UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2009
or
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number: | 0-24469 |
GenVec, Inc. |
(Exact name of registrant as specified in its charter) |
Delaware | 23-2705690 | |
(State or other jurisdiction of | (IRS Employer Identification | |
incorporation or organization) | Number) |
65 West Watkins Mill Road, Gaithersburg, Maryland | 20878 |
(Address of principal executive offices) | (Zip Code) |
240-632-0740 |
(Registrant's telephone number, including area code) |
(Former name, former address and former fiscal year, if changed since last report.) |
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes x No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes o No o
Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o | Accelerated filer x |
Non-accelerated filer o | Smaller reporting company o |
(do not check if a smaller reporting company) |
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes o No x
As of April 30, 2009, the Registrant had 88,604,454 shares of common stock, $.001 par value, outstanding.
GENVEC, INC.
FORM 10-Q
TABLE OF CONTENTS
PART I. | FINANCIAL INFORMATION | 3 | ||
Item 1. | Financial Statements | 3 | ||
Condensed Balance Sheets | 3 | |||
Condensed Statements of Operations | 4 | |||
Condensed Statement of Stockholders’ Equity and Comprehensive Loss | 5 | |||
Condensed Statements of Cash Flows | 6 | |||
Notes to Condensed Financial Statements | 7 | |||
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 14 | ||
Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 19 | ||
Item 4. | Controls and Procedures | 20 | ||
PART II. | OTHER INFORMATION | 21 | ||
Item 1. | Legal Proceedings | 21 | ||
Item 1A. | Risk Factors | 21 | ||
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 21 | ||
Item 3. | Defaults Upon Senior Securities | 21 | ||
Item 4. | Submission of Matters to a Vote of Security Holders | 21 | ||
Item 5. | Other Information | 21 | ||
Item 6. | Exhibits | 21 | ||
SIGNATURES | 22 |
2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
GENVEC, INC.
CONDENSED BALANCE SHEETS
(in thousands)
March 31, | December 31, | |||||||
2009 | 2008 | |||||||
(Unaudited) | ||||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 9,931 | $ | 14,315 | ||||
Short-term investments | 2,093 | 3,042 | ||||||
Accounts receivable | 1,462 | 2,091 | ||||||
Prepaid expenses and other | 371 | 1,407 | ||||||
Bond sinking fund | 531 | 355 | ||||||
Total current assets | 14,388 | 21,210 | ||||||
Property and equipment, net | 1,338 | 1,550 | ||||||
Other assets | 3 | 7 | ||||||
Total assets | $ | 15,729 | $ | 22,767 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current liabilities: | ||||||||
Current portion of long-term debt | $ | 774 | $ | 807 | ||||
Accounts payable | 1,938 | 1,953 | ||||||
Accrued clinical trial expenses | 1,164 | 1,437 | ||||||
Accrued other expenses | 2,007 | 2,792 | ||||||
Unearned revenue | 1,723 | 2,493 | ||||||
Total current liabilities | 7,606 | 9,482 | ||||||
Other liabilities | 161 | 194 | ||||||
Total liabilities | 7,767 | 9,676 | ||||||
Stockholders' equity: | ||||||||
Preferred stock, $0.001 par value, 5,000 shares authorized in 2009 and 2008; none issued and outstanding in 2009 and 2008 | - | - | ||||||
Common stock, $0.001 par value; 200,000 shares authorized; 88,604 and 88,423 shares issued and outstanding at March 31, 2009 and December 31, 2008, respectively | 89 | 88 | ||||||
Additional paid-in capital | 227,166 | 226,672 | ||||||
Accumulated other comprehensive income (loss) | 17 | (40 | ) | |||||
Accumulated deficit | (219,310 | ) | (213,629 | ) | ||||
Total stockholders' equity | 7,962 | 13,091 | ||||||
Total liabilities and stockholders' equity | $ | 15,729 | $ | 22,767 |
See accompanying notes to condensed financial statements.
3
GENVEC, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(Unaudited)
Three Months Ended | ||||||||
March 31, | ||||||||
2009 | 2008 | |||||||
Revenue | $ | 3,795 | $ | 3,729 | ||||
Operating expenses: | ||||||||
Research and development | 7,289 | 7,693 | ||||||
General and administrative | 1,930 | 2,440 | ||||||
Total operating expenses | 9,219 | 10,133 | ||||||
Loss from operations | (5,424 | ) | (6,404 | ) | ||||
Other income (expense): | ||||||||
Interest income | 27 | 261 | ||||||
Interest expense, net of change in fair value of Kingsbridge warrants | (13 | ) | (121 | ) | ||||
Other | (271 | ) | 4 | |||||
Total other income (expense), net | (257 | ) | 144 | |||||
Net loss | $ | (5,681 | ) | $ | (6,260 | ) | ||
Other comprehensive income: | ||||||||
Unrealized holding gain on securities available | ||||||||
for sale | $ | 57 | $ | 8 | ||||
Other comprehensive income | 57 | 8 | ||||||
Comprehensive loss | $ | (5,624 | ) | $ | (6,252 | ) | ||
Basic and diluted net loss per share | $ | (0.06 | ) | $ | (0.08 | ) | ||
Shares used in computing basic and diluted net loss per share | 88,600 | 75,401 |
See accompanying notes to condensed financial statements.
4
GENVEC, INC.
CONDENSED STATEMENT OF STOCKHOLDERS’ EQUITY AND COMPREHENSIVE LOSS
(in thousands)
(Unaudited)
Accumulated | ||||||||||||||||||||||||
Additional | Other | |||||||||||||||||||||||
Common Stock | Paid-in | Comprehensive | Accumulated | |||||||||||||||||||||
Shares | Amount | Capital | Income (Loss) | Deficit | Total | |||||||||||||||||||
Balance, December 31, 2008 | 88,423 | $ | 88 | $ | 226,672 | $ | (40 | ) | $ | (213,629 | ) | $ | 13,091 | |||||||||||
Comprehensive loss: | ||||||||||||||||||||||||
Net loss | - | - | - | - | (5,681 | ) | (5,681 | ) | ||||||||||||||||
Unrealized change in investments, net | - | - | - | 57 | - | 57 | ||||||||||||||||||
Total comprehensive loss | (5,624 | ) | ||||||||||||||||||||||
Common stock issued under stock benefit plans | 181 | 1 | 67 | - | - | 68 | ||||||||||||||||||
Stock-based compensation | - | - | 427 | - | - | 427 | ||||||||||||||||||
Balance, March 31, 2009 | 88,604 | $ | 89 | $ | 227,166 | $ | 17 | $ | (219,310 | ) | $ | 7,962 |
See accompanying notes to condensed financial statements.
5
GENVEC, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(in thousands)
(Unaudited)
Three Months Ended | ||||||||
March 31, | ||||||||
2009 | 2008 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | $ | (5,681 | ) | $ | (6,260 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 221 | 265 | ||||||
Non-cash adjustments for premiums/discounts on investments | 7 | (18 | ) | |||||
Non-cash charges for stock-based compensation | 427 | 563 | ||||||
Change in fair value of warrant | (3 | ) | 87 | |||||
Change in accounts receivable | 629 | (235 | ) | |||||
Change in accounts payable and accrued expenses | (1,068 | ) | (734 | ) | ||||
Change in unearned revenue | (795 | ) | 4,067 | |||||
Change in other assets and liabilities, net | 1,023 | (1,702 | ) | |||||
Net cash used in operating activities | (5,240 | ) | (3,967 | ) | ||||
Cash flows from investing activities: | ||||||||
Purchases of property and equipment | - | (183 | ) | |||||
Purchases of investment securities | (1,002 | ) | (1,983 | ) | ||||
Proceeds from sale and maturity of investment securities | 2,000 | 10,730 | ||||||
Net cash provided by investing activities | 998 | 8,564 | ||||||
Cash flows from financing activities: | ||||||||
Proceeds from issuance of common stock, | ||||||||
net of issuance costs | 68 | 62 | ||||||
Principal payments of long-term debt and change in sinking fund | (210 | ) | (200 | ) | ||||
Net cash used in financing activities | (142 | ) | (138 | ) | ||||
Increase (decrease) in cash and cash equivalents | (4,384 | ) | 4,459 | |||||
Beginning balance of cash and cash equivalents | 14,315 | 7,289 | ||||||
Ending balance of cash and cash equivalents | $ | 9,931 | $ | 11,748 | ||||
Supplemental disclosures of cash flow information: | ||||||||
Interest paid | $ | 16 | $ | 28 |
See accompanying notes to condensed financial statements.
6
GENVEC, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(Unaudited)
(1) | General |
The condensed financial statements included herein have been prepared by GenVec, Inc. (GenVec, we, our, or the Company) without audit pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States have been condensed or omitted pursuant to such rules and regulations. We believe the disclosures are adequate to make the information presented not misleading. The condensed financial statements included herein should be read in conjunction with the financial statements and the notes thereto included in our 2008 Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC).
In the opinion of management, the accompanying condensed, unaudited financial statements contain all adjustments (consisting of only normal recurring accruals) necessary to present fairly the financial position of the Company as of March 31, 2009 and December 31, 2008 and the results of its operations and cash flows for the three-month periods ended March 31, 2009 and March 31, 2008. The results of operations for any interim period are not necessarily indicative of the results of operations for any other interim period or for a full fiscal year.
(2) | Fair Value Measurements |
We apply the provisions of Statement of Financial Accounting Standards No. 157, “Fair Value Measurements” (SFAS No. 157). SFAS No. 157 establishes a three-level hierarchy for fair value measurements. The hierarchy is based upon the transparency of inputs to the valuation of an asset or liability as of the measurement date. The three levels of inputs used to measure fair value are as follows:
· | Level 1 – Quoted prices in active markets for identical assets or liabilities; |
· | Level 2 – Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data; and |
· | Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. These include certain pricing models, discounted cash flow methodologies, and similar techniques that use significant unobservable inputs. |
7
The following table presents information about assets and liabilities recorded at fair value on a recurring basis at March 31, 2009 on the Condensed Balance Sheet:
Quoted Prices in | ||||||||||||||||
Active Markets for | Significant | Significant | ||||||||||||||
Total Carrying | Identical | Other Observable | Unobservable | |||||||||||||
Value on the | Assets/Liabilities | Inputs | Inputs | |||||||||||||
(In thousands) | Balance Sheet | (Level 1) | (Level 2) | (Level 3) | ||||||||||||
Assets: | ||||||||||||||||
Cash & cash equivalents | $ | 9,931 | $ | 9,931 | $ | - | $ | - | ||||||||
Marketable securities | 2,093 | 2,093 | - | - | ||||||||||||
Total assets at fair value | $ | 12,024 | $ | 12,024 | $ | - | $ | - | ||||||||
Liabilities: | ||||||||||||||||
Interest rate swap agreement | $ | 11 | $ | - | $ | 11 | $ | - | ||||||||
Warrant liability | 31 | - | 31 | - | ||||||||||||
Total liabilities at fair value | $ | 42 | $ | - | $ | 42 | $ | - |
The following table presents information about assets and liabilities recorded at fair value on a recurring basis at December 31, 2008 on the Condensed Balance Sheet:
Quoted Prices in | ||||||||||||||||
Active Markets for | Significant | Significant | ||||||||||||||
Total Carrying | Identical | Other Observable | Unobservable | |||||||||||||
Value on the | Assets/Liabilities | Inputs | Inputs | |||||||||||||
(In thousands) | Balance Sheet | (Level 1) | (Level 2) | (Level 3) | ||||||||||||
Assets: | ||||||||||||||||
Cash & cash equivalents | $ | 14,315 | $ | 14,315 | $ | - | $ | - | ||||||||
Marketable securities | 3,042 | 3,042 | - | - | ||||||||||||
Total assets at fair value | $ | 17,357 | $ | 17,357 | $ | - | $ | - | ||||||||
Liabilities: | ||||||||||||||||
Interest rate swap agreement | $ | 19 | $ | - | $ | 19 | $ | - | ||||||||
Warrant liability | 35 | - | 35 | - | ||||||||||||
Total liabilities at fair value | $ | 54 | $ | - | $ | 54 | $ | - |
8
We determine fair value for marketable securities with Level 1 inputs through quoted market prices and have classified them as available-for-sale. Our marketable securities consist primarily of corporate bonds and government agency bonds.
Our interest rate swap agreement is valued at fair market value at the balance sheet date using observable market inputs including forward interest rates derived from yield curves, and therefore is classified within Level 2. The warrant liability has been valued using the Black-Scholes pricing model, the inputs of which are described more fully in Note 4 in this Form 10-Q. The warrant liability, related to the Kingsbridge warrants, has also been classified within Level 2.
All unrealized holding gains or losses related to our investments in marketable securities are reflected in accumulated other comprehensive income/loss in shareholders’ equity. Included in accumulated other comprehensive income was a net unrealized gain of $57,000 and $8,000 for the three months ending March 31, 2009 and 2008, respectively.
(3) | Stock Benefit Plans |
Stock Option Plans
At our Annual Meeting in June 2002, our stockholders approved the 2002 Incentive Stock Plan (2002 Plan) as the replacement for the 1993 Stock Incentive Plan (1993 Plan) and 2000 Director Plan (2000 Plan). Our stockholders have subsequently approved amendments to the 2002 Plan to increase the number of shares of common stock available to be issued under the 2002 Plan to 11,580,000. The Compensation Committee administers options granted under all stock option plans, approves the individuals to whom options were granted, and determines the number of options and exercise price of each option. At March 31, 2009 there are 2,997,022 shares available for future issuance under the 2002 Plan. Outstanding options under the 2002 Plan at March 31, 2009 expire through 2019. Outstanding options under the 1993 Plan and 2000 Plan at March 31, 2009 expire through 2012 and 2011, respectively.
In August 2003, GenVec, Inc. and Diacrin Inc. consummated a business combination under which we acquired Diacrin through an exchange of stock. Under the terms of the agreement, we agreed to assume each option, vested or unvested, granted by Diacrin pursuant to the Diacrin 1997 Stock Option Plan (1997 Plan). As of March 31, 2009, awards outstanding under the 1997 Plan were 85,634 shares, which expire through 2012.
Stock Option Valuation and Expense Information under SFAS No. 123(R)
The following table summarizes stock-based compensation expense related to employee stock options under SFAS No. 123(R) for the three-month periods ended March 31, 2009 and March 31, 2008, which was allocated as follows:
For the Three | For the Three | |||||||
Months Ended | Months Ended | |||||||
March 31, 2009 | March 31, 2008 | |||||||
(in thousands) | (in thousands) | |||||||
Research and development | $ | 319 | $ | 410 | ||||
General and administrative | 108 | 153 | ||||||
$ | 427 | $ | 563 |
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We use the Black-Scholes pricing model to value stock options. The Black-Scholes model requires the use of a number of complex assumptions including expected volatility of the Company’s stock price and the expected life of option grants. The weighted-average estimated fair value of employee stock options granted during the three months ended March 31, 2009 and 2008 was calculated using the Black-Scholes model with the following weighted-average assumptions:
For the Three | For the Three | |||||||
Months Ended | Months Ended | |||||||
March 31, 2009 | March 31, 2008 | |||||||
Risk-free interest rate | 1.61 | % | 2.99 | % | ||||
Expected dividend yield | 0.00 | % | 0.00 | % | ||||
Expected volatility | 94.59 | % | 83.28 | % | ||||
Expected life (years) | 5.87 | 5.67 | ||||||
Weighted-average fair value of options | $ | 0.31 | $ | 1.25 |
The volatility assumption for 2009 and 2008 is based on the weighted average volatility for the most recent 1-year period as well as the volatility over the expected life of 5.87 years and 5.67 years, respectively.
The risk-free interest rate assumption is based upon various U.S. Treasury rates as of the date of the grants, 1.61% for the three months ended March 31, 2009 and ranging from 2.75% to 3.16% for the three months ended March 31, 2008.
The dividend yield is based on the assumption that we do not expect to declare a dividend over the life of the options.
The expected life of employee stock options represents the weighted average obtained from combining the actual life of options that have already been exercised or cancelled with the expected life of all outstanding options. The expected life of outstanding options is calculated assuming the options will be exercised at the midpoint of the vesting date and the full contractual term. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures are estimated based on our historical forfeiture rates and standard probabilities of employee turnover based on the demographics of current option holders. We do not record tax related effects on stock-based compensation given our historical and anticipated operating experience and offsetting changes in our valuation allowance which fully reserves against potential deferred tax assets.
Stock Options
The status of the plans for the three months ended March 31, 2009 is as follows:
Weighted | Weighted | |||||||||||||||
average | average | Aggregate | ||||||||||||||
Number | exercise | contractual | intrinsic | |||||||||||||
(in thousands, except per share data) | of shares | price | life (years) | value | ||||||||||||
Stock options outstanding, December 31, 2008 | 7,060 | $ | 2.28 | |||||||||||||
Granted | 2,165 | 0.41 | ||||||||||||||
Exercised | - | - | ||||||||||||||
Forfeited | (161 | ) | 1.82 | |||||||||||||
Expired | (194 | ) | 3.42 | |||||||||||||
Stock options outstanding at March 31, 2009 | 8,870 | $ | 1.81 | 6.7 | $ | 65 | ||||||||||
Vested or expected to vest at March 31, 2009 | 5,631 | $ | 2.17 | 5.8 | $ | 28 | ||||||||||
Exercisable at March 31, 2009 | 4,403 | $ | 2.44 | 5.1 | $ | - |
Unrecognized stock-based compensation related to stock options was approximately $3.2 million as of March 31, 2009. This amount is expected to be expensed over a weighted average period of 2.5 years. The aggregate intrinsic value of stock options outstanding and exercisable as of March 31, 2009 and exercised during the three-month period ended March 31, 2009 is approximately $65,000, $0, and $0, respectively. We realized no proceeds from options exercised during the three months ended March 31, 2009 and 2008 as there were no options exercised during those periods.
10
The following table summarizes information about our stock options outstanding at March 31, 2009:
Outstanding | Exercisable | |||||||||||||||||||
Weighted | ||||||||||||||||||||
average | Weighted | Weighted | ||||||||||||||||||
remaining | average | average | ||||||||||||||||||
Range of exercise | Number | contractual | exercise | Number | exercise | |||||||||||||||
prices | of shares | life (in years) | price | of shares | price | |||||||||||||||
(number of shares in thousands) | ||||||||||||||||||||
$0.00 - $1.00 | 2,175 | 8.8 | $ | 0.41 | - | $ | - | |||||||||||||
$1.01 - $3.00 | 5,361 | 6.8 | 1.91 | 3,122 | 1.93 | |||||||||||||||
$3.01 - $4.00 | 880 | 3.6 | 3.23 | 866 | 3.23 | |||||||||||||||
$4.01 - $5.00 | 380 | 2.2 | 4.28 | 341 | 4.30 | |||||||||||||||
$5.01 - $10.00 | 74 | 1.7 | 6.07 | 74 | 6.07 | |||||||||||||||
8,870 | 6.7 | $ | 1.81 | 4,403 | $ | 2.44 |
Employee Stock Purchase Plan
In December 2000, we adopted the 2000 Employee Stock Purchase Plan (Purchase Plan). Under the Purchase Plan, employees may purchase our common stock through payroll deductions at a purchase price equal to 85 percent of the fair market value of our common stock on either the first business day or last business day of the applicable six month offering period, whichever is lower. Substantially all employees are eligible to participate. Participants may purchase common stock through payroll deductions of up to 15 percent of the participant’s compensation. The maximum number of shares a participant may purchase during a six-month offering period is 6,250 shares. In January 2009, subsequent to the offering period ending December 31, 2008, we sold 181,491 shares of common stock. As of March 31, 2009, there were 1,699,304 shares available for issuance under the Purchase Plan. The Purchase Plan will terminate on October 18, 2010, unless terminated earlier by the Board of Directors.
(4) | Committed Equity Financing Facility (CEFF) |
On March 15, 2006, we entered into a Committed Equity Financing Facility (CEFF) with Kingsbridge Capital Ltd. (Kingsbridge), under which Kingsbridge committed to purchase up to $30.0 million of our common stock within a 3-year period, subject to certain conditions and limitations. The CEFF expired on March 15, 2009. Due to the pricing formula under the CEFF the actual amount of financing available to us under the CEFF was substantially less than the committed amount. Net proceeds from the sale of common stock under the CEFF were used to help defray costs associated with expanded clinical testing of TNFerade™ in locally advanced pancreatic cancer and/or other indications and used for general corporate purposes. As part of the arrangement, we issued a warrant to Kingsbridge to purchase 520,000 shares of our common stock at an exercise price equal to $2.67 per share. The warrant became exercisable on September 15, 2006 and will remain exercisable until September 15, 2011. We classified the warrant as a current liability, which is recorded at its fair value as determined under a Black-Scholes pricing model. Assuming a 2.5 year remaining life for the warrant, a 1.72 percent risk-free interest rate, a 94.59 percent expected volatility, and no dividend yield, the fair value of the warrant liability as of March 31, 2009 was $31,000. Changes in fair value are recorded against operations in the reporting period in which they occur; increases and decreases in fair value are recorded to interest expense.
11
Under the CEFF, Kingsbridge was required, subject to certain conditions and limitations, to purchase shares of common stock at prices between 88 percent and 92 percent of the volume weighted average price (VWAP) on each trading day during an 8-day pricing period. Settlement for sales under the CEFF took place in two tranches after the fourth and eighth day of the pricing period. In June 2007, we initiated our first draw against the CEFF. On June 26, 2007, subsequent to the first 4 days of the pricing period, we sold 769,773 shares of common stock for gross proceeds of $1.8 million. On July 2, 2007, subsequent to the last 4 days of the pricing period, we sold 832,441 shares of common stock for gross proceeds of $1.8 million. In April 2008, we initiated our second draw against the CEFF. On April 18, 2008, subsequent to the first 4 days of the pricing period, we sold 777,057 shares of common stock for gross proceeds of $1.47 million. On April 25, 2008, subsequent to the last 4 days of the pricing period, we sold an additional 905,559 shares of common stock under the CEFF for gross proceeds of $1.47 million.
Prior to the expiration of the CEFF on March 15, 2009, we had sold 3,284,830 shares of common stock for gross proceeds of $6.5 million to Kingsbridge in the aggregate. Kingsbridge holds no shares of common stock purchased pursuant to the CEFF; therefore, all shares sold are recorded in permanent equity. During the three-month period ended March 31, 2009, we expensed the remaining $273,000 of deferred financing charges in connection with the expiration of the CEFF on March 15, 2009.
(5) | Net Loss per Share |
We calculate net loss per share in accordance with SFAS No. 128, Earnings per Share. Basic earnings per share is computed based upon the net loss available to common stock stockholders divided by the weighted average number of shares of common stock outstanding during the period. The dilutive effect of common stock equivalents is included in the calculation of diluted earnings per share only when the effect of the inclusion would be dilutive. For the three months ended March 31, 2009 and 2008, approximately 4.4 million and 3.6 million common stock equivalent shares, respectively, have not been considered in the denominator in the diluted loss per share calculation as their inclusion would have been antidilutive.
(6) | Stockholders’ Equity |
On June 11, 2008, pursuant to our shelf registration statement, we completed a registered direct offering to various investors of 11,258,279 shares of common stock and warrants to purchase 2,251,653 shares of common stock. The shares of common stock and warrants were offered in units consisting of one share of common stock and a warrant to purchase 0.20 shares of common stock at a per unit price of $1.51. The warrants, which have a term of 5 years and an exercise price of $2.016 per share, have been valued using the Black-Scholes pricing model as of the closing date and have been accounted for in permanent equity in accordance with EITF 00-19, “Accounting for Freestanding Derivative Financial Instruments Indexed to, and Potentially Settled in, the Stock of a Consolidated Subsidiary.” The estimated fair market value of the warrants at the date of issuance was $1,930,000. Proceeds of this offering, net of offering costs, totaled $15.7 million.
(7) | Reclassifications |
We have made certain reclassifications to prior year amounts to conform to the 2009 presentation.
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GENVEC, INC.
FORM 10-Q
FORWARD-LOOKING STATEMENTS
This report includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements also may be included in other statements that we make. All statements that are not descriptions of historical facts are forward-looking statements and are based on management’s estimates, assumptions, and projections that are subject to risks and uncertainties. These statements can generally be identified by the use of forward-looking words like “believe,” “expect,” “intend,” “may,” “will,” “should,” “anticipate,” “estimate,” or similar terminology.
Although we believe that the expectations reflected in our forward-looking statements are reasonable as of the date we make them, actual results could differ materially from those currently anticipated due to a number of factors, including risks relating to:
• | our financial condition and the sufficiency of our existing cash, cash equivalents, marketable securities, and cash generated from operations and our ability to lower our operating costs; |
• | our access to additional cash and working capital and our ability to raise capital to fund clinical programs and future operations, including through sales of common or preferred stock , the issuance of debt, or collaborative arrangements; |
• | certain of our product candidates being in the early stages of development; |
• | uncertainties with, and unexpected results and related analyses relating to, clinical trials of our product candidates (including the length of time required to enroll suitable patient subjects and our ability to secure clinical trial sites); |
• | the timing, amount, and availability of revenues from our government-funded vaccine programs; |
• | the timing and content of future FDA regulatory actions related to us, our product candidates, or our collaborators; |
• | our ability to find collaborators or commercialize our product candidates; and |
• | the scope and validity of patent protection for our product candidates and our ability to commercialize products without infringing the patent rights of others. |
Further information on the factors and risks that could affect our business, financial condition, and results of operations is set forth under Item 1A in our Annual Report on Form 10-K for the year ended December 31, 2008 and is contained in our other filings with the SEC. The filings are available on our website at www.genvec.com or at the SEC’s website, www.sec.gov.
These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q, and we assume no duty to update our forward-looking statements.
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ITEM 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
STRATEGIC AND CLINICAL OVERVIEW
GenVec, Inc. (GenVec, we, our, or the Company) is a clinical stage biopharmaceutical company developing novel, gene-based therapeutic drugs and vaccines. Our lead therapeutic product candidate, TNFeradeä biologic (TNFerade), is being developed for use in the treatment of cancer. TNFerade is currently the subject of a randomized, controlled, Phase III pivotal trial, known as PACT, for first-line treatment of inoperable, locally advanced pancreatic cancer. Interim data supporting a potential survival advantage in the TNFerade group were disclosed in November 2008. Interim data, based on an analysis after one-third of deaths expected in the trial, demonstrated an approximately 25% lower risk of death in the TNFerade plus standard of care (SOC) arm relative to the SOC arm alone (Hazard Ratio = 0.753; 95% Confidence Interval [0.494-1.15]). An independent Data Safety Monitoring Board reviewed the interim analysis data and recommended the trial continue as planned. In November 2008, TNFerade was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its proposed use in the treatment of locally advanced pancreatic cancer. Fast Track designation can potentially expedite the regulatory review of TNFerade by the FDA.
TNFerade is also being evaluated for possible use in the treatment of other types of cancer. Using our core adenovector technology, TNFerade stimulates the production of tumor necrosis factor alpha (TNFα), a known anti-tumor protein, in cells of the tumor. Encouraging results have previously been reported in studies for esophageal cancer and head and neck cancer. Encouraging preliminary data also emerged from a trial in rectal cancer, and the program is currently under review. Our melanoma program was suspended in order to dedicate resources to near-term indications.
Our core technology has the important advantage of localizing protein delivery in the body. This is accomplished by using our adenovector platform to locally deliver genes to cells, which then direct production of the desired protein. In the case of TNFerade, for example, this approach reduces the side effects typically associated with systemic delivery of the TNFα protein. For vaccines, the goal is to induce a broad immune response against a target protein or antigen. This is accomplished by using the adenovector to deliver a gene that causes production of antigen, which then stimulates the desired immune reaction by the body.
In partnership with our collaborators, we also have multiple vaccines in development. All of these funded programs utilize our core adenovector technology. Our lead vaccine candidate targets the prevention of a major animal health problem, foot-and-mouth disease (FMD). Development efforts for this program are supported by the U.S. Department of Homeland Security and the U.S. Department of Agriculture. It is anticipated that a license application for an FMD vaccine will be filed within a year. We have a collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) to develop a human immunodeficiency virus (HIV) vaccine and a program with the U.S. Naval Medical Research Center and the PATH Malaria Vaccine Initiative (MVI) to develop vaccines for malaria. GenVec also has grant-supported preclinical programs to develop vaccine candidates for the prevention of respiratory syncytial virus (RSV) and herpes simplex virus type 2 (HSV-2).
Our research and development activities have yielded additional therapeutic product candidates that utilize our technology platform and we believe they represent potential commercial opportunities. In the fields of hearing loss and balance disorders, preclinical research has been published suggesting that delivery of the atonal gene using a GenVec adenovector may re-establish sensory cells in the inner ear and restore both hearing and balance. There are currently no effective treatments available for patients who have lost all balance function, and hearing loss remains a major unmet medical problem.
Our product candidates also have not yet received regulatory approvals, either from the FDA for the United States or from regulatory agencies outside of the United States, which approvals are required before we can market them as therapeutic and/or vaccine products. In order to proceed to subsequent clinical trial stages and to ultimately achieve regulatory approval in the United States, the FDA must conclude that our clinical data establish safety and efficacy. Historically, the results from preclinical testing and early clinical trials have often not been predictive of results obtained in later clinical trials. A number of new drugs and biologic products have shown promising results in early clinical trials, but subsequently failed to establish sufficient safety and efficacy data to obtain necessary regulatory approvals.
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An element of our business strategy is to pursue, as resources permit, the research and development of a range of product candidates for a variety of indications. This is intended to allow us to diversify the risks associated with our research and development expenditures. To the extent we are unable to maintain a broad range of product candidates, our dependence on the success of one or a few product candidates would increase.
Furthermore, our business strategy includes the option of entering into collaborative arrangements with third parties to complete the development and commercialization of our product candidates. In the event that third parties take over the clinical trial process for one or more of our product candidates, the estimated completion date would largely be under the control of that third party. We cannot forecast with certainty which proprietary products or indications, if any, will be subject to future collaborative arrangements, in whole or in part, and how such arrangements would affect our development plan or capital requirements. Our programs may also benefit from subsidies, grants, or government or agency-sponsored studies that could reduce our development costs.
As a result of the uncertainties discussed above, among others, we are unable to estimate the duration and completion costs of our research and development projects or when, if ever, and to what extent we will receive cash inflows from the commercialization and sale of a product. Our inability to complete our research and development projects in a timely manner or our failure to enter into collaborative agreements, when appropriate, could significantly increase our capital requirements and could adversely impact our liquidity. These uncertainties could force us to seek additional, external sources of financing from time to time in order to continue with our business strategy. Our inability to raise additional capital, or to do so on terms reasonably acceptable to us, would jeopardize the future success of our business.
Furthermore, the current domestic and global economic conditions have made it more difficult for companies like us to access capital from the financial and credit markets. Prolonged negative changes in domestic and global economic conditions, such as the current economic conditions, or further disruptions of either or both of the financial and credit markets will further adversely affect our ability to access additional capital. While our estimated future capital requirements are uncertain and will depend on, and could increase or decrease as a result of many factors, including the extent to which we choose to advance our research, development, clinical, manufacturing, and commercialization activities, it is clear we will need significant additional capital to develop our product candidates through clinical development, manufacturing, and commercialization. The continued advancement of TNFerade through the Phase III portion of the pivotal trial for locally advanced pancreatic cancer, the FDA regulatory review process, and the establishment of manufacturing capabilities will continue to require capital, and we expect to have to incur significant additional costs to manufacture and commercialize TNFerade if we receive marketing approval. We do not know whether we will be able to access additional capital when needed or on terms favorable to us or our stockholders.
If adequate funds are not available through either the capital markets, strategic alliances, or collaborators, we may be required to further delay, reduce the scope of or eliminate our research, development, clinical programs, manufacturing, or commercialization efforts, effect additional changes to our facilities or personnel, or obtain funds through other arrangements that may require us to relinquish some of our assets or rights to certain of our existing or future technologies, product candidates, or products on terms not favorable to us.
In light of the difficulties in accessing capital, we have taken and are continuing to take steps to lower our operating costs in order to reduce costs. These steps included announcing on January 29, 2009 that we eliminated 22 positions, as a result of which we incurred $269,000 of expenses in the first quarter of 2009. Further, where possible we are minimizing our unfunded expenditures on activities not critical to the clinical development of TNFerade. This includes reducing our current spending on contract manufacturing. In March 2009, we entered into a letter agreement amending the manufacturing development agreement that we had previously entered into with Cobra Biomanufacturing Plc in January 2008 to produce commercial quantities of TNFerade. Under the terms of the amendment, Cobra will suspend its activities under the original agreement until the end of the second quarter of 2009, when at our sole discretion, we may terminate the original agreement, or we may resume performance pursuant to a newly negotiated schedule of services and fees.
As a clinical stage biopharmaceutical company, our business and our ability to execute our strategy to achieve our corporate goals are subject to numerous risks and uncertainties. Material risks and uncertainties relating to our business and our industry are described in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2008. The description of our business in this Form 10-Q should be read in conjunction with the information described in Item 1A of the 10-K.
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FINANCIAL OVERVIEW FOR THE THREE MONTHS ENDED MARCH 31, 2009 AND 2008
Results of Operations
GenVec’s net loss was $5.7 million (or $0.06 per share) on revenues of $3.8 million for the three months ended March 31, 2009. This compares to a net loss of $6.3 million (or $0.08 per share) on revenues of $3.7 million in the same period in the prior year. Included in our net loss for the first three months of 2009 was stock-based compensation expense of $427,000 as compared to $563,000 for the same period in the prior year. GenVec ended the first quarter of 2009 with $12.0 million in cash and investments.
Revenue
Revenues for the three-month period ended March 31, 2009 were primarily derived from the Company’s funded research and development programs with the Department of Homeland Security (DHS), the National Institute of Allergy and Infectious Diseases (NIAID), and the National Institutes of Health (NIH), all of which use GenVec’s proprietary adenovector technology for the development of either vaccine candidates against foot-and-mouth disease for livestock or vaccines against malaria, HIV, RSV, and HSV-2.
In March 2009, we signed a one-year contract with the MVI to support the development of vaccines to fight malaria. We will receive approximately $770,000 in program funding, and this contract will continue work funded by MVI that began in 2004. The scope of work under this contract includes the development and testing of novel adenovirus-based vaccines. There have been no revenues recognized under this agreement in the three months ending March 31, 2009.
Revenues for the three-month period ended March 31, 2009 were $3.8 million, which represent an increase of 2 percent when compared to revenues of $3.7 million in the comparable prior year period.
The increase in revenues for the three-month period ended March 31, 2009 are primarily due to increases in revenues associated with our grant programs and our HIV program of $255,000 and $135,000, respectively, as compared to the comparable prior year period. Higher revenues under our grant programs result, in part, from work performed under our HSV-2 and RSV grants in the three-month period ended March 31, 2009 that had not begun in the comparable prior year period. In addition, higher revenues are a result of an increased effort in our hearing loss and balance disorders program in the first quarter of 2009 period compared to the same period in 2008. Higher revenues associated with our HIV program are due to increased efforts associated with the development of an alternate adenovirus serotype as a vector. Partially offsetting the increases is a decrease in revenue of $274,000 under our malaria program as compared to the prior year period.
Expenses
Operating expenses were $9.2 million for the three-month period ended March 31, 2009, which represents a decrease of 9 percent as compared to $10.1 million in the comparable prior year period. In January 2009, we announced we eliminated 22 positions, as a result of which we incurred $269,000 of expense. Of these 22 positions, 15 positions were classified in our research and development area and 7 positions were classified in our general and administrative area.
Research and development expenses for the three-month period ended March 31, 2009 decreased 5 percent to $7.3 million as compared to $7.7 million for the comparable prior year period. The decrease is primarily due to lower personnel costs, reduced patient site and lab costs related to our TNFerade program and reduced materials costs related to our funded programs and to a lesser extent TNFerade and general lab materials and supplies. These decreases are partially offset by increased costs related to the manufacturing costs of TNFerade, as it relates to the amendment to our Cobra amendment more fully described in the following paragraph, and our FMD program. Included in the personnel costs are $193,000 in severance costs as a result of our reduction of 15 positions in January 2009. There were no severance costs in the comparable period in 2008. Additionally, stock-based compensation expense allocated to research and development decreased $91,000 as compared to the comparable prior year period.
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In January 2008, we entered into a manufacturing development agreement with Cobra Biomanufacturing Plc to produce commercial quantities of TNFerade, our lead product candidate. The manufacturing development agreement covers technology transfer, scale-up, and validation of the manufacturing process for TNFerade through cGMP consistency lots. Under the terms of the agreement, we made an advance payment of $1.0 million. This advance payment was recorded in accordance with EITF 07-3, Accounting for Nonrefundable Advance Payments, which requires us to defer and capitalize nonrefundable advance payments until the related services are performed.
In March 2009, we entered into a letter agreement amending the original agreement and the associated services. Under the terms of the amendment, Cobra suspended its activities under the original agreement until the end of the second quarter of 2009, when at our sole discretion, we may terminate the original agreement, or we may resume performance pursuant to a newly negotiated schedule of services and fees. Under the terms of the amendment, we paid Cobra an initial payment of $700,000 in March, and will pay an additional $1.1 million through June 30, 2009. These payments will provide us with access to the Cobra facility in 2009 through June 30th. In addition, we waived our rights to amounts remaining unused as of the date of the amendment relating to the advanced payment. As a result, in March 2009 we expensed the remaining $669,000 of the advance payment. Prior to the amendment being signed, we made an additional advance payment of $425,000. All amounts paid to Cobra on or before March 31, 2009 have been charged to expense. If we decide to terminate the agreement at the end of the second quarter of 2009, we will be obligated to pay Cobra a termination fee of $350,000.
General and administrative expense for the three-month period ended March 31, 2009 decreased 21 percent to $1.9 million as compared to $2.4 million for the comparable prior year period. The decrease is primarily due to lower personnel costs, seminar and conference costs, travel costs, professional costs, and depreciation costs, partially offset by higher insurance costs and facility costs in the period. Included in the personnel costs are $76,000 in severance costs as a result of our reduction of 7 positions in January 2009. There was $81,000 in severance costs in the comparable period in 2008. Additonally, stock-based compensation expense allocated to general and administrative expenses, which is included in the personnel costs, decreased $45,000 for the three-month period ended March 31, 2009 as compared to the same period in 2008.
Other Income (Expense)
Total other income (expense) decreased $401,000 for the three-month period ended March 31, 2009 as compared to the prior year period. Total other income is composed of interest income, interest expense, net of the change in fair value of the Kingsbridge warrants, and other income.
Interest income for the three-month period ending March 31, 2009 was $27,000 compared to $261,000 in the comparable prior year period. The decreases in interest income were due mainly to lower investment balances and, to a lesser extent, lower yields earned on our investment portfolio.
Interest expense, net of the change in the fair market value of the Kingsbridge warrants, for the three-month period ending March 31, 2009 was $13,000 compared to $121,000 in the comparable prior year period. The decrease in interest expense was primarily due to a decrease in expense associated with the Kingsbridge warrant of $90,000 as compared to the corresponding period in the prior year. Additionally, in the three-month period ending March 31, 2009, interest expense associated with our debt obligations has decreased due to the declining balances of these obligations as compared to the corresponding period in the prior year.
Other income (expense) for the three-month period ending March 31, 2009 was a net expense for the period of $271,000 as compared to net income of $4,000 in the comparable prior year period. The decrease resulted primarily from the expensing of the remaining $273,000 of deferred financing charges when our Committed Equity Financing Facility (CEFF) with Kingsbridge Capital Ltd. (Kingsbridge) expired on March 15, 2009.
Liquidity and Capital Resources
We have experienced significant losses since our inception. As of March 31, 2009 we have an accumulated deficit of $219.3 million. The process of developing and commercializing our product candidates requires significant research and development work and clinical trial work, as well as significant manufacturing and process development efforts. These activities, together with our general and administrative expenses, are expected to continue to result in significant operating losses for the foreseeable future.
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As of March 31, 2009, cash and investments totaled $12.0 million as compared to $17.4 million at December 31, 2008.
For the three months ended March 31, 2009, we used $5.2 million of cash for operating activities. This consisted of a net loss for the period of $5.7 million, which included approximately $221,000 of non-cash depreciation and amortization, $427,000 of non-cash stock option expenses, and $273,000 from the write off of our deferred financing charges due to the expiration of our CEFF with Kingsbridge. Net cash was used primarily for the advancement of our TNFerade pancreatic clinical trial, including our manufacturing activities, and to a lesser extent general and administrative activities.
Net cash provided from investing activities during the three months ended March 31, 2009 was $998,000. There were no purchases of property and equipment during the period.
Net cash used in financing activities during the three months ended March 31, 2009 was $142,000, which included $68,000 of cash provided from the issuance of common stock under our Employee Stock Purchase Plan. This cash provided was offset by cash used in financing activities of $210,000 for the repayment of our debt obligations.
On March 15, 2006, we entered into a Committed Equity Financing Facility (CEFF) with Kingsbridge Capital Ltd. (Kingsbridge), under which Kingsbridge committed to purchase up to $30.0 million of our common stock within a three-year period, subject to certain conditions and limitations. During the three-year term of the CEFF, which expired on March 15, 2009, we sold 3,284,830 shares of common stock to Kingsbridge for total gross proceeds of $6.5 million.
On February 1, 2007, we filed with the Securities and Exchange Commission a $100 million shelf registration statement on Form S-3. The shelf registration statement was declared effective February 12, 2007 and allows us to obtain financing through the issuance of any combination of common stock, preferred stock, warrants, or debt securities. However, SEC rules limit our ability to use the shelf registration, including by generally providing that until such time as the aggregate market value of our common stock held by non-affiliates is $75 million or more, we may only sell pursuant to the shelf registration statement up to one-third of the aggregate market value of our common stock held by non-affiliates in any 12-month period.
On June 11, 2008, pursuant to our shelf registration statement, we completed a registered direct offering to various investors of 11,258,279 shares of common stock and warrants to purchase 2,251,653 shares of common stock. The shares of common stock and warrants were offered in units consisting of one share of common stock and a warrant to purchase 0.20 shares of common stock at a per unit price of $1.51. The warrants, which have a term of 5 years and an exercise price of $2.016 per share, have been valued using the Black-Scholes pricing model as of the closing date and have been accounted for in permanent equity. Proceeds of this offering, net of offering costs, totaled $15.7 million.
Our estimated future capital requirements are uncertain and could change materially as a result of many factors, including the progress of our research, development, clinical, manufacturing, and commercialization activities.
We have also taken and are continuing to take steps to lower our operating costs in order to reduce our expenses. These steps included our announcement on January 29, 2009 that we were eliminating 22 positions, as a result of which we incurred $269,000 of expenses in the first quarter of 2009. Further, where possible, we are minimizing our unfunded expenditures on activities that are not critical to the clinical development of TNFerade. This includes reducing our current spending on contract manufacturing, which is reflected in the amendment to our manufacturing development agreement with Cobra as described above. We currently estimate we will use approximately $9.0 to $10.0 million of cash in the 12 months ending March 31, 2010. Our estimated cash to be used includes approximately $2.1 million in contractual obligations, including amounts due under our Cobra amendment, and, $0.1 million for capital expenditures. Based on this estimate we have sufficient resources to fund our operations into the second quarter of 2010.
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Significant additional capital will be required to develop our product candidates through clinical development, manufacturing, and commercialization, including the continued advancement of TNFerade through the pivotal trial for locally advanced pancreatic cancer, the FDA regulatory review process for TNFerade and the establishment of manufacturing capabilities for TNFerade. We may seek additional capital through further public or private equity offerings, debt financing, additional strategic alliance and licensing arrangements, collaborative arrangements, or some combination of these financing alternatives. The current domestic and global economic conditions have made it more difficult for companies like us to access capital from the financial and credit markets, and have made it more likely we will have to pursue additional strategic alliances, licensing arrangements or collaborations for our product candidates, including for TNFerade. If we are successful in raising additional funds through the issuance of equity securities, investors will likely experience dilution, or the equity securities may have rights, preferences, or privileges senior to those of the holders of our common stock. If we raise funds through the issuance of debt securities, those securities would have rights, preferences, and privileges senior to those of our common stock. If we seek strategic alliances, licenses, or other alternative arrangements, such as arrangements with collaborative partners or others, we may need to relinquish rights to certain of our existing or future technologies, product candidates, or products we would otherwise seek to develop or commercialize on our own, or to license the rights to our technologies, product candidates, or products on terms that are not favorable to us. The overall status of the economic climate could also result in the terms of any equity offering, debt financing, or alliance, license or other arrangement being even less favorable to us and our stockholders than if the overall economic climate were stronger. We also will continue to look for government sponsored research collaborations and grants to help offset future anticipated losses from operations, as we expect to continue to rely on government funding for a significant portion of our revenues for the next few years and, to a lesser extent, interest income.
If adequate funds are not available through either the capital markets, strategic alliances, or collaborators, we may be required to delay, reduce the scope of or eliminate our research, development, clinical programs, manufacturing, or commercialization efforts, effect additional changes to our facilities or personnel, or obtain funds through other arrangements that may require us to relinquish some of our assets or rights to certain of our existing or future technologies, product candidates, or products on terms not favorable to us.
Off-Balance Sheet Arrangements and Contractual Obligations
We have no off-balance sheet financing arrangements other than in connection with our operating leases, which are disclosed in the contractual commitments table in our Form 10-K for the year ended December 31, 2008.
Significant Accounting Policies and Estimates
We describe our significant accounting policies in Note 2, Summary of Significant Accounting Policies, of the Notes to Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2008. We discuss our critical accounting estimates in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, in our Annual Report on Form 10-K for the year ended December 31, 2008. There has been no significant change in our significant accounting policies or critical accounting estimates since the end of 2008.
Recently Issued Accounting Pronouncements
In December 2007, the FASB ratified Emerging Issues Task Force (EITF) Issue No. 07-1, “Accounting for Collaborative Arrangements” (EITF 07-1), which defines collaborative arrangements and establishes reporting and disclosure requirements for transactions between participants in a collaborative arrangement and between participants in the arrangements and third parties. EITF 07-1 is effective for periods beginning after December 15, 2008 and applies to arrangements in existence as of the effective date. On January 1, 2009 we adopted of EITF 07-01 and it did not have a material impact on our financial position or results of operations.
Other new pronouncements issued but not effective until after March 31, 2009 are not expected to have a significant effect on our financial position or results of operations.
ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
The primary objective of our investment activities is to preserve our capital until it is required to fund operations while at the same time maximizing the income we receive from our investments without significantly increasing risk. Our cash flow and earnings are subject to fluctuations due to changes in interest rates in our investment portfolio. We maintain a portfolio of various issuers, types, and maturities. These securities are classified as available-for-sale and, consequently, are recorded on the balance sheet at fair value with unrealized gains or losses reported as a component of accumulated other comprehensive income (loss) included in stockholders’ equity.
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As of March 31, 2009, we have an outstanding bond payable totaling $0.7 million. This bond bears interest at a variable rate based on LIBOR. During 2000, we entered into an interest rate swap agreement that effectively fixed the interest rate over the life of the bond at 6.7% plus a remarketing fee. The remaining debt has a fixed rate and is not subject to interest rate exposure.
ITEM 4. | CONTROLS AND PROCEDURES |
As of March 31, 2009, under the supervision and with the participation of our President and Chief Executive Officer and our Chief Financial Officer, Treasurer, and Corporate Secretary (our principal executive officer and principal financial officer, respectively), we have reviewed and evaluated the effectiveness of the design and operation of our disclosure controls and procedures. Based on that evaluation, the President and Chief Executive Officer and the Chief Financial Officer, Treasurer, and Corporate Secretary have concluded that, as of March 31, 2009, these disclosure controls and procedures are effective at the reasonable assurance level in alerting them in a timely manner to material information required to be included in our periodic SEC reports.
There were no changes in our internal controls over financial reporting during the quarter ended March 31, 2009 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II. OTHER INFORMATION
ITEM 1. | LEGAL PROCEEDINGS |
We are not currently a party to any material legal proceedings.
ITEM 1A. | RISK FACTORS |
For information regarding factors that could affect the Company’s results of operations, financial condition and liquidity, see the risk factors discussion provided under “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2008. See also, “Forward-Looking Statements” included in this Quarterly Report on Form 10-Q. In addition, the following information reflects the current conditions of the capital markets, which present uncertainties to all companies that rely on capital markets for liquidity or financing.
ITEM 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
Not applicable.
ITEM 3. | DEFAULTS UPON SENIOR SECURITIES |
Not applicable.
ITEM 4. | SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS |
Not applicable.
ITEM 5. | OTHER INFORMATION |
Not applicable.
ITEM 6. | EXHIBITS |
10.37 | March 20, 2009 Letter Agreement amending the Manufacturing Development Agreement between the Company and Cobra Biomanufacturing Plc dated January 18, 2008. |
31.1 | Certification of Chief Executive Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
31.2 | Certification of Chief Financial Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
32.1 | Certification of Chief Executive Officer, pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
32.2 | Certification of Chief Financial Officer, pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
GENVEC, INC. | ||
(Registrant) | ||
Date: May 8, 2009 | By: | /s/ Paul H. Fischer, Ph.D. |
Paul H. Fischer, Ph.D. | ||
President and Chief Executive Officer |
Date: May 8, 2009 | By: | /s/ Douglas J. Swirsky |
Douglas J. Swirsky | ||
Chief Financial Officer, Treasurer, and Corporate Secretary |
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