INHIBITEX, INC.
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
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| þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES AND EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2006
OR
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| o |
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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)
| |
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| Delaware
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74-2708737 |
| (State or other jurisdiction of
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(I.R.S. Employer Identification No.) |
| incorporation or organization) |
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| 9005 Westside Parkway |
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| Alpharetta, Georgia
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30004 |
| (Address of principal executive
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(Zip Code) |
| offices) |
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(678) 746-1100
(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 is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition
of accelerated filer and large accelerated filer in Rule 12b-2 of the Exchange Act. (Check one):
|
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| Large Accelerated Filer o
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Accelerated Filer þ
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Non Accelerated Filer o |
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
April 30, 2006, 30,251,800 shares of the Registrants Common Stock were outstanding.
TABLE OF CONTENTS
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PAGE |
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PART I FINANCIAL INFORMATION |
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Item 1. Financial Statements |
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Balance Sheets as of March 31, 2006 and December 31, 2005 |
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3 |
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Statements
of Operations for the Three Months Ended March 31, 2006 and 2005 and for the Period
from Inception (May 13, 1994) through March 31, 2006 |
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4 |
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Statements of Cash Flows for the Three Months Ended March 31, 2006 and 2005 and for the
Period from Inception (May 13, 1994) through March 31, 2006 |
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5 |
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Notes to Financial Statements |
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6 |
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Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations |
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11 |
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Item 3. Quantitative and Qualitative Disclosures About Market Risk |
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17 |
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Item 4. Controls and Procedures |
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17 |
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PART II OTHER INFORMATION |
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Item 1A. Risk Factors |
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19 |
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Item 6. Exhibits |
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25 |
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Signatures |
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26 |
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Exhibit Index |
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EX-31.1 SECTION 302 CERTIFICATION OF THE CEO |
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EX-31.2 SECTION 302 CERTIFICATION OF THE CFO |
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EX-32.1
SECTION 906 CERTIFICATION OF THE CEO & CFO |
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2
PART I
FINANCIAL INFORMATION
INHIBITEX, INC.
(A DEVELOPMENT STAGE COMPANY)
BALANCE SHEETS
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March 31, |
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December 31, |
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2006 |
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2005 |
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(unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
|
$ |
33,722,314 |
|
|
$ |
33,842,937 |
|
Short-term investments |
|
|
43,446,875 |
|
|
|
53,288,016 |
|
Prepaid expenses and other current assets |
|
|
1,486,252 |
|
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|
1,917,436 |
|
Accounts receivable |
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|
283,428 |
|
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|
44,923 |
|
|
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|
|
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Total current assets |
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78,938,869 |
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89,093,312 |
|
Property and equipment, net |
|
|
7,912,088 |
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|
8,175,074 |
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|
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Total assets |
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$ |
86,850,957 |
|
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$ |
97,268,386 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
2,524,706 |
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$ |
1,879,191 |
|
Accrued expenses |
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3,632,476 |
|
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|
5,316,906 |
|
Current portion of notes payable |
|
|
1,111,111 |
|
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|
1,319,445 |
|
Current portion of capital lease obligations |
|
|
857,154 |
|
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|
869,043 |
|
Current portion of deferred revenue |
|
|
191,667 |
|
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|
191,667 |
|
Other current liabilities |
|
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1,152,751 |
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1,152,702 |
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Total current liabilities |
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9,469,865 |
|
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|
10,728,954 |
|
Long-term liabilities: |
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Notes payable, net of current portion |
|
|
1,250,000 |
|
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|
1,458,333 |
|
Capital lease obligations, net of current portion |
|
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1,434,492 |
|
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|
1,646,323 |
|
Deferred revenue, net of current portion |
|
|
650,000 |
|
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|
687,500 |
|
Other liabilities, net of current portion |
|
|
1,255,890 |
|
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|
1,294,210 |
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Total long-term liabilities |
|
|
4,590,382 |
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5,086,366 |
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Total liabilities |
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14,060,247 |
|
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|
15,815,320 |
|
Stockholders equity: |
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|
Preferred stock, $.001 par value; 5,000,000
shares authorized at March 31, 2006 and
December 31, 2005; none issued and outstanding |
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Common stock, $.001 par value; 75,000,000 shares
authorized at March 31, 2006 and December 31,
2005; 30,243,262 and 30,219,715 shares issued
and outstanding at March 31, 2006 and December
31, 2005, respectively |
|
|
30,243 |
|
|
|
30,220 |
|
Warrants |
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|
11,514,793 |
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|
11,514,793 |
|
Additional paid-in capital |
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|
211,757,980 |
|
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|
212,210,931 |
|
Deferred stock compensation |
|
|
|
|
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|
(772,347 |
) |
Deficit accumulated during the development stage |
|
|
(150,512,306 |
) |
|
|
(141,530,531 |
) |
|
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|
|
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Total stockholders equity |
|
|
72,790,710 |
|
|
|
81,453,066 |
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|
|
|
|
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Total liabilities and stockholders equity |
|
$ |
86,850,957 |
|
|
$ |
97,268,386 |
|
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|
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|
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|
The accompanying notes are an integral part of these financial statements.
3
INHIBITEX, INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF OPERATIONS
(unaudited)
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Period from |
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Inception |
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(May 13, 1994) |
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Three Months Ended |
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Through |
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March 31, |
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March 31, |
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2006 |
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2005 |
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2006 |
|
Revenue: |
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License fees and milestones |
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$ |
37,500 |
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$ |
37,500 |
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$ |
1,200,000 |
|
Collaborative research and development |
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|
125,000 |
|
|
|
125,000 |
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|
3,124,455 |
|
Grants and other revenue |
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165,387 |
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114,631 |
|
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751,861 |
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Total revenue |
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327,887 |
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277,131 |
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|
5,076,316 |
|
Operating expense: |
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Research and development |
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7,426,552 |
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9,187,792 |
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117,222,136 |
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General and administrative |
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2,766,453 |
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1,474,424 |
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26,832,108 |
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Total operating expense |
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10,193,005 |
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|
10,662,216 |
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144,054,244 |
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Loss from operations |
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|
(9,865,118 |
) |
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|
(10,385,085 |
) |
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|
(138,977,928 |
) |
Other income, net |
|
|
58,460 |
|
|
|
|
|
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|
716,125 |
|
Interest income, net |
|
|
824,883 |
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|
442,397 |
|
|
|
4,131,560 |
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|
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Net loss |
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|
(8,981,775 |
) |
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|
(9,942,688 |
) |
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|
(134,130,243 |
) |
Dividends and accretion to redemption value of
redeemable preferred stock |
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(16,382,063 |
) |
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Net loss attributable to common stockholders |
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$ |
(8,981,775 |
) |
|
$ |
(9,942,688 |
) |
|
$ |
(150,512,306 |
) |
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Basic and diluted net loss per share |
|
$ |
(0.30 |
) |
|
$ |
(0.40 |
) |
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Weighted average shares used to compute basic
and diluted net loss per share |
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30,233,142 |
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25,147,579 |
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The accompanying notes are an integral part of these financial statements.
4
INHIBITEX, INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF CASH FLOWS
(unaudited)
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Period from |
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Inception |
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(May 13, 1994) |
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Three Months Ended |
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Through |
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March 31, |
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March 31, |
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2006 |
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2005 |
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2006 |
|
Cash flows from operating activities: |
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Net loss |
|
$ |
(8,981,775 |
) |
|
$ |
(9,942,688 |
) |
|
$ |
(134,130,243 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
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Depreciation and amortization |
|
|
488,235 |
|
|
|
225,514 |
|
|
|
5,391,294 |
|
Stock compensation |
|
|
333,477 |
|
|
|
124,188 |
|
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|
1,479,753 |
|
Loss on sale of equipment |
|
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|
|
|
|
|
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|
99,991 |
|
Amortization of investment premium or discount |
|
|
74,147 |
|
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|
(1,717 |
) |
|
|
638,892 |
|
Forgiveness of receivables from stockholders |
|
|
|
|
|
|
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|
28,695 |
|
Amortization of warrants and discount on debt |
|
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|
|
|
|
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|
176,477 |
|
Stock issued for interest |
|
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|
|
|
|
|
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|
126,886 |
|
Cumulative effect of change in accounting principle |
|
|
(58,460 |
) |
|
|
|
|
|
|
41,040 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid expenses and other assets |
|
|
431,184 |
|
|
|
69,908 |
|
|
|
(1,486,252 |
) |
Accounts receivable |
|
|
(238,505 |
) |
|
|
(219,577 |
) |
|
|
(283,428 |
) |
Accounts payable and other liabilities |
|
|
607,244 |
|
|
|
1,346,834 |
|
|
|
4,933,347 |
|
Accrued expenses |
|
|
(1,684,430 |
) |
|
|
917,813 |
|
|
|
3,632,476 |
|
Deferred revenue |
|
|
(37,500 |
) |
|
|
(37,500 |
) |
|
|
841,667 |
|
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|
|
|
|
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Net cash used in operating activities |
|
|
(9,066,383 |
) |
|
|
(7,517,225 |
) |
|
|
(118,509,405 |
) |
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Cash flows from investing activities: |
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|
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|
|
|
Purchases of property and equipment |
|
|
(225,249 |
) |
|
|
(2,145,624 |
) |
|
|
(8,955,427 |
) |
Purchases of short-term investments |
|
|
(5,696,984 |
) |
|
|
(56,001,384 |
) |
|
|
(157,405,314 |
) |
Proceeds from maturities of short-term investments |
|
|
15,460,000 |
|
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|
31,664,319 |
|
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|
113,235,598 |
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|
|
|
|
|
|
|
|
|
Net cash provided by (used) in investing activities |
|
|
9,537,767 |
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|
|
(26,482,689 |
) |
|
|
(53,125,143 |
) |
|
|
|
|
|
|
|
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Cash flows from financing activities: |
|
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|
|
|
|
|
|
|
|
|
|
Proceeds from promissory notes, notes payable and related warrants |
|
|
|
|
|
|
1,024,680 |
|
|
|
5,513,492 |
|
Payments on promissory notes and capital leases |
|
|
(640,387 |
) |
|
|
(344,562 |
) |
|
|
(5,308,681 |
) |
Proceeds from bridge loan and related warrants |
|
|
|
|
|
|
|
|
|
|
2,220,000 |
|
Net proceeds from the issuance of preferred stock and warrants |
|
|
|
|
|
|
|
|
|
|
81,788,868 |
|
Proceeds from the issuance of common stock, net of issuance costs |
|
|
48,380 |
|
|
|
168,359 |
|
|
|
121,143,183 |
|
|
|
|
|
|
|
|
|
|
|
Net cash (used) provided by in financing activities |
|
|
(592,007 |
) |
|
|
848,477 |
|
|
|
205,356,862 |
|
| |
(Decrease) increase in cash and cash equivalents |
|
|
(120,623 |
) |
|
|
(33,151,437 |
) |
|
|
33,722,314 |
|
Cash and cash equivalents at beginning of period |
|
|
33,842,937 |
|
|
|
71,580,823 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
33,722,314 |
|
|
$ |
38,429,386 |
|
|
$ |
33,722,314 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental cash flow information: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
65,844 |
|
|
$ |
232,318 |
|
|
$ |
1,050,771 |
|
Supplemental non-cash investing and financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Fixed assets capitalized using promissory notes and capital leases |
|
|
|
|
|
|
379,351 |
|
|
|
4,447,946 |
|
Conversion of bridge loans and interest payable into preferred stock |
|
|
|
|
|
|
|
|
|
|
2,124,576 |
|
Preferred stock dividends and accretion of preferred stock to
redemption value |
|
|
|
|
|
|
|
|
|
|
16,382,063 |
|
Unrealized loss on short-term investments |
|
|
(3,978 |
) |
|
|
(44,089 |
) |
|
|
(83,949 |
) |
The accompanying notes are an integral part of these financial statements.
5
INHIBITEX, INC.
(A Development Stage Company)
NOTES TO UNAUDITED 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 discovery and development of novel
antibody-based products for the prevention and treatment of serious bacterial and fungal
infections. The Companys primary activities since incorporation have been establishing its
offices, recruiting personnel, conducting research, conducting pre-clinical studies and clinical
trials, performing business and financial planning, and raising capital. Accordingly, the Company
is considered to be in the development stage for financial reporting purposes.
The Company has incurred operating losses
since inception and expects such losses to continue for
the foreseeable future. These losses have largely been the result of research and development
expenses related to advancing the Companys clinical stage
product candidates, Veronate® and
Aurexis®. Veronate, which was the subject of a recently completed pivotal Phase III clinical trial
that failed to meet its primary endpoint, has been in development to prevent hospital-associated
infections in very low birth weight infants. The Company recently
announced that in light of the
Phase III results, it did not foresee performing additional clinical trials in very low birth
weight infants with the current donor-selected immune globulin form of Veronate, and was
discontinuing the manufacture of the current form of Veronate. Aurexis is currently being developed
to treat, in combination with antibiotics, serious, life-threatening Staphylococcus aureus (S.
aureus) bloodstream infections in hospitalized patients. 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 or proceeds from potential future collaborations or
partnerships. The Companys ability to continue its operations is dependent, in the near term, upon
carefully managing its cash resources, successfully developing its product candidates,
entering into collaboration or partnership agreements, executing future financings and
ultimately upon achieving profitable operations. There can be no assurance that additional funds
will be available on terms acceptable to the Company or that the Company will ever become
profitable.
2. Summary of Significant Accounting Policies
Use of Estimates. The
preparation of financial statements in conformity with U.S. generally accepted
accounting principles, or U.S. GAAP, requires management to make
estimates and assumptions that affect the reported amounts of assets and liabilities, the
disclosure of contingent assets and liabilities as of the date of the financial statements and the
reported amounts of revenue and expenses during the reporting period. Actual results could differ
from those estimated.
Cash, Cash Equivalents and Short-Term Investments. Cash equivalents consist of short-term, highly
liquid investments with original maturities of 90 days or less when purchased. Cash equivalents are
carried at cost, which approximates their fair market value. Investments with original maturities
beyond 90 days when purchased are considered to be short-term investments. These investments are
accounted for in accordance with Statement of Financial Accounting Standard (SFAS) No. 115,
Accounting for Certain Investments in Debt and Equity Securities (SFAS No. 115). The Company is
required to maintain a cash balance on deposit with a commercial bank equal to two times the loan
balance it has with that bank pursuant to a loan and security
agreement.
The Company has classified its entire
investment portfolio as available-for-sale. These securities
are recorded as either cash equivalents or short-term investments. Short-term investments are
carried at estimated fair value based upon quoted market prices. The amortized cost of debt
securities is adjusted for amortization of premiums and accretion of discounts to maturity.
Amortization and accretion are included in interest income, net and realized gains and
losses are also included in interest income, net. The cost basis of all securities sold
is based on the specific identification method.
Available-for-sale securities as of March 31, 2005 and 2006 consisted of commercial paper,
government agency obligations, corporate bonds, and money-market funds.
Property and Equipment, Net. Property and equipment are recorded at cost and depreciated using the
straight-line method over the following estimated useful lives of the related assets:
| |
|
|
|
|
| Asset |
|
Estimated Life |
Computer software
and
equipment |
|
3 years |
Furniture and
fixtures |
|
7 years |
Laboratory
equipment |
|
5 years |
Leasehold
improvements |
|
Lesser of estimated useful life or life of lease |
6
The Company also includes in property and equipment its capitalized costs related to computer
software developed for internal use in accordance with Statement of Position 98-1, Accounting for
the Costs of Computer Software Developed or Obtained for Internal Use. When assets are retired or
sold, the assets and accumulated depreciation are removed from the respective accounts and any gain
or loss is recognized in other income, net. Expenditures for repairs and maintenance are
charged to expense as incurred.
Revenue Recognition. To date, the Company has not generated any revenues from the sale of products.
Revenues to date relate to fees recovered or paid for licensed technology, collaborative research
and development agreements, materials transfer agreements, and a grant awarded to the Company by
the FDAs Office of Orphan Products Development. The Company follows the revenue recognition
criteria outlined in Staff Accounting Bulletin (SAB) No. 101, Revenue Recognition in Financial
Statements (SAB No. 101) as amended by SAB No. 104, Revenue Recognition. Accordingly, up-front,
non-refundable license fees under agreements where the Company has an ongoing research and
development commitment are amortized, on a straight-line basis, over the term of such commitment.
Revenues received for ongoing research and development activities under collaborative arrangements
and materials transfer agreements are recognized as these activities are performed pursuant to the
terms of the related agreements. Any amounts received in advance of performance are recorded as
deferred revenue until earned. Revenue related to grant awards is recognized as related research
and development expenses are incurred.
Accrued Expenses. As part of the process of preparing the Companys financial statements,
management is required to estimate expenses that the Company has incurred, but for which it has not
been invoiced. This process involves identifying services that have been performed on the Companys
behalf and estimating the level of services performed by third parties and the associated cost
incurred for such services as of each balance sheet date. Examples of expenses for which the
Company accrues based on estimates include fees for services, such as those provided by clinical
research and data management organizations, investigators, and contract manufacturers in
conjunction with the manufacture of clinical trial materials. Estimates of these fees and the
related accrual are derived based upon managements understanding of the status and timing of
services provided relative to the actual levels of services incurred by such service providers. The
majority of the Companys service providers invoice the Company monthly in arrears for services
performed. Management makes these estimates based upon the facts and circumstances known to it at
the time and in accordance with U.S. GAAP.
Prepaid Expenses and Other Current Assets. Prepaid expenses and other current assets consist
primarily of annual license fees, insurance premiums, payments to clinical research organizations
that the Company has made in advance of the services being performed, and interest receivable.
Stock-based
Compensation. On January 1, 2006, the Company adopted SFAS No. 123(R),
Share-Based Payment, or (SFAS No. 123 (R)). Prior to January 1, 2006, the Company accounted for
options granted pursuant to its 2004 Stock Incentive Plan and the 2002 Non-Employee Directors Stock
Option Plan under the recognition and measurement provisions of APB Opinion No. 25, Accounting for
Stock Issued to Employees, and related Interpretations, as
permitted by SFAS No. 123,
Accounting for Stock-Based Compensation (SFAS No.
123). No stock-based employee compensation cost was recognized
in the Statement of Operations for the years ended December 31, 2005, 2004, or 2003, nor in the
three-month period ended March 31, 2005, as all options granted under those plans had an exercise
price equal to the market value of the underlying common stock on the date of grant. The Company
adopted the fair value recognition provisions of SFAS No. 123(R), using the
modified-prospective transition method. Under that transition method, compensation cost recognized
in the first quarter of 2006 includes: (a) compensation cost for all share-based payments granted
prior to, but not yet vested as of January 1, 2006, based on the grant date fair value estimated in
accordance with the original provisions of SFAS No. 123, and (b) compensation cost for
all share-based payments granted subsequent to January 1, 2006, based on the grant-date fair value
estimated in accordance with the provisions of SFAS No. 123 (R). Results for prior periods have
not been restated. The Company uses the Black-Scholes method to estimate the value of stock options
granted to employees and applied it not only to new awards, but to previously granted awards that
are not fully vested on the effective date of January 1, 2006. Awards granted prior to the
Companys initial public offering that were unvested as of January 1, 2006 are valued under the
minimum value method.
Upon the adoption of SFAS No. 123(R) the Company recorded a cumulative effect of a change in
accounting principle totaling $58,460 related to expected forfeitures for previously expensed
stock-based compensation. The Company's forfeiture rate is based on
historical experience as well as anticipated turnover and other
qualitative factors.
Prior to the adoption of SFAS No. 123(R), the Company would have presented all tax benefits of
deductions resulting from the exercise of stock options as operating cash flows in the Statement of
Cash Flows. SFAS No. 123(R) requires the cash flows resulting from the tax benefits resulting from
tax deductions in excess of the compensation cost recognized for those options (excess tax
benefits) to be classified as financing cash flows. The Company currently records a full valuation
allowance for all tax benefits due to uncertainties with respect to the Companys ability to
generate sufficient taxable income in the future.
7
The following table illustrates the effect on net income and earnings per share if the Company had
applied the fair value recognition provisions of SFAS No. 123(R) to options granted under the
Companys stock option plans in all periods presented. For purposes of this pro forma disclosure,
the value of the options is estimated using a Black-Scholes option-pricing formula and expensed
over the options respective vesting periods.
| |
|
|
|
|
|
|
|
|
| |
|
Three Months Ended |
|
| |
|
March 31, |
|
| |
|
2006 |
|
|
2005 |
|
Net loss attributable to common
stockholders as reported |
|
$ |
(8,981,775 |
) |
|
$ |
(9,942,688 |
) |
Add: Amortization of deferred stock
compensation included in
net loss as reported |
|
|
333,477 |
|
|
|
124,188 |
|
Deduct: Stock compensation expense
determined under fair value method |
|
|
(333,477 |
) |
|
|
(480,111 |
) |
|
|
|
|
|
|
|
Net loss
attributable to common stockholders pro forma |
|
$ |
(8,981,775 |
) |
|
$ |
(10,298,611 |
) |
|
|
|
|
|
|
|
Net loss attributable to common
stockholders per share (basic and
diluted): |
|
|
|
|
|
|
|
|
As reported |
|
$ |
(0.30 |
) |
|
$ |
(0.40 |
) |
|
|
|
|
|
|
|
Pro forma |
|
$ |
(0.30 |
) |
|
$ |
(0.41 |
) |
|
|
|
|
|
|
|
As noted above, the Company recorded stock compensation expense of $333,477, or $0.01 per share,
for the three months ended March 31, 2006. As of March 31,
2006, the Company has $2,674,997, net of
forfeitures, of unvested awards not yet recognized as an expense. This amount will be recognized
and expensed over the respective vesting period of the options on a
straight-line basis, which is generally four years. Note
that the above pro forma disclosures are provided because employee stock options were not accounted
for using the fair-value method during 2005. The Companys previous pro forma disclosures under
SFAS No. 123 did not include implied forfeitures. With the adoption of SFAS No. 123 (R),
current stock compensation expense includes forfeiture assumptions.
The fair value of each stock option was estimated at the date of grant using the Black-Scholes
method with the following assumptions:
| |
|
|
|
|
|
|
|
|
| |
|
Three Months Ended |
| |
|
March 31, |
| |
|
2006 |
|
2005 |
Risk-free interest rate |
|
|
4.51 |
% |
|
|
3.71 |
% |
Dividend yield |
|
|
|
|
|
|
|
|
Expected weighted average volatility |
|
|
.70 |
|
|
|
.50 |
|
Expected life of options (years) |
|
|
4.0 |
|
|
|
4.0 |
|
Weighted average fair value of options granted |
|
$ |
5.79 |
|
|
$ |
3.89 |
|
For purposes of pro forma disclosure, the estimated fair value of the options is amortized to
expense over the vesting period of the related options.
Fair Value of Financial Instruments. The carrying amounts of the Companys financial instruments,
which include cash, cash equivalents, short-term investments, accounts payable, accrued expenses,
and capital lease and debt obligations, approximate their fair values.
Concentrations of Credit Risk and Limited Suppliers. Cash and cash equivalents consist of financial
instruments that potentially subject the Company to concentrations of credit risk to the extent
recorded on the balance sheets. The Company believes that it has established guidelines for
investment of its excess cash that maintains principal and liquidity through its policies on
diversification and investment maturity.
The Company relies on certain raw materials and supplies used in its development process that are
procured from a small group of suppliers as well as certain single-sourced third-party contract
manufacturers that make its product candidates. The failure of these suppliers or a contract
manufacturer to deliver on schedule, or at all, could delay or interrupt the development process
and adversely
8
affect the Companys operating results.
Research and Development Expense. Research and development expense primarily consists of costs
incurred in the discovery, development, testing, and manufacturing of the Companys product
candidates. These expenses consist primarily of (i) fees paid to third-party service providers to
monitor and accumulate data related to the Companys clinical trials, (ii) costs related to
obtaining patents and licenses and sponsored research agreements, (iii) the costs to procure and
manufacture materials used in clinical trials, (iv) supplies and facility expenses, and (v) salaries and related expenses for personnel, including
stock compensation expense. These costs are charged to expense as incurred.
General and Administrative Expense . General and administrative expense consists of costs incurred
to manage the Company and support the Companys research and development activities. These costs
primarily consist of salaries and other related costs for personnel in executive, finance,
accounting, information technology, business development, sales and marketing and human resource
functions, including stock compensation expense. Other significant costs
include professional fees for legal and accounting services, market research and other consulting
services, as well as insurance premiums, including those for directors and officers liability.
Income Taxes. The Company utilizes the liability method of accounting for income taxes as required
by SFAS No. 109, Accounting for Income Taxes (SFAS No. 109). Under this method, deferred tax
assets and liabilities are determined based on the differences between the financial reporting and
tax reporting bases of assets and liabilities and are measured using the enacted tax rates and laws
that are expected to be in effect when the differences are expected to reverse. A full valuation
allowance has been recorded to reduce the carrying amounts of net deferred tax assets to an amount
the Company expects to realize in the future based upon the available evidence at the time.
Comprehensive Loss. The Company has adopted the provisions of SFAS No. 130, Comprehensive Income
(SFAS No. 130). SFAS No. 130 establishes standards for the reporting and display of comprehensive
loss and its components for general purpose financial statements. For the periods presented,
comprehensive loss did not differ materially from reported net loss.
Lease Accounting. The Company entered into a lease for its new facility where leasehold
improvements paid by the lessor pursuant to the lease agreement are being amortized over the life
of the lease as a discount to rent expense and as amortization expense to related leasehold
improvements. The balances of the lessor paid leasehold improvements and rent discounts are
classified in the balance sheet as leasehold improvements and other liabilities, respectively.
Reclassifications. The Company reclassified
previously recognized stock-based compensation expense
to the expense line items of Research and development expense and General and administrative
expense to conform to the current year presentation as required under U.S. GAAP.
Recent
Accounting Pronouncements. In May 2005, the Financial
Accounting Standards Board issued SFAS No. 154, Accounting Changes and
Error Corrections (SFAS No. 154). SFAS No. 154 requires retrospective application of a voluntary
change in accounting principle to prior period financial statements unless it is impracticable.
SFAS No. 154 also requires that a change in method of depreciation, amortization, or depletion for
long-lived, non-financial assets be accounted for as a change in accounting estimate affected by a
change in accounting principle. SFAS No. 154 replaces APB Opinion No. 20, Accounting Changes, and
SFAS No. 3, Reporting Accounting Changes in Interim Financial Statements. SFAS No. 154 is effective
for fiscal years beginning after December 15, 2005. The Company
adopted the
provisions of SFAS No. 154 as of January 1, 2006 and had no material impact on its results of operations or financial
condition.
3. Net Loss Per Share
The Company calculates net loss per share in accordance with SFAS No. 128, Earnings Per Share
(SFAS No. 128) and SEC SAB No. 98, Earnings Per Share, (SAB No. 98). Under the provisions of
SFAS No. 128 and SAB No. 98, basic net loss per share is computed by dividing the net loss for the
period by the weighted average number of common shares outstanding for the period. Diluted net loss
per share is computed by dividing the net loss by the weighted average number of common shares and
dilutive common stock equivalents then outstanding. Common stock equivalents consist of common
shares issuable upon the exercise of stock options and warrants. Diluted net loss per share is the
same as basic net loss per share since common stock equivalents are excluded from the calculation
of diluted net loss per share as their effect is anti-dilutive.
The following table sets forth the computation of historical and pro forma basic and diluted net
loss attributable to common stockholders per share:
9
| |
|
|
|
|
|
|
|
|
| |
|
Three Months Ended |
|
| |
|
March 31, |
|
| |
|
2006 |
|
|
2005 |
|
Historical |
|
|
|
|
|
|
|
|
Numerator: |
|
|
|
|
|
|
|
|
Net loss attributable to common stockholders |
|
$ |
(8,981,775 |
) |
|
$ |
(9,942,688 |
) |
|
|
|
|
|
|
|
| |
Denominator: |
|
|
|
|
|
|
|
|
Weighted average common shares outstanding |
|
|
30,233,142 |
|
|
|
25,147,579 |
|
|
|
|
|
|
|
|
| |
Basic and diluted net loss per share |
|
$ |
(0.30 |
) |
|
$ |
(0.40 |
) |
|
|
|
|
|
|
|
The following table outlines potentially dilutive common stock equivalents outstanding that are not
included in the above calculations as the effect of their inclusion was anti-dilutive.
| |
|
|
|
|
|
|
|
|
| |
|
March 31, |
| |
|
2006 |
|
2005 |
Common stock options |
|
|
2,347,528 |
|
|
|
2,057,999 |
|
Warrants |
|
|
3,800,143 |
|
|
|
3,800,143 |
|
| |
|
|
Total |
|
|
6,147,671 |
|
|
|
5,858,142 |
|
| |
|
|
4. Stock Option Plans
1998 Equity Ownership Plan. In May 1998, the Board of Directors approved the 1998 Equity Ownership
Plan (the Plan), which provided for the grant of stock options to directors, officers,
employees and consultants. Under the Plan, both incentive stock options and non-qualified stock options, among
other equity related awards, could be granted. The Board of Directors determined the term and vesting
dates of all options at their grant date, provided that such price shall not be less than the fair market
value of the Companys stock on the date of grant. Under the Plan, the maximum term for an option grant is
10 years from the grant date, and options generally vest ratably over a period of four years from the grant
date. Upon the adoption of the 2002 Stock Incentive Plan (2002 Plan) as discussed below, no
additional grants of stock option grants or equity awards were authorized under the 1998 Equity Ownership Plan. All
options outstanding under the Plan will remain in full force and effect until they expire or are exercised.
However, future forfeitures of any stock options granted under the 1998 Equity Ownership Plan are added to
the number of shares available under the 2002 Plan.
2004 Stock Incentive Plan and 2002 Non-Employee Directors Stock Option Plan. In February 2002, the
Board of Directors approved the 2002 Plan, which provided for the grant of incentive stock options,
non-
qualified stock options and other equity related awards to employees, contractors and consultants
of the
Company. At that time, the Company also adopted the 2002 Non-Employee Directors Stock Option Plan
(the Director Plan) which provided for the grant of non-qualified stock options and
other equity related
awards to non-employee members of the Board of Directors. On February 20, 2004, the Board of
Directors
amended the 2002 Plan and the Director Plan, whereby the 2002 Plan was renamed the 2004 Stock
Incentive Plan (the2004 Plan). The 2004 Plan was further modified to provide for option
grants to non-
employee directors and 1,420,180 shares of common stock have been added to the number of reserved
shares. Upon the adoption of the 2004 Plan, no further options were authorized to be granted under
the
Director Plan. In May 2005, pursuant to a stockholder vote the plan was further modified by adding
1,500,000 shares of common stock to the number of the reserved shares available for grant.
The 2004 Plan and the Director Plan are administered by the Compensation Committee of the Board of
Directors, which has the authority to select the individuals to whom awards are to be granted, the
number
of shares granted, and the vesting schedule. Under the 2004 Plan and Director Plan, the maximum
term for
an option grant is ten and six years from the grant date, respectively. Options granted under the
2004 Plan
and Director Plan generally vest ratably over a period of four years and three years, respectively,
from the grant date.
The following is a summary of all stock option activity and related information related to all the
Companys stock option plans, and 13,972 shares issued outside these plans, from December 31,
2005
through the period ended March 31, 2006;
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate |
|
| |
|
|
|
|
|
Weighted Average |
|
|
Weighted Average |
|
|
Intrinsic |
|
| |
|
Number of |
|
|
Exercise Price |
|
|
Remaining Contractual |
|
|
Value |
|
| |
|
Share |
|
|
per Share |
|
|
term |
|
|
($000) |
|
Balance at December 31, 2005 |
|
|
2,304,242 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
72,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
27,381 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
1,833 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2006 |
|
|
2,347,528 |
|
|
$ |
5.96 |
|
|
|
4.05 |
|
|
$ |
4,085 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested or expect to vest at March 31, 2006 |
|
|
2,011,960 |
|
|
$ |
5.55 |
|
|
|
0.57 |
|
|
$ |
4,012 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at March 31, 2006 |
|
|
1,089,166 |
|
|
$ |
3.99 |
|
|
|
3.35 |
|
|
$ |
3,242 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted-average grant date fair value of options granted during the period ended March
31, 2006 was $8.79. The total intrinsic value of options exercised during the three months ended March
31, 2006 was $226,167 with cash proceeds of $37,430 received by the Company.
5. Subsequent Events
On
February 8, 2006, the Compensation Committee of the
Companys Board of Directors granted
performance-based stock options to executives and employees to purchase 800,000 shares of the
Companys common stock. The performance condition associated with these grants was the achievement
of the primary endpoint in the pivotal Phase III trial of Veronate. On March 30, 2006, the Company
learned that this trial failed to achieve its primary endpoint, as filed by the Company on Form 8-K
on April 3, 2006. Based upon the performance condition not being met, all 800,000 performance-based
options were forfeited. Any stock compensation expense related to these grants for the period
beginning on the grant date to March 30, 2006 was reversed upon
the forfeiture in the three months ended March 31, 2006.
On April 17, 2006, the Company implemented a reduction in its workforce, for which it expects to
record a charge of approximately $1.2 million in the second quarter of 2006 related to one-time
termination benefits as filed by the Company on Form 8-K on April 21, 2006.
On
April 24, 2006, the Compensation Committee of the Board of Directors approved an incentive
program designed to retain key executives and employees of the Company. This plan includes
incentives consisting of a combination of cash, restricted stock and stock options, which vest over
periods of up to two years as filed by the Company on Form 8-K on April 28, 2006.
On
April 25, 2006, the Company
terminated its contract manufacturing
agreement with Nabi BioPharmaceuticals as filed by the Company on Form 8-K on April 28, 2006. On April 26, 2006,
Nabi BioPharmaceuticals invoiced the Company for approximately $3.3 million for cancellation penalties
associated with forecasted future production that Nabi BioPharmaceuticals contends are due as a result of the
termination. The Company does not believe that termination will result in any material cancellation penalties.
On
May 5, 2006, the Company announced that it has received authorization from the U.S. Food and Drug
Administration (FDA) to initiate a 16-patient safety and pharmacokinetic trial of two-doses of
Aurexis, its humanized monoclonal antibody, in patients with S. aureus bloodstream infections. The
Company expects to begin enrolling patients in this trial during the third quarter of 2006 and to
complete enrollment around year end. The Company also reported that in addition to completing this
small safety and pharmacokinetic trial, the FDA will also require the Company to complete
additional preclinical toxicological studies to evaluate two doses of Aurexis in combination with
antibiotics. The Company plans to perform these studies in parallel with the safety and
pharmacokinetic trial.
10
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:
| |
|
our ability to discover and develop novel therapies to prevent or treat serious, life threatening infections
based on our expertise in MSCRAMM® proteins; |
| |
| |
|
the potential advantages of using antibody-based products over existing therapies; |
| |
| |
|
the ability of antibodies that target MSCRAMM proteins to reduce the incidence and severity of bacterial and
fungal infections; |
| |
| |
|
estimated cash burn rates or operating expenses for the remainder of 2006; |
| |
| |
|
the annualized savings related to workforce reductions and one-time charges related to termination benefits; |
| |
| |
|
the consideration of other strategic pathways to create shareholder value; |
| |
| |
|
our intent to complete analyses on the Veronate Phase III trial, convene a panel in May 2006 and complete its
review near the end of June 2006; |
| |
| |
|
our plan to not conduct any further clinical trials in very low birth weight infants with the
current donor-selected immune globulin form of Veronate; |
| |
| |
|
our plans to commence a clinical trial to assess the safety and efficacy of two doses of Aurexis; |
| |
| |
|
the expected timing of additional preclinical toxicological studies of two doses of Aurexis; |
| |
| |
|
the potential to discover, develop or commercialize any product candidates resulting from existing or future
collaborations, including those with Dyax and Wyeth; |
| |
| |
|
potential future revenue from collaborative research agreements, partnerships, or materials transfer agreements; |
| |
| |
|
the number of months that our current cash, cash equivalents, short-term investments under existing
arrangements will allow us to operate; |
| |
| |
|
our future financing requirements and how we expect to fund them; |
| |
| |
|
our ability to successfully commercialize our products and generate product-related revenue in the future; |
| |
| |
|
our plan to establish partnerships or collaborations with other entities to develop and commercialize our
product candidates in other countries outside of the United States; |
| |
| |
|
the potential volatility of our quarterly and annual operating results; |
| |
| |
|
the expectation of continued substantial net losses; |
| |
| |
|
the potential benefits related to Fast Track, Orphan Drug and Orphan Medicinal Product status; |
| |
| |
|
and our intention to apply for Fast Track and Orphan Drug status for our other product candidates. |
11
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: that the
preceding preclinical and clinical results related to our antibody-based products, including
Aurexis and other product candidates, are not reflective of future results; Wyeth terminating our
license and collaborative research agreement; our ability to contract with a sufficient number of
clinical trial sites to perform our clinical trials; the cost and rate at which investigators at
such sites can recruit patients into our clinical trials; our ongoing or future clinical trials not
demonstrating the appropriate safety and efficacy of our product candidates; our ability to
successfully develop current and future product candidates either independently or in collaboration
with business partners; our ability to secure and our use of third-party contract clinical research
and data management organizations, raw material suppliers and manufacturers, who may not fulfill
their contractual obligations or otherwise perform satisfactorily in the future; manufacturing and
maintaining sufficient quantities of clinical trial material on hand to complete our clinical
trials on a timely basis; our failure to obtain Data Safety Monitoring Board or DSMB, or regulatory
approval to commence or continue our clinical trials or to market our product candidates; our
ability to protect and maintain our proprietary intellectual property rights from unauthorized use
by others; our collaborators do not 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, particularly outside of the United States; that no
viable product candidates result from the collaborations with Wyeth or Dyax or that product
candidates from these collaborations do not demonstrate any therapeutic benefit or an acceptable
safety profile in clinical trials; our collaborators do not fulfill their obligations under the our
agreements with them in the future; 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 related governmental laws and regulations; changes in general
economic business or competitive conditions; and other statements contained elsewhere in this
Quarterly Report on Form 10-Q and risk factors described in or referred to in greater detail in the
Risk Factors section of this Form 10-Q and the Companys Form 10-K for the year ended December
31, 2005. 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
have 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.
Inhibitex®, MSCRAMM®, Veronate®, 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 condensed financial statements and
the notes thereto included in Item 1A of this Quarterly Report on Form 10-Q.
Overview
We are a biopharmaceutical company focused on the
discovery and development of novel antibody-based
products for the prevention and treatment of serious bacterial and fungal infections. In November
2005, we completed enrollment in a 2,017 patient Phase III clinical
trial of Veronate, a product
candidate that we have been developing for the prevention of certain hospital-associated infections
in premature, very low birth weight, or VLBW, infants. On April 3, 2006, we announced that this
Phase III trial did not achieve its primary endpoint or any of its secondary endpoints. We
recently announced that in light of these Phase III results, we did not foresee performing
additional clinical trials in very low birth weight infants with the current donor-selected immune
globulin form of Veronate and we discontinued the manufacture of the
current form of Veronate. Our
second product candidate in clinical development is Aurexis, for which we completed a 60 patient
Phase II clinical trial in May 2005, evaluating it as first-line therapy, in combination with
antibiotics, to treat serious, life-threatening S. aureus, bloodstream infections in hospitalized
patients. We plan to initiate a small safety and pharmacokinetic trial of a two-dose regimen of
Aurexis in this same patient population during the third quarter of 2006. In addition to Veronate
and Aurexis, we have four preclinical stage programs.
All of our product candidates and preclinical programs are based on our MSCRAMM protein platform,
for which we own or have licensed numerous patents and patent applications. We have retained all
worldwide rights to both Veronate and Aurexis. We have neither received regulatory approval for,
nor derived any commercial revenues from, any of our product candidates. We currently have little,
if any, commercialization capabilities, and it is possible that we may never successfully derive
any commercial revenues from any of our product candidates or preclinical programs.
12
We are a development stage company that has generated significant losses since our inception in May
1994. To date, we have devoted substantially all of our efforts towards research and development
activities related to our product candidates and preclinical programs. We expect to incur
substantial losses for the foreseeable future as we plan to continue the development of our
MSCRAMM-based research and development activities and consider other strategic pathways to create
shareholder value.
As of March 31, 2006, we had an accumulated deficit of $150.5 million.
Recent Developments
On
April 3, 2006, we announced that Veronate had failed to meet its primary endpoint in a pivotal
Phase III clinical trial for the prevention of hospital-associated infections due to Staphylococcus
aureus (S. aureus) in premature infants weighing between 500 and 1,250 grams at birth. We further
reported that there were no measurable effects or trends in favor of Veronate relative to the
primary endpoint or any of the secondary endpoints in this trial. We also reported that the
observed event rate for the primary endpoint was consistent with the assumptions used to design and
power the trial. Additionally, there were no significant differences in frequencies of adverse
events between the treatment and placebo groups.
Based on these results, we have undertaken the following activities and actions.
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We have assembled an independent panel of experts in the fields of neonatology,
immunology and infectious diseases to review the Veronate program in its entirety. The
panel is scheduled to convene in May. |
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We are currently conducting various analyses of our preclinical and clinical data, as
well as analyzing the various lots of clinical trial material used in the Phase II and
Phase III trials in an effort to determine whether the results of the Phase III Veronate
trial were a consequence of one or more factors, including the potency and consistency
of the clinical trial material, the immune status of very low birth weight infants, the
change in the dosing schedule, and the utility of donor-selected polyclonal
anti-MSCRAMM® antibodies against staphylococcal organisms. |
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We have halted the manufacture of clinical trial material used in the
clinical development of Veronate as a donor-selected immune globulin. We do not intend
to conduct future clinical trials in VLBW infants with the current donor-selected immune
globulin form of Veronate. |
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We terminated our contract manufacturing agreement with Nabi Biopharmaceuticals and
suspended collections of all plasma used to manufacture the current donor-selected
immune globulin form of Veronate. Nabi BioPharmaceuticals invoiced
us for approximately $3.3 million for cancellation penalties
associated with forecasted future production that Nabi BioPharmaceutical contends are due as a result of the termination. We do
not believe that termination will result in any material cancellation penalties. |
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We reduced our workforce by eliminating 35 positions. This reduction, which represents
approximately 40% of our workforce, was largely focused in areas dedicated to the planned
commercialization of Veronate. As a result, we anticipate recording a charge of
approximately $1.2 million in the second quarter of 2006 related to the cost of one-time
termination benefits. |
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We established an incentive program designed to retain our key executives and employees.
This plan includes incentives consisting of a combination of cash, restricted stock and
stock options. |
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We have initiated a review of other strategic pathways that
we may consider in the future to
optimize shareholder value pending the results of the ongoing review of the Veronate Phase
III trial results. |
In
April 2006, we and Biosynexus, Inc. amicably resolved matters
without any financial or other material obligation to each other.
On
May 5, 2006, we announced that we had received authorization from the FDA to initiate a
16-patient safety and pharmacokinetic trial of two doses of Aurexis® in patients with S.
aureus bloodstream infections. Patients in the trial will be administered two doses of Aurexis
and will also receive standard of care antibiotic therapy. We expect to begin enrolling patients in
this trial during the third quarter of 2006.
On
May 5, 2006, we also provided financial guidance for the remainder of 2006. We announced that
based on the cost reductions we have recently implemented, we estimated that our net cash burn rate
for the second quarter of 2006 will approximate $10 to $11 million and we expect this to decrease
to $5 to $6 million per quarter during the second half of the year. The uncertain status of our
Veronate program, coupled with the timing and progress of our clinical trials and research and
development efforts, the timing and outcome of regulatory approvals, if any, payments made or
received pursuant to existing or future licensing, collaboration or partnership agreements, and our
the potential that we may pursue a different strategic direction in the future make meaningful
13
predictions of our future operations
difficult to make. We may delay, curtail or terminate the
development of any or all of our product candidates, resulting in potentially smaller quarterly and
annual operating expenses, or we may undertake new strategic initiatives in the future that may increase our expenses.
Based upon the results of our recently completed Phase III Veronate trial, our strategic direction
is uncertain. We currently do not intend to conduct future clinical trials in VLBW infants with the
current donor-selected immune globulin form of Veronate. Pending the outcome of our analyses of the
Phase III Veronate results, we may or may not determine that future investment in the development
of Veronate is warranted, or may only be warranted if we can share the risk and expense of further
development with a strategic collaborator or partner. In addition, we may decide to terminate the
development of Aurexis if our assessment of the Phase III Veronate results cast doubt on the
utility of antibody-based products that target MSCRAMM proteins. Further, if we continue to proceed
with the development of Aurexis, we may or may not decide to develop it independently and may not
advance it beyond the planned safety and pharmacokinetic clinical trial unless we are able to
attract a strategic, corporate or financial collaborator or partner. While we currently anticipate
expending additional resources on our MSCRAMM-based clinical and preclinical programs, we are also
considering other strategic pathways with which to utilize our assets
to maximize shareholder value
in the future. We intend to make a full assessment of our overall strategic direction based upon
the completion of our ongoing analyses of the Veronate Phase III results and the findings of an
independent panel of experts that is reviewing the entire Veronate program.
Critical Accounting Policies
Managements Discussion and Analysis of Results of Operations discusses our financial statements,
which 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 are 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:
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Revenue Recognition |
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Accrued Expenses |
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Stock-based Compensation |
There has been no change in the underlying accounting assumptions and estimates used in the above critical accounting policies in
the first quarter of 2006, except for stock-based compensation as described in detail below:
Stock-Based Compensation
We adopted SFAS No. 123(R), Share-Based Payment, (SFAS No. 123(R)) on January 1,
2006. We adopted the fair value recognition provisions of SFAS No. 123(R), using the
modified-prospective transition method. Under this transition method, compensation cost recognized
in the first quarter of 2006 includes: (a) compensation cost for all share-based payments granted
prior to, but not yet vested as of January 1, 2006, based on the grant date fair value estimated in
accordance with the original provisions of SFAS No. 123,
Accounting for Stock-Based Compensation, (SFAS No. 123) and (b) compensation cost for
all share-based payments granted subsequent to January 1, 2006, based on the grant-date fair value
estimated in accordance with the provisions of SFAS No. 123(R). Results for prior periods have not
been restated. We use the Black-Scholes method to estimate the value of stock options granted to
employees and apply it not only to new awards, but to previously
granted awards that were not fully
vested on the effective date of January 1, 2006. Awards granted prior to our initial public
offering that were unvested as of January 1, 2006 are valued using the minimum value method.
Upon the adoption of SFAS No. 123(R), we recorded a cumulative effect of change in accounting
principle of $58,000 related to expected forfeitures for previously expensed stock-based
compensation.
We
recorded stock compensation expense of $0.3 million, or $0.01 per share, in the quarter ending
March 31, 2006, of which $0.1 million was recorded as a research and development expense and
$0.2 million was recorded as a general and administrative
14
expense. As of March 31, 2006, we have
$2.7 million, net of forfeitures, of unvested awards not yet recognized as an expense. This
amount will be recognized and expensed over the respective vesting period of the options, which
is generally four years. Our previous pro forma
disclosures under SFAS No. 123 did not include implied forfeitures. With the adoption of SFAS No. 123(R)
stock compensation expense includes our forfeiture assumptions. Please see Note 2 to our
Financial Statements for further information on stock-based compensation.
Results of Operations
Three Months Ended March 31, 2006 and 2005
Revenue. Revenue increased to $328,000 for the three months ended March 31, 2006 from $277,000 for
the same period in 2005. This increase of $51,000, or 18%, was the result of additional proceeds
received from research activities performed under a materials transfer agreement. Other revenue
consists of quarterly collaborative research and development support fees and license fees from
Wyeth. The collaborative research and development support fees and license fees from Wyeth are
based on the number of our employees that support the program.
Research and Development Expense. Research and
development expense decreased to $7.4 million during
the three months ended March 31, 2006 from $9.2 million for the same period in 2005. This decrease
of $1.8 million or 19%, resulted from a $1.8 million decrease in expenses related to the
manufacturing of clinical trial material and a $0.9 million decrease in direct
clinical trial expenses, offset in part by a $0.5 million
increase in license fees, patent-related legal fees, and
other expenses, a $0.3 million increase in salaries, benefits and stock compensation expenses, and
$0.1 million increase in depreciation and facility-related expenses. Manufacturing expenses
decreased by $1.6 million due to the manufacture of clinical trial material for the Aurexis program
during the first quarter of 2005, and by $0.2 million for the manufacturing of clinical trial
material for the Veronate program as compared to the same period in 2005. Clinical trial expenses
associated with the Veronate program decreased by $0.5 million due to the completion of the Phase
III Veronate trial. In addition there was a decrease of $0.4 million in clinical trial expenses for
the Aurexis program primarily related to completion of the 60 patient
Phase II clinical trial advisory in 2005. License fees, legal and other expenses increased
due to a $0.2 million increase in sponsored research, a $0.2 million increase in legal fees related
to establishing, maintaining and protecting our patents and intellectual property portfolio and a
$0.1 million increase in laboratory supplies . Salaries, benefits and stock compensation expense
increased due to the hiring of additional personnel to support our clinical trials and perform
research, increased salaries for existing employees, and higher stock compensation expense.
Depreciation and facility-related expenses increased due to higher rent and operating expenses
related to our new facility.
The following table summarizes the components of our research and development expense for the three
months ended March 31, 2006 and 2005.
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Three Months Ended |
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March 31, |
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2006 |
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2005 |
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(in thousands) |
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Clinical and manufacturing-related expense |
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$ |
3,645 |
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$ |
6,359 |
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Salaries, benefits and stock compensation expense |
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1,786 |
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1,520 |
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License fees, legal, and other expense |
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1,348 |
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781 |
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Depreciation and facility-related expense |
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648 |
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528 |
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Total research and development expense |
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$ |
7,427 |
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$ |
9,188 |
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General and Administrative Expense. General and administrative expense increased to $2.8 million
for the three months ended March 31, 2006 from $1.5 million for the same period in 2005. The
increase of $1.3 million, or 87%, was primarily due to higher costs associated with ongoing
corporate consulting, legal and accounting fees and insurance premiums of $0.6 million, a $0.3
million increase in market research expenses, and an increase of $0.4 million in salaries, benefits and
stock compensation expense. Corporate consulting, legal and accounting, and insurance expenses
increased due to an increase in premiums for clinical trial, property, and directors and officers
insurance, advisory services rendered during the first quarter of 2006, an increase in
fees related to investor relations activities, and an increase in
legal and accounting fees. Market
research expense increased due to expenditures related to the Veronate program. Salaries, benefits
and stock compensation expense increased due to the hiring of additional personnel for the planned
commercialization of Veronate, higher salaries for existing employees and higher stock compensation
expense.
15
Interest Income, net. Interest income, net increased to $0.8 million for the three months
ended March 31, 2006 from $0.4 million for the comparable quarter in 2005. This increase of $0.4
million was the result of an increase in interest income of $0.4 million, which was principally due
to higher interest rates in the first quarter of 2006 as compared to the same period in 2005.
Liquidity and Capital Resources
Sources of Liquidity
Since our
inception (May 13, 1994) through March 31, 2006, we have funded our operations primarily with
$214.4 million in gross proceeds raised from a series of five private equity financings, our
initial public offering in June 2004, and two private placements in November 2004 and August 2005.
From inception through March 31, 2006, we have also borrowed a total of $12.2 million under several
notes payable, credit facilities with a commercial bank and a local development authority and
capital lease lines. We have also received approximately $6.9 million in license fees,
collaborative research payments, proceeds from a materials transfer agreement, and grants, of which
$0.8 million is recorded as deferred revenue as of March 31, 2006.
At
March 31, 2006, our cash, cash equivalents and short-term investments totaled $77.2 million and
we held no investments with a planned maturity greater than 12 months. Our cash, cash equivalents
and short-term investments are generally held in a variety of interest-bearing instruments,
generally consisting of United States government agency securities, high-grade corporate bonds,
asset-backed securities, commercial paper, certificates of deposit, and money market accounts.
From January 1, 2006 to March 31, 2006, we made payments of $0.6 million on our existing capital
leases and notes payable. We currently are and have been compliant on all debt covenants.
Cash Flows
For the three months ended March 31, 2006, cash, cash equivalents and short-term investments
decreased by $9.9 million, from $87.1 million to $77.2 million. This decrease was primarily the
result of cash used for operating activities, the repayment of capital lease obligations and notes
payable, and capital expenditures.
Net cash
used in operating activities was $9.1 million for the three months ended March 31, 2006,
reflecting the net loss for the three month period of $9.0 million and a net decrease in operating
liabilities over operating assets of $0.9 million, which was offset in part by non-cash charges of
$0.8 million. The net loss was the result of conducting clinical trials associated with Veronate
and Aurexis, research and development activities, and ongoing general and administrative expenses.
The net decrease in current liabilities over current assets reflected a net decrease in accounts
payable and accrued liabilities of $1.1 million resulting from reduced clinical trial and
manufacturing-related expenses, which was offset in part by a net decrease of $0.2 million in
prepaid expenses, deferred revenue, and accounts receivable associated with prepaid insurance
payments, revenue earned, billed receivables, and interest receivable from our short-term
investments.
We received approximately $9.5 million of cash from investing activities during the three months
ended March 31, 2006, which consisted of net proceeds from short-term investments of $9.7 million,
offset in part by the purchase of laboratory and computer equipment of $0.2 million.
We used net cash of $0.6 million from financing activities during the three months ended March 31,
2006 for scheduled payments on our capital leases and notes payable.
Funding Requirements
Our future funding requirements are difficult to
determine and will depend on a number of factors,
including the timing and costs involved in conducting future clinical trials, if any; obtaining
regulatory approvals for our product candidates, if ever; the number of new product candidates we
may advance into clinical development; future payments received or made under existing or future
license or collaboration agreements; the cost of filing, prosecuting and enforcing patent and other
intellectual property claims; and the need to acquire additional licenses to or acquire new
products or compounds. We may also need additional funds for possible future strategic acquisitions
of businesses, products or technologies complementary to our business, although currently no
arrangements, agreements, or understandings are in place.
16
Based upon the results of our recently completed Phase III Veronate trial, our strategic direction
is uncertain. We currently do not intend to conduct future clinical trials in VLBW infants with the
current donor-selected immune globulin form of Veronate. Pending the outcome of our analyses of the
Phase III Veronate results, we may or may not determine that future investment in the development
of Veronate is warranted, or may only be warranted if we can share the risk and expense of further
development with a strategic collaborator or partner. In addition, we may decide to terminate the
development of Aurexis if our assessment of the Phase III Veronate results cast doubt on the
utility of antibody-based products that target MSCRAMM proteins. Further, if we continue to proceed
with the development of Aurexis, we may or may not decide to develop it independently and may not
advance it beyond the planned safety and pharmacokinetic clinical trial unless we are able to
attract a strategic, corporate or financial collaborator or partner. While we currently anticipate
expending additional resources on our MSCRAMM-based clinical and preclinical programs, we are also
considering other strategic pathways with which to utilize our assets to optimize shareholder value
in the future. We intend to make a full assessment of our overall strategic direction based upon
the completion of our ongoing analyses of the Veronate Phase III results and the findings of an
independent panel of experts that is reviewing the entire Veronate program. We anticipate
completing these analyses near the end of June 2006.
Based upon our current business and operating plans, we believe that our existing cash, cash
equivalents and short-term investments of $77.2 million as of March 31, 2006 will enable us to
operate for a period of at least 24 months. We currently do not have any commitments for future
funding, nor do we anticipate that we will generate revenue from the sale of any products for the
foreseeable future. Therefore, in order to meet our anticipated liquidity needs beyond 24 months,
we will need to raise additional capital. We expect to continue to fund our operations with our
existing cash, cash equivalents and short-term investments, or through the sale of additional common
stock or other securities, strategic collaborations, partnerships, and additional debt financing.
These funds may not be available to us on acceptable terms, if at all, and our failure to raise
such funds could have a material adverse impact on our 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, delay or curtail our clinical trials or obtain funds through collaborative
arrangements or partnerships that may require us to relinquish rights to certain product candidates
that we might otherwise choose to develop or commercialize independently. 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.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our primary exposure to market risk relates to changes in interest rates on our cash, cash
equivalents, and short-term investments. The objective of our investment activities is to preserve
principal. To achieve this objective, we invest in highly liquid and high-quality investment grade
debt instruments of financial institutions, corporations, and United States government agency
securities with a weighted average maturity of no longer than 12 months. Due to the relatively
short-term nature of these investments, we believe that we are not subject to any material market
risk exposure, and as a result, the estimated fair value of our cash, cash equivalents and
short-term investments approximates their principal amounts. If market interest rates were to
increase immediately and uniformly by 10% from levels at March 31, 2006, we estimate that the fair
value of our investment portfolio would decline by an immaterial amount. We do not have any foreign
currency or other derivative financial instruments and we do not have significant interest rate
risk associated with our debt obligations. We have the ability to hold any of our fixed income
investments until maturity, and therefore we would not expect our operating results or cash flows
to be affected to any significant degree by the effect of a change in market interest rates on our
investments.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of 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 is recorded, processed, summarized, and reported within the time periods specified in the SECs
rules and forms and that such information is accumulated and communicated to our management,
including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely
decisions regarding required disclosure. Our management, under the supervision of the Chief
Executive Officer and 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 and 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.
17
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting during the quarter ended
March 31, 2006 that have materially affected, or are reasonably likely to materially affect, our
internal control over financial reporting.
18
PART II
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 financial condition, and 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, 2005 have not materially
changed except as set forth below.
Risks Relating to Our Business
Our
prospects to date have been largely dependent on the success of Veronate, which was the subject
of a pivotal Phase III clinical trial that failed to meet its primary endpoint. Although we have
implemented a reduction in our workforce and decreased our operating expenses, we may be unable to
successfully manage our remaining resources, including available cash, cash equivalents and
short-term investments, while we seek to determine the implications, if any, of the Phase III
Veronate results on our other MSCRAMM-based product candidates and consider other potential
strategic pathways.
On
April 3, 2006, we announced that in a pivotal
Phase III clinical trial of Veronate for the prevention of
hospital-associated infections due to S. aureus in premature
infants weighing between 500 and 1,250 grams at birth had failed to
meet its primary endpoints. We further
reported that there were no measurable effects or trends in favor of Veronate relative to the
primary endpoint or any of the secondary endpoints in this trial. Up to this point in time, we had
devoted a substantial amount of our research, development and clinical efforts and financial
resources toward the development and potential commercialization of Veronate. In light of these
Phase III results, we announced that we have reduced our workforce from 83 to 48 positions, and
estimated that we will incur approximately $1.2 million of one-time termination benefits, all of
which will be cash expenditures. We have also halted the manufacture of the current donor-selected
form of Veronate and have terminated our related contract
manufacturing agreement.
We are currently conducting various analyses of our preclinical and clinical data related to
Veronate, as well as analyzing the various lots of clinical trial material used in the Phase II
and Phase III trials in an effort to determine whether the results of the Phase III Veronate
trial were a consequence of one or more factors, including the potency and consistency of the
clinical trial material, the immune status of very low birth weight infants, the change in the
dosing schedule, and the utility of donor-selected polyclonal anti-MSCRAMM®
antibodies against staphylococcal organisms. We anticipate completing these analyses near the
end of June 2006. We have also assembled an independent panel of experts in the fields of
neonatology, immunology and infectious diseases to review the Veronate program in its entirety.
The panel is scheduled to convene in May.
Based upon the results of our recently completed Phase III Veronate trial and the status of our
ongoing analyses of these results, our future strategic direction is uncertain. We currently do
not intend to conduct future clinical trials in VLBW infants with the current donor-selected
immune globulin form of Veronate. Pending the outcome of our analyses of the Phase III Veronate
results, we may or may not determine that future investment in the development of Veronate is
warranted, or may only be warranted if we can share the risk and expense of further development
with a strategic collaborator or partner. In addition, we may decide to terminate the
development of Aurexis if our assessment of the Phase III Veronate
results casts doubt on the
utility of antibody-based products that target MSCRAMM proteins. Further, if we continue to
proceed with the development of Aurexis, we may or may not decide to develop it independently
and may not advance it beyond the planned safety and pharmacokinetic clinical trial unless we
are able to attract a strategic, corporate financial collaborator or partner. While we
currently anticipate expending additional resources on our MSCRAMM-based clinical and
preclinical programs, we are also considering other strategic pathways with which to utilize our
assets to maximize shareholder value in the future. We intend to make a full assessment of our
overall strategic direction based upon the completion of our ongoing analyses of the Veronate
Phase III results and the findings of an independent panel of experts that is reviewing the
entire Veronate program.
We may not be able to determine the factors that may have caused our Phase III Veronate trial to be
unsuccessful, or whether the outcome of this trial casts doubt on the utility of antibody-based
products that target MSCRAMM proteins. In addition, in the event we decide to further develop
Veronate, Aurexis, or both, we may not be able to attract a strategic collaborator or partner to
co-develop these product candidates in the future. Further, we may not be able to successfully
identify, execute or implement any other strategic
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alternative,
and even if we decide to pursue one or more alternatives, we may be unable to do so
on terms acceptable to us or our stockholders. Any potential future strategic decisions we make may
disappoint investors and further depress the price of our common stock and the value of your
investment in our common stock, and may require us to raise more
money, incur non-recurring or other charges and may
pose significant integration challenges and/or management and business disruptions, any of which
could materially and adversely affect our business and financial results.
The use of MSCRAMM proteins to develop antibody-based products is an unproven approach, and no
antibody-based products that target MSCRAMM proteins have been successfully developed or approved.
All of our
clinical stage and preclinical programs, including Veronate and Aurexis,
target various MSCRAMM proteins on the surface of pathogenic organisms. We recently announced that
our pivotal 2,017 patient Phase III trial of Veronate had failed to meet its primary
endpoint for the prevention of hospital-associated infections due to
S. aureus in premature infants weighing between 500 and 1,250 grams at birth. We further reported
that there were no measurable effects or trends in favor of Veronate for the primary or any of the
secondary endpoints.
The use of MSCRAMM proteins to develop antibody-based products is an unproven approach. These
proteins, or the antibodies that target them, have yet to be used by us or others to achieve
statistically significant clinical trial results or successfully develop any approved drugs.
MSCRAMM proteins may ultimately prove to be a non-viable target for developing anti-infective or
other drug candidates, and the Phase III clinical trial results for Veronate may cast doubt on the
viability of our MSCRAMM protein approach and our entire portfolio of
potential product candidates. If
MSCRAMM proteins prove to be non-viable drug targets, we may need to curtail or cease the
development of our product candidates, restructure the Company and seek other strategic
alternatives.
If the clinical trials involving our product candidates are unsuccessful or delayed, we could be
delayed or precluded from further developing or ultimately selling our product candidates.
You must evaluate us in light of the uncertainties, complexities and risks present in a development
stage biopharmaceutical company. In order to receive regulatory approval to sell our product
candidates, we must conduct extensive, and numerous clinical trials to demonstrate their safety and
efficacy to the satisfaction of the FDA or other regulatory authorities. Clinical testing is
expensive, takes many years to complete, and its outcome is highly uncertain. Delays, or clinical
setbacks or failures may occur at any time, or in any phase of the clinical development process for
a number of reasons, including safety concerns, a lack of demonstrated efficacy, poor trial design,
and manufacturing-related issues related to the material used to conduct the clinical trials. If
the enrollment of patients into our clinical trials is delayed or proceeds at a slower pace than
expected, our clinical trials will take longer, and cost more, to complete. The results of
preclinical studies and prior clinical trials of our product candidates may not predict the results
of later-stage clinical trials. Product candidates in later stages of clinical development may fail
to show desired safety and efficacy traits despite having successfully demonstrated so in earlier
clinical testing. Even if the data collected from clinical trials involving our product candidates
are satisfactory and demonstrate safety and efficacy, such results may not be sufficient to support
the submission of a Biologic License Application, BLA, or to obtain regulatory approval from the FDA in the United States, or
elsewhere.
We recently completed a 2,017 patient Phase III trial of Veronate
that failed to meet the primary
endpoint. We have also completed a 512 patient Phase II trial for Veronate and a 60 patient Phase
II trial for Aurexis, both of which demonstrated favorable trends but
were not powered to demonstrate statistically significant differences
or results. We cannot assure you that the results of any early-stage trials we perform are
predictive of the outcome of later-stage trials. Even if our product candidates are ultimately
granted regulatory approval, post-approval or Phase IV clinical trials may demonstrate safety
concerns that require removing the product from the marketplace.
We may be forced to delay, curtail, or terminate the development or commercialization of our
clinical or preclinical product candidates if we are unable to obtain additional funding.
In order to complete the clinical
development of our clinical or preclinical stage product candidates, we expect that we will need additional capital in the future. The extent of
this need will depend on many factors, some of which are beyond our control, including:
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the successful development of our product candidates in preclinical and clinical testing; |
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the time it takes to receive the regulatory approvals needed to market or advance our product candidates
through clinical development; |
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future payments, if any, received or made under existing or
possible future collaborative arrangements or licences; |
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the costs associated with protecting and expanding our patent and other intellectual property rights; and |
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the need to acquire rights or licenses to new products or compounds. |
In the
event we continue further develop our product candidates, we may require a
collaborator or partner to do so. Except for our license and collaboration agreements
with Wyeth and Dyax, we have not entered into any such arrangements, and we cannot assure you that
we will be able to reach an agreement with a suitable collaborator or partner on acceptable terms, if at all.
We
anticipate that our existing cash, cash equivalents and short-term investments will enable us
to operate for a period of at least 24 months from the date of this filing. 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 on terms that we find acceptable, or at all, 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 or restructure our operations, obtain funds by
entering into arrangements with collaborators or partners on unattractive terms, 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 our operations.
If third-party suppliers upon whom we rely or may rely to provide us with the critical raw material
for Veronate do not perform or fail to comply with strict regulations, our clinical trials for, and
the commercialization of, Veronate could be terminated, delayed, or adversely affected.
We purchased the vast majority of the plasma we used to manufacture clinical trial materials for
the clinical development of Veronate from DCI Management Group, LLC, or DCI, under a long-term
supply contract. We also entered into long-term supply arrangements with two other suppliers to
provide us with plasma for our planned commercialization of Veronate. Based upon the results of our
Phase III Veronate trial, we have suspended the collection of plasma from all of these suppliers.
In the event we determine that we need to resume the collection of similar or different plasma in
the future, it may be difficult for us to find a sufficient supply from these or other vendors on
commercially acceptable terms, if at all, without undue delays, which could adversely impact our
costs, as well as our ability to manufacture sufficient quantities of the similar or different form
of Veronate in the future to conduct additional clinical trials or meet commercial demands.
The collection, shipment, storage and testing of plasma, including screening procedures for plasma
donors, are subject to extensive and strict regulation by the FDA and other foreign regulatory
authorities. In the event that DCI, or any other existing or future supplier, fails to comply with
these stringent regulations, it could be precluded from shipping us an adequate supply of plasma,
which could adversely impact our ability to manufacture Veronate on a timely basis, if at all.
In the event that we need to change our third-party contract manufacturers, our clinical trials and
the commercialization of our products could be delayed, adversely affected or terminated, result in
higher costs, or deprive us of potential product revenues.
Due to regulatory restrictions inherent in a Biologic License Application, or BLA, the manufacture
of many biologic-based products, including our product candidates, is generally sole-sourced. In
accordance with FDA-mandated cGMPs, changing manufacturers for a biologic product generally
requires re-validation of the manufacturing processes and procedures, and may require further
clinical trials. Changing our current or future contract manufacturers may be difficult for us and
could be costly and take several years to complete, which could result in our inability to
manufacture our products or product candidates for an extended period of time. Further, we do not
have any alternate manufacturing plans for our product candidates at this time. It may be difficult
or impossible for us to find alternative manufacturers on commercially acceptable terms, if at all.
We recently terminated our contract manufacturing agreement with Nabi Biopharmaceuticals, or Nabi,
for the manufacture of Veronate in its current form as a donor-selected immune globulin. In the
event that we need to manufacture additional quantities of a plasma-derived or other form of
Veronate in the future, it may be difficult for us to find alternative manufacturers, if at all.
If we fail to establish marketing and sales capabilities or fail to enter into effective sales,
marketing and distribution arrangements with third parties, we may not be able to successfully
commercialize our products.
21
In light of the Phase III Veronate results, we have indefinitely postponed the planned development
of hospital focused internal sales and marketing capabilities to potentially market and promote our product
candidates, particularly Veronate, if approved. There can be no
assurance that we will be able to establish these specialized sales
and marketing capabilities if and when we intend to market and sell our product candidates. We
currently have no infrastructure to support such activities or the commercialization of
hospital-based pharmaceutical products. Our future profitability may depend in part on
our ability to develop a capable hospital-based sales force and suitable marketing capabilities.
The development of our own hospital-based sales force and marketing capabilities may result in us
incurring significant costs before the time that we may generate
significant commercial revenues. We may not
be able to attract and retain qualified marketing personnel, or be able to establish an
effective hospital-based sales force. To the extent that we enter into marketing and sales
arrangements with other companies to sell, promote or market our products in the United States or
abroad, our product revenues, which may be in the form of direct
revenue, a royalty, or a split of
profits, will depend on their efforts, which may not be successful.
Veronate, in its current form, is a blood product derived from human plasma. The administration of
blood products could result in the transmission of infectious diseases or impurities that could
prevent us from selling Veronate or expose us to liability.
We had been developing Veronate as a donor-selected immune globulin. Immune globulins contain
antibodies derived from human plasma, which is a component of blood. Certain pathogenic organisms
and impurities may be found in blood. While the collection, testing, processing, manufacture, and
storage of immune globulins like Veronate are designed to eliminate harmful pathogens or other
impurities, we cannot assure you that this will prevent the transmission of either known or unknown
pathogens or impurities to patients that are treated with Veronate. In the event such pathogens or
other impurities were suspected or known to have been transmitted to any patient, we may be subject
to product liability claims from those individuals that participated in our clinical trials of Veronate.
Based on the results of our Phase III Veronate clinical trial, we currently do not intend to
conduct future clinical trials in very low birth weight infants with the current donor-selected
immune globulin form of Veronate, and we have halted the manufacture of Veronate as a
donor-selected immune globulin. If we were to continue the development of Veronate as a
blood-product, and it was suspected or known to have transmitted any harmful pathogens or
impurities, its approval may be delayed, suspended or withdrawn, we could be forced to recall it or
certain lots of it, and we may be subject to product liability claims. Further, if public concern
arises that any blood product other than Veronate or blood products in general may transmit a
disease or unknown pathogens or impurities, approval for Veronate may be delayed or withdrawn, or
the potential use of Veronate may be reduced or limited due to these concerns.
If a third party claims we are infringing on its intellectual property rights, we could incur
significant litigation or licensing expenses, or be prevented from further developing or
commercializing our products.
Our commercial success depends in part on our ability to operate without infringing the patents and
other proprietary rights of third parties. The biotechnology and pharmaceutical industries are
characterized by extensive litigation regarding patents and other intellectual property rights. The
defense and prosecution of intellectual property claims, United States Patent and Trademark Office
interference proceedings and related legal and administrative proceedings in the United States and
internationally involve complex legal and factual questions. As a result, such proceedings are
lengthy, costly and time-consuming and their outcome is uncertain. We may become involved in
litigation in order to determine the enforceability, scope and validity of the proprietary rights
of others.
Scientific research relating to surface proteins located on pathogenic organisms has been conducted
for many years in the areas in which we have focused our research and development efforts, which
has resulted in third parties having a number of issued patents and still-pending patent
applications. Patent applications in the United States are, in most cases, maintained in secrecy
until the patent is issued. The publication of discoveries in the scientific or patent literature
frequently occurs substantially later than the date on which the underlying discoveries were made.
Therefore, patent applications relating to products similar to our product candidates may have
already been filed by others without our knowledge. In the event an infringement claim is brought
against us, we may be required to pay substantial legal and other expenses to defend such a claim
and, if we are unsuccessful in defending the claim, we may be prevented from pursuing related
product development and commercialization and may be subject to damage awards.
If we become involved in any patent litigation, interference or other administrative proceedings,
we will incur substantial expense, and the efforts of our technical and management personnel will
be significantly diverted. A detrimental outcome of such litigation or proceedings may expose us to
loss of our proprietary position or to significant liabilities, or require us to seek licenses that
may not be available from third parties on commercially acceptable terms, if at all. We may be
restricted or prevented from developing, manufacturing and selling our product candidates in the
event of an adverse determination in a judicial or administrative proceeding or if we fail to
obtain necessary licenses.
Our current and future product candidates may be covered by third-party patents or other
intellectual property rights, in which case we would need to obtain a license or sublicense to
these rights in order to develop or commercialize them. Any required licenses may not be available
to us on acceptable terms, if at all. If we do not obtain the required licenses or sublicenses, we
could encounter delays in
22
the development of our product candidates or be prevented from
manufacturing and commercializing our products. If it is determined that we have infringed an
issued patent, we could be compelled to pay significant damages, including punitive damages. In
cases where we have in-licensed intellectual property, our failure to comply with the terms and
conditions of such agreements could harm our business.
In January 2003 in the Superior Court of Fulton County, Georgia, Biosynexus, Inc. filed suit
against us alleging the misappropriation of trade secrets, which we purportedly received through a
large, nationally recognized third-party contract research organization and utilized in the design
of our clinical trials for Veronate. In April 2006, we amicably
resolved this matter with Biosynexus, Inc. without any financial or other material
obligation to each other.
If we are unable to retain or attract key employees, advisors or consultants, we may be unable to
successfully develop and commercialize our product candidates or otherwise manage our business
effectively.
Our success depends in part on our ability to retain and attract qualified management and
personnel, directors, and academic scientists and clinicians as advisors or consultants. We are
currently dependent upon the efforts of our executive officers and a number of key employees. In
light of the results of our recently completed Phase III Veronate clinical trial, we implemented a
company-wide workforce reduction in which we eliminated 35 positions. We have also implemented
certain incentives designed to retain five of our executive officers and certain key employees over
the next two years. We cannot assure you that these retention incentives will be sufficient to
retain our executive officers or key employees, and if we are unable to retain these individuals,
the ability to attract suitable replacements on a timely basis may be difficult, and our business
may be harmed.
We have experienced losses since our inception. We expect to continue to incur such losses for the
foreseeable future and we may never become profitable.
Since
inception (May 13, 1994) through March 31, 2006, we have incurred a cumulative deficit of approximately
$150.5 million. Our losses to date have resulted principally from:
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costs related to our research programs and the clinical development of our product candidates; and |
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general and administrative costs relating to our operations. |
We anticipate incurring losses for the foreseeable future as we further develop our product
candidates, which will generally require us to conduct significant research and laboratory testing,
conduct extensive and expensive clinical trials, as well as seek regulatory approvals. We cannot
assure you that we will generate direct or royalty revenue from the sale of products or ever become
profitable.
We may be unable to successfully develop or commercialize product candidates that are the subject
of collaborations if our collaborators do not perform.
We have
entered into and expect to continue to enter into and rely on
collaborations, license agreements, or other
arrangements with third parties to develop and/or commercialize our product candidates in the
future. If we do so, such collaborators may not perform as agreed, or may fail to comply with
strict regulations or elect to delay or terminate their efforts in developing or commercializing
our product candidates. We currently have collaborations with Dyax Corp. to jointly develop a
monoclonal antibody that targets MSCRAMM proteins on enterococci and with Wyeth to develop a
vaccine to prevent staphylococcal infections in humans. We believe these collaborations are
desirable for us to fund research and development activities, provide a suitable manufacturer, and
obtain regulatory approvals and to successfully commercialize any product candidates that result
from these collaborations. We cannot assure you that any products will emerge from our
relationships with Dyax or Wyeth, or from other collaborations we may enter into in the future related
any of our other product candidates.
Our revenues, expenses and results of operations will be subject to significant fluctuations, which
will make it difficult to compare our operating results from period to period.
Until we have successfully developed and commercialized a product candidate, we expect that
substantially all of our revenues will result from payments we receive under collaborative
arrangements or license agreements where we grant others the right to our intellectual property. To
date, these payments have been in the form of up-front license and ongoing research and development
support payments and from time to time, payments under materials transfer agreements. We may not be
able to generate additional revenues under existing or future collaborative agreements.
Furthermore, payments potentially due to us under our existing and any future collaborative
arrangements, including any milestone and up-front payments, are subject to significant fluctuation
in both timing and amount, or may never be earned or paid. Therefore, our historical and current
revenues may not be indicative of our ability to
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achieve additional research and development
support payments or payment-generating milestones. In addition, our supply and manufacturing
agreements with respect to Aurexis may require us to purchase certain minimum amounts that we may
not need and therefore may not be cost effective to us. We expect that our operating results will
vary significantly from quarter to quarter and year to year as a result of the timing of our
research and development efforts, the execution or termination of collaborative arrangements, the
initiation, success or failure of clinical trials, the timing of the manufacture of our product
candidates, or other development related factors.
Based upon the results of our recently completed Phase III Veronate trial, our strategic direction
is uncertain. We currently do not intend to conduct future clinical trials in VLBW infants with the
current donor-selected immune globulin form of Veronate. Pending the outcome of our analyses of the
Phase III Veronate results, we may or may not determine that future investment in the development
of Veronate is warranted, or may only be warranted if we can share the risk and expense of further
development with a strategic collaborator or partner. In addition, we may decide to terminate the
development of Aurexis if our assessment of the Phase III Veronate results cast doubt on the
utility of antibody-based products that target MSCRAMM proteins. Further, if we continue to proceed
with the development of Aurexis, we may or may not decide to develop it independently and may not
advance it beyond the planned safety and pharmacokinetic clinical trial unless we are able to
attract a strategic, corporate or financial collaborator or partner. While we currently anticipate
expending additional resources on our MSCRAMM-based clinical and preclinical programs, we are also
considering other strategic pathways with which to utilize our assets to optimize shareholder value
in the future. Accordingly, our revenues and results of operations for any period may not be
comparable to the revenues or results of operations for any other period.
Risks Related to the Ownership of Our Common Stock
Our common stock price has been highly volatile, and your investment in us could suffer a decline
in value.
The market price of our common stock has been highly volatile since we completed our initial public
offering in June 2004. The market price of our common stock is likely to continue to be highly
volatile and could be subject to wide fluctuations in response to various factors and events,
including but not limited to:
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disclosure of our or our competitors clinical trial status or data; |
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the approval or commercialization of new products by us or our competitors, and the disclosure thereof; |
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announcements of scientific innovations by us or our competitors; |
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rumors relating to us or our competitors; |
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public concern about the safety of our product candidates, products or similar classes of products; |
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litigation to which we may become subject; |
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disclosures of any favorable or unfavorable clinical or regulatory developments concerning our
clinical trials, manufacturing, or product candidates; |
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actual or anticipated variations in our annual and quarterly operating results; |
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changes in general conditions or trends in the biotechnology and pharmaceutical industries; |
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changes in drug reimbursement rates or government policies related to reimbursement; |
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announcements by us or our competitors of significant acquisitions, strategic partnerships, joint
ventures or capital commitments; |
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new regulatory legislation adopted in the United States or abroad; |
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our failure to achieve or meet equity research analysts expectations or their estimates of our
business, or a change in their recommendations concerning our company, the value of our common stock
or our industry in general; |
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termination or delay in any of our existing or future collaborative arrangements; |
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future sales of equity or debt securities, including large block trades or the sale of shares held by
our directors or management; |
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the loss of our eligibility to use Form S-3 due to the amount of our market capitalization
falling below specified levels; |
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the loss of our eligibility to trade our shares of common stock on the Nasdaq National Exchange due to
our market capitalization and/or price per share falling below specified levels; |
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changes in accounting principles; |
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failure to comply with the periodic reporting requirements of publicly-owned companies, under the
Securities Exchange Act of 1934, as amended, and the Sarbanes-Oxley Act of 2002; and |
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general economic conditions. |
In addition, the stock market in general, and the Nasdaq National Market and the market for
biotechnology stocks in particular, have historically experienced significant price and volume
fluctuations. Volatility in the market price for a particular companys stock has often been
unrelated or disproportionate to the operating performance of that company. Market and industry
factors may seriously harm the market price of our common stock, regardless of our operating
performance. Due to this volatility, you may be unable to sell your shares of common stock at or
above the price you paid.
ITEM 6. EXHIBITS
The following is a list of exhibits filed as part of this Report:
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| Exhibit No. |
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Description |
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31.1
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Section 302 Certification of the Chief Executive 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 |
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31.2
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Section 302 Certification of the 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 |
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32.1
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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.
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Date: May 10, 2006
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INHIBITEX, INC |
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/s/ Russell H. Plumb |
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Russell H. Plumb |
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Vice President, Finance and Administration, |
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Chief Financial Officer |
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EXHIBIT INDEX
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| Exhibit No. |
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Description |
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31.1
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Section 302 Certification of the Chief Executive 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 |
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31.2
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Section 302 Certification of the 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 |
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32.1
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Section 906 Certifications of the Chief Executive Officer and the Chief Financial Officer |
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