Attached files
file | filename |
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EX-31.1 - EX-31.1 SECTION 302 CERTIFICATION OF THE CEO & CFO - INHIBITEX, INC. | c92492exv31w1.htm |
EX-32.1 - EX-32.1 SECTION 906 CERTIFICATION OF THE CEO & CFO - INHIBITEX, INC. | c92492exv32w1.htm |
EX-10.55 - EXHIBIT 10.55 - INHIBITEX, INC. | c92492exv10w55.htm |
Table of Contents
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 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 No. 0-50772
INHIBITEX, INC.
(Exact name of registrant as specified in its charter)
Delaware (State or other jurisdiction of incorporation or organization) |
74-2708737 (I.R.S. Employer Identification No.) |
|
9005 Westside Parkway Alpharetta, Georgia (Address of principal executive offices) |
30009 (Zip Code) |
(678) 746-1100
(Registrants telephone number, including area code)
Not Applicable
(Former name, former address and former fiscal year,
if changed since last report)
(Registrants telephone number, including area code)
Not Applicable
(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 þ 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 (§232.405 of this chapter) 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 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 o | Non-Accelerated Filer o | Smaller Reporting Company þ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Act). Yes o No þ
As of November 4, 2009, 61,522,795 shares of the Registrants Common Stock were outstanding.
TABLE OF CONTENTS
PAGE | ||||||||
Item 1. Financial Statements |
||||||||
3 | ||||||||
4 | ||||||||
5 | ||||||||
6 | ||||||||
11 | ||||||||
17 | ||||||||
18 | ||||||||
20 | ||||||||
21 | ||||||||
22 | ||||||||
Exhibit 10.55 | ||||||||
EX-31.1 SECTION 302 CERTIFICATION OF THE CEO & CFO | ||||||||
EX-32.1 SECTION 906 CERTIFICATION OF THE CEO & CFO |
2
Table of Contents
PART I
FINANCIAL INFORMATION
FINANCIAL INFORMATION
INHIBITEX, INC.
CONSOLIDATED BALANCE SHEETS
September 30, | December 31, | |||||||
2009 | 2008 | |||||||
(unaudited) | ||||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 8,177,449 | $ | 11,507,137 | ||||
Short-term investments |
12,901,906 | 21,634,880 | ||||||
Prepaid expenses and other current assets |
934,172 | 621,797 | ||||||
Accounts receivable |
79,443 | 108,558 | ||||||
Total current assets |
22,092,970 | 33,872,372 | ||||||
Property and equipment, net |
1,698,141 | 2,328,707 | ||||||
Other assets |
138,039 | 31,876 | ||||||
Total assets |
$ | 23,929,150 | $ | 36,232,955 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,492,789 | $ | 1,276,215 | ||||
Accrued expenses |
1,618,787 | 1,001,047 | ||||||
Current portion of notes payable |
78,125 | 312,500 | ||||||
Current portion of capital lease obligations |
201,472 | 254,291 | ||||||
Current portion of deferred revenue |
441,667 | 441,667 | ||||||
Other current liabilities |
202,373 | 224,922 | ||||||
Total current liabilities |
4,035,213 | 3,510,642 | ||||||
Long-term liabilities: |
||||||||
Notes payable, net of current portion |
546,875 | 390,625 | ||||||
Capital lease obligations, net of current portion |
234,731 | 387,892 | ||||||
Deferred revenue, net of current portion |
125,000 | 237,500 | ||||||
Other liabilities, net of current portion |
1,143,411 | 1,279,994 | ||||||
Total long-term liabilities |
2,050,017 | 2,296,011 | ||||||
Total liabilities |
6,085,230 | 5,806,653 | ||||||
Stockholders equity: |
||||||||
Preferred stock, $.001 par value; 5,000,000
shares authorized at September 30, 2009 and
December 31, 2008; none issued and outstanding |
| | ||||||
Common stock, $.001 par value; 150,000,000 and
75,000,000 shares authorized at September 30,
2009 and December 31, 2008, respectively;
43,547,136 and 43,380,570 shares issued and
outstanding at September 30, 2009 and December
31, 2008, respectively |
43,547 | 43,381 | ||||||
Warrants |
13,619,076 | 13,742,630 | ||||||
Accumulated other comprehensive income |
7,588 | 111,450 | ||||||
Additional paid-in capital |
244,366,603 | 243,825,057 | ||||||
Accumulated deficit |
(240,192,894 | ) | (227,296,216 | ) | ||||
Total stockholders equity |
17,843,920 | 30,426,302 | ||||||
Total liabilities and stockholders equity |
$ | 23,929,150 | $ | 36,232,955 | ||||
The accompanying notes are an integral part of these financial statements.
3
Table of Contents
INHIBITEX, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(unaudited)
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
Revenue: |
||||||||||||||||
License fees and milestones |
$ | 37,500 | $ | 412,500 | $ | 112,500 | $ | 1,237,500 | ||||||||
Collaborative research and
development |
250,000 | 375,000 | 750,000 | 1,125,000 | ||||||||||||
Total revenue |
287,500 | 787,500 | 862,500 | 2,362,500 | ||||||||||||
Operating expense: |
||||||||||||||||
Research and development |
3,945,464 | 3,468,184 | 11,123,072 | 8,982,333 | ||||||||||||
General and administrative |
831,264 | 1,519,205 | 2,840,108 | 4,083,112 | ||||||||||||
Total operating expense |
4,776,728 | 4,987,389 | 13,963,180 | 13,065,445 | ||||||||||||
Loss from operations |
(4,489,228 | ) | (4,199,889 | ) | (13,100,680 | ) | (10,702,945 | ) | ||||||||
Other income, net |
1,562 | 5,077 | 39,634 | 19,557 | ||||||||||||
Interest income, net |
15,929 | 239,280 | 164,368 | 1,071,182 | ||||||||||||
Net loss |
$ | (4,471,737 | ) | $ | (3,955,532 | ) | $ | (12,896,678 | ) | $ | (9,612,206 | ) | ||||
Basic and diluted net loss per share |
$ | (0.10 | ) | $ | (0.09 | ) | $ | (0.30 | ) | $ | (0.22 | ) | ||||
Weighted average shares used to
compute basic and diluted net loss
per share |
43,545,057 | 43,273,487 | 43,499,678 | 42,992,372 | ||||||||||||
The accompanying notes are an integral part of these financial statements.
4
Table of Contents
INHIBITEX, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(unaudited)
Nine Months Ended | ||||||||
September 30, | ||||||||
2009 | 2008 | |||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (12,896,678 | ) | $ | (9,612,206 | ) | ||
Adjustments to reconcile net loss to net cash
used in operating activities: |
||||||||
In-process research and development |
| (129,251 | ) | |||||
Depreciation and amortization |
635,547 | 737,491 | ||||||
Share-based compensation |
413,123 | 1,252,338 | ||||||
Gain on sale of equipment |
(39,890 | ) | (24,439 | ) | ||||
Amortization of investment premium or discount |
16,811 | (555,607 | ) | |||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses and other assets |
(418,538 | ) | 343,777 | |||||
Accounts receivable |
29,115 | (147,671 | ) | |||||
Accounts payable and other liabilities |
57,442 | 27,690 | ||||||
Accrued expenses |
617,740 | (4,678,317 | ) | |||||
Deferred revenue |
(112,500 | ) | 12,500 | |||||
Net cash used in operating activities |
(11,697,828 | ) | (12,773,695 | ) | ||||
Cash flows from investing activities: |
||||||||
Purchases of property and equipment |
(4,981 | ) | (464,281 | ) | ||||
Proceeds from sale of property and equipment |
39,890 | 30,230 | ||||||
Purchases of investments |
(15,277,699 | ) | (33,757,870 | ) | ||||
Proceeds from maturities and sales of investments |
23,890,000 | 45,250,077 | ||||||
Cash paid in connection with acquisition |
| (151,748 | ) | |||||
Net cash provided by investing activities |
8,647,210 | 10,906,408 | ||||||
Cash flows from financing activities: |
||||||||
Proceeds from capital lease financing |
| 368,121 | ||||||
Payments on promissory notes and capital leases |
(284,105 | ) | (795,388 | ) | ||||
Repurchase of common stock |
(3,213 | ) | (130,583 | ) | ||||
Proceeds from the issuance of common stock |
8,248 | 13,301 | ||||||
Net cash used in financing activities |
(279,070 | ) | (544,549 | ) | ||||
Decrease in cash and cash equivalents |
(3,329,688 | ) | (2,411,836 | ) | ||||
Cash and cash equivalents at beginning of period |
11,507,137 | 14,178,143 | ||||||
Cash and cash equivalents at end of period |
$ | 8,177,449 | $ | 11,766,307 | ||||
Supplemental cash flow information: |
||||||||
Interest paid |
$ | 50,954 | $ | 44,514 |
The accompanying notes are an integral part of these financial statements.
5
Table of Contents
INHIBITEX, INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
1. Operations
Inhibitex, Inc. (Inhibitex or the Company) was incorporated in the state of Delaware in May
1994. Inhibitex is a biopharmaceutical company focused on the development of differentiated
anti-infective products to treat serious infections.
The Company is currently targeting its development efforts on small molecule, oral antiviral
therapies to treat shingles (herpes zoster) and infections caused by hepatitis C virus (HCV).
Currently available antiviral therapies for these infections have various limitations or
shortcomings, such as sub-optimal potency, diminishing efficacy due to the emergence of
drug-resistant viruses, toxic and adverse side effects, complex dosing schedules and inconvenient
routes of administration. The Company believes that its antiviral product candidates have the
potential to be differentiated from existing therapies by addressing a number of these limitations
and other unmet needs in their respective, intended indications.
The Company has not received regulatory approval for any of its product candidates, and the Company
does not have any commercialization capabilities; therefore, it is possible that the Company may
never successfully derive significant collaboration revenues or any commercial revenues from any of
its existing or future product candidates or preclinical development programs.
The Company plans to continue to finance its operations with its existing cash, cash equivalents
and short-term investments, or through future equity and/or debt financings; with proceeds from
potential future collaborations or partnerships; or through other financing vehicles. The Companys
ability to continue its operations is dependent, in the near-term, upon managing its cash
resources, the successful development of its product candidates, entering into collaboration or
partnership agreements, executing future financings and ultimately, upon the approval of its
products for sale and achieving positive cash flow from operations. There can be no assurance that
additional funds will be available on terms acceptable to the Company, or that the Company will
ever generate significant revenue and become profitable.
2. Summary of Significant Accounting Policies
The accompanying unaudited condensed consolidated financial statements have been prepared in
accordance with accounting principles generally accepted in the United States (U.S.) for interim
financial information and with the instructions to Form 10-Q and Rule 8-03 of Regulation S-X. They
do not include all information and notes required by generally accepted accounting principles
(GAAP) for complete financial statements. However, except as disclosed herein, there has been no
material change in the information disclosed in the notes to the consolidated financial statements
included in the Annual Report on Form 10-K for the year ended December 31, 2008.
The Company evaluated all events or transactions that occurred after the balance sheet date of
September 30, 2009 through November 13, 2009, the date it issued these financial statements.
The Companys significant accounting policies have not changed since December 31, 2008, except as
outlined below:
In the third quarter of 2009, the Company adopted the Financial Accounting Standards Board (FASB)
Accounting Standards Codification (ASC). The ASC became the single official source of
authoritative U.S. generally accepted accounting principles recognized by FASB, other than guidance
issued by the Securities and Exchange
Commission. The adoption of the ASC did not impact the Companys financial position or results of
operations. However, the adoption of the ASC changed the Companys references to GAAP in its
consolidated financial statements.
In September 2009, the FASB amended the guidance for the fair value measurement of investments in
certain entities that calculate net asset value per share (or its equivalent). This amendment
permits entities to measure the fair value of certain investments, including those with fair values
that are not readily determinable, on the basis of the net asset value per share of the investment
(or its equivalent) if such net asset value is calculated in a manner consistent with the
measurement principles in Financial Services-Investment Companies as of the reporting entitys
measurement date. This amendment also requires enhanced disclosures about the nature and risks of
investments within its scope that are measured at fair value on a recurring or nonrecurring basis.
This amendment will be effective for the Company beginning October 1, 2009 and is not expected to
have a significant impact on the Companys consolidated financial position or results of
operations.
6
Table of Contents
In October 2009, the FASB amended the guidance for revenue recognition in multiple-element
arrangements. The guidance now requires an entity to provide updated guidance on whether multiple
deliverables exist, how the deliverables in an arrangement should be separated, and the
consideration allocated; and allocate revenue in an arrangement using estimated selling prices of
deliverables if a vendor does not have vendor-specific objective evidence (VSOE) or third-party
evidence of selling price. The guidance also eliminates the use of the residual method and
requires an entity to allocate revenue using the relative selling price method. This amendment is
effective for the Company beginning January 1, 2011 and can be applied prospectively or
retrospectively. We are currently evaluating the impact of this accounting amendment on our
consolidated financial statements.
3. Net Loss Per Share
Basic and diluted net loss per share have been computed based on net loss and the weighted-average
number of common shares outstanding during the applicable period. For diluted net loss per share,
common stock equivalents (common shares issuable upon the exercise of stock options and warrants)
are excluded from the calculation of diluted net loss per share if their effect is antidilutive.
The Company has excluded all options and warrants to purchase common stock, as such potential
shares are antidilutive.
The following table sets forth the computation of historical basic and diluted net loss per share:
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
Net loss available for common stockholders |
$ | (4,471,737 | ) | $ | (3,955,532 | ) | $ | (12,896,678 | ) | $ | (9,612,206 | ) | ||||
Weighted average common shares outstanding used to compute basic earnings per share |
43,545,057 | 43,273,487 | 43,499,678 | 42,992,372 | ||||||||||||
Dilutive effect of: |
||||||||||||||||
Stock options |
| | | | ||||||||||||
Warrants |
| | | | ||||||||||||
Shares used to compute diluted earnings per share |
43,545,057 | 43,273,487 | 43,499,678 | 42,992,372 | ||||||||||||
Basic net loss per share |
$ | (0.10 | ) | $ | (0.09 | ) | $ | (0.30 | ) | $ | (0.22 | ) | ||||
Diluted loss per share |
$ | (0.10 | ) | $ | (0.09 | ) | $ | (0.30 | ) | $ | (0.22 | ) | ||||
Number of antidilutive stock options excluded from
computation |
4,631,736 | 4,966,762 | 4,631,736 | 4,966,762 | ||||||||||||
Number of antidilutive warrants excluded from
computation |
8,000,597 | 8,557,288 | 8,000,597 | 8,557,288 | ||||||||||||
4. Stockholders Equity
Common Stock . In June 2009, the Companys stockholders approved an amendment to the Companys
Eighth Amended and Restated Certificate of Incorporation to increase the Companys authorized
common stock, $0.001 par value per share, from 75,000,000 shares to 150,000,000 shares.
Common Stock Warrants. For the nine months ended September 30, 2009, a total of 22,266 warrants
expired with a weighted average exercise price of $9.26. The total Black-Scholes value of those
warrants was $123,554, and such amount was reclassified from warrants to additional paid-in
capital. As of September 30, 2009, and 2008, there were 8,000,597 and 8,557,288 warrants
outstanding, respectively. The weighted average exercise price as of September 30, 2009 and 2008
was $2.85 and $3.57, respectively. As of September 30, 2009, all of the outstanding warrants are
exercisable and expire from November 10, 2009 to September 26, 2018.
7
Table of Contents
5. Share-Based Award Plans
For the three months ended September 30, 2009 and 2008, the Company recorded share-based
compensation expense related to grants from the 2004 Stock Incentive Plan of $112,806 and $396,685,
respectively, or $0.00 and $0.01 basic and fully diluted per share. For the nine months ended
September 30, 2009 and 2008, the Company recorded share-based compensation expense related to
grants from this plan of $413,123 and $1,252,338, respectively, or $0.01 and $0.03 basic and fully
diluted per share. No income tax benefit was recognized in the statements of operations and no
share-based compensation expense was capitalized as part of any assets for the three and nine
months ended September 30, 2009 and 2008.
Stock Options
The fair value of each stock option award was estimated at its respective date of grant using
the Black-Scholes method with the following assumptions:
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
Weighted average risk-free interest rate |
| 3.12 | % | 1.87 | % | 2.72 | % | |||||||||
Dividend yield |
| | | | ||||||||||||
Expected weighted average volatility |
| .67 | .69 | .68 | ||||||||||||
Expected weighted average
life of options (years) |
| 4.0 | 4.0 | 4.0 | ||||||||||||
Weighted average fair value of options granted |
| $ | 0.33 | $ | 0.17 | $ | 0.43 |
The risk-free rate interest rate is based on the expected life of the option and the corresponding
United States (U.S.) Treasury bond, which in most cases is the U.S. five year Treasury bond. The
expected term of stock options granted is derived from actual and expected option behavior and
represents the period of time that options granted are expected to be outstanding. The Company uses
historical data to estimate option exercise patterns and future employee terminations to determine
expected life and forfeitures. Expected volatility is based on the historical volatility of the
Companys publicly traded common stock.
Weighted Average | Weighted-Average | Aggregate Intrinsic | ||||||||||||||
Number of | Exercise Price | Remaining Contractual | Value | |||||||||||||
Stock Options | Per Option | Term | ($000) | |||||||||||||
Balance at December 31, 2008 |
4,820,459 | $ | 2.33 | |||||||||||||
Granted |
70,500 | 0.32 | ||||||||||||||
Exercised |
| | ||||||||||||||
Forfeited or expired |
(259,223 | ) | 3.28 | |||||||||||||
Balance at September 30, 2009 |
4,631,736 | $ | 2.25 | 5.5 | $ | 132 | ||||||||||
The weighted-average fair value of stock options granted during the nine month period ended
September 30, 2009 was $0.17. As of September 30, 2009 there was $855,646 of unrecognized
share-based compensation expense related to unvested stock option awards, not discounted for future
forfeitures. This balance is expected to be recognized over a weighted-average period of 1.9 years.
6. Comprehensive Loss
The components of comprehensive loss for the three and nine months ended September 30, 2009 and
2008 are as follows:
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
Net loss |
$ | (4,471,737 | ) | $ | (3,955,532 | ) | $ | (12,896,678 | ) | $ | (9,612,206 | ) | ||||
Change in net unrealized losses on investments |
$ | (14,422 | ) | $ | (40,129 | ) | $ | (103,862 | ) | $ | (140,257 | ) | ||||
Comprehensive loss |
$ | (4,486,159 | ) | $ | (3,995,661 | ) | $ | (13,000,540 | ) | $ | (9,752,463 | ) | ||||
8
Table of Contents
7. Fair Value Measurements
In accordance with the Fair Value Measurements and Disclosures Codification Topic, a fair
value hierarchy is established which requires an entity to maximize the use of observable inputs,
where available, and minimize the use of unobservable inputs when measuring fair value. The
Codification describes three levels of inputs that may be used to measure fair value:
Level 1 | Quoted prices in active markets for identical assets or liabilities. |
||
Level 2 | Observable inputs other than Level 1 prices, such as quoted prices
for similar assets or liabilities; quoted prices in markets that
are not active; or other inputs that are observable or can be
corroborated by observable market data for substantially the full
term of the assets or liabilities. |
||
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. |
The following table sets forth the financial assets and liabilities that were measured at fair
value on a recurring basis at September 30, 2009, by level within the fair value hierarchy. As
required by the Fair Value Measurements and Disclosures Codification Topic, assets and liabilities
measured at fair value are classified in their entirety based on the lowest level of input that is
significant to the fair value measurement.
Quoted prices in | ||||||||||||||||
active markets for | Significant other | Significant | ||||||||||||||
identical assets | observable inputs | unobservable inputs | ||||||||||||||
September 30, 2009 | Total | (Level 1) | (Level 2) | (Level 3) | ||||||||||||
Cash equivalents |
$ | 7,066,198 | $ | 5,559,485 | $ | 1,506,713 | $ | | ||||||||
Short-term investments available-for-sale |
12,901,906 | 251,865 | 12,650,041 | | ||||||||||||
Total |
$ | 19,968,104 | $ | 5,811,350 | $ | 14,156,754 | $ | | ||||||||
Cash equivalents consist primarily of money market funds and commercial paper with original
maturity dates of three months or less. Short-term investments consist of U.S. agency securities
and U.S. Treasury securities classified as available-for-sale and have maturities greater than 90
days, but less than 365 days from the date of acquisition.
The Companys cash, cash equivalents and short-term investments are generally held in a variety of
interest-bearing instruments, generally consisting of U.S. agency securities, U.S. Treasury
securities, commercial paper issued under government liquidity programs, and money market accounts.
The Company has had no realized gains or losses from the sale of investments for the nine months
ended September 30, 2009. The following table shows the unrealized gains and losses and fair
values for those investments as of September 30, 2009 and December 31, 2008 aggregated by major
security type:
Unrealized | Unrealized | |||||||||||||||
September 30, 2009 | At Cost | Gains | (Losses) | At Fair Value | ||||||||||||
Certificates of deposit and money market
funds |
$ | 5,559,485 | $ | | $ | | $ | 5,559,485 | ||||||||
Debt securities of U.S. government agencies |
14,149,456 | 10,010 | (2,712 | ) | 14,156,754 | |||||||||||
US Treasury securities |
251,575 | 290 | | 251,865 | ||||||||||||
Total |
$ | 19,960,516 | $ | 10,300 | $ | (2,712 | ) | $ | 19,968,104 | |||||||
Unrealized | Unrealized | |||||||||||||||
December 31, 2008 | At Cost | Gains | (Losses) | At Fair Value | ||||||||||||
Certificates of deposit and money market
funds |
$ | 11,603,992 | $ | | $ | (386 | ) | $ | 11,603,606 | |||||||
Commercial paper |
845,999 | 1,551 | | 847,550 | ||||||||||||
Corporate debt notes |
9,122,672 | 30,488 | (8,117 | ) | 9,145,043 | |||||||||||
Debt securities of U.S. government agencies |
10,458,387 | 88,584 | (791 | ) | 10,546,180 | |||||||||||
US Treasury securities |
754,641 | 157 | (36 | ) | 754,762 | |||||||||||
Total |
$ | 32,785,691 | $ | 120,780 | $ | (9,330 | ) | $ | 32,897,141 | |||||||
9
Table of Contents
As of September 30, 2009, the Company had investments in an unrealized loss position. The
Company has determined that the unrealized losses on these investments at September 30, 2009 are
temporary in nature and expects the security to mature at its stated maturity principal.
All available-for-sale securities held at September 30, 2009 will mature within one year.
8. Notes Payable
Notes Payable. On August 3, 2009, the Company entered into a second amendment to its interest free
loan agreement with a local development authority for laboratory-related leasehold improvements at
the Companys research and headquarters facility; whereas, the Company will make one payment of
$78,125 on January 1, 2010 and then make eight quarterly installments of $60,764 beginning January
1, 2011 with a final payment $60,763 payable on January 1, 2013. As of September 30, 2009 and
December 31, 2008, $625,000 and $703,125 were outstanding under this note payable, respectively.
Future minimum payments due under notes payable as of September 30, 2009 are as follows:
Year Ending December 31, | ||||
2009 |
$ | | ||
2010 |
78,125 | |||
2011 |
243,056 | |||
2012 |
243,056 | |||
2013 |
60,763 | |||
Total future payments |
$ | 625,000 | ||
9. Subsequent Event
On October 23, 2009, the Company entered into Stock and Warrant Purchase Agreements with certain
new and existing institutional investors through a private placement financing (Private
Placement), pursuant to which the Company agreed to sell, at a price of $1.28 per share
(reflecting the consolidated closing bid price of one share of common stock on the Nasdaq Capital
Market on October 23, 2009 plus $0.06 reflecting the purchase price of one warrant), an aggregate
of 17,968,747 shares of its common stock and warrants to purchase 8,085,932 shares of its common
stock at an exercise price of $1.46 per share. The warrants are immediately exercisable and expire
on October 28, 2013. The sale and issuance of shares and warrants was completed on October 28, 2009
with the Company raising gross proceeds of approximately $23 million. The Company intends to use
the proceeds for research and development, working capital and general corporate purposes.
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ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This Quarterly Report on Form 10-Q contains forward-looking statements. These forward-looking
statements involve known and unknown risks, uncertainties and other factors that may cause actual
results, performance or achievements to be materially different from any future results,
performance or achievements expressed or implied by the forward-looking statements. In some cases,
you can identify forward-looking statements by terms such as may, will, should, could,
would, expect, plan, intend, anticipate, believe, estimate, project, predict,
forecast, potential, likely or possible, as well as the negative of such expressions, and
similar expressions intended to identify forward-looking statements. These forward-looking
statements include, without limitation, statements relating to:
| The anticipated completion of the FV-100 Phase II trial in shingles patients around the middle of next year; | |
| our plans and timing to file an investigational new drug application for INX-189 and initiate clinical trials in the first half of 2010; | |
| the number of months that our current cash, cash equivalents and short-term investments will allow us to operate; | |
| our future financing requirements, the factors that may influence the timing and amount of these requirements, and our ability to fund them; | |
| potential future revenue from collaborative research agreements, partnerships, license agreements, product related revenue or materials transfer agreements; | |
| our product candidates may have the potential to address a number of current therapeutic limitations, such as inadequate potency, diminishing efficacy due to the emergence of drug-resistant viruses, toxic or adverse side effects, complex dosing schedules, and inconvenient routes of administration and other unmet needs in their intended indications; and | |
| anticipated future and increased net losses from operations. |
These statements reflect our current views with respect to future events and are based on
assumptions and subject to risks and uncertainties including, without limitation: not obtaining
regulatory approval on a timely basis, or at all, to advance the development of an HCV clinical
candidate into clinical trials; either we, the FDA, or an investigational review board suspending
or terminating the clinical development of FV-100 for lack of safety, manufacturing issues or other
clinical reasons; FV-100 not demonstrating sufficient efficacy in reducing the incidence and
severity of shingles-related symptoms, including acute pain and PHN, to be clinically relevant or
commercially viable; the results of ongoing or future preclinical studies of INX-189 not supporting
its further development; Wyeth not terminating our license and collaborative research agreements;
our maintaining sufficient resources, including executive management and key employees; our ability
to successfully develop current and future product candidates either in collaboration with a
partner or independently and through the regulatory process; our ongoing or future preclinical
studies or clinical trials not demonstrating an appropriate safety and/or efficacy profile of our
product candidates; our ability to secure and use third-party clinical and preclinical research
and data management organizations and manufacturers not fulfilling their contractual obligations or
otherwise performing satisfactorily in the future; manufacturing and maintaining sufficient
quantities of preclinical and clinical trial material on hand to complete our preclinical studies
or clinical trials on a timely basis; failure to obtain regulatory approval to market our product
candidates; our ability to protect and maintain our proprietary intellectual property rights from
unauthorized use by others or not infringing on the intellectual property rights of others; our
collaborators failing to fulfill their obligations under our agreements with them in the future;
our ability to attract suitable organizations to collaborate on the development and
commercialization of our product candidates; the condition of the financial equity and debt markets
and our ability to raise sufficient funding in such markets; our ability to manage our current cash
reserves as planned; changes in general economic business or competitive conditions; and other
statements contained elsewhere in this Quarterly Report on Form 10-Q (including
the Risk Factors section herein) and risk factors described in or referred to in greater detail
in the Risk Factors section of our Form 10-K for the year ended December 31, 2008 and in the
Risk Factors section of our Form 10-Q for the quarters ended March 31, 2009 and June 30, 2009.
There may be events in the future that we are unable to predict accurately, or over which we have
no control. You should read this Form 10-Q and the documents that we reference herein and which
been filed or incorporated by reference as exhibits completely and with the understanding that our
actual future results may be materially different from what we expect. Our business, financial
condition, results of operations, and prospects may change. We may not update these forward-looking
statements, even though our situation may change in the future, unless we have obligations under
the federal securities laws to update and disclose material developments related to previously
disclosed information. We qualify all of the information presented in this Form 10-Q, and
particularly our forward-looking statements, by these cautionary statements.
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Inhibitex®, MSCRAMM® and Aurexis® are
registered trademarks of Inhibitex, Inc. MSCRAMM is an acronym for Microbial Surface Components
Recognizing Adhesive Matrix Molecules.
The following discussion should be read in conjunction with the financial statements and the notes
thereto included in Item 1 of this Quarterly Report on Form 10-Q.
Overview
We are a biopharmaceutical company focused on the development of differentiated anti-infective
products to treat serious infections. We are currently targeting our efforts and resources on the
development of small molecule antiviral compounds, and in particular, oral therapies to treat
shingles (herpes zoster) and infections caused by hepatitis C virus, (HCV). Many currently
available antiviral therapies have various limitations and shortcomings, such as sub-optimal
potency, diminishing efficacy due to the emergence of drug-resistant viruses, toxic or adverse side
effects, complex dosing schedules, and inconvenient routes of administration. We believe that our
product candidates have the potential to address a number of these limitations and other unmet
needs in their intended indications.
Our lead product candidate, FV-100, is an orally available nucleoside analogue prodrug being
developed for the treatment of shingles (herpes zoster), which is caused by varicella zoster virus,
(VZV). We initiated a Phase II clinical trial of FV-100 in May 2009. Our preclinical pipeline
includes INX-189, the lead compound from our series of nucleotide polymerase inhibitors, which we
refer to as protides, which we are developing to treat infections caused by HCV, and we have also
licensed to Wyeth the rights to use certain intellectual property for its use in the development of
staphylococcal vaccines.
We foresee completing our Phase II clinical trial of FV-100 around the middle 2010. We are also
engaged in various preclinical Good Laboratory Practice (GLP) studies with respect to INX-189.
Subject to the successful completion of our GLP studies, we plan on filing an investigational new
drug application, (IND) for INX-189 and initiate clinical trials in the first half of 2010.
We have neither received regulatory approval for any of our product candidates, nor do we have
any commercialization capabilities; therefore, it is possible that we may never successfully
derive significant collaboration revenues or any product revenues from any of our existing or
future preclinical development programs or product candidates. We expect to incur losses for
the foreseeable future as we intend to support the development of our antiviral programs.
Recent Developments
FV-100- In November 2009, the Company reported that it had approximately 60 sites initiated and
qualified to enroll patients in its Phase II clinical trial to evaluate the safety and biologic
activity of FV-100 for the treatment of shingles.
INX -189 In November 2009, the Company reported that during the third quarter, it advanced
INX-189, its lead HCV protide polymerase inhibitor, into formal GLP studies based upon the results
of extensive preclinical in vitro and in vivo studies.
NASDAQ Listing Transfer In October 2009, the Company received written notification from The
Nasdaq Stock Market (Nasdaq) stating that the closing bid price of the Companys common stock had
been at or above $1.00 per share for 10 consecutive business days, and therefore the Company had
regained compliance with Nasdaqs Listing Rule 5550(a)(2) and its delisting matter was closed.
Private Placement Financing In October 2009, the Company completed a previously announced
private placement of common stock and warrants with a group of new and existing institutional
investors, raising gross proceeds of approximately $23 million. In connection with the private
placement, the Company expects to file a registration statement on Form S-3 with the Securities and
Exchange Commission to register the shares of common stock and the shares of common stock issuable
upon the exercise of the warrants issued pursuant to the private placement financing.
Presentation at AASLD Meeting In November 2009, the Company presented preclinical
pharmacokinetic data on INX-189 in a poster at the 60th Annual Meeting of the American
Association for the Study of Liver Diseases (AASLD) in Boston, MA. A copy of the poster
presentation is available on the Companys website at www.inhibitex.com.
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Critical Accounting Policies
Managements Discussion and Analysis of Results of Operations discusses our financial statements,
which (except to the extent described in the Notes thereto) have been prepared in accordance with
U.S. generally accepted accounting principles. The preparation of these financial statements
requires us to make estimates and assumptions that affect the reported amounts of assets and
liabilities and the disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the reporting period.
We base our estimates and judgments on historical experience, current economic and industry
conditions and on various other factors that we believed to be reasonable under the circumstances.
This forms the basis for making judgments about the carrying values of assets and liabilities that
are not readily apparent from other sources. Actual results may differ from these estimates under
different assumptions or conditions. We believe the following critical accounting policies require
significant judgment and estimates:
| Revenue Recognition | ||
| Accrued Expenses |
There has been no change in these critical accounting policies used to create the underlying
accounting assumptions and estimates used in 2009.
In the third quarter of 2009, the Company adopted the Financial Accounting Standards Board (FASB)
Accounting Standards Codification (ASC). The ASC became the single official source of
authoritative U.S. generally accepted accounting principles recognized by FASB, other than guidance
issued by the Securities and Exchange Commission. The adoption of the ASC did not impact the
Companys financial position or results of operations. However, the adoption of the ASC changed
the Companys references to GAAP in its consolidated financial statements.
In September 2009, the FASB amended the guidance for the fair value measurement of investments in
certain entities that calculate net asset value per share (or its equivalent). This amendment
permits entities to measure the fair value of certain investments, including those with fair values
that are not readily determinable, on the basis of
the net asset value per share of the investment (or its equivalent) if such net asset value is
calculated in a manner consistent with the measurement principles in Financial Services-Investment
Companies as of the reporting entitys measurement date. This amendment also requires enhanced
disclosures about the nature and risks of investments within its scope that are measured at fair
value on a recurring or nonrecurring basis. This amendment will be effective for the Company
beginning October 1, 2009 and is not expected to have a significant impact on the Companys
consolidated financial position or results of operations.
In October 2009, the FASB amended the guidance for revenue recognition in multiple-element
arrangements. The guidance now requires an entity to provide updated guidance on whether multiple
deliverables exist, how the deliverables in an arrangement should be separated, and the
consideration allocated; and allocate revenue in an arrangement using estimated selling prices of
deliverables if a vendor does not have vendor-specific objective evidence (VSOE) or third-party
evidence of selling price. The guidance also eliminates the use of the residual method and
requires an entity to allocate revenue using the relative selling price method. This amendment is
effective for the Company beginning January 1, 2011 and can be applied prospectively or
retrospectively. We are currently evaluating the impact of this accounting amendment on our
consolidated financial statements.
Results of Operations
Three Months Ended September 30, 2009 and 2008
Summary. We reported a net loss of $4.5 million for the three months ended September 30, 2009,
as compared to a net loss of $4.0 million in the same quarter in 2008. Basic and diluted net
loss per share was $0.10 for the three months ended September 30, 2009, as compared to basic
and diluted net loss of $0.09 for the same quarter in 2008. The increase in net loss and net
loss per share in the third quarter of 2009 was the result of higher research and development
expense, lower revenue from collaborative license and development agreements and a decrease in
net interest income, offset in part by a reduction in general and administrative expense. We
expect to incur losses for the foreseeable future as we intend to continue to support the
development of our antiviral programs.
Revenue. Revenue decreased to $0.3 million for the three months ended September 30, 2009 from
$0.8 million in the same quarter in 2008. This decrease of $0.5 million, or 63%, was the result
of certain upfront license fees received by the Company in 2007 and 2008 being fully amortized
to revenue as of the end of 2008 and to a lesser extent, lower periodic research-associated
support fees received by the Company.
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Research and Development Expense. Research and development expense increased to $3.9 million during
the three months ended September 30, 2009 from $3.5 million in the same quarter in 2008. The
following table summarizes the components of our research and development expense for the three
months ended September 30, 2009 and 2008.
September 30, | ||||||||
2009 | 2008 | |||||||
(In millions) | ||||||||
Direct clinical, preclinical and manufacturing-related expenses |
$ | 2.0 | $ | 1.5 | ||||
Salaries, benefits and share-based compensation expense |
1.0 | 0.9 | ||||||
License fees, patent-related legal fees and other expense |
0.4 | 0.5 | ||||||
Depreciation and facility related expenses |
0.5 | 0.6 | ||||||
Total research and development expense |
$ | 3.9 | $ | 3.5 | ||||
Direct clinical, preclinical and manufacturing costs increased due to a $0.7 million increase in
expenses for our HCV program for preclinical studies and material, offset by $0.2 million decrease
in other program costs. Salaries, benefits and share-based compensation expense increased slightly
due to increase in personnel and benefit costs. License fees, patent-related legal fees and other
expenses decreased slightly due to reduced spending. Depreciation and facility related expenses
decreased slightly due to a reduction in our facility costs as a result of partially subleasing our
facility in 2008.
General and Administrative Expense. General and administrative expense decreased to $0.8 million
for the three months ended September 30, 2009 from $1.5 million in the same quarter in 2008. The
following table summarizes the components of our general and administrative expense for the three
months ended September 30, 2009 and 2008.
September 30, | ||||||||
2009 | 2008 | |||||||
(In millions) | ||||||||
Salaries, benefits and share-based compensation expense |
$ | 0.4 | $ | 0.6 | ||||
Professional and legal fees |
0.2 | 0.2 | ||||||
Other expenses |
0.2 | 0.3 | ||||||
Depreciation and facility related expenses |
| 0.4 | ||||||
Total general and administrative expense |
$ | 0.8 | $ | 1.5 | ||||
Salaries, benefits and share-based compensation expense decreased primarily due to a decrease in
share-based compensation expense. Other expenses decreased slightly due to lower insurance
premiums and a decrease in various other expenses. Depreciation and facility related expenses
decreased primarily due to a $0.3 million loss on rent accrual in 2008 and a reduction in our
facility costs as a result of partially subleasing our facility in 2008.
Nine Months Ended September 30, 2009 and 2008
Summary. We reported a net loss of $12.9 million for the nine months ended September 30, 2009,
as compared to a net loss of $9.6 million for the same period in 2008. Basic and diluted net
loss per share was $0.30 for the nine months ended September 30, 2009, as compared to basic and
diluted net loss of $0.22 per share for the same period in 2008. The increase in net loss and
net loss per share for the nine months ended September 30, 2009, as compared to the same period
of 2008, was the result of an increase in research and development expense, a decrease in
revenue from collaborative license and development agreements and lower net interest income,
offset in part by a reduction in general and administrative expense. We expect to incur losses
for the foreseeable future as we intend to continue to support the development of our antiviral
programs.
Revenue. Revenue decreased to $0.9 million for the nine months ended September 30, 2009 from
$2.4 million for the same period in 2008. This decrease of $1.5 million, or 63%, was the result
of certain upfront license fees received by the Company in 2007 and 2008 being fully amortized
to revenue as of the end of 2008 and to a lesser extent, lower periodic research-associated
support fees received by the Company.
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Research and Development Expense. Research and development expense increased to $11.1 million
during the nine months ended September 30, 2009, from $9.0 million for the same period in 2008.
The following table summarizes the components of our research and development expense for the nine
months ended September 30, 2009 and 2008.
September 30, | ||||||||
2009 | 2008 | |||||||
(In millions) | ||||||||
Direct clinical, preclinical and manufacturing-related expenses |
$ | 5.0 | $ | 2.4 | ||||
Salaries, benefits and share-based compensation expense |
3.0 | 3.1 | ||||||
License fees, patent-related legal fees and other expenses |
1.7 | 1.8 | ||||||
Depreciation and facility related expenses |
1.4 | 1.7 | ||||||
Total research and development expense |
$ | 11.1 | $ | 9.0 | ||||
Direct clinical, preclinical and manufacturing costs increased due to a $1.1 million increase in
expenses for our HCV program for preclinical studies and material, a $0.6 million increase in
expenses related to our Phase I and Phase II trials for FV-100, and a $1.4 million reduction in
expense resulting from a favorable settlement of a prior arbitration
award against us in the second quarter of 2008, offset in part by $0.5 million reduction in
expenses for other programs. Salaries, benefits, and share-based compensation decreased primarily
due to lower share-based compensation expenses and lower recruiting and relocation fees. License
fees, patent-related legal fees and other expenses decreased slightly due to reduced spending.
Depreciation and facility related expenses decreased primarily due to a reduction in our facility
costs as a result of partially subleasing our facility in 2008.
General and Administrative Expense. General and administrative expense decreased to $2.8 million
during the nine months ended September 30, 2009, from $4.1 million for the same period in 2008.
The following table summarizes the components of our general and administrative expense for the
nine months ended September 30, 2009 and 2008.
September 30, | ||||||||
2009 | 2008 | |||||||
(In millions) | ||||||||
Salaries, benefits and share-based compensation expense |
$ | 1.2 | $ | 1.8 | ||||
Professional and legal fees |
0.8 | 0.9 | ||||||
Other expenses |
0.7 | 0.9 | ||||||
Depreciation and facility-related expenses |
0.1 | 0.5 | ||||||
Total general and administrative expense |
$ | 2.8 | $ | 4.1 | ||||
Salaries, benefits and share-based compensation expense decreased primarily due to a decrease in
share-based compensation expense. Professional and legal fees decreased due to lower legal
expenses. Other expenses decreased slightly due to lower insurance premiums and a decrease in
various other expenses. Depreciation and facility related expenses decreased primarily due to a
$0.3 million loss on rent accrual in 2008 and a reduction in our facility costs as a result of
partially subleasing our facility in 2008.
Liquidity and Capital Resources
For the nine months ended September 30, 2009, cash, cash equivalents and short-term investments
decreased by $12.0 million, from $33.1 million to $21.1 million. This decrease was primarily the
result of net cash used for operating activities and to a lesser extent, the repayment of capital
lease obligations and notes payable.
Net cash used for operating activities was $11.7 million for the nine months ended September 30,
2009, reflecting our net loss for the period of $12.9 million, which was offset by a net increase
in operating liabilities over operating assets of $0.2 million and non-cash charges of $1.0
million. Our net loss resulted largely from the cost of funding our clinical trials, preclinical
studies, other research and development activities, and general and administrative expenses, offset
in part by the amortization of deferred revenue from our license and collaboration agreements and
net interest income. The net increase in operating liabilities over operating assets reflects a
$0.6 million increase in accrued expenses and a $0.1 million increase in accounts payable, offset
by a $0.4 million increase in prepaid expenses and other assets and a $0.1 million decrease in
deferred revenue.
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Net cash provided from investing activities during the nine months ended September 30, 2009 was
$8.7 million, which consisted of net proceeds from our short-term investments.
Net cash used in financing activities during the nine months ended September 30, 2009 was $0.3
million, which consisted of scheduled capital leases and notes payable.
At September 30, 2009, our cash, cash equivalents, and short-term investments totaled $21.1 million
and our investments had a planned average maturity of less than 12 months. Our cash, cash
equivalents and short-term investments are generally held in a variety of interest-bearing
instruments, generally consisting of U.S. agency securities, U.S. Treasury securities, commercial
paper issued under government liquidity programs, and money market accounts.
Our future funding requirements are difficult to determine and will depend on a number of factors,
including:
| our development plans for our product candidates, including any changes in our strategy; | |
| the variability, timing and costs associated with conducting clinical trials, the rate of enrollment in such clinical trials and the results of these clinical trials; | |
| the variability, timing and costs associated with conducting preclinical studies; | |
| the cost of manufacturing preclinical and clinical trial materials for our product candidates; | |
| the cost to obtain and the timing of regulatory approvals required to advance the development of our product candidates; | |
| the terms and timing of any collaborative, licensing and other arrangements that we may establish; | |
| future payments we may receive or make under existing or future license or collaboration agreements, if any; | |
| the cost to maintain a corporate infrastructure to support being a publicly-traded company; and | |
| the cost of filing, prosecuting, and enforcing patent and other intellectual property claims. |
Based on our current strategy and operating plan, and considering the potential costs associated
with advancing the development of FV-100 and INX-189 on our planned timelines, we believe that our
existing cash, cash equivalents and short-term investments of $21.1 million as of September 30,
2009, including planned future proceeds from our existing licensing and collaboration agreements
and our completed private placement in October 2009 that raised $23 million in gross proceeds, will
enable us to operate for a period of 24 months from date of this filing. Our estimate assumes that
we complete the FV-100 Phase II around the middle of next year as planned, and file an IND for
INX-189 and initiate clinical trials, for our lead HCV nucleotide polymerase inhibitor, in the
first half of 2010. This estimate does not include any costs for the further development of any
other additional programs, any significant strategic or financing transaction, or a change in our
strategy or operating plans.
We currently do not have any commitments for future funding, nor do we anticipate that we will
generate significant revenue from the sale of any products in the foreseeable future. Therefore, in
order to meet our anticipated liquidity needs beyond 24 months, or possibly sooner in the event our
existing cash, cash equivalents and investments are not sufficient to fund our operations for a
period of 24 months because, among other reasons, we enter into other transactions or change our
strategy or operating plans, we will need to secure additional funding. Such funding could be
raised through the sale of additional common stock or other equity securities, as well as through
proceeds from licensing agreements, strategic collaborations, forms of debt financing, or any other
financing vehicle. Funds from these sources may not be available to us on acceptable terms in the
future, if at all, and our failure to raise such funds could have a material adverse impact on our
future business strategy, plans, financial condition and results of operations. If adequate funds
are not available to us in the future, we may be required to delay, reduce the scope of, or
eliminate one or more of our research and development programs or delay or curtail our preclinical
studies and clinical trials. If additional capital is not available to us, we may need to obtain
funds through license agreements or collaborative or partner arrangements pursuant to which we will
likely relinquish rights to certain product candidates that we might otherwise choose to develop or
commercialize independently, or be forced to enter into such arrangements earlier than we would
prefer, which would likely result in less favorable transaction terms, and there is no assurance
that any license agreements or collaborative or partner arrangements will be available to us at
all. Additional equity financings may be dilutive to holders of our common stock, and debt
financing, if available, may involve significant payment obligations and restrictive covenants that
restrict how we operate our business. Further, failure to obtain adequate capital on a timely basis
may result in our independent registered public accountant issuing a going concern qualification in
the future.
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ITEM 4T. | CONTROLS AND PROCEDURES |
Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in the reports that we file or submit pursuant to the Securities Exchange
Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods
specified in the Securities and Exchange Commissions rules and forms and that such information is
accumulated and communicated to our management, including our Chief Executive Officer and Chief
Financial Officer, who is currently the same individual, to allow timely decisions regarding
required disclosure. Our management, under the supervision of the Chief Executive Officer/Chief
Financial Officer, carried out an evaluation of the effectiveness of the design and operation of
our disclosure controls and procedures as of the end of the period covered by this report. Based on
the evaluation of these disclosure controls and procedures, the Chief Executive Officer/Chief
Financial Officer concluded that our disclosure controls and procedures were effective. It should
be noted that any system of controls, however well designed and operated, can provide only
reasonable, and not absolute, assurance that the objectives of the system are met. In addition, the
design of any control system is based in part upon certain assumptions about the likelihood of
future events. Because of these and other inherent limitations of control systems, there can be no
assurance that any design will succeed in achieving its stated goals under all potential future
conditions, regardless of how remote.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting during the quarter ended
September 30, 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
OTHER INFORMATION
ITEM 1A. | RISK FACTORS |
You should carefully consider the following discussion of risks, together with the other
information contained in this Form 10-Q. The occurrence of any of the following risks could
materially harm our business, our ability to continue to operate our business, our financial
condition, or our ability to raise additional capital in the future, or ever become profitable. In
that event, the market price of our common stock could decline and you could lose part or all of
your investment. The Risk Factors included in the Companys Annual Report on Form 10-K for the year
ended December 31, 2008 and the Companys Quarterly Reports on Form 10-Q for the periods ended
March 31, 2009 and June 30, 2009 have not materially changed, except as set forth below.
Risks Relating to our Development of our Product Candidates
All of our product candidates are in the early stages of development and their commercial viability
remains subject to future preclinical studies, clinical trials, regulatory approvals and the risks
generally inherent in these activities. If we are unable to successfully advance or develop our
product candidates, our business will be materially harmed.
In the near-term, failure to successfully advance the development of one or more of our product
candidates may have a material adverse effect on us. To date, we have not successfully developed
or commercially marketed, distributed or sold any product candidates. The success of our business
depends primarily upon our ability to successfully advance the development of our product
candidates through preclinical and clinical studies, have these candidates approved for sale by the
U.S. Food and drug Administration, or FDA, or regulatory authorities in other countries, and
ultimately, have our product candidates successfully commercialized by us or a strategic
collaborator. In May 2009, we initiated a Phase II trial for FV-100 and anticipate completing this
trial around the middle of 2010. Further, we currently plan on filing an investigational new drug
application, or IND, for INX-189 in the first half of 2010 and initiate clinical trials. We cannot
assure you that the results of ongoing preclinical studies or clinical trials and will support or
justify the continued development of one or both of these product candidates.
Our product candidates must satisfy rigorous regulatory standards of safety and efficacy before
they can be approved for sale. To satisfy these standards, we must engage in expensive and lengthy
testing, preclinical studies and clinical trials, and obtain regulatory approval of our product
candidates. Despite our efforts, our product candidates may not:
| offer therapeutic or other benefits over existing comparable drugs or other drug candidates in development; | |
| be proven to be safe and effective in clinical trials; | |
| have the desired effects (or may include undesirable or unexpected effects); | |
| meet applicable regulatory standards; | |
| be capable of being produced in commercial quantities at acceptable costs; or | |
| be successfully commercialized by us or by collaborators. |
Even if we achieve success in preclinical studies and early-stage clinical trials, there can be no
assurance that later- stage clinical trials will be successful and continue to support the
development of our product candidates. A number of companies in the pharmaceutical and
biopharmaceutical industries have experienced significant setbacks and
failure in all stages of development, including late-stage clinical trials, even after achieving
promising results in preclinical testing or early-stage clinical trials. Accordingly, results from
completed preclinical studies and early-stage clinical trials of our product candidates may not be
predictive of the results we may obtain in later-stage trials.
Our product candidates will require significant additional research and development efforts, the
commitment of substantial financial resources, and regulatory approvals prior to advancing into
further clinical development or being commercialized by us or collaborators. We cannot be certain
that any of our product candidates will successfully progress through the drug development process
or will result in clinically or commercially viable products. We do not expect any of our product
candidates to be commercialized by us or collaborators for at least several years. If we are unable
to successfully develop our product candidates, our business will be materially harmed.
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In order to develop our product candidates and support our operations beyond the next 24 months
from the date of this filing, we expect that we will need to raise additional capital. Such capital
may not be available to us on acceptable terms, if at all, which could materially harm our business
and business prospects, and the price of our common stock could suffer a decline in value.
We anticipate that our existing cash and cash equivalents and short-term investments from the
date of this filing, together with proceeds we expect to receive from our existing license and
collaboration agreement and the recent completed private placement in October 2009 will enable us
to operate for a period of at least 24 months. We have no other committed sources of additional
capital at this time. We cannot assure you that funds will be available to us in the future on
acceptable terms, if at all. If adequate funds are not available to us at all or, on terms that we
find acceptable we may be required to delay, reduce the scope of, or eliminate research and
development efforts or clinical trials on any or all of our product candidates. We may also be
forced to curtail, restructure, sell, or merge our operations, or obtain funds by entering into
arrangements with licensees, collaborators or partners on unattractive terms, or sell or relinquish
rights to certain technologies, product candidates or our intellectual property that we would not
otherwise sell or relinquish in order to continue operations or the development of our product
candidates, assuming any such arrangements are available at all.
The timing and extent of our future financing needs will depend on many factors, some of which are
very difficult to predict and others that are beyond our control, including:
| our development plans for our product candidates, including any changes in our strategy; | |
| the variability, timing and costs associated with conducting clinical trials, the rate of enrollment in such clinical trials and the results of these clinical trials; | |
| the variability, timing and costs associated with conducting preclinical studies; | |
| the cost of manufacturing preclinical and clinical trial materials for our product candidates; | |
| the cost to obtain and the timing of regulatory approvals required to advance the development of our product candidates; | |
| the terms and timing of any collaborative, licensing and other arrangements that we may establish; | |
| future payments we may receive or make under existing or future license or collaboration agreements, if any; | |
| the cost to maintain a corporate infrastructure to support being a publicly-traded company; and | |
| the cost of filing, prosecuting, and enforcing patent and other intellectual property claims. |
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ITEM 6. | EXHIBITS |
The following is a list of exhibits filed as part of this Report:
Exhibit No. | Description | |||
10.55 | Second Amendment to Loan Agreement, dated August 3, 2009, by and between the Development
Authority of Fulton County and Inhibitex, Inc. |
|||
31.1 | Section 302 Certification of the Chief Executive Officer and Chief Financial Officer
Required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as
Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|||
32.1 | Section 906 Certifications of the Chief Executive Officer and the Chief Financial Officer |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Date: November 13, 2009
|
INHIBITEX, INC | |
/s/ Russell H. Plumb | ||
Russell H. Plumb | ||
President, Chief Executive Officer, | ||
Chief Financial Officer and Chief Accounting Officer |
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EXHIBIT INDEX
Exhibit No. | Description | |||
10.55 | Second Amendment to Loan Agreement, dated August 3, 2009, by and between the Development
Authority of Fulton County and Inhibitex, Inc. |
|||
31.1 | Section 302 Certification of the Chief Executive Officer and Chief Financial Officer as
Required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as
Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|||
32.1 | Section 906 Certifications of the Chief Executive Officer and the Chief Financial Officer |
22