þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 |
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware | 74-2708737 | |
(State or other jurisdiction of | (I.R.S. Employer Identification No.) | |
incorporation or organization) | ||
9005 Westside Parkway | ||
Alpharetta, Georgia | 30009 | |
(Address of principal executive | (Zip Code) | |
offices) |
Large Accelerated Filer o | Accelerated Filer þ | Non-Accelerated Filer o | Smaller Reporting Company o | |||
(Do not check if a smaller reporting company) |
2
June 30, 2011 | December 31, 2010 | |||||||
(Unaudited) | ||||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 16,713,120 | $ | 8,554,151 | ||||
Short-term investments |
33,946,530 | 11,014,747 | ||||||
Prepaid expenses and other current assets |
1,016,097 | 599,042 | ||||||
Accounts receivable |
74,592 | 178,654 | ||||||
Total current assets |
51,750,339 | 20,346,594 | ||||||
Property and equipment, net |
828,680 | 1,090,029 | ||||||
Long-term investments |
7,297,127 | | ||||||
Other assets |
54,053 | 52,514 | ||||||
Total assets |
$ | 59,930,199 | $ | 21,489,137 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 2,305,001 | $ | 2,768,020 | ||||
Accrued expenses |
1,987,345 | 2,917,347 | ||||||
Current portion of notes payable |
243,056 | 243,056 | ||||||
Capital lease obligations |
68,313 | 180,792 | ||||||
Deferred revenue |
54,167 | 129,167 | ||||||
Other current liabilities |
304,663 | 238,703 | ||||||
Total current liabilities |
4,962,545 | 6,477,085 | ||||||
Long-term liabilities: |
||||||||
Notes payable, net of current portion |
182,291 | 303,819 | ||||||
Other liabilities, net of current portion |
743,655 | 867,455 | ||||||
Total long-term liabilities |
925,946 | 1,171,274 | ||||||
Total liabilities |
5,888,491 | 7,648,359 | ||||||
Stockholders equity: |
||||||||
Preferred stock, $.001 par value; 5,000,000 shares authorized at June
30, 2011 and December 31, 2010, none issued and outstanding |
| | ||||||
Common stock, $.001 par value; 150,000,000 shares authorized at June
30, 2011 and December 31, 2010, respectively; 77,889,178 and
62,423,358 shares issued and outstanding at June 30, 2011 and December
31, 2010 respectively |
77,889 | 62,423 | ||||||
Additional paid-in capital |
325,856,561 | 270,187,742 | ||||||
Accumulated other comprehensive income |
375 | 542 | ||||||
Warrants |
8,392,001 | 11,145,558 | ||||||
Accumulated deficit |
(280,285,118 | ) | (267,555,487 | ) | ||||
Total stockholders equity |
54,041,708 | 13,840,778 | ||||||
Total liabilities and stockholders equity |
$ | 59,930,199 | $ | 21,489,137 | ||||
3
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Revenue: |
||||||||||||||||
License fees and milestones |
$ | 37,500 | $ | 37,500 | $ | 75,000 | $ | 786,667 | ||||||||
Collaborative research and development |
250,000 | 250,000 | 500,000 | 500,000 | ||||||||||||
Total revenue |
287,500 | 287,500 | 575,000 | 1,286,667 | ||||||||||||
Operating expense: |
||||||||||||||||
Research and development |
4,599,325 | 4,915,899 | 11,172,135 | 9,705,514 | ||||||||||||
General and administrative |
965,132 | 958,834 | 2,162,315 | 1,982,875 | ||||||||||||
Total operating expense |
5,564,457 | 5,874,733 | 13,334,450 | 11,688,389 | ||||||||||||
Loss from operations |
(5,276,957 | ) | (5,587,233 | ) | (12,759,450 | ) | (10,401,722 | ) | ||||||||
Other income (loss), net |
(36 | ) | 12,194 | 8,602 | 15,714 | |||||||||||
Interest income, net |
18,022 | 16,249 | 21,217 | 34,065 | ||||||||||||
Net loss |
$ | (5,258,971 | ) | $ | (5,558,790 | ) | $ | (12,729,631 | ) | $ | (10,351,943 | ) | ||||
Basic and diluted net loss per share |
$ | (0.07 | ) | $ | (0.09 | ) | $ | (0.19 | ) | $ | (0.17 | ) | ||||
Weighted average shares used to compute basic
and diluted net loss per share |
75,071,418 | 61,835,222 | 68,789,220 | 61,698,884 | ||||||||||||
4
Six Months Ended | ||||||||
June 30, | ||||||||
2011 | 2010 | |||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (12,729,631 | ) | $ | (10,351,943 | ) | ||
Adjustments to reconcile net loss to net cash used in
operating activities: |
||||||||
Depreciation and amortization |
322,920 | 323,839 | ||||||
Share-based compensation |
728,365 | 276,354 | ||||||
Amortization of investment premium or discount |
135,908 | 305,325 | ||||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses and other assets |
(418,594 | ) | 157,077 | |||||
Accounts receivable |
104,062 | (6,795 | ) | |||||
Accounts payable and other liabilities |
(520,859 | ) | 629,575 | |||||
Accrued expenses |
(930,002 | ) | (119,122 | ) | ||||
Deferred revenue |
(75,000 | ) | 175,000 | |||||
Net cash used in operating activities |
(13,382,831 | ) | (8,610,690 | ) | ||||
Cash flows from investing activities: |
||||||||
Purchases of property and equipment |
(61,571 | ) | (42,848 | ) | ||||
Purchases of investments |
(41,364,985 | ) | (11,586,670 | ) | ||||
Proceeds from maturities of investments |
11,000,000 | 15,506,000 | ||||||
Net cash provided by (used in) investing activities |
(30,426,556 | ) | 3,876,482 | |||||
Cash flows from financing activities: |
||||||||
Payments on promissory notes and capital leases |
(234,007 | ) | (178,820 | ) | ||||
Proceeds from the exercise of stock options and warrants |
1,615,336 | 530,147 | ||||||
Proceeds from the issuance of common stock |
50,807,000 | | ||||||
Public offering expenses |
(219,973 | ) | | |||||
Net cash provided by financing activities |
51,968,356 | 351,327 | ||||||
Increase (decrease) in cash and cash equivalents |
8,158,969 | (4,382,881 | ) | |||||
Cash and cash equivalents at beginning of period |
8,554,151 | 11,290,332 | ||||||
Cash and cash equivalents at end of period |
$ | 16,713,120 | $ | 6,907,451 | ||||
Supplemental cash flow information: |
||||||||
Interest paid |
$ | 10,206 | $ | 21,235 | ||||
Non-cash financing activities: |
||||||||
Issuance of common stock from cashless warrant exercise |
$ | 90,431 | $ | |
5
6
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Net loss |
$ | (5,258,971 | ) | $ | (5,558,790 | ) | $ | (12,729,631 | ) | $ | (10,351,943 | ) | ||||
Weighted average common shares outstanding used to |
||||||||||||||||
compute basic earnings per share |
75,071,418 | 61,835,222 | 68,789,220 | 61,698,884 | ||||||||||||
Dilutive effect of: |
||||||||||||||||
Stock options |
| | | | ||||||||||||
Warrants |
| | | | ||||||||||||
Shares used to compute diluted earnings per share |
75,071,418 | 61,835,222 | 68,789,220 | 61,698,884 | ||||||||||||
Basic net loss per share |
$ | (0.07 | ) | $ | (0.09 | ) | $ | (0.19 | ) | $ | (0.17 | ) | ||||
Diluted loss per share |
$ | (0.07 | ) | $ | (0.09 | ) | $ | (0.19 | ) | $ | (0.17 | ) | ||||
Number of antidilutive stock options excluded from
computation |
6,325,299 | 5,660,098 | 6,325,299 | 5,660,098 | ||||||||||||
Number of antidilutive warrants excluded from
computation |
10,732,147 | 13,460,107 | 10,732,147 | 13,460,107 | ||||||||||||
7
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Net loss |
$ | (5,258,971 | ) | $ | (5,558,790 | ) | $ | (12,729,631 | ) | $ | (10,351,943 | ) | ||||
Change in net
unrealized gains
(losses) on
investments |
(706 | ) | 3,807 | (167 | ) | (10,660 | ) | |||||||||
Comprehensive loss |
$ | (5,259,677 | ) | $ | (5,554,983 | ) | $ | (12,729,798 | ) | $ | (10,362,603 | ) | ||||
Quoted prices in | ||||||||||||||||
active markets for | Significant other | Significant | ||||||||||||||
identical assets | observable inputs | unobservable inputs | ||||||||||||||
June 30, 2011 | Total | (Level 1) | (Level 2) | (Level 3) | ||||||||||||
Cash equivalents |
$ | 15,041,759 | $ | 15,041,759 | $ | | $ | | ||||||||
Short-term investments available-for-sale |
33,946,530 | | 33,946,530 | | ||||||||||||
Long-term investments available-for-sale |
7,297,127 | | 7,297,127 | | ||||||||||||
Total |
$ | 56,285,416 | $ | 15,041,759 | $ | 41,243,657 | $ | | ||||||||
Unrealized | Unrealized | |||||||||||||||
June 30, 2011 | At Cost | Gains | (Losses) | At Fair Value | ||||||||||||
Short-term |
||||||||||||||||
Money market funds |
$ | 15,041,759 | $ | | $ | | $ | 15,041,759 | ||||||||
Commercial paper |
7,488,864 | 10,181 | | 7,499,045 | ||||||||||||
Corporate debt |
26,454,326 | 5,817 | (12,658 | ) | 26,447,485 | |||||||||||
Long-term |
||||||||||||||||
Debt securities of U.S. government agencies |
7,300,092 | | (2,965 | ) | 7,297,127 | |||||||||||
Total |
$ | 56,285,041 | $ | 15,998 | $ | (15,623 | ) | $ | 56,285,416 | |||||||
8
Unrealized | Unrealized | |||||||||||||||
December 31, 2010 | At Cost | Gains | (Losses) | At Fair Value | ||||||||||||
Short-term |
||||||||||||||||
Money market funds |
$ | 7,932,606 | $ | | $ | | $ | 7,932,606 | ||||||||
Commercial paper |
6,494,842 | 2,713 | | 6,497,555 | ||||||||||||
Corporate debt |
4,519,363 | 221 | (2,392 | ) | 4,517,192 | |||||||||||
Total |
$ | 18,946,811 | $ | 2,934 | $ | (2,392 | ) | $ | 18,947,353 | |||||||
9
ITEM 2. | MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
| timing of initiation of a Phase 2 clinical trial for INX-189 in HCV-infected genotype 2 and 3 treatment naïve patients; | |
| the plan and timing to evaluate the safety, tolerability and viral kinetics of doses greater than 100mg of INX-189 administered as monotherapy; | |
| the plan and clinical strategy to advance the development of FV-100; | |
| the timing of filing a protocol for a Phase 2b clinical trial of FV-100 and other related submissions to the FDA and obtain feedback; | |
| the planned trial design and endpoints of the proposed Phase 2b clinical trial of FV-100 and whether such a study will be initiated; | |
| 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; | |
| our potential future revenue from collaborative research agreements, partnerships, license agreements, product related revenue or materials transfer agreements; | |
| the potential of our product candidates to address a number of current therapeutic limitations, such as inadequate potency, significant adverse side effects, complex and inconvenient dosing schedules and diminishing efficacy due to the emergence of drug-resistant viruses; and | |
| anticipated future net losses from operations. |
10
| INX-189 25mg QD with pegylated interferon and ribavirin for 12 weeks and up to 24 weeks (n=25) | ||
| INX-189 50 mg QD with pegylated interferon and ribavirin for 12 weeks and up to 24 weeks (n=25) | ||
| INX-189 100 mg QD with pegylated interferon and ribavirin for 12 weeks and up to 24 weeks (n=25) | ||
| Placebo with pegylated interferon and ribavirin for 24 weeks (n=15) |
11
| Antiviral Activity and Safety of INX-08189, a Nucleotide Polymerase Inhibitor, Following 7-Days of Oral Therapy in Naïve Genotype-1 Chronic HCV Patients | ||
| Preclinical Characterization of a Series of Highly Potent Phophorodiamidate Nucleotide Analogue Inhibitors of Hepatitis C Polymerase. |
Critical Accounting Policies |
| Use of Estimates |
| Revenue Recognition |
| Accrued Expenses |
| Share-Based Compensation |
12
13
June 30, | ||||||||
2011 | 2010 | |||||||
(In millions) | ||||||||
Direct clinical, preclinical and manufacturing expense |
$ | 2.4 | $ | 3.0 | ||||
Salaries, benefits and share-based compensation expense |
1.2 | 1.0 | ||||||
License fees, patent-related legal and other expense |
0.6 | 0.5 | ||||||
Depreciation and facility related expense |
0.4 | 0.4 | ||||||
Total research and development expense |
$ | 4.6 | $ | 4.9 | ||||
June 30, | ||||||||
2011 | 2010 | |||||||
(In millions) | ||||||||
Salaries, benefits and share-based compensation expense |
$ | 0.4 | $ | 0.4 | ||||
Professional and legal expense |
0.2 | 0.3 | ||||||
Other expense |
0.4 | 0.3 | ||||||
Total general and administrative expense |
$ | 1.0 | $ | 1.0 | ||||
June 30, | ||||||||
2011 | 2010 | |||||||
(In millions) | ||||||||
Direct clinical, preclinical and manufacturing expense |
$ | 6.7 | $ | 5.6 | ||||
Salaries, benefits and share-based compensation expense |
2.4 | 2.0 | ||||||
License fees, patent-related legal and other expense |
1.2 | 1.2 | ||||||
Depreciation and facility related expense |
0.9 | 0.9 | ||||||
Total research and development expense |
$ | 11.2 | $ | 9.7 | ||||
14
June 30, | ||||||||
2011 | 2010 | |||||||
(In millions) | ||||||||
Salaries, benefits and share-based compensation expense |
$ | 1.0 | $ | 0.8 | ||||
Professional and legal expense |
0.6 | 0.6 | ||||||
Other expense |
0.6 | 0.6 | ||||||
Total general and administrative expense |
$ | 2.2 | $ | 2.0 | ||||
| our development timelines and plans for our INX-189, FV-100 and any of 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, and the results of these studies; | |
| the cost of formulating and manufacturing preclinical and clinical trial materials to evaluate our product candidates; |
15
| whether we receive regulatory approval to advance the clinical development of our product candidates in a timely manner, if at all; | |
| the cost and time to obtain regulatory approvals required to advance the development of our product candidates; | |
| the scope and size of our research and development efforts; | |
| the terms and timing of any collaborative, licensing and other arrangements that we may establish in the future; | |
| 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. |
16
ITEM 4. | CONTROLS AND PROCEDURES |
17
ITEM 1A. | RISK FACTORS |
| our development timelines and plans for INX-189, FV-100 and any of 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, and the results of these studies; | |
| the cost of formulating and manufacturing preclinical and clinical trial materials to evaluate our product candidates; | |
| whether we receive regulatory approval to advance the clinical development of our product candidates in a timely manner, if at all; | |
| the cost and time to obtain regulatory approvals required to advance the development of our product candidates; | |
| the scope and size of our research and development efforts; | |
| the terms and timing of any collaborative, licensing and other arrangements that we may establish in the future; | |
| 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. |
18
ITEM 6. | EXHIBITS |
Exhibit No. | Description | |
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 | |
101.INS*
|
XBRL Instance Document | |
101.SCH*
|
XBRL Taxonomy Extension Schema Document | |
101.CAL*
|
XBRL Taxonomy Extension Calculation Linkbase Document | |
101.LAB*
|
XBRL Taxonomy Extension Labels Linkbase Document | |
101.PRE*
|
XBRL Taxonomy Extension Presentation Linkbase Document |
* | Pursuant to Rule 406T of Regulation S-T, these interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, are deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934 and otherwise are not subject to liability under those sections. |
19
Date: August 9, 2011
|
INHIBITEX, INC | |||
/s/ Russell H. Plumb
|
||||
Russell H. Plumb | ||||
President, Chief Executive Officer, | ||||
Chief Financial Officer and Chief Accounting Officer |
20
Exhibit No. | Description | |
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 | |
101.INS*
|
XBRL Instance Document | |
101.SCH*
|
XBRL Taxonomy Extension Schema Document | |
101.CAL*
|
XBRL Taxonomy Extension Calculation Linkbase Document | |
101.LAB*
|
XBRL Taxonomy Extension Labels Linkbase Document | |
101.PRE*
|
XBRL Taxonomy Extension Presentation Linkbase Document |
* | Pursuant to Rule 406T of Regulation S-T, these interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, are deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934 and otherwise are not subject to liability under those sections. |
21
/s/ Russell H. Plumb
Chief Financial Officer and Chief Accounting Officer |
/s/ Russell H. Plumb
Chief Financial Officer, and Chief Accounting Officer |
Consolidated Balance Sheets (Unaudited) (Parenthetical) (USD $)
|
Jun. 30, 2011
|
Dec. 31, 2010
|
---|---|---|
Stockholders' equity: | Â | Â |
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 77,889,178 | 62,423,358 |
Common stock, shares outstanding | 77,889,178 | 62,423,358 |
Consolidated Statements of Operations (Unaudited) (USD $)
|
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2011
|
Jun. 30, 2010
|
Jun. 30, 2011
|
Jun. 30, 2010
|
|
Revenue: | Â | Â | Â | Â |
License fees and milestones | $ 37,500 | $ 37,500 | $ 75,000 | $ 786,667 |
Collaborative research and development | 250,000 | 250,000 | 500,000 | 500,000 |
Total revenue | 287,500 | 287,500 | 575,000 | 1,286,667 |
Operating expense: | Â | Â | Â | Â |
Research and development | 4,599,325 | 4,915,899 | 11,172,135 | 9,705,514 |
General and administrative | 965,132 | 958,834 | 2,162,315 | 1,982,875 |
Total operating expense | 5,564,457 | 5,874,733 | 13,334,450 | 11,688,389 |
Loss from operations | (5,276,957) | (5,587,233) | (12,759,450) | (10,401,722) |
Other income (loss), net | (36) | 12,194 | 8,602 | 15,714 |
Interest income, net | 18,022 | 16,249 | 21,217 | 34,065 |
Net loss | $ (5,258,971) | $ (5,558,790) | $ (12,729,631) | $ (10,351,943) |
Basic and diluted net loss per share | $ (0.07) | $ (0.09) | $ (0.19) | $ (0.17) |
Weighted average shares used to compute basic and diluted net loss per share | 75,071,418 | 61,835,222 | 68,789,220 | 61,698,884 |
Document and Entity Information (USD $)
|
6 Months Ended | ||
---|---|---|---|
Jun. 30, 2011
|
Aug. 04, 2011
|
Jun. 30, 2010
|
|
Document and Entity Information [Abstract] | Â | Â | Â |
Entity Registrant Name | INHIBITEX, INC. | Â | Â |
Entity Central Index Key | 0001274913 | Â | Â |
Document Type | 10-Q | Â | Â |
Document Period End Date | Jun. 30, 2011 | ||
Amendment Flag | false | Â | Â |
Document Fiscal Year Focus | 2011 | Â | Â |
Document Fiscal Period Focus | Q2 | Â | Â |
Current Fiscal Year End Date | --12-31 | Â | Â |
Entity Well-known Seasoned Issuer | No | Â | Â |
Entity Voluntary Filers | No | Â | Â |
Entity Current Reporting Status | Yes | Â | Â |
Entity Filer Category | Accelerated Filer | Â | Â |
Entity Public Float | Â | Â | $ 126,536,217 |
Entity Common Stock, Shares Outstanding | Â | 78,185,452 | Â |
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Net Loss Per Share
|
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Jun. 30, 2011
|
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Net Loss Per Share [Abstract] | Â | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss Per Share |
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
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Operations
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6 Months Ended |
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Jun. 30, 2011
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Operations [Abstract] | Â |
Operations |
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 prevent and treat serious infections.
The Company is currently focused on developing oral, small molecule compounds to treat viral
infections, and in particular, chronic infections caused by hepatitis C virus (“HCV”), and herpes
zoster, also referred to as shingles, which is caused by the varicella zoster virus (“VZV”).
Currently available antiviral therapies that are used to treat these and other infections have a
number of therapeutic limitations that include inadequate potency, significant adverse side
effects, complex and inconvenient dosing schedules and diminishing efficacy due to the emergence of
drug-resistant viruses. The Company believes that its antiviral drug candidates have the potential
to address a number of these limitations, as well as unmet medical needs in their respective
intended indications. In addition to the Company’s antiviral programs it has licensed certain
intellectual property from its MSCRAMM protein platform to Pfizer for the development of active
vaccines to prevent staphylococcal infections.
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 any significant revenues from any of its existing or future product
candidates.
The Company plans to continue to finance its operations with its existing cash, cash equivalents
and investments; through future equity and/or debt financings; with proceeds from existing or
potential future collaborations or partnerships; or through other financing vehicles. The Company’s
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 in the future, or that the
Company will ever generate significant revenue and become profitable.
|
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Comprehensive Loss
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6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2011
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Comprehensive Loss [Abstract] | Â | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comprehensive Loss |
4. Comprehensive Loss
The components of comprehensive loss for the three and six months ended June 30, 2011 and 2010 are
as follows:
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Fair Value Measurements
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6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2011
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Fair Value Measurements [Abstract] | Â | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurements |
5. Fair Value Measurements
The following table sets forth the financial assets and liabilities that were measured at fair
value on a recurring basis at June 30, 2011, by level within the fair value hierarchy. The 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.
The Company’s short-term and long-term investments have been classified as Level 2, which have been
initially valued at the transaction price and subsequently revalued, at the end of each reporting
period, utilizing a third party pricing service. The pricing service utilizes industry standard
valuation models and observable market inputs to determine value that include surveying the bond
dealer community, obtaining benchmark quotes, incorporating relevant trade data, and updating
spreads daily.
There have been no transfers of assets or liabilities between the fair value measurement
classifications.
Cash equivalents consist of money market funds. Short-term investments consist of commercial paper
and corporate debt notes classified as available-for-sale and have maturities greater than 90 days,
but less than 365 days from the date of maturity. Long-term investments consist of debt securities
of U.S. government agencies with maturities over 365 days from the date of maturity.
The Company has had no realized gains or losses from the sale of investments for the three months
and six months ended June 30, 2011. The following table shows the unrealized gains and losses and
fair values for those investments as of June 30, 2011 and December 31, 2010 aggregated by major
security type:
As of June 30, 2011, the Company had investments in an unrealized loss position. The Company
has determined that the unrealized losses on these investments at June 30, 2011 are temporary in
nature and expects the securities to mature at their stated principal. The Company does not intend
to sell the investments and it is not more likely than not that the Company will be required to
sell the investments before recovery of their amortized costs bases, which may be maturity.
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Stockholders' Equity
|
6 Months Ended |
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Jun. 30, 2011
|
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Stockholders' Equity [Abstract] | Â |
Stockholders' Equity |
6. Stockholders’ Equity
Public Offering. In April 2011, the Company closed a public offering of 13,182,927 shares of its
common stock, at a purchase price of $4.10 per share, for an aggregate offering amount of
$54,050,000. The net proceeds from the sale of the shares, after underwriting discounts and
commissions and other offering expenses, was $50,587,027. The Company intends to use the net
proceeds from the offering for working capital and general corporate purposes, including a Phase 2
clinical trial for INX-189, a nucleotide polymerase inhibitor that it is developing for the
treatment of chronic hepatitis C infections, and research and development expenses related to its
other development programs.
Common Stock Warrants. For the six months ended June 30, 2011, a total of 2,135,183 warrants were
exercised with a weighted average exercise price of $0.77 and a total Black-Scholes value of
$2,749,873. As of June 30, 2011 and December 31, 2010, there were 10,732,147 and 12,868,100
warrants outstanding, respectively. As of June 30, 2011, all outstanding warrants are exercisable
and expire from September 22, 2012 to September 26, 2018. The weighted average strike price as of
June 30, 2011 and December 31, 2010 was $1.21 and $1.14, respectively.
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Summary of Significant Accounting Policies
|
6 Months Ended |
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Jun. 30, 2011
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Summary of Significant Accounting Policies [Abstract] | Â |
Summary of Significant Accounting Policies |
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 10-01 of Regulation S-X. In
the opinion of the Company’s management, all material adjustments (consisting of normal recurring
accruals) considered necessary for a fair presentation have been included. They do not include all
information and notes required by generally accepted accounting principles 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, 2010.
The Company’s significant accounting policies have not changed since December 31, 2010, except as
outlined below:
Recent Accounting Pronouncements.
In June 2011, the Financial Accounting Standards Board (“FASB”) amended the guidance for reporting
other comprehensive income. Under this amendment, the Company has the option to present the total
of comprehensive income, the components of net income, and the components of other comprehensive
income either in a single continuous statement of comprehensive income or in two separate but
consecutive statements. Additionally, the Company will be required to display reclassification
adjustments to be displayed on the face of the financial statements in which other comprehensive
income is reported or disclosed in the notes to the financial statements. This amendment should be
applied retrospectively and is effective for fiscal years, and interim periods within those years,
beginning after December 15, 2011. Early adoption is permitted. This amendment is effective for
the Company beginning January 1, 2012. The
adoption of this amendment is not expected to have a material impact on the Company’s consolidated
financial position or results of operations.
In May 2011, the FASB amended the guidance for reporting fair value measurements and disclosure
requirements. The amendments in this update change the wording used to describe the requirements
in U.S. Generally Accepted Accounting Principles (“GAAP”) for measuring fair value and for
disclosing information about fair value measurements. This amendment should be applied
prospectively and is effective during interim and annual periods beginning after December 15, 2011.
Early application is not permitted. The amendment is effective for the Company beginning January
1, 2012. The adoption of this amendment is not expected to have a material impact on the
Company’s consolidated financial position or results of operations.
In April 2010, the FASB amended the guidance for applying the milestone method of revenue
recognition to research or development arrangements. Under this guidance, the Company may recognize
revenue contingent upon the achievement of a milestone in its entirety in the period in which the
milestone is achieved, only if the milestone meets all the criteria within the guidance to be
considered substantive. This amendment was effective on a prospective basis for research and
development milestones achieved in fiscal years, and interim periods within those years, beginning
on or after June 15, 2010. Early adoption was permitted. This amendment was effective for the
Company beginning January 1, 2011. The adoption of this amendment did not have a material impact
on the Company’s consolidated financial position or results of operations.
In October 2009, the FASB amended the guidance for revenue recognition in multiple-element
arrangements. The guidance requires an entity to provide updated guidance on whether multiple
deliverables exist, how the deliverables in an arrangement should be separated, and how the
consideration should be allocated and; then 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 was effective for the Company beginning January 1, 2011. The adoption of this
amendment did not have a material impact on the Company’s consolidated financial position or
results of operations.
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