. IMO-2055 is a TLR9 agonist currently in Phase 2 clinical testing
as a monotherapy in renal cell carcinoma and in combination with the chemotherapy agents
gemcitabine and carboplatin in a Phase 1/2 oncology trial. We are also collaborating with Novartis
International Pharmaceuticals, Ltd., or Novartis, to develop treatments for asthma and allergy
indications. We also have been a pioneer in the development of antisense technology, which uses
synthetic DNA to block the production of disease-causing proteins at the cellular level. Since
2003, we have devoted substantially all of our research and development efforts to our IMO
technology and products and expect to continue that focus in the fourth quarter of 2005 and in
future years.
We have incurred total losses of $309.1 million through September 30, 2005 and expect to incur
substantial operating losses in the future. In order to commercialize our therapeutic products, we
need to address a number of technological challenges and to comply with comprehensive regulatory
requirements.
12
APPLICATION OF CRITICAL ACCOUNTING POLICIES
This managements discussion and analysis of financial condition and results of operations is
based on our consolidated financial statements, which have been prepared in accordance with
accounting principles generally accepted in the United States. The preparation of these financial
statements requires management to make estimates and assumptions that affect the reported amounts
of assets and liabilities and the disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenues and expenses during the reporting
period. On an ongoing basis, management evaluates its estimates and judgments, including those
related to revenue recognition. Management bases its estimates and judgments on historical
experience and on various other factors that it believes to be reasonable under the circumstances,
the results of which form the basis for making judgments about the carrying values of assets and
liabilities that are not readily apparent from other sources. Actual results may differ from these
estimates under different assumptions or conditions.
We regard an accounting estimate or assumption underlying our financial statements as a
critical accounting estimate where (i) the nature of the estimate or assumption is material due
to the level of subjectivity and judgment necessary to account for highly uncertain matters or the
susceptibility of such matters to change; and (ii) the impact of the estimates and assumptions on
financial condition or operating performance is material.
Our significant accounting policies are described in Note 2 of the Notes to Consolidated
Financial Statements in our Annual Report on Form 10-K for the year ended December 31, 2004. Not
all of these significant accounting policies, however, fit the definition of critical accounting
estimates. We believe that our accounting policies relating to revenue recognition, as described
under the caption Item 7. Managements Discussion and Analysis of Financial Condition and Results
of Operations Critical Accounting Policies in our Annual Report on Form 10-K for the year ended
December 31, 2004, fit the definition of critical accounting estimates and judgments.
RESULTS OF OPERATIONS
Three and Nine Months Ended September 30, 2005 and 2004
Alliance Revenues
Total alliance revenue increased by $467,000, or 599%, from $78,000 for the three months ended
September 30, 2004 to $545,000 for the three months ended September 30, 2005 and increased by
$217,000, or 27%, from $811,000 for the nine months ended September 30, 2004 to $1,028,000 for the
nine months ended September 30, 2005. Alliance revenue consists of revenue we receive under our
collaboration and licensing agreements and includes research and development payments, milestone
payments, license fees, sublicense fees, and royalty payments. In
July 2005, we received from Novartis the $4,000,000 upfront fee
under the Novartis agreements. Of this $4,000,000, we recognized
$500,000 and $667,000, as revenue in the third quarter
and first nine months of 2005, respectively, with the balance being recorded in deferred revenue.
The increase in revenue in the third quarter and first nine months of 2005 reflects the recognition
of these amounts, as well as research and development revenue associated with the Novartis
agreements. The increase in the nine months ended September 30, 2005, as compared to the
same period one year earlier, was partially offset by research and development revenue in 2004
associated with supplying a collaborator, Aegera Therapeutics, Inc., with drug product for clinical
trials during the first quarter of 2004 and the achievement of a milestone for which milestone fees
were earned in the first quarter of 2004.
Research and Development Expenses
Research and development expenses were $2,580,000 in the third quarter of 2005, which was
approximately the same as the $2,610,000 in the third quarter of 2004. Research and development
expenses increased by $275,000, or 3%, from $7,956,000 for the nine months ended September 30, 2004
to $8,231,000 for the nine months ended September 30, 2005. The increase for the nine months ended
September 30, 2005 primarily reflects higher clinical trial costs and increased raw material and
other costs of manufacturing the clinical drug supply being utilized in our ongoing Phase 2 study
of IMOxine for the treatment of renal cell carcinoma and other future trials. The increase in
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costs in the nine-month period ending September 30, 2005, as compared to the same period one
year earlier, was partially offset by lower preclinical development costs in the first nine months
of 2005 and a decrease in the cost resulting from supplying Aegera with drug product for clinical trials during the first quarter of 2004. Our
other research and development costs in both periods relate primarily to the cost of advancing our
basic IMO research program and developing our IMO technology. These costs include salaries,
allocated overhead, general lab supplies and patent preparation costs and related filing fees.
Our lead drug candidate in our IMO program is IMO-2055 (also known as HYB2055). We are
developing IMO-2055 for oncology applications under the name IMOxine. In connection with developing
IMO-2055, we incurred approximately $0.9 million and $0.6 million in direct external expenses in
the three months ended September 30, 2005 and 2004, respectively, and we incurred approximately
$2.8 million and $1.9 million in direct external expenses in the nine months ended September 30,
2005 and 2004, respectively. These expenses include payments to independent contractors and vendors
for clinical and preclinical studies and drug manufacturing and related costs but exclude internal
costs such as payroll and overhead.
In October 2004, we commenced patient recruitment for an open label, multi-center Phase 2
clinical trial of IMOxine as a monotherapy in patients with metastatic or recurrent clear cell
renal carcinoma. We originally planned to recruit a minimum of 46 patients who had previously
failed one prior therapy, or second-line patients, into the first stage of the trial. We also
expected to enroll in the trial some treatment-naïve patients, although the original protocol did
not specify a target enrollment for treatment-naïve patients. On October 20, 2005, in response to a
higher than expected enrollment rate of treatment-naïve patients in the Phase 2 trial, we submitted to the U.S. Food and Drug Administration a protocol amendment that provides for enrollment of up to 46 treatment-naïve patients in the first stage of the trial, in
addition to the 46 second-line patients provided for by the original study design. As a result, we plan to
continue first stage patient recruitment into the first half of 2006 and we are now seeking to
enroll a total of up to 92 patients in the first stage of the trial.
On
October 26, 2005, we initiated a new Phase 1/2 clinical trial of IMO-2055
in combination with the chemotherapy agents gemcitabine, marketed by Eli Lilly and Company as
Gemzar®,
and carboplatin at the Lombardi Comprehensive Cancer Center at Georgetown
University Medical Center. We are seeking to enroll 12 to 18 refractory solid tumor patients
in the Phase 1 portion of the trial. If successful, we plan to use Phase 1 data for dose selection
for the subsequent Phase 2 portion of the trial in the treatment of naïve non-small cell lung
cancer patients.
We
are also conducting a Phase 1 clinical trial of IMOxine as a
monotherapy in patients with refractory solid
tumor cancers, which is being conducted at the Lombardi Comprehensive Cancer Center. Except for one patient who has received IMOxine
treatment in the trial for over twenty-one months, treatment under the protocol was completed in
September 2004 and results were presented at the American Society of Clinical Oncology annual
meeting in May 2005. In the trial, 19 advanced cancer patients received weekly IMOxine treatment
for at least 4 weeks. IMOxine dosage was escalated to 0.64 mg/kg/week
and was well tolerated at all dose levels.
IMOxine treatment was associated with evidence of immunological activity by several parameters.
Because these projects are in the early stage of development and given the technological and
regulatory hurdles likely to be encountered in the development and commercialization of our
products, the future timing and costs of our various research and development programs are
uncertain.
General and Administrative Expenses
General and administrative expenses decreased by $758,000, or 49%, from $1,551,000 in the
three months ended September 30, 2004 to $793,000 in the three months ended September 30, 2005 and
decreased by $887,000, or 26%, from $3,472,000 in the nine months ended September 30, 2004 to
$2,585,000 in the nine months ended September 30, 2005. The decrease for the three- and nine-month
periods, as compared to the same periods one year earlier, primarily reflects the charge of
$720,000 we incurred relating to the resignation of
our former Chief Executive Officer in August 2004, representing the amount to be paid to our former
Chief Executive Officer through September 1, 2006 under his employment agreement.
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Stock-Based Compensation
As a result of repricing of our stock options in September 1999, some of our outstanding stock
options are subject to variable plan accounting which requires us to measure the intrinsic value of
the repriced options through the earlier of the date of exercise, cancellation or expiration at
each reporting date. Operating results include charges of $121,000 for the third quarter of 2005
and $149,000 for the first nine months of 2005 as a result of increases in the instrinsic value of
the repriced options during these periods. Operating results include credits of $19,000 for the
third quarter of 2004 and $592,000 for the first nine months of 2004 as a result of decreases in
the intrinsic value of the repriced options during those periods. Compensation charges and credits
will likely occur in the future based upon changes in the market value of our common stock.
Investment Income, net
Investment income increased by approximately $50,000, or 88%, from $57,000 in the three months
ended September 30, 2004 to $107,000 in the three months ended September 30, 2005 and increased by
approximately $113,000, or 78%, from $144,000 in the nine months ended September 30, 2004 to
$257,000 in the nine months ended September 30, 2005. The change for the three and nine months
ended September 30, 2005 was primarily a result of higher interest rates.
Interest Expense
Interest expense in the three and nine months ended September 30, 2005 consisted of interest
on our 4% notes issued in May 2005 and amortization of deferred financing costs associated with
these notes. Our interest expense for the nine months ended September 30, 2004 consisted of
interest on our 9% notes. On April 1, 2004, upon the maturity of our 9% notes, we paid $1,306,000
representing the outstanding principal amount of our 9% notes, plus accrued interest. As a result,
we had no interest expense for the three months ended September 30, 2004.
Preferred Stock Dividends
Dividends on the remaining 655 shares of Series A preferred stock outstanding are accreted at
an annual rate of 1%. Accretion of preferred stock dividends decreased by approximately $2,676,000,
or 100%, from $2,676,000 for the nine months ended September 30, 2004 to nearly zero for the nine
months ended September 30, 2005. The decrease for the nine-month period was primarily attributable
to the conversions of Series A convertible preferred stock into common stock in the fourth quarter
of 2003 and the first quarter of 2004. The conversion took place in accordance with an amendment to
our Restated Certificate of Incorporation approved by our stockholders on December 4, 2003 that
increased the number of shares of our common stock issuable upon conversion of our series A
convertible preferred stock by 25% over the number of shares that would otherwise have been
issuable upon conversion during a 60-day conversion period. The value of the additional shares
issued during the 60-day conversion period was recorded as an addition to dividends in the
statement of operations at the time of conversion. The value of the additional dividend amounted to
$3,245,000 during the first nine months of 2004 and was partially offset by a reversal of $570,000
of dividends accreted during the year ended December 31, 2003 with respect to these shares that was
reversed during the nine month period ended September 30, 2004 because the former holders of these
shares of Series A convertible preferred stock were no longer entitled to such dividends once their
shares of series A convertible preferred stock were converted into common stock.
Net Loss Applicable to Common Stockholders
As a result of the factors discussed above, our net loss applicable to common stockholders
amounted to approximately $2,950,000 and $4,007,000 for the three months ended September 30, 2005
and 2004, respectively and to approximately $9,826,000 and $12,587,000 for the nine months ended
September 30, 2005 and 2004, respectively.
15
LIQUIDITY AND CAPITAL RESOURCES
Sources of Liquidity
We require cash to fund our operating expenses, to make capital expenditures and to pay debt
service. We have funded our cash requirements primarily through equity and debt financing, license
fees and research funding under collaborative and license agreements.
Cash Flows
As of September 30, 2005, we had approximately $12,145,000 in cash, cash equivalents and
short-term investments, a decrease of approximately $2,268,000 from December 31, 2004.
We used $6,783,000 of cash for operating activities during the nine months ended September 30,
2005, principally to fund our research and development expenses and our general and administrative
expenses. The $6,783,000 primarily consists of our net loss of $9,825,000 for the period, less the
$3,256,000 increase in our deferred revenue reflecting, primarily, the unamortized portion of the
upfront license fee received pursuant to our collaboration agreement with Novartis.
Net cash provided by investing activities reflects the proceeds of $7,600,000 and $5,000,000
that we received from the sale and maturity, respectively, of available-for-sale securities
offset by the purchase of $9,909,000 in available-for-sale securities and $207,000 in equipment
purchases during the nine months ended September 30, 2005.
Net cash provided by financing activities primarily reflects the $5,033,000 we received from
the issuance of our 4% notes offset by the expenses associated with their issuance in the nine
months ended September 30, 2005.
Funding Requirements
Based on our current operating plan, we believe that our existing cash, cash equivalents and
short-term investments will be sufficient to fund operations through mid 2006. Our actual cash
requirements will depend on many factors, including particularly the scope and pace of our research
and development efforts and our success in entering into strategic alliances.
In May 2005, we issued $5,033,000 in principal amount of 4% convertible subordinated notes due
April 30, 2008. Interest on the 4% convertible subordinated notes is payable in arrears on December
15, 2005 for the period from issuance to that date, and thereafter semi-annually on April 30 and
October 30 and at maturity or conversion. We have the option to pay interest on the 4% convertible
subordinated notes in cash or in shares of common stock at the then current market value of the
common stock.
We do not expect to generate significant additional funds internally until we successfully
complete development and obtain marketing approval for products, either alone or in collaboration
with third parties, which we expect will take a number of years. In addition, we have no committed
external sources of funds. As a result, in order for us to continue to pursue our clinical and
preclinical development programs and continue operations beyond mid 2006, we will need to raise
additional funds from debt or equity financings or from collaborative arrangements with
biotechnology or pharmaceutical companies. There can be no assurance that the requisite funds will
be available in the necessary time frame or on terms acceptable to us. Should we be unable to raise
sufficient funds, we may be required to significantly curtail our operating plans and possibly
relinquish rights to portions of our technology or products. In addition, increases in expenses or
delays in clinical development may adversely impact our cash position and require further cost
reductions. No assurance can be given that we will be able to operate profitably on a consistent
basis, or at all, in the future. We believe that the key factors that will affect our internal and
external sources of cash are:
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the success of our clinical and preclinical development programs; |
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the receptivity of the capital markets to financings by biotechnology companies; and |
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our ability to enter into strategic collaborations with biotechnology and
pharmaceutical companies and the success of such collaborations. |
Contractual Obligations
We have contractual obligations in the form of employment agreements, operating leases and
consulting and collaboration agreements. Our contractual obligations as of December 31, 2004 were
set forth under the caption Contractual Obligations in our Annual Report on Form 10-K for the
year ended December 31, 2004 and have not materially changed from such date except as provided
below.
In May 2005, we issued approximately $5,033,000 in principal amount of 4% convertible
subordinated notes. On April 30, 2008 the entire principal amount of 4% convertible subordinated
notes will become due and payable.
On October 19, 2005, we entered into an amended and restated employment agreement with Sudhir
Agrawal, D. Phil., our Chief Executive Officer and Chief Scientific Officer. This agreement is
filed as Exhibit 10.1 to this quarterly report.
FORWARD-LOOKING STATEMENTS
This quarterly report contains forward-looking statements within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements,
other than statements of historical facts, included or incorporated in this report regarding our
strategy, future operations, financial position, future revenues, projected costs, prospects, plans
and objectives of management are forward-looking statements. The words believes, anticipates,
estimates, plans, expects, intends, may, projects, will, and would and similar
expressions are intended to identify forward-looking statements, although not all forward-looking
statements contain these identifying words. We cannot guarantee that we actually will achieve the
plans, intentions or expectations disclosed in our forward-looking statements and you should not
place undue reliance on our forward-looking statements. There are a number of important factors
that could cause our actual results to differ materially from those indicated or implied by
forward-looking statements. These important factors include those set forth below under Risk
Factors. These factors and the other cautionary statements made in this quarterly report should be
read as being applicable to all related forward-looking statements whenever they appear in this
quarterly report. In addition, any forward-looking statements represent our estimates only as of
the date that this quarterly report is filed with the SEC and should not be relied upon as
representing our estimates as of any subsequent date.
We do not assume any obligation to update any forward-looking statements. We disclaim any
intention or obligation to update or revise any forward-looking statement, whether as a result of
new information, future events or otherwise.
RISK FACTORS
Investing in our common stock involves a high degree of risk, and you should carefully
consider the risks and uncertainties described below in addition to the other information included
or incorporated by reference in this quarterly report. If any of the following risks actually
occurs, our business, financial condition or results of operations would likely suffer, possibly
materially. In that case, the trading price of our common stock could fall.
Risks Relating to Our Financial Results and Need for Financing
We have incurred substantial losses and expect to continue to incur losses. We will not be
successful unless we reverse this trend.
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We have incurred losses in every year since our inception, except for 2002 when our
recognition of revenues under a license and collaboration agreement resulted in us reporting net
income for that year. As of September 30, 2005, we had incurred operating losses of approximately
$309.1 million. We expect to continue to incur substantial operating losses in future periods.
These losses, among other things, have had and will continue to have an adverse effect on our
stockholders equity, total assets and working capital.
We have received no revenues from the sale of drugs. To date, almost all of our revenues have
been from collaborative and license agreements. We have devoted substantially all of our efforts to
research and development, including clinical trials, and we have not completed development of any
drugs. Because of the numerous risks and uncertainties associated with developing drugs, we are
unable to predict the extent of any future losses, whether or when any of our products will become
commercially available, or when we will become profitable, if at all.
We will need additional financing, which may be difficult to obtain. Our failure to obtain
necessary financing or doing so on unattractive terms could adversely affect our discovery and
development programs and other operations.
We will require substantial funds to conduct research and development, including preclinical
testing and clinical trials of our drugs. We will also require substantial funds to conduct
regulatory activities and to establish commercial manufacturing, marketing and sales capabilities.
We believe that, based on our current operating plan, our existing cash, cash equivalents and
short-term investments will be sufficient to fund our operations through mid 2006. However, we
could reduce planned activities if we need to conserve such funds.
We will need to raise additional funds to operate our business beyond such time. We believe
that the key factors that will affect our ability to obtain additional funding are:
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the success of our clinical and preclinical development programs; |
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the receptivity of the capital markets to financings by biotechnology companies; and |
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our ability to enter into strategic collaborations with biotechnology and
pharmaceutical companies and the success of such collaborations. |
Additional financing may not be available to us when we need it or may not be available to us
on favorable terms. We could be required to seek funds through arrangements with collaborators or
others that may require us to relinquish rights to some of our technologies, drug candidates or
drugs which we would otherwise pursue on our own. In addition, if we raise additional funds by
issuing equity securities, our then existing stockholders will experience dilution. The terms of
any financing may adversely affect the holdings or the rights of existing stockholders. If we are
unable to obtain adequate funding on a timely basis or at all, we may be required to significantly
curtail one or more of our discovery or development programs. For example, we significantly
curtailed expenditures on our research and development programs during 1999 and 2000 because we did
not have sufficient funds available to advance these programs at planned levels.
Risks Relating to Our Business, Strategy and Industry
We are depending heavily on the success of our lead drug candidate, IMOxine, which is in clinical
development. If we are unable to commercialize this product, or experience significant delays in
doing so, our business will be materially harmed.
We are investing a significant portion of our time and financial resources in the development
of our lead drug candidate, IMOxine. We anticipate that our ability to generate product revenues
will depend heavily on the successful development and commercialization of this product. The
commercial success of this product will depend on several factors, including the following:
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successful completion of clinical trials; |
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receipt of marketing approvals from the FDA and equivalent foreign regulatory authorities; |
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establishing commercial manufacturing arrangements with third party manufacturers; |
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launching commercial sales of the product, whether alone or in collaboration with others; and |
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acceptance of the product in the medical community and with third party payors. |
Our efforts to commercialize this product are at an early stage, as we are currently
conducting a Phase 2 clinical trial in patients with metastatic or recurrent clear cell renal
carcinoma. If we are not successful in commercializing this product, or are significantly delayed
in doing so, our business will be materially harmed.
If our clinical trials are unsuccessful, or if they are significantly delayed, we may not be able
to develop and commercialize our products.
We may not be able to successfully complete any clinical trial of a potential product within
any specified time period. In some cases, we may not be able to complete the trial at all.
Moreover, clinical trials may not show our potential products to be both safe and efficacious.
Thus, the FDA and other regulatory authorities may not approve any of our potential products for
any indication.
In order to obtain regulatory approvals for the commercial sale of our products, we will be
required to complete extensive clinical trials in humans to demonstrate the safety and efficacy of
our drug candidates. We may not be able to obtain authority from the FDA or other equivalent
foreign regulatory agencies to complete these trials or commence and complete any other clinical
trials.
The results from preclinical testing of a drug candidate that is under development may not be
predictive of results that will be obtained in human clinical trials. In addition, the results of
early human clinical trials may not be predictive of results that will be obtained in larger scale,
advanced stage clinical trials. A failure of one or more of our clinical trials can occur at any
stage of testing. Further, there is to date little data on the long-term clinical safety of our
lead compounds under conditions of prolonged use in humans, nor on any long-term consequences
subsequent to human use. We may experience numerous unforeseen events during, or as a result of,
preclinical testing and the clinical trial process that could delay or inhibit our ability to
receive regulatory approval or commercialize our products, including:
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regulators or institutional review boards may not authorize us to commence a clinical
trial or conduct a clinical trial at a prospective trial site; |
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our preclinical tests or clinical trials may produce negative or inconclusive results,
and we may decide, or regulators may require us, to conduct additional preclinical testing
or clinical trials or we may abandon projects that we expect may not be promising; |
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we might have to suspend or terminate our clinical trials if the participating patients
are being exposed to unacceptable health risks; |
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regulators or institutional review boards may require that we hold, suspend or
terminate clinical research for various reasons, including noncompliance with regulatory
requirements; |
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the cost of our clinical trials may be greater than we currently anticipate; and |
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the effects of our products may not be the desired effects or may include undesirable
side effects or the products may have other unexpected characteristics. |
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As an example, in 1997, after reviewing the results from the clinical trial of GEM91, a 1st
generation antisense compound and our lead drug candidate at the time, we determined not to
continue the development of GEM91 and suspended clinical trials of this product candidate.
The rate of completion of clinical trials is dependent in part upon the rate of enrollment of
patients. The statistical design of our ongoing Phase 2 clinical trial of IMO-2055 in renal cell
carcinoma was originally based on patients who had already failed one course of therapy
(second-line patients). As of October 14, 2005, our enrollment of second-line patients has been
slower than anticipated, whereas the enrollment of treatment-naïve patients has been higher than
expected. As a result, the trial protocol was subsequently amended to accommodate statistical
endpoints for both treatment-naïve and second-line patients, thus extending the completion of the
trial beyond the time we expected. Patient accrual is a function of many factors, including:
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the proximity of patients to clinical sites, |
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the eligibility criteria for the study, |
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the nature of the study, |
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the existence of competitive clinical trials and |
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the availability of alternative treatments. |
Our product development costs will increase if we experience delays in our clinical trials. We
do not know whether planned clinical trials will begin as planned, will need to be restructured or
will be completed on schedule, if at all. Significant clinical trial delays also could allow our
competitors to bring products to market before we do and impair our ability to commercialize our
products.
We face substantial competition which may result in others discovering, developing or
commercializing drugs before or more successfully than us.
The biotechnology industry is highly competitive and characterized by rapid and significant
technological change. We face, and will continue to face, intense competition from organizations
such as pharmaceutical and biotechnology companies, as well as academic and research institutions
and government agencies. Some of these organizations are pursuing products based on technologies
similar to our technologies. Other of these organizations have developed and are marketing
products, or are pursuing other technological approaches designed to produce products, that are
competitive with our product candidates in the therapeutic effect these competitive products have
on diseases targeted by our product candidates. Our competitors may discover, develop or
commercialize products or other novel technologies that are more effective, safer or less costly
than any that we are developing. Our competitors may also obtain FDA or other regulatory approval
for their products more rapidly than we may obtain approval for ours.
Many of our competitors are substantially larger than we are and have greater capital
resources, research and development staffs and facilities than we have. In addition, many of our
competitors are more experienced than we are in drug discovery, development and commercialization,
obtaining regulatory approvals and drug manufacturing and marketing.
We anticipate that the competition with our products and technologies will be based on a
number of factors including product efficacy, safety, availability and price. The timing of market
introduction of our products and competitive products will also affect competition among products.
We expect the relative speed with which we can develop products, complete the clinical trials and
approval processes and supply commercial quantities of the products to the market to be important
competitive factors. Our competitive position will also depend upon our ability to attract and
retain qualified personnel, to obtain patent protection or otherwise develop proprietary products
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or processes and to secure sufficient capital resources for the period between technological
conception and commercial sales.
Because the products that we may develop will be based on new technologies and therapeutic
approaches, the market may not be receptive to these products upon their introduction.
The commercial success of any of our products for which we may obtain marketing approval from
the FDA or other regulatory authorities will depend upon their acceptance by the medical community
and third party payors as clinically useful, cost-effective and safe. Many of the products that we
are developing are based upon technologies or therapeutic approaches that are relatively new and
unproven. The FDA has only granted marketing approval for one product based on antisense technology
which is currently being marketed by another company for the treatment of cytomegalovirus
retinitis, an infectious disease, in patients with AIDs. The FDA has not granted marketing approval
to any products based on IMO technology and no such products are currently being marketed. As a
result, it may be more difficult for us to achieve regulatory approval or market acceptance of our
products. Our efforts to educate the medical community on these potentially unique approaches may
require greater resources than would be typically required for products based on conventional
technologies or therapeutic approaches. The safety, efficacy, convenience and cost-effectiveness of
our products as compared to competitive products will also affect market acceptance.
Competition for technical and management personnel is intense in our industry, and we may not be
able to sustain our operations or grow if we are unable to attract and retain key personnel.
Our success is highly dependent on the retention of principal members of our technical and
management staff, including Sudhir Agrawal. Dr. Agrawal serves as our Chief Scientific Officer and
Chief Executive Officer. Dr. Agrawal has extensive experience in the pharmaceutical industry, has
made significant contributions to the field of nucleic acid chemistry and is named as an inventor
on over 200 patents and patent applications worldwide. Dr. Agrawal provides the scientific
leadership for our research and development activities and directly supervises our research staff.
The loss of Dr. Agrawals services would be detrimental to our ongoing scientific progress and the
execution of our business plan.
We are a party to an employment agreement with Dr. Agrawal for a term ending on October 19,
2008, subject to annual renewals. This agreement may be terminated by us or Dr. Agrawal for any
reason or no reason at any time upon notice to the other party. We do not carry key man life
insurance for Dr. Agrawal.
Furthermore, our future growth will require hiring a significant number of qualified technical
and management personnel. Accordingly, recruiting and retaining such personnel in the future will
be critical to our success. There is intense competition from other companies and research and
academic institutions for qualified personnel in the areas of our activities. If we are not able to
continue to attract and retain, on acceptable terms, the qualified personnel necessary for the
continued development of our business, we may not be able to sustain our operations or grow.
Regulatory Risks
We may not be able to obtain marketing approval for products resulting from our development
efforts.
All of the products that we are developing or may develop in the future will require
additional research and development, extensive preclinical studies and clinical trials and
regulatory approval prior to any commercial sales. This process is lengthy, often taking a number
of years, is uncertain and is expensive. Since our inception, we have conducted clinical trials of
a number of compounds. In 1997, we determined not to continue clinical development of GEM91, our
lead product candidate at the time. Currently, we are conducting clinical trials of IMOxine, our
lead IMO drug candidate.
We may need to address a number of technological challenges in order to complete development
of our products. Moreover, these products may not be effective in treating any disease or may prove
to have undesirable or
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unintended side effects, unintended alteration of the immune system over time, toxicities or
other characteristics that may preclude our obtaining regulatory approval or prevent or limit
commercial use.
We are subject to comprehensive regulatory requirements, which are costly and time consuming to
comply with; if we fail to comply with these requirements, we could be subject to adverse
consequences and penalties.
The testing, manufacturing, labeling, advertising, promotion, export and marketing of our
products are subject to extensive regulation by governmental authorities in Europe, the United
States and elsewhere throughout the world.
In general, submission of materials requesting permission to conduct clinical trials may not
result in authorization by the FDA or any equivalent foreign regulatory agency to commence clinical
trials. In addition, submission of an application for marketing approval to the relevant regulatory
agency following completion of clinical trials may not result in the regulatory agency approving
the application if applicable regulatory criteria are not satisfied, and may result in the
regulatory agency requiring additional testing or information.
Any regulatory approval of a product may contain limitations on the indicated uses for which
the product may be marketed or requirements for costly post-marketing testing and surveillance to
monitor the safety or efficacy of the product. Any product for which we obtain marketing approval,
along with the facilities at which the product is manufactured, any post-approval clinical data and
any advertising and promotional activities for the product will be subject to continual review and
periodic inspections by the FDA and other regulatory agencies.
Both before and after approval is obtained, violations of regulatory requirements may result
in:
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the regulatory agencys delay in approving, or refusal to approve, an application for
approval of a product; |
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restrictions on such products or the manufacturing of such products; |
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withdrawal of the products from the market; |
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warning letters; |
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voluntary or mandatory recall; |
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fines; |
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suspension or withdrawal of regulatory approvals; |
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product seizure; |
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refusal to permit the import or export of our products; |
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injunctions or the imposition of civil penalties; and |
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criminal penalties. |
We have only limited experience in regulatory affairs and our products are based on new
technologies; these factors may affect our ability or the time we require to obtain necessary
regulatory approvals.
We have only limited experience in filing the applications necessary to gain regulatory
approvals. Moreover, the products that result from our research and development programs will
likely be based on new technologies and new therapeutic approaches that have not been extensively
tested in humans. The regulatory requirements governing these types of products may be more
rigorous than for conventional drugs. As a result, we may experience a longer regulatory process in
connection with obtaining regulatory approvals of any product that we develop.
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Risks Relating to Collaborators
We need to establish collaborative relationships in order to succeed.
An important element of our business strategy includes entering into collaborative
relationships for the development and commercialization of products based on our discoveries. We
face significant competition in seeking appropriate collaborators. Moreover, these arrangements are
complex to negotiate and time-consuming to document. We may not be successful in our efforts to
establish collaborative relationships or other alternative arrangements.
The success of collaboration arrangements will depend heavily on the efforts and activities of
our collaborators. Our collaborators will have significant discretion in determining the efforts
and resources that they will apply to these collaborations. The risks that we face in connection
with these collaborations include the following:
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disputes may arise in the future with respect to the ownership of rights to technology
developed with collaborators; |
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disagreements with collaborators could delay or terminate the research, development or
commercialization of products, or result in litigation or arbitration; |
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we may have difficulty enforcing the contracts if one of our collaborators fails to
perform; |
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our collaborators may terminate their collaborations with us, which could make it
difficult for us to attract new collaborators or adversely affect the perception of us in
the business or financial communities; |
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collaborators have considerable discretion in electing whether to pursue the
development of any additional drugs and may pursue technologies or products either on their
own or in collaboration with our competitors that are similar to or competitive with our
technologies or products that are the subject of the collaboration with us; and |
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our collaborators may change the focus of their development and commercialization
efforts. Pharmaceutical and biotechnology companies historically have re-evaluated their
priorities following mergers and consolidations, which have been common in recent years in
these industries. The ability of our products to reach their potential could be limited if
our collaborators decrease or fail to increase spending relating to such products. |
Given these risks, it is possible that any collaborative arrangements into which we enter may
not be successful. In May 2005, we entered into collaborative arrangements with Novartis involving
our IMO technology. Previous collaborative arrangements to which we were a party with F.
Hoffmann-La Roche and G.D. Searle & Co, involving our antisense technology, both were terminated
prior to the development of any product. The failure of any of our collaborative relationships
could delay our drug development or impair commercialization of our products.
Risks Relating to Intellectual Property
If we are unable to obtain patent protection for our discoveries, the value of our technology and
products will be adversely affected.
Our patent positions, and those of other drug discovery companies, are generally uncertain and
involve complex legal, scientific and factual questions.
Our ability to develop and commercialize drugs depends in significant part on our ability to:
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obtain licenses to the proprietary rights of others on commercially reasonable terms; |
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operate without infringing upon the proprietary rights of others; |
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prevent others from infringing on our proprietary rights; and |
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protect trade secrets. |
We do not know whether any of our patent applications or those patent applications which we
license will result in the issuance of any patents. Our issued patents and those that may issue in
the future, or those licensed to us, may be challenged, invalidated or circumvented, and the rights
granted thereunder may not provide us proprietary protection or competitive advantages against
competitors with similar technology. Furthermore, our competitors may independently develop similar
technologies or duplicate any technology developed by us. Because of the extensive time required
for development, testing and regulatory review of a potential product, it is possible that, before
any of our products can be commercialized, any related patent may expire or remain in force for
only a short period following commercialization, thus reducing any advantage of the patent.
Because patent applications in the United States and many foreign jurisdictions are typically
not published until 18 months after filing, or in some cases not at all, and because publications
of discoveries in the scientific literature often lag behind actual discoveries, neither we nor our
licensors can be certain that we or they were the first to make the inventions claimed in issued
patents or pending patent applications, or that we or they were the first to file for protection of
the inventions set forth in these patent applications.
Third parties may own or control patents or patent applications and require us to seek licenses,
which could increase our development and commercialization costs, or prevent us from developing or
marketing products.
We may not have rights under some patents or patent applications related to our products.
Third parties may own or control these patents and patent applications in the United States and
abroad. Therefore, in some cases, to develop, manufacture, sell or import some of our products, we
or our collaborators may choose to seek, or be required to seek, licenses under third party patents
issued in the United States and abroad or under patents that might issue from United States and
foreign patent applications. In such an event, we would be required to pay license fees or
royalties or both to the licensor. If licenses are not available to us on acceptable terms, we or
our collaborators may not be able to develop, manufacture, sell or import these products.
We may lose our rights to patents, patent applications or technologies of third parties if our
licenses from these third parties are terminated. In such an event, we might not be able to develop
or commercialize products covered by the licenses.
We are party to ten royalty-bearing license agreements under which we have acquired rights to
patents, patent applications and technology of third parties. Under these licenses we are obligated
to pay royalties on net sales by us of products or processes covered by a valid claim of a patent
or patent application licensed to us. We also are required in some cases to pay a specified
percentage of any sublicense income that we may receive. These licenses impose various
commercialization, sublicensing, insurance and other obligations on us. Our failure to comply with
these requirements could result in termination of the licenses. These licenses generally will
otherwise remain in effect until the expiration of all valid claims of the patents covered by such
licenses or upon earlier termination by the parties. The issued patents covered by these licenses
expire at various dates ranging from 2006 to 2022. If one or more of these licenses is terminated,
we may be delayed in our efforts, or be unable, to develop and market the products that are covered
by the applicable license or licenses.
We may become involved in expensive patent litigation or other proceedings, which could result in
our incurring substantial costs and expenses or substantial liability for damages or require us to
stop our development and commercialization efforts.
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There has been substantial litigation and other proceedings regarding patent and other
intellectual property rights in the biotechnology industry. We may become a party to various types
of patent litigation or other proceedings regarding intellectual property rights from time to time
even under circumstances where we are not practicing and do not intend to practice any of the
intellectual property involved in the proceedings. For instance, in 2002 and 2003, we became
involved in two interference proceedings declared by the United States Patent and Trademark Office,
or USPTO, which have since been resolved. In September 2005, we became aware of a third
interference declared by the USPTO related to our Ribozyme technology. We are neither practicing
nor intending to practice the intellectual property that is associated with any of these
interference proceedings.
The cost to us of any patent litigation or other proceeding, including the interferences
referred to above, even if resolved in our favor, could be substantial. Some of our competitors may
be able to sustain the cost of such litigation or proceedings more effectively than we can because
of their substantially greater financial resources. If any patent litigation or other proceeding is
resolved against us, we or our collaborators may be enjoined from developing, manufacturing,
selling or importing our drugs without a license from the other party and we may be held liable for
significant damages. We may not be able to obtain any required license on commercially acceptable
terms or at all.
Uncertainties resulting from the initiation and continuation of patent litigation or other
proceedings could have a material adverse effect on our ability to compete in the marketplace.
Patent litigation and other proceedings may also absorb significant management time.
Risks Relating to Product Manufacturing, Marketing and Sales and Reliance on Third Parties
Because we have limited manufacturing experience, we are dependent on third-party manufacturers to
manufacture products for us. If we cannot rely on third-party manufacturers, we will be required to
incur significant costs and devote significant efforts to establish our own manufacturing
facilities and capabilities.
We have limited manufacturing experience and no commercial scale manufacturing capabilities.
In order to continue to develop our products, apply for regulatory approvals and ultimately
commercialize products, we need to develop, contract for or otherwise arrange for the necessary
manufacturing capabilities.
We currently rely upon third parties to produce material for preclinical and clinical testing
purposes and expect to continue to do so in the future. We also expect to rely upon third parties
to produce materials that may be required for the commercial production of our products.
There are a limited number of manufacturers that operate under the FDAs current good
manufacturing practices regulations capable of manufacturing our products. As a result, we may have
difficulty finding manufacturers for our products with adequate capacity for our needs. If we are
unable to arrange for third party manufacturing of our products on a timely basis, or to do so on
commercially reasonable terms, we may not be able to complete development of our products or market
them.
Reliance on third party manufacturers entails risks to which we would not be subject if we
manufactured products ourselves, including:
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reliance on the third party for regulatory compliance and quality assurance, |
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the possibility of breach of the manufacturing agreement by the third party because of
factors beyond our control, |
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the possibility of termination or nonrenewal of the agreement by the third party, based
on its own business priorities, at a time that is costly or inconvenient for us, |
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the potential that third party manufacturers will develop know-how owned by such third
party in connection with the production of our products that is necessary for the
manufacture of our products, and |
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reliance upon third party manufacturers to assist us in preventing inadvertent
disclosure or theft of our proprietary knowledge. |
We purchased oligonucleotides for preclinical and clinical testing from Avecia Biotechnology
at a preferential price under a supply agreement, which expired in March 2004. We have continued to
purchase all of the oligonucleotides we are using in our ongoing clinical trials and pre-clinical
testing from Avecia. The terms of the agreement have been extended until such time as a new
agreement is negotiated. If Avecia determines not to accept any purchase order for oligonucleotides
or we are unable to enter into a new manufacturing arrangement with Avecia or a new contract
manufacturer on a timely basis or at all, our ability to supply the product needed for our clinical
trials could be materially impaired.
We have no experience selling, marketing or distributing products and no internal capability to do
so.
If we receive regulatory approval to commence commercial sales of any of our products, we will
face competition with respect to commercial sales, marketing and distribution. These are areas in
which we have no experience. To market any of our products directly, we would need to develop a
marketing and sales force with technical expertise and with supporting distribution capability. In
particular, we would need to recruit a large number of experienced marketing and sales personnel.
Alternatively, we could engage a pharmaceutical or other healthcare company with an existing
distribution system and direct sales force to assist us. However, to the extent we entered into
such arrangements, we would be dependent on the efforts of third parties. If we are unable to
establish sales and distribution capabilities, whether internally or in reliance on third parties,
our business would suffer materially.
If third parties on whom we rely for clinical trials do not perform as contractually required or as
we expect, we may not be able to obtain regulatory approval for or commercialize our products and
our business may suffer.
We do not have the ability to independently conduct the clinical trials required to obtain
regulatory approval for our products. We depend on independent clinical investigators, contract
research organizations and other third party service providers in the conduct of the clinical
trials of our products and expect to continue to do so. For example, we have contracted with
PAREXEL International to manage our Phase 2 clinical trial of IMO-2055 in renal cell carcinoma. We
rely heavily on these parties for successful execution of our clinical trials, but do not control
many aspects of their activities. We are responsible for ensuring that each of our clinical trials
is conducted in accordance with the general investigational plan and protocols for the trial.
Moreover, the FDA requires us to comply with standards, commonly referred to as good clinical
practices, for conducting, recording and reporting clinical trials to assure that data and reported
results are credible and accurate and that the rights, integrity and confidentiality of trial
participants are protected. Our reliance on third parties that we do not control does not relieve
us of these responsibilities and requirements. Third parties may not complete activities on
schedule or may not conduct our clinical trials in accordance with regulatory requirements or our
stated protocols. The failure of these third parties to carry out their obligations could delay or
prevent the development, approval and commercialization of our products. If we seek to conduct any
of these activities ourselves in the future, we will need to recruit appropriately trained
personnel and add to our infrastructure.
If we are unable to obtain adequate reimbursement from third party payors for any products that we
may develop or acceptable prices for those products, our revenues and prospects for profitability
will suffer.
Most patients will rely on Medicare and Medicaid, private health insurers and other third
party payors to pay for their medical needs, including any drugs we may market. If third party
payors do not provide adequate coverage or reimbursement for any products that we may develop, our
revenues and prospects for profitability will suffer. Congress recently enacted a limited
prescription drug benefit for Medicare recipients in the Medicare Prescription Drug and
Modernization Act of 2003. While the program established by this statute may increase demand for
our products, if we participate in this program, our prices will be negotiated with drug
procurement organizations for Medicare beneficiaries and are likely to be lower than we might
otherwise obtain. Non-Medicare third party drug procurement organizations may also base the price
they are willing to pay on the rate paid by drug procurement organizations for Medicare
beneficiaries.
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A primary trend in the United States healthcare industry is toward cost containment. In
addition, in some foreign countries, particularly the countries of the European Union, the pricing
of prescription pharmaceuticals is subject to governmental control. In these countries, pricing
negotiations with governmental authorities can take six to 12 months or longer after the receipt of
regulatory marketing approval for a product. To obtain reimbursement or pricing approval in some
countries, we may be required to conduct a clinical trial that compares the cost effectiveness of
our product candidates or products to other available therapies. The conduct of such a clinical
trial could be expensive and result in delays in commercialization of our products.
Third party payors are challenging the prices charged for medical products and services, and
many third party payors limit reimbursement for newly-approved healthcare products. In particular,
third party payors may limit the indications for which they will reimburse patients who use any
products that we may develop. Cost control initiatives could decrease the price we might establish
for products that we may develop, which would result in lower product revenues to us.
We face a risk of product liability claims and may not be able to obtain insurance.
Our business exposes us to the risk of product liability claims that is inherent in the
manufacturing, testing and marketing of human therapeutic drugs. Although we have product liability
and clinical trial liability insurance that we believe is adequate, this insurance is subject to
deductibles and coverage limitations. We may not be able to obtain or maintain adequate protection
against potential liabilities. If we are unable to obtain insurance at acceptable cost or otherwise
protect against potential product liability claims, we will be exposed to significant liabilities,
which may materially and adversely affect our business and financial position. These liabilities
could prevent or interfere with our commercialization efforts.
Risks Relating to an Investment in Our Common Stock
Our corporate governance structure, including provisions in our certificate of incorporation and
by-laws, our stockholder rights plan and Delaware law, may prevent a change in control or
management that stockholders may consider desirable.
Section 203 of the Delaware General Corporation Law and our certificate of incorporation,
by-laws and stockholder rights plan contain provisions that might enable our management to resist a
takeover of our company or discourage a third party from attempting to take over our company. These
provisions include:
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a classified board of directors, |
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limitations on the removal of directors, |
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limitations on stockholder proposals at meetings of stockholders, |
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the inability of stockholders to act by written consent or to call special meetings, and |
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the ability of our board of directors to designate the terms of and issue new series of
preferred stock without stockholder approval. |
These provisions could have the effect of delaying, deferring, or preventing a change in
control of us or a change in our management that stockholders may consider favorable or beneficial.
These provisions could also discourage proxy contests and make it more difficult for you and other
stockholders to elect directors and take other corporate actions. These provisions could also limit
the price that investors might be willing to pay in the future for shares of our common stock.
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Our stock price has been and may in the future be extremely volatile. In addition, because an
active trading market for our common stock has not developed, our investors ability to trade our
common stock may be limited. As a result, investors may lose all or a significant portion of their
investment.
Our stock price has been volatile. During the period from January 1, 2003 to September 30,
2005, the closing sales price of our common stock ranged from a high of $1.69 per share to a low of
$0.41 per share. The stock market has also experienced significant price and volume fluctuations,
and the market prices of biotechnology companies in particular have been highly volatile, often for
reasons that have been unrelated to the operating performance of particular companies. The market
price for our common stock may be influenced by many factors, including:
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results of clinical trials of our product candidates or those of our competitors; |
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the regulatory status of our product candidates; |
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failure of any of our product candidates, if approved, to achieve commercial success; |
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the success of competitive products or technologies; |
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regulatory developments in the United States and foreign countries; |
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developments or disputes concerning patents or other proprietary rights; |
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the departure of key personnel; |
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variations in our financial results or those of companies that are perceived to be similar to us; |
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our cash resources; |
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the terms of any financing conducted by us; |
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changes in the structure of healthcare payment systems; |
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market conditions in the pharmaceutical and biotechnology sectors and issuance of new
or changed securities analysts reports or recommendations; and |
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general economic, industry and market conditions. |
In addition, our common stock has historically been traded at low volume levels and may
continue to trade at low volume levels. As a result, any large purchase or sale of our common stock
could have a significant impact on the price of our common stock and it may be difficult for
investors to sell our common stock in the market without depressing the market price for the common
stock or at all.
As a result of the foregoing, investors may not be able to resell their shares at or above the
price they paid for such shares. Investors in our common stock must be willing to bear the risk of
fluctuations in the price of our common stock and the risk that the value of their investment in
our stock could decline.
We may be unable to repay our 4% convertible subordinated notes when due or to repurchase the
convertible subordinated notes if we are required to do so under the terms of our agreement with
the holders of the 4% convertible subordinated notes.
In May 2005, we sold approximately $5.0 million in principal amount of 4% convertible
subordinated notes. On April 30, 2008, the entire outstanding principal amount of our 4%
convertible subordinated notes will become due and payable, unless the notes are converted to
common stock prior to expiration. In addition, we may be required to redeem all or part of the
convertible subordinated notes prior to the final maturity date if specified events occur. We
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may not have sufficient funds or may be unable to arrange for additional financing to pay the
amount due under the convertible subordinated notes at maturity or to pay the price to repurchase
the convertible subordinated notes. Any future borrowing arrangements or debt agreements to which
we may become a party may restrict or prohibit us from repaying or repurchasing the convertible
subordinated notes. If we are prohibited from repaying or repurchasing the convertible subordinated
notes, we could try to obtain the consent of lenders under those arrangements, or we could attempt
to refinance the indebtedness that contains the restrictions. If we could not obtain the necessary
consents or refinance the indebtedness, we would be unable to repay or repurchase the convertible
subordinated notes. Any such failure would constitute an event of default under the agreement with
the holders of the 4% convertible subordinated notes, which could, in turn, constitute a default
under the terms of any future indebtedness.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Historically, our primary exposures have been related to nondollar-denominated operating
expenses in Europe. As of September 30, 2005, we have no assets and liabilities related to
nondollar-denominated currencies.
We maintain investments in accordance with our investment policy. The primary objectives of
our investment activities are to preserve principal, maintain proper liquidity to meet operating
needs and maximize yields. Although our investments are subject to credit risk, our investment
policy specifies credit quality standards for our investments and limits the amount of credit
exposure from any single issue, issuer or type of investments. We do not own derivative financial
investment instruments in our investment portfolio.
Based on a hypothetical ten percent adverse movement in interest rates, the potential losses
in future earnings, fair value of risk sensitive financial instruments, and cash flows are
immaterial, although the actual effects may differ materially from the hypothetical analysis.
ITEM 4. CONTROLS AND PROCEDURES
(a) Evaluation of Disclosure Controls and Procedures. Our management, with the participation
of our chief executive officer and our chief financial officer, evaluated the effectiveness of our
disclosure controls and procedures as of September 30, 2005. The term disclosure controls and
procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and
other procedures of a company that are designed to ensure that information required to be disclosed
by a company in the reports that it files or submits under the Exchange Act is recorded, processed,
summarized and reported, within the time periods specified in the SECs rules and forms. Disclosure
controls and procedures include, without limitation, controls and procedures designed to ensure
that information required to be disclosed by a company in the reports that it files or submits
under the Exchange Act is accumulated and communicated to the companys management, including its
principal executive and principal financial officers, as appropriate to allow timely decisions
regarding required disclosure. Management recognizes that any controls and procedures, no matter
how well designed and operated, can provide only reasonable assurance of achieving their objectives
and management necessarily applies its judgment in evaluating the cost-benefit relationship of
possible controls and procedures. Based on the evaluation of our disclosure controls and procedures
as of September 30, 2005, our chief executive officer and chief financial officer concluded that,
as of such date, our disclosure controls and procedures were effective at the reasonable assurance
level.
(b) Changes in Internal Controls. No change in our internal control over financial reporting
(as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act) occurred during the
fiscal quarter ended September 30, 2005 that has materially affected, or is reasonably likely to
materially affect, our internal control over financial reporting.
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IDERA PHARMACEUTICALS, INC.
PART II
OTHER INFORMATION
ITEM 6. EXHIBITS
The list of Exhibits filed as part of this Quarterly Report on Form 10-Q are set forth on the
Exhibit Index immediately preceding such Exhibits, and is incorporated herein by this reference.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the
registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly
authorized.
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IDERA PHARMACEUTICALS, INC |
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Date: November 9, 2005
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/s/ Sudhir Agrawal |
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Sudhir Agrawal |
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Chief Executive Officer and |
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Chief Scientific Officer and Director |
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(Principal Executive Officer) |
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Date: November 9, 2005
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/s/ Robert G. Andersen |
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Robert G. Andersen |
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Chief Financial Officer and |
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Vice President of Operations |
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(Principal Financial and Accounting Officer) |
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Exhibit Index
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Exhibit No. |
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10.1
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Employment agreement dated October 19, 2005 between
Idera Pharmaceuticals, Inc. and Sudhir Agrawal, D.
Phil. |
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31.1
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Certification of Chief Executive Officer pursuant to
Exchange Act Rules 13a-14 and 15d-14, as adopted
pursuant to Section 302 of Sarbanes-Oxley Act of
2002. |
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31.2
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Certification of Chief Financial Officer pursuant to
Exchange Act Rules 13a-14 and 15d-14, as adopted
pursuant to Section 302 of Sarbanes-Oxley Act of
2002. |
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32.1
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Certification of Chief Executive Officer pursuant to
18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002. |
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32.2
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Certification of Chief Financial Officer pursuant to
18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002. |
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Management contract or compensatory plan or
arrangement required to be filed as an Exhibit to the Quarterly Report on Form
10-Q |
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Exhibit 10.1
IDERA PHARMACEUTICALS, INC.
EMPLOYMENT AGREEMENT
THIS EMPLOYMENT AGREEMENT (this "Agreement") is entered into by and between
Sudhir Agrawal ("Executive") and Idera Pharmaceuticals, Inc., a Delaware
corporation (the "Company"), and is effective as of the 19th day of October,
2005 (the "Effective Date"). Executive and the Company are referred to herein
individually as a "Party", and collectively as the "Parties".
WHEREAS, the Company and Executive are a party to an Employment Agreement
dated April 1, 2002 (the "Original Employment Agreement");
WHEREAS, Executive became the Company's Chief Executive Officer on August
30, 2004;
WHEREAS, the Company desires to establish its right to the services of
Executive, in his capacity as Chief Executive Officer, on the terms and
conditions hereinafter set forth, and Executive is willing to accept such
employment on such terms and conditions; and
WHEREAS, the Company and Executive desire to enter into this Agreement, as
an amendment and restatement of the Original Employment Agreement and to
terminate the Original Employment Agreement, effective as of the Effective Date.
NOW, THEREFORE, in consideration of the mutual agreements hereinafter set
forth, Executive and the Company have agreed and do hereby agree as follows:
1. Definitions. The capitalized terms in this Agreement shall have the
meanings set forth in this Agreement or Appendix A attached hereto.
2. Engagement. The Company hereby agrees to employ Executive as its Chief
Executive Officer and Chief Scientific Officer, and Executive hereby accepts
such employment on the terms and conditions hereinafter set forth.
3. Employment Period. Executive's employment with the Company under this
Agreement shall commence on the Effective Date and shall continue until the
third anniversary of the Effective Date (as such period may be extended as set
forth below, the "Employment Period"), unless such employment is sooner
terminated as hereinafter provided. The Employment Period shall automatically be
extended for an additional year on each anniversary of the Effective Date;
provided however, that the
Employment Period shall not be extended if prior to any such anniversary of the
Effective Date either Party provides written notice to the other Party that the
then-current Employment Period shall not be extended.
4. Duties and Responsibilities.
(a) Responsibilities. During the Employment Period, Executive shall
perform his duties and responsibilities fully and faithfully as Chief Executive
Officer and Chief Scientific Officer, subject to the direction and supervision
of the Board of Directors of the Company (the "Board") and the terms and
conditions of this Agreement. During such period, Executive shall report solely
to the Board. Executive shall have the duties and responsibilities customarily
assigned to the Chief Executive Officer and Chief Scientific Officer with such
other duties not inconsistent therewith as may from time to time be assigned to
Executive by the Board. Executive agrees he shall devote substantially his full
business time and attention to, and exert his best efforts in, the performance
of his duties hereunder, so as to promote the business and best interests of the
Company and to comply with the Company's policies as in effect from time to
time. Notwithstanding the foregoing, Executive may engage in ordinary and
customary interactions with the scientific and academic communities, including
writing and reviewing articles and grants, editing books and attending
conferences.
(b) Location. Executive's principal place of business shall be in
Cambridge, Massachusetts, within 30 miles of Cambridge, Massachusetts or within
10 miles east of Worcester, Massachusetts (the "Permitted Area").
Notwithstanding the foregoing, Executive shall perform services for the Company
at such other locations where Executive's services might be required to be
performed from time to time, provided that Executive shall not be required to
perform services at a location other than in the Permitted Area for a period in
excess of 30 consecutive days without Executive's prior written consent, except
in the event of a change in location of the headquarters of the Company to a
site within the continental United States following a Change of Control.
5. Compensation. For all services rendered by Executive pursuant to this
Agreement, the Company shall pay Executive, and Executive agrees to accept, the
salary, bonuses and other benefits described below in this Section 5.
(a) Base Salary. During the Employment Period, the Company shall pay
Executive an annual base salary of $ 425,000.00 ("Base Salary") and such Base
Salary shall be payable at periodic intervals in accordance with the Company's
payroll practices for salaried employees. In accordance with Section 5(c) below,
the amount of Base Salary shall be reviewed and approved, if applicable, by the
Board or the Compensation
-2-
Committee of the Board (the "Compensation Committee"; it being agreed that, for
purposes of this Agreement, any action that may be taken by the Board under this
Agreement may be taken by the Compensation Committee instead of the Board,
whether or not expressly provided in this Agreement) on at least an annual
basis, and any increases in the amount of Base Salary shall be effective as of
the date determined by the Board or the Compensation Committee. Executive's Base
Salary may be increased for any reason, including to reflect inflation or such
other adjustments as the Board or the Compensation Committee may deem
appropriate; provided, however, that Executive's Base Salary, as in effect on
the date hereof or as increased in accordance with the terms of this Agreement,
may not be subsequently decreased, except with the prior written consent of
Executive.
(b) Bonus. In addition to Base Salary, Executive shall be eligible to
receive, for each fiscal year of the Company ending with or within the
Employment Period, an annual bonus ("Bonus") equal to between 20% and 70% of
Executive's Base Salary on the last day of such fiscal year, whether pursuant to
a formal bonus or incentive plan or program of the Company or otherwise. Subject
to this Section 5(b) and Section 5(c) below, such Bonus shall be based on
criteria, and subject to the achievement of milestones, determined by the Board
or the Compensation Committee, in its discretion. Any Bonus earned by Executive
for service or performance rendered in any fiscal year within the Employment
Period shall be paid to Executive in accordance with the applicable plan or
program, if any, and the Company's policies governing such matters.
(c) Annual Compensation Review. Executive's compensation, consisting
of salary, equity incentive awards and bonuses, shall be reviewed annually by
the Board or the Compensation Committee.
(d) Medical, Dental and Other Healthcare Benefits. During the
Employment Period, Executive shall be eligible to participate in and receive
benefits under the Company's medical, dental or other healthcare plans, as in
effect from time to time, that are available to officers and employees of the
Company.
(e) Retirement Plan Benefits. Executive shall be entitled to
participate in the Company's tax-qualified and nonqualified retirement plans, as
in effect from time to time, that are available to officers and employees of the
Company and shall be entitled to receive the benefit of contributions to be
made, if any, by the Company for the benefit of Executive under the terms of the
applicable tax-qualified or nonqualified retirement plan.
(f) Incentive Plans. During the Employment Period, Executive shall be
eligible to receive all benefits, including those under stock option, equity
participation or bonus programs, to which key employees are or
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become eligible under such plans or programs as may be established by the
Company from time to time.
(g) Other Benefits. During the Employment Period, in addition to the
benefit plans contemplated by Sections 5(d), 5(e) and 5(f), Executive shall be
entitled to participate in the other benefit and fringe benefit programs
afforded by the Company to its executives from time to time. Executive shall be
entitled to paid vacation in accordance with the Company's standard vacation
policies in effect from time to time.
(h) Options. The Company has agreed to grant Executive from and after
the date hereof stock options to purchase shares of common stock as set forth
below if and when the milestones set forth below are achieved, to the extent
such milestones are achieved during the Employment Period. These stock options
shall not be granted until the achievement of the applicable milestones. The
exercise price of stock options granted hereunder shall equal the closing price
of the Company's common stock on the principal trading market on which the
Company's common stock is then traded on the date of the option grant or, if the
common stock is not then traded, the fair market value of one share of common
stock on the date of the option grant as determined in good faith by the Board
in its sole discretion. Options granted hereunder shall vest quarterly over a
three-year period with the first installment vesting upon the end of the first
quarterly period after the date of the option grant. These options shall be
evidenced by an option agreement that is consistent with the form of option
agreement generally used by the Company at the time of the grant and the terms
of this Agreement. The achievement of the milestones shall be determined by the
Board of Directors of the Company in its sole discretion.
(i) The Company shall grant stock options to purchase 200,000
shares of common stock upon full enrollment on or prior to December 31, 2005 of
the Company's ongoing phase 2 clinical trial of IMOxine in patients with
metastatic or recurrent clear cell renal carcinoma.
(ii) The Company shall grant stock options to purchase 200,000
shares of common stock upon the Company having cash and cash equivalents on or
prior to May 1, 2006 in excess of $30.0 million.
(iii) The Company shall grant stock options to purchase 200,000
shares of common stock upon the Company executing on or prior to a date to be
determined by the Board of Directors in its sole discretion a collaboration
agreement that includes specified minimum terms to be determined by the Board of
Directors in its sole discretion.
The number of shares of common stock issuable upon exercise of the options to be
granted hereunder shall be subject to appropriate adjustment for stock
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splits, stock dividends, combinations, recapitalizations and other similar
events affecting the common stock.
6. Termination of Employment. The remedies described in this Section 6 are
the exclusive remedies of the Executive in connection with the termination of
Executive's employment under this Agreement.
(a) Death. If Executive's employment hereunder is terminated by reason
of Executive's death, the Company shall pay Executive's designated beneficiary
or beneficiaries any Unpaid Obligations, plus the Termination Bonus Obligations;
provided that such amounts shall be paid in a lump sum cash payment within 30
days after the Company's receipt of notification of Executive's death.
Additionally, any stock options or other equity incentive awards previously
granted to Executive by the Company and held by Executive on the date of his
death shall vest as of such date to the extent such options or equity incentive
awards, as applicable, would have vested had Executive continued to be an
employee of the Company for a period ending on the final day of the Employment
Period in effect immediately prior to Executive's death. Executive's designated
beneficiary or beneficiaries shall be permitted to exercise such stock options
until the second anniversary of Executive's death; provided that such provision
shall not affect and shall be subject to (i) the provisions of the applicable
stock option agreement and/or equity incentive plan relating to the termination
of such stock options in connection with an Acquisition Event, a Change of
Control or a similar transaction involving the Company or (ii) the maximum term
of any such stock option (the "Option Limitation Provisions").
(b) Disability. The Company may terminate Executive's employment at
any time upon at least 30 days' prior written notice due to the Disability of
Executive. If Executive's employment hereunder is terminated due to Disability,
the Company shall pay Executive any Unpaid Obligations plus the Termination
Bonus Obligations; provided that such amounts shall be paid in a lump sum cash
payment within 30 days after the termination date. Additionally, any stock
options or other equity incentive awards previously granted to Executive by the
Company and held by Executive on the termination date shall vest as of such date
to the extent such options or equity incentive awards, as applicable, would have
vested had Executive continued to be an employee of the Company for a period
ending on the final day of the Employment Period in effect immediately prior to
such termination date. Executive shall be permitted to exercise such stock
options until the second anniversary of the termination date; provided that such
provision shall not affect and shall be subject to the Option Limitation
Provisions.
(c) Termination by the Company for Cause. The Company may terminate
Executive's employment under this Agreement for Cause at
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any time. If Executive's employment hereunder is terminated by the Company for
Cause, the Company shall pay Executive any Unpaid Obligations, provided that
such amounts shall be paid in a lump sum cash payment within 30 days after such
termination date. All options or other equity incentive awards, whether vested
or unvested on the termination date, shall expire and terminate on that date.
(d) Termination by the Company Other than for Death, Disability or
Cause. The Company may, at its option and upon 30 days' prior written notice,
terminate Executive's employment under this Agreement without Cause at any time.
If Executive's employment is terminated by the Company other than on account of
Executive's death, Disability, or for Cause, then the Company shall pay
Executive any Unpaid Obligations plus the Termination Bonus Obligations;
provided that such amounts shall be paid in a lump sum cash payment within 30
days after the termination date. In addition, subject to Section 6(h)(i) below,
the Company shall pay Executive (i) on the date six months and one day after the
termination date a lump sum payment in cash equal to six months of Executive's
Base Salary as in effect immediately prior to such termination and (ii) in
accordance with the Company's payroll practices applicable to salaried
executives, Executive's Base Salary as in effect immediately prior to such
termination for a period commencing on the date six months and one day after the
termination date and ending on the earlier of (x) the final day of the
Employment Period in effect immediately prior to such termination and (y) the
second anniversary of the termination date. Additionally, any stock options or
other equity incentive awards previously granted to Executive by the Company and
held by Executive on the termination date shall vest as of such date to the
extent such options or equity incentive awards, as applicable, would have vested
had Executive continued to be an employee of the Company for a period ending on
the final day of the Employment Period in effect immediately prior to such
termination. Executive shall be permitted to exercise such stock options until
the second anniversary of the termination date; provided that such provision
shall not affect and shall be subject to the Option Limitation Provisions.
(e) Termination by Executive for Good Reason. Executive may, for Good
Reason, terminate this Agreement upon 30 days' prior written notice to the
Company. If Executive's employment is terminated by Executive for Good Reason,
the Company shall pay Executive any Unpaid Obligations plus the Termination
Bonus Obligations; provided that such amounts shall be paid in a lump sum cash
payment within 30 days after the termination date. In addition, subject to
Section 6(h)(i) below, the Company shall pay Executive (i) on the date six
months and one day after the termination date a lump sum payment in cash equal
to six months of Executive's Base Salary as in effect immediately prior to such
termination
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and (ii) in accordance with the Company's payroll practices applicable to
salaried executives, Executive's Base Salary in effect immediately prior to such
termination for a period commencing on the date six months and one day after the
termination date and ending on the earlier of (x) the final day of the
Employment Period in effect immediately prior to such termination and (y) the
second anniversary of the termination date. Additionally, any stock options or
other equity incentive awards previously granted to Executive by the Company and
held by Executive on the termination date shall vest as of such date to the
extent such options or equity incentive awards, as applicable, would have vested
had Executive continued to be an employee of the Company for a period ending on
the final day of the Employment Period in effect immediately prior to such
termination. Executive shall be permitted to exercise such stock options until
the second anniversary of the termination date; provided that such provision
shall not affect and shall be subject to the Option Limitation Provisions.
(f) Voluntary Termination by Executive. Executive may, without Good
Reason, terminate Executive's employment upon 30 days' prior written notice to
the Company. If Executive's employment is terminated by Executive without Good
Reason, the Company shall pay Executive any Unpaid Obligations, provided that
such amounts shall be paid in a lump sum cash payment within 30 days after such
termination date. All options that remain unvested on such termination date
shall expire and terminate as of that date. Executive shall be permitted to
exercise such stock options until the first anniversary of the termination date;
provided that such provision shall not affect and shall be subject to the Option
Limitation Provisions.
(g) No Offset. Any compensation derived by Executive from any
subsequent employment or self-employment shall not be offset against or reduce
any amounts to which Executive is entitled under this Agreement.
(h) Change of Control.
(i) Continuation of Salary. If Executive's employment with the
Company is terminated by Executive for Good Reason or by the Company other than
for death, Disability or Cause in connection with, or within one year after the
effective date of, a Change of Control, in lieu of the severance payments
provided for in the third sentence of Section 6(d) or the third sentence of
Section 6(e), as applicable, the Company shall pay Executive a lump sum cash
payment in an amount equal to Executive's Base Salary as in effect immediately
prior to the termination date multiplied by the lesser of (x) the aggregate
number of years (or any portion thereof, calculated on a daily basis) remaining
in the Employment Period in effect immediately prior to such termination and (y)
two years. Such amounts shall be paid to Executive within 10 days after the
termination date.
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(ii) Parachute Payments. If all or any portion of the amounts
payable to Executive under this Agreement or otherwise are subject to the excise
tax imposed by Section 4999 of the Internal Revenue Code of 1986, as amended or
a similar state tax or assessment, the Company shall pay to Executive an amount
necessary to place Executive in the same after-tax position as Executive would
have been had no such excise tax or assessment been imposed. The amount payable
pursuant to the preceding sentence shall be increased to the extent necessary to
pay income and excise taxes on such amounts. The determination of any amounts
payable under this Section 6(h)(ii) shall be made by an independent accounting
firm employed by the Company and such determination shall be final, binding and
conclusion on the Parties.
(iii) Acceleration of Vesting. Any provisions of this Agreement
regarding vesting of stock options notwithstanding, the vesting of all stock
options held by Executive shall be accelerated in full and such stock options
shall become fully exercisable upon the execution by the Company of an agreement
to effect an Acquisition Event or, if not previously accelerated in full, upon
the consummation of a Change of Control.
(i) Continuation of Benefits. If Executive's employment with the
Company is terminated pursuant to Section 6(d) or 6(e) (irrespective of whether
such termination follows a Change of Control), the Company shall provide, for
the period ending on the earlier of (i) the final day of the Employment Period
in effect immediately prior to such termination and (ii) the second anniversary
of the termination date, and at its sole cost and expense, Executive and his
eligible dependents (if any) with healthcare, disability, and life insurance
benefits substantially similar to those benefits Executive and his eligible
dependents (if any) were receiving immediately prior to the termination date;
provided, however, that
(A) the Company shall not be required to provide medical
coverage to the extent another employer of the Executive provides comparable
coverage,
(B) with respect to death and disability coverage, the
Company shall not be required to provide coverage to the extent another employer
of Executive provides comparable coverage; and shall pay the cost of
supplemental coverage if a new employer provides less than comparable coverage,
to allow Executive to purchase coverage to make total coverage comparable, and
(C) the coverage provided by the Company pursuant to this
Section 6(i) shall be in lieu of any other continued coverage for which
Executive or his dependents, if any, would otherwise be eligible pursuant to
COBRA.
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7. Proprietary Information; Company Documents and Materials.
(a) Proprietary Information. Executive acknowledges that during his
employment with the Company, Executive has occupied and will occupy a position
of trust and confidence with respect to Proprietary Information of the Company.
Executive understands that he possesses or will possess Proprietary Information
that is important to the Company's business and operation. Executive
acknowledges that such Proprietary Information is specialized, unique in nature
and of great value to the Company and its Affiliates, and that such information
gives the Company and its Affiliates a competitive advantage. Executive
acknowledges that all Proprietary Information is and shall remain the sole
property of the Company or any of its Affiliates. Executive shall not disclose
to others or use, whether directly or indirectly, any Proprietary Information,
or anything relating to such information, regarding the Company or any of its
Affiliates; provided, however that Executive's obligations under this Section 7
shall not apply to any information that (i) is or becomes known to the general
public under circumstances involving no breach by Executive of the terms of this
Section 7, (ii) is generally disclosed to third parties by the Company without
restriction on such third parties, (iii) is approved for release by written
authorization of the Board or an authorized employee of the Company, (iv) is
communicated to Executive by a third party under no duty of confidentiality with
respect to such information to the Company or another party, or (v) is required
to be disclosed by Executive to comply with applicable laws, governmental
regulations, or court order, provided that Executive provides prior written
notice of such disclosure to the Company and an opportunity for the Company to
object to such disclosure and further provided that Executive cooperates with
the Company and takes reasonable and lawful actions requested by the Company
(the out-of-pocket costs of which shall be paid by the Company) to avoid and/or
minimize the extent of such disclosure.
(b) Company Documents and Materials. Executive agrees that during
Executive's employment by the Company, Executive will not remove any Company
documents or materials, including Proprietary Information, from the business
premises of the Company or deliver any such Company documents or materials to
any person or entity outside the Company, except as Executive is required to do
in connection with performing the duties of Executive's employment. Executive
agrees that, immediately upon the termination of Executive's employment by
Executive or by the Company for any reason, or during Executive's employment if
so requested by the Company, Executive will return all Company documents and
materials, computer tapes and disks, records, lists, data, drawings, prints,
notes and written information, apparatus, equipment and other physical property,
or any reproduction of such property, excepting only (i) Executive's personal
copies of records relating to Executive's compensation;
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(ii) Executive's personal copies of any materials previously distributed
generally to stockholders of the Company; and (iii) Executive's copy of this
Agreement. Provided that the Company has copies and the matters covered therein
do not contain Proprietary Information, Executive may keep copies of
correspondence or publications relating to scientific or academic matters.
8. Non-solicitation and Non-competition.
(a) Non-solicitation. Executive agrees that during his employment with
the Company and for a period of one year following the termination of his
employment with the Company, Executive shall not hire, attempt to hire, or
assist in or facilitate in any way the hiring of any person who, at the time of
any such action by Executive, is an employee of the Company (or any of its
Affiliates).
(b) Non-competition. Executive agrees that if his employment with the
Company is terminated for any reason, including upon the expiration of the
Employment Period, for a period of one year from the date of such termination of
employment, Executive shall not, directly or indirectly, engage in any business
or enterprise (whether as owner, partner, officer, director, employee,
consultant, investor, lender or otherwise, except as the holder of not more than
1% of the outstanding stock of a publicly-held company) that develops,
manufactures, markets, licenses or sells any products developed using antisense
therapeutics or oligonucleotide-based immunostimulatory therapeutics or any
other technology or product developed, manufactured, marketed, licensed or sold
by the Company while the Executive is employed by the Company (the "Restricted
Business").
(c) Notwithstanding the foregoing, Section 8(b) shall not preclude
Executive from becoming an employee of, or from otherwise providing services to,
a separate division or operating unit of a multi-divisional pharmaceutical
business or enterprise (a "Division") if: (i) the Division by which Executive is
employed, or to which the Employee provides services, is not competitive with
the Restricted Business, (ii) Executive does not provide services, directly or
indirectly, to any other division or operating unit of such multi-divisional
pharmaceutical business or enterprise that is competitive with the Restricted
Business (individually, a "Competitive Division" and collectively, the
"Competitive Divisions") and (iii) the Competitive Divisions, in the aggregate,
accounted for less than one-third of the multi-divisional pharmaceutical
business or enterprises' consolidated revenues for the fiscal year, and each
subsequent quarterly period, prior to the Executive's commencement of employment
with the Division.
9. Assignment of Rights. All inventions, discoveries, computer programs,
data, technology, designs, innovations and improvements (whether or not
patentable and whether or not copyrightable) related to the business of
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the Company that are or have been made, conceived, reduced to practice, created,
written, designed or developed by Executive, solely or jointly with others and
whether during normal business hours or otherwise, during his employment by the
Company pursuant to this Agreement ("Inventions") shall be the sole property of
the Company. Executive hereby assigns to the Company all such Inventions and any
and all related patents, copyrights, trademarks, trade names, and other
industrial and intellectual property rights and applications therefor, in the
United States and elsewhere and appoints any officer of the Company as his duly
authorized attorney, but without any out-of-pocket expenses to Executive, to
executive, file, prosecute and protect the same before any government agency,
court or authority. Executive hereby waives all claims to moral rights in any
Invention. Upon the request of the Company and at the Company's expense,
Executive shall execute such further assignments, documents and other
instruments as may be necessary or desirable to fully and completely assign all
such Inventions to the Company and to assist the Company in applying for,
obtaining and enforcing patents or copyrights or other rights in the United
States and in any foreign county with respect to any such Invention. Executive
shall promptly disclose to the Company all such Inventions and will maintain
adequate and current written records (in the form of notes, sketches, drawings
and as may be reasonably specified by the Company) to document the conception
and/or first actual reduction to practice of any such Invention. Such written
records shall be available to and remain the sole property of the Company at all
times. Executive shall, upon the Company's request, whether during or after the
Employment Period, promptly execute and deliver to the Company all such
assignments, certificates and instruments, and shall promptly perform such other
acts, as the Company may from time to time in its discretion deem necessary or
desirable to evidence, establish, maintain, perfect, enforce or defend the
Company's rights in the inventions. These services (the "IP Services"), shall be
rendered by Executive without additional compensation during the Employment
Period, and at any time when the Company is paying Executive his Base Salary
pursuant to Section 6(b), 6(d), 6(e), 6(f) or 6(h). Executive shall otherwise
render the IP Services at the rate of compensation provided in the last sentence
of this paragraph. In addition, Executive agrees, from time to time, and for as
long as reasonably required, to make himself available on a consulting basis to
assist the Company in the prosecution of patent applications or other filings or
proceedings before the Office of Patents and Trademarks and to advise with
respect to issues arising in the licensing of the Company's patents and the
pursuit or defense of infringement claims. The Company's requests under the
preceding sentence shall be made upon reasonable notice to Executive, and the
Company shall pay Executive for such services at the hourly rate of $300 per
hour plus reasonable expenses.
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10. Publications. Following the expiration or termination of the Employment
Period, Executive will have a continuing right, on the terms and conditions set
forth in this Section 10, to disclose in scientific journals or publications or
in presentations at scientific conferences the results of any research performed
by Executive while employed by the Company. Executive will provide the Company
with an advance copy of any proposed publication or presentation before
submission of such advance copy to any publisher or before the intended date of
presentation, as the case may be. If the Company informs Executive, within 30
days of receipt of such advance copy, that such publication or presentation
would have an adverse effect on the confidentiality of any Proprietary
Information of the Company or on the ability of the Company to obtain, enforce
or maintain any intellectual property rights in any Proprietary Information of
the Company, Executive will delay or prevent such publication or presentation as
proposed by the Company. In addition, Executive will incorporate in such
proposed publication or presentation prior to its submission such changes,
including without limitation deletions, as the Company believes are necessary to
preserve the confidentiality of any Proprietary Information, and Executive will
delay such proposed publication or presentation until such time as the Company
has filed a U.S. patent application covering any proprietary information.
11. Successors. Any successor to the Company (whether direct or indirect
and whether by purchase, lease, merger, consolidation, liquidation or otherwise)
or to all or substantially all of the Company's business and/or assets shall
assume the obligations under this Agreement and shall perform the obligations
under this Agreement in the same manner and to the same extent as the Company
would be required to perform such obligations in the absence of a succession.
The Company may assign this Agreement without Executive's consent to any company
that acquires all or substantially all of the Company's stock or assets.
Executive may not assign this Agreement and no person other than Executive (or
his estate) may assert Executive's rights under this Agreement.
12. Notice. All notices, requests, consents and other communications
hereunder to any Party shall be contained in a written instrument addressed to
such Party at the address set forth below or such other address as may hereafter
be designated in writing by the addressee to the addressor listing all Parties
and shall be deemed given (a) when delivered in person or duly sent by fax
showing confirmation of receipt, (b) three days after being duly sent by first
class mail postage prepaid, or (c) two days after being duly sent by DHL,
Federal Express or other recognized express courier service:
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(a) if to the Company, to:
Idera Pharmaceuticals, Inc.
345 Vassar Street
Cambridge, MA 02139
fax: (617) 679-5582
(b) if to Executive, to:
Sudhir Agrawal
61 Lamplighter Drive
Shrewsbury, MA 01545
13. Company Plans. To the extent any provision of this Agreement conflicts
with or is inconsistent with any awards made to Executive under any Company
compensation or benefit plan, program, or arrangement, the provisions of this
Agreement shall govern. Except to the extent otherwise explicitly provided by
this Agreement, any awards made to Executive under any Company compensation or
benefit plan, program, or arrangement shall be governed by the terms of that
plan, program, or arrangement and any applicable award agreement thereunder, as
in effect from time to time.
14. Miscellaneous Provisions.
(a) Entire Agreement. This Agreement constitutes the entire agreement
between the Parties and terminates and supersedes any and all prior agreements
and understandings (whether written or oral) between the Parties with respect to
the subject matter of this Agreement, including the Original Employment
Agreement; provided that (i) the Parties acknowledge that Executive has served
as an employee of the Company since 1990 and (ii) the Employee hereby agrees
that any Proprietary Information disclosed to him or of which he otherwise
became aware during the course of his employment with the Company shall be
deemed Proprietary Information for all purposes under this Agreement, that any
Inventions made, conceived, reduced to practice, created, written, designed or
developed by the Executive in the course of his employment with the Company
shall be deemed Inventions for all purposes under this Agreement and that
notwithstanding any prior agreements the provisions of this Agreement shall
govern such Proprietary Information and Inventions. Executive acknowledges and
agrees that neither the Company, nor anyone acting on its behalf has made, and
in executing this Agreement Executive has not relied upon, any representations,
promises, or inducements except to the extent the same is expressly set forth
herein.
(b) Waiver. No provision of this Agreement shall be modified, waived,
or discharged unless the modification, waiver, or discharge is agreed
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to in writing and signed by Executive and by an authorized officer or
representative of the Company (other than Executive). No waiver by either Party
of any breach of, or of compliance with, any condition or provision of this
Agreement by the other Party shall be considered a waiver of any other condition
or provision or of the same condition or provision at a preceding or subsequent
time.
(c) Capacity. Executive represents and warrants to the Company that he
is not now under any obligation, of a contractual nature or otherwise, to any
person, firm, corporation, association or other entity that is inconsistent, or
in conflict, with this Agreement or that would prevent, limit or impair in any
way the performance by Executive of his obligations hereunder.
(d) Consulting. Executive and the Company may, but are not required
to, enter into an agreement pursuant to which Executive will provide consulting
services to the Company after the date of Executive's retirement or termination
of employment with the Company. Any consulting fees paid to Executive will be in
addition to any retirement or severance payments Executive is entitled to
receive from the Company or under any plans, programs, or arrangements
maintained by the Company.
(e) Severability. In the event that a court of competent jurisdiction
determines that any portion of this Agreement is in violation of any law or
public policy, only the portion of this Agreement that violates such law or
public policy shall be stricken. All portions of this Agreement that do not
violate any statute or public policy shall continue in full force and effect.
Further, any court order striking any portion of this Agreement shall modify the
stricken terms as narrowly as possible to give effect to the intentions of the
Parties to this Agreement, as expressed herein.
(f) Survival of Provisions. The obligations contained in Sections 7,
8, 9, and 10 above shall survive the termination or expiration of the Employment
Period or this Agreement, as applicable, and shall be fully enforceable
thereafter in accordance with the terms of this Agreement.
(g) Withholding. Executive acknowledges that salary and all other
compensation payable under this Agreement shall be subject to withholding for
income and other applicable taxes to the extent required by law, as determined
by the Company in its sole discretion.
(h) Headings. The headings or other captions contained in this
Agreement are for convenience of reference only and shall not be used in
interpreting, construing or enforcing any of the provisions of this Agreement.
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(i) Governing Law. This Agreement shall be governed by the laws of the
Commonwealth of Massachusetts without giving effect to any conflict of law rules
that would require the application of the laws of any jurisdiction other than
the internal laws of the Commonwealth of Massachusetts to the rights and duties
of the Parties, except to the extent the laws of the Commonwealth of
Massachusetts are preempted by federal law.
(j) Terms. Where appropriate in this Agreement, words used in the
singular shall include the plural, and words used in the masculine shall include
the feminine or neuter.
(k) Legal Fees. The Company shall pay or reimburse to Executive an
amount equal to reasonable fees for legal representation incurred by Executive
in connection with the preparation of this Agreement and the amendment of
existing options agreements in an amount not to exceed $8,000.
(l) Counterparts. This Agreement may be executed in multiple
counterparts, each of which shall be deemed to be an original, and all of which
together shall constitute one agreement binding on the Parties hereto.
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement
effective as of the date first mentioned above.
IDERA PHARMACEUTICALS, INC. SUDHIR AGRAWAL
BY: /s/ James B. Wyngaarden /s/ Sudhir Agrawal
--------------------------------- ----------------------------------------
James B. Wyngaarden
TITLE: Chairman
DATE: October 19, 2005 DATE: October 19, 2005
------------------------------- ----------------------------------
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APPENDIX A
DEFINITIONS
ACQUISITION EVENT means
(i) any merger or consolidation that results in the voting
securities of the Company outstanding immediately prior thereto representing
(either by remaining outstanding or by being converted into voting securities of
the surviving or acquiring entity) less than 60% of the combined voting power of
the voting securities of the Company or such surviving or acquiring entity
outstanding immediately after such merger or consolidation;
(ii) any sale of all or substantially all of the assets of the
Company;
(iii) the complete liquidation of the Company; or
(iv) the acquisition of "beneficial ownership" (as defined in
Rule 13d-3 under the Exchange Act) of securities of the Company representing 50%
or more of the combined voting power of the Company's then outstanding
securities (other than through a merger or consolidation or an acquisition of
securities directly from the Company) by any "person," as such term is used in
Sections 13(d) and 14(d) of the Exchange Act, other than the Company, any
trustee or other fiduciary holding securities under an employee benefit plan of
the Company or any corporation owned directly or indirectly by the stockholders
of the Company in substantially the same proportion as their ownership of stock
of the Company.
AFFILIATE. "Affiliate" shall mean any person or entity that directly or
indirectly controls, is controlled by or is under common control with the
Company, including any entity directly or indirectly controlled by the Company
through the Company's ownership of 50% or more of the voting interests of such
entity.
CAUSE. "Cause" shall mean Executive's (i) material breach of any material
term of this Agreement, (ii) plea of guilty or nolo contendre to, or conviction
of, the commission of a felony offense, (iii) repeated unexplained or
unjustified absence, or refusals to carry out the lawful directions of the Board
or (iv) material breach of a fiduciary duty owed to the Company under this
Agreement, provided that any action or inaction described by (i), (iii) or (iv),
above, shall not be the basis of a termination of Executive's employment with
the Company for "Cause" unless the Company provided Executive with at least 20
days advance written notice specifying in reasonable detail the
conduct in need of being cured and such conduct was not cured within the notice
period.
CHANGE OF CONTROL. "Change of Control" shall mean the occurrence of any of
the following events:
(i) a change in the composition of the Board over a period of thirty-six
consecutive months or less such that a majority of the members of the Board
ceases to be comprised of individuals who are Continuing Members; for such
purpose, a "Continuing Member" shall mean an individual who is a member of the
Board on the date of this Agreement and any successor of a Continuing Member who
is elected to the Board or nominated for election by action of a majority of
Continuing Members then serving on the Board; or
(ii) the consummation of an Acquisition Event.
DISABILITY. "Disability" shall mean the inability of Executive to perform
all the material duties of Executive's position for a continuous period of at
least 90 days due to a permanent physical or mental impairment, as determined
and certified by a physician selected by Executive and with the concurrence of a
physician selected by the Company, provided that if the physician selected by
Executive and the physician selected by the Company do not agree regarding the
determination and certification, a determination and certification rendered by
an independent physician mutually agreed upon by Executive and the Company shall
be final and binding on the Parties with respect to this Agreement.
GOOD REASON. "Good Reason" shall mean the occurrence of one or more of the
following: (i) any action by the Company that results in a material diminution
of Executive's position, title, annual base salary, authority, duties or
responsibilities or reporting structure; (ii) any material breach of this
Agreement by the Company that is not remedied by the Company within 30 days
after receipt by the Company of notice thereof given by Executive specifying in
reasonable detail the alleged breach; (iii) failure to elect Executive to serve
on the Board during the Employment Period; or (iv) relocation of the Company's
headquarters outside the Permitted Area, except in the event of a change in the
location of the headquarters of the Company to a site within the continental
United States following a Change of Control.
PROPRIETARY INFORMATION. "Proprietary Information" shall mean information
that was developed, created, or discovered by or on behalf of the Company, or
that became or will become known by, or was or is conveyed to the Company;
including, but not limited to, trade secrets, designs, technology, know-how,
processes, data, ideas, techniques, inventions (whether patentable or not),
works of authorship, formulae, business and development plans,
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client or customer lists, software programs and subroutines, source and object
code, algorithms, terms of compensation and performance levels of Company
employees, information about the Company or any of its Affiliates, and their
clients and customers that is not disclosed by the Company or any of its
Affiliates for financial reporting purposes and that was learned by Executive in
the course of employment by the Company or any of its Affiliates, other
information concerning the Company's actual or anticipated business, research or
development, or that is received in confidence by or for the Company from any
other person, and all papers, resumes, and records (including electronic or
computer-generated records) of the documents containing such Proprietary
Information. Proprietary Information shall not include information that is
publicly available or available through third party sources so long as it has
not become available through a breach of this Agreement by Executive.
TERMINATION BONUS OBLIGATIONS. "Termination Bonus Obligations" shall mean
the pro rata portion (based on the total number of days in the calendar year
prior to and including the termination date divided by 365) of the Bonus, if
any, that Executive earned in respect of the year preceding the termination of
Executive's employment with the Company.
UNPAID OBLIGATIONS. "Unpaid Obligations" shall mean the sum of (i) any
salary earned but unpaid through the date of termination of employment, and (ii)
reimbursement of any reimbursable expense incurred by Executive through the date
of termination of employment.
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EX-31.1 SECTION 302 CERTIFICATION OF C.E.O.
EXHIBIT 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO EXCHANGE ACT RULES 13a-14 AND 15d-14, AS
ADOPTED PURSUANT TO SECTION 302 OF SARBANES-OXLEY ACT OF 2002
I, Sudhir Agrawal, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Idera Pharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period
covered by this report;
3. Based on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the registrant as of, and for, the periods presented in
this report;
4. The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls
and procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being
prepared;
b) [Not Applicable]
c) Evaluated the effectiveness of the registrants disclosure controls and procedures
and presented in this report our conclusions about the effectiveness of the disclosure
controls and procedures, as of the end of the period covered by this report based on such
evaluation; and
d) Disclosed in this report any change in the registrants internal control over
financial reporting that occurred during the registrants most recent fiscal quarter (the
registrants fourth fiscal quarter in the case of an annual report) that has materially
affected, or is reasonably likely to materially affect, the registrants internal control
over financial reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the
audit committee of the registrants board of directors (or persons performing the equivalent
functions):
a) All significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to adversely affect
the registrants ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who
have a significant role in the registrants internal control over financial reporting.
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/s/ SUDHIR AGRAWAL
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Sudhir Agrawal |
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Chief Executive Officer |
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Dated: November 9, 2005
EX-31.2 SECTION 302 CERTIFICATION OF C.F.O.
EXHIBIT 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO EXCHANGE ACT RULES 13a-14 AND 15d-14, AS
ADOPTED PURSUANT TO SECTION 302 OF SARBANES-OXLEY ACT OF 2002
I, Robert G. Andersen certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Idera Pharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period
covered by this report;
3. Based on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the registrant as of, and for, the periods presented in
this report;
4. The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls
and procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being
prepared;
b) [Not Applicable]
c) Evaluated the effectiveness of the registrants disclosure controls and procedures
and presented in this report our conclusions about the effectiveness of the disclosure
controls and procedures, as of the end of the period covered by this report based on such
evaluation; and
d) Disclosed in this report any change in the registrants internal control over
financial reporting that occurred during the registrants most recent fiscal quarter (the
registrants fourth fiscal quarter in the case of an annual report) that has materially
affected, or is reasonably likely to materially affect, the registrants internal control
over financial reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the
audit committee of the registrants board of directors (or persons performing the equivalent
functions):
a) All significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to adversely affect
the registrants ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who
have a significant role in the registrants internal control over financial reporting.
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/s/ ROBERT G. ANDERSEN
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Robert G. Andersen |
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Chief Financial Officer |
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Dated: November 9, 2005
EX-32.1 SECTION 906 CERTIFICATION OF C.E.O.
EXHIBIT 32.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Idera Pharmaceuticals, Inc. (the
Company) for the period ended September 30, 2005 as filed with the Securities and Exchange
Commission on the date hereof (the Report), the undersigned, Sudhir Agrawal, Chief Executive
Officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, that:
(1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the
Securities Exchange Act of 1934; and
(2) the information contained in the Report fairly presents, in all material respects,
the financial condition and results of operations of the Company.
A signed original of this written statement has been provided to Idera Pharmaceuticals, Inc.
and will be retained by Idera Pharmaceuticals, Inc. and furnished to the Securities and Exchange
Commission or its staff upon request.
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/s/ SUDHIR AGRAWAL
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Sudhir Agrawal |
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Chief Executive Officer |
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Date: November 9, 2005
EX-32.2 SECTION 906 CERTIFICATION OF C.F.O.
EXHIBIT 32.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Idera Pharmaceuticals, Inc. (the
Company) for the period ended September 30, 2005 as filed with the Securities and Exchange
Commission on the date hereof (the Report), the undersigned, Robert G. Andersen, Chief Financial
Officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, that:
(1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the
Securities Exchange Act of 1934; and
(2) the information contained in the Report fairly presents, in all material respects,
the financial condition and results of operations of the Company.
A signed original of this written statement has been provided to Idera Pharmaceuticals, Inc.
and will be retained by Idera Pharmaceuticals, Inc. and furnished to the Securities and Exchange
Commission or its staff upon request.
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/s/ ROBERT G. ANDERSEN
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Robert G. Andersen |
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Chief Financial Officer |
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Date: November 9, 2005