e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2008,
or
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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
No.) |
167 Sidney Street
Cambridge, Massachusetts 02139
(Address of principal executive offices)
(617) 679-5500
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated
filer o | Accelerated
filer þ | Non-accelerated filer o (Do not check if a smaller reporting company) | Smaller reporting company o |
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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22,387,293 |
Class
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Outstanding as of April 30, 2008 |
IDERA PHARMACEUTICALS, INC.
FORM 10-Q
INDEX
IMOtm, Idera® and GEM® are our trademarks. All other trademarks and
service marks appearing in this quarterly report are the property of their respective owners.
2
FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended. All statements, other than statements of historical fact, included or
incorporated in this report regarding our strategy, future operations, collaborations, intellectual
property, 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, could, should, potential, likely, projects,
continue, 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 Part II, Item 1A Risk Factors. These factors and the other
cautionary statements made in this Quarterly Report on Form 10-Q should be read as being applicable
to all related forward-looking statements whenever they appear in this Quarterly Report on Form
10-Q. In addition, any forward-looking statements represent our estimates only as of the date that
this Quarterly Report on Form 10-Q 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.
3
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
IDERA PHARMACEUTICALS, INC.
CONDENSED
BALANCE SHEETS
(UNAUDITED)
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March 31, |
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December 31, |
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(in thousands, except per share amounts) |
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2008 |
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2007 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
51,622 |
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$ |
12,588 |
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Short-term investments |
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10,164 |
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11,155 |
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Receivables |
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483 |
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628 |
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Prepaid expenses and other current assets |
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737 |
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656 |
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Total current assets |
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63,006 |
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25,027 |
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Property and equipment, net |
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2,091 |
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1,964 |
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Non-current portion of prepaid expenses |
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104 |
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104 |
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Restricted cash |
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619 |
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619 |
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Total assets |
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$ |
65,820 |
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$ |
27,714 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,404 |
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$ |
1,177 |
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Accrued expenses |
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2,168 |
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1,745 |
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Current portion of capital lease |
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19 |
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20 |
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Current portion of note payable |
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266 |
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Current portion of deferred revenue |
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22,726 |
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5,911 |
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Total current liabilities |
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26,317 |
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9,119 |
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Capital lease obligation, net of current portion |
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45 |
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50 |
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Note payable, net of current portion |
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877 |
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Deferred revenue, net of current portion |
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28,804 |
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9,874 |
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Other liabilities |
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107 |
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75 |
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Total liabilities |
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55,273 |
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19,995 |
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Commitments and contingencies |
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Stockholders equity: |
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Preferred stock, $0.01 par value, |
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Authorized 5,000 shares |
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Series A convertible preferred stock, |
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Designated 1,500 shares, |
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Issued and outstanding 1 share at March 31, 2008 and December 31, 2007 |
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Common stock, $0.001 par value, |
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Authorized 40,000 shares |
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Issued and outstanding 22,271 and 21,569 shares at March 31, 2008 and December 31, 2007, respectively |
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22 |
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22 |
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Additional paid-in capital |
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355,432 |
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350,423 |
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Accumulated deficit |
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(344,905 |
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(342,734 |
) |
Accumulated other comprehensive (loss) income |
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(2 |
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8 |
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Total stockholders equity |
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10,547 |
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7,719 |
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Total liabilities and stockholders equity |
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$ |
65,820 |
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$ |
27,714 |
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The accompanying notes are an integral part of these financial statements.
4
IDERA PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(UNAUDITED)
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Three Months Ended |
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(in thousands, except per share amounts) |
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March 31, |
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2008 |
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2007 |
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Alliance revenue |
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$ |
4,772 |
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$ |
1,829 |
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Operating expenses: |
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Research and development |
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4,534 |
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2,819 |
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General and administrative |
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2,416 |
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1,953 |
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Total operating expenses |
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6,950 |
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4,772 |
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Loss from operations |
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(2,178 |
) |
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(2,943 |
) |
Other income (expense): |
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Investment income, net |
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406 |
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477 |
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Interest expense |
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(82 |
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(62 |
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Foreign currency exchange loss |
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(267 |
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Loss before income taxes |
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(2,121 |
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(2,528 |
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Income tax provision |
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(50 |
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Net loss |
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$ |
(2,171 |
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$ |
(2,528 |
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Basic and diluted net loss per common share (Note 13) |
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$ |
(0.10 |
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$ |
(0.12 |
) |
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Shares used in computing basic and diluted net loss per common share |
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21,899 |
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20,787 |
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The accompanying notes are an integral part of these financial statements.
5
IDERA PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(UNAUDITED)
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Three Months Ended |
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(in thousands) |
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March 31, |
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2008 |
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2007 |
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Cash Flows From Operating Activities: |
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Net loss |
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$ |
(2,171 |
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$ |
(2,528 |
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Adjustments to reconcile net loss to net cash provided by (used in) operating activities - |
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Gain on disposal of property and equipment |
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(3 |
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Stock-based compensation |
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659 |
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345 |
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Non-employee stock options |
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103 |
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90 |
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Depreciation and amortization |
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128 |
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86 |
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Issuance of common stock for services rendered |
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12 |
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14 |
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Changes in operating assets and liabilities - |
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Accounts receivable |
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145 |
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(174 |
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Prepaid expenses and other current assets |
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(81 |
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(49 |
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Accounts payable and accrued expenses |
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|
682 |
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(88 |
) |
Deferred revenue |
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35,745 |
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(1,693 |
) |
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Net cash provided by (used in) operating activities |
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35,222 |
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(4,000 |
) |
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Cash Flows From Investing Activities: |
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Purchase of available-for-sale securities |
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(7,071 |
) |
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(26,206 |
) |
Proceeds from sale of available-for-sale securities |
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8,275 |
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Proceeds from maturity of available-for-sale securities |
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8,045 |
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|
1,500 |
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Purchase of property and equipment |
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(249 |
) |
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(874 |
) |
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Net cash provided by (used in) investing activities |
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725 |
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(17,305 |
) |
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Cash Flow From Financing Activities: |
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Proceeds from exercise of common stock options and warrants and employee stock purchases |
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4,236 |
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192 |
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Payments on note payable |
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(1,143 |
) |
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Payments on capital lease |
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(6 |
) |
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(1 |
) |
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Net cash provided by financing activities |
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3,087 |
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191 |
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Net increase (decrease) in cash and cash equivalents |
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39,034 |
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(21,114 |
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Cash and cash equivalents, beginning of period |
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12,588 |
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24,596 |
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Cash and cash equivalents, end of period |
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$ |
51,622 |
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$ |
3,482 |
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Supplemental disclosure of cash flow information: |
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Cash paid for interest |
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$ |
82 |
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$ |
65 |
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Cash paid for income taxes |
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$ |
50 |
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$ |
45 |
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Supplemental disclosure of non-cash financing and investing activities: |
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Conversion of 4% convertible subordinated notes into common stock |
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$ |
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$ |
5,033 |
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The accompanying notes are an integral part of these financial statements.
6
IDERA PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
MARCH 31, 2008
(UNAUDITED)
(1) (a) Organization
Idera Pharmaceuticals, Inc. (Idera or the Company) is a biotechnology company engaged in
the discovery and development of DNA- and RNA-based drug candidates targeted to Toll-Like
Receptors, or TLRs, to treat infectious diseases, autoimmune diseases, cancer, and asthma and
allergies, and for use as vaccine adjuvants. Drug candidates are compounds that the Company is
developing and have not been approved for any commercial use. TLRs are specific receptors present
in immune system cells that recognize the DNA or RNA of pathogens such as bacteria or viruses and
initiate an immune response. Relying on its expertise in DNA and RNA chemistry, the Company has
designed and created proprietary TLR agonists and antagonists to modulate immune responses. A TLR
agonist is a compound that stimulates an immune response through the targeted TLR. A TLR antagonist
is a compound that blocks activation of an immune response through the targeted TLR.
The Company is focused on developing TLR-targeted compounds for the potential treatment of
infectious diseases, autoimmune diseases, and cancer. IMO-2125, a TLR9 agonist, is the Companys
lead drug candidate for infectious diseases. At present, a Phase 1 clinical trial of IMO-2125 is
underway in patients with chronic hepatitis C virus infection who have not responded to current
standard of care therapy. The Companys infectious disease program also includes evaluation of
RNA-based compounds that act as agonists of TLR7 and TLR8. The Company has evaluated these
compounds in preclinical studies in human cell-based assays and in vivo in non-human primates and
intends to further evaluate these compounds in preclinical models of infectious disease. In the
Companys autoimmune disease program, it has identified DNA-based compounds that act as antagonists
of TLR7 and TLR9. These compounds have been evaluated in various preclinical studies, including in
mouse models of lupus and rheumatoid arthritis. The Company is conducting further preclinical
studies to explore the potential of these novel compounds in treating multiple sclerosis and
psoriasis. The Companys cancer treatment research program is focused on potential applications of
TLR7 and TLR8 agonists. The Company intends to further evaluate these compounds in preclinical
models of cancer.
In addition, Idera is collaborating with three pharmaceutical companies to advance the
Companys TLR-targeted compounds in multiple disease areas. The Company is collaborating with Merck
KGaA for cancer treatment excluding cancer vaccines, with Merck & Co. Inc., for vaccine adjuvants,
and with Novartis International Pharmaceutical, Ltd., or Novartis, for treatment of asthma and
allergies. Merck KGaA and Merck & Co. are not related.
The Company has incurred operating losses in all fiscal years except 2002 and had an
accumulated deficit of $344.9 million at March 31, 2008. The Company may incur substantial
operating losses in future periods. The Company does not expect to generate significant 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 order to commercialize its therapeutic products, the Company needs to address a number
of technological challenges and to comply with comprehensive regulatory requirements.
(b) Recently Adopted Accounting Pronouncement
In July 2007,
the Emerging Issues Task Force (EITF) issued EITF 07-3, Accounting for
Nonrefundable Advance Payments for Goods or Services to be Used in Future Research and Development
Activities (EITF 07-3). EITF 07-3 clarifies the accounting for nonrefundable advance payments
for goods or services that will be used or
7
rendered for research and development activities. EITF 07-3 states that such payments should
be capitalized and recognized as an expense as the goods are delivered or the related services are
performed. If an entity does not expect the goods to be delivered or the services rendered, the
capitalized advance payment should be charged to expense.
The Company adopted EITF 07-3 on January 1, 2008. The adoption of EITF 07-3 did not have a
material effect on the Companys financial statements.
In December 2007, the EITF issued EITF 07-1, Accounting for Collaborative ArrangementsRelated
to the Development and Commercialization of Intellectual Property (EITF 07-1). EITF 07-1
defines collaborative arrangements and establishes reporting and disclosure requirements for
transactions between participants in a collaborative arrangement and between participants in the
arrangement and third parties. EITF 07-1 is effective for fiscal years beginning after December
15, 2008. The Company is currently evaluating the effect of EITF 07-1 on its financial statements.
(2) Unaudited Interim Financial Statements
The accompanying unaudited 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 United States 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-month period ended March 31, 2008 are not necessarily indicative of results that may be
expected for the year ended December 31, 2008. For further information, refer to the financial
statements and footnotes thereto included in the Companys Annual Report on Form 10-K for the
fiscal year ended December 31, 2007, which was filed with the Securities and Exchange Commission on
March 11, 2008.
(3) (a) 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 March 31, 2008 and December 31, 2007
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 (SFAS
No. 115). 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 balance sheets. 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 for all available-for-sale
securities are included in Investment income, net on the accompanying statements of operations.
The Company had no held-to-maturity investments, as defined by SFAS No. 115, at March 31, 2008
and December 31, 2007. The cost of securities sold is based on the specific identification method.
The Company had no realized gains or losses from available-for-sale securities for the
three-months ended March 31, 2008 and 2007. There were no losses or permanent declines in value
included in investment income, net for any securities in the three months ended March 31, 2008
and 2007.
The Company had no long-term investments as of March 31, 2008 and December 31, 2007.
Available-for-sale securities are classified as short-term regardless of their maturity date as the
Company considers them available for
8
use to fund operations within one year of the balance sheet date. The Companys short-term
available-for-sale investments at market value consisted of the following at March 31, 2008 and
December 31, 2007:
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March 31, |
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December 31, |
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(in thousands) |
|
2008 |
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|
2007 |
|
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|
Certificates of deposit |
|
$ |
802 |
|
|
$ |
2,801 |
|
Corporate bonds due in one year or less |
|
|
3,026 |
|
|
|
1,653 |
|
Corporate bonds due in more than one year |
|
|
1,005 |
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|
Corporate notes due in one year or less |
|
|
2,023 |
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Corporate notes due in more than one year |
|
|
1,005 |
|
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Government bonds due in one year or less |
|
|
2,303 |
|
|
|
6,701 |
|
|
|
|
|
|
|
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Total |
|
$ |
10,164 |
|
|
$ |
11,155 |
|
|
|
|
|
|
|
|
(3) (b) Fair Values of Assets and Liabilities
In September 2006, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards (SFAS) No. 157, Fair Value Measurements, effective for financial
statements issued for fiscal years beginning after November 15, 2007. SFAS No. 157 replaces
multiple existing definitions of fair value with a single definition, establishes a consistent
framework for measuring fair value and expands financial statement disclosures regarding fair value
measurements. This Statement applies only to fair value measurements that already are required or
permitted by other accounting standards and does not require any new fair value measurements. The
adoption of SFAS No. 157 in the first quarter of 2008 did not have a material impact on the
Companys financial position or results of operations.
In accordance with the provisions of SFAS No. 157, the Company measures fair value at the
price that would be received to sell an asset or paid to transfer a liability in an orderly
transaction between market participants at the measurement date. The Statement prioritizes the
assumptions that market participants would use in pricing the asset or liability (the inputs)
into a three-tier fair value hierarchy. This fair value hierarchy gives the highest priority
(Level 1) to quoted prices in active markets for identical assets or liabilities and the lowest
priority (Level 3) to unobservable inputs in which little or no market data exists, requiring
companies to develop their own assumptions. Observable inputs that do not meet the criteria of
Level 1, and include quoted prices for similar assets or liabilities in active markets or quoted
prices for identical assets and liabilities in markets that are not active, are categorized as
Level 2. Level 3 inputs are those that reflect the Companys estimates about the assumptions
market participants would use in pricing the asset or liability, based on the best information
available in the circumstances. Valuation techniques for assets and liabilities measured using
Level 3 inputs may include unobservable inputs such as projections, estimates and managements
interpretation of current market data. These unobservable Level 3 inputs are only utilized to the
extent that observable inputs are not available or cost-effective to obtain.
The table below presents the assets and liabilities measured at fair value on a recurring
basis at March 31, 2008 categorized by the level of inputs used in the valuation of each asset and
liability.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted |
|
|
|
|
|
|
|
|
|
|
Prices |
|
|
|
|
|
|
|
|
|
|
in Active |
|
|
|
|
|
|
|
|
|
|
Markets |
|
Significant |
|
|
|
|
|
|
|
|
for Identical |
|
Other |
|
Significant |
|
|
|
|
|
|
Assets or |
|
Observable |
|
Unobservable |
|
|
|
|
|
|
Liabilities |
|
Inputs |
|
Inputs |
(in thousands) |
|
Total |
|
(Level 1) |
|
(Level 2) |
|
(Level 3) |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
50,385 |
|
|
$ |
50,385 |
|
|
$ |
|
|
|
$ |
|
|
Short-term investments |
|
|
10,164 |
|
|
|
|
|
|
|
10,164 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
60,549 |
|
|
$ |
50,385 |
|
|
$ |
10,164 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9
The money market funds are classified as Level 1 since they are actively traded daily at $1.00 per
share.
The fair value of short-term investments is generally determined from quoted market prices
received from pricing services based upon quoted prices from active markets and/or other
significant observable market transactions at fair value. Since these prices may not represent
actual transactions of identical securities, they are classified as Level 2. Since all short-term
investments are classified as available-for-sale securities, any gains or losses are recorded in
other comprehensive gains or losses in the equity section of the balance sheet.
The Company also adopted the provisions of SFAS No. 159 The Fair Value Option for Financial
Assets and Financial Liabilities Including an Amendment of FASB Statement No. 115 in the first
quarter of 2008. This Statement allows companies to choose to measure eligible assets and
liabilities at fair value with changes in value recognized in earnings. Fair value treatment may be
elected either upon initial recognition of an eligible asset or liability or, for an existing asset
or liability, if an event triggers a new basis of accounting. The Company did not elect to
re-measure any of its existing financial assets or liabilities under the provisions of this
Statement.
(4) Property and Equipment
At March 31, 2008 and December 31, 2007, net property and equipment at cost consists of the
following:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
Leasehold improvements |
|
$ |
432 |
|
|
$ |
430 |
|
Laboratory equipment and other |
|
|
2,832 |
|
|
|
2,585 |
|
|
|
|
|
|
|
|
Total property and equipment, at cost |
|
|
3,264 |
|
|
|
3,015 |
|
Less: Accumulated depreciation and amortization |
|
|
1,173 |
|
|
|
1,051 |
|
|
|
|
|
|
|
|
Property and equipment, net |
|
$ |
2,091 |
|
|
$ |
1,964 |
|
|
|
|
|
|
|
|
As of March 31, 2008 and December 31, 2007, laboratory equipment and other includes
approximately $98,000 of office equipment financed under a capital lease with accumulated
depreciation of approximately $24,000 and $19,000, respectively. Depreciation expense, which
includes amortization of assets recorded under capital leases, was approximately $122,000 and
$66,000 for the three months ended March 31, 2008 and 2007, respectively. In the three months ended
March 31, 2007, the Company sold and wrote off unused furniture and obsolete software, computers
and other equipment that had an aggregate cost of approximately $49,000 resulting in a gain of
approximately $3,000.
(5) Restricted Cash
As part of the operating lease entered into by the Company in October 2006, the Company was
required to restrict $619,000 of cash for a security deposit. These funds are held in certificates
of deposit securing a line of credit for the lessor. The restricted cash is expected to be reduced
by approximately $103,000 upon each of the second, third and fourth anniversaries of the lease
commencement date of June 2007, subject to certain conditions.
(6) Note Payable
In June 2007, the Company executed a promissory note in the aggregate principal amount of $1.3
million (the Note) in favor of General Electric Capital Corporation (GE). The Note was fully
secured by specific laboratory, manufacturing, office and computer equipment and was subject to the
terms of a master security agreement dated April 23, 2007 by and between the Company and GE. The
Note bore interest at a fixed rate of 11% per annum, and
10
was payable in 48 consecutive monthly installments of principal and accrued interest, with the
first installment having been paid out of the proceeds of the borrowing.
In March 2008, the Company paid approximately $1,189,000 to General Electric Capital
Corporation as payment in full of all obligations outstanding under the Companys Note with GE. The
payment represented approximately $1,121,000 of principal amount outstanding plus accrued interest
through the date of payment of approximately $12,000 and a prepayment premium of approximately
$56,000. The Note was cancelled in March 2008.
(7) 4% Convertible Notes Payable
In May 2005, the Company sold approximately $5,033,000 in aggregate principal amount of 4%
convertible subordinated notes that were due April 30, 2008 (the 4% Notes). In February 2007, the
Company automatically converted these 4% Notes into 706,844 shares of the Companys common stock.
In accordance with the terms of the 4% Notes and an agreement dated May 20, 2005, among the Company
and the holders of the 4% Notes, the Company was entitled to exercise this right of automatic
conversion because the volume-weighted average of the closing prices of the Companys common stock,
for a period of ten consecutive trading days, exceeded $8.90 per share, which represented 125% of
the conversion price of the 4% Notes. As of February 20, 2007, the 4% Notes were no longer
considered outstanding and interest ceased to accrue. Holders of the 4% Notes were paid cash in
lieu of any fractional shares and $61,000 in accrued interest through February 19, 2007.
The Company capitalized its financing costs associated with the sale of the 4% Notes and
amortized them as interest expense through February 19, 2007. The unamortized balance of the
deferred financing costs of $266,000 was reclassified to additional paid-in-capital in connection
with the automatic conversion of the 4% Notes in the three months ended March 31, 2007.
(8) Comprehensive Loss
The following table includes the components of comprehensive loss for the three months ended
March 31, 2008 and 2007.
|
|
|
|
|
|
|
|
|
(in thousands) |
|
March 31, 2008 |
|
|
March 31, 2007 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(2,171 |
) |
|
$ |
(2,528 |
) |
Other comprehensive loss |
|
|
(10 |
) |
|
|
(8 |
) |
|
|
|
|
|
|
|
Total comprehensive loss |
|
$ |
(2,181 |
) |
|
$ |
(2,536 |
) |
|
|
|
|
|
|
|
Other comprehensive loss represents the net unrealized losses on available-for-sale investments.
(9) License Agreement with Merck KGaA
In December 2007, the Company entered into an exclusive, worldwide license agreement with
Merck KGaA to research, develop and commercialize products containing the Companys TLR9 agonists
for the treatment of cancer, excluding cancer vaccines, which agreement became effective February
4, 2008. Under the terms of the agreement, Idera granted Merck KGaA worldwide exclusive rights to
its lead TLR9 agonists, IMO-2055 and IMO-2125, and to a specified number of novel, follow-on TLR9
agonists to be identified by Merck KGaA and the Company under a research collaboration, for use in
the treatment, cure and/or delay of the onset or progression of cancer in humans. Under the terms
of the agreement, in February 2008 Merck KGaA paid the Company a $40.0 million upfront license fee
in Euros of which $39.7 million was received due to foreign currency exchange rates in effect at
that time. The Company is recognizing the $40.0 million upfront payment paid under the
collaboration as revenue over the expected period of the Companys continuing involvement. Merck
KGaA also agreed to reimburse future development costs for certain of the Companys on-going
IMO-2055 clinical trials, which will continue to be conducted by Idera; Merck KGaA agreed to pay up
to EUR 264 million in development, regulatory approval, and commercial success milestone payments
if products containing the Companys TLR9 agonist compounds are successfully developed and marketed
11
for treatment, cure and/or delay of the onset or progression of cancer in humans; and Merck
KGaA agreed to pay royalties on net sales of products containing our TLR9 agonists that are
marketed.
(10) Collaboration and License Agreement with Novartis International Pharmaceutical, Ltd.
In May 2005, the Company entered into a research collaboration and option agreement and a
separate license, development and commercialization agreement with Novartis to discover, develop
and potentially commercialize TLR9 agonists that are identified as potential treatments for asthma
and allergies. The Company and Novartis agreed that the term of the research and collaboration
phase would be two years commencing in May 2005. The Company initially was recognizing the $4.0
million upfront payment paid under the collaboration as revenue over the two-year term of the
research collaboration. In February 2007, Novartis elected to extend the research collaboration by
an additional year. As a result of such extension, Novartis paid the Company an additional $1.0
million in May 2007. In March 2008, the Company agreed to extend the research collaboration until
December 31, 2008. The extension is anticipated to allow for the advancement of QAX935, a novel
agonist of TLR9, into human clinical trials prior to the end of the research collaboration term.
The Company amortizes the upfront payment and the extension payment over the expected research
term.
(11) Stock-Based Compensation
The Company accounts for share-based payments to employees under SFAS No. 123R, Share-Based
Payment, (SFAS No. 123R). This statement requires the Company to recognize all share-based
payments to employees in the financial statements based on their fair values. Under SFAS No. 123R,
the Company is required to record compensation expense over an awards vesting period based on the
awards fair value at the date of grant. The Companys policy is to charge the fair value of stock
options as an expense on a straight-line basis over the vesting period. The Company included
charges of $659,000 and $345,000 in its statements of operations for the three months ended March
31, 2008 and 2007, respectively, representing the stock compensation expense computed in accordance
with SFAS No. 123R.
The Companys
stock compensation plans include the 1995 Stock Option Plan, the 1995 Director
Stock Option Plan, the 1995 Employee Stock Purchase Plan, the 1997 Stock Incentive Plan and the
2005 Stock Incentive Plan, all of which have been approved by the
Companys stockholders. No additional options are being granted
under the 1995 Stock Option Plan, the 1995 Director Stock Option Plan and the 1997 Stock Incentive Plan. In 2001, the Company also granted options to purchase shares of
Common Stock pursuant to agreements that were not approved by stockholders.
The fair value of each option award is estimated on the date of grant using the Black-Scholes
option-pricing model and expensed over the requisite service period on a straight-line basis. The
following assumptions apply to the options granted for the three months ended March 31, 2008 and
2007:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2008 |
|
2007 |
Average risk free interest rate |
|
|
3.3 |
% |
|
|
4.7 |
% |
Expected dividend yield |
|
|
|
|
|
|
|
|
Expected lives |
|
5 years |
|
6 years |
Expected volatility |
|
|
65.0 |
% |
|
|
70.6 |
% |
Weighted average grant date
fair value of options granted
during the period (per share) |
|
$ |
7.57 |
|
|
$ |
4.91 |
|
The Company
also awarded non-employee stock options to purchase 60,000 shares of common stock
during the first quarter of 2008. These options had a Black-Scholes fair value of $710,000 at the
time of grant based on a risk free interest rate of 3.9%, an expected life of 10 years, and an
expected volatility of 95%. The fair value of the nonvested portion of the non-employee options
will be remeasured each quarter in accordance with EITF No. 96-18, Accounting for Equity
Instruments That Are Issued to Other than Employees for Acquiring, or in Conjunction with
12
Selling, Goods or Services (EITF No. 96-18). Approximately $103,000 and $90,000 was recorded
as an expense for non-employee stock options in the three months ended March 31, 2008 and 2007,
respectively.
(12) Alternative Minimum Tax
Merck KGaA paid the Company in February 2008 a $40.0 million upfront license fee in Euros of
which $39.7 million was received due to foreign currency exchange rates in effect at that time. As
of March 31, 2008, the Company made an estimated quarterly tax payment of $50,000 as a result of
this payment generating income subject to the alternative minimum tax or AMT. The Company did not
have income subject to AMT for the three months ended March 31, 2007.
(13) Net Loss per Common Share
Basic and diluted net loss per common share is computed using the weighted average number of
shares of common stock outstanding during the period. For the three months ended March 31, 2008 and
2007, diluted net loss per share of common stock is the same as basic net loss per share of common
stock, as the effects of the Companys potential common stock equivalents are antidilutive. Total
antidilutive securities were 6,976,663 and 7,475,086 for the three months ended March 31, 2008 and
2007, respectively, and consist of stock options, warrants and convertible preferred stock. Net
loss applicable to common stockholders is the same as net loss for the three months ended March 31,
2008 and 2007.
(14) Warrant Redemption
In January 2008, the Company sent notice to holders of the Companys warrants to purchase
common stock that were issued in August 2004 with an expiration date of August 27, 2009 (the
August 2004 Warrants) that under the terms of the warrant agreement, it intended to redeem on
March 31, 2008 any August 2004 Warrants not exercised as of that date for a redemption price of
$0.08 per share of common stock underlying the August 2004 Warrants. The Company was entitled to
exercise this redemption right because the closing price of the Companys common stock for twenty
consecutive trading days ending December 20, 2007 was greater than $10.72 or 200% of the exercise
price of the warrant. The August 2004 Warrants were exercisable by cash payment only and had an
exercise price of $5.36 per share of common stock. Following such notice and through March 31,
2008, the Company received approximately $1,472,000 in proceeds from the exercise of August 2004
Warrants to purchase 274,650 shares of common stock. As of March 31, 2008, all August 2004 Warrants
had been exercised.
(15) Related Party Transactions
During the three months ended March 31, 2008, the Company paid Dr. Robert W. Karr, a director
of the Company, $47,000 for consulting services. The Company had no related party transactions in
the three months ended March 31, 2007.
(16) Subsequent Event
In April 2008, the Company, under its collaboration agreement with Merck & Co., achieved a
preclinical milestone with one of its novel TLR9 agonists used as an adjuvant in cancer vaccines.
As a result, the Company is entitled to receive a $1.0 milestone payment from Merck & Co.
13
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
GENERAL
We are engaged in the discovery and development of DNA- and RNA-based drug candidates targeted
to Toll-Like Receptors, or TLRs, to treat infectious diseases, autoimmune diseases, cancer, and
asthma and allergies, and for use as vaccine adjuvants. Drug candidates are compounds that we are
developing and have not been approved for any commercial use. TLRs are specific receptors present
in immune system cells that recognize the DNA or RNA of pathogens such as bacteria or viruses and
initiate an immune response. Relying on our expertise in DNA and RNA chemistry, we have designed
and created proprietary TLR agonists and antagonists to modulate immune responses. A TLR agonist is
a compound that stimulates an immune response through the targeted TLR. A TLR antagonist is a
compound that blocks activation of an immune response through the targeted TLR.
We are focused on developing TLR-targeted compounds for the potential treatment of infectious
diseases, autoimmune diseases, and cancer. IMO-2125, a TLR9 agonist, is our lead drug candidate for
infectious diseases. At present, we are conducting a Phase 1 clinical trial of IMO-2125 in patients
with chronic hepatitis C virus infection who have not responded to current standard of care
therapy. As part of our infectious disease program, we are also evaluating RNA-based compounds
that act as agonists of TLR7 and TLR8. We have evaluated these compounds in preclinical studies in
human cell-based assays and in vivo in non-human primates. We intend to further evaluate these
compounds in preclinical models of infectious disease. In our autoimmune disease program, we have
identified DNA-based compounds that act as antagonists of TLR7 and TLR9. We have evaluated these
compounds in various preclinical studies, including in mouse models of lupus and rheumatoid
arthritis. We are currently conducting further preclinical studies to explore the potential of
these compounds in treating multiple sclerosis and psoriasis. Our cancer treatment research program
is focused on potential applications of our TLR7 and TLR8 agonists. We intend to further evaluate
these compounds in preclinical models of cancer.
In addition, we are collaborating with three pharmaceutical companies to advance our
TLR-targeted compounds in multiple disease areas. We are collaborating with Merck KGaA to research,
develop, and commercialize products containing our TLR9 agonists, including IMO-2055, for the
treatment of cancer, excluding cancer vaccines. We are also collaborating with Merck & Co., Inc.
for the use of our TLR7, 8 and 9 agonists in combination with Merck & Co.s therapeutic and
prophylactic vaccines in the areas of oncology, infectious diseases, and Alzheimers disease and
with Novartis International Pharmaceutical, Ltd., for the discovery, development, and
commercialization of our TLR9 agonists for the treatment of asthma and allergy indications. Merck
KGaA and Merck & Co. are not related.
As of March 31, 2008, we had an accumulated deficit of $344.9 million. We may incur
substantial operating losses in future periods. We do not expect to generate significant funds
until we successfully complete development and obtain marketing approval for products, either alone
or in collaborations with third parties, which we expect will take a number of years. In order to
commercialize our products, we need to address a number of technological challenges and to comply
with comprehensive regulatory requirements. In 2008, we expect that our research and development
expenses will be higher than our research and development expenses in 2007 as we expand our
IMO-2125 development program and accelerate our early-stage programs on TLR antagonists and on
agonists of TLR7 and TLR8.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
This managements discussion and analysis of financial condition and results of operations is
based on our 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
14
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 are believed 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 Financial
Statements in our Annual Report on Form 10-K for the year ended December 31, 2007. 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 and stock based compensation,
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, 2007, fit the definition of critical accounting estimates and
judgments.
RESULTS OF OPERATIONS
Three Months Ended March 31, 2008 and 2007
Revenue
Total alliance revenue increased by $2,943,000, or 161%, from $1,829,000 for the three months
ended March 31, 2007 to $4,772,000 for the three months ended March 31, 2008. This increase was
primarily due to $2,667,000 of license fees we recognized under our collaboration agreement with
Merck KGaA, which became effective February 4, 2008. We are recognizing the $40.0 million upfront
payment we received from Merck KGaA in February 2008 over the expected research
term under the agreement. The increase is also attributable to reimbursed expenses of $103,000
related to conducting certain clinical trials under our collaboration
agreement with Merck KGaA and increased reimbursed research costs of $301,000 under our collaboration agreement with Merck & Co. Revenue
for both periods also includes $1,250,000 in license fee revenue recognized under our collaboration
with Merck & Co. For the three months ended March 31, 2008, we recognized $309,000 in license fee
revenue under our collaboration with Novartis compared to $297,000 recognized in the three months
ended March 31, 2007.
Our revenues for both periods were comprised of revenue earned under various collaboration and
licensing agreements for research and development, including reimbursement of internal and
third-party expenses, and license fees, sublicense fees, and royalty payments.
Research and Development Expenses
Research and development expenses increased by $1,715,000, or 61%, from $2,819,000 for the
three months ended March 31, 2007 to $4,534,000 for the three months ended March 31, 2008. The
increase in research and development expenses in the three months ended March 31, 2008 compared to
the three months ended March 31, 2007 was primarily due to increased non-clinical safety studies
and clinical costs associated with IMO-2125, increased clinical costs associated with IMO-2055, a
portion of which are reimbursed under our agreement with Merck KGaA, and increased research
expenses under our Merck & Co. agreement, which are also reimbursed.
15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
Percentage |
|
|
|
(In thousands) |
|
|
Increase |
|
|
|
2008 |
|
|
2007 |
|
|
(Decrease) |
|
IMO-2055 External Development Expense |
|
$ |
556 |
|
|
$ |
375 |
|
|
|
48 |
% |
IMO-2125 External Development Expense |
|
|
1,262 |
|
|
|
|
|
|
|
|
|
Other Drug Development Expense |
|
|
1,024 |
|
|
|
1,183 |
|
|
|
(13 |
%) |
Basic Discovery Expense |
|
|
1,692 |
|
|
|
1,261 |
|
|
|
34 |
% |
|
|
|
|
|
|
|
|
|
|
|
Total Research and Development Expense |
|
$ |
4,534 |
|
|
$ |
2,819 |
|
|
|
61 |
% |
|
|
|
|
|
|
|
|
|
|
|
In the preceding table, research and development expense is set forth in the following four
categories:
IMO-2055 External Development Expenses. These expenses include external expenses that we have
incurred in connection with IMO-2055, our lead compound being developed for oncology applications.
These external expenses reflect payments to independent contractors and vendors for drug
development activities conducted after the initiation of IMO-2055 clinical trials and drug
manufacturing and related costs but exclude internal costs such as payroll and overhead expenses.
Since 2003, when we commenced clinical development of IMO-2055, we have incurred approximately
$13.1 million in external expenses through March 31, 2008 in connection with IMO-2055. External
development expenses for IMO2055 increased by $181,000, or 48%, from $375,000 for the three months
ended March 31, 2007 to $556,000 for the three months ended March 31, 2008. The increase in
IMO-2055 expenses for the three months ended March 31, 2008 compared to the same period in 2007 was
primarily attributable to higher clinical trial expenses as we advanced our Phase 1b combination
trial of IMO-2055 in patients with non-small cell lung cancer and preparations for data analysis
and report preparation for our Phase 2 clinical trial of IMO-2055 in patients with metastatic or
recurrent clear cell renal cancer. Under our collaboration agreement with Merck KGaA, we will be
reimbursed approximately $0.1 million for the Phase 1b combination trial expenses incurred in the
three months ended March 31, 2008.
In October 2004, we commenced patient recruitment for an open label, multi-center Phase 2
Stage A clinical trial of IMO-2055 as a monotherapy in patients with metastatic or recurrent clear
cell renal cancer. Under the protocol for the trial, we sought to enroll a total of up to 92
patients in Stage A of the trial, 46 who had failed one prior therapy and 46 who were
treatment-naïve. We closed enrollment in this trial on June 29, 2007. As of that date, we had
enrolled 46 treatment-naïve patients and 45 patients who had failed one prior therapy. At present,
the last patient has stopped receiving treatment in the trial and has entered the follow-up period.
Data collection and preparations for the analysis are underway and we expect the data to be
available in the third quarter of 2008. Once the final results are available, we expect to report
them at an appropriate scientific meeting and under our collaboration with Merck KGaA, they will
determine how to proceed with IMO-2055 in the treatment of metastatic or recurrent clear cell renal
cancer.
In October 2005, we began patient recruitment in the Phase 1 portion of a clinical trial of
IMO-2055 in combination with the chemotherapy agents gemcitabine and carboplatin in patients with
refractory solid tumor cancers. The purpose of the Phase 1 portion of the trial, which was a single
center, open label study, was to evaluate the safety of the chemotherapy combination. Three dose
levels of IMO-2055 and three treatment schedules of IMO-2055 were investigated in this trial. We
enrolled twenty-two patients in this trial and closed enrollment in July 2007. We reported interim
data from 19 patients from this trial at the 12th World Conference on Lung Cancer in Seoul, Korea,
in September 2007. The interim data suggested that it was feasible for the combination of IMO-2055,
gemcitabine, and carboplatin to be administered in patients with advanced solid tumors. The only
dose-limiting toxicities observed in these patients were common side effects observed with
gemcitabine and carboplatin. In these 19 patients, the response rate, progression-free survival,
and overall survival were 5%, 4.1 months, and 12.9 months, respectively. In the subset of eight
patients with non-small cell lung cancer, the response rate, progression-free survival, and overall
survival were 13%, 6.5 months and 12.9 months, respectively.
In December 2007, we initiated a Phase 1b trial of IMO-2055 in combination with Avastin and
Tarceva in non-small cell lung cancer patients whose cancer had progressed during a prior course of
standard therapy. The trial is designed to assess safety of the IMO-2055, Tarceva and Avastin
combination and to determine the recommended dosage of IMO-2055 for potential use in a subsequent
Phase 2 trial. Three dose levels of IMO-2055 are being investigated with standard dosages and
schedules of Tarceva and Avastin. IMO-2055 is administered subcutaneously once a week, with each
patient continuing to receive therapy until disease progression as determined by Response
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Evaluation Criteria in Solid Tumors, or RECIST, or another protocol-specified stopping criterion is
met. We are currently recruiting patients for the trial, which was designed with a target
enrollment of up to 40 patients.
In 2007, we made plans to initiate a clinical trial in the U.S. to investigate IMO-2055 in
combination with Erbitux, a recombinant, humanized antibody to epidermal growth factor receptor,
and Camptosar, a cytotoxic, chemotherapeutic agent that inhibits topoisomerase I function, in
patients with colorectal cancer. The Phase 1b trial is designed to evaluate multiple dose levels of
IMO-2055 with established treatment regimens for Erbitux and Camptosar.
Under our agreement with Merck KGaA, we will complete the ongoing Phase 2 Stage A renal cell
cancer trial and the Phase 1 refractory solid tumor chemotherapy combination trial. We also have
agreed with Merck KGaA that we will continue to conduct on its behalf the on-going Phase 1b
non-small cell lung cancer trial and that we may initiate the proposed Phase 1b colorectal cancer
trial. Merck KGaA has agreed to reimburse us for the development costs associated with these two
Phase 1b clinical trials incurred after February 4, 2008, which is the date our agreement with
Merck KGaA became effective.
IMO-2125 External Development Expenses. These expenses include external expenses that we have
incurred in connection with IMO-2125, our lead compound initially being developed for chronic
hepatitis C virus infection. These external expenses reflect payments to independent contractors
and vendors for drug development activities conducted after the initiation of the first IMO-2125
clinical trial but exclude internal costs such as payroll and overhead expenses. We commenced
clinical development of IMO-2125 in May 2007 and since then we have incurred approximately $2.4
million in external development expenses through March 31, 2008 in connection with IMO-2125,
including costs associated with the initiation of our Phase 1 clinical trial and related
non-clinical studies and manufacturing process development.
In May 2007, we submitted an investigational new drug, or IND, application for IMO-2125 to the
United States Food and Drug Administration, or FDA, and in September 2007, we initiated a Phase 1
study of IMO-2125 in patients with chronic hepatitis C virus infection who have not responded to
the current standard of care treatment. We plan to enroll up to 40 patients in four cohorts at
escalating IMO-2125 dose levels, with four weeks of treatment. Of the ten patients per cohort,
eight will be randomized to receive IMO-2125 treatment and two will be randomized to receive
placebo treatment. The trial is designed to assess the safety of IMO-2125 at each dose level.
Secondary objectives include assessments of the effects of IMO-2125 on hepatitis C virus RNA levels
and parameters of immune system activation. We anticipate interim results from this trial to be
available in the first half of 2009.
Other Drug Development Expenses. These expenses include internal and external expenses
associated with preclinical development of identified compounds in anticipation of advancing these
compounds into clinical development in addition to internal costs associated with products in
clinical development.
The internal and external expenses associated with preclinical compounds include payments to
contract vendors for manufacturing and the related stability studies, preclinical studies including
animal toxicology and pharmacology studies and professional fees, as well as payroll and overhead
expenses. Expenses associated with products in clinical development include costs associated with
our Hepatitis C Clinical Advisory Board, our Oncology Clinical Advisory Board, payroll and overhead
expenses.
Other drug development expenses decreased by $159,000, or 13%, from $1,183,000 for the three
months ended March 31, 2007 to $1,024,000 for the three months ended March 31, 2008. The decrease
in the three months ended March 31, 2008 compared to the same period in 2007 was primarily due to
pre-IND direct external expenses related to IMO-2125, which were included for the three months
ended March 31, 2007 but not March 31, 2008 since costs incurred after the May 2007 submission of
the IMO-2125 IND have been shown separately in the above table. The decrease in other drug
development expenses during 2008 was offset, in part, by increased allocated costs associated with
the move to our new facility during the second quarter of 2007.
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Basic Discovery Expenses. These expenses include our internal and external expenses relating
to the discovery and development of our TLR-targeted programs, including agonists and antagonists
of TLRs 7, 8 and 9. These expenses reflect payments for laboratory supplies, external research, and
professional fees, as well as payroll and overhead expenses. Basic discovery expenses increased by
$431,000, or 34%, from $1,261,000 for the three months
ended March 31, 2007 to $1,692,000 for the three months ended March 31, 2008. The increase for
the three months ended March 31, 2008 compared to the same period in 2007 was primarily
attributable to an increase in payroll expenses, in part, relating to expanding research under our
Merck & Co. collaboration, an increase in compensation costs attributable, in part, to employee
stock options and an increase in allocated costs associated with the move to our new facility
during the second quarter of 2007.
We do not know if we will be successful in developing any drug candidate from our research and
development programs. At this time, without knowing the results of our ongoing clinical trials and
without an established plan for future clinical tests of drug candidates, we cannot reasonably
estimate or know the nature, timing and costs of the efforts that will be necessary to complete the
remainder of the development of, or the period, if any, in which material net cash inflows may
commence from, any drug candidate from our research and development programs. Moreover, the
clinical development any drug candidate from our research and development programs is subject to
numerous risks and uncertainties associated with the duration and cost of clinical trials, which
vary significantly over the life of a project as a result of unanticipated events arising during
clinical development.
General and Administrative Expenses
General and administrative expenses increased by $463,000 or 24%, from $1,953,000 in the three
months ended March 31, 2007 to $2,416,000 in the three months ended March 31, 2008. General and
administrative expenses consisted primarily of salary expense, stock compensation expense,
consulting fees and professional legal fees associated with our patent applications and
maintenance, our regulatory filing requirements, and our business development initiatives.
The increase in general and administrative expenses in the three months ended March 31, 2008
compared to the three months ended March 31, 2007 was primarily due to higher compensation expense
related to employee stock options and increased allocated costs associated with our new facility to
which we moved during the second quarter of 2007. The increase in employee stock option cost
during the three months ended March 31, 2008 is primarily attributable to options granted in the
current quarter at a time when our stock price was higher than in other quarters. These increased
expenses were offset, in part, by lower professional fees associated with marketing research.
Investment Income, net
Investment income decreased by approximately $71,000, or 15%, from $477,000 in the three
months ended March 31, 2007 to $406,000 in the three months ended March 31, 2008. This decrease
resulted from lower interest rates and lower average investment balances in the three months ended
March 31, 2008. These decreases were offset by interest earned on higher average cash balances in
the three months ended March 31, 2008.
Interest Expense
Interest expense increased by approximately $20,000, or 32%, from $62,000 in the three months
ended March 31, 2007 to $82,000 in the three months ended March 31, 2008. The increase is due to
interest and a prepayment premium associated with the note payable. We repaid the note payable in
full in March 2008 and the note was cancelled. This increase was offset, in part, by the conversion
of all our 4% notes, issued in May 2005, in the aggregate principal amount of approximately
$5,033,000 into 706,844 shares of common stock on February 20, 2007.
Foreign
Currency Exchange Loss
Foreign currency exchange loss was $267,000 in the three months ended March 31, 2008. There was no
foreign currency exchange loss in the three months ended March 31, 2007. In February 2008, Merck
KGaA paid us a $40,000,000 upfront license fee denominated in Euros. We received $39,733,000 U.S.
dollars due to foreign currency exchange rates in effect at the time we received the payment, which
resulted in the foreign currency exchange loss.
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Income Tax Expense
For the three months ended March 31, 2008, we recorded approximately $50,000 as income tax
expense as a result of income subject to the alternative minimum tax. We did not have income
subject to the alternative minimum tax for the three months ended March 31, 2007.
Net Loss Applicable to Common Stockholders
As a result of the factors discussed above, our net loss applicable to common stockholders was
$2,171,000 for the three months ended March 31, 2008 compared to $2,528,000 for the three months
ended March 31, 2007. We have incurred losses of $84.7 million since January 1, 2001. We also
incurred net losses of $260.2 million prior to December 31, 2000 during which time we were involved
in the development of antisense technology. Since our inception, we had an accumulated deficit of
$344.9 million through March 31, 2008. We may continue to incur substantial operating losses in the
future.
LIQUIDITY AND CAPITAL RESOURCES
Sources of Liquidity
We require cash to fund our operating expenses, to make capital expenditures and to pay debt
service. Historically, we have funded our cash requirements primarily through the following:
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equity and debt financing; |
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license fees and research funding under collaborative and license agreements; |
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interest income; and |
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lease financings. |
In January 2008, we sent notice to holders of our warrants to purchase common stock that were
issued in August 2004 with an expiration date of August 27, 2009, or the August 2004 Warrants, that
under the terms of the warrant agreement, we intended to redeem on March 31, 2008 any August 2004
Warrants not exercised as of that date for a redemption price of $0.08 per share of common stock
underlying the August 2004 Warrants. We were entitled to exercise this redemption right because the
closing price of our common stock for twenty consecutive trading days ending December 20, 2007 was
greater than $10.72 or 200% of the exercise price of the warrant. The August 2004 Warrants were
exercisable by cash payment only and had an exercise price of $5.36 per share of common stock.
Following the January 2008 notice of redemption and through March 31, 2008, we received
approximately $1,472,000 in proceeds from the exercise of August 2004 Warrants to purchase 274,650
shares of common stock. As of March 31, 2008, all August 2004 Warrants had been exercised.
In December 2007, we entered into an exclusive, worldwide license agreement with Merck KGaA to
research, develop and commercialize products containing our TLR9 agonists for the treatment of
cancer, excluding cancer vaccines. Under the terms of the agreement, in February 2008 Merck KGaA
paid us a $40.0 million upfront license fee in Euros of which we received $39.7 million due to
foreign currency exchange rates.
In June 2007, we executed a promissory note in the aggregate principal amount of $1.3 million
in favor of General Electric Capital Corporation. The promissory note was secured by specific
laboratory, manufacturing, office and computer equipment and was subject to the terms of a master
security agreement between us and GE. The promissory note bore interest at a fixed rate of 11% per
annum, and was payable in 48 consecutive monthly installments of principal and accrued interest,
with the first installment having been paid out of the proceeds of the borrowing. In March 2008, we
paid approximately $1.2 million to GE as payment in full of all obligations outstanding under our
promissory note with GE. The payment represented approximately $1.1 million of principal amount
outstanding plus accrued interest through the date of payment and a prepayment premium of
approximately $0.1 million. The note has been cancelled.
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Cash Flows
As of March 31, 2008, we had approximately $61.8 million in cash and cash equivalents and
investments, a net increase of approximately $38.1 million from December 31, 2007. Operating
activities provided $35.2 million of cash during the first quarter of 2008. The $35.2 million
primarily reflects the $40.0 million upfront payment less the $0.3
million foreign currency exchange loss under our agreement with Merck KGaA offset, in part, by
our $2.1 million net loss for the period, as adjusted for non-cash revenue and expenses, including
depreciation and amortization, stock-based compensation, and changes in deferred revenue and our
accounts receivable and payable.
The net cash provided by investing activities during the first quarter of 2008 of $0.7 million
reflects our purchase of approximately $7.1 million in securities offset by the proceeds of
approximately $8.0 million from securities that matured in the first quarter of 2008. The net cash
used in investing activities also reflects our purchases of laboratory and computer equipment in
the first quarter of 2008.
The net cash provided by financing activities during the first quarter of 2008 of $3.1 million
reflects proceeds received from the exercise of stock options and warrants during the first quarter
of 2008 offset by the repayment of our promissory note.
Funding Requirements
We have incurred operating losses in all fiscal years except 2002 and had an accumulated
deficit of $344.9 million at March 31, 2008. We had cash, cash equivalents and short-term
investments of $61.8 million at March 31, 2008. We believe that our existing cash, cash equivalents
and short-term investments will be sufficient to fund our operations at least through March 31,
2010. We may 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 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. Should we be unable to raise sufficient funds in the future, 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 success of our existing strategic collaborations with Merck KGaA, Merck & Co. and
Novartis; |
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the cost, timing and outcome of regulatory reviews; and |
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our ability to enter into new strategic collaborations with biotechnology and
pharmaceutical companies and the success of such collaborations.
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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 that 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. Debt financing,
if available, may involve agreements that include covenants limiting or restricting our ability to
take specific actions, such as incurring additional debt, making capital expenditures or declaring
dividends, and are
likely to include rights that are senior to the holders of our common stock. Any additional
debt financing or equity that we raise may contain terms, such as liquidation and other
preferences, or liens or other restrictions on our assets, which are not favorable to us or our
stockholders. 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.
Contractual Obligations
We have contractual obligations in the form of operating and capital leases. In March 2008, we
paid approximately $1.2 million to General Electric Capital Corporation as payment in full of all
obligations outstanding under our note with GE. The payment represented approximately $1.1 million
of principal amount outstanding plus accrued interest through the date of payment and a prepayment
premium. The note has been cancelled.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As of March 31, 2008, we had approximately $0.1 million of receivables denominated in Euros.
We had no other assets and liabilities related to non-dollar-denominated currencies as of March 31,
2008.
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 period covered by this report. 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 March 31, 2008, 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.
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(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 March 31, 2008 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 1A. RISK FACTORS
Investing in our common stock involves a high degree of risk. 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 on Form 10-Q before purchasing our common stock.
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, and you may lose all or part of the money you paid to buy our common stock.
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.
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 our reporting net
income for that year. As of March 31, 2008, we had an accumulated deficit of $344.9 million. We
have incurred losses of $84.7 million since January 1, 2001. We also incurred losses of $260.2
million prior to December 31, 2000 during which time we were primarily involved in the development
of antisense technology. We may 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 never had any products of our own available for commercial sale and 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 research and
development programs and other operations.
We will require substantial funds to conduct research and development, including preclinical
testing and clinical trials of our drug candidates. 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 at least through
March 31, 2010.
We will need to raise additional funds to operate our business beyond such time, including
completing any on-going clinical trials involving IMO-2125 or other drug candidates we may develop.
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 success of our existing strategic collaborations with Merck KGaA, Merck & Co.
and Novartis; |
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the cost, timing and outcome of regulatory reviews; |
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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 additional strategic collaborations with biotechnology
and pharmaceutical companies and the success of such collaborations. |
If we cannot obtain adequate funds, we may terminate, modify or delay preclinical or clinical
trials of one or more of our drug candidates, fail to establish or delay the establishment of
manufacturing, sale or marketing capabilities, or curtail research and development programs for new
drug candidates.
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 that 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. Debt
financing, if available, may involve agreements that include covenants limiting or restricting our
ability to take specific actions, such as incurring additional debt, making capital expenditures or
declaring dividends, and are likely to include rights that are senior to the holders of our common
stock. Any additional debt financing or equity that we raise may contain terms, such as liquidation
and other preferences, or liens or other restrictions on our assets, which are not favorable to us
or our 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 for infectious diseases,
IMO-2125, and our collaborative programs. If we or our collaborators are unable to successfully
develop and commercialize our drug candidates, 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 clinical stage lead drug candidate for infectious diseases, IMO-2125. We anticipate that our
ability to generate product revenues will depend heavily on the successful development and
commercialization of IMO-2125 and other drug candidates including drug candidates being developed
by our collaborators. The commercial success of these drug candidates will depend on several
factors, including the following:
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acceptable safety profile during clinical trials; |
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demonstration of statistically recognized efficacy in clinical trials; |
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ability to combine IMO-2125 safely and successfully with other antiviral agents; |
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receipt of marketing approvals from the FDA and equivalent foreign regulatory authorities; |
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establishment of commercial manufacturing arrangements with third-party manufacturers; |
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the successful commercial launch of the drug candidates, whether alone or in collaboration
with other products; |
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acceptance of the products by the medical community and third-party payors; |
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competition from other companies and their therapies; |
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successful protection of our intellectual property rights from competing products in the
United States and abroad; and |
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a continued acceptable safety and efficacy profile of our drug candidates following approval. |
Our efforts to commercialize IMO-2125 are at an early stage, as we are currently conducting
the initial Phase 1 safety clinical trial of this drug candidate in a defined patient population.
If we are not successful in commercializing this or our other drug candidates, or are significantly
delayed in doing so, our business will be materially harmed.
If our clinical trials are unsuccessful, or if they are delayed or terminated, we may not be able
to develop and commercialize our products.
In order to obtain regulatory approvals for the commercial sale of our products, we are
required to complete extensive clinical trials in humans to demonstrate the safety and efficacy of
our drug candidates. Clinical trials are lengthy, complex and expensive processes with uncertain
results. We may not be able to complete any clinical trial of a potential product within any
specified time period. Moreover, clinical trials may not show our potential products to be both
safe and efficacious. The FDA and other regulatory authorities may not approve any of our potential
products for any indication. 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. Furthermore, interim results of a clinical trial do not necessarily
predict final results and failure of any of our clinical trials can occur at any stage of testing.
Companies in the biotechnology and pharmaceutical industries, including companies with greater
experience in preclinical testing and clinical trials than we have, have suffered significant
setbacks in clinical trials, even after demonstrating promising results in earlier trials. For
example in June 2007, Coley Pharmaceutical Group, which since has been acquired by Pfizer, Inc.,
discontinued four clinical trials in lung cancer for PF-3512676, its investigational TLR9 agonist
compound, in combination with cytotoxic chemotherapy. In addition, in January 2007, Coley
Pharmaceutical Group announced that it had suspended its development of a TLR9 agonist,
Actilon ® , for hepatitis C virus infection. In July 2007, Anadys Pharmaceuticals, Inc.
and its partner Novartis announced that they had decided to discontinue the development of ANA975,
the investigational TLR7 agonist compound for hepatitis C virus infection. In March 2008, Dynavax
Technologies announced that two investigational new drug applications for its proprietary TLR9
agonist, HEPLISAV, had been placed on clinical hold by the FDA.
There are to date few data on the long-term clinical safety of our lead compounds under
conditions of prolonged use in humans, or on any long-term consequences subsequent to human use.
Effects seen in preclinical studies, even if not observed in clinical trials, may result in
limitations or restrictions on our clinical trials. We may experience numerous unforeseen events
during, or as a result of, preclinical testing, nonclinical testing, or the clinical trial process
that could delay or inhibit our ability to receive regulatory approval or to 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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nonclinical or clinical data may not be readily interpreted, which may lead to delays and/or
misinterpretation; |
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our nonclinical tests, including toxicology studies, or clinical trials may produce negative or
inconclusive results, and we may decide, or regulators may require us, to conduct additional
nonclinical testing or clinical trials or we may abandon projects that we expect may not be
promising; |
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the rate of enrollment or retention of patients in our clinical trials may be less than expected; |
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we might have to suspend or terminate our clinical trials if the participating patients
experience serious adverse events or undesirable side effects or are 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,
including any issues identified through inspections of manufacturing or clinical trial
operations or clinical trial sites; |
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regulators may hold or suspend our clinical trials while collecting supplemental information on,
or clarification of, our clinical trials or other clinical trials, including trials conducted in
other countries or trials conducted by other companies; |
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we, along with our collaborators and subcontractors, may not employ, in any capacity, persons
who have been debarred under the FDAs Application Integrity Policy. Employment of such debarred
persons, even if inadvertently, may result in delays in the FDAs review or approval of our
products, or the rejection of data developed with the involvement of such person(s); |
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the cost of our clinical trials may be greater than we currently anticipate; and |
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our products may not cause the desired effects or may cause undesirable side effects or our
products may have other unexpected characteristics. |
As an example, in 1997, after reviewing the results from the clinical trial of GEM91, a first
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 drug candidate.
The rate of completion of clinical trials is dependent in part upon the rate of enrollment of
patients. For example, in Stage A of our Phase 2 trial of IMO-2055 in renal cell cancer, enrollment
was slower than projected due to the recent approval of two new therapies, Sutent ® and
Nexavar ®, developed by other companies for treatment of the same patient populations.
Patient accrual is a function of many factors, including:
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the size of the patient population; |
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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. |
We do not know whether 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.
Delays in commencing clinical trials of potential products could increase our costs, delay any
potential revenues and reduce the probability that a potential product will receive regulatory
approval.
Our drug candidates and our collaborators drug candidates will require preclinical and other
nonclinical testing and extensive clinical trials prior to submission of any regulatory application
for commercial sales. In 2007, we commenced a new Phase 1b clinical trial of IMO-2055 in oncology,
and we commenced a Phase 1 clinical trial of IMO-2125 for chronic hepatitis C virus infection. In
conducting clinical trials, we cannot be certain that any planned clinical trial will begin on
time, if at all. Delays in commencing clinical trials of potential products could increase our
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product development costs, delay any potential revenues and reduce the probability that a
potential product will receive regulatory approval.
Commencing clinical trials may be delayed for a number of reasons, including delays in:
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manufacturing sufficient quantities of drug candidate that satisfy the required quality
standards for use in clinical trials; |
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demonstrating sufficient safety to obtain regulatory approval for conducting a clinical trial; |
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reaching an agreement with any collaborators on all aspects of the clinical trial; |
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reaching agreement with contract research organizations, if any, and clinical trial sites on
all aspects of the clinical trial; |
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resolving any objections from the FDA or any regulatory authority on an IND application or
proposed clinical trial design; |
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obtaining Institutional Review Board approval for conducting a clinical trial at a
prospective site; and |
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enrolling patients in order to commence the clinical trial. |
The technologies on which we rely are unproven and may not result in any approved and marketable
products.
Our technologies or therapeutic approaches are relatively new and unproven. We have focused
our efforts on the research and development of RNA- and DNA-based compounds targeted to TLRs.
Neither we nor any other company have obtained regulatory approval to market such compounds as
therapeutic drugs, and no such products currently are being marketed. It is unknown whether the
results of preclinical studies with TLR-targeted compounds will be indicative of results that may
be obtained in clinical trials, and results we have obtained in the initial small-scale clinical
trials we have conducted to date may not be predictive of results in subsequent large-scale trials.
Further, the chemical and pharmacological properties of RNA- and DNA-based compounds targeted to
TLRs may not be fully recognized in preclinical and small-scale clinical trials, and such compounds
may interact with human biological systems in unforeseen, ineffective, or harmful ways that we have
not yet identified. As a result of these factors, we may never succeed in obtaining a regulatory
approval to market any product. Furthermore, 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, safe,
and cost-effective. In addition, if products based upon TLR technology being developed by our
competitors have negative clinical trial results or otherwise are viewed negatively, the perception
of our TLR technology and market acceptance of our products could be impacted negatively. For
example, we are pursuing an indication for treatment of chronic hepatitis C virus infection for
IMO-2125 and commenced a Phase 1 clinical trial of IMO-2125 in patients with chronic hepatitis C
virus infection in the third quarter of 2007. Pfizer, Inc. and Anadys Pharmaceuticals, Inc. each
have performed early clinical trials of TLR-targeted compounds for the treatment of chronic
hepatitis C virus infection, and both programs have been discontinued. We cannot be certain whether
such discontinuations will negatively impact the perception of our TLR technology.
Our efforts to educate the medical community on our 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.
We face substantial competition, which may result in others discovering, developing or
commercializing drugs before or more successfully than us.
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The biotechnology industry is highly competitive and characterized by rapid and significant
technological change. We face, and will continue to face, intense competition from 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
drug candidates in the therapeutic effect these competitive products have on diseases targeted by
our drug 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. As examples, the FDA recently approved drugs developed by other
companies, Sutent ® and Nexavar ® , for use in renal cell cancer, which is
the indication for which we are evaluating IMO-2055 monotherapy in our Phase 2 trial. Pfizer, Inc.,
is conducting clinical trials of PF-3512676, a TLR9 agonist for treating cancer. In addition,
Dynavax Technologies Corporation has announced initiation of a clinical trial for its TLR9 agonist
1018 ISS for cancer. Both Pfizer, Inc., and Dynavax Technologies Corporation have clinical
programs, either independently or with collaborators, in therapeutic fields other than cancer, such
as asthma and allergy treatments and for use as vaccine adjuvants, that also potentially compete
with our drug candidates.
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
or processes and protect our intellectual property, and to secure sufficient capital resources for
the period between technological conception and commercial sales.
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 Dr. Sudhir Agrawal. Dr. Agrawal serves as our Chief Executive Officer
and Chief Scientific Officer. Dr. Agrawal has made significant contributions to the field of
oligonucleotide-based drug candidates, and has led the discovery and development of our compounds
targeted to TLRs. He is named as an inventor on over 380 patents and patent applications worldwide.
Dr. Agrawal provides us leadership for management, research and development activities. 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 that expires on October 19, 2010,
but automatically extends annually for an additional year. 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 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 growth.
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Regulatory Risks
We may not be able to obtain marketing approval for products resulting from our development
efforts.
All of the drug candidates 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. Currently, we are conducting clinical trials of IMO-2125 and IMO-2055.
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 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. Further, permission to continue ongoing trials may be withdrawn by the FDA or other
regulatory agencies at any time after initiation, based on new information available after the
initial authorization 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 marketing of a product; |
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restrictions on our products or the manufacturing of our products; |
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withdrawal of our 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.
Risks Relating to Collaborators
We need to establish additional collaborative relationships in order to succeed.
If we do not reach agreements with additional collaborators in the future, we may fail to meet
our business objectives. We believe collaborations can provide us with expertise and resources. If
we cannot enter into additional collaboration agreements, we may not be able to obtain the
expertise and resources necessary to achieve our business objectives. We face, and will continue to
face, significant competition in seeking appropriate collaborators. Moreover, collaboration
arrangements are complex and time consuming to negotiate, document and implement. We may not be
successful in our efforts to establish and implement collaborations or other alternative
arrangements. The terms of any collaborations or other arrangements that we establish, if any, may
not be favorable to us.
The failure of these collaborative relationships could delay our drug development or impair
commercialization of our products and could materially harm our business and might accelerate our
need for additional capital.
Any collaboration that we enter into may not be successful. The success of our collaboration
arrangements, if any, will depend heavily on the efforts and activities of our collaborators.
Possible future collaborations have risks, including the following:
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disputes may arise in the future with respect to the ownership of
rights to technology developed with future collaborators; |
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disagreements with future collaborators could delay or terminate the
research, development or commercialization of products, or result in
litigation or arbitration; |
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future collaboration agreements are likely to be for fixed terms and
subject to termination by our collaborators in the event of a material
breach or lack of scientific progress by us; |
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future collaborators are likely to have the first right to maintain or
defend our intellectual property rights and, although we would likely
have the right to assume the maintenance and defense of our
intellectual property rights if our collaborators do not, our ability
to do so may be compromised by our collaborators acts or omissions; |
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future collaborators may utilize our intellectual property rights in
such a way as to invite litigation that could jeopardize or invalidate
our intellectual property rights or expose us to potential liability; |
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future 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 future collaborators decrease or fail to increase
spending relating to such products; |
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future collaborators may underfund or not commit sufficient resources
to the testing, marketing, distribution or development of our
products; and |
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future collaborators may develop alternative products either on their
own or in collaboration with others, or encounter conflicts of
interest or changes in business strategy or other business issues,
which could adversely affect their willingness or ability to fulfill
their obligations to us. |
Given these risks, it is possible that any collaborative arrangements into which we enter may
not be successful.
Our existing collaborations and any collaborations we enter into in the future may not be
successful.
An important element of our business strategy includes entering into strategic collaborations
with corporate collaborators, primarily large pharmaceutical companies, for the development,
commercialization, marketing and distribution of some of our drug candidates. In December 2007, we
entered into an exclusive, worldwide license agreement with Merck KGaA to research, develop, and
commercialize products containing our TLR9 agonists for treatment of cancer, excluding cancer
vaccines. In December 2006, we entered into an exclusive license and research collaboration with
Merck & Co. to research, develop, and commercialize vaccine products containing our TLR7, 8, and 9
agonists in the fields of cancer, infectious diseases, and Alzheimers disease. In May 2005, we
entered into a collaboration with Novartis to discover, develop and potentially commercialize TLR9
agonists that are identified as potential treatments for asthma and allergies. The failure of these
collaborations or any others we enter into in the future could delay our drug development or impair
commercialization of our products and could materially harm our business and might accelerate our
need for additional capital.
The success of our collaboration arrangements, if any, will depend heavily on the efforts and
activities of our collaborators. Our existing collaborations have risks, including the following:
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our collaborators control the development of the drug candidates being developed with our
technologies and compounds including the timing of development; |
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our collaborators may control the public release of information regarding the
developments, and we may not be able to make announcements or data presentations on a
schedule favorable to us; |
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disputes may arise in the future with respect to the ownership of rights to technology
developed with our collaborators; |
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disagreements with our 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 any of our collaborators fail 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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our collaboration agreements are likely to be for fixed terms and subject to termination
by our collaborators in the event of a material breach or lack of scientific progress by
us; |
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our collaborators may have the first right to maintain or defend our intellectual property
rights and, although we would likely have the right to assume the maintenance and defense
of our intellectual property rights if our collaborators do not, our ability to do so may
be compromised by our collaborators acts or omissions; |
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our collaborators may utilize our intellectual property rights in such a way as to invite
litigation that could jeopardize or invalidate our intellectual property rights or expose
us to potential liability; |
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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; |
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our collaborators may underfund or not commit sufficient resources to the testing,
marketing, distribution or development of our products; and |
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our collaborators may develop alternative products either on their own or in collaboration
with others, or encounter conflicts of interest or changes in business strategy or other
business issues, which could adversely affect their willingness or ability to fulfill
their obligations to us. |
Collaborations with pharmaceutical companies and other third parties often are terminated or
allowed to expire by the other party. Such terminations or expirations may adversely affect us
financially and could harm our business reputation in the event we elect to pursue collaborations
that ultimately expire or are terminated in such a manner.
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 patents; |
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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 that we
license will result in the issuance of any patents. Our issued patents and those that may be issued
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 provided by
the patent.
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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.
Currently, we have not in-licensed any patents or patent applications related to our
TLR-targeted drug candidate programs. However in the field of antisense technology we are party to
five 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 2014 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.
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, 2003, and 2005, we became
involved in interference proceedings declared by the United States Patent and Trademark Office for
certain of our antisense and ribozyme patents. All of these interferences have since been resolved.
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 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
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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, facilities or infrastructure, 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 manufacturing facilities, infrastructure or
clinical or 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 nonclinical 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. Our
current and anticipated future dependence upon others for the manufacture of our drug candidates
may adversely affect our future profit margins and our ability to develop drug candidates and
commercialize any drug candidates on a timely and competitive basis. We currently do not have any
long term supply contracts and rely on only one contract manufacturer.
There are a limited number of manufacturers that operate under the FDAs current good
manufacturing practices, or cGMP, 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. |
Additionally, contract manufacturers may not be able to manufacture our TLR-targeted drug
candidates at a cost or in quantities necessary to make them commercially viable. To date, our
third-party manufacturers have met our manufacturing requirements, but we cannot be assured that
they will continue to do so. Furthermore, changes in the manufacturing process or procedure,
including a change in the location where the drug is manufactured or a change
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of a third-party
manufacturer, may require prior FDA review and approval in accordance with the FDAs cGMP
regulations. There are comparable foreign requirements. This review may be costly and
time-consuming and could delay or prevent the launch of a product. The FDA or similar foreign
regulatory agencies at any time may also implement new standards, or change their interpretation
and enforcement of existing standards for manufacture, packaging or testing of products. If we or
our contract manufacturers are unable to comply, we or they may be subject to regulatory action,
civil actions or penalties.
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. We have contracted with contract research
organizations to manage our current Phase 1 clinical trial of IMO-2125 in patients with chronic
hepatitis C virus infection. 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.
The commercial success of any drug candidates that we may develop will depend upon the degree of
market acceptance by physicians, patients, third party payors and others in the medical community.
Any products that we ultimately bring to the market, if they receive marketing approval, may
not gain market acceptance by physicians, patients, third party payors and others in the medical
community. If these products do not achieve an adequate level of acceptance, we may not generate
significant product revenue and we may not become profitable. The degree of market acceptance of
our drug candidates, if approved for commercial sale, will depend on a number of factors,
including:
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the prevalence and severity of any side effects, including any
limitations or warnings contained in the products approved labeling; |
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the efficacy and potential advantages over alternative treatments; |
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the ability to offer our drug candidates for sale at competitive prices; |
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relative convenience and ease of administration; |
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the willingness of the target patient population to try new therapies
and of physicians to prescribe these therapies; |
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the strength of marketing and distribution support and the timing of
market introduction of competitive products; and |
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publicity concerning our products or competing products and treatments. |
Even if a potential product displays a favorable efficacy and safety profile, market
acceptance of the product will not be known until after it is launched. Our efforts to educate the
medical community and third party payors on the benefits of our drug candidates may require
significant resources and may never be successful. Such efforts to educate the marketplace may
require more resources than are required by conventional technologies marketed by our competitors.
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 rely on Medicare, 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 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.
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 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 drug 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. These further
clinical trials would require additional time, resources and expenses. If reimbursement of our
products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory
levels, our prospects for generating revenue, if any, could be adversely affected and our business
may suffer.
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. We face an inherent risk of
product liability exposure related to the testing of our drug candidates in human clinical trials
and will face an even greater risk if we commercially sell any products. Regardless of merit or
eventual outcome, liability claims and product recalls may result in:
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decreased demand for our drug candidates and products; |
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damage to our reputation; |
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regulatory investigations that could require costly recalls or product modifications; |
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withdrawal of clinical trial participants; |
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costs to defend related litigation; |
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substantial monetary awards to trial participants or patients, including awards that
substantially exceed our product liability insurance, which we would then have to
pay using other sources, if available, and would damage our ability to obtain
liability insurance at reasonable costs, or at all, in the future; |
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loss of revenue; |
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the diversion of managements attention away from managing our business; and |
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the inability to commercialize any products that we may develop. |
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. |
In addition, Section 203 of the Delaware General Corporation Law imposes restrictions on our
ability to engage in business combinations and other specified transactions with significant
stockholders. 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, 2007 to March 31, 2008,
the closing sales price of our common stock ranged from a high of $13.29 per share to a low of
$5.28 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 drug candidates or those of our competitors; |
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the regulatory status of our drug candidates; |
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failure of any of our drug 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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our success in entering into collaborative agreements; |
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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.
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: May 12, 2008 |
/s/ Sudhir Agrawal
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Sudhir Agrawal |
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Chief Executive Officer, Chief Scientific
Officer and Director
(Principal Executive Officer) |
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Date: May 12, 2008 |
/s/ Louis J. Arcudi, III
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Louis J. Arcudi, III |
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Chief Financial Officer
(Principal Financial and Accounting Officer) |
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Exhibit Index
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Exhibit No. |
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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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