UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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| For the quarterly period ended September 30, 2006. |
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| or |
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o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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| For the transition period from to . |
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| Commission File Number 000-51171 |
COMBINATORX, INCORPORATED
(Exact name of registrant as specified in its charter)
Delaware | | 04-3514457 |
(State or other jurisdiction of | | (IRS Employer Identification Number) |
incorporation or organization) | | |
| | |
245 First Street | | |
Sixteenth Floor | | |
Cambridge, Massachusetts | | 02142 |
(Address of Principal Executive Offices) | | (Zip Code) |
(617) 301-7000
(Registrant’s telephone number, including area code)
None
(Former name, former address and former fiscal year, if changes since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. Please see definition of “accelerated and large accelerated filer” in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer: o Accelerated Filer: o Non-Accelerated Filer: x
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes o No x
Number of shares of the registrant’s Common Stock, $0.001 par value per share, outstanding as of November 8, 2006: 28,777,473 shares
COMBINATORX, INCORPORATED
QUARTERLY REPORT
ON FORM 10-Q
INDEX
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PART I
FORWARD-LOOKING STATEMENTS
This quarterly report on Form 10-Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause the results of CombinatoRx to differ materially from those expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including any projections of financing needs, revenue, expenses, earnings or losses from operations, or other financial items; any statements of the plans, strategies and objectives of management for future operations; any statements concerning product research, development and commercialization plans and timelines; any statements regarding safety and efficacy of product candidates, any statements of expectation or belief; and any statements of assumptions underlying any of the foregoing. In addition, forward-looking statements may contain the words “believe,” “anticipate,” “expect,” “estimate,” “intend,” “plan,” “project,” “will be,” will continue,” “will result,” “seek,” “could,” “may,” “might,” or any variations of such words or other words with similar meanings.
The risks, uncertainties and assumptions referred to above include risks that are described in “Risk Factors” and elsewhere in this quarterly report and that are otherwise described from time to time in our annual report on Form 10-K and the other Securities and Exchange Commission reports filed after this report.
The forward-looking statements included in this quarterly report represent our estimates as of the date of this quarterly report. We specifically disclaim any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing our estimates or views as of any date subsequent to the date of this quarterly report.
Item 1. Financial Statements - - Unaudited
The financial information set forth below should be read in conjunction with our “Management’s Discussion and Analysis of Financial Condition and Results of Operations” appearing elsewhere in this Quarterly Report on Form 10-Q.
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CombinatoRx, Incorporated
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
(Unaudited)
| | As of | | As of | |
| | September 30, | | December 31, | |
| | 2006 | | 2005 | |
| | | | | |
Assets | | | | | |
Current assets: | | | | | |
Cash and cash equivalents | | $ | 9,826 | | $ | 9,079 | |
Short-term investments | | 114,655 | | 90,668 | |
Restricted cash | | 148 | | 148 | |
Unbilled accounts receivable | | 766 | | 230 | |
Prepaid expenses and other current assets | | 1,052 | | 2,974 | |
Total current assets | | 126,447 | | 103,099 | |
| | | | | |
Property and equipment, net | | 9,193 | | 2,702 | |
Restricted cash | | 4,000 | | 2,500 | |
Total assets | | $ | 139,640 | | $ | 108,301 | |
| | | | | |
Liabilities and stockholders’ equity | | | | | |
Current liabilities: | | | | | |
Accounts payable | | $ | 1,187 | | $ | 1,230 | |
Accrued expenses | | 3,408 | | 2,312 | |
Deferred revenue | | 9,051 | | 9,334 | |
Current portion of notes payable | | 1,709 | | 1,048 | |
Current portion of lease incentive obligation | | 365 | | 87 | |
Total current liabilities | | 15,720 | | 14,011 | |
| | | | | |
Convertible notes payable of subsidiary | | 9,171 | | 5,362 | |
Notes payable, net of current portion and discount | | 1,622 | | 816 | |
Deferred revenue, net of current portion | | 10,323 | | 16,250 | |
Deferred rent | | 1,780 | | 109 | |
Lease incentive obligation, net of current portion | | 3,408 | | 861 | |
| | | | | |
Minority interest in subsidiary | | 2,638 | | 2,542 | |
| | | | | |
Stockholders’ equity: | | | | | |
Common stock, $0.001 par value: 60,000 shares authorized; 28,723 and 23,285 shares issued and outstanding at September 30, 2006 and December 31, 2005, respectively | | 29 | | 23 | |
Additional paid-in capital | | 217,623 | | 177,777 | |
Deferred compensation | | — | | (11,052 | ) |
Accumulated other comprehensive income (loss) | | 70 | | (65 | ) |
Accumulated deficit | | (122,744 | ) | (98,333 | ) |
Stockholders’ equity | | 94,978 | | 68,350 | |
Total liabilities and stockholders’ equity | | $ | 139,640 | | $ | 108,301 | |
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CombinatoRx, Incorporated
Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited)
| | Three months ended September 30, | | Nine months ended September 30, | |
| | 2006 | | 2005 | | 2006 | | 2005 | |
| | | | | | | | | |
Revenue: | | | | | | | | | |
Collaborations | | $ | 3,182 | | $ | 904 | | $ | 9,825 | | $ | 1,647 | |
| | | | | | | | | |
Operating expenses: | | | | | | | | | |
Research and development (1) | | 8,526 | | 6,650 | | 24,380 | | 16,890 | |
General and administrative (1) | | 4,488 | | 2,073 | | 13,563 | | 7,516 | |
Total operating expenses | | 13,014 | | 8,723 | | 37,943 | | 24,406 | |
| | | | | | | | | |
Loss from operations | | (9,832 | ) | (7,819 | ) | (28,118 | ) | (22,759 | ) |
Interest income | | 1,689 | | 165 | | 4,298 | | 521 | |
Interest expense | | (211 | ) | (107 | ) | (495 | ) | (281 | ) |
Net loss | | (8,354 | ) | (7,761 | ) | (24,315 | ) | (22,519 | ) |
| | | | | | | | | |
Accretion of preferred stock dividends | | — | | 1,748 | | — | | 5,244 | |
Net loss applicable to common shareholders | | $ | (8,354 | ) | $ | (9,509 | ) | $ | (24,315 | ) | $ | (27,763 | ) |
| | | | | | | | | |
Net loss per share applicable to common stockholders—basic and diluted | | $ | (0.29 | ) | $ | (9.53 | ) | $ | (0.91 | ) | $ | (29.37 | ) |
Weighted-average number of common shares used in calculation of basic and diluted net loss per share | | 28,442,946 | | 997,573 | | 26,787,787 | | 945,216 | |
(1) Amounts include stock-based compensation
expense, as follows:
Research and development | | 787 | | 1,670 | | 2,269 | | 2,611 | |
General and administrative | | 980 | | 590 | | 2,904 | | 1,502 | |
Total stock-based compensation expense | | $ | 1,767 | | $ | 2,260 | | $ | 5,173 | | $ | 4,113 | |
| | | | | | | | | | | | | |
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CombinatoRx, Incorporated
Consolidated Statements of Cash Flow
(in thousands)
(Unaudited)
| | Nine months ended September 30, | |
| | 2006 | | 2005 | |
| | | | | |
Operating activities | | | | | |
Net loss | | $ | (24,315 | ) | $ | (22,519 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | |
Depreciation and amortization | | 1,344 | | 830 | |
Noncash interest expense | | 325 | | 120 | |
Noncash rent expense | | (236 | ) | — | |
Stock-based compensation expense | | 5,173 | | 4,113 | |
Increase in deferred rent | | 1,671 | | — | |
Change in assets and liabilities: | | | | | |
Increase in unbilled accounts receivable | | (536 | ) | (610 | ) |
Decrease in prepaid expenses and other current assets | | 968 | | 728 | |
(Decrease) increase in accounts payable | | (43 | ) | 629 | |
Increase in accrued expenses | | 1,096 | | 391 | |
(Decrease) increase in deferred revenue | | (6,210 | ) | 793 | |
Net cash used in operating activities | | (20,763 | ) | (15,525 | ) |
| | | | | |
Investing activities | | | | | |
Purchases of property and equipment | | (7,835 | ) | (141 | ) |
Purchases of short-term investments | | (505,752 | ) | (57,658 | ) |
Sales and maturities of short-term investments | | 481,900 | | 73,487 | |
Increase in restricted cash | | (1,500 | ) | 53 | |
Net cash (used in) provided by investing activities | | (33,187 | ) | 15,741 | |
| | | | | |
Financing activities | | | | | |
Proceeds from issuance of common stock | | 45,340 | | — | |
Proceeds from exercise of stock options | | 391 | | 87 | |
Proceeds from the issuance of convertible notes payable | | 3,500 | | 5,500 | |
Proceeds from preferred stock, subsidiary | | — | | 2,500 | |
Proceeds from notes payable | | 2,412 | | 159 | |
Repayment of notes payable | | (961 | ) | (708 | ) |
Proceeds from landlord for tenant improvements | | 4,015 | | — | |
Net cash provided by financing activities | | 54,697 | | 7,538 | |
| | | | | |
Net increase in cash and cash equivalents | | 747 | | 7,754 | |
| | | | | |
Cash and cash equivalents at beginning of the period | | 9,079 | | 2,156 | |
Cash and cash equivalents at end of the period | | $ | 9,826 | | $ | 9,910 | |
| | | | | |
Non-cash financing activity | | | | | |
Lease incentive obligation | | $ | 2,825 | | $ | — | |
Write-off of deferred compensation for terminated employees | | — | | 398 | |
Deferred compensation for terminated employees | | — | | 2,491 | |
Issuances of warrants with debt issuances | | — | | 247 | |
Issuances of warrants in connection with equity financing | | — | | 114 | |
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CombinatoRx, Incorporated
Notes to Consolidated Financial Statements
(in thousands, except share and per share amounts)
(Unaudited)
1. Basis of Presentation
The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included. When preparing financial statements in conformity with GAAP, the Company must make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the three and nine months ended September 30, 2006 are not necessarily indicative of the results that may be expected for any other interim period or for the fiscal year ending December 31, 2006. For further information, refer to the financial statements and footnotes included in the Company’s Annual Report on Form 10-K as filed with the Securities and Exchange Commission (SEC) on March 20, 2006.
2. Comprehensive Loss
The Company’s total comprehensive loss consists of the following:
| | Three months ended September 30, | | Nine months ended September 30, | |
| | 2006 | | 2005 | | 2006 | | 2005 | |
| | | | | | | | | |
Net loss applicable to common shareholders | | $ | (8,354 | ) | $ | (9,509 | ) | $ | (24,315 | ) | $ | (27,763 | ) |
Other comprehensive income: | | | | | | | | | |
Unrealized gain on investments | | 100 | | 17 | | 135 | | 32 | |
Comprehensive loss | | $ | (8,254 | ) | $ | (9,492 | ) | $ | (24,180 | ) | $ | (27,731 | ) |
3. Accounting for Stock-Based Compensation
The Company adopted Statement of Financial Accounting Standards No. 123 (revised 2004), “Share-Based Payment” (“SFAS 123R”) effective January 1, 2006. Under SFAS 123R, the Company is required to recognize, as expense, the estimated fair value of all share based payments to employees. For the three and nine months ended September 30, 2006, the Company recorded stock-based compensation expense of approximately $1,767 and $5,173, respectively, in connection with its share-based payment awards.
Stock Plans
In 2000, the Company adopted the 2000 Stock Option Plan (“2000 Plan”), as amended, under which 3,028,571 shares of the Company’s common stock were reserved for issuance to employees, officers, directors, advisors and consultants. Options granted under the 2000 Plan may be incentive stock options or nonstatutory stock options. In December 2004, the Board of Directors and stockholders adopted the 2004 Incentive Plan, which was effective upon the Company’s initial public offering on November 9, 2005. On June 1, 2006, the Company’s stockholders approved the Amended and Restated 2004 Incentive Plan (“2004 Plan”). The Company has reserved 3,714,286 shares of the Company’s common stock for issuance under the 2004 Plan. The 2004 Plan includes an “evergreen provision” that allows for an annual increase in the number of shares of common stock available for issuance under the 2004 Plan, which annual increase will be added on the first day of each fiscal year from 2007 through 2011, inclusive, and will be equal to the least of (i) 2,000,000 shares of common stock, (ii) 4% of the outstanding shares on that date or (iii) such lesser amount determined by the Board of Directors. The 2004 Plan provides for the grant of incentive stock options, nonstatutory stock options, restricted stock and unrestricted stock awards, stock appreciation rights, cash awards, performance awards and stock units. Awards under the 2004 Plan may be granted to employees, directors, consultants and advisors. Generally, stock options and restricted stock granted to employees pursuant to
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the 2000 and 2004 Plans fully vest four years from the grant date, with 25% of the award vesting after one year and 6.25% of the award vesting quarterly thereafter. Stock options have a term of 10 years.
The Board of Directors, or the Compensation Committee of the Board of Directors, administers the 2000 Plan and the 2004 Plan and has sole discretion to grant options to purchase shares of the Company’s common stock and other stock-based awards or to delegate to certain officers of the Company the ability to make specified grants. The Compensation Committee or the respective officers of the Company determine the exercise price and the period over which options become exercisable. However, incentive stock options may not be granted at less than 100% of the fair market value of the Company’s common stock as determined by the Compensation Committee at the time of grant, or for a term in excess of ten years. For holders of more than 10% of the Company’s total combined voting power of all classes of stock, incentive stock options may not be granted at less than 110% of the fair market value of the Company’s common stock at the date of grant, and for a term not to exceed five years.
The Company adopted SFAS 123R under the prospective method for stock options granted prior to January 1, 2005 since stock options granted prior to that date were valued under the minimum value method with no volatility factor. The Company applied the modified prospective method for stock options and restricted stock awards granted after January 1, 2005, since once the Company was in registration for its initial public offering in 2005, it began to value the stock options granted in 2005 under the Black-Scholes Method using a volatility factor for purposes of proforma footnote disclosure under SFAS 123. Under the modified prospective method, the Company recognized compensation expense for all share-based payments to employees based on the grant date estimate of fair value for those awards beginning on January 1, 2006. Prior period financial information has not been restated.
For periods prior to the adoption of SFAS 123R, the Company had elected to follow Accounting Principles Board Opinion No. 25 “Accounting for Stock Issued to Employees,” (APB 25) and related interpretations in accounting for its share-based payment awards. Under APB 25, since the exercise price of certain of the Company’s employee stock options was less than the market price of the underlying stock on the date of the grant in 2003, 2004 and 2005, the Company had recorded compensation expense in its financial statements. For the three and nine months ended September 30, 2005, the Company recorded $997 and $2,805, respectively, as stock-based compensation expense under APB 25.
The following table illustrates the effect on net loss and net loss per share as if the Company had applied the fair value recognition provisions of SFAS 123 to its stock-based employee compensation for the three and nine months ended September 30, 2005.
(in thousands, except per share amounts) | | Three Months Ended September 30, 2005 | | Nine Months Ended September 30, 2005 | |
| | | | | |
Net loss applicable to common shareholders, as reported | | $ | (9,509 | ) | $ | (27,763 | ) |
Add: Stock-based employee compensation expense included in reported net loss | | 997 | | 2,805 | |
Deduct: Total stock-based employee compensation expense determined under fair value based method for all awards | | (756 | ) | (2,693 | ) |
| | | | | |
Pro forma net loss | | $ | (9,268 | ) | $ | (27,651 | ) |
| | | | | |
Net loss per share applicable to common stockholders, as reported-basic and diluted: | | $ | (9.53 | ) | $ | (29.37 | ) |
| | | | | |
Pro forma net loss per share applicable to common stockholders-basic and diluted: | | $ | (9.29 | ) | $ | (29.25 | ) |
Upon adoption of SFAS 123R, the Company recognized the stock-based compensation expense associated with awards granted after January 1, 2006 and the unamortized compensation expense related to the unvested awards outstanding as of January 1, 2006. During the three and nine months ended September 30, 2006, the Company recognized stock-based compensation expense of $1,593 and $4,636, respectively, for outstanding stock options and $174 and $537, respectively, for outstanding awards of restricted stock. Upon the adoption of SFAS 123R, the Company reversed deferred stock-based compensation expense of $11,052 to additional paid-in-capital. No cumulative catch-up adjustment related to forfeitures was recorded.
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As a result of the adoption of SFAS 123R, loss from operations, net loss and net loss per basic and diluted share for the three months ended September 30, 2006, increased by $818, $818 and $0.03, respectively. For the nine months ended September 30, 2006, loss from operations, net loss and net loss per basic and diluted share increased by $2,224, $2,224 and $0.08, respectively. The adoption of SFAS 123R had no effect on the statement of cash flows due to the Company’s net loss position.
A summary of the status of our stock option plans at September 30, 2006 and changes during the nine months then ended is presented in the table and narrative below:
| | Options | | Weighted- Average Exercise Price | | Weighted Average Remaining Contractual Term | | Aggregate Intrinsic Value | |
Options outstanding at December 31, 2005 | | 3,585,876 | | $ | 3.22 | | | | | |
Options granted | | 1,311,607 | | 8.62 | | | | | |
Options forfeited and expired | | (120,569 | ) | 5.96 | | | | | |
Options exercised | | (456,542 | ) | 0.85 | | | | | |
| | | | | | | | | |
Options outstanding at September 30, 2006 | | 4,320,372 | | $ | 5.03 | | 8.56 | | $ | 10,417 | |
Vested or expected to vest at September 30, 2006 | | 4,130,352 | | $ | 4.94 | | 8.53 | | $ | 10,231 | |
Options exercisable at September 30, 2006 | | 1,294,337 | | $ | 1.45 | | 7.30 | | $ | 6,378 | |
In August 2005, the Company modified certain stock option grants to an employee upon a change in status to a non-employee. In accordance with EITF No. 00-23, Issues Related to the Accounting for Stock Compensation under APB Opinion No. 25 and FASB Interpretation No. 44 and FIN 44, Accounting for Certain Transactions Involving Stock Compensation, the stock options were accounted for as a new grant and were valued using the Black-Scholes method. The Company recorded compensation expense of $944 in the nine months ended September 30, 2006. The non-employee ceased performing services for the Company effective December 31, 2005.
The aggregate intrinsic value in the table above represents the value (the difference between the Company’s closing common stock price on the last trading day of the nine months ended September 30, 2006 and the exercise price of the options, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on September 30, 2006. The weighted-average grant date fair value of options for the three and nine months ended September 30, 2006 was $4.47 and $5.22, respectively.
The following table presents weighted-average price information about significant option groups exercisable at September 30, 2006:
Range of Exercise Prices | | Number Exercisable | | Weighted- Average Exercise Price | |
$0.18 to $0.87 | | 160,542 | | $ | 0.79 | |
$0.88 to $1.31 | | 1,057,606 | | 1.03 | |
$7.79 to $9.85 | | 76,189 | | 8.74 | |
| | 1,294,337 | | $ | 1.45 | |
As of September 30, 2006, there was $10,759 of total unrecognized compensation expense related to stock options granted under the plans. The expense is expected to be recognized over a weighted-average period of 2.99 years.
Upon the exercise of stock options, the Company issues new common stock from its authorized shares. Cash received from stock options exercised during the three and nine months ended September 30, 2006 was $112 and $391, respectively. Cash received from stock options exercised during the three and nine months ended September 30, 2005 was $12 and $87, respectively. The intrinsic value of stock options exercised for the three and nine months ended September 30, 2006 was $772 and $3,513, respectively, and was $112 and $984 for the three and nine months ended September 30, 2005, respectively.
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The Company valued stock options using a Black-Scholes method of valuation, and the resulting fair value is recorded as compensation cost on a straight line basis over the requisite service period, which generally equals the option vesting period. The Company has estimated forfeitures based upon an average of its historical data of option cancellations and employee turnover rates, derived from periods of business activity most likely to be representative of future periods. The Company will adjust the estimate of forfeitures over the requisite service period based on the extent to which actual forfeitures differ, or are expected to differ, from such estimates. Changes in estimated forfeitures will be recognized through a cumulative true-up adjustment in the period of change and will also impact the amount of compensation expense to be recognized in future periods. The Company’s estimated forfeiture rates were 4.89%, 4.54% and 4.33% for the first, second and third quarters of 2006, respectively.
During the three and nine months ended September 30, 2006, the weighted-average fair value of the options granted under the stock option plans was $4.47 and $5.22, respectively, using the assumptions in the following table.
| | Three Months Ended September 30, | | Nine Months Ended September 30, | |
| | 2006 | | 2005 | | 2006 | | 2005 | |
| | | | | | | | | |
Expected term (life in years) | | 5.62 | | | | 5.61 | | | |
Interest rate | | 4.59 | % | % | | 4.75 | % | % | |
Volatility | | 62.17 | % | % | | 63.54 | % | % | |
Dividend yield | | — | | — | | — | | — | |
Since the Company completed its initial public offering in November 2005, it did not have sufficient history as a publicly traded company to evaluate its volatility factor and expected term. As such, the Company analyzed the volatilities and expected terms of several peer companies to support the assumptions used in its calculations for the three and nine months ended September 30, 2006. The Company averaged the volatilities and expected terms of these peer companies with a similar amount of in-the-money options, sufficient trading history and similar vesting terms to generate the assumptions detailed above. The risk free interest rates used in the analysis are based on the United States Treasury yield curve in effect for periods corresponding with the expected life of the stock option.
Restricted Stock
Prior to January 1, 2006, the Company had not granted awards of restricted stock. A summary of the status of non-vested restricted stock as of September 30, 2006 and changes during the quarter ended September 30, 2006 are as follows:
| | Restricted Stock | | Weighted- Average Grant Date Fair Value | |
Nonvested at December 31, 2005 | | — | | — | |
Granted | | 265,000 | | $ | 9.92 | |
Vested | | (15,000 | ) | 10.93 | |
Canceled | | — | | — | |
| | | | | |
Nonvested at September 30, 2006 | | 250,000 | | $ | 9.86 | |
As of September 30, 2006, there was $1,883 of total unrecognized compensation expense related to non-vested restricted stock arrangements granted under the 2004 Plan. The expense is expected to be recognized over a weighted-average period of 3.01 years. The total fair value of shares vested was $53 and $164 in the three and nine months ended September 30, 2006, respectively.
Stock Options Granted to Non-Employees
The Company accounts for transactions in which services are received from non-employees in exchange for equity instruments based on the fair value of such services received or of the equity instruments issued, whichever is more reliably measured, in accordance with SFAS 123 and the Emerging Issues Task Force EITF Issue No. 96-18, Accounting for Equity Instruments that Are Issued to Other than Employees for Acquiring, or in Conjunction with Selling, Goods or Services. During the three and nine months ended September 30, 2006, the Company did not issue any stock options and issued 100,000 stock options to non-employees, respectively. Some of the stock options previously granted vest immediately and others vest over periods up to two years. The unvested portion of the stock options will be re-measured at each reporting
10
period. Total stock-based compensation expense for non-employee stock option grants in the three and nine months ended September 30, 2006 was $58 and $483, respectively.
4. Net Loss Per Share
The Company calculates net loss per share in accordance with SFAS No. 128, Earnings Per Share. Basic and diluted net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted-average common shares outstanding during the period. The Company’s potentially dilutive shares, which include outstanding common stock options, unvested restricted stock, convertible preferred stock, redeemable convertible preferred stock, convertible notes and warrants, have not been included in the computation of diluted net loss per share for all periods as the result would be anti-dilutive. The following common share equivalents, prior to the use of the treasury stock method, have been excluded from the computation of diluted weighted-average shares outstanding as of September 30, 2006 and 2005, as they would be anti-dilutive.
| | Three and Nine Months Ended September 30, | |
| | 2006 | | 2005 | |
Convertible preferred stock and redeemable convertible preferred stock | | — | | 13,366,644 | |
Options and unvested restricted stock outstanding | | 4,570,372 | | 2,690,355 | |
Warrants outstanding | | 96,252 | | 196,924 | |
Convertible notes payable | | 811,589 | | 814,815 | |
5. Notes Payable
In July 2004, the Company entered into a loan agreement (the “2004 GE Agreement”) with General Electric Capital Corporation (GECC). Borrowings are collateralized by substantially all of the Company’s assets. The Company borrowed all $3,000 available under the 2004 GE Agreement during 2004. In June 2005, the 2004 GE Agreement was amended (the “Amended 2004 GE Agreement”) to establish a new line of credit which enabled the Company to borrow an additional $1,000 through June 2006. In March 2006, the Company borrowed an additional $806 under the Amended 2004 GE Agreement repayable over a 36 month term at an interest rate of 10.52%. In June 2006, the Company amended the Amended 2004 GE Agreement (the “2006 Amendment”) to increase the line of credit by $3,310, and on June 30, 2006, the Company borrowed $1,606 under the 2006 Amendment, repayable over 48 months for laboratory and scientific equipment and 36 months for other equipment, at an annual interest rate of 10.68%. At September 30, 2006, $3,359 was payable under the Amended 2004 GE Agreement and 2006 Amendment and $1,739 was available to be borrowed through March 31, 2007. The Amended 2004 GE Agreement and 2006 Amendment contain a subjective acceleration clause which provides GECC the ability to demand repayment of the loan early upon a material adverse event, as defined.
6. CombinatoRx (Singapore) Pte Ltd
In August 2005, the Company formed a subsidiary in Singapore, CombinatoRx (Singapore) Pte Ltd (the “Subsidiary”), for the purpose of conducting discovery and development of product candidates to treat infectious diseases. The Company owns 51% of the Subsidiary capital stock. The Company has agreed to provide assay development and screening services for the subsidiary over a four year period. BioMedical Sciences Investment Fund Pte Ltd (“BioMedical Sciences”) invested $2,500 in 2,500,000 shares of redeemable, convertible preferred stock (the “Subsidiary Preferred Stock”) of the subsidiary and committed to invest up to an additional $17,500 in the subsidiary through the purchase of a series of convertible promissory notes (“Notes”), $5,500 of which were purchased concurrently with its investment in the Subsidiary Preferred Stock (the “Series 1 Note”). The remaining $12,000 in funding is to be provided through the purchase of additional series of Notes over the following four years, provided that the subsidiary achieves certain milestones related to the development of infectious disease product candidates. On June 8, 2006, upon the achievement of a milestone, BioMedical Sciences invested an additional $3,500 in the Subsidiary for which it was issued a new $3,500 convertible promissory note (the “Series 2 Note”).
The Notes bear interest at an annual rate of 5% and are due and payable on December 31, 2009, unless the Company elects to prepay the Notes before that date through the subsidiary. The Notes are secured by a security interest in the non-intellectual property assets of the subsidiary and by a negative pledge by the subsidiary with respect to its intellectual property rights. The Company has pledged its shares in the subsidiary as additional collateral for the subsidiary’s obligations under the Notes. The Notes are convertible into the Company’s common stock at the option of BioMedical Sciences only upon maturity,
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acceleration or default or any proposed prepayment. Upon maturity or any proposed prepayment, the Series 1 Note is convertible at a price obtained by dividing the aggregate principal balance of such Note by $10.803, and the Series 2 Note is convertible at a price obtained by dividing the aggregate principal balance of such Note by $11.572.
Upon a default by the Company or Subsidiary, the Notes and the Subsidiary Preferred Stock are convertible at the option of BioMedical Sciences as described with respect to a conversion upon maturity or prepayment except that (i) the conversion price of the Notes would include a 10% default interest rate accrued from the date of issuance and the Subsidiary Preferred Stock would also include a 10% dividend accrual accrued from the date of issuance and (ii) no conversion premium would apply.
On April 19, 2006, the Subsidiary received approval for a grant from the Economic Development Board of Singapore (EDB) Biomedical Sciences Group for up to approximately $5,830 to support infectious disease drug research and development. The grant covers a percentage of qualifying costs of the research and development project on a reimbursement basis. Qualifying costs include salaries, equipment, scientific consumables and intellectual property costs. Reimbursement for these costs under the grant is subject to the satisfaction of certain conditions by the Subsidiary, including completion of the development project for infectious disease within a specified timeline, spending specified amounts on the project, the completion of other development milestones and the maintenance of specified levels of employment in Singapore. Subject to agreed upon audit rights by the EDB, cumulative qualifying costs are reimbursed upon application until 70% of the initial grant amount has been submitted by the Subsidiary. The remaining 30% of the award may be paid by the EDB once the Company completes the research and development project. The grant extends through September 30, 2010. If the Subsidiary breaches a condition of the grant, after good faith negotiations, the EDB may recover previously released grant funds from the Subsidiary. In addition, the EDB retains the right to change the terms and conditions of the grant as deemed necessary by the EDB. The Company recognizes revenue under the grant as qualifying costs are incurred up to a maximum of 70% of the initial grant amount (approximately $4,081). Reimbursements for qualifying costs in excess of 70% of the initial grant amount will be recognized once the reimbursements are deemed to be fixed or determinable. The Company recognizes revenue for equipment costs that are reimbursed ratably over the remaining term of the grant, which approximates the estimated useful life of the equipment. During the three months ended September 30, 2006, the Company recorded $256 of revenue based upon qualifying costs incurred and deferred $104 of revenue pertaining to equipment reimbursements.
7. Research and Development Agreements
On January 30, 2006 (the “Effective Date”), the Company entered into a research and license agreement with Fovea Pharmaceuticals SA (“Fovea”). Under the terms of the agreement, Fovea agreed to fund and conduct pre-clinical and clinical development of combination drug candidates it selects from the Company’s portfolio, including creating ophthalmic formulations. Additionally, Fovea agreed to develop selected combination candidates up to the start of Phase III clinical trials. In exchange for Fovea’s development investment, the Company granted to Fovea an exclusive license to commercialize selected products in Europe and certain additional countries. The Company will retain exclusive rights to commercialize selected products in North America. The parties will have co-exclusive rights in Japan and Taiwan. Under the agreement, the Company also granted to Fovea an exclusive worldwide license to certain preclinical drug combinations to treat specified diseases of the front of the eye. In connection with this exclusive license, Fovea is entitled to select up to 10 drug combinations from the Company, pursuant to certain selection criteria which includes limiting the selected combinations to Selective Steroid Amplifiers, as defined in the agreement, during a period beginning as of the Effective Date and continuing for 135 days, which may be extended for not more than 60 days. In consideration for the license of these combinations to treat specified diseases of the front of the eye, the Company is entitled to receive license execution fees, development milestones and royalties from Fovea if certain conditions within the agreement are satisfied. The Company received $750 in non-refundable license execution fees. The Company may also receive up to approximately $20,000 in development milestone payments for each licensed combination successfully developed and approved by the regulatory authorities in the European Union, United States and Japan. The Company could receive an additional milestone payment of $10,000 for the approval by any regulatory authority of a licensed combination developed to treat a specifically identified indication within the agreement. The Company is also eligible to receive royalties for product(s) commercialized by Fovea.
On June 26, 2006, the Company and Fovea amended the research and license agreement to provide, among other things, for the payment by Fovea to the Company of the second portion of the license execution fee in the amount of $500 by July 31, 2006 and providing Fovea until December 31, 2006 to determine which of the Company’s compounds it would license for further research and development in certain diseases of the front of the eye. The $500 license execution fee was received on August 3, 2006, which the Company has accepted as satisfaction of the terms of the amended research and license agreement
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pertaining to the payment of the license execution fee. As of September 30, 2006, the Company has recorded $750 of license execution fees as long-term deferred revenue. The second portion of the license execution fee of $500 will also be recorded as long term deferred revenue. Once the drug combinations for diseases of the front of the eye are selected, the Company will determine the appropriate period over which the $750 of deferred revenue will be recognized as revenue.
On May 31, 2006, the Company entered into a research, development and commercialization agreement (the “CF Agreement”) with Cystic Fibrosis Foundation Therapeutics Incorporated (“CFFT”). Under the terms of the CF Agreement, CFFT has agreed to award the Company up to $13.8 million in research funding and expenses. In addition, CFFT has agreed to fund up to 75% of the clinical development expenses incurred by the Company through a Phase 2a clinical trial of the first potential product candidate, provided both parties have agreed to commence clinical development of the product candidate. The Company is eligible to receive milestone payments from CFFT upon successful completion of specified clinical and regulatory events for each product candidate developed under the CF Agreement. CFFT will be eligible to receive variable royalties from the Company on the net sales of any approved products that are discovered under the CF Agreement. The Company retains worldwide commercialization rights for any product candidates discovered or developed under the agreement, and the Company will own all new intellectual property and data generated by the research and development project.
The CF Agreement has no definite term, but the research and development project will terminate upon the earlier of the completion of one Phase 2a clinical trial of the first product candidate developed under the CF Agreement and seven years after the initiation of research under the CF Agreement. The Company’s royalty payment obligations to CFFT do not terminate, but its royalties in the field of cystic fibrosis and certain other pulmonary diseases may be reduced on a country-by-country basis upon the expiration of all valid patents covering a royalty bearing product under the agreement. During the three months ended September 30, 2006, the Company recognized $29 of revenue under the CF Agreement.
8. Common Stock
On March 24, 2006, the Company completed a private placement (the “Private Placement”) of 4,682,942 shares of common stock (the “Shares”) at a price of $10.25 per share for net proceeds of approximately $45,340.
The Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with the purchasers of Shares in the Private Placement in which the Company agreed to file a Registration Statement on Form S-1 with the Securities and Exchange Commission (the “Commission”) by April 24, 2006 to register the resale of the Shares sold through the Private Placement. The Company filed a resale Registration Statement on Form S-1 with the Commission on April 24, 2006. The Company also agreed to use its commercially reasonable efforts to have the Registration Statement declared effective within 90 days after the closing of the Private Placement if the Registration Statement receives no Commission review or 150 days after the closing of the Private Placement if the Registration Statement receives Commission review. The Registration Statement was declared effective by the Commission on May 23, 2006. In addition, the Company agreed to use its commercially reasonable efforts to keep the Registration Statement effective until the earlier of two years after the effective date of the Registration Statement, the date on which the Shares may be resold pursuant to Rule 144 under the Securities Act of 1933, as amended (the “Securities Act”). If, after the Registration Statement is declared effective, the Company suspends the use of the Registration Statement by the purchasers for the resale of the Shares, the Company has agreed to pay each purchaser as liquidated damages an amount equal to 1.0% of the purchase price paid by each such purchaser in the Private Placement for each month that the use of the Registration Statement is suspended in excess of 30 consecutive days or more than 60 days in any 12-month period, subject to the aggregate limit on liquidated damages. Under the Purchase Agreement, the maximum aggregate amount of liquidated damages payable to each purchaser is limited to 10% of the purchase price paid by each such purchaser in the Private Placement. As of September 30, 2006, the Company has not incurred any liquidated damages relating to these provisions.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our financial statements and their notes appearing elsewhere in this quarterly report. The following discussion contains forward-looking statements that involve risks and uncertainties. Our actual results and the timing of certain events could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including those discussed below and elsewhere in this quarterly report or in our annual report on form 10-K, particularly under the heading ‘‘Risk Factors That May Affect Future Results.’’
Overview
We are a biopharmaceutical company focused on developing synergistic combinations of approved drugs with a portfolio of product candidates in Phase II clinical development. To date, we have devoted substantially all of our resources to the development of our drug discovery technology and the research and development of our drug candidates, including conducting preclinical and clinical trials and seeking intellectual property protection for our technology and product candidates. Since our inception in March 2000, we have had no revenue from product sales, and have funded our operations principally through private and public sales of equity securities, debt financings and revenue from collaboration agreements. We have never been profitable and, as of September 30, 2006, we have an accumulated deficit of $122.7 million. We had net losses of $29.5 million for the year ended December 31, 2005 and $24.3 million for the nine months ended September 30, 2006.
We expect to incur significant and increasing operating losses for the foreseeable future as we advance our product candidates from discovery through preclinical and clinical trials and seek regulatory approval prior to the eventual commercialization of our product candidates. In addition to these increasing research and development expenses, we expect general and administrative costs to increase as we add personnel and continue to operate as a public company. We will need to raise additional capital and generate significant revenues to achieve profitability and may never do so.
Critical Accounting Policies
We believe that several accounting policies are important to understanding our historical and future performance. We refer to these policies as “critical” because these specific areas generally require us to make judgments and estimates about matters that are uncertain at the time we make the estimate, and different estimates - which also would have been reasonable - could have been used, which would have resulted in different financial results.
The critical accounting policies we identified in our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2005 related to revenue recognition and stock-based compensation. With the adoption of SFAS 123R on January 1, 2006, we have identified the estimates and assumptions that accompany the fair value determination of our stock option awards as critical, as discussed below. It is important that the discussion of our operating results that follows be read in conjunction with the critical accounting policies discussed below as well as those disclosed in our Annual Report on Form 10-K, as filed with the SEC on March 20, 2006.
Revenue Recognition
We recognize revenue in accordance with Securities and Exchange Commission Staff Accounting Bulletin No. 104, “Revenue Recognition in Financial Statements” (“SAB 104”). We have also adopted the provisions of Emerging Issues Task Force, Issue No. 00-21, “Revenue Arrangements with Multiple Deliverables” (“EITF 00-21”). Revenue is recognized when there is persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed and determinable, and collection is reasonably assured. We do not have any allowances for uncollectible amounts as we have no product sales. License fees or other amounts received in advance of performance obligations, or in cases where we have a continuing obligation to perform services, are deferred and recognized over the performance period. Revenues from milestone payments that are deemed to be substantive and represent the culmination of a separate earnings process are recorded when the milestone is achieved. Contract revenues are recorded as the services are performed. The periods over which revenue should be recognized are subject to estimates by management and may change over the course of the collaborative agreement.
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Stock-Based Compensation
We adopted Statement of Financial Accounting Standards No. 123 (revised 2004), “Share-Based Payment” (“SFAS 123R”) on January 1, 2006, using the prospective method for stock option grants prior to January 1, 2005 and the modified-prospective transition method for stock option grants and restricted stock issued after January 1, 2005. As a result, the unamortized compensation expense from stock options granted prior to January 1, 2005 is not included in the statement of operations. Stock options granted after January 1, 2005 are included due to the fact that once we were in registration for our initial public offering, we included a volatility factor in our Black-Scholes calculations for purposes of the proforma footnote disclosures under SFAS 123. SFAS 123R requires all share-based payments to employees to be recognized in the income statement based on their fair values. Under the modified-prospective transition method, compensation cost recognized for the three and nine months ended September 30, 2006 includes: (a) compensation cost for all share-based payments granted, but not yet vested as of January 1, 2006 based on the grant-date fair value estimated in accordance with the original provisions of SFAS 123, and (b) compensation cost for all share-based payments granted subsequent to January 1, 2006, based on the grant-date fair value estimated in accordance with the provisions of SFAS 123R. Such amounts are reduced by our estimate of forfeitures of all unvested awards.
Prior to January 1, 2006, we accounted for our stock-based compensation plans under the intrinsic-value method prescribed in Accounting Principles Board Opinion No. 25 “Accounting for Stock Issued to Employees,” (“APB 25”) and related interpretations as permitted by Statement of Financial Accounting Standards No. 123, “Accounting for Stock-Based Compensation.” (“SFAS 123”). Under APB 25, when the exercise price of stock options granted to employees equals the market price of the common stock on the date of grant, no compensation expense is recorded. When the exercise price of options granted to employees is less than the market price of the common stock on the date of grant, compensation expense is recognized over the vesting period.
SFAS 123R requires share-based payments to employees to be measured at fair value. However, the valuation of employee stock options is an inherently subjective process, since market values are generally not available for long-term, non-transferable employee stock options. Accordingly, an option pricing model is utilized to derive an estimated fair value. We use the Black-Scholes pricing model in order to calculate the estimated fair value for our stock options. The Black-Scholes calculation requires input values for the following variables:
· the stock option exercise price,
· the expected term of the option,
· the grant date price of our common stock,
· the expected volatility of our common stock,
· expected dividends on our common stock (we do not anticipate paying dividends for the foreseeable future), and
· the risk free interest rate for the expected option term.
Making estimates for the values required by Black-Scholes is more easily accomplished if a company has a substantial public market trading history. Since we have a limited history as a publicly traded entity, we relied on data from several peer companies similar to ours in generating our assumptions. Of the variables mentioned above, the estimates for expected term and stock price volatility are the most subjective. In accordance with the guidance provided in Staff Accounting Bulletin No. 107, “Share-Based Payment” (“SAB 107”), we generated our estimates by performing an analysis of these peer companies’ expected term and volatility data as reported in their filings with the SEC. We started with a list of approximately 25 companies engaged in business operations similar to ours within the healthcare sector and reduced the list to six peers that were most reflective of the Company based upon having a similar amount of in-the-money stock options (options with exercise prices below the current market price of the underlying stock), a trading history of sufficient duration (at least as long as its expected term) and stock option life and vesting terms similar to ours (10 year options with approximately 4 year vesting).
The expected term represents the period of time that options granted are expected to be outstanding prior to being exercised. We believe the expected term of our stock options will follow the average term of our peer group. As a result, we selected 5.62 years for the three months ended September 30, 2006 as our expected term of our stock options which is the
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average term of the stock options of our peer group. The range of expected terms within our peer group was between 4.7 and 6.37 years. Volatility represents the expected change in the price of our common stock during the expected term of our stock options. To estimate our volatility, we calculated the average historical stock volatility of our peer group (over a period equal to our expected term) including a small weight applied to our own historical volatility and calculated our volatility to be 62.17% for the three months ended September 30, 2006. As we gain further trading history, we will continue to increase the weight applied to the actual volatility of our common stock in the overall volatility calculation.
The risk free interest rates used in the Black-Scholes model are based on the United States Treasury yield curve in effect for periods corresponding with the expected term of the stock option. We have not issued dividends in the past and have no plans to issue dividends for the foreseeable future.
The specific valuation assumptions discussed above have been applied to stock options that we granted subsequent to our adoption of SFAS 123R on January 1, 2006. However, approximately 86% of the stock-based compensation expense recorded in the three months ended September 30, 2006 relates to the continued vesting of stock options that were granted in 2005 and the amortization of the stock-based compensation expense for stock options granted at below fair value in 2003 and 2004. In accordance with the transition provisions of SFAS 123R, the grant date fair value estimates for these stock options have not been changed. The specific valuation assumptions that were utilized for purposes of deriving an estimate for the Black-Scholes value of stock options granted in 2005 are disclosed in our annual report on Form 10-K for the year ended December 31, 2005, as filed with the SEC.
Upon the adoption of SFAS 123R, we also began to estimate the level of stock-based award forfeitures expected to occur, and record compensation cost only for those awards that are ultimately expected to vest. This requirement applies to all awards that are not yet vested, including awards granted prior to January 1, 2006. We believe that using an average of our own historical data for percentage of option cancellations and actual employee turnover rates, derived from periods of business activity most likely to be representative of future periods, to be the most appropriate measure of forfeitures. Changes in estimated forfeitures will be recognized through a cumulative catch-up adjustment in the period of change and will also impact the amount of compensation expense to be recognized in future periods. The Company’s estimated forfeiture rates were 4.89%, 4.54% and 4.33% for the first, second and third quarters of 2006, respectively. Had we used a forfeiture rate of 0% in our calculations, the total stock-based compensation expense recorded for the nine months ended September 30, 2006 would have increased by approximately $0.4 million.
Beginning in 2006, we began to make grants of restricted stock in addition to grants of stock options. During the three and nine months ended September 30, 2006 we granted 50,000 and 265,000 shares of restricted stock, respectively.
As of September 30, 2006, there was approximately $12.7 million of total stock-based compensation expense not yet recognized relating to non-vested awards granted under our option plans and restricted stock agreements as calculated under SFAS 123R. This expense is net of estimated forfeitures and is expected to be recognized over a weighted-average period of approximately 3.0 years. Additionally, we have approximately $5.5 million of stock-based compensation expense related to stock options granted below fair market value prior to January 1, 2005 not yet recognized. This expense is net of estimated forfeitures and is expected to be recognized over a weighted-average period of approximately 2.0 years.
The amount of stock-based compensation expense to be recorded in any future period cannot be accurately predicted due to the uncertainty of future grant levels and actual forfeitures to be recorded. Additionally, changes to the assumptions used in the Black-Scholes model could cause a material change in the amount of compensation expense to be recorded in future reporting periods.
Results of Operations
Comparison of the Three Months ended September 30, 2006 and September 30, 2005
Revenue. For the three months ended September 30, 2006 we recorded $3.2 million of revenue from our research and development collaborations with Angiotech Pharmaceuticals, CHDI, Inc., CFFT, SAIC (NINDS) and Sirtris Pharmaceuticals and from grants from the NIAID and the Singapore Economic Development Board. For the three months ended September 30, 2005, we recorded revenue of $0.9 million from our research and development collaborations with the Spinal Muscular Atrophy Foundation, Accelerate Brain Cancer Cure, Inc., and Novartis Pharmaceuticals Corporation. The increase of $2.3 million from 2005 to 2006 was primarily due to the amortization of the upfront fee paid by Angiotech in October 2005.
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Research and Development. Research and development expense for the three months ended September 30, 2006 was $8.5 million compared to $6.7 million for the three months ended September 30, 2005. The $1.8 million increase in expense over the prior period was primarily due to a $1.4 million increase of facilities related expenses resulting from our move and expansion into our new facilities in Cambridge, Massachusetts, an increase of $1.1 million for personnel related expenses in order to support expanded activities in our research, clinical development, and regulatory departments and a $0.2 million increase of laboratory related expenses incurred to support a higher number of research and development collaborations, partially offset by a $0.9 million decrease in non-cash stock-based compensation expense due to a modification of a stock option grant in the third quarter of 2005.
General and Administrative. General and administrative expense for the three months ended September 30, 2006 was $4.5 million compared to $2.1 million for the three months ended September 30, 2005. The $2.4 million increase in expense over the prior period was primarily due to an increase of $1.3 million of personnel related expenses to support our operations as a publicly traded company as well as the expansion of our commercial development capabilities and an increase of $0.4 million relating to non-cash stock-based compensation expense under SFAS 123R.
Interest Income. Interest income for the three months ended September 30, 2006 was $1.7 million compared to $0.2 million for the three months ended September 30, 2005. The $1.5 million increase in interest income was primarily caused by increases in our average cash and short-term investments balances. The increase in our average cash balance for the three months ended September 30, 2006 as compared to the three months ended September 30, 2005 resulted from the completion of our initial public offering in November 2005, our collaboration with Angiotech, which was executed in October 2005, the closing of a private placement of common stock in March 2006 as well as reimbursement of leasehold improvement expenses from the landlord of our Cambridge facility.
Interest Expense. Interest expense increased to $0.2 million for the three months ended September 30, 2006 from $0.1 million for the three months ended September 30, 2005. The $0.1 million increase was primarily due to interest expense of $0.1 million incurred during the three months ended September 30, 2006 on $9.0 million of convertible notes issued to BioMedical Sciences Investment Fund Pte Ltd, an investor in our Singapore subsidiary.
Accretion of Dividends on Preferred Stock. Accretion of dividends on our convertible preferred stock for the three months ended September 30, 2006 was $0 compared to $1.7 million for the three months ended September 30, 2005. Our convertible preferred stock automatically converted into shares of common stock upon the completion of our initial public offering, after which, no further accretion of dividends was recorded.
Comparison of the Nine Months ended September 30, 2006 and September 30, 2005
Revenue. For the nine months ended September 30, 2006 we recorded $9.8 million of revenue from our research and development collaborations with Angiotech Pharmaceuticals, the Spinal Muscular Atrophy Foundation, CHDI, Inc., CFFT, SAIC (NINDS) and Sirtris Pharmaceuticals and from grants from the NIAID and the Singapore Economic Development Board. For the nine months ended September 30, 2005, we recorded revenue of $1.6 million from our research and development collaborations with the Spinal Muscular Atrophy Foundation, Accelerate Brain Cancer Cure, Inc., and Novartis Pharmaceuticals Corporation. The increase of $8.2 million in revenue from the nine months ended September 30, 2005 to the nine months ended September 30, 2006 was primarily due to the amortization of the upfront fee paid by Angiotech in October 2005 in connection with its collaboration agreement with us.
Research and Development. Research and development expense for the nine months ended September 30, 2006 was $24.4 million compared to $16.9 million for the nine months ended September 30, 2005. The $7.5 million increase over the prior period was primarily due to an increase of $2.4 million for personnel, outside services and travel related expenses in order to support expanded activities in our research, clinical development, and regulatory departments, a $1.7 million increase in laboratory and clinical related expenses incurred to support a higher number of research and development collaborations and $3.8 million of facilities and informatics related expenses resulting from our move and expansion into new facilities in Cambridge, Massachusetts, partially offset by a $0.4 million decrease relating to non-cash stock-based compensation expense due to a modification of a stock option grant in the third quarter of 2005.
General and Administrative. General and administrative expense for the nine months ended September 30, 2006 was $13.6 million compared to $7.5 million for the nine months ended September 30, 2005. The $6.1 million increase over the prior period was primarily due to a $3.5 million increase in personnel and professional services related expenses to support our operation as a publicly traded company as well as the expansion of our commercial development capabilities, a $1.4
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million increase relating to non-cash stock-based compensation expense under SFAS 123R, and a $1.4 million increase in facilities, informatics, insurance and permitting related expenses resulting from our move and expansion into new facilities in Cambridge, Massachusetts, partially offset by a $0.2 million decrease in external legal and investor relations services.
Interest Income. Interest income for the nine months ended September 30, 2006 was $4.3 million compared to $0.5 million for the nine months ended September 30, 2005. The $3.8 million increase in interest income was primarily caused by increases in our average cash and short-term investments balances. The increase in our average cash balance for the nine months ended September 30, 2006 as compared to the nine months ended September 30, 2005 resulted from the completion of our initial public offering in November 2005, payments and investments from our collaboration with Angiotech, the closing of a private placement of common stock in March 2006 as well as reimbursement of leasehold improvement expenses from the landlord of our Cambridge facility.
Interest Expense. Interest expense increased to $0.5 million for the nine months ended September 30, 2006 from $0.3 million for the nine months ended September 30, 2005. The increase was primarily due to interest expense of $0.2 million incurred during the nine months ended September 30, 2006 on $9.0 million of convertible notes issued to BioMedical Sciences Investment Fund Pte Ltd, an investor in our Singapore subsidiary.
Accretion of Dividends on Preferred Stock. Accretion of dividends on our convertible preferred stock for the nine months ended September 30, 2006 was $0 compared to $5.2 million for the nine months ended September 30, 2005. Our convertible preferred stock automatically converted into shares of common stock upon the completion of our initial public offering, after which, no further accretion of dividends was recorded.
Liquidity and Capital Resources
Since our inception in March of 2000 until our initial public offering on November 9, 2005, we have funded our operations principally through the private placement of equity securities, which provided net proceeds to us of approximately $104.9 million. Our initial public offering provided net proceeds to us of $43.8 million and a private placement of our common stock in March 2006 provided net proceeds to us of $45.3 million. We have also generated funds from debt financing and from payments from our collaboration partners. As of September 30, 2006, we had cash, cash equivalents and short-term investments of approximately $128.6 million, which includes $4.1 million of restricted cash. Our funds are primarily invested in short-term investment grade securities and money market funds. Based upon our current operating plans, we expect our existing resources to be sufficient to fund our planned operations for approximately the next two and one half years.
During the nine months ended September 30, 2006, we used $20.8 million of cash in operating activities, and during the nine months ended September 30, 2005, we used $15.5 million of cash in operating activities. The net use of cash from operations in both periods is attributed to our loss from operations adjusted for changes in working capital experienced during the periods. The change in the use of cash in operations in the 2006 period as compared to the 2005 period was due primarily to increases of $1.1 million in non-cash stock-based compensation expense, deferred rent of $1.7 million for our new facility and accrued expenses of $0.7 million related to clinical trial expense and costs associated with being a public company. However, these increases are offset by a decrease in deferred revenue of $7.0 million primarily due to amortization of the upfront license fee from our collaboration with Angiotech.
Our investing activities reflect a use of cash of $33.2 million for the nine months ended September 30, 2006 compared to cash provided by investing activities of $15.7 million for the nine months ended September 30, 2005. The cash used in investing activities in the nine months ended September 30, 2006 was primarily due to purchases of short-term investments. Our investing activities in all periods consist of purchases of property and equipment, primarily lab equipment, the purchases and maturities of marketable securities and additions of restricted cash to secure standby letters of credit for our Cambridge, Massachusetts facility lease. We incurred $7.8 million in capital expenditures for the nine months ended September 30, 2006 principally related to leasehold improvements, lab and computer equipment and furniture and fixtures for our new office and lab facility in Cambridge, Massachusetts.
Our financing activities provided $54.7 million of cash proceeds as of September 30, 2006 compared to $7.5 million of cash provided in the nine months ended September 30, 2005. The increase in the nine months ended September 30, 2006 is primarily due to the completion of a private placement of our common stock in March 2006 which resulted in net proceeds to us of $45.3 million. Other financing activities included a $3.5 million promissory note issued by CombinatoRx (Singapore)
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Pte Ltd to Biomedical Sciences, $4.0 million in tenant improvement allowances from our landlord for our new office and laboratory facility and a promissory note of $2.4 million issued by us to General Electric Capital Corporation.
For the nine months ended September 30, 2006, we received $3.1 million in payments from our collaborations and research and development agreements with Fovea Pharmaceuticals, SAIC (NINDS), the Spinal Muscular Atrophy Foundation (SMAF), CHDI, Inc., and a grant from NIAID. We expect that our sources of funding for the next several years will continue to include, in addition to funds raised through the sale of equity, and subject to our satisfying conditions, additional research funding, license fees, potential milestone payments and royalties relating to our collaborative agreements with Angiotech, Fovea, Cystic Fibrosis Foundation Therapeutics (CFFT), HenKan Pharmaceutical Company, SMAF, CHDI, Inc., SAIC and government grants from NIAID, and from any other collaborative agreements into which we might enter.
In March 2006, we borrowed approximately $0.8 million from our existing equipment line of credit with General Electric Capital Corporation. Amounts borrowed under the facility are repayable over 36 months and bear interest at 10.52% per annum. In June 2006, we amended the equipment line of credit to increase the line of credit by $3.3 million, and on June 30, 2006, we borrowed approximately $1.6 million under the amended agreement, repayable over 48 months in the case of laboratory and scientific equipment and 36 months in the case of other equipment at an annual interest rate of 10.68%. Once drawdowns under the facility are repaid, they may not be reborrowed. As of September 30, 2006, there was approximately $3.4 million outstanding under this line of credit, and approximately $1.7 million remained available. In the nine months ended September 30, 2006 we repaid approximately $1.0 million of the amounts borrowed under the facility, and no warrants previously granted to the lender in connection with providing the line of credit had been exercised.
On March 9, 2006, we entered into an amendment to the lease for our new Cambridge, Massachusetts office and laboratory facility in order to secure additional space. Because the amendment increases the total space we rent at the Cambridge location, we were obligated to increase the amount of the standby letter of credit required under the lease from $2.5 to $4.0 million. In addition, under the lease agreement as amended, we expect to receive approximately $6.9 million in tenant improvement funds from the landlord during 2006. We submitted approximately $4.0 million in tenant improvement reimbursements to the landlord for which we received payment in July 2006. We expect to invest approximately $3.5 million in additional leasehold improvements, equipment, furniture and fixtures associated with the construction of our expansion space.
Contractual Obligations
Other than the operating leases and indebtedness described in the Liquidity and Capital Resources section, there have been no additional material contractual obligations incurred by us that materially changes the disclosure of our contractual obligations in our Form 10-K for the year ended December 31, 2005.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements or relationships with unconsolidated entities of financial partnerships, such as entities often referred to as structured finance or special purpose entities.
Item 3. Quantitative and Qualitative Disclosure about Market Risk
We are exposed to market risk related to changes in interest rates and changes in the exchange rate of the United States dollar to the Singapore dollar. As of September 30, 2006, we had unrestricted cash, cash equivalents and marketable securities of $124.5 million consisting of cash and highly liquid and short-term investments. Our cash is deposited in and invested through highly rated financial institutions in North America and Singapore. Our marketable securities are subject to interest rate risk and will fall in value if market interest rates increase. If market interest rates were to increase immediately and uniformly by 5% from levels at September 30, 2006, we estimate that the fair value of our investments will decline by an immaterial amount, and therefore, our exposure to interest rate changes is immaterial. Our outstanding notes payable are at fixed interest rates and therefore have minimal exposure to changes in interest rates.
Transactions by our subsidiary, CombinatoRx Singapore, may be denominated in a currency other than the entity’s functional currency, which is the United States dollar. Exchange gains or losses resulting from the translation between the currency in which a transaction is denominated and CombinatoRx Singapore’s functional currency are included in net loss
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for our consolidated financial statements. Fluctuations in exchange rates, primarily between the United States dollar and the Singapore dollar, may adversely affect our results of operations, financial position and cash flows.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
As required by Rule 13a–15(b) of the 1934 Act, the Company’s management, including the Chief Executive Officer and the Chief Financial Officer, conducted an evaluation as of the end of the period covered by this Quarterly Report on Form 10-Q of the effectiveness of the design and operation of the Company’s disclosure controls and procedures. Based on that evaluation, the Company’s Chief Executive Officer and Chief Financial Officer concluded that the Company’s disclosure controls and procedures are effective at the reasonable assurance level in ensuring that information required to be disclosed by the Company in the reports that it files or submits under the 1934 Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.
Changes in Internal Control
As required by Rule 13a-15(d) of the 1934 Act, the Company’s management, including the Chief Executive Officer and the Chief Financial Officer, conducted an evaluation of the internal control over financial reporting to determine whether any changes occurred during the period covered by this Quarterly Report on Form 10-Q that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting. Based on that evaluation, the Chief Executive Officer and Chief Financial Officer concluded no such changes during the fiscal quarter covered by this Quarterly Report on Form 10-Q materially affected, or were reasonably likely to materially affect, the Company’s internal control over financial reporting.
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PART II
Item 1. Legal Proceedings
We are currently not a party to any material legal proceedings.
Item 1A. Risk Factors
RISK FACTORS THAT MAY AFFECT FUTURE RESULTS
Investment in our common stock involves a high degree of risk and uncertainty. You should carefully consider each of the risks and uncertainties described below before you decide to invest in our common stock. You should also refer to the other information in this annual report, including our financial statements and related notes. If any of the following risks and uncertainties actually occurs, our business, financial condition, and results of operations could be severely harmed. This could cause the trading price of our common stock to decline, and you could lose all or part of your investment.
Risks Related to Our Discovery, Development and Commercialization of New Medicines
Our approach to the discovery and development of combination drugs is unproven and may never lead to commercially viable products.
Our approach to drug discovery and development is complex and unproven and has not been successfully used or, to our knowledge, attempted by any company. Previously unrecognized or unexpected defects or limitations to our drug discovery technology may emerge, which we may also be unable to overcome or mitigate. We cannot be certain of the value of any of our current or future product candidates. None of the product candidates identified or developed to date, through the application of our business model and drug discovery technology, has been approved by any regulatory agency for commercial sale or been commercialized.
While we are advancing product candidates into phase I/II or phase IIa proof-of-concept clinical trials on the basis of their approved drug components, these product candidates could fail in these or future clinical trials. In addition, we may be required to conduct additional preclinical and phase I clinical studies for the new formulations we develop of our product candidates. If the additional preclinical or phase I clinical studies required for a product candidate’s formulation are extensive, it could delay or prevent further development of the product candidate. Regulatory approval for a combination drug generally requires additional clinical trials to compare the activity of each component drug with the combination. As a result, it may be more difficult and costly to obtain regulatory approval of a combination drug than of a new drug containing only a single active pharmaceutical ingredient.
Our business model is dependent on the ability of our proprietary high throughput discovery technology to identify additional promising product candidates. High throughput screening involves testing large numbers of compounds in cell-based assays using automated systems that measure the biological activity of the compounds and provide detailed data regarding the results. Because our high throughput discovery technology is unproven, we cannot be certain that we will be able to discover additional drug combinations that show promising effects in our cell-based disease models and preclinical studies, which we can advance into clinical trials. As a result, we may not be able to identify additional product candidates. Many other companies with substantially greater resources than ours use high throughput screening for drug discovery. These or other companies may have developed or could in the future develop combination screening technology equal or superior to our technology.
For these and other reasons, our approach to drug discovery and development may not be successful, and our business model may not generate viable products or revenue. Even if our approach is theoretically viable, we may not complete the significant research and development or obtain the financial resources and personnel required to further develop and apply our discovery technology, advance promising product candidates to and through clinical trials, and obtain required regulatory approvals.
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Our results to date provide no basis for predicting whether any of our product candidates will be safe or effective, or receive regulatory approval.
All of our product candidates are in an early stage of development and their risk of failure is high. To date, the data supporting our drug discovery and development programs is derived from either laboratory and preclinical studies and limited early stage clinical trials that were not all designed to be statistically significant or proof-of-concept clinical trials, some of which are exploratory in nature. It is impossible to predict when or if any one of our product candidates will prove effective or safe in humans or will receive regulatory approval. If we are unable to discover or successfully develop drugs that are effective and safe in humans, we will not have a viable business.
We may be unable to find safe and effective doses and dose ratios for our product candidates without extensive clinical trials and substantial additional costs, if at all.
We must select the doses, including the amount, frequency and duration, of each of the two active pharmaceutical ingredients included in our product candidates, and the relative amounts, or dose ratios, of these doses. Our clinical trials in humans may show that the doses or dose ratios we select based on our high throughput screening, animal testing or early clinical trials do not achieve the desired therapeutic effect in humans, or achieve this effect only in a small part of the population. Even if the doses or dose ratios we select show efficacy in humans, the resulting doses or dose ratios of our active pharmaceutical ingredients may not have acceptable safety profiles for our targeted indications. Furthermore, even if we believe that our preclinical and clinical studies adequately demonstrate that the doses or dose ratios we select for our product candidates are safe and effective in humans, the FDA or other regulatory agencies in foreign jurisdictions may conclude that our clinical trials do not support our conclusion. We may be required to conduct additional long-term clinical studies and provide more evidence substantiating the safety and effectiveness of the doses or dose ratios we select in a significant patient population. If we need to adjust the doses or dose ratios, we may need to conduct new clinical trials. We may also be required to make different doses or dose ratios available for different types of patients. All of this may result in significant delays and additional costs or prevent commercialization of our product candidates.
The approved drugs included in our product candidates may have adverse or unacceptable side effects and we may not be able to achieve an acceptable level of side effect risks, compared to the potential therapeutic benefits, for our product candidates.
The approved drugs included in our combination product candidates have known adverse side effects. These side effects may be acceptable when an ingredient is used in its approved dosage to achieve a therapeutic benefit for its currently approved indications, but the side effect risk compared to the therapeutic benefit may not be acceptable when used for the intended indications for the product candidate. These side effects may also make it difficult for us to obtain regulatory or other approval to initiate clinical trials of our product candidates. In addition, the therapeutic effect of an approved drug in its currently approved indications may be inappropriate or undesirable in the intended indication for our product candidate. Also, the adverse side effects of an approved drug may be enhanced when it is combined with the other approved drug in the product candidate or other drugs patients are taking, or the combined drugs in a product candidate may produce additional side effects. Adverse side effects of the approved drugs could, in any of these situations, prevent successful development and commercialization of some or all of our product candidates, because the risks associated with the approved drug component may outweigh the therapeutic benefit of the combination.
The development of a product candidate could be adversely affected by safety or efficacy issues that subsequently arise or become the focus of increased attention or publicity regarding use of either of the approved drugs which comprise the product candidate or similar drugs. We could be forced to abandon a product candidate or an approved product, if any, due to adverse side effects from long-term or other use of one of the active pharmaceutical ingredients in the product candidate or product, even if such long-term or other use is not contemplated for such product candidate or product.
Four of our product candidates, and several of our earlier stage preclinical products, seek to increase the therapeutic effect of a reduced-dose corticosteroid or a calcineurin inhibitor by the combination of such steroid or calcineurin inhibitor with a second pharmaceutical ingredient that serves as an enhancer agent. The adverse side effects of the steroids, the calcineurin inhibitor and the antidepressant or other enhancer agent included in these drug candidates are significant and generally increase as their dosage and/or duration of therapy increases. As a result, the success of these product candidates depends upon the ability of an acceptable dose of the candidate’s enhancer agent to selectively amplify the therapeutic effect of a reduced-dose steroid or reduced-dose calcineurin inhibitor, without causing unacceptable expected or unexpected adverse side effects. To achieve sufficient efficacy in humans, we may need to include higher doses of the steroid or
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calcineurin inhibitor, or of the enhancer agent, than we expected to include based on our screening procedures, preclinical trials and limited clinical trials. As a result, our selective steroid amplifier, our enhanced calcineurin inhibitor or synergistic cytokine modulator product candidates could have greater adverse side effects than anticipated and could fail to achieve risk-to-benefit profiles that would justify their continued development.
Certain antidepressants, including the antidepressants in our product candidates, CRx-139 and CRx-150, carry a black box warning and expanded warning statements that alert health care providers to an increased risk of suicidality in children and adolescents being treated with these drugs. Several scientific publications also suggest the possibility of an increased risk for suicidal behavior in adults, in addition to children and adolescents, who are being treated with antidepressant medications. In particular, studies and publications suggest that selective serotonin reuptake inhibitors, including the antidepressant included in CRx-139, may increase the risk of suicidal behavior in adults. The FDA has begun a complete review of all available data to determine whether there is an increased risk of suicidality in adults being treated with antidepressant medications. The outcome of this review may lead to additional product labeling or even suspension of the use of some or all of the anti-depressants included in our product candidates, which would delay or prevent the continuation of our clinical trials, development and eventual commercialization of these product candidates.
Significant adverse side effects of the component drugs included in our clinical stage product candidates include: in the case of our selective steroid amplifier product candidates, fluid and electrolyte imbalances, muscle and bone loss, diabetes, somnolence, suicidality, weakness, birth defects, abdominal distress, peptic ulceration, arrhythmias, cataracts, avascular osteonecrosis, glaucoma, myopathy, and nausea; in the case of our product candidate CRx-150, dizziness, abdominal distress and headache; and in the case of our oncology product candidate, drowsiness, low blood pressure, pancreatic damage, tardive dyskinesia, and confusional states. These side effects are not the only side effects of the components of our clinical stage product candidates, but are provided based on their severity and expected frequency of occurrence. The occurrence of these or other significant adverse side effects such as electrocardiogram changes, hepatic or renal dysfunction, myocardial infarction, infections, weight gain, immunosuppression, tachycardia and agranulocytosis could lead to difficulty in obtaining regulatory or other approval for clinical trials of our product candidates, the termination of our clinical trials or could result in product liability claims.
The active pharmaceutical ingredients in our product candidates may produce adverse side effects when delivered in combination.
While an active pharmaceutical ingredient in one of our product candidates may be safe, or have an acceptable risk-to-benefit profile when administered as a single agent for its approved indications, the same active pharmaceutical ingredient when delivered in combination with the other active pharmaceutical ingredient in the product candidate or other drugs being taken by patients we are seeking to treat may cause serious unexpected or unacceptable adverse side effects. Our discovery technology is not designed to and does not detect adverse side effects that may result from the combination of the two drugs, and these side effects may not be detected in any preclinical toxicology studies we conduct. Side effects resulting from the delivery in combination of our product candidates or the interaction with other drugs could be discovered in the course of performing clinical trials of our product candidates. In addition, the active pharmaceutical ingredients in a product candidate may not be approved for treatment of the product candidate’s targeted disease and may result in additional adverse side effects not typically associated with products for treatment of such a disease. The FDA or other regulators could require preclinical and phase I studies testing for combination side effects before we advance product candidates to further clinical trials.
We may not be able to initiate and complete clinical trials for our product candidates.
Conducting clinical studies for any of our drug candidates requires finding appropriate clinical sites and clinical investigators, securing approvals for such studies from the independent review board at each such site and local regulatory authorities and enrolling sufficient numbers of patients. We may not be able to arrange for appropriate clinical trials for our product candidates, secure the necessary approvals or enroll the necessary number of participants. In particular, we have experienced delays in enrollment of our Phase IIa Rheumatoid Arthritis clinical trials, primarily due to competing therapies otherwise available to the relevant patient population. In addition, we cannot guarantee that outside clinical investigators conducting our clinical trials will conduct them in compliance with applicable United States or foreign regulations. Clinical sites may fail the FDA’s or other regulatory agencies’ inspections or reviews and our trials could be halted for these or other reasons. As a result of these risks, our clinical trials may be extended, delayed or terminated, which could delay the receipt of clinical results for our product candidates, which could delay, impede or stop the development, regulatory approval or successful commercialization of our product candidates.
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Our product candidates are combinations of approved drugs that are commercially available and marketed by other companies. As a result, our products may be subject to substitution and competition.
We anticipate that the approved drugs that are combined to produce our product candidates are likely to be commercially available at prices lower than the prices at which we would seek to market our product candidates. We cannot be sure that physicians will view our products as sufficiently superior to a treatment regime of the individual active pharmaceutical ingredients as to justify the significantly higher cost we expect to seek for our combination products, and they may prescribe the individual drugs already approved and marketed by other companies instead of our combination products. Even if we are issued patents covering the composition of matter or method of use of our combination products, those patents may be ineffective as a practical matter to protect against physicians prescribing the individual drugs marketed by other companies instead of our combination products. To the extent that the price of our products is significantly higher than the prices of the individual components as marketed by other companies, physicians may have a greater incentive to write prescriptions for the individual components instead of for our combination products, and this may limit how we price our products. Similar concerns could also limit the reimbursement amounts private health insurers or government agencies in the United States are prepared to pay for our products, which could also limit market and patient acceptance of our products, and could negatively impact our revenues and net income, if any. Physicians might also prescribe the individual components of a product candidate prior to its approval, which could adversely affect our development of the product candidate due to our lack of control over the administration to patients of the combination of active pharmaceutical ingredients in our product candidate, the occurrence of adverse effects, and other reasons. Such pre-approval use could also adversely affect our ability to market and commercialize any such product candidate which we successfully develop.
In many countries where we plan to market our products, including Europe, Japan and Canada, the pricing of prescription drugs is controlled by the government or regulatory agencies. Regulatory agencies in these countries could determine that the pricing for our products should be based on prices for their active pharmaceutical ingredients when sold separately, rather than allowing us to market our products at a premium as new drugs.
We must create commercially viable pharmaceutical formulations for our product candidates.
The success of a product candidate may depend on our ability to develop a formulation of the product candidate that is superior to a treatment regime of the two approved drugs included in the product candidate taken separately. In some instances, to be commercially successful, this formulation must have a different method of administration than the approved drugs. Developing such formulations could be costly and difficult. We expect to rely on third party suppliers to develop the pharmaceutical formulations, delivery methods or packaging for our product candidates and they may not be successful in doing so. Defects in the formulation, delivery method or packaging of any of our product candidates could delay our ability to conduct clinical trials or require us to repeat clinical trials using a revised formulation, delivery method or packaging. If we are unsuccessful in creating commercially viable formulations, delivery methods or packaging, we may never generate product revenue or be profitable.
We may devote substantial time and resources to clinical trials that may not be predictive of efficacy in other indications or to screening a cell-based model which is not predictive of results in humans.
We have conducted exploratory Phase IIa clinical trials of two of our product candidates, CRx-102 and CRx-150, in patients with chronic adult periodontitis, a bacterial disease of the gums with an inflammatory component. Each of these product candidates has been or is being studied in clinical trials of other immuno-inflammatory diseases. These periodontitis clinical trials were designed as exploratory studies to measure the effect of our product candidates on a number of immuno-inflammatory biomarkers, in addition to an endpoint of efficacy in the treatment of periodontitis. We believe the results of these studies will allow us to compare and contrast the immuno-inflammatory properties of our portfolio of immuno-modulating product candidates and potentially inform our decisions as to which immuno-inflammatory diseases these product candidates should be developed. To our knowledge, the use of clinical trials in chronic adult periodontitis to predict the efficacy of a product candidate in another immuno-inflammatory disease has not been previously done. Due to the unproven nature of this approach to the clinical development of certain of our product candidates, there are risks that the results from these clinical trials will not be sufficient to inform our clinical development decisions regarding CRx-102 and CRx-150 or that positive or negative results from these clinical trials may not be predictive of efficacy of these product candidates in other immuno-inflammatory diseases we are interested in developing drugs to treat. If these periodontitis clinical trials do not provide useful data or are not predictive of efficacy in other indications, we will be required to make development decisions based on the results of the other clinical trials of these product candidates in specific immuno-inflammatory diseases, which
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could delay the development of these product candidates. In addition, we may be required to expend additional resources on additional clinical trials or other research to determine whether to develop these product candidates.
In addition, when conducting high throughput screening of selected cell-based models for specific diseases, we must devote months of time to testing thousands or millions of drug and dose combinations against a cell-based model for a selected disease. We may not be able to obtain, through our screening of a cell-based model, the information we seek regarding the effects of drug and dose combinations on multiple biological pathways. The cell-based model that we select may not accurately predict the effects in humans of the drug and dose combinations tested in the model. This failure may not be apparent until the completion of costly clinical trials. As a result, we may expend considerable resources and substantial time in generating results that are not useful or in conducting clinical trials that are not successful.
Financing arrangements for our subsidiary CombinatoRx (Singapore) Pte Ltd, which we refer to as CombinatoRx Singapore, may cause substantial dilution to our stockholders, limit our control over important development decisions, divert resources away from other projects, prevent us from entering into relationships with third parties for infectious disease indications and result in the loss of significant intellectual property rights.
Exercise by BioMedical Sciences of the rights granted to it to convert its shares of preferred stock in our Singapore subsidiary and convertible promissory notes issued by our Singapore subsidiary that they hold into shares of our common stock could result in substantial dilution to our stockholders. BioMedical Sciences may convert its shares of convertible preferred stock in our Singapore subsidiary with a $2.5 million liquidation preference and its original convertible promissory note with a $5.5 million principal amount into our common stock at a conversion price of $10.803 or, in the case of convertible promissory notes issued by the subsidiary on or after December 9, 2005, at a 40% premium to the volume-weighted average price of our common stock over the 20 trading days immediately prior to the issuance of the note, which in the case of the promissory note issued by our Singapore subsidiary with a $3.5 million principal amount on June 8, 2006, at a conversion price of $11.572. These prices may be substantially less than the market price of our shares at the time of conversion.
As a condition of the financing provided to our subsidiary by BioMedical Sciences, we agreed to enter into a Services Agreement requiring us to provide substantial assay development and screening services to our subsidiary over the next four years and to assign to our subsidiary ownership of all intellectual property rights covering combination therapies for the treatment of infectious disease discovered by us through our work under the Services Agreement. We have also agreed to provide screening services in the field of the therapeutic treatment of infectious disease through combination therapies exclusively to the subsidiary and not to compete with the subsidiary, which will prevent us from doing work in infectious disease indications for third parties. We will commit substantial personnel resources to support operations of the subsidiary, both directly and under the Services Agreement, which could adversely affect our other operations. The performance of this work for the subsidiary may limit our ability to perform work on other disease indications. Assignment of the intellectual property rights to the subsidiary exposes us to the risk that the subsidiary may be unable to successfully develop promising therapies.
Our Singapore subsidiary will need substantially greater resources to commercialize any promising combination therapy than the resources provided by the BioMedical Sciences financing and may not be able to obtain such financing on terms acceptable to the subsidiary, us or BioMedical Sciences. BioMedical Sciences has extensive control over the operations of the subsidiary and we will not control development decisions regarding the combination therapies assigned to the subsidiary or other major decisions to be made in regard to the subsidiary.
If we or our subsidiary defaults on our obligations to BioMedical Sciences, we could lose our entire interest in the subsidiary and have no further ability to commercialize the intellectual property assigned to the subsidiary for the therapeutic treatment of infectious diseases.
Our equity interest in the subsidiary is illiquid and cannot be transferred or sold for at least four years. In addition, our equity interest in the Singapore subsidiary is junior to the preferred stock and secured convertible promissory notes of the subsidiary held by Biomedical Sciences, and would likely be worthless in the event of any liquidation or forced sale of the subsidiary or its assets.
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A material component of our business strategy is to establish and maintain collaborative relationships to fund research and possible development and commercialization of combination product candidates, by us or by collaborators. If we or any collaborator terminates or fails to perform any obligations under our collaboration agreements, the development and commercialization of product candidates under these agreements could be delayed or terminated.
A material component of our business strategy is to establish and maintain collaborative arrangements with pharmaceutical, biotechnology and medical device companies, research institutions and foundations, and to seek grants from agencies of the United States government, to fund research and possible development and commercialization of combination drug products for the treatment of diseases. We also intend to seek to establish collaborative relationships to obtain domestic or international sales, marketing and distribution capabilities if any of our combination product candidates receive regulatory approval.
The process of establishing collaborative relationships is difficult, time-consuming and involves significant uncertainty. Moreover, even if we do establish collaborative relationships, it may be difficult for us to maintain or perform under such collaboration arrangements, as our funding resources may be limited or our collaborators may seek to renegotiate or terminate their relationships with us due to unsatisfactory clinical results, a change in business strategy, a change of control or other reasons. If we or any collaborator fails to fulfill any responsibilities in a timely manner, or at all, our research, clinical development or commercialization efforts related to that collaboration could be delayed or terminated. Additionally, it may become necessary for us to assume responsibility for activities that would otherwise have been the responsibility of our collaborator. Further, if we are unable to establish and maintain collaborative relationships on acceptable terms, we may have to delay or discontinue further development of one or more of our product candidates, undertake development and commercialization activities at our own expense or find alternative sources of funding.
Our collaborations are generally new, and we have only a short history of working together with Angiotech, Fovea, CFFT, HenKan or our other collaborators and cannot predict the success of any of our collaborations. Our collaborations typically involve a complex allocation of responsibilities, costs and benefits and provide for milestone payments to us upon the achievement of specified clinical and regulatory milestones. Our collaborations also may provide us with royalty-based revenue if product candidates are successfully commercialized. Under the Angiotech and other collaborations, we will rely on our collaborators to provide resources to develop new product candidates and to potentially achieve these milestones and commercialize any new products. We may not be able to achieve any of the milestones provided in our Angiotech or other collaboration agreements or derive any license or royalty revenue with respect to these collaborations.
If we fail to manage our growth, our operations and financial results could be adversely affected.
Since our inception in 2000, we have grown to approximately 135 employees and advanced seven product candidates into clinical trials. We have expanded our operations and strategic relationships at a rapid pace through numerous collaborations, including with Angiotech, Fovea, CFFT, the Spinal Muscular Atrophy Foundation, HenKan Pharmaceutical, CHDI, Inc., National Institutes of Health, Accelerate Brain Cancer Care and through our subsidiary CombinatoRx Singapore. We have experienced a period of rapid growth that has placed a strain on our administrative and operational infrastructure. We expect this strain to continue as we continue to grow and seek to obtain and manage collaborations and relationships with third parties. We must continue to refine and expand our research and development capabilities, our management of the clinical trial process, access to financing resources and technology. As we grow, we must continue to hire, train, supervise and manage new employees. We may not be successful in hiring sufficient research, development, clinical, regulatory and administrative personnel and management to manage our expansion effectively. If we are unable to manage our growth, our operations and financial results could be adversely affected.
We may fail to select or capitalize on the most scientifically, clinically or commercially promising or profitable product candidates.
We have limited technical, managerial and financial resources to determine which of our product candidates should proceed to initial clinical trials, later stage clinical development and potential commercialization. We may make incorrect determinations. Our decisions to allocate our research, management and financial resources toward particular product candidates or therapeutic areas may not lead to the development of viable commercial products and may divert resources from better opportunities. Similarly, our decisions to delay or terminate drug development programs may also be incorrect and could cause us to miss valuable opportunities.
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We have no manufacturing, sales or distribution capabilities and may not obtain the collaboration, development, commercialization, manufacturing or other third party relationships that we will require to develop, commercialize and manufacture some or all of our product candidates.
We have no manufacturing, sales or distribution capabilities and lack the collaborations, resources, capabilities, and experience necessary to clinically develop, fully formulate, manufacture, test, market and sell pharmaceuticals. As a result, to succeed in our business plan, we will be dependent on the efforts of third parties. We expect to depend on collaborators, licensees, clinical research organizations, manufacturers and other third parties to formulate product candidates, to conduct clinical trials for some or all of our product candidates, to manufacture clinical and commercial scale quantities of our product candidates and products and to market, sell, and distribute any products we successfully develop. We also rely on obtaining sufficient quantities of the approved drugs in our product candidates from sources acceptable to the FDA and other regulators for early stage clinical trials.
We expect to be able to develop and commercialize many of our product candidates only with the participation of pharmaceutical or biotechnology company collaborators or by out-licensing rights to the product candidates. Pharmaceutical and biotechnology companies and others may be reluctant to collaborate with us or to license rights to our product candidates due to the unproven nature of our drug discovery and development approach, the fact that the active pharmaceutical ingredients in our product candidates are approved drugs marketed by other companies, the risk that healthcare providers may substitute the component active pharmaceutical ingredients for our proposed combination products, concerns regarding the pricing of and reimbursement for our product candidates if they are successfully developed, or other factors.
We cannot guarantee that we will be able to successfully negotiate agreements for relationships with collaborators, partners, licensees, clinical investigators, manufacturers and other third parties on favorable terms, if at all. If we are unable to obtain these agreements, we may not be able to clinically develop, formulate, manufacture, test, obtain regulatory approvals for or commercialize our product candidates.
We expect to expend substantial funds and management time and effort to enter into relationships with these third parties and, if we successfully enter into such relationships, to manage these relationships. However, we cannot control the amount or timing of resources our contract partners will devote to our research and development programs, product candidates or potential product candidates, and we cannot guarantee that these parties will succeed in a timely fashion, if at all.
Disputes under key agreements could delay or prevent development or commercialization of our product candidates.
Any agreements we have or may enter into with third parties, such as collaboration, license, formulation supplier, manufacturing, testing, clinical research organization or clinical trial agreements, may give rise to disputes regarding the rights and obligations of the parties. Disagreements could develop over rights to ownership or use of intellectual property, the scope and direction of research and development, the approach for regulatory approvals or commercialization strategy. We intend to conduct research programs in a range of therapeutic areas, but our pursuit of these opportunities could result in conflicts with the other parties to these agreements who may be developing or selling pharmaceuticals or conducting other activities in these same therapeutic areas. Any disputes or commercial conflicts could lead to the termination of our agreements, delay progress of our product development programs, compromise our ability to renew agreements or obtain future agreements, lead to the loss of intellectual property rights or result in costly litigation.
We may not be able to gain market acceptance of our product candidates, which would prevent us from becoming profitable.
We cannot be certain that any of our product candidates, if approved, will gain market acceptance among physicians, patients, healthcare payors, pharmaceutical companies or others. Demonstrating the safety and efficacy of our product candidates and obtaining regulatory approvals will not guarantee future revenue. Sales of medical products largely depend on the reimbursement of patients’ medical expenses by government healthcare programs and private health insurers. Governments and private insurers closely examine medical products to determine whether they should be covered by reimbursement and if so, the level of reimbursement that will apply. We cannot be certain that third party payers will sufficiently reimburse sales of our products, or enable us to sell our products at profitable prices. Sales of medical products also depend on physicians’ willingness to prescribe the treatment, which is likely to be based on a determination by these physicians that the products are safe, therapeutically effective and cost-effective. We cannot predict whether physicians, other healthcare providers, government agencies or private insurers will determine that our products are safe, therapeutically
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effective and cost effective relative to competing treatments, including a treatment regime of the individual approved drugs included in our combination products.
If we are not able to retain our current senior management team or attract and retain qualified scientific, technical and business personnel, our business will suffer.
We are dependent on the members of our management team for our business success. In addition, an important element of our strategy is to take advantage of the development, regulatory and commercialization expertise of our current management. Our employment agreements with our executive officers are terminable on short notice or no notice. The loss of any one of our executive officers could result in a significant loss in the knowledge and experience that we, as an organization, possess and could cause significant delays, or outright failure, in the development and further commercialization of our product candidates. We currently have a key person life insurance policy on Mr. Borisy, in the amount of $1 million.
To grow, we will need to hire a significant number of qualified commercial, scientific and administrative personnel. However, there is intense competition for human resources, including management in the technical fields in which we operate, and we may not be able to attract and retain qualified personnel necessary for the successful development and commercialization of our product candidates. As we grow, the inability to attract new employees when needed or to retain existing employees could limit our growth and harm our business.
Risks Related to Our Financial Results and Need for Additional Financing
We have a history of operating losses, expect to incur significant and increasing operating losses and may never be profitable. Our stock is a highly speculative investment.
We commenced operations in March 2000 and have a very limited operating history for you to evaluate our business. We have no approved products and have generated no product revenue. We have incurred operating losses since our inception in 2000. As of September 30, 2006, we had an accumulated deficit of $122.7 million. We have spent, and expect to continue to spend, significant resources to fund research and development of our product candidates and to enhance our drug discovery technology. We expect to incur substantial and increasing operating losses over the next several years as our research, development, preclinical testing, and clinical trial activities increase. As a result, our accumulated deficit will also increase significantly.
Our product candidates are in the early stages of development and may never result in any revenue. We will not be able to generate product revenue unless and until one of our product candidates successfully completes clinical trials and receives regulatory approval. As our most advanced product candidates are in or are emerging from the proof-of-concept stage, we do not expect to receive revenue from any product candidate for the foreseeable future. We may seek to obtain revenue from collaboration or licensing agreements with third parties. Our current collaboration and license agreements may not provide us with material, sustainable ongoing future revenue, and we may not be able to enter into additional collaboration agreements. Even if we eventually generate product revenues, we may never be profitable, and if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
We may be unable to raise the substantial additional capital that we will need to sustain our operations.
We will need substantial additional funds to support our planned operations. Based on our current operating plans, we expect our existing resources to be sufficient to fund our planned operations for approximately the next two and one half years. We may, however, need to raise additional funds before that time if our research and development expenses exceed our current expectations or our collaboration funding is less than our current expectations. This could occur for many reasons, including:
· some or all of our product candidates fail in clinical or preclinical studies or prove to be less commercially promising than we expect and we are forced to seek additional product candidates;
· our product candidates require more extensive clinical or preclinical testing or our clinical trials take longer to complete than we currently expect;
· we advance more of our product candidates than expected into costly later stage clinical trials;
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· we advance more preclinical product candidates than expected into early stage clinical trials;
· we determine or are required to conduct more high throughput screening than expected against current or additional disease targets to develop additional product candidates;
· we are required, or consider it advisable, to acquire or license rights from one or more third parties; or
· we determine to acquire or license rights to additional product candidates or new technologies.
While we expect to seek additional funding through public or private financings, we may not be able to obtain financing on acceptable terms, or at all. In addition, the terms of our financings may be dilutive to, or otherwise adversely affect, holders of our common stock. We may also seek additional funds through arrangements with collaborators or others. These arrangements would generally require us to relinquish rights to some of our technologies, product candidates or products, and we may not be able to enter into such agreements, on acceptable terms, if at all. The arrangements also may include issuances of equity, which may also be dilutive to, or otherwise adversely affect, holders of our common stock. If we are unable to obtain additional funding on a timely basis, we may be required to curtail or terminate some or all of our research or development programs, including some or all of our product candidates.
Risks Related to Regulatory Approvals
The regulatory approval process is costly and lengthy and we may not be able to successfully obtain all required regulatory approvals.
The preclinical development, clinical trials, manufacturing, marketing, testing, and labeling of pharmaceuticals and medical devices are all subject to extensive regulation by numerous governmental authorities and agencies in the United States and other countries. We or our collaborators must obtain regulatory approval for product candidates before marketing or selling any of them. The approval process is typically lengthy and expensive, and approval is never certain. It is not possible to predict how long the approval processes of the FDA or any other applicable federal or foreign regulatory authority or agency for any of our products will take or whether any such approvals ultimately will be granted. The FDA and foreign regulatory agencies have substantial discretion in the drug and medical device approval process, and positive results in preclinical testing or early phases of clinical studies offer no assurance of success in later phases of the approval process. Generally, preclinical and clinical testing of products and medical devices can take many years and require the expenditure of substantial resources, and the data obtained from these tests and trials can be susceptible to varying interpretations that could delay, limit or prevent regulatory approval. Any delay in obtaining, or failure to obtain, approvals could prevent or adversely affect the marketing of our products or our collaborator’s products and our ability to generate product revenue. The risks associated with the approval process include delays or rejections in the regulatory approval process based on the failure of clinical or other data to meet expectations, or the failure of the product or medical device to meet a regulatory agency’s requirements for safety, efficacy and quality. In addition, regulatory approval, if obtained, may significantly limit the indicated uses for which a product may be marketed.
We or our collaborators may delay, suspend or terminate clinical trials for commercial distribution of any of our product candidates or their associated medical devices or products at any time for reasons including:
· ongoing discussions with the FDA or comparable foreign authorities regarding the scope or design of our clinical trials;
· delays or the inability to obtain required approvals from institutional review boards or other governing entities at clinical sites selected for participation in our clinical trials;
· delays in enrolling patients and volunteers into clinical trials;
· lower than anticipated retention rates of patients and volunteers in clinical trials;
· the need to repeat clinical trials as a result of inconclusive or negative results or poorly executed testing;
· lack of effectiveness of a product candidate in other clinical trials;
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· lack of sufficient funds for further clinical development;
· insufficient supply or deficient quality of product candidate materials or other materials necessary to conduct our clinical trials;
· unfavorable regulatory inspection of a manufacturing, testing, labeling or packaging facility for drug substance or drug product;
· unfavorable regulatory inspection and review of a clinical or pre-clinical trial site or records of any clinical or preclinical investigation;
· serious and unexpected drug-related side effects or adverse device effects experienced by participants in our clinical trials or following commercialization; or
· the placement of a clinical hold on a product candidate in an ongoing clinical trial.
Positive or timely results from preclinical studies and early clinical trials do not ensure positive or timely results in late stage clinical trials or product approval by the FDA or any other regulatory authority. Product candidates that show positive preclinical or early clinical results often fail in later stage clinical trials. Data obtained from preclinical and clinical activities is susceptible to varying interpretations, which could delay, limit, or prevent regulatory approvals.
We have limited experience in conducting the clinical trials required to obtain regulatory approval. We may not be able to conduct clinical trials at preferred sites, enlist clinical investigators, enroll sufficient numbers of patients, or begin or successfully complete clinical trials in a timely fashion, if at all. Any failure to perform may delay or terminate the trials. Our current clinical trials may be insufficient to demonstrate that our potential products are active, safe, or effective and as a result we may decide to abandon further development of such product candidates. Additional clinical trials may be required if clinical trial results are negative or inconclusive, which will require us to incur additional costs and significant delays. If we do not receive the necessary regulatory approvals, we will not be able to generate product revenues and will not become profitable. We may encounter significant delays in the regulatory process that could result in excessive costs that may prevent us from continuing to develop our product candidates. In addition, the failure to comply with applicable regulatory requirements may result in criminal prosecution, civil penalties, product recalls, withdrawal of product approval, mandatory restrictions and other actions that could impair our ability to conduct our business.
The FDA and other regulatory agencies may require additional preclinical and phase I clinical data for our combination products.
Our proposed products are composed of drugs previously approved as single agents, and as a result, there is significant pre-existing information on the safety of those drugs as single agents for their approved indications in the form of animal studies, phase I pharmacokinetic and other clinical studies and actual clinical experience. Nonetheless, new safety issues may arise when the previously approved drugs are used in combination in our products or when the proposed combination products are used in different treatment regimens for disease indications different than the disease indications for which the components are used as single agents. For example, the combination might be proposed for long-term use for a chronic condition, while the single agents are currently approved for short-term use in acute conditions. In addition, if a component has not been approved in all jurisdictions in which approval of the combination is sought, the regulatory agencies having authority over the combination in the jurisdictions that had not approved each component as a single agent may require us to submit data that would not otherwise be required. If any of these issues arises, we may be required to conduct additional preclinical and phase I clinical trials for the formulations we develop of our product candidates. If the additional preclinical or phase I clinical trials required for a product candidate’s formulation are extensive, it could delay or prevent further development of the product candidate.
The FDA and other regulatory agencies may require more extensive or expensive trials for our combination product candidates than may be required for single agent pharmaceuticals.
To obtain regulatory approval for our combination product candidates, we may be required to show that each active pharmaceutical ingredient in the product candidate makes a contribution to the combined product candidate’s claimed effects and that the dosage of each component, including amount, frequency and duration, is such that the combination is safe and effective for a significant patient population requiring such concurrent therapy. As a result, we may be required to conduct
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clinical trials comparing each component drug with the combination. This could require us to conduct more extensive and more expensive clinical trials than would be the case for many single agent pharmaceuticals. The need to conduct such trials could make it more difficult and costly to obtain regulatory approval of a combination drug than of a new drug containing only a single active pharmaceutical ingredient.
Even if we receive regulatory approvals for marketing our product candidates, if we fail to comply with continuing regulatory requirements, we could lose our regulatory approvals, and our business would be adversely affected.
The FDA and other regulatory authorities continue to review products and medical devices even after they receive initial approval. If we receive approval to commercialize any product candidates, the manufacturing, testing, marketing and sale of these drugs and medical devices will be subject to continuing regulation, including compliance with quality systems regulations, good manufacturing practices, adverse event reporting requirements, and prohibitions on promoting a product for unapproved uses. Enforcement actions resulting from failure to comply with government requirements could result in fines, suspension of approvals, withdrawal of approvals, recalls of products, product seizures, operating restrictions, and civil or criminal penalties. These enforcement actions could affect the manufacturing, testing, marketing and sale of our products.
Healthcare reform measures could adversely affect our business.
The efforts of governmental and third-party payers to contain or reduce the costs of healthcare may adversely affect the business and financial condition of pharmaceutical, biotechnology and medical device companies. In the United States and in foreign jurisdictions there have been, and we expect that there will continue to be, a number of legislative and regulatory proposals aimed at changing the healthcare system. For example, in some countries other than the United States, pricing of prescription drugs and medical devices is subject to government control, and we expect proposals to implement similar controls in the United States to continue. The pendency or approval of such proposals could result in a decrease in our common stock price or limit our ability to raise capital or to enter into collaborations or license rights to our products.
Federal legislation may increase the pressure to reduce prices of pharmaceutical products paid for by Medicare, which could adversely affect our revenues, if any.
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or MMA, expanded Medicare coverage for drug purchases by the elderly and disabled beginning in 2006. Under the MMA, private insurance plans subsidized by the government offer prescription drug coverage to Medicare beneficiaries who elect to enroll in their plans. Although almost all prescription drugs are potentially available to plan enrollees, the plans are allowed to use formularies, preferred drug lists and similar mechanisms to favor selected drugs and limit access to other drugs except in certain circumstances. The price of a drug as negotiated between the manufacturer and a plan is a factor that the plan can consider in determining its availability to enrollees.
As a result, we expect that there will be increased pressure to reduce prices for drugs to obtain favorable status for them under the plans offering prescription drug coverage to Medicare beneficiaries. This pressure could decrease the coverage and price that we receive for our products in the future and could seriously harm our business. It is possible that our products, if successfully developed, could be particularly subject to price reduction initiatives because they are based on combinations of lower priced existing drugs.
In addition, some members of Congress advocate that the federal government should negotiate directly with manufacturers for lower prices for drugs in the Medicare program, rather than rely on private plans. If the law were changed to allow or require such direct negotiation, there could be additional reductions in the coverage of and prices that we receive for our products.
Federal laws or regulations on drug importation could make lower cost versions of our future products available, which could adversely affect our revenues, if any.
The prices of some drugs are lower in other countries than in the United States because of government regulation and market conditions. Under current law, importation of drugs into the United States is generally not permitted unless the drugs are approved in the United States and the entity that holds that approval consents to the importation. Various proposals have been advanced to permit the importation of drugs from other countries to provide lower cost alternatives to the products available in the United States. In addition, the MMA requires the Secretary of Health and Human Services to promulgate
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regulations for drug reimportation from Canada into the United States under some circumstances, including when the drugs are sold at a lower price than in the United States.
If the laws or regulations are changed to permit the importation of drugs into the United States in circumstances not now permitted, such a change could have an adverse effect on our business by making available lower priced alternatives to our future products.
Failure to obtain regulatory and pricing approvals in foreign jurisdictions could delay or prevent commercialization of our products abroad.
If we succeed in developing any products, we intend to market them in the European Union and other foreign jurisdictions. In order to do so, we must obtain separate regulatory approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing. The time required to obtain approval abroad may differ from that required to obtain FDA approval. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval and additional risks because there may be additional variations between how our combinations of approved drugs and single agent drugs are treated in foreign jurisdictions. We may not obtain foreign regulatory approvals on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or by the FDA. We and our collaborators may not be able to file for regulatory approvals and may not receive necessary approvals to commercialize our products in any market outside the United States. The failure to obtain these approvals could materially adversely affect our business, financial condition and results of operations. Even if we are successful at obtaining these approvals, regulatory agencies in foreign countries where pricing of prescription drugs or medical devices is controlled by the government, could determine that pricing for our products should be based on prices for the existing drugs that comprise the active pharmaceutical ingredients in our combination products instead of allowing us to price our products at a premium as novel medicines.
Risks Related to Our Intellectual Property
Our success depends upon our ability to obtain and maintain intellectual property protection for our products and technologies.
Our success will depend on our ability to obtain and maintain adequate protection of our intellectual property, including our proprietary drug discovery technology and any products or product candidates we plan to develop. In addition to taking other steps to protect our intellectual property, we intend to apply for patents with claims covering our technologies, processes, products and product candidates when and where we deem it appropriate to do so. We have applied for patent protection covering our clinical and preclinical product candidates and our drug discovery technologies in the United States, and some, but not all, foreign countries. In countries where we have not and do not seek patent protection, third parties may be able to manufacture and sell our products without our permission, and we may not be able to stop them from doing so.
Similarly to other biotechnology companies, our patent position is generally uncertain and involves complex legal and factual questions. In addition, the laws of some foreign countries do not protect proprietary rights to the same extent as the laws of the United States, and other biotechnology companies have encountered significant problems in protecting and defending their proprietary rights in foreign jurisdictions. Whether filed in the United States or abroad, our patent applications may be challenged or may fail to result in issued patents. In addition, our existing patents and any future patents we obtain may not be sufficiently broad to prevent others from practicing our technologies or from developing or commercializing competing products. Furthermore, others may independently develop or commercialize similar or alternative technologies or drugs, or design around our patents. Our patents may be challenged, invalidated or fail to provide us with any competitive advantages.
The United States Patent and Trademark Office and similar agencies in foreign jurisdictions may not agree with our view that our combination product candidates and our drug discovery technologies are patentable or novel and non-obvious, and on this basis may deny us patent protection. Even if we receive patent protection, others, including those who own patent or trade secret rights associated with the approved drugs that are active pharmaceutical ingredients of our product candidates, may attempt to invalidate our patent or trade secret rights. Even if our patent or trade secret rights are not directly challenged, disputes among third parties could lead to the weakening or invalidation of our intellectual property rights.
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If we do not obtain or we are unable to maintain adequate patent or trade secret protection for our products in the United States, competitors could duplicate them without repeating the extensive testing that we will be required to undertake to obtain approval of the products by the FDA and other regulatory authorities. Regardless of any patent protection, under the current statutory framework the FDA is prohibited by law from approving any generic version of any of our combination products for three years after it has approved our product. Upon the expiration of that period, or if that time period is altered, the FDA could approve a generic version of our product unless we have patent protection sufficient for us to block that generic version. Without sufficient patent protection, the applicant for a generic version of our product would be required only to conduct a relatively inexpensive study to show that its product is bioequivalent to our product and would not have to repeat the studies that we conducted to demonstrate that the product is safe and effective. In the absence of adequate patent protection in other countries, competitors may similarly be able to obtain regulatory approval of products that duplicate our products.
We may not be able to develop or commercialize our product candidates due to intellectual property rights held by third parties.
If a third party holds a patent to a composition or method of use of an approved drug that is a component of one or more of our product candidates or a formulation technology related to our planned formulation of a product candidate, we may not be able to develop or commercialize such product candidates without first obtaining a license to such patent, or waiting for the patent to expire. In particular, there are issued patents and patent applications that cover or claim the use of pentamidine, one drug in product candidate CRx-026, for the treatment of cancer. We may not be able to develop or commercialize CRx-026 without first obtaining a license to these patents, or waiting for them to expire. In the event that one or more of the pending counterpart applications issues as a patent, we may not be able to develop or commercialize CRx-026 in a country in which such a counterpart patent issues without first obtaining a license to such patent, or waiting for it to expire. For two of our other product candidates, CRx-139 and CRx-170, some of the various formulations and methods of use of one drug in the combination are covered by third party patents which could pose an impediment to our ability to develop and commercialize these products. We believe that other formulations and methods of use of these drugs, which are not covered by any third party patents, are available. However, we cannot be sure that the unpatented formulations or methods of use of these drugs will be the optimal formulation, or that a feasible formulation for these product candidates will be available. Additionally, there are three United States patents that may cover therapeutic uses of our preclinical Type II diabetes product candidates. We may not be able to develop or commercialize our preclinical Type II diabetes product candidates without first obtaining a license to these patents, or waiting for them to expire. Our business will be harmed if we are unable to use the optimal formulation or methods of use of the component drugs that comprise our product candidates. This may occur because the formulations or methods of use are covered by one or more third party patents, and a license to such patents is unavailable or is available on terms that are unacceptable to us.
We may be unable to in-license intellectual property rights or technology necessary to develop and commercialize our products.
Depending on its ultimate formulation and method of use, before we can develop, clinically test, make, use, or sell a particular product candidate, we may need to obtain a license from one or more third parties who have patent or other intellectual property rights covering components of our product candidate or its method of use. There can be no assurance that such licenses will be available on commercially reasonable terms, or at all. Because our product candidates are based on combinations of existing drugs, there may be a significant number of patents covering both the active pharmaceutical ingredients in our product candidates and their method of use. If a third party does not offer us a necessary license or offers a license only on terms that are unattractive or unacceptable to us, we might be unable to develop and commercialize one or more of our product candidates.
Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information.
In our activities, we rely substantially upon proprietary materials, information, trade secrets and know-how to conduct our research and development activities, and to attract and retain collaborators, licensees and customers. We take steps to protect our proprietary rights and information, including the use of confidentiality and other agreements with our employees and consultants and in our academic and commercial relationships. However, these steps may be inadequate, agreements may be violated, or there may be no adequate remedy available for a violation of an agreement. Our proprietary information may be inadvertently disclosed, or we may lose the protection of our trade secrets. Our competitors may independently develop
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substantially equivalent proprietary information or may otherwise gain access to our trade secrets, which could adversely affect our ability to compete in the market.
Litigation or third party claims of intellectual property infringement could require substantial time and money to resolve. Unfavorable outcomes in these proceedings could limit our intellectual property rights and our activities.
We may need to resort to litigation to enforce or defend our intellectual property rights, including any patents issued to us. If a competitor or collaborator files a patent application claiming technology also invented by us, in order to protect our rights, we may have to participate in an expensive and time consuming interference proceeding before the United States Patent and Trademark Office. We cannot guarantee that our product candidates will be free of claims by third parties alleging that we have infringed their intellectual property rights. Third parties may assert that we are employing their proprietary technologies without authorization and they may resort to litigation to attempt to enforce their rights. Third parties may have or obtain patents in the future and claim that the use of our technology or any of our product candidates infringes their patents. We may not be able to develop or commercialize combination product candidates because of patent protection others have. Our business will be harmed if we cannot obtain a necessary or desirable license, can obtain such a license only on terms we consider to be unattractive or unacceptable, or if we are unable to redesign our product candidates or processes to avoid actual or potential patent or other intellectual property infringement.
Our efforts to obtain, protect and defend our patent and other intellectual property rights, whether we are successful or not, can be expensive and may require us to incur substantial costs, including the diversion of management and technical personnel. An unfavorable ruling in patent or intellectual property litigation could subject us to significant liabilities to third parties, require us to cease developing, manufacturing or selling the affected products or using the affected processes, require us to license the disputed rights from third parties, or result in awards of substantial damages against us. In addition, defending patent or other intellectual property litigation, whether we are successful or not, can be very expensive and may require us to incur substantial costs, including the diversion of management and technical personnel. During the course of any patent litigation, there may be public announcements of the results of hearings, motions, and other interim proceedings or developments in the litigation. If securities analysts or investors regard these announcements as negative, the market price of our common stock may decline. General proclamations or statements by key public figures may also have a negative impact on the perceived value of our intellectual property.
There can be no assurance that we would prevail in any intellectual property infringement action, will be able to obtain a license to any third party intellectual property on commercially reasonable terms, successfully develop non-infringing alternatives on a timely basis, or license non-infringing alternatives, if any exist, on commercially reasonable terms. Any significant intellectual property impediment to our ability to develop and commercialize our products could seriously harm our business and prospects.
Risks Related to Our Industry
Our competitors and potential competitors may develop products and technologies that make ours less attractive or obsolete.
Many companies, universities, and research organizations developing competing product candidates have greater resources and significantly greater experience in financial, research and development, manufacturing, marketing, sales, distribution, and technical regulatory matters than we have. In addition, many competitors have greater name recognition and more extensive collaborative relationships. Our competitors could commence and complete clinical testing of their product candidates, obtain regulatory approvals, and begin commercial-scale manufacturing of their products faster than we are able to for our products. They could develop drug discovery technology or products that would render our drug discovery technology and product candidates, and those of our collaborators, obsolete and noncompetitive. They may also employ high throughput screening technologies to the discovery of combination drugs, which may render our technologies or our approach to drug discovery and development obsolete or noncompetitive. Our drug discovery technology will compete against well-established techniques to discover new drugs. If we are unable to compete effectively against these existing techniques and the companies that support them, then we may not be able to commercialize our product candidates or achieve a competitive position in the market. This would adversely affect our ability to generate revenues.
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We may have significant product liability exposure which may harm our business and our reputation.
We face exposure to product liability and other claims if our product candidates, products or processes are alleged to have caused harm. These risks are inherent in the testing, manufacturing, and marketing of human therapeutic products and medical devices. We currently maintain product liability insurance covering our clinical trials in the amount of $5 million. We may not have sufficient insurance coverage, and we may not be able to obtain sufficient coverage at a reasonable cost, if at all. Our inability to obtain product liability insurance at an acceptable cost or to otherwise protect against potential product liability claims could prevent or inhibit the commercialization of any products or product candidates that we develop. If we are sued for any injury caused by our products, product candidates or processes, our liability could exceed our product liability insurance coverage and our total assets. Claims against us, regardless of their merit or potential outcome, may also generate negative publicity or hurt our ability to obtain physician endorsement of our products or expand our business.
We use and generate materials that may expose us to expensive and time-consuming legal claims.
Our development programs involve the use of hazardous materials, chemicals, and biological materials. We are subject to foreign, federal, state and local laws and regulations governing the use, manufacture, storage, and disposal of materials and waste products. We believe that our safety procedures for handling these materials comply with the standards prescribed by laws and regulations. However, we may incur significant costs to comply with current or future environmental laws and regulations. In addition, we cannot completely eliminate the risk of contamination or injury from hazardous materials. In the event of an accident, an injured party may seek to hold us liable for any damages that result. Any liability could exceed the limits or fall outside the coverage of our insurance, and we may not be able to maintain insurance on acceptable terms, if at all.
Risks Related to an Investment in Our Common Stock
Our common stock may have a volatile public trading price.
An active public market for our common stock has not developed. The market prices for securities of companies comparable to us have been highly volatile. Often, these stocks have experienced significant price and volume fluctuations for reasons unrelated to the operating performance of the individual companies. Factors giving rise to this volatility may include:
• disclosure of actual or potential clinical results with respect to product candidates we are developing;
• regulatory developments in both the United States and abroad;
• developments concerning proprietary rights, including patents and litigation matters;
• public concern about the safety or efficacy of our product candidates or technology, or related technology, or new technologies generally;
• public announcements by our competitors, collaborators or others; and
• general market conditions and comments by securities analysts and investors.
Fluctuations in our operating losses could adversely affect the price of our common stock.
Our operating losses may fluctuate significantly on a quarterly basis. Some of the factors that may cause our operating losses to fluctuate on a period-to-period basis include the status of our preclinical and clinical development programs, level of expenses incurred in connection with our preclinical and clinical development programs, implementation or termination of collaboration, licensing, manufacturing or other material agreements with third parties, non-recurring revenue or expenses under any such agreement, and compliance with regulatory requirements. Period-to-period comparisons of our historical and future financial results may not be meaningful, and investors should not rely on them as an indication of future performance. Our fluctuating losses may fail to meet the expectations of securities analysts or investors. Our failure to meet these expectations may cause the price of our common stock to decline.
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We have limited experience attempting to comply with public company obligations. Attempting to comply with these requirements will increase our costs and require additional management resources, and we still may fail to comply.
As a newly public company, we face and will continue to face increased legal, accounting, administrative and other costs and expenses as a public company that we did not incur as a private company. Compliance with the Sarbanes Oxley Act of 2002, as well as other rules of the SEC, the Public Company Accounting Oversight Board and The Nasdaq Global Market has resulted in a significant initial cost to us as well as an ongoing increase in our legal, audit and financial compliance costs. As a public company, we are subject to Section 404 of the Sarbanes Oxley Act relating to internal control over financial reporting. We have commenced a formal process to evaluate our internal controls for purposes of Section 404, and we cannot assure that our internal control over financial reporting will prove to be effective.
Effective internal controls over financial reporting are necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, are designed to prevent fraud. If we cannot provide reliable financial reports or prevent fraud, our operating results could be harmed. We have commenced a formal process to evaluate our internal control over financial reporting. Given the status of our efforts, coupled with the fact that guidance from regulatory authorities in the area of internal controls continues to evolve, substantial uncertainty exists regarding our ability to comply by applicable deadlines. Any failure to implement required new or improved controls, or difficulties encountered in their implementation, could harm our operating results or cause us to fail to meet our reporting obligations. Ineffective internal controls could also cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of our common stock.
Our product development strategy may cause volatility in our stock price, and we may incur significant costs from class action litigation.
Our strategy of initiating proof-of-concept clinical trials for multiple product candidates and making development decisions based on the results of these trials may result in a greater number of public announcements regarding the progress of our development efforts than would be true for a company developing fewer products or advancing products less quickly into proof-of-concept clinical trials. These announcements, including announcements regarding decisions to terminate further development of one or more product candidates, may cause significant volatility in our stock price.
Recently, when the market price of a stock has been volatile, as our stock price may be, holders of that stock have occasionally brought securities class action litigation against the company that issued the stock. If any of our stockholders were to bring a lawsuit of this type against us, even if the lawsuit is without merit, we could incur substantial costs defending the lawsuit. A stockholder lawsuit could also divert the time and attention of our management.
Anti-takeover provisions in our charter documents and provisions of Delaware law may make an acquisition more difficult and could result in the entrenchment of management.
We are incorporated in Delaware. Anti-takeover provisions of Delaware law and our charter documents may make a change in control or efforts to remove management more difficult. Also, under Delaware law, our board of directors may adopt additional anti-takeover measures.
Our charter authorizes our board of directors to issue up to 5,000,000 shares of preferred stock and to determine the terms of those shares of stock without any further action by our stockholders. If the board of directors exercises this power to issue preferred stock, it could be more difficult for a third party to acquire a majority of our outstanding voting stock and vote the stock they acquire to remove management or directors.
Our charter also provides staggered terms for the members of our board of directors. Under Section 141 of the Delaware General Corporation Law, our directors may be removed by stockholders only for cause and only by vote of the holders of a majority of voting shares then outstanding. These provisions may prevent stockholders from replacing the entire board in a single proxy contest, making it more difficult for a third party to acquire control of us without the consent of our board of directors. These provisions could also delay the removal of management by the board of directors with or without cause. In addition, our directors may only be removed for cause and our bylaws limit the ability our stockholders to call special meetings of stockholders.
Our equity incentive plans generally permit our board of directors to provide for acceleration of vesting of options granted under these plans in the event of certain transactions that result in a change of control. If our board of directors uses
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its authority to accelerate vesting of options, this action could make an acquisition more costly, and it could prevent an acquisition from going forward.
Under Section 203 of the Delaware General Corporation Law, a corporation may not engage in a business combination with any holder of 15% or more of its capital stock until the holder has held the stock for three years unless, among other possibilities, the board of directors approves the transaction. Our board of directors could use this provision to prevent changes in management. The existence of the foregoing provisions could limit the price that investors might be willing to pay in the future for shares of our common stock.
Under our research and license agreement with Angiotech, we have agreed that upon a change of control of us, as defined in the research and license agreement, the agreement would remain in effect, although Angiotech would have the right to terminate the agreement in the six months after a change of control if we were acquired by an entity operating primarily in Angiotech’s field.
Item 2. Uses of Proceeds from Registered Securities
Use of Proceeds from Registered Securities
On November 15 and 18, 2005, we completed an initial public offering of 6,900,000 shares of our common stock at a price to the public of $7.00 per share. The offer and sale of all of the shares in the initial public offering were registered under the Securities Act of 1933, as amended, pursuant to a registration statement on Form S-1 (File No. 333-121173), which was declared effective by the Securities and Exchange Commission on November 9, 2005. SG Cowen & Co., LLC, Pacific Growth Equities, LLC, Lazard Capital Markets LLC and A.G. Edwards & Sons, Inc. were the managing underwriters of the initial public offering. The offering commenced on November 9, 2005 and did not terminate until after the sale of all of the securities registered in the Registration Statement. As part of the initial public offering, we granted these underwriters an over-allotment option to purchase up to an additional 900,000 shares of our common stock from us and the underwriters exercised the over-allotment option. There were no selling stockholders in the offering.
The aggregate price of the offering amount registered on our behalf was $48.3 million. In connection with the offering, we paid approximately $3.4 million in underwriting discounts and commissions to the underwriters and incurred $1.1 million in other offering expenses. None of the underwriting discounts and commissions or offering expenses were incurred or paid to directors or officers of ours or their associates or to persons owning ten percent or more of our common stock or to any affiliates of ours. After deducting the underwriting discounts and commissions and offering expenses, we received net proceeds from the offering of approximately $43.8 million. We have used the net proceeds from the initial public offering to fund the development of our clinical and preclinical product candidates, to discover and develop additional product candidates and for working capital, capital expenditures and other general corporate purposes. We have also invested the unused proceeds from the offering in accordance with our investment policy. The use of proceeds is not materially different from the use of proceeds described in the prospectus for our initial public offering.
Item 6. Exhibits.
(a) Exhibits.
The Exhibits listed in the Exhibit Index immediately preceding the Exhibits are filed as a part of this Quarterly Report on Form 10-Q.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| | | | COMBINATORX, INCORPORATED |
| | | | |
| | By: | | /s/ Alexis Borisy |
| | | | Alexis Borisy |
| | | | President and Chief Executive Officer |
Date: November 14, 2006
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EXHIBIT INDEX
| | | | Incorporated by Reference to: |
Exhibit No. | | Description | | Form or Schedule | | Exhibit No. | | Filing Date with SEC | | SEC File Number |
3.1 | | Sixth Amended and Restated Certificate of Incorporation. | | S-1/A | | 3.2 | | 11/4/2005 | | 333-121173 |
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3.2 | | Amended and Restated By-Laws. | | S-1 | | 3.4 | | 12/10/2004 | | 333-121173 |
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4.1 | | Specimen Common Stock Certificate. | | S-1/A | | 4.1 | | 1/19/2005 | | 333-121173 |
| | | | | | | | | | |
4.2 | | Warrant issued to General Electric Capital Corporation on September 15, 2004 to purchase up to 8,892 shares of the Registrant’s Common Stock. | | S-1 | | 10.7 | | 12/10/2004 | | 333-121173 |
| | | | | | | | | | |
4.3 | | Warrant issued to General Electric Capital Corporation on June 28, 2005 to purchase 471 shares of the Registrant’s Common Stock. | | 10-K | | 4.5 | | 3/20/2006 | | 000-51171 |
| | | | | | | | | | |
4.4 | | Warrant issued to Silicon Valley Bank on April 25, 2001 to purchase up to 10,019 of the Registrant’s Common Stock. | | S-1 | | 10.9 | | 12/10/2004 | | 333-121173 |
| | | | | | | | | | |
4.5 | | Registration Rights Agreement dated as of April 25, 2001 by and between Silicon Valley Bank and the Registrant. | | S-1 | | 10.10 | | 12/10/2004 | | 333-121173 |
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4.6 | | Form of Warrant to purchase shares of the Registrant’s Stock, together with a schedule of warrant holders. | | S-1 | | 10.11 | | 12/10/2004 | | 333-121173 |
| | | | | | | | | | |
4.7 | | Form of Warrant issued to BioMedical Sciences Investment Fund Pte Ltd on August 19, 2005 to purchase up to 25,000 shares of the Registrant’s Common Stock. | | S-1/A | | 10.45 | | 8/19/2005 | | 333-121173 |
| | | | | | | | | | |
4.8 | | Second Amended and Restated Investors’ Rights Agreement, dated as of February 18, 2004, by and between the Registrant and the investors named therein, as amended. | | S-1 | | 10.17 | | 12/10/2004 | | 333-121173 |
| | | | | | | | | | |
4.9 | | Amendment to the Second Amended and Restated Investors’ Rights Agreement by and between the Registrant and the investors named therein, dated as of December 8, 2004. | | S-1 | | 10.18 | | 12/10/2004 | | 333-121173 |
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4.10 | | Securities Purchase Agreement, dated March 22, 2006, between the Registrant and the purchasers named on Exhibit A thereto. | | 8-K | | 10.1 | | 3/24/2006 | | 000-51171 |
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#10.1 | | 2000 Stock Option Plan, as amended. | | S-1 | | 10.1 | | 12/10/2004 | | 333-121173 |
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#10.2 | | Amended and Restated 2004 Incentive Plan. | | 8-K | | 10.1 | | 6/5/2006 | | 000-51171 |
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#10.3 | | Form Incentive Stock Option Agreement under the 2004 Incentive Plan. | | 10-K | | 10.3 | | 3/20/2006 | | 000-51171 |
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#10.4 | | Form Non-Qualified Option Agreement under the 2004 Incentive Plan. | | 10-K | | 10.4 | | 3/20/2006 | | 000-51171 |
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10.5 | | Master Security Agreement, dated as of July 20, 2004, by and between the Registrant and General Electric Capital Corporation. | | S-1 | | 10.12 | | 12/10/2004 | | 333-121173 |
| | | | | | | | | | |
10.6 | | Form of Promissory Note issued by the Registrant to General Electric Capital Corporation. | | S-1 | | 10.13 | | 12/10/2004 | | 333-121173 |
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10.7 | | Revised Loan Proposal, dated as of May 3, 2005, between General Electric Capital Corporation and the Registrant. | | 10-K | | 10.8 | | 3/20/2006 | | 000-51171 |
| | | | | | | | | | |
10.8 | | Revised Loan Proposal dated as of April 19, 2006, between General Electric Capital Corporation and the Registrant. | | 8-K | | 10.2 | | 6/30/2006 | | 000-51171 |
| | | | | | | | | | |
#10.9 | | First Amended Employment, Confidentiality and Non-Competition Agreement with Alexis Borisy, dated as of July 1, 2004. | | S-1 | | 10.22 | | 12/10/2004 | | 333-121173 |
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#10.10 | | Employment, Confidentiality and Non-Competition Agreement with Robert Forrester, dated as of February 23, 2004. | | S-1 | | 10.23 | | 12/10/2004 | | 333-121173 |
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#10.11 | | Employment Letter Agreement with Daniel Grau, dated as of March 1, 2005. | | 10-K | | 10.15 | | 3/20/2006 | | 000-51171 |
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#10.12 | | Second Amended Employment, Confidentiality and Non-Competition Agreement with Curtis Keith, dated as of July 1, 2005. | | S-1/A | | 10.26 | | 8/19/2006 | | 333-121173 |
| | | | | | | | | | |
#10.13 | | Employment, Confidentiality and Non-Competition Agreement with Jan Lessem, dated as of September 21, 2006. | | 8-K | | 10.1 | | 9/26/2006 | | 000-51171 |
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#10.14 | | Employment Letter Agreement with Jason F. Cole, dated as of January 23, 2006. | | 10-K | | 10.15 | | 3/20/2006 | | 000-51171 |
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#10.15 | | Employment Letter Agreement with Lynn Baird, dated as of March 31, 2006. | | 8-K | | 10.1 | | 4/24/2006 | | 000-51171 |
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#10.16 | | Restricted Stock Award Agreement, dated January 26, 2006, by and between Alexis Borisy and the Registrant. | | 8-K | | 10.1 | | 1/26/2006 | | 000-51171 |
| | | | | | | | | | |
#10.17 | | Restricted Stock Award Agreement, dated January 26, 2006, by and between Robert Forrester and the Registrant. | | 8-K | | 10.2 | | 1/26/2006 | | 000-51171 |
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#10.18 | | Restricted Stock Award Agreement, dated January 26, 2006, by and between Jan Lessem and the Registrant. | | 8-K | | 10.3 | | 1/26/2006 | | 000-51171 |
| | | | | | | | | | |
#10.19 | | Restricted Stock Award Agreement, dated January 26, 2006, by and between Curtis Keith and the Registrant. | | 8-K | | 10.4 | | 1/26/2006 | | 000-51171 |
| | | | | | | | | | |
#10.20 | | Restricted Stock Award Agreement, dated January 26, 2006, by and between Daniel Grau and the Registrant. | | 8-K | | 10.5 | | 1/26/2006 | | 000-51171 |
| | | | | | | | | | |
#10.21 | | Restricted Stock Award Agreement, dated April 24, 2006, by and between Lynn Baird and the Registrant. | | 8-K | | 10.2 | | 4/24/2006 | | 000-51171 |
| | | | | | | | | | |
10.22 | | Founder’s Agreement with Alexis Borisy, dated as of January 26, 2001. | | S-1 | | 10.28 | | 12/10/2004 | | 333-121173 |
| | | | | | | | | | |
10.23 | | Founder’s Agreement with Curtis Keith, dated as of January 26, 2001. | | S-1 | | 10.29 | | 12/10/2004 | | 333-121173 |
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10.24 | | Founder’s Agreement with Michael Foley, dated as of January 26, 2001. | | S-1 | | 10.30 | | 12/10/2004 | | 333-121173 |
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10.25 | | Founder’s Agreement with Brent Stockwell, dated as of January 26, 2001. | | S-1 | | 10.31 | | 12/10/2004 | | 333-121173 |
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10.26 | | Form of Indemnification Agreement for directors. | | S-1/A | | 10.32 | | 1/19/2005 | | 333-121173 |
| | | | | | | | | | |
10.27 | | Sponsored Research Agreement, dated as of August 19, 2004, by and between Spinal Muscular Atrophy Foundation and the Registrant. | | S-1 | | 10.19 | | 12/10/2004 | | 333-121173 |
| | | | | | | | | | |
10.28 | | Agreement, dated as of February 18, 2005, by and between the Registrant and Novartis Pharmaceuticals Corporation. | | S-1/A | | 10.33 | | 2/18/2005 | | 333-121173 |
| | | | | | | | | | |
10.29 | | License Agreement, dated as of May 4, 2005, by and between HenKan Pharmaceutical Company and the Registrant. | | S-1/A | | 10.34 | | 8/19/2005 | | 333-121173 |
| | | | | | | | | | |
10.30 | | Research Agreement, dated as of August 9, 2005, by and between the Registrant and CHDI, Inc. | | S-1/A | | 10.35 | | 8/19/2005 | | 333-121173 |
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10.31 | | First Amendment to Research Agreement, dated as of December 15, 2005, by and between CHDI, Inc. and the Registrant. | | 10-K | | 10.30 | | 3/20/2006 | | 000-51171 |
| | | | | | | | | | |
10.32 | | Subcontract Agreement, effective August 10, 2005, between Science Application International Corporation and the Registrant. | | S-1/A | | 10.36 | | 8/19/2005 | | 333-121173 |
| | | | | | | | | | |
10.33 | | Research Project Cooperative Agreement, dated April 10, 2005, between the National Institutes of Health and the Registrant. | | S-1/A | | 10.37 | | 8/19/2005 | | 333-121173 |
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10.34 | | Form of Subscription and Shareholders Agreement, among CombinatoRx (Singapore) Pte Ltd, BioMedical Sciences Investment Fund Pte Ltd and the Registrant. | | S-1/A | | 10.38 | | 8/19/2005 | | 333-121173 |
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10.35 | | Form of Terms and Conditions of the Notes, of CombinatoRx (Singapore) Pte Ltd. | | S-1/A | | 10.39 | | 8/19/2005 | | 333-121173 |
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10.36 | | Form of Debenture between CombinatoRx (Singapore) Pte Ltd and BioMedical Sciences Investment Fund Pte Ltd. | | S-1/A | | 10.40 | | 8/19/2005 | | 333-121173 |
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10.37 | | Form of Services Agreement, by and between the Registrant and CombinatoRx (Singapore) Pte Ltd. | | S-1/A | | 10.41 | | 8/19/2005 | | 333-121173 |
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10.38 | | Form of Registration Rights Agreement, by and among the Registrant and BioMedical Sciences Investment Fund Pte Ltd. | | S-1/A | | 10.42 | | 8/19/2005 | | 333-121173 |
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10.39 | | Form of Swap-up Agreement, among CombinatoRx (Singapore) Pte Ltd, BioMedical Sciences Investment Fund Pte Ltd and the Registrant. | | S-1/A | | 10.43 | | 8/19/2005 | | 333-121173 |
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10.40 | | Form of Share Charge, between the Registrant and BioMedical Sciences Investment Fund Pte Ltd. | | S-1/A | | 10.44 | | 8/19/2005 | | 333-121173 |
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†10.41 | | Research and License Agreement, dated as of October 3, 2005, between Angiotech Pharmaceuticals, Inc. and the Registrant. | | S-1/A | | 10.46 | | 10/5/2005 | | 333-121173 |
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10.42 | | Stock Purchase Agreement, dated as of October 3, 2005, by and among the Registrant and Angiotech Pharmaceuticals, Inc. | | S-1/A | | 10.47 | | 10/3/2005 | | 333-121173 |
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10.43 | | Research and License Agreement, dated January 30, 2006, between Fovea Pharmaceuticals SA and the Registrant. | | 10-K | | 10.42 | | 3/20/2006 | | 000-51171 |
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10.44 | | Amendment to Research and License Agreement, dated June 26, 2006, between Fovea Pharmaceuticals SA and the Registrant. | | 8-K | | 10.1 | | 6/30/2006 | | 000-51171 |
| | | | | | | | | | |
10.45 | | Office and Laboratory Lease Agreement, as of October 18, 2005, by and between MA-Riverview, 1245 First Street, L.L.C. and the Registrant. | | S-1/A | | 10.48 | | 10/24/2005 | | 333-121173 |
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10.46 | | First Amendment to Office and Laboratory Lease Agreement, as of March 9, 2006, by and between MA-Riverview, 245 First Street, L.L.C. and the Registrant. | | 10-K | | 10.44 | | 3/20/2006 | | 000-51171 |
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†10.47 | | Research, Development and Commercialization Agreement, dated May 31, 2006, between the Cystic Fibrosis Foundation Therapeutics Incorporated and the Registrant. | | 8-K | | 10.1 | | 6/5/2006 | | 000-51171 |
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21.1 | | List of subsidiaries. | | 10-K | | 21.1 | | 3/20/2006 | | 000-51171 |
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*31.1 | | Certification of Chief Executive Officer pursuant to Exchange Act rules 13a-14 or 15d-14 | | | | | | | | |
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*31.2 | | Certification of Chief Financial Officer pursuant to Exchange Act rules 13a-14 or 15d-14 | | | | | | | | |
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*32.1 | | Certifications of Chief Executive Officer and Chief Financial Officer pursuant to Exchange Act rules 13a-14(b) or 15d-14(b) and 18 U.S.C. Section 1350. | | | | | | | | |
* Filed herewith.
† Confidential treatment requested as to certain portions, which portions are omitted and filed separately with the Securities and Exchange Commission.
# Management contract or compensatory plan or arrangement filed as an Exhibit to this report pursuant to Items 15(a) and 15(c) of Form 10-Q.
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