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F-1
|
Securities
offered hereby:
|
46,666,670 ordinary shares, par value NIS 0.02 per share, in the form of ADRs, and 23,333,335 ordinary shares underlying warrants, also in the form of ADRs. | |
Use
of proceeds:
|
Except for proceeds, if any, received in connection with the exercise of warrants, we will not receive any proceeds from the sale of ADRs by the Selling Shareholders. Any proceeds received in connection with the exercise of warrants will be used for general corporate purposes. | |
ADRs:
|
Each ADR represents the right to receive ten ordinary shares. See "Description of American Depositary Shares." | |
|
||
|
·
|
The
depositary will hold the shares underlying your ADRs. You will have
rights
as provided in the deposit agreement.
|
|
·
|
We
do not expect to pay dividends in the foreseeable future. If, however,
we
declare dividends on our ordinary shares, the depositary will pay
you the
cash dividends and other distributions it receives on our ordinary
shares,
after deducting its fees and expenses.
|
|
·
|
You
may turn in your ADRs to the depositary in exchange for our ordinary
shares. The depositary will charge you fees for any such
exchange.
|
|
·
|
We
may amend or terminate the deposit agreement without your consent.
If you
continue to hold your ADRs, you agree to be bound by the deposit
agreement, as amended.
|
Depositary:
|
The Bank of New York | |
Timing
and Settlement for ADRs:
|
The ADRs will be deposited with a custodian for, and registered in the name of a nominee of, The Depository Trust Company, or DTC, in New York, New York. DTC and its direct and indirect participants will maintain records that will show the beneficial interests in the ADRs and facilitate any transfer of the beneficial interests. | |
Nasdaq
Stock Market symbol for ADRs:
|
“XTLB” |
Year
Ended December 31,
|
||||||||||||||||
2005
|
2004
|
2003
|
2002
|
2001
|
||||||||||||
|
(In
thousands, except per share amounts)
|
|||||||||||||||
Statements
of Operations Data:
|
||||||||||||||||
Revenues
|
|
|
|
|
||||||||||||
Reimbursed
out of pocket expenses
|
$
|
2,743
|
$
|
3,269
|
$
|
--
|
$
|
--
|
$
|
--
|
||||||
License
|
454
|
185
|
--
|
--
|
--
|
|||||||||||
3,197
|
3,454
|
--
|
--
|
--
|
||||||||||||
Cost
of Revenues
|
|
|
|
|
||||||||||||
Reimbursed
out of pocket expenses
|
2,743
|
3,269
|
--
|
--
|
--
|
|||||||||||
License
|
54
|
32
|
--
|
--
|
--
|
|||||||||||
2,797
|
3,301
|
|
|
|
||||||||||||
Gross
Margin
|
400
|
153
|
--
|
--
|
--
|
|||||||||||
|
|
|
|
|
|
|||||||||||
Research
and development
|
|
|
|
|
|
|||||||||||
Research
and development costs
|
7,313
|
11,985
|
14,022
|
13,231
|
12,187
|
|||||||||||
Less
participations
|
--
|
--
|
3,229
|
75
|
1,133
|
|||||||||||
|
7,313
|
11,985
|
10,793
|
13,156
|
11,054
|
|||||||||||
In-process
research and development
|
1,783
|
--
|
--
|
--
|
--
|
|||||||||||
General
and administrative
|
5,457
|
4,134
|
3,105
|
3,638
|
3,001
|
|||||||||||
Business
development costs
|
227
|
810
|
664
|
916
|
1,067
|
|||||||||||
|
|
|
|
|||||||||||||
Operating
loss
|
(14,380
|
)
|
(16,776
|
)
|
(14,562
|
)
|
(17,710
|
)
|
(15,122
|
)
|
||||||
|
|
|
||||||||||||||
Other
income (expense)
|
|
|
|
|
||||||||||||
Financial
income, net
|
443
|
352
|
352
|
597
|
2,448
|
|||||||||||
Taxes
on income
|
(78
|
)
|
(49
|
)
|
(78
|
)
|
(27
|
)
|
--
|
|||||||
|
|
|
|
|
||||||||||||
Net
loss
|
$
|
(14,015
|
)
|
$
|
(16,473
|
)
|
$
|
(14,288
|
)
|
$
|
(17,140
|
)
|
$
|
(12,674
|
)
|
|
|
|
|
||||||||||||||
Net
loss per ordinary share
|
|
|
||||||||||||||
Basic
and diluted
|
$
|
(0.08
|
)
|
$
|
(0.12
|
)
|
$
|
(0.13
|
)
|
$
|
(0.15
|
)
|
$
|
(0.11
|
)
|
|
Weighted
average shares outstanding
|
170,123,003
|
134,731,766
|
111,712,916
|
111,149,292
|
110,941,014
|
|||||||||||
As
of December 31,
|
||||||||||||||||
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
2002
|
|
|
2001
|
|||
|
(In
thousands, except per share amounts)
|
|||||||||||||||
Balance
Sheet Data:
|
||||||||||||||||
Cash,
cash equivalents, bank deposits and
marketable
securities
|
$
|
13,360
|
$
|
22,924
|
$
|
22,262
|
$
|
35,706
|
$
|
52,188
|
||||||
Working
capital
|
11,385
|
20,240
|
19,967
|
33,396
|
50,433
|
|||||||||||
Total
assets
|
15,151
|
25,624
|
24,853
|
38,423
|
55,106
|
|||||||||||
Long-term
obligations
|
1,493
|
2,489
|
1,244
|
1,017
|
526
|
|||||||||||
Total
shareholders’ equity
|
11,252
|
19,602
|
20,608
|
34,830
|
51,953
|
(1)
|
issued
1,314,420 of our ordinary shares with an aggregate value of $1,391,000
(calculated based upon the average of the closing prices per share
for the
period commencing two days before, and ending two days after, the
closing
of the transaction);
|
(2)
|
paid
approximately $400,000 to VivoQuest to fund certain of their operating
expenses prior to the closing of the transaction, and incurred $148,000
in
direct expenses associated with the transaction;
|
(3)
|
agreed
to make additional contingent milestone payments triggered by certain
regulatory and sales targets, totaling up to $34.6 million, $25.0
million
of which will be due upon or following regulatory approval or actual
product sales, which are payable in cash or ordinary shares at our
election (no contingent consideration has been paid pursuant to the
license agreement as of the balance sheet date, because none of the
milestones have been achieved - the contingent consideration will
be
recorded as part of the acquisition costs in the future); and
|
(4)
|
agreed
to make royalty payments on future product
sales.
|
($
in thousands)
|
||||
Fair
value of XTLbio’s ordinary shares
|
$ |
1,391
|
||
Cash
consideration paid
|
400
|
|||
Direct
expenses associated with the VivoQuest transaction
|
148
|
|||
Total
purchase price
|
$ |
1,939
|
||
($
in thousands)
|
||||
Tangible
assets acquired - property and equipment
|
$ |
113
|
||
Intangible
assets acquired:
|
||||
In-process
research and development
|
1,783
|
|||
Assembled
workforce
|
43
|
|||
Total
intangible assets acquired
|
1,826
|
|||
Total
tangible and intangible assets acquired
|
$ |
1,939
|
|
Historical
XTLbio
|
Historical
VivoQuest1
|
Pro
forma
adjustments
|
Pro
forma
combined
|
|||||||||
Revenues
|
$ |
3,197
|
--
|
--
|
$ |
3,197
|
|||||||
Cost
of revenues
|
2,797
|
--
|
--
|
2,797
|
|||||||||
Gross
margin
|
400
|
--
|
--
|
400
|
|||||||||
Research
and development
|
7,313
|
2,186
|
623(a)(b
|
)
|
10,122
|
||||||||
In-process
research and development
|
1,783
|
--
|
(1,783)(c
|
)
|
--
|
||||||||
General
and administrative
|
5,457
|
740
|
70(b
|
)
|
6,267
|
||||||||
Business
development
|
227
|
--
|
--
|
227
|
|||||||||
Depreciation
and amortization
|
--
|
282
|
(282)(b
|
)
|
--
|
||||||||
Operating
loss
|
(14,380
|
)
|
(3,208
|
)
|
|
(16,216
|
)
|
||||||
Other
income (expense)
|
|||||||||||||
Financial
income, net
|
443
|
(342
|
)
|
358(d
|
)
|
459
|
|||||||
Dividends
on preferred stock
|
--
|
(1,108
|
)
|
1,108(e
|
)
|
|
|||||||
Taxes
on income
|
(78
|
)
|
--
|
(78
|
)
|
||||||||
Net
loss
|
$ |
(14,015
|
)
|
(4,568
|
)
|
|
$ |
(15,835
|
)
|
||||
Net
loss per ordinary share
|
(0.08
|
)
|
(0.09
|
)
|
|||||||||
Weighted
average shares outstanding
|
170,123,003
|
947,102(f |
)
|
171,070,105
|
|
(a)
|
An
amount of $400,000 representing the interim funding provided by XTLbio
to
VivoQuest which reduced VivoQuest’s research and development costs has
been eliminated (the amount has been included in in-process research
and
development in our historical financial statements). In addition,
an
amount of $11,000 has been included to account for the amortization
of the
assembled workforce, as if the transaction had occurred on January
1,
2005.
|
|
(b)
|
VivoQuest’s
historical depreciation and amortization expense of $282,000 has
been
allocated between research and development ($212,000) and general
and
administrative ($70,000).
|
|
(c)
|
The
one-time charge of $1,783,000 to expense for the fair value of the
in-process research and development has been excluded from the unaudited
pro forma condensed combined consolidated statement of operations
due to
its non-recurring nature.
|
|
(d)
|
Interest
expense of $358,000 related to VivoQuest’s convertible debentures, that
were not assumed, has been eliminated.
|
|
(e)
|
Dividends
on preferred stock of $1,018,000, that were not assumed, have been
eliminated.
|
(f)
|
An
amount of 947,102 ordinary shares have been added to the weighted
average
shares outstanding to present the weighted average shares outstanding
as
if the transaction had occurred on January 1,
2005.
|
·
|
assist
us in developing, testing and obtaining regulatory approval for some
of
our compounds and technologies;
|
·
|
manufacture
our drug candidates; and
|
·
|
market
and distribute our products.
|
·
|
perceptions
by members of the health care community, including physicians, of
the
safety and efficacy of our products;
|
·
|
the
rates of adoption of our products by medical practitioners and the
target
populations for our products;
|
·
|
the
potential advantages that our products offer over existing treatment
methods or other products that may be developed;
|
·
|
the
cost-effectiveness of our products relative to competing products;
|
·
|
the
availability of government or third-party payor reimbursement for
our
products;
|
·
|
the
side effects or unfavorable publicity concerning our products or
similar
products; and
|
·
|
the
effectiveness of our sales, marketing and distribution efforts.
|
·
|
difficulty
and expense of assimilating the operations, technology and personnel
of
the acquired business;
|
·
|
our
inability to retain the management, key personnel and other employees
of
the acquired business;
|
·
|
our
inability to maintain the acquired company’s relationship with key third
parties, such as alliance partners;
|
·
|
exposure
to legal claims for activities of the acquired business prior to
the
acquisition;
|
·
|
the
diversion of our management’s attention from our core business; and
|
·
|
the
potential impairment of substantial goodwill and write-off of in-process
research and development costs, adversely affecting our reported
results
of operations.
|
·
|
decreased
demand for a product;
|
·
|
injury
to our reputation;
|
·
|
inability
to continue to develop a drug candidate or technology;
|
·
|
withdrawal
of clinical trial volunteers; and
|
·
|
loss
of revenues.
|
·
|
the
progress of our development activities;
|
·
|
the
progress of our research activities;
|
·
|
the
number and scope of our development programs;
|
·
|
our
ability to establish and maintain current and new licensing or acquisition
arrangements;
|
·
|
our
ability to achieve our milestones under our licensing arrangements;
|
·
|
the
costs involved in enforcing patent claims and other intellectual
property
rights; and
|
·
|
the
costs and timing of regulatory approvals.
|
·
|
developments
concerning our drug candidates;
|
·
|
announcements
of technological innovations by us or our competitors;
|
·
|
introductions
or announcements of new products by us or our competitors;
|
·
|
announcements
by us of significant acquisitions, strategic partnerships, joint
ventures
or capital commitments;
|
·
|
changes
in financial estimates by securities analysts;
|
·
|
actual
or anticipated variations in interim operating results;
|
·
|
expiration
or termination of licenses, research contracts or other collaboration
agreements;
|
·
|
conditions
or trends in the regulatory climate and the biotechnology and
pharmaceutical industries;
|
·
|
changes
in the market valuations of similar companies; and
|
·
|
additions
or departures of key personnel.
|
·
|
there
is a limitation on acquisition of any level of control of the company;
or
|
·
|
the
acquisition of any level of control requires the purchaser to do
so by
means of a tender offer to the
public.
|
|
British
Pence (p)
|
U.S.
Dollar
|
|||||||||||
Last
Six Calendar Months
|
High
|
Low
|
High
|
Low
|
|||||||||
March
2006
|
44.00
|
34.25
|
0.77
|
0.60
|
|||||||||
February
2006
|
40.25
|
35.25
|
0.70
|
0.61
|
|||||||||
January
2006
|
45.00
|
40.25
|
0.78
|
0.70
|
|||||||||
December
2005
|
48.25
|
42.00
|
0.84
|
0.73
|
|||||||||
November
2005
|
53.00
|
44.75
|
0.92
|
0.78
|
|||||||||
October
2005
|
52.25
|
44.75
|
0.91
|
0.78
|
|||||||||
Financial
Quarters During the Past Two Full Fiscal Years
|
|||||||||||||
First
Quarter of 2006
|
45.00
|
34.25
|
0.78
|
0.60
|
|||||||||
Fourth
Quarter of 2005
|
53.00
|
42.00
|
0.92
|
0.73
|
|||||||||
Third
Quarter of 2005
|
61.75
|
38.00
|
1.08
|
0.66
|
|||||||||
Second
Quarter of 2005
|
40.50
|
36.00
|
0.71
|
0.63
|
|||||||||
First
Quarter of 2005
|
43.50
|
26.00
|
0.76
|
0.45
|
|||||||||
Fourth
Quarter of 2004
|
25.50
|
13.00
|
0.44
|
0.23
|
|||||||||
Third
Quarter of 2004
|
19.50
|
13.75
|
0.34
|
0.24
|
|||||||||
Second
Quarter of 2004
|
32.25
|
17.00
|
0.56
|
0.30
|
|||||||||
Last
Five Full Financial Years
|
|||||||||||||
2005
|
61.75
|
26.00
|
1.08
|
0.45
|
|||||||||
2004
|
32.25
|
13.00
|
0.56
|
0.23
|
|||||||||
2003
|
18.75
|
5.75
|
0.33
|
0.10
|
|||||||||
2002
|
64.00
|
11.50
|
1.11
|
0.20
|
|||||||||
2001
|
153.00
|
33.50
|
2.67
|
0.58
|
|
New
Israeli Shekel
|
U.S.
Dollar
|
|||||||||||
Last
Six Calendar Months
|
High
|
Low
|
High
|
Low
|
|||||||||
March
2006
|
3.61
|
2.86
|
0.77
|
0.61
|
|||||||||
February
2006
|
3.35
|
2.93
|
0.72
|
0.63
|
|||||||||
January
2006
|
3.66
|
3.21
|
0.78
|
0.69
|
|||||||||
December
2005
|
3.94
|
3.44
|
0.84
|
0.74
|
|||||||||
November
2005
|
4.31
|
3.69
|
0.92
|
0.79
|
|||||||||
October
2005
|
4.38
|
3.65
|
0.94
|
0.78
|
|||||||||
Financial Quarters Since Listing | |||||||||||||
First
Quarter of 2006
|
3.66
|
2.86
|
0.78
|
0.61
|
|||||||||
Fourth
Quarter of 2005
|
4.38
|
3.44
|
0.94
|
0.74
|
|||||||||
U.S.
Dollar
|
|||||||
Last
Six Calendar Months
|
High
|
Low
|
|||||
March 2006
|
7.95
|
6.13
|
|||||
February 2006
|
7.23
|
6.39
|
|||||
January 2006
|
8.12
|
6.90
|
|||||
December 2005
|
8.84
|
7.10
|
|||||
November 2005
|
9.08
|
7.86
|
|||||
October 2005
|
9.50
|
7.91
|
|||||
Financial Quarters Since Listing | |||||||
First Quarter of 2006
|
8.12 | 6.13 | |||||
Fourth Quarter of 2005
|
9.50 | 7.10 |
(In
thousands, except per share amounts)
|
As
of
December
31, 2005
|
Private
Placement March 2006
|
As
Adjusted
|
|||||||
Cash,
cash equivalents, bank deposits and
marketable securities
|
$
|
13,360
|
$
|
24,400
|
$
|
37,760
|
||||
Shareholders’
equity:
|
||||||||||
Ordinary
shares of NIS 0.02 par value (authorized
300,000,000 as of December
31, 2005; issued and outstanding:
173,180,441 as of December
31, 2005; issued and outstanding as
adjusted for the private placement: 219,847,111)
|
864
|
200
|
1,064
|
|||||||
Additional
paid in capital
|
110,179
|
24,200
|
134,379
|
|||||||
Deficit
accumulated during development stage
|
(99,791
|
)
|
--
|
(99,791
|
)
|
|||||
Total
shareholders’ equity
|
11,252
|
24,400
|
35,652
|
|||||||
Total
capitalization
|
$
|
11,252
|
$
|
24,400
|
$
|
35,652
|
Year
Ended December 31,
|
||||||||||||||||
|
2005
|
2004
|
2003
|
2002
|
2001
|
|||||||||||
(In
thousands, except per share amounts)
|
||||||||||||||||
Statements
of Operations Data:
|
||||||||||||||||
Revenues
|
|
|
|
|
||||||||||||
Reimbursed
out of pocket expenses
|
$
|
2,743
|
$
|
3,269
|
$
|
--
|
$
|
--
|
$
|
--
|
||||||
License
|
454
|
185
|
--
|
--
|
--
|
|||||||||||
3,197
|
3,454
|
--
|
--
|
--
|
||||||||||||
Cost
of Revenues
|
|
|
|
|
||||||||||||
Reimbursed
out of pocket expenses
|
2,743
|
3,269
|
--
|
--
|
--
|
|||||||||||
License
|
54
|
32
|
--
|
--
|
--
|
|||||||||||
2,797
|
3,301
|
|
|
|
||||||||||||
Gross
Margin
|
400
|
153
|
--
|
--
|
--
|
|||||||||||
|
|
|
|
|
|
|||||||||||
Research
and development
|
|
|
|
|
|
|||||||||||
Research
and development costs
|
7,313
|
11,985
|
14,022
|
13,231
|
12,187
|
|||||||||||
Less
participations
|
--
|
--
|
3,229
|
75
|
1,133
|
|||||||||||
|
7,313
|
11,985
|
10,793
|
13,156
|
11,054
|
|||||||||||
In-process
research and development
|
1,783
|
--
|
--
|
--
|
--
|
|||||||||||
General
and administrative
|
5,457
|
4,134
|
3,105
|
3,638
|
3,001
|
|||||||||||
Business
development costs
|
227
|
810
|
664
|
916
|
1,067
|
|||||||||||
|
|
|
|
|||||||||||||
Operating
loss
|
(14,380
|
)
|
(16,776
|
)
|
(14,562
|
)
|
(17,710
|
)
|
(15,122
|
)
|
||||||
|
|
|
||||||||||||||
Other
income (expense)
|
|
|
|
|
||||||||||||
Financial
income, net
|
443
|
352
|
352
|
597
|
2,448
|
|||||||||||
Taxes
on income
|
(78
|
)
|
(49
|
)
|
(78
|
)
|
(27
|
)
|
--
|
|||||||
|
|
|
|
|
||||||||||||
Net
loss
|
$
|
(14,015
|
)
|
$
|
(16,473
|
)
|
$
|
(14,288
|
)
|
$
|
(17,140
|
)
|
$
|
(12,674
|
)
|
|
|
|
|
||||||||||||||
Net
loss per ordinary share
|
|
|
||||||||||||||
Basic
and diluted
|
$
|
(0.08
|
)
|
$
|
(0.12
|
)
|
$
|
(0.13
|
)
|
$
|
(0.15
|
)
|
$
|
(0.11
|
)
|
|
Weighted
average shares outstanding
|
170,123,003
|
134,731,766
|
111,712,916
|
111,149,292
|
110,941,014
|
As
of December 31,
|
||||||||||||||||
|
2005
|
2004
|
2003
|
2002
|
2001
|
|||||||||||
|
(In
thousands, except per share amounts)
|
|||||||||||||||
Balance
Sheet Data:
|
||||||||||||||||
Cash,
cash equivalents, bank deposits and marketable
securities
|
$
|
13,360
|
$
|
22,924
|
$
|
22,262
|
$
|
35,706
|
$
|
52,188
|
||||||
Working
capital
|
11,385
|
20,240
|
19,967
|
33,396
|
50,433
|
|||||||||||
Total
assets
|
15,151
|
25,624
|
24,853
|
38,423
|
55,106
|
|||||||||||
Long-term
obligations
|
1,493
|
2,489
|
1,244
|
1,017
|
526
|
|||||||||||
Total
shareholders’ equity
|
11,252
|
19,602
|
20,608
|
34,830
|
51,953
|
·
|
the
timing of expenses associated with manufacturing and product development
of the proprietary drug candidates within our portfolio and those
that may
be in-licensed, partnered or acquired;
|
·
|
our
ability to achieve our milestones under licensing
arrangements;
|
·
|
the
timing of the in-licensing, partnering and acquisition of new product
opportunities; and
|
·
|
the
costs involved in prosecuting and enforcing patent claims and other
intellectual property rights.
|
Payment
due by period
|
||||||||||||||||
Contractual
obligations
|
Total
|
Less
than
1
year
|
1-3
years
|
3-5
years
|
More
than
5
years
|
|||||||||||
Research
& development agreements
|
$
|
652,000
|
$
|
585,000
|
$
|
67,000
|
$
|
--
|
$
|
--
|
||||||
Operating
leases
|
2,067,000
|
720,000
|
921,000
|
426,000
|
--
|
|||||||||||
Total
|
$
|
2,719,000
|
$
|
1,305,000
|
$
|
988,000
|
$
|
426,000
|
$
|
--
|
Years
ended December 31,
|
|||||||||||||
2005
|
2004
|
2003
|
Cumulative,
as of December 31, 2005
|
||||||||||
XTL-2125
|
|||||||||||||
Research
and development costs
|
$
|
3,367,000
|
$
|
3,232,000
|
$
|
1,780,000
|
$
|
9,365,000
|
|||||
Less
participations
|
--
|
--
|
(168,000
|
)
|
(168,000
|
)
|
|||||||
3,367,000
|
3,232,000
|
1,612,000
|
9,197,000
|
||||||||||
XTL-6865
|
|||||||||||||
Research
and development costs
|
2,706,000
|
5,452,000
|
6,287,000
|
21,619,000
|
|||||||||
Less
participations
|
--
|
--
|
(1,459,000
|
)
|
(2,540,000
|
)
|
|||||||
2,706,000
|
5,452,000
|
4,828,000
|
19,079,000
|
||||||||||
HepeX-B1
|
|||||||||||||
Research
and development costs
|
2,743,000
|
6,570,000
|
4,036,000
|
26,985,000
|
|||||||||
Less
participations
|
(2,743,000
|
)
|
(3,269,000
|
)
|
(1,602,000
|
)
|
(10,173,000
|
)
|
|||||
|
--
|
3,301,000
|
2,434,000
|
16,812,000
|
|||||||||
Other
research and development programs2
|
|||||||||||||
Research
and development costs
|
1,240,000
|
--
|
1,919,000
|
30,933,000
|
|||||||||
Less
participations
|
--
|
--
|
--
|
(4,081,000
|
)
|
||||||||
1,240,000
|
--
|
1,919,000
|
26,852,000
|
||||||||||
Total
Research and development
|
|||||||||||||
Research
and development costs
|
10,056,000
|
15,254,000
|
14,022,000
|
88,902,000
|
|||||||||
Less
participations
|
(2,743,000)
|
(3,269,000)
|
(3,229,000
|
)
|
(16,962,000)
|
||||||||
7,313,000
|
11,985,000
|
10,793,000
|
71,940,000
|
·
|
XTL-2125
is
being developed for the treatment of hepatitis C. XTL-2125 is a novel
orally-available non-nucleoside HCV RNA polymerase inhibitor. XTL-2125
has
demonstrated potent activity against the hepatitis C virus in several
pre-clinical systems. IND-enabling GLP studies demonstrated that
XTL-2125
has favorable oral pharmacokinetics and a good safety profile in
multiple
animal species. In May 2006, we announced the initiation of a Phase
I,
placebo-controlled, dose escalation trial of XTL-2125 in chronic
HCV
patients. The compound was in-licensed by us from B&C Biopharm Co.,
Ltd., a Korean drug development company.
|
·
|
XTL-6865
is
also being developed for the treatment of hepatitis C. XTL-6865 (formerly
known as the HepeX-C program) is a combination of two fully human
monoclonal antibodies (Ab68 and Ab65) against the hepatitis C virus
E2
envelope protein. The antibodies comprising XTL-6865 are expected
to
“trap” the virus in the patient’s serum and prevent the infection of
healthy liver cells. A single antibody version of this product was
tested
in a pilot clinical program that included both Phase I and Phase
II
clinical trials. In April 2005, we submitted an IND to the FDA in
order to
commence a Phase Ia/Ib clinical trial for XTL-6865, the dual-antibody
product. In September 2005, we announced the initiation of a Phase
Ia
clinical trial with XTL-6865 in patients with chronic hepatitis
C.
|
·
|
DOS
is
a pre-clinical program focused on the development of novel hepatitis
C
small molecule inhibitors. Compounds developed to date inhibit HCV
replication in a pre-clinical cell-based assay with potencies comparable
to clinical stage drugs. These compounds are presently being optimized.
We
expect to identify the first clinical candidate from the Diversity
Oriented Synthesis, or DOS, program and start IND-enabling GLP-safety
studies with this clinical candidate in the second half of 2006.
|
·
|
HepeX-B
is
being developed to prevent re-infection with hepatitis B, known as
HBV, in
liver transplant patients. HepeX-B is a mixture of two fully human
monoclonal antibodies, which bind to the HBV surface antigen, or
HBsAg. In
December 2005, data from the Phase IIb trial in liver transplant
patients
showed that patients treated with HepeX-B experienced no evidence
of viral
reinfection. Worldwide rights for HepeX-B were licensed to Cubist
in 2004,
in exchange for certain milestone payments and future royalties on
Cubist’s net sales. Cubist recently met with the FDA to discuss proposed
changes to the method of manufacture and formulation of HepeX-B.
Cubist is
expected to meet with the FDA again in the first half of 2006 to
discuss
the implications of these changes on the next stage of the clinical
program.
|
·
|
continue
the clinical development of XTL-2125 and XTL-6865;
|
·
|
identify
clinical candidates from our DOS program and advance them into clinical
development; and
|
·
|
seek
to in-license or acquire additional
candidates.
|
·
|
A
Phase Ia/Ib Clinical Program in Patients with Chronic
HCV,
which
demonstrated the safety and tolerability of using single and multi-doses
of Ab 68 up to 120mg for a 28 day dosing period. In terms of efficacy,
eight out of 25 patients had at least a 90% reduction in HCV-RNA
levels
from pre-treatment levels following administration of Ab68. These
trials
provided safety data, as well as a preliminary indication of anti-viral
activity in humans.
|
·
|
A
Phase IIa Clinical Trial with Ab68 Following Liver
Transplant,
which demonstrated the safety and tolerability of Ab68 up to 240mg
for a
12 week dosing period. The study was planned as a blinded,
placebo-controlled, dose-escalating study in a total of 24 liver
transplant patients receiving six different doses of Ab68 (20mg,
40mg,
80mg, 120mg, 240mg, and 480mg). Ab68 was administered once during
the
transplantation, then up to three times during the first 24 hours
following transplantation, then daily during the following six days,
and
then in decreasing frequency during the following eleven weeks. The
480mg
dose level was not tested due to a clinical hold as a result of an
intraoperative death of the first patient tested at the 480mg dose
level
(later determined by the medical examiner to be related to pulmonary
emboli (blood clots in the lung). The FDA later cleared the clinical
hold,
but we decided to discontinue the study and focus further development
efforts on the dual antibody product, XTL-6865. No other drug-related
serious adverse events were reported during this study.
|
During
the period of daily dosing (the first seven days following the
transplant), reduction in viral load from baseline were greater in
the two
highest dose groups (120 mg and 240 mg) compared to the placebo group.
On
day one following the transplant (when Ab68 was administered three
times)
the median reduction in viral load from baseline of the highest dose
group
(240mg) was 1-log (90%) greater than the placebo group. The 120mg
and
240mg dose groups had a greater reduction in viral load than the
placebo
group during the first week when dosed daily. This effect was less
evident
when dosed less frequently than daily. This data provided additional
evidence of anti-viral activity in immunosuppressed patients. It
should be
noted that the small number of patients in this pilot study did not allow
us to draw statistical analysis.
|
·
|
to
generate humanized monoclonal antibodies, or hMAbs (the “Trimera hMAb
Technology”); and/or
|
·
|
as
an animal model of human disease (the “Trimera Model Technology”).
|
·
|
is
intended to treat a serious or life-threatening
condition;
|
·
|
is
intended to treat a serious aspect of the condition;
and
|
·
|
has
the potential to address unmet medical needs, and this potential
is being
evaluated in the planned drug development
program.
|
·
|
Phase
I:
The drug is administered to a small group of humans, either healthy
volunteers or patients, to test for safety, dosage tolerance, absorption,
metabolism, excretion, and clinical pharmacology.
|
·
|
Phase
II:
Studies are conducted on a larger number of patients to assess the
efficacy of the product, to ascertain dose tolerance and the optimal
dose
range, and to gather additional data relating to safety and potential
adverse events.
|
·
|
Phase
III:
Studies establish safety and efficacy in an expanded patient population.
|
·
|
Phase
IV:
The FDA may require a Phase IV to conduct post-marketing studies
for
purposes of gathering additional evidence of safety and
efficacy.
|
·
|
slow
patient enrollment due to the nature of the clinical trial plan,
the
proximity of patients to clinical sites, the eligibility criteria
for
participation in the study or other factors;
|
·
|
inadequately
trained or insufficient personnel at the study site to assist in
overseeing and monitoring clinical trials or delays in approvals
from a
study site’s review board;
|
·
|
longer
treatment time required to demonstrate efficacy or determine the
appropriate product dose;
|
·
|
insufficient
supply of the drug candidates;
|
·
|
adverse
medical events or side effects in treated patients; and
|
·
|
ineffectiveness
of the drug candidates.
|
Name
|
Age
|
Position
|
||
Michael
S. Weiss
|
40
|
Chairman
of the Board of Directors
|
||
William
J. Kennedy, Ph.D
|
61
|
Non
Executive Director
|
||
Ido
Seltenreich (1)
|
34
|
Non
Executive and External Director
|
||
Vered
Shany, D.M.D (1)
|
41
|
Non
Executive and External Director
|
||
Jonathan
R. Spicehandler, M.D
|
57
|
Non
Executive Director
|
||
Ben
Zion Weiner, Ph.D (1)
|
61
|
Non
Executive Director
|
||
Ron
Bentsur
|
40
|
Chief
Executive Officer
|
||
Jonathan
Burgin (1)
|
44
|
Chief
Financial Officer
|
·
|
first,
our audit committee reviews the proposal for
compensation;
|
·
|
second,
provided that the audit committee approves the proposed compensation,
the
proposal is then submitted to our board of directors for review,
except
that a director who is the beneficiary of the proposed compensation
does
not participate in any discussion or voting with respect to such
proposal;
and
|
·
|
finally,
if our board of directors approves the proposal, it must then submit
its
recommendation to our shareholders, which is usually done in connection
with our shareholders’ general
meeting.
|
·
|
an
employment relationship;
|
·
|
a
business or professional relationship maintained on a regular
basis;
|
·
|
control;
and
|
·
|
service
as an office holder, other than service as an officer for a period
of not
more than three months, during which the company first offered shares
to
the public.
|
·
|
the
majority of shares voted at the meeting, including at least one-third
of
the shares held by non-controlling shareholders voted at the meeting,
vote
in favor of election of the director, with abstaining votes not being
counted in this vote; or
|
·
|
the
total number of shares held by non-controlling shareholders voted
against
the election of the director does not exceed one percent of the aggregate
voting rights in the company.
|
Year
ended December 31,
|
||||||||||
2005
|
2004
|
2003
|
||||||||
Research
and Development
|
||||||||||
Israel
|
22
|
44
|
42
|
|||||||
U.S
|
19
|
8
|
5
|
|||||||
41
|
52
|
47
|
||||||||
Financial
and general management
|
||||||||||
Israel
|
4
|
7
|
6
|
|||||||
U.S
|
--
|
--
|
--
|
|||||||
4
|
7
|
6
|
||||||||
Business
development
|
||||||||||
Israel
|
--
|
--
|
--
|
|||||||
U.S
|
1
|
1
|
2
|
|||||||
1
|
1
|
2
|
||||||||
Total
|
46
|
60
|
55
|
|||||||
Average
number of full-time employees
|
54
|
58
|
68
|
Amount
and nature of beneficial ownership
|
|||||||||||||
|
Ordinary
shares
beneficially
owned
excluding
options
|
Options
exercisable
within
60 days
of March 31,
2006
|
Total
ordinary
shares
beneficially
owned
|
Percent
of
ordinary
shares
beneficially
owned(1)
|
|||||||||
Michael
S. Weiss
Chairman
of the Board
|
--
|
3,083,333
|
3,083,333
|
1.75
|
%
|
||||||||
William
Kennedy
Director
|
--
|
--
|
--
|
--
|
|||||||||
Jonathan
Spicehandler
Director
|
--
|
--
|
--
|
--
|
|||||||||
Ben
Zion Weiner
Director
|
--
|
666,667
|
666,667
|
0.38
|
%
|
||||||||
Ido
Seltenreich
Director
|
250,000
|
--
|
250,000
|
0.14
|
%
|
||||||||
Vered
Shany
Director
|
--
|
--
|
--
|
--
|
|||||||||
Ron
Bentsur
Chief
Executive Officer
|
--
|
--
|
--
|
--
|
|||||||||
Jonathan
Burgin
Chief
Financial Officer
|
20,000
|
1,382,053
|
1,402,053
|
0.80
|
%
|
||||||||
All
directors and executive officers as a group
(8 persons)
|
270,000
|
5,132,053
|
5,402,053
|
3.03
|
%
|
||||||||
|
|
Name
and Address of Selling Shareholder
|
Number
of ADRs representing ordinary shares obtained as the result of the
private
placement and registered hereby (includes ADRs receivable upon the
exercise of Warrants)
|
Number
of ADRs receivable upon the exercise of Warrants
|
Number
of ADRs representing ordinary shares obtained as the result of the
private
placement and registered hereby beneficially owned as of the date
hereof
(1)
|
|||||||
Catalytix,
LDC
c/o
CIBC Bank and Trust Company (Cayman) Limited
CIBC
Financial Centre
11
Dr. Roy’s Drive
P.O.
Box 694 GT
Grand
Cayman, Cayman Islands, B.W.I.
|
18,750
|
6,250
|
0
|
|||||||
Catalytix
LDC Life Science Hedge AC
c/o
CIBC Bank and Trust Company (Cayman) Limited
CIBC
Financial Centre
11
Dr. Roy’s Drive
P.O.
Box 694 GT
Grand
Cayman, Cayman Islands, B.W.I.
|
18,750
|
6,250
|
0
|
|||||||
Formula
Investment House, Ltd.
Trident
Chambers, P.O. Box 146
Road
Town, Tortola
British
Virgin Islands
|
75,000
|
25,000
|
0
|
|||||||
GLG
North American Opportunity Fund
Walker
House
P.O.
Box 908GT
George
Town, Grand Cayman
Cayman
Islands
|
249,999
|
83,333
|
0
|
|||||||
North
Sound Legacy Institutional Fund LLC
c/o
North Sound Capital LLC
20
Horseneck Lane
Greenwich,
CT 06830
|
210,000
|
70,000
|
0
|
Name
and Address of Selling Shareholder
|
Number
of ADRs representing ordinary shares obtained as the result of
the private
placement and registered hereby (includes ADRs receivable upon
the
exercise of Warrants)
|
Number
of ADRs receivable upon the exercise of Warrants
|
Number
of ADRs representing ordinary shares obtained as the result of
the private
placement and registered hereby beneficially owned as of the date
hereof
(1)
|
North
Sound Legacy International Ltd.
c/o
North Sound Capital LLC
20
Horseneck Lane
Greenwich,
CT 06830
|
540,000
|
180,000
|
0
|
|||||||
Merlin
Biomed, LP
230
Park Avenue, Suite 928
New
York, NY 10169
|
195,000
|
65,000
|
0
|
|||||||
Merlin
Biomed Round Table Fund, LP
230
Park Avenue, Suite 928
New
York, NY 10169
|
11,550
|
3,850
|
0
|
|||||||
Merlin
Biomed II, LP
230
Park Avenue, Suite 928
New
York, NY 10169
|
57,949.5
|
19,316.5
|
0
|
|||||||
Merlin
Biomed International, Ltd.
230
Park Avenue, Suite 928
New
York, NY 10169
|
235,500
|
78,500
|
0
|
|||||||
Capital
Ventures International
c/o
Heights Capital Management, Inc.
101
California Street, Suite 3250
San
Francisco, CA 94111
|
124,999.5
|
41,666.5
|
0
|
|||||||
RAQ,
LLC
787
Seventh Ave., 48th
Floor
New
York, NY 10019
|
62,500.5
|
20,833.5
|
0
|
|||||||
Valesco
Healthcare Partners I LP
787
Seventh Ave., 48th
Floor
New
York, NY 10019
|
21,000
|
7,000
|
0
|
|||||||
Valesco
Healthcare Partners II LP
787
Seventh Ave., 48th
Floor
New
York, NY 10019
|
43,999.5
|
14,666.5
|
0
|
|||||||
Valesco
Healthcare Overseas Fund, Ltd.
787
Seventh Ave., 48th
Floor
New
York, NY 10019
|
34,999.5
|
11,666.5
|
0
|
|||||||
Fore
Convertible Master Fund, Ltd.
c/o
Fore Research & Management, L.P.
280
Park Avenue, 43rd
Floor
New
York, NY 10017
|
323,100
|
107,700
|
0
|
|||||||
Fore
Multi Strategy Master Fund, Ltd.
c/o
Fore Research & Management, L.P.
280
Park Avenue, 43rd
Floor
New
York, NY 10017
|
201,450
|
67,150
|
0
|
|||||||
Fore
Erisa Fund, Ltd.
c/o
Fore Research & Management, L.P.
280
Park Avenue, 43rd
Floor
New
York, NY 10017
|
39,450
|
13,150
|
0
|
Name
and Address of Selling Shareholder
|
Number
of ADRs representing ordinary shares obtained as the result of
the private
placement and registered hereby (includes ADRs receivable upon
the
exercise of Warrants)
|
Number
of ADRs receivable upon the exercise of Warrants
|
Number
of ADRs representing ordinary shares obtained as the result of
the private
placement and registered hereby beneficially owned as of the date
hereof
(1)
|
Man
Mac 1, Ltd.
c/o
Fore Research & Management, L.P.
280
Park Avenue, 43rd
Floor
New
York, NY 10017
|
186,000
|
62,000
|
0
|
|||||||
Narragensett
I, LP
540
Madison Avenue, 38th
Floor
New
York, NY 10022
|
360,000
|
120,000
|
0
|
|||||||
Narragensett
Offshore, Ltd.
540
Madison Avenue, 38th
Floor
New
York, NY 10022
|
390,000
|
130,000
|
0
|
|||||||
Highbridge
International LLC
c/o
Highbridge Capital Management, LLC
9
W. 57th
Street, 27th
Floor
New
York, NY 10019
|
750,000
|
250,000
|
0
|
|||||||
Portside
Growth and Opportunity Fund
c/o
Ramius Capital Group, LLC
666
Third Avenue, 26th
Floor
New
York, NY 10017
|
249,999
|
83,333
|
0
|
|||||||
Senvest
Master Fund LP
110
East 55th
Street, Suite 1600
New
York, NY 10022
|
156,499.5
|
52,166.5
|
0
|
|||||||
Senvest
Israel Partners LP
110
East 55th
Street, Suite 1600
New
York, NY 10022
|
156,000
|
52,000
|
0
|
|||||||
Sonostar
Capital Partners LLC
191
King Street
Chappaqua,
NY 10514
|
124,999.5
|
41,666.5
|
0
|
|||||||
Kenneth
Hoberman
28
Avenue at Port Imperial #327
West
New York, NJ 07657
|
63,501
|
21,167
|
0
|
|||||||
Nortrust
Nominees Ltd.
c/o
Invesco Asset Management
30
Finsbury Square
London,
England EC2A 1AG
|
1,206
|
402
|
0
|
|||||||
Chase
Nominees Ltd.
c/o
Invesco Asset Management
30
Finsbury Square
London,
England EC2A 1AG
|
43,812
|
14,604
|
0
|
|||||||
Vidacos
Nominees Limited
c/o
Invesco Asset Management
30
Finsbury Square
London,
England EC2A 1AG
|
7,797
|
2,599
|
0
|
Name
and Address of Selling Shareholder
|
Number
of ADRs representing ordinary shares obtained as the result of
the private
placement and registered hereby (includes ADRs receivable upon
the
exercise of Warrants)
|
Number
of ADRs receivable upon the exercise of Warrants
|
Number
of ADRs representing ordinary shares obtained as the result of
the private
placement and registered hereby beneficially owned as of the date
hereof
(1)
|
Vidacos
Nominees Limited
c/o
Invesco Asset Management
30
Finsbury Square
London,
England EC2A 1AG
|
142,185
|
47,395
|
0
|
|||||||
James
Oliviero III
220
Riverside Boulevard, #6A
New
York, NY 10069
|
16,509
|
5,503
|
0
|
|||||||
Diamondback
Master Fund, Ltd.
One
Landmark Square - 15th
Floor
Stamford,
CT 06901
|
249,999
|
83,333
|
0
|
|||||||
Cimarron
Biomedical Equity Master Fund L.P.
2626
Cole Avenue, Suite 400
Dallas,
TX 75204
|
75,000
|
25,000
|
0
|
|||||||
Rock
Securities Limited
20
Balderton Street - 4th
Floor
London,
England WIK 6TL
|
124,999.5
|
41,666.5
|
0
|
|||||||
Iroquois
Master Fund Ltd.
641
Lexington Avenue, 26th
Floor
New
York, NY 10022
|
187,500
|
62,500
|
0
|
|||||||
Bank
Julius Baer & Co. Ltd.
Bahnhofstrasse
36
P.O.
Box
CH-8010
Zurish
|
999,999
|
333,333
|
0
|
|||||||
Apex
Investments Ltd.
2
Koyfman Street
Tel-Aviv,
Israel 68012
|
49,999.5
|
16,666.5
|
0
|
|||||||
Apex
Provident Funds
2
Koyfman Street
Tel-Aviv,
Israel 68012
|
49,999.5
|
16,666.5
|
0
|
|||||||
Yourdent
Ltd.
Sharet
1/26
Natanya,
Israel
|
49,999.5
|
16,666.5
|
0
|
|||||||
Aviv
Raiz
17
Haarbaa Street
Tel
Aviv, Israel
|
99,999
|
33,333
|
0
|
|||||||
Total
|
7,000,000.5
|
2,333,333.5
|
0
|
·
|
ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
|
·
|
block
trades in which the broker-dealer will
attempt
to sell the ADRs as agent but may position and resell a portion of
the
block as principal to facilitate the transaction;
|
·
|
purchases
by a broker-dealer as principal and resale by the broker-dealer for
its
account;
|
·
|
an
exchange distribution in accordance with the rules of the applicable
exchange;
|
·
|
privately
negotiated transactions;
|
·
|
settlement
of short sales created
after the date of the private placement;
|
·
|
broker-dealers
may agree with the Selling Shareholders to sell a specified number
of such
ADRs at a stipulated price per ADR;
|
·
|
a
combination of any such methods of sale; and
|
·
|
any
other method permitted pursuant to applicable
law.
|
Placement
Agents
|
$
|
2,510,000
|
||
Securities
and Exchange Commission Registration Fee
|
$
|
5,540
|
||
Legal
Fees and Expenses
|
$
|
704,460
|
|
|
Accountants'
Fees and Expenses
|
$
|
305,000
|
||
Printing
and Duplicating Expenses
|
$
|
30,000
|
||
Miscellaneous
Expenses
|
$
|
45,000
|
||
Total
|
$
|
3,600,000
|
Beneficial
owner
|
Number
of ordinary shares beneficially owned (1)
|
Percent
of
ownership
(1)
|
|||||
Bank
Julius Baer
|
15,369,644
|
8.87
|
%
|
||||
Perpetual
Income & Growth Investment Trust plc
|
13,732,146
|
7.93
|
%
|
||||
(1) |
Does
not include ADRs representing ordinary shares obtained as a result
of the
private placement that we completed on March 22,
2006.
|
·
|
a
breach of the office holder’s duty of care to the company or to another
person;
|
·
|
a
breach of the office holder’s fiduciary duty to the company, provided that
he or she acted in good faith and had reasonable cause to believe
that the
act would not prejudice the company; and
|
·
|
a
financial liability imposed upon the office holder in favor of another
person.
|
·
|
monetary
liability imposed upon him or her in favor of a third party by a
judgment,
including a settlement or an arbitral award confirmed by the court;
and
|
·
|
reasonable
litigation expenses, including attorneys’ fees, actually incurred by the
office holder or imposed upon him or her by a court, in a proceeding
brought against him or her by or on behalf of the company or by a
third
party, or in a criminal action in which he or she was acquitted,
or in a
criminal action which does not require criminal intent in which he
or she
was convicted; furthermore, a company can, with a limited exception,
exculpate an office holder in advance, in whole or in part, from
liability
for damages sustained by a breach of duty of care to the
company.
|
·
|
any
amendment to the Articles of Association;
|
·
|
an
increase of the company's authorized share capital;
|
·
|
a
merger; and
|
·
|
approval
of interested party transactions that require shareholders
approval.
|
·
|
there
is a limitation on acquisition of any level of control of the company;
or
|
·
|
the
acquisition of any level of control requires the purchaser to do
so by
means of a tender offer to the
public.
|
·
|
the
judgment was obtained after due process before a court of competent
jurisdiction, that recognizes and enforces similar judgments of Israeli
courts, and the court had authority according to the rules of private
international law currently prevailing in Israel;
|
·
|
adequate
service of process was effected and the defendant had a reasonable
opportunity to be heard;
|
·
|
the
judgment is not contrary to the law, public policy, security or
sovereignty of the State of Israel and its enforcement is not contrary
to
the laws governing enforcement of judgments;
|
·
|
the
judgment was not obtained by fraud and does not conflict with any
other
valid judgment in the same matter between the same
parties;
|
·
|
the
judgment is no longer appealable; and
|
·
|
an
action between the same parties in the same matter is not pending
in any
Israeli court at the time the lawsuit is instituted in the foreign
court.
|
ADR
holders must pay:
|
For:
|
|
$5.00
(or less) per 100 ADSs
(or
portion thereof)
|
Each
issuance of an ADS, including as a result of a distribution of shares
or
rights or other property.
Each
cancellation of an ADS, including if the agreement
terminates.
|
|
$0.02
(or less) per ADS
|
Any
cash payment.
|
|
Registration
or Transfer Fees
|
Transfer
and registration of shares on the share register of the Foreign Registrar
from your name to the name of The Bank of New York or its agent when
you
deposit or withdraw shares.
|
|
Expenses
of The Bank of New York
|
Conversion
of foreign currency to U.S. dollars.
Cable,
telex and facsimile transmission expenses.
Servicing
of shares or deposited securities.
|
|
$0.02
(or less) per ADS per calendar year (if the depositary has not collected
any cash distribution fee during that year)
|
Depositary
services.
|
|
Taxes
and other governmental charges
|
As
necessary The Bank of New York or the Custodian have to pay on any
ADR or
share underlying an ADR, for example, stock transfer taxes, stamp
duty or
withholding taxes.
|
|
A
fee equivalent to the fee that would be payable if securities distributed
to you had been ordinary shares and the ordinary shares had been
deposited
for issuance of ADSs
|
Distribution
of securities distributed to holders of deposited securities which
are
distributed by the depositary to ADR
holders.
|
If
we:
|
Then:
|
|
Change
the nominal or par value of our shares; Reclassify, split up or
consolidate any of the deposited securities;
|
The
cash, shares or other securities received by The Bank of New York
will
become deposited securities. Each ADR will automatically represent
its
equal share of the new deposited securities. The Bank of New York
may, and
will if we ask it to, distribute some or all of the cash, shares
or other
securities it received. It may also issue new ADRs or ask you to
surrender
your outstanding ADRs in exchange for new ADRs, identifying the new
deposited securities.
|
|
Distribute
securities on the shares that are not distributed to you;
or
|
||
Recapitalize,
reorganize, merge, liquidate, sell all or substantially all of
our
assets, or takes any similar action.
|
·
|
are
only obligated to take the actions specifically set forth in
the agreement
without negligence or bad faith;
|
·
|
are
not liable if either is prevented or delayed by law or circumstances
beyond their control from performing their obligations under
the
agreement;
|
·
|
are
not liable if either exercises discretion permitted under the
agreement;
|
·
|
have
no obligation to become involved in a lawsuit or other proceeding
related
to the ADRs or the agreement on your behalf or on behalf of any
other
party; and
|
·
|
may
rely upon any documents they believe in good faith to be genuine
and to
have been signed or presented by the proper
party.
|
·
|
payment
of stock transfer or other taxes or other governmental charges
and
transfer or registration fees charged by third parties for
the
|
·
|
transfer
of any shares or other deposited
securities;
|
·
|
production
of satisfactory proof of the identity and genuineness of any signature
or
other information it deems necessary,
and
|
·
|
compliance
with regulations it may establish, from time to time, consistent
with the
agreement, including presentation of transfer
documents.
|
·
|
when
temporary delays arise because: (1) The Bank of New York or we
have closed
its transfer books; (2) the transfer of shares is blocked to
permit voting
at a shareholders' meeting; or (3) we are paying a dividend on
the shares;
or
|
· | when it is necessary to prohibit withdrawals in order to comply with any laws or governmental regulations that apply to ADRs or to the withdrawal of shares or other deposited securities. |
·
|
DTC
is unwilling or unable to continue as depositary or if DTC ceases
to be a
clearing agency registered under applicable law and a successor depositary
is not appointed by us within 90 days; or
|
·
|
we
determine not to require all of the ADRs to be represented by a global
security.
|
For
a company with foreign investment of
|
Company
tax rate
|
|||
More
than 25% and less than 49%
|
25%
|
|
||
49%
or more and less than 74%
|
20%
|
|
||
74%
or more and less than 90%
|
15%
|
|
||
90%
or more
|
10%
|
|
·
|
deduction
of purchase of know-how and patents over an eight-year period;
and
|
·
|
the
right to elect, under specified conditions, to file a consolidated
tax
return with additional related Israeli industrial companies and an
industrial holding company.
|
·
|
where
a company's equity, as defined in the law, exceeds the cost of fixed
assets as defined in the Inflationary Adjustments Law, a deduction
from
taxable income that takes into account the effect of the applicable
annual
rate of inflation on the excess is allowed up to a ceiling of 70%
of
taxable income in any single tax year, with the unused portion permitted
to be carried forward on a linked basis. If the cost of fixed assets,
as
defined in the Inflationary Adjustments Law, exceeds a company's
equity,
then the excess multiplied by the applicable annual rate of inflation
is
added to taxable income;
|
·
|
subject
to specified limitations, depreciation deductions on fixed assets
and
losses carried forward are adjusted for inflation based on the increase
in
the consumer price index; and
|
·
|
a
citizen or resident of the United States;
|
·
|
a
corporation created or organized under the laws of the United States,
the
District of Columbia, or any state; or
|
·
|
a
trust or estate, treated, for United States federal income tax purposes,
as a domestic trust or estate.
|
·
|
have
elected mark-to-market accounting;
|
·
|
hold
our ordinary shares as part of a straddle, hedge or conversion transaction
with other investments;
|
·
|
own
directly, indirectly or by attribution at least 10% of our voting
power;
|
·
|
are
tax exempt entities;
|
·
|
are
persons who acquire shares in connection with employment or other
performance of services; and
|
·
|
have
a functional currency that is not the U.S.
dollar.
|
·
|
You
must include the gross amount of the dividend, not reduced by the
amount
of Israeli tax withheld, in your U.S. taxable income.
|
·
|
You
may be able to claim the Israeli tax withheld as a foreign tax credit
against your U.S. income tax liability. However, to the extent that
25% or
more of our gross income from all sources was effectively connected
with
the conduct of a trade or business in the United States (or treated
as
effectively connected, with limited exceptions) for a three-year
period
ending with the close of the taxable year preceding the year in which
the
dividends are declared, a portion of this dividend will be treated
as U.S.
source income, possibly reducing the allowable foreign
tax.
|
·
|
The
foreign tax credit is subject to significant and complex limitations.
Generally, the credit can offset only the part of your U.S. tax
attributable to your net foreign source passive income. Additional
special
rules currently apply to taxpayers predominantly engaged in the active
conduct of a banking, insurance, financing or similar business.
Additionally, if we pay dividends at a time when 50% or more of our
stock
is owned by U.S. persons, you may be required to treat the part of
the
dividend attributable to U.S. source earnings and profits as U.S.
source
income, possibly reducing the allowable credit, unless you elect
to
calculate your foreign tax credit separately with respect to XTLbio
dividends.
|
·
|
A
U.S. holder will be denied a foreign tax credit with respect to Israeli
income tax withheld from dividends received on the ordinary shares
to the
extent the U.S. holder has not held the ordinary shares for at least
16
days of the 30-day period beginning on the date which is 15 days
before
the ex-dividend date or to the extent the U.S. holder is under an
obligation to make related payments with respect to substantially
similar
or related property. Any days during which a U.S. holder has substantially
diminished its risk of loss on the ordinary shares are not counted
toward
meeting the 16-day holding period required by the
statute.
|
·
|
If
you do not elect to claim foreign taxes as a credit, you will be
entitled
to deduct the Israeli income tax withheld from your XTLbio dividends
in
determining your taxable income.
|
·
|
Individuals
who do not claim itemized deductions, but instead utilize the standard
deduction, may not claim a deduction for the amount of the Israeli
income
taxes withheld.
|
·
|
If
you are a U.S. corporation holding our stock, the general rule is
that you
cannot claim the dividends-received deduction with respect to our
dividends. There is an exception to this rule if you own at least
10% of
our ordinary shares (by vote or value) and certain conditions are
met,
including that we were not a PFIC during the period you have held
our
ordinary shares.
|
·
|
gain
recognized by the U.S. holder upon the disposition of, as well as
income
recognized upon receiving certain dividends on the ordinary shares
and/or
ADRs would be taxable as ordinary income;
|
·
|
the
U.S. holder would be required to allocate such dividend income and/or
disposition gain ratably over such U.S. holder's entire holding period
for
such XTLbio ordinary shares and/or ADRs;
|
·
|
the
amount allocated to each year other than the year of the dividend
payment
or disposition and pre-PFIC years would be subject to tax at the
highest
applicable tax rate, and an interest charge would be imposed with
respect
to the resulting tax liability;
|
·
|
the
U.S. holder would be required to file an annual return on IRS Form
8621
regarding distributions received on, gain recognized on dispositions
of,
our ordinary shares and/or ADRs; and
|
·
|
any
U.S. holder who acquired the ordinary shares and/or ADRs upon the
death of
the shareholder would not receive a step-up to market value of his
income
tax basis for such ordinary shares and/or ADRs. Instead such U.S.
holder
beneficiary would have a tax basis equal to the decedent's basis,
if
lower.
|
·
|
the
item is effectively connected with the conduct by the Non-U.S. holder
of a
trade or business in the United States and, in the case of a resident
of a
country which has a tax treaty with the United States, the item is
attributable to a permanent establishment or, in the case of an
individual, a fixed place of business, in the United States;
|
·
|
the
Non-U.S. holder is subject to tax under the provisions of United
States
tax law applicable to U.S. expatriates; or
|
·
|
the
individual non-U.S. holder is present in the United States for 183
days or
more in the taxable year of the sale and certain other conditions
are
met.
|
Page
|
|
F-2
|
|
F-4
|
|
F-5
|
|
F-6
|
|
F-10
|
|
F-12
|
December
31
|
|||||||
2005
|
2004
|
||||||
A
s s e t s
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and cash equivalents
|
13,360
|
12,788
|
|||||
Short-term
bank deposits
|
—
|
10,136
|
|||||
Accounts
receivable - trade
|
—
|
543
|
|||||
Accounts
receivable - other
|
431
|
306
|
|||||
T
o
t a l current assets
|
13,791
|
23,773
|
|||||
EMPLOYEE
SEVERANCE PAY FUNDS
|
449
|
830
|
|||||
RESTRICTED
LONG-TERM DEPOSIT
|
110
|
113
|
|||||
PROPERTY
AND EQUIPMENT, NET
|
762
|
908
|
|||||
INTANGIBLE
ASSETS, NET
|
39
|
—
|
|||||
T
o
t a l assets
|
15,151
|
25,624
|
|||||
Liabilities
and shareholders’ equity
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable and accruals
|
2,007
|
3,134
|
|||||
Deferred
gain
|
399
|
399
|
|||||
T
o
t a l current liabilities
|
2,406
|
3,533
|
|||||
LIABILITY
IN RESPECT OF EMPLOYEE
|
|||||||
SEVERANCE
OBLIGATIONS
|
695
|
1,291
|
|||||
DEFERRED
GAIN
|
798
|
1,198
|
|||||
COMMITMENTS
AND CONTINGENCIES (Note 7)
|
|||||||
T
o
t a l liabilities
|
3,899
|
6,022
|
|||||
SHAREHOLDERS’
EQUITY:
|
|||||||
Ordinary
shares of NIS 0.02 par value (authorized: 300,000,000
as
of December 31, 2005 and 2004; issued and outstanding:
173,180,441
as of December 31, 2005 and 168,079,196 as of
December
31, 2004)
|
864
|
841
|
|||||
Additional
paid in capital
|
110,179
|
104,537
|
|||||
Deficit
accumulated during the development stage
|
(99,791
|
)
|
(85,776
|
)
|
|||
T
o
t a l shareholders’ equity
|
11,252
|
19,602
|
|||||
T
o
t a l liabilities and shareholders’ equity
|
15,151
|
25,624
|
/s/
Michael Weiss
|
/s/
Ron Bentsur
|
|
Michael
Weiss
|
Ron
Bentsur
|
|
Chairman
of the Board of Directors
|
Chief
Executive Officer
|
|
Period
from
|
|||||||||||||
March
9, 1993*
|
|||||||||||||
Year
ended December 31
|
to
December 31,
|
||||||||||||
REVENUES:
|
2005
|
2004
|
2003
|
2005
|
|||||||||
Reimbursed
out-of-pockets expenses
|
2,743
|
3,269
|
—
|
6,012
|
|||||||||
License
|
454
|
185
|
—
|
639
|
|||||||||
3,197
|
3,454
|
—
|
6,651
|
||||||||||
COST
OF REVENUES:
|
|||||||||||||
Reimbursed
out-of-pockets expenses
|
2,743
|
3,269
|
—
|
6,012
|
|||||||||
License
(with respect to royalties)
|
54
|
32
|
—
|
86
|
|||||||||
2,797
|
3,301
|
—
|
6,098
|
||||||||||
GROSS
MARGIN
|
400
|
153
|
—
|
553
|
|||||||||
RESEARCH
AND DEVELOPMENT
|
|
||||||||||||
COSTS
(includes non-cash compensation
|
|||||||||||||
of
$112, $30 and $0, in 2005, 2004
|
|||||||||||||
and
2003, respectively)
|
7,313
|
11,985
|
14,022
|
82,890
|
|||||||||
L
E S S - PARTICIPATIONS
|
—
|
—
|
3,229
|
10,950
|
|||||||||
7,313
|
11,985
|
10,793
|
71,940
|
||||||||||
IN
- PROCESS RESEARCH AND
|
|||||||||||||
DEVELOPMENT
COSTS
|
1,783
|
—
|
—
|
1,783
|
|||||||||
GENERAL
AND ADMINISTRATIVE
|
|||||||||||||
EXPENSES
(includes non-cash
|
|||||||||||||
compensation
of $2,641, $2 and $0,
|
|||||||||||||
in
2005, 2004 and 2003, respectively)
|
5,457
|
4,134
|
3,105
|
29,012
|
|||||||||
BUSINESS
DEVELOPMENT COSTS
|
|||||||||||||
(includes
non-cash compensation of $10 in
|
|||||||||||||
2005,
and $0, in 2004 and 2003, respectively)
|
227
|
810
|
664
|
4,513
|
|||||||||
OPERATING
LOSS
|
14,380
|
16,776
|
14,562
|
106,695
|
|||||||||
FINANCIAL
INCOME -
net
|
443
|
352
|
352
|
7,143
|
|||||||||
LOSS
BEFORE INCOME TAXES
|
13,937
|
16,424
|
14,210
|
99,552
|
|||||||||
INCOME
TAXES
|
78
|
49
|
78
|
239
|
|||||||||
LOSS
FOR THE PERIOD
|
14,015
|
16,473
|
14,288
|
99,791
|
|||||||||
BASIC
AND DILUTED LOSS PER
|
|||||||||||||
ORDINARY
SHARE
|
$
|
0.08
|
$
|
0.12
|
$
|
0.13
|
|||||||
WEIGHTED
AVERAGE NUMBER OF
|
|||||||||||||
SHARES
USED IN COMPUTING BASIC
|
|||||||||||||
AND
DILUTED LOSS PER ORDINARY
|
|||||||||||||
SHARE
|
170,123,003
|
134,731,766
|
111,712,916
|
Preferred
shares
|
Ordinary
shares
|
Additional
|
||||||||||||||
Number
of
|
Number
of
|
paid-in
|
||||||||||||||
shares
|
Amount
|
shares
|
Amount
|
capital
|
||||||||||||
CHANGES
DURING THE PERIOD
|
||||||||||||||||
FROM
MARCH 9, 1993 (DATE OF
|
||||||||||||||||
INCORPORATION)
TO
DECEMBER
31, 2002 :
|
||||||||||||||||
Comprehensive
loss:
|
||||||||||||||||
Loss
for the period
|
—
|
—
|
—
|
—
|
—
|
|||||||||||
Net
unrealized loss
|
—
|
—
|
—
|
—
|
—
|
|||||||||||
Comprehensive
loss
|
—
|
—
|
—
|
—
|
—
|
|||||||||||
Employee
stock options expenses
|
—
|
—
|
—
|
—
|
377
|
|||||||||||
Non-employee
stock option expenses
|
—
|
—
|
—
|
—
|
106
|
|||||||||||
Exercise
of share warrants in 2000
|
—
|
—
|
1,499,980
|
7
|
340
|
|||||||||||
Exercise
of share warrants in 2001
|
—
|
—
|
208,000
|
1
|
74
|
|||||||||||
Exercise
of employee stock
options
in 1999
|
15,600
|
**
|
—
|
—
|
**
|
|||||||||||
Exercise
of employee stock
options
in 2000
|
—
|
—
|
162,500
|
1
|
—
|
|||||||||||
Exercise
of employee stock
options
in 2001
|
—
|
—
|
59,138
|
**
|
26
|
|||||||||||
Exercise
of employee stock
options
in 2002
|
—
|
—
|
38,326
|
**
|
20
|
|||||||||||
Issuance
of share capital in 1993 (net
of
$912 - issuance expenses)
|
7,705,470
|
45
|
—
|
—
|
5,545
|
|||||||||||
Issuance
of share capital in 1994 (net
of
$22 - issuance expenses)
|
717,500
|
5
|
—
|
—
|
2,103
|
|||||||||||
Issuance
of share capital in 1996 (net
of
$646 - issuance expenses)
|
6,315,810
|
49
|
—
|
—
|
5,314
|
|||||||||||
Issuance
of share capital in 1998 (net
of
$1,650 - issuance expenses)
|
26,319,130
|
139
|
—
|
—
|
12,036
|
|||||||||||
Issuance
of share capital in 1999 (net
of
$49 - issuance expenses)
|
2,513,940
|
12
|
—
|
—
|
1,189
|
|||||||||||
Issuance
of share capital in 2000
|
—
|
—
|
15,183,590
|
75
|
16,627
|
|||||||||||
Bonus
shares
|
7,156,660
|
41
|
19,519,720
|
97
|
(138
|
)
|
||||||||||
Conversion
of preferred shares into
ordinary
shares
|
(50,744,110
|
)
|
(291
|
)
|
50,744,110
|
291
|
—
|
|||||||||
Receipts
in respect of share warrants
|
||||||||||||||||
(expired
in 1999)
|
—
|
—
|
—
|
—
|
89
|
|||||||||||
Initial
public offering (“IPO”) of the
|
||||||||||||||||
Company’s
shares under a prospectus
|
||||||||||||||||
dated
September 20, 2000 (net of
|
||||||||||||||||
$ 5,199-issuance
expenses)
|
—
|
—
|
23,750,000
|
118
|
45,595
|
|||||||||||
BALANCE
AT DECEMBER 31, 2002
|
—
|
—
|
111,165,364
|
590
|
89,303
|
Deficit
|
||||||||||
Accumulated
|
accumulated
|
|||||||||
other
|
during
the
|
|||||||||
comprehensive
|
development
|
|||||||||
income
(loss)
|
stage
|
Total
|
||||||||
CHANGES
DURING THE PERIOD
|
||||||||||
FROM
MARCH 9, 1993 (DATE OF
|
||||||||||
INCORPORATION)
TO
DECEMBER
31, 2002 :
|
||||||||||
Comprehensive
loss:
|
||||||||||
Loss
for the period
|
—
|
(55,015
|
)
|
(55,015
|
)
|
|||||
Net
unrealized loss
|
(48
|
)
|
—
|
(48
|
)
|
|||||
Comprehensive
loss
|
(48
|
)
|
(55,015
|
)
|
(55,063
|
)
|
||||
Employee
stock options expenses
|
—
|
—
|
377
|
|||||||
Non-employee
stock option expenses
|
—
|
—
|
106
|
|||||||
Exercise
of share warrants in 2000
|
—
|
—
|
347
|
|||||||
Exercise
of share warrants in 2001
|
—
|
—
|
75
|
|||||||
Exercise
of employee stock
options
in 1999
|
—
|
—
|
**
|
|||||||
Exercise
of employee stock
options
in 2000
|
—
|
—
|
1
|
|||||||
Exercise
of employee stock
options
in 2001
|
—
|
26
|
||||||||
Exercise
of employee stock
options
in 2002
|
—
|
20
|
||||||||
Issuance
of share capital in 1993 (net
of
$912 - issuance expenses)
|
—
|
—
|
5,590
|
|||||||
Issuance
of share capital in 1994 (net
of
$22 - issuance expenses)
|
—
|
—
|
2,108
|
|||||||
Issuance
of share capital in 1996 (net
of
$646 - issuance expenses)
|
—
|
—
|
5,363
|
|||||||
Issuance
of share capital in 1998 (net
of
$1,650 - issuance expenses)
|
—
|
—
|
12,175
|
|||||||
Issuance
of share capital in 1999 (net
of
$49 - issuance expenses)
|
—
|
—
|
1,201
|
|||||||
Issuance
of share capital in 2000
|
—
|
—
|
16,702
|
|||||||
Bonus
shares
|
—
|
—
|
—
|
|||||||
Conversion
of preferred shares into
|
||||||||||
ordinary
shares
|
—
|
—
|
—
|
|||||||
Receipts
in respect of share warrants
|
||||||||||
(expired
in 1999)
|
—
|
—
|
89
|
|||||||
Initial
public offering (“IPO”) of the
|
||||||||||
Company’s
shares under a prospectus
|
||||||||||
dated
September 20, 2000 (net of
|
||||||||||
$ 5,199
-issuance expenses)
|
—
|
—
|
45,713
|
|||||||
BALANCE
AT DECEMBER 31, 2002
|
(48
|
)
|
(55,015
|
)
|
34,830
|
Ordinary
shares
|
Additional
|
|||||||||
Number
of
|
paid
in
|
|||||||||
shares
|
Amount
|
capital
|
||||||||
BALANCE
AT DECEMBER 31, 2002 -
brought
forward
|
111,165,364
|
590
|
89,303
|
|||||||
CHANGES
DURING 2003:
|
||||||||||
Comprehensive
loss:
|
||||||||||
Loss
for the period
|
—
|
—
|
—
|
|||||||
Net
unrealized gain
|
—
|
—
|
—
|
|||||||
Comprehensive
loss
|
—
|
—
|
—
|
|||||||
Exercise
of stock options
|
854,100
|
4
|
—
|
|||||||
BALANCE
AT DECEMBER 31, 2003
|
112,019,464
|
594
|
89,303
|
|||||||
CHANGES
DURING 2004:
|
||||||||||
Comprehensive
loss:
|
||||||||||
Net
loss
|
—
|
—
|
—
|
|||||||
Net
unrealized loss
|
—
|
—
|
—
|
|||||||
Comprehensive
loss
|
—
|
—
|
—
|
|||||||
Non-employee
stock option compensation expenses
|
—
|
—
|
32
|
|||||||
Exercise
of stock options
|
50,000
|
**
|
19
|
|||||||
Issuance
of shares, net of $2,426
share
issuance expenses
|
56,009,732
|
247
|
15,183
|
|||||||
BALANCE
AT DECEMBER 31, 2004
|
168,079,196
|
841
|
104,537
|
|||||||
CHANGES
DURING 2005:
|
||||||||||
Comprehensive
loss - loss for the period
|
— | — | — | |||||||
Non-employee
stock option compensation expenses
|
—
|
—
|
45
|
|||||||
Employee
stock option compensation expenses
|
—
|
—
|
2,718
|
|||||||
Exercise
of stock options
|
3,786,825
|
17
|
1,494
|
|||||||
Issuance
of ordinary shares in respect of license
|
||||||||||
and
purchases of assets (Note 3)
|
1,314,420
|
6
|
1,385
|
|||||||
BALANCE
AT DECEMBER 31, 2005
|
173,180,441
|
864
|
110,179
|
Deficit
|
||||||||||
Accumulated
|
accumulated
|
|||||||||
other
|
during
the
|
|||||||||
comprehensive
|
development
|
|||||||||
income
(loss)
|
stage
|
Total
|
||||||||
BALANCE
AT DECEMBER 31, 2002 -
|
||||||||||
brought
forward
|
(48
|
)
|
(55,015
|
)
|
34,830
|
|||||
CHANGES
DURING 2003:
|
||||||||||
Comprehensive
loss:
|
||||||||||
Loss
for the period
|
—
|
(14,288
|
)
|
(14,288
|
)
|
|||||
Net
unrealized gain
|
62
|
—
|
62
|
|||||||
Comprehensive
loss
|
62
|
(14,288
|
)
|
(14,226
|
)
|
|||||
Exercise
of stock options
|
—
|
—
|
4
|
|||||||
BALANCE
AT DECEMBER 31, 2003
|
14
|
(69,303
|
)
|
20,608
|
||||||
CHANGES
DURING 2004:
|
||||||||||
Comprehensive
loss:
|
||||||||||
Loss
for the period
|
—
|
(16,473
|
)
|
(16,473
|
)
|
|||||
Net
unrealized loss
|
(14
|
)
|
—
|
(14
|
)
|
|||||
Comprehensive
loss
|
(14
|
)
|
(16,473
|
)
|
(16,487
|
)
|
||||
Non-employee
stock option expenses
|
—
|
—
|
32
|
|||||||
Exercise
of stock options
|
—
|
—
|
19
|
|||||||
Issuance
of shares, net of $2,426
|
||||||||||
share
issuance expenses
|
—
|
—
|
15,430
|
|||||||
BALANCE
AT DECEMBER 31, 2004
|
—
|
(85,776
|
)
|
19,602
|
||||||
CHANGES
DURING 2005:
|
||||||||||
Comprehensive
loss - loss for the period
|
—
|
(14,015
|
)
|
(14,015
|
)
|
|||||
Non-employee
stock option compensation expenses
|
—
|
—
|
45
|
|||||||
Employee
stock option compensation expenses
|
—
|
—
|
2,718
|
|||||||
Exercise
of stock options
|
—
|
—
|
1,511
|
|||||||
Issuance
of ordinary shares in respect of license
|
||||||||||
and
purchases of assets (Note 3)
|
—
|
—
|
1,391
|
|||||||
BALANCE
AT DECEMBER 31, 2005
|
—
|
(99,791
|
)
|
11,252
|
Period
from
|
|||||||||||||
March
9, 1993 (a)
|
|||||||||||||
Year
ended December 31
|
to
December 31,
|
||||||||||||
2005
|
2004
|
2003
|
2005
|
||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||||||||
Loss
for the period
|
(14,015
|
)
|
(16,473
|
)
|
(14,288
|
)
|
(99,791
|
)
|
|||||
Adjustments
to reconcile loss to net cash used in operating
activities:
|
|||||||||||||
Depreciation
and amortization
|
242
|
319
|
440
|
2,829
|
|||||||||
Linkage
difference on restricted long-term deposits
|
3
|
—
|
—
|
3
|
|||||||||
Acquisition
of in process research and development
|
1,783
|
—
|
—
|
1,783
|
|||||||||
Loss
on disposal of property and equipment
|
6
|
1
|
2
|
18
|
|||||||||
Increase
(decrease) in liability in respect of employee severance
obligations
|
(159
|
)
|
30
|
129
|
1,228
|
||||||||
Impairment
charges
|
26
|
—
|
354
|
380
|
|||||||||
Loss
(gain) from sales of available for sale securities
|
—
|
13
|
(27
|
)
|
(410
|
)
|
|||||||
Stock
based compensation expenses (employee and non-employee)
|
2,763
|
32
|
—
|
3,278
|
|||||||||
Loss
(gain) on amounts funded in respect of employee severance pay
funds
|
(6
|
)
|
(4
|
)
|
5
|
(91
|
)
|
||||||
Changes
in operating assets and liabilities:
|
|||||||||||||
Decrease
(increase) in accounts receivable - trade
|
543
|
(543
|
)
|
—
|
—
|
||||||||
Decrease
(increase) in accounts receivable - other
|
(125
|
)
|
400
|
(440
|
)
|
(431
|
)
|
||||||
Increase
(decrease) in accounts payable and accruals
|
(1,127
|
)
|
133
|
499
|
2,007
|
||||||||
Increase
(decrease) in deferred gain
|
(400
|
)
|
1,597
|
—
|
1,197
|
||||||||
Net
cash used in operating activities
|
(10,466
|
)
|
(14,495
|
)
|
(13,326
|
)
|
(88,000
|
)
|
|||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||||||||
Decrease
in short-term deposits
|
10,136
|
7,193
|
14,724
|
—
|
|||||||||
Restricted
long-term deposits, net
|
—
|
46
|
(20
|
)
|
(113
|
)
|
|||||||
Investment
in available for sale securities
|
—
|
—
|
(71
|
)
|
(3,363
|
)
|
|||||||
Proceeds
from sales of available for sale securities
|
—
|
722
|
1,048
|
3,773
|
|||||||||
Employee
severance
pay funds
|
(50
|
)
|
(136
|
)
|
(112
|
)
|
(891
|
)
|
|||||
Purchase
of property and equipment
|
(38
|
)
|
(180
|
)
|
(81
|
)
|
(4,021
|
)
|
|||||
Proceeds
from disposals of property and equipment
|
27
|
5
|
2
|
149
|
|||||||||
Acquisition
in respect of license and purchase of assets
|
(548
|
)
|
—
|
—
|
(548
|
)
|
|||||||
Net
cash provided by (used in) investing activities
|
9,527
|
7,650
|
15,490
|
(5,014
|
)
|
Period
from
|
|||||||||||||
March
9, 1993 (a)
|
|||||||||||||
Year
ended December 31
|
to
December 31,
|
||||||||||||
2005
|
2004
|
2003
|
2005
|
||||||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||||||||
Issuance
of share capital - net of share issuance expenses
|
—
|
15,430
|
—
|
104,371
|
|||||||||
Exercise
of share warrants and stock options
|
1,511
|
19
|
4
|
2,003
|
|||||||||
Proceeds
from long-term debt
|
—
|
—
|
—
|
399
|
|||||||||
Proceeds
from short-term debt
|
—
|
—
|
—
|
50
|
|||||||||
Repayment
of long-term debt
|
—
|
—
|
—
|
(399
|
)
|
||||||||
Repayment
of short-term debt
|
—
|
—
|
—
|
(50
|
)
|
||||||||
Net
cash provided by financing activities
|
1,511
|
15,449
|
4
|
106,374
|
|||||||||
NET
INCREASE (DECREASE) IN CASH AND
|
|||||||||||||
CASH
EQUIVALENTS
|
572
|
8,604
|
2,168
|
13,360
|
|||||||||
BALANCE
OF CASH AND CASH EQUIVALENTS AT BEGINNING
OF PERIOD
|
12,788
|
4,184
|
2,016
|
—
|
|||||||||
BALANCE
OF CASH AND CASH EQUIVALENTS AT END OF
PERIOD
|
13,360
|
12,788
|
4,184
|
13,360
|
|||||||||
Supplementary
information on investing and financing
activities not involving cash flows:
|
|||||||||||||
Issuance
of ordinary shares in respect of license,
and purchase of assets
|
1,391
|
—
|
—
|
1,391
|
|||||||||
Conversion
of convertible subordinated debenture into shares
|
—
|
—
|
—
|
1,700
|
|||||||||
Supplemental
disclosures of cash flow information:
|
|||||||||||||
Income
taxes paid (mainly - tax advance in respect of excess
expenses)
|
49
|
107
|
161
|
321
|
|||||||||
Interest
paid
|
—
|
—
|
—
|
350
|
|||||||||
(a) Incorporation
date, see note 1a.
|
1)
|
XTL
Biopharmaceuticals Ltd. (“the Company”) was incorporated under the Israel
Companies Ordinance on March 9, 1993. The Company is a development
stage
company in accordance with Financial Accounting Standard (“FAS”) 7
“Accounting and Reporting by Development Stage Enterprises.”
The
Company is a biopharmaceutical company engaged in the acquisition,
development and commercialization of pharmaceutical products
for the
treatment of infectious diseases, particularly the prevention
and
treatment of hepatitis B and C.
The
Company licensed its product candidate HepeX-B to Cubist Pharmaceuticals,
Inc. (hereinafter “Cubist”) during 2004, see Notes 1k and 2 as to details
of the agreement.
During
September 2005, the Company licensed perpetually from VivoQuest
Inc.
(“VivoQuest”), a US privately-held company which is a development stage
enterprise, exclusive worldwide rights to VivoQuest’s intellectual
property and technology, covering a proprietary compound library,
including VivoQuest’s lead hepatitis C compounds. In addition, the Company
also acquired from VivoQuest certain assets, see Note 3.
The
Company has a wholly-owned subsidiary in the United States, XTL
Biopharmaceuticals Inc. (“Subsidiary”), which was incorporated in 1999
under the law of the State of Delaware. The Subsidiary is primarily
engaged in development activities and business
development.
|
2)
|
The
consolidated financial statements of the Company are presented on
a going
concern basis, which contemplates the realization of assets and
satisfaction of liabilities in the normal course of business. The
Company
has experienced a significant loss from operations. For the year
ended
December 31, 2005, the Company incurred a net loss of $14 million
and had
an accumulated deficit of $100 million. These matters raise substantial
doubt about the Company’s ability to continue as a going concern.
The
Company’s ability to continue as a going concern will depend upon its
ability to raise additional capital in the short term. The Company
is
actively pursuing raising additional capital to fund its operations
although there is no assurance that such capital will be available
to the
Company. Failure to secure additional capital or to expand its revenue
base would result in the Company depleting its available funds and
not
being able to pay its obligations when they become due. The accompanying
consolidated financial statements do not include any adjustments
to
reflect the possible future effects on the recoverability and
classification of assets or the amounts and
classification of liabilities that may result from the possible inability
of the Company to continue as a going
concern.
|
3)
|
The
consolidated financial statements are prepared in accordance with
generally accepted accounting principles in the United States (“US
GAAP”).
|
4)
|
The
preparation of the financial statements, in conformity with US GAAP,
requires management to make estimates and assumptions that affect
the
reported amounts of assets and liabilities and the disclosure of
contingent assets and liabilities, at the date of the financial
statements, and the reported expenses during the reporting periods.
Actual
results may vary from these
estimates.
|
%
|
|
Laboratory
equipment
|
10-20
|
(mainly
15)
|
|
Computers
|
33
|
Furniture
and office equipment
|
6-15
|
Using
previous
accounting
|
Impact
of the adoption of
FAS
123R
|
As
reported
|
|
Loss for the year |
12,130
|
1,885
|
14,015
|
Basic and diluted loss per ordinary share |
(0.07)
|
(0.08)
|
Period
from
|
||||||||||
March
9, 1993*
|
||||||||||
Year
ended December 31
|
to
December 31,
|
|||||||||
2004
|
2003
|
2004
|
||||||||
($
in thousands except per share amounts)
|
||||||||||
Loss
for the period, as reported
|
16,473
|
14,288
|
85,776
|
|||||||
Deduct:
stock- based employee
|
||||||||||
compensation
expense,
|
||||||||||
included
in reported loss
|
—
|
—
|
(483
|
)
|
||||||
Add:
stock-based employee
|
||||||||||
compensation
expense
|
||||||||||
determined
under fair value
|
||||||||||
method
for all awards
|
239
|
821
|
6,355
|
|||||||
Loss
- pro-forma
|
16,712
|
15,109
|
91,648
|
Basic
and diluted loss per share:
|
||||||||||
As
reported
|
0.12
|
0.13
|
||||||||
Pro-forma
|
0.12
|
0.14
|
December
31,
|
|||||||
2005
|
2004
|
||||||
($
in thousands)
|
|||||||
Deferred
revenue
|
1,361
|
1,815
|
|||||
Less
- Deferred expenses related to Yeda
|
164
|
218
|
|||||
Deferred
gain
|
1,197
|
1,597
|
(1) |
the
Company issued the fair value equivalent of $1,391,000 of its ordinary
shares for a total of 1,314,420 ordinary shares (calculated based
upon the
average of the closing prices per share for the period commencing
two days
before, and ending two days after the closing of the transaction),
made
cash payments of approximately $400,000 to cover VivoQuest’s operating
expenses prior to the closing of the Transaction, and incurred $148,000
in
direct expenses associated with the
Transaction;
|
(2) |
the
Company agreed to make additional contingent milestone payments triggered
by certain regulatory and sales targets, totaling up to $34.6 million,
$25.0 million of which will be due upon or following regulatory approval
or actual product sales, and are payable in cash or ordinary shares
at the
Company’s election. No contingent consideration has been paid pursuant to
the license agreement as of the balance sheet date, because none
of the
milestones have been achieved. The contingent consideration will
be
recorded as part of the acquisition costs in the future; and
|
(3) |
the
Company agreed to make royalty payments on future product
sales.
|
($
in thousands)
|
||||
Fair
value of the Company’s ordinary shares
|
1,391
|
|||
Cash
consideration paid
|
400
|
|||
Direct
expenses associated with the Transaction
|
148
|
|||
Total
purchase price
|
1,939
|
|||
($
in thousands)
|
||||
Tangible
assets acquired - property and equipment
|
113
|
|||
Intangible
assets acquired:
|
||||
In-process
research and development
|
1,783
|
|||
Assembled
workforce
|
43
|
|||
Total
intangible assets acquired
|
1,826
|
|||
Total
tangible and intangible assets acquired
|
1,939
|
a.
|
Composition
of the assets, grouped by major classifications, is as
follows:
|
December
31
|
|||||||
2005
|
2004
|
||||||
($
in thousands)
|
|||||||
Property
and equipment
|
|||||||
Cost:
|
|||||||
Laboratory
equipment
|
1,960
|
1,828
|
|||||
Computers
|
232
|
517
|
|||||
Leasehold
improvements
|
698
|
698
|
|||||
Furniture
and office equipment
|
238
|
269
|
|||||
3,128
|
3,312
|
||||||
Accumulated
depreciation and amortization:
|
|||||||
Laboratory
equipment
|
1,333
|
1,120
|
|||||
Computers
|
217
|
488
|
|||||
Leasehold
improvements
|
697
|
691
|
|||||
Furniture
and office equipment
|
119
|
105
|
|||||
2,366
|
2,404
|
||||||
762
|
908
|
b.
|
Under
the provisions of FAS 144, the Company’s management reviewed the carrying
value of certain laboratory equipment, and recorded an impairment
charge
in an amount of $ 26,000 in 2005. See Note 9.
During
2003, the Company’s management determined to put on hold early-stage
research activities, and consequently, to sell an asset used in one
of
these activities. Under the provisions of FAS 144, the Company’s
management reviewed the carrying value of this asset (original cost
$ 415,000, depreciated amount - $ 354,000) and determined to
write it off. An impairment charge in an amount of $ 354,000 was
recorded.
|
c.
|
Depreciation
totaled $ 238,000, $ 319,000 and $ 440,000 for the years ended December
31, 2005, 2004 and 2003,
respectively.
|
a. |
The
Company
|
1) |
On
June 30, 2001, the Company entered into an agreement with each employee
implementing Section 14 of the Severance Compensation Act, 1963 (the
“Law”) and the General Approval of the Labor Minister issued in accordance
to the said Section 14, mandating that upon termination of such employee’s
employment, the Company shall release to the employee all the amounts
accrued in its insurance policies. Accordingly, the Company remits
each
month to each of its employee’s insurance policy, the amounts required by
the law to cover the severance pay liability.
The
employee severance obligations covered by these contribution plans
are not
reflected in the financial statements, as the severance payment obligation
has been irrevocably transferred to the severance
funds.
|
2) |
Insurance
policies for certain employees (senior managers): the policies provide
most of the coverage for severance pay and pension liabilities of
managerial personnel, the remainder of the liabilities are covered
by the
Company.
The
Company has recorded an employee severance obligation for the amount
that
would be paid if all those employees were dismissed at the balance
sheet
date, on an undiscounted basis, in accordance with Israeli labor
law. This
liability is computed based upon the number of years of service
multiplied
by the latest monthly salary. The amount of accrued severance represents
the Company’s severance obligation in accordance with labor agreements in
force and based on salary components, which in management’s opinion,
create an entitlement to severance.
The
Company may only utilize the severance pay funds in the insurance
policies
for the purpose of disbursement of
severance.
|
b. |
The
Subsidiary
The
Subsidiary’s severance obligation is calculated based on the employment
agreements between the Subsidiary and its employees.
|
c. |
Severance
expenses
Severance
expenses (income) totaled $ (159,000), $ 30,000 and $ 129,000
for the
years ended December 31, 2005, 2004 and 2003, respectively.
Loss
(gain) on employee severance pay funds in respect of employee
severance
obligations totaled $(6,000), $(4,000), and $5,000 for the years
ended
December 31, 2005, 2004 and 2003, respectively.
|
d.
|
Cash
flow information regarding the Company’s liability for employee rights
upon retirement:
|
1) |
The
Company contributed in 2005, 2004 and 2003 to the insurance companies,
in
respect to its severance obligations to Israeli employees, $166,000,
$276,000 and $348,000, respectively, and expects to contribute, in
2006, $
90,000 to the insurance companies in respect to its severance obligations
to Israeli employees.
|
2) |
The
Company expects to pay future benefits to certain employees who will
reach
retirement, as follows:
|
($
in thousands)
|
|
2010
|
9
|
2011-2015
|
59
|
68
|
a.
|
Share
Capital
As
of December 31, 2005, the Company’s ordinary shares are traded on the
London Stock Exchange (“LSE”) and on the Tel Aviv Stock Exchange (“TASE”).
The closing price per share, as of December 31, 2005 was 45p
on the LSE
($0.78) and NIS 3.64 on the TASE ($0.79). In addition, the Company’s
ADRs
trade on the Nasdaq National Market, with each ADR representing
ten
ordinary shares. The closing price of the Company’s ADRs, as of December
31, 2005, was $7.74
On
September 20, 2000 the Company completed an IPO, as result of
which
20,900,000 ordinary shares of NIS 0.02 each have been issued.
The proceeds
of the issuance of shares in the amount of ₤ 31.3 million (before
deduction of share issue expenses) were received as $ 44.7 million.
The
underwriters of the IPO were granted an over-allotment option.
Accordingly, on October 26, 2000, the Company issued 2,850,000
Ordinary
Shares of NIS 0.02 for a consideration of $ 6.2 million (before
deduction
of share issue expenses) at the price of ₤ 1.5 per share or $2.1 per share
(the IPO price) to meet over-allotments in connection with the
placing.
On
August 2, 2004, the Company completed a Placing and Open Offer
for new
ordinary shares, as result of which 56,009,732 Ordinary shares
of NIS 0.02
each have been issued. The gross proceeds of the issuance of
shares
amounted to ₤9.8 million - $17.8 million (approximately ₤8.5 million -
$15.4 million, net of issuance costs).
On
September 21, 2005, the Company issued to VivoQuest Inc. the
fair value
equivalent of $1,391,000 of its ordinary shares for a total of
1,314,420
ordinary shares (see Note 3).
|
b.
|
Stock
Option Plans:
|
1)
|
The
Company maintains the following share option plans for its employees,
directors and consultants.
The
Company’s board of directors administers its share option plans and has
the authority to designate all terms of the options granted under
the
Company’s plans including the grantees, exercise prices, grant dates,
vesting schedules and expiration dates, which may be no more than
ten
years after the grant date.
As
of December 31, 2005, the Company has granted to employees, directors
and
consultants options that are outstanding to purchase up to 24,793,975
ordinary shares, under the five share option plans discussed below
and
pursuant to certain grants apart from these plans also discussed
below.
|
(a)
|
1998
Share Option Plan
Under
a share option plan established in 1998, (“the 1998 Plan”), the Company
granted options to employees during 1998, which are held by a trustee
under section 3(i) of the Israeli tax ordinance, of which 3,884,810
are
outstanding and exercisable as of December 31, 2005 at an exercise
price
per share of $0.497.
The
option term is for a period of 10 years from grant date. If the options
are not exercised and the shares not paid for by such date, all interests
and rights of any grantee shall expire. These options were granted
for no
consideration. There are no options available for grant from this
plan.
|
(b)
|
1999
Share Option Plan
Under
a share option plan established in 1999, (“the 1999 Plan”), the Company
granted options to employees during 1999, which are held by a trustee
under section 3(i) of the Tax Ordinance, of which 955,920 are outstanding
and exercisable as of December 31, 2005, at an exercise price of
$0.497.
The
option term is for a period of 10 years from grant date. If the options
are not exercised and the shares not paid for by such date, all interests
and rights of any grantee shall expire. These options were granted
for no
consideration. There are no options available for grant from this
plan.
|
(c)
|
1999
International Share Option Plan
Under
an international share option plan established in 1999, (“the
International Plan”), the Company granted options to employees during 1999
and 2000, of which 1,380,000 are outstanding and exercisable as of
December 31, 2005, at an exercise price between $0.497 and $1.10.
|
|
The
options granted thereunder are outstanding and exercisable until
October
2007. If the options are not exercised and the shares are not paid
for by
such date, all interests and rights of any grantee shall expire.
These
options were granted for no consideration. There are no options
available
for grant from this plan.
|
(d)
|
2000
Share Option Plan
Under
a share option plan established in 2000, (“the 2000 Plan”), the Company
granted options to employees during 2000, which are held by a
trustee
under section 3(i) of the Tax Ordinance, of which 855,300 are
outstanding
and exercisable as of December 31, 2005, at an exercise price
of $1.10.
The
option term is for a period of 10 years from grant date. If the
options
are not exercised and the shares not paid for by such date, all
interests
and rights of any grantee shall expire. These options were granted
for no
consideration. There are no options available for grant from
this plan.
|
(e)
|
2001
Share Option Plan
Under
a share option plan established in 2001, (“the 2001 Plan”), the Company
granted options to employees during
2001-2004,
including directors, according to which up to 11,000,000 options
were
available to be granted, of which 2,703,485 are outstanding as
of December
31, 2005, at an exercise price per share between $0.106 and $0.931.
These
options were granted in accordance with section 102 of the Tax
Ordinance,
under the capital gains option set out in section 102(b)(2) of
the
ordinance.
The
option term is for a period of 10 years from grant date.
The options were granted for no consideration. The options vest
over a
four year period, with vesting occurring on the 2nd, 3rd and
4th
anniversary from the grant date, and in addition, the lock up
period of
the options is for two years from the date of grant. Compensation
expenses
are calculated based on the straight line method. As of December
31, 2005,
2,316,820 options are fully vested. As of December 31, 2005,
the remaining
number of options available for future grants in this pool is
7,919,960.
|
(f)
|
Non-Plan
Share Options
In
addition to the options granted under the Company’s share option plans,
there are 15,014,460 outstanding options, and 7,224,460 exercisable
options, as of December 31, 2005, which were granted by the Company
to
employees, directors and consultants not under an option plan
during
1997-2005.
The options were granted at an exercise price per share between
$0.20 and
$2.11. The options expire between 2007 and 2015. The options
which were
granted during 2005, are from the Non-Plan
Share Options, see 2(a) and 2(b) below for the term of the options.
|
2)
|
The
following table summarizes options granted to employees and directors
under the Company's stock option plans, as discussed
above:
|
Year
ended December 31
|
|||||||||||||||||||
2005
|
2004
|
2003
|
|||||||||||||||||
Weighted
|
Weighted
|
Weighted
|
|||||||||||||||||
Average
|
average
|
average
|
|||||||||||||||||
Number
|
exercise
price
|
Number
|
exercise
price
|
Number
|
exercise
price
|
||||||||||||||
$
|
$
|
$
|
|||||||||||||||||
Balance
outstanding at
|
|||||||||||||||||||
beginning
of year
|
17,805,661
|
0.69
|
17,552,661
|
0.69
|
19,891,823
|
0.71
|
|||||||||||||
Changes
during the year:
|
|||||||||||||||||||
Granted
*
|
11,370,000
|
0.36
|
432,000
|
0.33
|
824,900
|
0.13
|
|||||||||||||
Exercised
**
|
(3,786,825
|
)
|
0.40
|
(50,000
|
)
|
0.37
|
(854,100
|
)
|
0.01
|
||||||||||
Expired
and forfeited
|
(1,119,861
|
)
|
0.47
|
(129,000
|
)
|
0.68
|
(2,309,962
|
)
|
0.87
|
||||||||||
Balance
outstanding at
|
|||||||||||||||||||
end
of year***
|
24,268,975
|
0.59
|
17,805,661
|
0.69
|
17,552,661
|
0.69
|
|||||||||||||
Balance
exercisable at end
|
|||||||||||||||||||
of
year***
|
16,262,310
|
0.70
|
16,051,324
|
0.72
|
11,924,323
|
0.63
|
|
The
following table summarizes information about stock options granted
to
employees and directors outstanding and exercisable at December 31,
2005:
|
Options
outstanding
|
Options
exercisable
|
||||||||||||
Weighted
|
Weighted
|
||||||||||||
average
|
average
|
||||||||||||
Balance
at
|
remaining
|
|
Balance
at
|
remaining
|
|||||||||
December 31,
|
|
contractual
|
|
December 31,
|
contractual
|
||||||||
2005
|
life
|
2005
|
life
|
||||||||||
Number
|
In
years
|
Number
|
In
years
|
||||||||||
Exercise
prices:
|
|||||||||||||
$
0.106
|
355,523
|
6.4
|
102,658
|
4.4
|
|||||||||
$
0.250
|
125,000
|
7.7
|
41,667
|
7.7
|
|||||||||
$
0.315
|
6,200
|
1.0
|
6,200
|
1.0
|
|||||||||
$
0.354
|
11,250,000
|
4.6
|
3,750,000
|
4.6
|
|||||||||
$
0.365
|
1,045,120
|
1.1
|
1,045,120
|
1.1
|
|||||||||
$
0.482
|
19,600
|
4.2
|
15,600
|
3.5
|
|||||||||
$
0.486
|
9,900
|
0.6
|
9,900
|
0.6
|
|||||||||
$
0.497
|
6,180,070
|
2.5
|
6,180,070
|
2.5
|
|||||||||
$
0.766
|
108,800
|
5.1
|
108,800
|
5.1
|
|||||||||
$
0.851
|
150,200
|
5.8
|
103,733
|
5.6
|
|||||||||
$
0.853
|
120,000
|
9.6
|
—
|
—
|
|||||||||
$
0.931
|
1,928,262
|
4.1
|
1,928,262
|
4.1
|
|||||||||
$
1.10
|
1,695,300
|
3.0
|
1,695,300
|
3.0
|
|||||||||
$
2.110
|
1,275,000
|
4.7
|
1,275,000
|
4.7
|
|||||||||
|
24,
268,975
|
3.9
|
16,262,310
|
3.4
|
(a)
|
In
August 2005, the Company’s shareholders granted its Chairman of the Board
(the “Chairman”) and one of its non-executive directors, options to
purchase a total of 9,250,000 and 2,000,000 ordinary shares,
respectively,
at an exercise price equal to $0.354 per share (which was below
market
price) . These options are exercisable for a period of five
years from the
date of issuance, and granted under the same terms and conditions
as the
2001 Plan. The options shall vest upon achievement of certain
market
conditions (each 1/3 of the options will vest upon achievement
of a
certain market condition). In addition, with regard to the
Chairman, in
the event of a merger, acquisition or other change of control
or in the
event that the Company terminates the Chairman, either without
cause or as
a result of his death or disability, or he terminates his agreement
for
good reason, the exercisability of any of the options granted
to him
(9,250,000 options) that are unexercisable at the time of such
event or
termination shall accelerate and the time period during which
he shall be
allowed to exercise such options shall be extended by two years
from the
date of the termination of his agreement. Additionally, the
Company’s
board of directors shall have the discretion to accelerate
all or a
portion of the Chairman’s options at any time. As of December 31, 2005,
3,083,333 options that were granted to the Chairman and 666,667
options
that were granted to one of its non-executive directors are
vested (the
first milestone was reached and therefore 1/3 of the options
were vested).
The compensation expenses are amortized using the graded method.
The
Company used a lattice model that incorporated a Monte Carlo
Simulation
method as the fair value option pricing model, which was
estimated by
management with the assistance of an independent third-party
appraiser.
The following assumptions under this method were used for
the stock
options granted: risk free interest rate of 4.6% (in dollar
terms),
expected volatility of 50%, dividend yield of 0%, and derived
expected
life of 1.43 to 4.37 years. The weighted average fair value
of options
granted during the year, estimated by using the Monte Carlo
Simulation
Method was $0.53 per option.
|
(b)
|
In
August 2005, the Company granted to two of its
non-executive directors a grant of 60,000 options each, having
an exercise
price equal to $0.853 per share (which was at market price),
vesting over
the three years from the date of grant. In addition, they also
provided
for an annual grant of 20,000 options each, for three years,
at an
exercise price equivalent to the then current closing price of
the
Company’s ADR’s on the Nasdaq National Market. The future grants are
contingent on them being members of the board of directors at
such time.
The
Company used a Black & Scholes model as the fair value option pricing
model. The following assumptions under the Black & Scholes model were
used for the stock option granted: expected
volatility of: 50%; risk-free interest rates (in dollar terms)
of: 4.6%,
dividend yield of 0% and expected life of 5 years (based on
management
estimation).
The
weighted average fair value of options using the Black & Scholes
model, granted during the year, estimated by using the model
was $0.42 per
option.
|
(c)
|
The
weighted average fair value of options granted during 2004
and 2003,
estimated by using the Black & Scholes option-pricing model, was $
0.10 and $ 0.07 for the year ended December 31, 2004, and
2003,
respectively. The fair value of options was estimated on
the date of
grant, based on the following weighted average assumptions:
dividend yield
of 0% for all relevant years; expected volatility of: 2004
- 35% and 2003
- 45%; risk-free interest rates (in dollar terms) of: 2004
- 2.9% and 2003
- 2.75%; and expected life of 2 to 4 years, for each of the
reported
years, depending on the vesting period of the options.
|
(d)
|
The non-cash compensation relating to options granted to employees and directors were $2,718,000 in 2005 (of which $67,000 was charged to research and development costs, $2,641,000 was charged to general and administrative expenses and $10,000 was charged to business development costs.). The total compensation costs related to nonvested awards not recognized as of December 31, 2005 is $3,408,000, and the weighted average period over which it is expected to be recognized is 3.6 years. |
3)
|
The
following table summarizes options granted to consultants (including
consultants and members of the scientific advisory board and
other
third-party service providers) under the Company's stock option
plans, as
discussed above:
|
Year
ended December 31
|
|||||||||||||||||||
2005
|
2004
|
2003
|
|||||||||||||||||
Weighted
|
Weighted
|
Weighted
|
|||||||||||||||||
average
|
average
|
average
|
|||||||||||||||||
Number
|
exercise
price
|
Number
|
exercise
price
|
Number
|
exercise
price
|
||||||||||||||
$
|
$
|
$
|
|||||||||||||||||
Balance
outstanding at beginning of year
|
525,000
|
0.33
|
205,000
|
0.54
|
205,000
|
0.54
|
|||||||||||||
Changes
during the year - granted*
|
—
|
—
|
320,000
|
0.20
|
—
|
—
|
|||||||||||||
Balance
outstanding at end of year**
|
525,000
|
0.33
|
525,000
|
0.33
|
205,000
|
0.54
|
|||||||||||||
Balance
exercisable at end of year**
|
355,000
|
0.39
|
280,901
|
0.45
|
205,000
|
0.54
|
* |
The
options exercise price was equal to the share price on the grant
date.
|
** | The aggregate intrinsic value as of December 31, 2005 is $236,000 for outstanding options, and $137,000 for exercisable options. |
Options
outstanding
|
Options
exercisable
|
||||||||||||
Weighted
|
|
Weighted
|
|||||||||||
average
|
|
average
|
|||||||||||
Balance
at
|
remaining
|
Balance
at
|
remaining
|
||||||||||
December 31,
|
contractual
|
December 31,
|
contractual
|
||||||||||
2005
|
life
|
2005
|
life
|
||||||||||
Number
|
In
years
|
Number
|
In
years
|
||||||||||
Exercise
prices:
|
|||||||||||||
$
0.20
|
150,000
|
2.7
|
150,000
|
2.7
|
|||||||||
$
0.20
|
170,000
|
*
|
—
|
—
|
|||||||||
$
0.497
|
10,000
|
3.4
|
10,000
|
3.4
|
|||||||||
$
0.538
|
195,000
|
1.0
|
195,000
|
1.0
|
|||||||||
525,000
|
355,000
|
||||||||||||
*
Two years from date of regulators approval to sell in any geographic
location. The options were granted during 2004.
|
(a)
|
The
Company used the Black & Scholes fair value option pricing model. The
following assumptions under this method were used in 2005:
expected
volatility of 50%, risk free interest rates (in dollars
terms) of 4.6% and
expected life of three years. The following assumptions
under this method
were used in 2004: expected volatility of 33%, risk free
interest rates
(in dollars terms) of 3.6% and expected life of five years.
The weighted
average fair value of options granted during 2004, estimated
by using the
Black & Scholes fair value option pricing model was $0.30 for 2004,
and $0.88 per option for 2005.
|
(b)
|
The
non-cash compensation relating to options granted to consultants
were
$45,000 in 2005 and were charged to research and development
costs. The
charges for non-cash compensation relating to options granted
to
consultants were $32,000 in 2004 (of which $30,000 was
charged to research
and development costs, and $2,000 was charged to general
and
administrative expenses). There is no compensation costs
related to
nonvested awards not recognized as of December 31,
2005.
|
a.
|
Royalty
Bearing Agreements:
|
1) |
Under
a Research and License agreement with Yeda Research and Development
Company Ltd. (“Yeda”), the Company is committed to pay royalty payments at
rates determined in the agreement not exceeding 3% of net sales,
or
royalty rates mainly between 20% to 25% of sublicensing fees, for
products
in development and research under such an agreement.
The
Company has entered into certain license agreements with third
parties in
respect of particular projects. In connection with such agreements,
the
Company may incur royalty and milestone obligations commitments
at varying
royalty rates not exceeding 5 % of future net sales or 25 % of
sublicensing fees of products developed, based on such agreements.
Additionally,
the Company has undertaken to make contingent milestone payments
to
certain licensors of up to approximately $49.0 million over the
life of
the licenses, of which $34.0 million will be due upon or following
regulatory approval of the drugs (for contingent milestones related
to
VivoQuest’s purchase agreement which are included in these figures, see
Note 3).
In
some cases, these contingent milestone payments will only be
triggered
upon receipt of royalties on sales of related products and in
certain
cases will partially offset royalties the Company would otherwise
owe
those
licensors.
In addition, the Company is required to pay one of its licensors
an amount
of $100,000-$200,000 per year, as minimum royalties, during the
life of
the license. The Company may terminate at any time the agreement
with the
licensor upon advance notice of six months.
|
2) |
The
Company is committed to pay royalties to the Government of Israel
on
proceeds from sales of products in the research and development
of which
the Government participates by way of grants. At the time grants
were
received, successful development of the related projects was not
assured.
In the case of failure of a project that was partly financed as
above, the
Company is not obligated to pay any such royalties. Under the terms
of
Company's funding from the Israeli Government, royalties of 3%
- 5% are
payable on sales of products developed from projects so funded,
up to 100%
of the amount of the grant received by the Company (dollar linked);
as
from January 1, 1999 - with the addition of an annual interest
based on
Libor.
At
December 31, 2005, the maximum amount of the contingent liability
in
respect of royalties related to ongoing projects to the government
is
$3,778,000.
|
In
addition, the Company has received the approval of the Government
of Israel for the transfer of manufacturing rights of its HepeX-B
product,
under the terms of the agreement with Cubist (see Note 2). As
a
consequence, thereof, the Company is obligated to repay the grants
received from the
Government
of Israel for the financing of the HepeX-B product from any amounts
received by the Company from Cubist due to the sales of HepeX-B
product,
at a percentage rate, per annum, calculated based on the aggregate
amount
of grants received from the Government
of Israel divided by all amounts invested by the Company in the
research
and development activities of HepeX-B, and up to an aggregate
amount of
300% of the original amounts received for such project, including
interest
at the Libor rate. As of December 31, 2005, the aggregate amount
received
from the
Government
of Israel for the financing of the HepeX-B project including
interest and
Libor rate is equal to $4,213,000.
|
3) |
The
Company provided for annual
grants, over three years, of options to two of its non-executive
directors. The future grants are contingent on them being
members of the
board of directors at such time (see note
6(b)2b).
|
b.
|
Operating
lease
commitments:
|
1) |
The
Company leases its office space under lease agreements
that expire through
2009.
Future
minimum rental payments under these agreements are as
follows:
|
December
31, 2005
|
|
($
in thousands)
|
In
2006
|
667
|
In
2007
|
437
|
In
2008
|
450
|
In
2009
|
426
|
1,980
|
To
secure the lease agreement in Israel, the Company provided
a bank
guarantee. As of December 31, 2005, the guarantee is
secured by a pledge
on a long-term deposit amounting to $110,000 (December
31, 2004- $113,000)
linked to the Israeli Consumer Price Index (“CPI”), which is included in
the balance sheet as long-term deposit.
Rental
expenses for the years ended December 31, 2005, 2004
and 2003 were
$524,000, $394,000 and $427,000, respectively. The Company
has an option
to extend certain rental agreements for up to 5 years.
|
2) |
The
Company leases vehicles under the terms of certain
operating lease
agreements that expire through 2007. Future minimum
lease payments -
linked to the CPI - are as
follows:
|
December
31, 2005
|
|
($
in thousands)
|
In
2006
|
53
|
In
2007
|
34
|
87
|
Vehicle
lease expense for the years ended December 31, 2005,
2004 and 2003 were
$76,000, $84,000 and $105,000, respectively.
|
c.
|
Research
and development agreement commitments
The
Company has commitments to pay amounts aggregating $ 652,000,
in respect
of research and development costs (mainly to outside service
providers),
of which $585,000 relates to 2006 and $67,000 relates to
2007.
|
d.
|
Tax
Assessment
In
2005, the Company received an assessment from the Israeli
tax authorities
of approximately $730,000 (including fines and interest
expenses) related
to withholding taxes for the periods of 2001-2004. The
Company has
recorded an accrual to reflect the probable liability
associated with this
assessment, based on the opinion of management, which
is included as part
of general and administrative expenses.
|
a.
|
The
Company
Measurement
of results for tax purposes under the Income Tax (Inflationary
Adjustments) Law, 1985
Under
this law, results for tax purposes are measured in real
terms, having
regard to the changes in the CPI. The Company is taxed
under this
law.
Results
for tax purposes are measured on a real basis - adjusted
to reflect the
increase in the Israeli consumer price index (hereafter
- the CPI). As
explained in Note 1b, the financial statements are presented
in dollars.
The difference between the change in the Israeli CPI and
the NIS-dollar
exchange rate - both on annual and cumulative basis - causes
a difference
between taxable income and income reflected in these financial
statements
(see also Note
1i).
|
|
Tax
benefits under the Israeli Law for Encouragement of
Capital Investments,
1959
The
Company has been granted an “approved enterprise” status under the Israeli
Law for Encouragement of Capital Investments, 1959.
Income derived from
the approved enterprise during a period of 7 years
from the year in which
this enterprise first realizes taxable income, provided
the maximum period
to which it is restricted by the law has not elapsed,
is entitled to tax
benefits as follows:
Tax
exemption for two years and reduced tax rate for the
remaining eight
years. The Company has not yet incurred taxable income.
The reduced tax
rate is dependent upon the percentage of foreign-owned
holdings (10% -
25%). Since the Company is currently over 25% foreign
owned, it is
entitled to reduced tax rate of 25% .
The
Company has an “approved enterprise” plan from 2001. The expiration of
this plan is in 2015.
If
the Company subsequently
pays a dividend out of income derived from the “approved enterprise”
during the tax exemption period, it will be subject
to tax on the amount
distributed, including any company tax on these amounts,
at the rate which
would have been applicable had such income not been
exempt (25%).
The
entitlement to the above benefits is conditional upon
the Company
fulfilling the conditions stipulated by the law, regulations
published
there-under and the instruments of approval for the
specific investment in
approved enterprise. In the event of failure to comply
with these
conditions, the benefits may be cancelled and the Company
may be required
to refund the amount of the benefits, in whole or in
part, with the
addition of interest. The
Investment center is currently reviewing the Company’s final
implementation report and as a result, the Company
has not yet received a
final implementation approval with respect to its “approved enterprise”
from the Investment Center. Additionally, given the
Company’s significant
amount of net-operating losses and the limitation mentioned
above to the
benefit period, there is no certainty, if and when
the Company would be
able to enjoy the tax benefits described above.
Tax
benefits under the Israeli law for the Encouragement
of Industry
(Taxation), 1969
The
Company qualifies as “industrial company” under the above law. In
accordance with this law the Company is entitled
to certain benefits
including accelerated depreciation on industrial
buildings and equipment,
a deduction of 12.5% per year of the purchase price
of a good-faith
acquisition of patent and certain other intangible
property
rights.
|
Tax
rates in Israel applicable to income from other
sources
The
income of the Company not eligible for “approved enterprise” benefits,
mentioned above (other than income from “approved enterprises”, see c.
below) is taxed at the regular rate. Through December 31, 2003,
the
corporate tax was 36%. The corporate tax rates for 2004 and thereafter
are
as follows: 2004 - 35%, 2005 - 34%, 2006 - 31%, 2007 - 29%, 2008
- 27%,
2009 - 26% and for 2010 and thereafter -
25%.
|
b.
|
The
Subsidiary
The
Subsidiary is taxed according to U.S. tax
laws.
|
c.
|
Current
tax losses for tax
purposes
|
1) |
Company
Income
tax of the Company is computed on the basis of the income
in Israeli
currency as determined for statutory purposes.
The
Company incurred losses for tax purposes from inception.
The
carryforward loss for tax purposes as of December 31, 2005
is
approximately $ 94 million (linked to the CPI), which may
be offset
against future taxable income generated from a business,
(including
capital gains from the sale of assets used in the business)
with no
expiration date.
|
2) |
Subsidiary
The
Subsidiary is remunerated under a cost plus agreement
with the Company.
The subsidiary has incurred taxable income and recorded
tax expenses and
is taxed under the applicable U.S. tax
laws.
|
|
The
following table summarizes the taxes on income for the Company
and its
subsidiary for 2005, 2004 and
2003:
|
2005
|
2004
|
2003
|
|||||||||||||||||
($
in thousands)
|
($
in thousands)
|
($
in thousands)
|
|||||||||||||||||
Company
|
Subsidiary
|
Company
|
Subsidiary
|
|
Company
|
Subsidiary
|
|||||||||||||
Net
income (loss) before
|
|||||||||||||||||||
income
taxes
|
(14,187
|
)
|
250
|
(16,582
|
)
|
158
|
(14,327
|
)
|
117
|
||||||||||
Income
Taxes
|
—
|
78
|
—
|
49
|
—
|
78
|
|||||||||||||
Net
income (loss) for the year
|
(14,187
|
)
|
172
|
(16,582
|
)
|
109
|
(14,327
|
)
|
39
|
d.
|
Deferred
income taxes
As
a result of the“approved
enterprise” status of the Company, the Company’s current tax rate is 0%,
and therefore no deferred tax assets have been included in these
financial
statements in respect of carryforward losses.
|
e.
|
Reconciliation
of the theoretical tax expense to actual tax expense
The
main reconciling item, between the statutory tax rate of the Company
and
the effective rate is the non-recognition of tax benefits from
carryforward
tax losses due to the uncertainty of the realization of such tax
benefits
(see above).
|
f.
|
Tax
assessments
|
1)
|
Income
taxes
The
Company received tax assessments for the years up to and including
the
1998 tax year.
The
Company’s tax returns until 2001are considered final. The Subsidiary has
not been assessed for tax purposes since
incorporation.
|
2)
|
Withholding
taxes - see Note 7d.
|
a.
|
2005
Restructuring
In
2005, the Company implemented a restructuring plan designed to
focus its
resources on the development of its lead programs, with the goal
of moving
these programs through to clinical proof of concept. The 2005
restructuring included a 32 person reduction in the Company’s workforce,
31 of whom were in research and development and one of whom was
in general
and administrative. As part of the 2005 restructuring, the Company
took a
charge in 2005 of $168,000, relating to employee dismissal costs,
$163,000
of which was included in research and development costs and $5,000
of
which was included in general and administrative expenses.
As
of December 31, 2005, 28 employees have left the Company under
the 2005
restructuring plan and approximately $147,000 of dismissal costs
have been
paid. The other 4 employees left the Company in early 2006. As
of December
31, 2005, approximately $21,000 in employee dismissal obligations
are
included in accounts payable and accruals. The balance of these
obligations was paid in early 2006.
In
December 2005, as a result of the Company's restructuring, and
in
accordance with the provisions of FAS 144, the
Company reviewed the carrying value of certain lab equipment assets,
and
recorded an impairment charge in
research and development costs
in
an amount of $26,000 in 2005 (see also Note 4b).
|
b.
|
2003
Restructuring
In
2003, the Company implemented and completed a restructuring plan.
As a
result of this restructuring, the Company ceased all early-stage
discovery
research activities related to infectious diseases. The 2003 restructuring
included a 20-person reduction in its workforce in Israel, 18 of
whom were
in research and development and two of whom were in general and
administrative. As part of the 2003 restructuring, the Company
took a
charge in 2003 of $74,000, relating to employee dismissal costs,
$58,000
of which was included in research and development costs and $16,000
of
which was included in general and administrative expenses. The
Company
paid all of these amounts in 2003. As part of the 2003 restructuring,
the
Company reevaluated its long-lived assets in accordance with FAS
No. 144,
and recorded a non-cash impairment charge of $354,000 of fixed
assets for
the year ended December 31, 2003 (see Note 4b).
|
a.
|
Short-term
bank deposits
The
deposits are denominated in dollars and bear a weighted average
annual
interest rate of 4.23 % as of December 31, 2005 (as of December
31, 2004 -
1.81%).
|
b.
|
Accounts
receivable - other:
|
December
31
|
|||||||
2005
|
2004
|
||||||
($
in thousands)
|
|||||||
Prepaid
expenses
|
285
|
165
|
|||||
Employees
|
75
|
24
|
|||||
Value
added tax authorities
|
17
|
101
|
|||||
Other
|
54
|
16
|
|||||
431
|
306
|
c.
|
Accounts
payable and
accruals:
|
Suppliers
|
655
|
1,108
|
|||||
Accrued
expenses
|
940
|
1,337
|
|||||
Institutions
and employees in respect of salaries
|
|||||||
and
related benefits
|
250
|
294
|
|||||
Provision
for vacation pay and recreation pay
|
160
|
385
|
|||||
Other
|
2
|
10
|
|||||
2,007
|
3,134
|
|
Statements
of operations:
|
d.
|
Research
and development
costs:
|
Period
from
|
|||||||||||||
March
9, 1993
|
|
||||||||||||
Year
ended December 31
|
to
December 31,
|
||||||||||||
2005
|
2004
|
2003
|
2005
|
||||||||||
($
in thousands)
|
|||||||||||||
Wages,
salaries and related benefits
|
|||||||||||||
(includes
non-cash compensation
|
|||||||||||||
of
$67 in 2005, and $0
|
|||||||||||||
in
2004 and 2003)
|
2,764
|
2,776
|
3,450
|
23,709
|
|||||||||
Outside
service providers
|
2,054
|
6,430
|
6,799
|
35,910
|
|||||||||
Lab
supplies
|
558
|
754
|
1,128
|
8,964
|
|||||||||
Consultants
(includes non-cash
|
|||||||||||||
compensation
of $45 in 2005,
|
|||||||||||||
$30
in 2004 and $0 in 2003)
|
531
|
549
|
494
|
3,725
|
|||||||||
Rent
and maintenance
|
752
|
725
|
866
|
4,756
|
|||||||||
Impairment
loss
|
26
|
354
|
380
|
||||||||||
Depreciation
and amortization
|
212
|
277
|
369
|
2,929
|
|||||||||
Other
|
416
|
474
|
562
|
2,517
|
|||||||||
7,313
|
11,985
|
14,022
|
82,890
|
e.
|
General
and administrative expenses:
|
|
|||||||||||||
Wages,
salaries and related benefits
|
|||||||||||||
(includes
non-cash compensation
|
|||||||||||||
of
$5 in 2005, and $0 in 2004
|
|||||||||||||
and
2003)
|
454
|
1,890
|
1,244
|
11,534
|
|||||||||
Corporate
communications
|
140
|
289
|
228
|
2,350
|
|||||||||
Professional
fees
|
890
|
647
|
564
|
4,405
|
|||||||||
Director
fees and related (includes
|
|||||||||||||
non-cash
compensation of $2,636
|
|||||||||||||
in
2005, and $0 in 2004 and 2003)
|
2,821
|
243
|
183
|
4,208
|
|||||||||
Rent
and maintenance
|
91
|
90
|
104
|
956
|
|||||||||
Communications
|
25
|
34
|
33
|
220
|
|||||||||
Depreciation
and amortization
|
30
|
42
|
70
|
619
|
|||||||||
Patent
registration fees
|
174
|
271
|
125
|
1,191
|
|||||||||
Other
|
832
|
628
|
554
|
3,529
|
|||||||||
5,457
|
4,134
|
3,105
|
29,012
|
f.
|
Business
development costs:
|
Wages,
salaries and related
|
|||||||||||||
benefits
(includes non-cash
|
|||||||||||||
compensation
of $10 in 2005,
|
|||||||||||||
and
$0 in 2004 and 2003)
|
171
|
410
|
408
|
2,672
|
|||||||||
Travel
|
22
|
36
|
136
|
764
|
|||||||||
Professional
fees
|
34
|
364
|
120
|
1,077
|
|||||||||
227
|
810
|
664
|
4,513
|
g.
|
Financial
income,
net:
|
March
9, 1993
|
|||||||||||||
Year
ended December 31
|
to
December 31,
|
||||||||||||
2005
|
2004
|
2003
|
2005
|
||||||||||
($
in thousands)
|
|||||||||||||
Financial
income:
|
|
||||||||||||
Interest
income
|
503
|
297
|
458
|
9,228
|
|||||||||
Foreign
exchange differences-gain
|
—
|
67
|
—
|
203
|
|||||||||
Gain
from available for sale securities
|
—
|
13
|
62
|
13
|
|||||||||
Other
|
—
|
—
|
—
|
156
|
|||||||||
503
|
377
|
520
|
9,600
|
||||||||||
Financial
expenses:
|
|||||||||||||
Foreign
exchange differences-loss
|
39 |
—
|
148 |
1,960
|
|||||||||
Interest
expense
|
—
|
—
|
374
|
||||||||||
Loss
from available for sale securities
|
—
|
—
|
—
|
14
|
|||||||||
Other
|
21
|
25
|
20
|
109
|
|||||||||
60
|
25
|
168
|
2,457
|
||||||||||
Financial
income, net
|
443
|
352
|
352
|
7,143
|
a.
|
Linkage
terms of balances in non-dollars
currency:
|
1)
|
As
follows:
|
December 31,
2005
|
|||||||
Israeli
currency
|
Other
|
||||||
Unlinked
|
|||||||
($
in thousands)
|
|||||||
Assets
|
934
|
122
|
|||||
Liabilities
|
987
|
45
|
|
The
above balances do not include Israeli currency balances linked
to the
dollar.
|
2)
|
Data
regarding the changes in the exchange rate of the dollar and the
Israeli
CPI:
|
Year
ended December 31
|
||||||||||
2005
|
2004
|
2003
|
||||||||
Devaluation
(evaluation) of the Israeli currency
against the dollar
|
6.85%
|
|
(1.6)%
|
|
(7.6)%
|
|
||||
Changes
in the Israeli CPI
|
2.4 %
|
|
1.2%
|
|
(1.9)%
|
|
||||
Exchange
rate of one dollar (at end of year)
|
NIS
4.603
|
NIS
4.308
|
NIS
4.379
|
b.
|
Fair
value of financial instruments
The
financial instruments of the Company consist of non-derivative
assets and
liabilities, included in working capital.
In
view of their nature, the fair value of these financial instruments
is
usually identical or close to their carrying
value.
|
c.
|
Concentration
of credit risks
Most
of the Company’s cash and cash equivalents and bank deposits at the
balance sheet dates were deposited with Israeli banks. The
Company is of
the opinion that the credit risk in respect of those balances
is
remote.
|
Page
|
|
F-44
|
|
Financial
Statements:
|
|
F-46
|
|
F-47
|
|
F-48
|
|
F-51
|
|
F-52
|
VIVOQUEST,
INC.
|
|||
(A
DEVELOPMENT STAGE ENTERPRISE)
|
|||
June
30,
|
December
31,
|
||||||
ASSETS
|
2005
|
2004
|
|||||
(unaudited)
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
764,359
|
$
|
1,069,640
|
|||
Prepaid
expenses and other current assets
|
93,174
|
74,317
|
|||||
Total
current assets
|
857,533
|
1,143,957
|
|||||
Fixed
assets, at cost, net of accumulated depreciation
|
|||||||
and
amortization
|
581,201
|
792,503
|
|||||
Security
deposits
|
14,740
|
44,740
|
|||||
Other
assets
|
24,925
|
24,924
|
|||||
Total
assets
|
$
|
1,478,399
|
$
|
2,006,124
|
|||
LIABILITIES,
REDEEMABLE CONVERTIBLE PREFERRED STOCK
AND
|
|||||||
STOCKHOLDERS'
DEFICIENCY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
633,335
|
$
|
198,025
|
|||
Notes
payable
|
4,184,643
|
2,084,642
|
|||||
Total
liabilities
|
4,817,978
|
2,282,667
|
|||||
Redeemable
Preferred stock, $1.00 par value; 33,844,305 shares
authorized:
|
|||||||
Series
A Convertible Preferred stock, $1.00 par value; 471,145
|
|||||||
shares
designated, issued and outstanding in 2005 and 2004
|
|||||||
(at
liquidation value), respectively
|
684,430
|
667,942
|
|||||
Series
B Convertible Preferred stock, $1.00 par value; 1,904,762
|
|||||||
shares
designated; 1,904,762 shares issued and outstanding in
|
|||||||
2005
and 2004 (at liquidation value), respectively
|
7,005,166
|
6,830,164
|
|||||
Series
C Convertible Preferred stock, $.01 par value; 31,468,398
|
|||||||
shares
designated; 28,224,878 shares issued and outstanding
|
|||||||
in
2005 and 2004 (liquidation value $23,280,389)
|
17,330,482
|
16,803,278
|
|||||
Total
redeemable preferred stock
|
25,020,078
|
24,301,384
|
|||||
Stockholders'
deficiency:
|
|||||||
Common
stock, $0.01 par value; 49,400,000 shares authorized;
|
|||||||
shares
issued and outstanding 5,769,999 shares in 2005
|
|||||||
and
5,756,294 shares in 2004
|
57,700
|
57,563
|
|||||
Additional
paid-in capital
|
(2,154,423
|
)
|
(1,437,396
|
)
|
|||
Stock
subscription receivable
|
(117,378
|
)
|
(116,399
|
)
|
|||
Deficit
accumulated during the development stage
|
(26,145,556
|
)
|
(23,081,695
|
)
|
|||
Total
stockholders' deficiency
|
(28,359,657
|
)
|
(24,577,927
|
)
|
|||
Total
liabilities, redeemable convertible preferred
|
|||||||
stock
and stockholders' deficiency
|
$
|
1,478,399
|
$
|
2,006,124
|
|||
|
The
notes to financial statements are made a part
hereof.
|
VIVOQUEST,
INC.
|
|||||||||
(A
DEVELOPMENT STAGE ENTERPRISE)
|
|||||||||
Cumulative
from
|
|||||||||||||
September
29, 1998
|
|||||||||||||
Six
Months Ended
|
Year
Ended
|
(inception)
to
|
|||||||||||
June
30,
|
December
31,
|
June
30,
|
|||||||||||
2005
|
2004
|
2004
|
2005
|
||||||||||
(unaudited)
|
(unaudited)
|
(unaudited)
|
|||||||||||
Operating
expenses:
|
|||||||||||||
Research
and development
|
$
|
2,051,705
|
$
|
1,715,119
|
$
|
3,430,162
|
$
|
14,284,983
|
|||||
General
and administrative
|
545,332
|
479,499
|
1,071,546
|
6,383,182
|
|||||||||
Depreciation
and amortization
|
213,009
|
372,957
|
722,817
|
2,750,701
|
|||||||||
Total
operating expenses
|
2,810,046
|
2,567,575
|
5,224,525
|
23,418,866
|
|||||||||
Other
(income) and expenses:
|
|||||||||||||
Interest
income
|
(14,740
|
)
|
(13,584
|
)
|
(27,142
|
)
|
(491,607
|
)
|
|||||
Interest
expense
|
268,555
|
60,482
|
2,334,991
|
||||||||||
Loss
on extinguishment of debt
|
350,450
|
||||||||||||
253,815
|
(13,584
|
)
|
33,340
|
2,193,834
|
|||||||||
Net
loss
|
(3,063,861
|
)
|
(2,553,991
|
)
|
(5,257,865
|
)
|
(25,612,700
|
)
|
|||||
|
|||||||||||||
Dividend
related to Series A , Series B
|
|||||||||||||
and
Series C Preferred stock
|
(717,027
|
)
|
(718,696
|
)
|
(1,437,154
|
)
|
(4,483,971
|
)
|
|||||
Net
loss attributable to common stockholders
|
$
|
(3,780,888
|
)
|
$
|
(3,272,687
|
)
|
$
|
(6,695,019
|
)
|
$
|
(30,096,671
|
)
|
|
VIVOQUEST,
INC.
|
|||||||||||||||||||||
(A
DEVELOPMENT STAGE ENTERPRISE)
|
|||||||||||||||||||||
FOR
THE PERIOD FROM SEPTEMBER 29, 1998 (INCEPTION) TO DECEMBER 31,
2004,
INCLUDING
|
|||||||||||||||||||||
THE
YEARS ENDED DECEMBER 31, 1999, 2000, 2001, 2002, 2003 and 2004
and
the
|
|||||||||||||||||||||
SIX
MONTHS ENDED JUNE 30, 2005
|
Stockholders'
Deficiency
|
||||||||||||||||||||||||||||||||||
Redeemable
Preferred Stock
|
Additional
|
Stock
|
||||||||||||||||||||||||||||||||
Series
A
|
Series
B
|
Common
Stock
|
Paid-in
|
Unearned
|
Subscriptions
|
Accumulated
|
||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Compensation
|
Receivable
|
Deficit
|
Total
|
||||||||||||||||||||||||
Sale
of Common Stock for cash ($0.025 per share)
|
750,120
|
$
|
7,501
|
$
|
11,252
|
$
|
(825
|
)
|
$
|
17,928
|
||||||||||||||||||||||||
Sale
of Series A Convertible Preferred Stock ($1.00 per share, net
of issuance
costs of $2,195)
|
235,572
|
$
|
235,572
|
(2,195
|
)
|
(2,195
|
)
|
|||||||||||||||||||||||||||
Accretion
to redemption value of Series A Convertible
|
||||||||||||||||||||||||||||||||||
Preferred
Stock
|
4,473
|
(4,473
|
)
|
(4,473
|
)
|
|||||||||||||||||||||||||||||
Net
loss for the period September 29, 1998 (inception) to December
31,
1998
|
$
|
(96,405
|
)
|
(96,405
|
)
|
|||||||||||||||||||||||||||||
Balance
at December 31, 1998
|
235,572
|
240,045
|
750,120
|
7,501
|
4,584
|
(825
|
)
|
(96,405
|
)
|
(85,145
|
)
|
|||||||||||||||||||||||
Issuance
of Common Stock to executive consultants ($0.025 per
share)
|
200,000
|
2,000
|
3,000
|
5,000
|
||||||||||||||||||||||||||||||
Sale
of Common Stock for cash and notes ($0.025 per
share)
|
1,979,970
|
19,800
|
29,699
|
(35,071
|
)
|
14,428
|
||||||||||||||||||||||||||||
Sales
of Series A Convertible Preferred Stock ($1.00 per share, net
of issuance
costs of $12,824)
|
235,573
|
235,573
|
(12,824
|
)
|
(12,824
|
)
|
||||||||||||||||||||||||||||
Sale
of Series B convertible Preferred Stock ($2.625 per share, net
of issuance
costs of $ 73,119)
|
1,904,762
|
$
|
5,000,000
|
(73,119
|
)
|
(73,119
|
)
|
|||||||||||||||||||||||||||
Sale
of warrants to purchase Common Stock at $0.13125 per share to
Series B
Preferred stockholders ($0.01 per share)
|
2,000
|
2,000
|
||||||||||||||||||||||||||||||||
Issuance
of Common Stock to executive consultants ($0.13125 per
share)
|
400,000
|
4,000
|
48,500
|
$
|
(52,500
|
)
|
|
|||||||||||||||||||||||||||
Amortization
of unearned compensation
|
26,250
|
26,250
|
||||||||||||||||||||||||||||||||
Accretion
to redemption value of Series A Convertible Preferred
Stock
|
27,423
|
(1,840
|
)
|
(25,583
|
)
|
(27,423
|
)
|
|||||||||||||||||||||||||||
Accretion
to redemption value of Series B Convertible Preferred
Stock
|
80,164
|
(80,164
|
)
|
(80,164
|
)
|
|||||||||||||||||||||||||||||
Repayment
of Stock Subscriptions Receivable
|
825
|
825
|
||||||||||||||||||||||||||||||||
Net
loss for the year ended December 31, 1999
|
(679,166
|
)
|
(679,166
|
)
|
||||||||||||||||||||||||||||||
Balance
at December 31, 1999
|
471,145
|
503,041
|
1,904,762
|
5,080,164
|
3,330,090
|
33,301
|
—
|
(26,250
|
)
|
(35,071
|
)
|
(881,318
|
)
|
(909,338
|
)
|
|||||||||||||||||||
Sale
of Common Stock for cash and notes ($0.13125 per
share)
|
1,010,000
|
10,100
|
122,463
|
(93,984
|
)
|
38,579
|
||||||||||||||||||||||||||||
Amortization
of unearned compensation
|
26,250
|
26,250
|
||||||||||||||||||||||||||||||||
Accretion
to redemption value of Series A Convertible Preferred
Stock
|
32,980
|
(32,980
|
)
|
(32,980
|
)
|
|||||||||||||||||||||||||||||
Accretion
to redemption value of Series B Convertible Preferred
Stock
|
350,000
|
(55,599
|
)
|
(294,401
|
)
|
(350,000
|
)
|
|||||||||||||||||||||||||||
Repurchase
of 200,000 shares ($0.13125 per share)
|
(200,000
|
)
|
(2,000
|
)
|
(24,250
|
)
|
(26,250
|
)
|
||||||||||||||||||||||||||
Repayment
of Stock Subscription Receivable
|
4,881
|
4,881
|
||||||||||||||||||||||||||||||||
Purchase
of unvested Common shares from a terminated employee ($0.13125
per
share)
|
(111,000
|
)
|
(1,110
|
)
|
(9,634
|
)
|
10,744
|
|||||||||||||||||||||||||||
Net
loss for the year ended December 31, 2000
|
(1,207,635
|
)
|
(1,207,635
|
)
|
||||||||||||||||||||||||||||||
Balance
at December 31, 2000 (carry forward)
|
471,145
|
536,021
|
1,904,762
|
5,430,164
|
4,029,090
|
40,291
|
—
|
—
|
(113,430
|
)
|
(2,383,354
|
)
|
(2,456,493
|
)
|
||||||||||||||||||||
Securities
issued in connection with services are valued based upon the
estimate of
fair value of the securities issued as determined by an independent
third
party appraisal or as determined by the Board of
Directors.
|
||||||||||||||||||||||||||||||||||
VIVOQUEST,
INC.
|
|||||||||||||||||||||||
(A
DEVELOPMENT STAGE ENTERPRISE)
|
|||||||||||||||||||||||
STATEMENT
OF REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS'
DEFICIENCY
|
|||||||||||||||||||||||
FOR
THE PERIOD FROM SEPTEMBER 29, 1998 (INCEPTION) TO DECEMBER 31,
2004,
INCLUDING
|
|||||||||||||||||||||||
THE
YEARS ENDED DECEMBER 31, 1999, 2000, 2001, 2002, 2003 AND 2004
AND
THE
|
|||||||||||||||||||||||
SIX
MONTHS ENDED JUNE 30, 2005
(CONTINUED)
|
Stockholders'
Deficiency
|
|||||||||||||||||||||||||||||||||||||
Redeemable
Preferred Stock
|
Additional
|
Stock
|
|||||||||||||||||||||||||||||||||||
Series
A
|
Series
B
|
Series
C
|
Common
Stock
|
Paid-in
|
Subscriptions
|
Accumulated
|
|||||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Receivable
|
Deficit
|
Total
|
||||||||||||||||||||||||||
Balance
at December 31, 2000 (Brought forward)
|
471,145
|
$
|
536,021
|
1,904,762
|
$
|
5,430,164
|
4,029,090
|
$
|
40,291
|
$
|
-
|
$
|
(113,430
|
)
|
$
|
(2,383,354
|
)
|
$
|
(2,456,493
|
)
|
|||||||||||||||||
Sale
of Common Stock for cash and notes ($0.13125 per
share)
|
548,000
|
5,480
|
66,445
|
(71,925
|
)
|
|
|||||||||||||||||||||||||||||||
Accretion
to redemption value of Series A Convertible Preferred
Stock
|
32,980
|
(32,980
|
)
|
(32,980
|
)
|
||||||||||||||||||||||||||||||||
Accretion
to redemption value of Series B Convertible Preferred
Stock
|
350,000
|
(350,000
|
)
|
(350,000
|
)
|
||||||||||||||||||||||||||||||||
Purchase
of unvested Common shares from terminated employees ($0.13125
per
share)
|
(444,000
|
)
|
(4,440
|
)
|
(53,835
|
)
|
56,475
|
(1,800
|
)
|
||||||||||||||||||||||||||||
Repayment
of Stock Subscription Receivable
|
16,356
|
16,356
|
|||||||||||||||||||||||||||||||||||
Issuance
of 659,421 warrants ($1.3125 per share) in connection with Bridge
Notes
(see Note 8b)
|
1,177,366
|
1,177,366
|
|||||||||||||||||||||||||||||||||||
Net
loss for the year ended December 31, 2001
|
(4,382,517
|
)
|
(4,382,517
|
)
|
|||||||||||||||||||||||||||||||||
Balance
at December 31, 2001
|
471,145
|
569,001
|
1,904,762
|
5,780,164
|
4,133,090
|
41,331
|
806,996
|
(112,524
|
)
|
(6,765,871
|
)
|
(6,030,068
|
)
|
||||||||||||||||||||||||
Sale
of Common Stock for cash and notes ($0.13125 per
share)
|
100,000
|
1,000
|
12,125
|
(13,125
|
)
|
|
|||||||||||||||||||||||||||||||
Accretion
to redemption value of Series A Convertible Preferred
Stock
|
32,980
|
(32,980
|
)
|
(32,980
|
)
|
||||||||||||||||||||||||||||||||
Accretion
to redemption value of Series B Convertible Preferred
Stock
|
350,000
|
(350,000
|
)
|
(350,000
|
)
|
||||||||||||||||||||||||||||||||
Issuance
of stock option granted in consideration for consulting
services
|
1,956
|
1,956
|
|||||||||||||||||||||||||||||||||||
Repayment
of Stock Subscription Receivable
|
9,250
|
9,250
|
|||||||||||||||||||||||||||||||||||
Issuance
of 605,714 warrants ($1.3125 per share) in connection with Bridge
Notes
(see Note 8b)
|
475,987
|
475,987
|
|||||||||||||||||||||||||||||||||||
Net
loss for the year ended December 31, 2002
|
(5,923,000
|
)
|
(5,923,000
|
)
|
|||||||||||||||||||||||||||||||||
Balance
at December 31, 2002
|
471,145
|
601,981
|
1,904,762
|
6,130,164
|
4,233,090
|
42,331
|
914,084
|
(116,399
|
)
|
(12,688,871
|
)
|
(11,848,855
|
)
|
||||||||||||||||||||||||
Sale
of Common Stock for cash and notes ($0.13125 per
share)
|
1,523,159
|
15,232
|
76,158
|
91,390
|
|||||||||||||||||||||||||||||||||
Sale
of Series C Convertible Preferred Stock for notes ($.01 per share,
net of
issuance costs of $58,836)
|
28,224,878
|
$
|
15,063,053
|
(61,140
|
)
|
(61,140
|
)
|
||||||||||||||||||||||||||||||
Accretion
to redemption value of Series A Convertible Preferred
Stock
|
32,980
|
(32,980
|
)
|
(32,980
|
)
|
||||||||||||||||||||||||||||||||
Accretion
to redemption value of Series B Convertible Preferred
Stock
|
350,000
|
(350,000
|
)
|
(350,000
|
)
|
||||||||||||||||||||||||||||||||
Accretion
to redemption value of Series C Convertible Preferred
Stock
|
685,810
|
(553,102
|
)
|
(132,708
|
)
|
(685,810
|
)
|
||||||||||||||||||||||||||||||
Issuance
of stock option granted in consideration for consulting
services
|
6,980
|
6,980
|
|||||||||||||||||||||||||||||||||||
Net
loss for the year ended December 31, 2003
|
(5,002,251
|
)
|
(5,002,251
|
)
|
|||||||||||||||||||||||||||||||||
Balance
at December 31, 2003 (carry forward)
|
471,145
|
634,961
|
1,904,762
|
6,480,164
|
28,224,878
|
15,748,863
|
5,756,249
|
57,563
|
—
|
(116,399
|
)
|
(17,823,830
|
)
|
(17,882,666
|
)
|
VIVOQUEST,
INC.
|
|||||||||||||||||||||||
(A
DEVELOPMENT STAGE ENTERPRISE)
|
|||||||||||||||||||||||
STATEMENT
OF REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS'
DEFICIENCY
|
|||||||||||||||||||||||
FOR
THE PERIOD FROM SEPTEMBER 29, 1998 (INCEPTION) TO DECEMBER
31, 2004,
INCLUDING
|
|||||||||||||||||||||||
THE
YEARS ENDED DECEMBER 31, 1999, 2000, 2001, 2002, 2003 AND 2004
AND
THE
|
|||||||||||||||||||||||
SIX
MONTHS ENDED JUNE 30, 2005
(CONTINUED)
|
Stockholders'
Deficiency
|
|||||||||||||||||||||||||||||||||||||
Redeemable
Preferred Stock
|
Additional
|
Stock
|
|||||||||||||||||||||||||||||||||||
Series
A
|
Series
B
|
Series
C
|
Common
Stock
|
Paid-in
|
Subscriptions
|
Accumulated
|
|||||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Receivable
|
Deficit
|
Total
|
||||||||||||||||||||||||||
Balance
at December 31, 2003 (brought forward)
|
471,145
|
634,961
|
1,904,762
|
6,480,164
|
28,224,878
|
15,748,863
|
5,756,249
|
57,563
|
—
|
(116,399
|
)
|
(17,823,830
|
)
|
(17,882,666
|
)
|
||||||||||||||||||||||
Accretion
to redemption value of Series A Convertible Preferred
Stock
|
32,981
|
(32,981
|
)
|
(32,981
|
)
|
||||||||||||||||||||||||||||||||
Accretion
to redemption value of Series B Convertible Preferred
Stock
|
350,000
|
(350,000
|
)
|
(350,000
|
)
|
||||||||||||||||||||||||||||||||
Accretion
to redemption value of Series C Convertible Preferred
Stock
|
1,054,415
|
(1,054,415
|
)
|
(1,054,415
|
)
|
||||||||||||||||||||||||||||||||
Net
loss for the year ended December 31, 2004
|
(5,257,865
|
)
|
(5,257,865
|
)
|
|||||||||||||||||||||||||||||||||
Balance
at December 31, 2004
|
471,145
|
667,942
|
1,904,762
|
6,830,164
|
28,224,878
|
16,803,278
|
5,756,249
|
57,563
|
(1,437,396
|
)
|
(116,399
|
)
|
(23,081,695
|
)
|
(24,577,927
|
)
|
|||||||||||||||||||||
(Unaudited):
|
|||||||||||||||||||||||||||||||||||||
Exercise
of stock option for common stock
|
13,750
|
137
|
1,667
|
(979
|
)
|
825
|
|||||||||||||||||||||||||||||||
Accretion
to redemption value of Series A Convertible Preferred
Stock
|
16,488
|
(16,488
|
)
|
(16,488
|
)
|
||||||||||||||||||||||||||||||||
Accretion
to redemption value of Series B Convertible Preferred
Stock
|
175,002
|
(175,002
|
)
|
(175,002
|
)
|
||||||||||||||||||||||||||||||||
Accretion
to redemption value of Series C Convertible Preferred
Stock
|
527,204
|
(527,204
|
)
|
(527,204
|
)
|
||||||||||||||||||||||||||||||||
Net
loss for the six months ended June 30, 2005
|
(3,063,861
|
)
|
(3,063,861
|
)
|
|||||||||||||||||||||||||||||||||
Balance
at June 30, 2005
|
471,145
|
$
|
684,430
|
1,904,762
|
$
|
7,005,166
|
28,224,878
|
$
|
17,330,482
|
5,769,999
|
$
|
57,700
|
$
|
(2,154,423
|
)
|
$
|
(117,378
|
)
|
$
|
(26,145,556
|
)
|
$
|
(28,359,657
|
)
|
|||||||||||||
Securities
issued in connection with services are valued based upon the
estimate of
fair value of the securities issued as determined by an independent
third
party appraisal or as determined by the Board of
Directors.
|
|||||||||||||||||||||||||||||||||||||
VIVOQUEST,
INC.
|
|||||||
(A
DEVELOPMENT STAGE ENTERPRISE)
|
|||||||
Cumulatve
from
|
|||||||||||||
Six
Months
|
September
29, 1998
|
||||||||||||
Ended
|
Year
Ended
|
(inception)
to
|
|||||||||||
June
30,
|
December
31,
|
June
30,
|
|||||||||||
2005
|
2004
|
2004
|
2005
|
||||||||||
(unaudited)
|
(unaudited)
|
(unaudited)
|
|||||||||||
Cash
flows from operating activities:
|
|||||||||||||
Net
loss
|
$
|
(3,063,861
|
)
|
$
|
(2,553,991
|
)
|
$
|
(5,257,865
|
)
|
$
|
(25,612,700
|
)
|
|
Adjustments
to reconcile net loss to
|
|||||||||||||
net
cash used in operating activities:
|
|||||||||||||
Depreciation
and amortization
|
213,009
|
372,957
|
722,817
|
2,750,701
|
|||||||||
Amortization
of discount on notes payable
|
1,302,903
|
||||||||||||
Loss
on extinguishment of debt
|
350,450
|
||||||||||||
Stock
issued for accrued interest on notes
|
155,896
|
||||||||||||
Stock
and stock options issued in consideration
|
|||||||||||||
for
services rendered
|
157,826
|
||||||||||||
Changes
in assets and liabilities:
|
|||||||||||||
Decrease
(increase) in prepaid expenses, other
|
|||||||||||||
current
assets and other assets
|
(18,857
|
)
|
135,286
|
304,754
|
(162,596
|
)
|
|||||||
(Decrease)
increase in accounts payable
|
|||||||||||||
and
accrued expenses
|
435,310
|
12,587
|
11,800
|
1,180,250
|
|||||||||
Net
cash used for operating activities
|
(2,434,399
|
)
|
(2,033,161
|
)
|
(4,218,494
|
)
|
(19,877,270
|
)
|
|||||
Cash
flows from investing activities:
|
|||||||||||||
Capital
expenditures
|
(1,707
|
)
|
(131,670
|
)
|
(141,149
|
)
|
(3,331,902
|
)
|
|||||
Cash
flows from financing activities:
|
|||||||||||||
Refund
of security deposits
|
30,000
|
30,000
|
|||||||||||
Sale
of common stock
|
1,804
|
104,050
|
|||||||||||
Stock
subscriptions receivable
|
(979
|
)
|
(979
|
)
|
|||||||||
Repurchase
of common stock
|
(28,050
|
)
|
|||||||||||
Proceeds
from sale of Series A preferred stock
|
471,145
|
||||||||||||
Proceeds
from sale of Series B preferred stock
|
5,000,000
|
||||||||||||
Proceeds
from sale of Series C preferred stock
|
4,000,000
|
||||||||||||
Proceeds
from sale of Warrants
|
1,655,353
|
||||||||||||
Costs
associated with issuance of preferred stock
|
(149,278
|
)
|
|||||||||||
Accured
interest on notes payable
|
12,891,290
|
||||||||||||
Proceeds
from notes payable
|
2,100,000
|
|
2,084,642
|
||||||||||
Net
cash provided by financing activities
|
2,130,825
|
2,084,642
|
23,973,531
|
||||||||||
NET
INCREASE (DECREASE) IN CASH
|
|||||||||||||
AND
CASH EQUIVALENTS
|
(305,281
|
)
|
(2,164,831
|
)
|
(2,275,001
|
)
|
764,359
|
||||||
Cash
and cash equivalents at beginning of period
|
1,069,640
|
3,344,641
|
3,344,641
|
||||||||||
Cash
and cash equivalents at end of period
|
$
|
764,359
|
$
|
1,179,810
|
$
|
1,069,640
|
$
|
764,359
|
|||||
Supplemental
disclosure of noncash investing
|
|||||||||||||
and
financing activities:
|
|||||||||||||
Accretion
to redemption value of Series A
|
|||||||||||||
Preferred
stock
|
$
|
16,488
|
$
|
16,490
|
$
|
32,981
|
$
|
180,304
|
|||||
Accretion
to redemption value of Series B
|
|||||||||||||
Preferred
stock
|
175,002
|
174,999
|
350,000
|
1,655,166
|
|||||||||
Accretion
to redemption value of Series C
|
|||||||||||||
Preferred
stock
|
527,204
|
527,207
|
1,054,415
|
2,267,429
|
|||||||||
Series
C Preferred stock issued for notes
|
217,608
|
||||||||||||
payable
and accrued interest
|
|||||||||||||
Discount
on notes payable
|
1,653,353
|
||||||||||||
1. |
Organization
and Business:
|
VivoQuest,
Inc. (the "Company") is engaged in the discovery, development and
manufacture of therapeutic agents derived from chemical compounds
existing
in nature for the diagnosis, prophylaxis and treatment of human
diseases
and disorders. The Company was incorporated in the State of Delaware
on
September 18, 1998 and commenced operations on September 29,
1998. The Company’s operations are in the United States. As a development
stage enterprise, the Company’s primary efforts, to date, have been
devoted to raising capital, forming strategic relationships with
research
institutes, universities and commercial entities to complement
its
research and development activities, recruiting senior management
and key
scientific personnel, securing a corporate facility for research
and
administration (Valley Cottage, New York) and commencing research
operations at the corporate facility. In addition to the normal
risks
associated with a new business venture, there can be no assurance
that the
Company’s research and development will be successfully completed or that
any approved product will be commercially viable. In addition,
the Company
operates in an environment of rapid change in technology, and is
dependent
upon the services of its employees, executive officers and consultants.
The Company operates under a single
segment.
|
On
February 7, 2002, the Company’s Board of Directors approved a 2-for-1
stock dividend of the outstanding shares of common stock, while
maintaining the par value of common stock at $0.01. All common
share and
per share amounts included herein have been adjusted as if the
stock
dividend had occurred at inception.
|
2. |
Summary
of Significant Accounting Policies:
|
The
financial statements have been prepared on a going concern basis,
which
contemplates realization of assets and liquidation of liabilities
in the
ordinary course of business. The Company has limited capital resources,
net operating losses and negative cash flows from operations since
inception and expects these conditions to continue for the foreseeable
future. In addition, it is anticipated that the Company will not
generate
revenues from product sales in the twelve months following
December 31, 2004 and in the several years following that period.
These conditions raise substantial doubt about the Company’s ability to
continue as a going concern.
|
2. |
Summary
of Significant Accounting Policies (Continued):
|
Basis
of Preparation (Continued)
|
As
of June 30, 2005 and December 31, 2004, the Company had approximately
$760,000, and $1,069,000 in cash and cash equivalents, respectively.
During 2001 and 2002, the Company issued approximately $10.4 million
in
convertible term notes (“Bridge Notes”) (see Note 8b), the principal and
accrued interest on which were converted to shares of the Company’s Series
C Preferred Stock in March 2003. The funds raised from the Bridge
Notes
were used to pay for rent, leasehold improvements and equipment
necessary
to set up laboratory facilities as well as salaries and other operating
expenses. During April 2003 and September 2003 the Company raised
an
additional $4 million through the sale of Series C Preferred Stock.
The
Company will be required to raise additional funds to meet other
planned
obligations in the future and has sought to raise such amounts
through the
private sale of its equity securities. The Company may also seek
to raise
capital through collaborative arrangements with corporate sources
or other
sources of financing. There can be no assurance that such additional
financing, if at all available, can be obtained on terms reasonable
to the
Company. In the event that sufficient funds are not available,
the Company
will need to postpone, scale back or discontinue future operations.
Continuance of the Company as a going concern is dependent upon,
among
other things, the Company’s ability to obtain adequate long-term
financing, the success of its research and development program
and its
attainment of profitable operations. The financial statements do
not
include any adjustments that might result from the outcome of this
uncertainty.
|
The
Company considers all highly liquid investments which have maturities
of
three months or less, when acquired, to be cash equivalents. The
carrying
amount reported in the balance sheet for cash and cash equivalents
approximates its fair value. Cash and cash equivalents subject
the Company
to concentrations of credit risk. At June 30, 2005 and December 31,
2004, the Company held approximately $760,000 and $1,069,000 respectively,
in a single commercial bank.
|
2. |
Summary
of Significant Accounting Policies (Continued):
|
Computer
and telephone equipment
|
3
years
|
|||
Furniture
and lab equipment
|
5
years
|
|||
Leasehold
improvements
|
Life
of lease
|
Financial
instruments which potentially subject the Company to concentrations
of
credit risk consist of cash and cash
equivalents.
|
2. |
Summary
of Significant Accounting Policies (Continued):
|
The
Company accounts for income taxes in accordance with the provisions
of
Statement of Financial Accounting Standards No. 109, "Accounting
for
Income Taxes" ("SFAS No. 109"). SFAS No. 109 requires that the
Company
recognize deferred tax liabilities and assets for the expected
future tax
consequences of events that have been included in the financial
statements
or tax returns. Under this method, deferred tax liabilities and
assets are
determined on the basis of the difference between the tax basis
of assets
and liabilities and their respective financial reporting amounts
("temporary differences") at enacted tax rates in effect for the
years in
which the temporary differences are expected to
reverse.
|
The
preparation of financial statements in conformity with generally
accepted
accounting principles requires management to make estimates and
assumptions that affect the amounts reported in the financial statements
and accompanying notes. Significant estimates include useful lives
of
fixed assets and valuation of common stock and stock options (see
below).
Actual results could differ from those
estimates.
|
The
accompanying financial position and results of operations of the
Company
have been prepared in accordance with APB Opinion No. 25, "Accounting
for
Stock Issued to Employees" ("APB No. 25"). Under APB No. 25, generally,
no
compensation expense is recognized in the financial statements
in
connection with the sale of common stock or awarding of stock option
grants to employees provided that, as of the sale or grant date,
all terms
associated with the sale or award are fixed and the fair value
of the
Company's stock, as of the sale or grant date, is equal to or less
than
the amount an employee must pay to acquire the stock. The Company
will
recognize compensation expense in situations where the terms of
a stock
sale or an option grant are not fixed or where the fair value of
the
Company's common stock on the sale or grant date is greater than
the
amount an employee must pay to acquire the stock.
|
2.
|
Summary
of Significant Accounting Policies (Continued):
|
The
Company has stock-based incentive plans, which are described in
Note 9.
The following table illustrates the effect on the Company’s net loss
attributable to common stockholders had compensation costs for
the
incentive plans been determined in accordance with the fair value
based
method of accounting for stock-based compensation as prescribed
by
Statement of Financial Accounting Standards No. 123, Accounting
for Stock-Based Compensation
(“SFAS No. 123”) as amended by Statement of Financial Accounting Standards
No. 148 “Accounting for Stock-Based Compensation Transaction and
Disclosure, an amendment of SFAS 123”. Since option grants awarded vest
over several years and additional awards may be issued in the future,
the
pro forma results shown below are not likely to be representative
of the
effects on future years of the application of the fair value based
method.
|
Cumulative
from
|
|||||||||||||
Year
|
September
29,
|
||||||||||||
Six
Months Ended
|
Ended
|
1998
(Inception)
|
|||||||||||
June
30,
|
December
31,
|
to
June 30,
|
|||||||||||
2005
|
2004
|
2004
|
2005
|
||||||||||
Net
loss attributable to common stockholders, as reported
|
$
|
(3,780,888
|
)
|
$
|
(3,272,687
|
)
|
$
|
(6,695,019
|
)
|
$
|
(30,096,671
|
)
|
|
Deduct:
total stock-based employee compensation expense determined under
fair
value based method for all awards
|
(328
|
)
|
(26,572
|
)
|
(77,549
|
)
|
|||||||
Pro
forma net loss attributable to common stockholders
|
$
|
(3,781,216
|
)
|
$
|
(3,272,687
|
)
|
$
|
(6,721,591
|
)
|
$
|
(30,174,220
|
)
|
2. |
Summary
of Significant Accounting Policies (Continued):
|
For
the purposes of the above pro forma calculations, the fair value
of each
option granted from the 1999 Stock Plan during the period and was
estimated on the date of grant using the Black Scholes option pricing
model. The following table summarizes the assumptions used in computing
the fair value of option grants for the periods presented
above.
|
Expected
volatility
|
85
|
%
|
||
Expected
lives
|
5
|
|||
Dividend
yield
|
0
|
%
|
||
Risk
free interest rate
|
3.18
|
%
|
Other
disclosures required by SFAS No. 123 have been included in Note
9.
|
The
fair value of options and warrants granted to nonemployees for
financing,
goods or services are included in the financial statements and
expensed
over the life of the debt, as the goods are utilized or the services
performed, respectively.
|
Comprehensive
loss represents the change in net assets of a business enterprise
during a
period from transactions and other events and circumstances from
nonowner
sources. For all periods presented, there are no differences between
net
loss and comprehensive net loss.
|
3. |
Property
Plant and Equipment:
|
Property,
plant and equipment as of June 30, 2005 and December 31, 2004 consist
of
the following:
|
June
30,
|
December
31,
|
||||||
2005
|
2004
|
||||||
Computer
and telephone equipment
|
$
|
237,279
|
$
|
235,572
|
|||
Furniture
and lab equipment
|
2,009,203
|
2,009,203
|
|||||
Leasehold
improvements
|
1,085,770
|
1,085,770
|
|||||
3,332,252
|
3,330,545
|
||||||
Less
accumulated depreciation and amortization
|
(2,751,051
|
)
|
(2,538,042
|
)
|
|||
$
|
581,201
|
$
|
792,503
|
Depreciation
and amortization of fixed assets was approximately $213,000, $373,000,
$723,000 and $2,751,000 for the six months ended June 30, 2005,
June 30,
2004, the year ended December 31, 2004 and the cumulative period
from
September 29, 1998 (inception) to June 30, 2005,
respectively.
|
4. |
Accounts
Payable and Accrued Expenses:
|
Accounts
payable and accrued expenses as of June 30, 2005 and December 31,
2004
consist of the following:
|
June
30,
|
December
31,
|
||||||
2005
|
2004
|
||||||
Accounts
payable
|
$
|
75,014
|
$
|
80,822
|
|||
Accrued
professional fees
|
53,619
|
56,480
|
|||||
Accrued
interest payable
|
329,038
|
60,481
|
|||||
Accrued
research contract expenses
|
175,422
|
—
|
|||||
$
|
633,093
|
$
|
197,783
|
5. |
Convertible
Secured Promissory Note Payable:
|
In
September 2004, the Company entered into a convertible secured
promissory
note with UPMC Health System, a Pennsylvania non-profit corporation
(“the
Holder”). The Company can borrow up to $2,500,000 with an interest of
10%.
The note is automatically due and payable on the earlier of (a)
12 months
after the date of the note or (b) the occurrence of an event of
default as
specified in the agreement. Any unpaid portion of principal with
accrued
interest will be automatically converted into shares of the Company’s
equity securities issued and sold at the closing of a Qualified
Financing
that occurs on or prior to the maturity date. As of June 30, 2005
and
December 31, 2004, the note has an outstanding balance of approximately
$2,485,000 and $1,235,000,
respectively.
|
In
September 2004, the Company entered into another convertible secured
promissory note with Highmark Health Ventures Investment Fund,
L.P. (“the
Holder”). The Company can borrow up to $1,700,000 with an interest at
10%
a year. The note is automatically due and payable on the earlier
of (a) 12
months after the date of the note or (b) the occurrence of an event
of
default as specified in the agreement. Any unpaid portion of principal
with accrued interest will be automatically converted into shares
of the
Company’s equity securities issued and sold at the closing of a Qualified
Financing that occurs on or prior to the maturity date, September
16,
2005. As of June 30, 2005 and December 31, 2004, the note has an
outstanding principal balance of approximately $1,700,000 and $850,000,
respectively.
|
Per
the note payable agreements, if there is a change in control prior
to the
maturity date of the notes, the notes shall be payable in the amount
of
2.5 times the sum of the principal plus any accrued interest. Due
to the
Asset Purchase Agreement (see Note 11), a change in control occurred.
In
relation to a distribution of assets agreement, the note holders
agreed
that the maximum amount that the Company would be liable for the
notes
would be $7,500,000 payable upon receipt of additional monies into
the
Company in a ratio of 91.3% of all distributable
assets.
|
6. |
Stockholders’
Equity:
|
In
connection with the purchase of Common Stock, employees, consultants
and
investors issued full recourse promissory notes to the Company
for a
portion of the purchase price. The principal accrues interest at
a rate of
5.74% per annum. Principal and accrued interest is due on various
dates
between July 1, 2004 and June 30, 2007. Purchasers may prepay
principal and accrued interest without penalty. In the case of
events of
default by these individuals, as defined, the unpaid principal
and accrued
interest will become immediately due to the Company. The agreements
provide for restriction of future sale or transfer of a portion
of the
Common Stock issued to employees and consultants. Such restrictions
lapse
ratably from March 1, 2002 through November 21, 2005. Upon termination
of
employment of any consultant or employee, the Company will have
the right,
but not the obligation, to purchase remaining restricted shares
at their
then fair value. The Company recorded a receivable of $116,399
at December
31, 2004 and $117,378 at June 30, 2005 from the sale of Common
Stock
issued to employees and
consultants.
|
As
of April 6, 2006, the date of this report, none of the promissory
notes
have been repayed to the Company.
|
6. |
Stockholders’
Equity (Continued):
|
On
September 30, 1999, the Company entered into agreements (the “Management
Agreements”) with the Company’s Chairman and Interim Chief Executive
Officer and Chief Financial Officer (the “Officers”) for services they had
performed in organizing and raising financing for the Company and
services
they will perform in the future in those same capacities. In consideration
for services rendered under the Management Agreements, the Company
issued
200,000 shares of Common Stock to each of the Officers. The fair
value of
those shares of Common Stock on the issuance date was $0.2625 per
share as
determined by an independent third party appraisal which was subsequently
revalued at $0.13125 after a 2-for-1 stock split. Accordingly,
the Company
recorded unearned compensation of $52,500 in connection with the
shares
issued to the Officers. For each of the years ended December 31,
2000 and
1999, the Company recognized compensation expense of $26,250 in
connection
with the shares issued to the Officers. The Management Agreements
terminated on March 31, 2001.
|
During
2003, the Company granted a total of 1,523,159 shares of common
stock to
employees and one nonemployee consultant for services rendered.
In
connection with these awards, the Company recognized $91,390 of
compensation expense, reflecting a fair value of common stock of
$0.06 on
the dates of grant as determined by the Board of Directors. During
2005,
the Company issued 13,750 shares of common stock due to an employee
exercising an option at an exercised price of $0.13125 (see Note
9).
|
7. |
Mandatorily
Redeemable Convertible Preferred Stock and
Warrants:
|
The
Company’s Certificate of Incorporation, as amended, authorizes the Company
to issue 33,844,305 shares of preferred stock (the “Preferred Stock”), of
which 471,145 shares are designated as Series A Convertible Preferred
Stock $1.00 par value (the “A Preferred”), and 1,904,762 shares are
designated as Series B Convertible Preferred Stock $1.00 par value
(the “B
Preferred”), and 31,468,398 shares are designated as Series C Convertible
Preferred Stock $.01 par value (the “C
Preferred”).
|
7. |
Mandatorily
Redeemable Convertible Preferred Stock and Warrants
(Continued):
|
In
September 1998 and May 1999, an investor (the “Initial Investor”)
purchased 235,572 shares and 235,573 shares, respectively, of A
Preferred
for $1.00 per share. In September and December 1999, four investors,
including the Initial Investor, purchased a total of 1,904,762
shares of B
Preferred for $2.625 per share. In the event of liquidation, dissolution
or winding up of the Company, holders of A Preferred and B Preferred
will
be entitled to be paid $1.00 and $2.625 per share, respectively,
subject
to adjustment for stock dividends, stock splits, mergers or other
recapitalization, as defined, plus all dividends accrued or declared
but
unpaid, out of the assets of the Company. The order of preference
of
payments will be to holders of B Preferred, then A Preferred and
then
Common Stock.
|
Each
share of A Preferred and B Preferred is convertible into the number
of
shares of Common Stock determined by dividing $1.00 by the Series
A
Conversion Price or $2.625 by the Series B Conversion Price, respectively.
The Conversion Price at which shares of Common Stock shall be delivered
upon conversion of A Preferred or B Preferred without payment of
any
additional consideration by the holder thereof shall initially
be $1.00 or
$2.625 per share of Common Stock, respectively. The Series A Conversion
Price and Series B Conversion Price are subject to adjustments
under
certain circumstances as defined, in effect at the time of the
conversion
including each time the Company sells additional shares of Common
Stock
that are not part of a stock option, stock purchase or stock bonus
plan,
at a fair market value which is below the Conversion Price in effect
at
the time of sale. The Initial Investor, the sole owner of A Preferred,
has
waived all rights to an adjustment to the Conversion Price resulting
from
issuances of Common Stock prior to October 1, 1999. Accrued but
unpaid dividends are forfeited upon conversion of A Preferred or
B
Preferred. As of June 30, 2005, the Series A Conversion Price was
$0.50
and the Series B Conversion Price was $0.75424 after the effect
of the
2-for-1 stock dividend (see Note 1) and the anti-dilution provision
resulting from issuance of C Preferred (see below). The outstanding
A
Preferred and B Preferred were convertible into 942,290 and 6,629,190
shares of Common Stock,
respectively.
|
7. |
Mandatorily
Redeemable Convertible Preferred Stock and Warrants
(Continued):
|
In
March, April and September 2003, the Company authorized 25,847,050
shares
of Series C Preferred Stock with a stated value of $0.53368 per
share in
connection with a Qualified Financing. At that time, the principal
and
accrued interest on Bridge Notes issued in 2001 and 2002 (see Note
8b),
totaling approximately $11.1 million, were converted into 20,729,747
shares of C Preferred at a conversion price of $0.53368 and an
additional
1,873,782 shares of C Preferred were purchased for $1.0 million
by the
initial Investor. In September 2003, the Company authorized an
additional
5,621,348 shares of Series C Preferred Stock with a stated value
of
$.053368 per share, which were purchased by two investors. The
C Preferred
has the same terms as B Preferred as to liquidation, conversion,
redemption, dividends and voting except that the stated value and
redemption value for C Preferred are $0.53368 per share and the
liquidation value for C Preferred is $0.80052 per share. Upon events
of
liquidation and payment of dividends, the preference of payments
is to
holders of C Preferred and B Preferred, before holders of A Preferred
and
Common Stock.
|
As
a result of the anti-dilution provisions associated with the B
Preferred,
upon issuance of the shares of C Preferred in March 2003, the Conversion
Price of B Preferred changed from $1.3125 to $0.75424 and the 3,804,524
shares of B Preferred are convertible into 6,629,190
shares.
|
Shares
of A Preferred, B Preferred and C Preferred will automatically
convert
into shares of Common Stock based upon the Series A Conversion
Price,
Series B Conversion Price and Series C Conversion Price in effect
at the
time upon (i) the closing of an initial public offering of the
Company’s
Common Stock, within defined terms or (ii) written election of
the holders
of at least two-thirds of A Preferred, B Preferred or C
Preferred.
|
Holders
of A Preferred, B Preferred and C Preferred have the number of
votes equal
to the number of shares of Common Stock into which the shares of
Preferred
Stock held by that shareholder would be converted at the date on
which the
vote is held. As of December 31, 2004 and June 30, 2005, such votes
total
35,796,358.
|
7. |
Mandatorily
Redeemable Convertible Preferred Stock and Warrants
(Continued):
|
Dividends
may be declared and paid on Common Stock, as determined by the
Company’s
Board of Directors, provided (i) that all dividends, accrued or
declared,
to holders of Preferred Stock have previously been paid and (ii)
that at
the same time, the Company declares and pays a dividend to the
holders of
Preferred Stock equal to that which would be payable to them if
their
Preferred Stock had been converted into Common Stock on the date
of
determination of holders of Common Stock to receive such
dividend.
|
Dividends
may be declared and paid on Preferred Stock, as determined by the
Company’s Board of Directors provided (i) that no dividends will be paid
to holders of A Preferred until all dividends, accrued or declared,
to
holders of B Preferred and C Preferred have previously been paid
and (ii)
that at the time dividends are declared and paid to holders of
A
Preferred, the Company declares and pays a dividend to the holders
of B
Preferred and C Preferred equal to that which would be payable
to them if
their B Preferred and C Preferred had been converted into Common
Stock.
|
A
,
B and C Preferred shareholders are entitled to receive dividends
at the
rate of 7.0% per share per annum of the stated value, $1.00, $2.625
and
$0.53368, respectively, subject to adjustment for stock dividends,
stock
splits, mergers or recapitalizations, as defined. As of December
31, 2004
and June 30, 2005, the stated value was $1.00 per share of A Preferred,
2.625 per share of B Preferred and $0.53368 per share of C Preferred.
Dividends are cumulative and accrue from the date of issue, whether
or not
earned or declared.
|
At
the written election of any holder of Preferred Stock made within
30 days
of each of March 20, 2008, 2009 and 2010, the Company will redeem,
within
60 days after each March 20, from such holder up to one-third of
the
shares of Preferred Stock held by such holder, at a redemption
price per
share of $1.00, plus dividends accrued or declared but unpaid,
for A
Preferred and $2.625, plus dividends accrued or declared but unpaid,
for B
Preferred and $0.53368, plus dividends accrued or declared but
unpaid for
C Preferred (the “Redemption Price”). The Redemption Price is subject to
adjustment for stock dividends, stock splits, mergers or
recapitalizations, as defined.
|
7. |
Mandatorily
Redeemable Convertible Preferred Stock and Warrants
(Continued):
|
Mandatorily
redeemable preferred stock is recorded at redemption value, which
equals
issuance price plus accretion of dividends accrued or declared
but unpaid.
At June 30, 2005 and December 31, 2004 such accretion amounted
to $213,286
and $196,796 for A Preferred and $2,005,164 and $1,830,164 for
B Preferred
and $2,267,431 and $1,740,225 for C Preferred,
respectively.
|
In
connection with the sale of B Preferred in September 1999, the
Company
sold warrants to individuals who were employees of the investors
in B
Preferred. Each warrant entitles the holder to purchase a defined
number
of shares of Common Stock (“Warrant Shares”) (aggregating 200,000 shares
for all warrant holders) at an exercise price of $0.13125 per share.
Each
warrant holder had paid $0.01 per Warrant Share. The exercise price
per
share and number of Warrant Shares are subject to adjustment, as
defined.
The warrants expire in September 2009. At June 30, 2005 and
December 31, 2004, none of the warrants had been
exercised.
|
8. |
Commitments
and Contingencies:
|
(a) |
Operating
Leases
|
In
September, 1998 and July 1999 the Company entered into a series
of
agreements with the Initial Investor for the assignment of noncancelable
lease agreements for office space in New York City into which the
Initial
Investor had entered (the “Leases”). The Leases have terms of three to six
months, are automatically renewable at the option of the assignee
and
provide for escalation of the minimum rent at each anniversary
for each
lease. Rental expense in connection with the Leases amounted to
approximately $18,000 for each of the six month periods ended June
30,
2005 and 2004, $36,000 for the year ended December 31, 2004 and
$310,000
the period from September 29, 1998 (inception) to June 30,
2005.
|
8. |
Commitments
and Contingencies (Continued):
|
(a) |
Operating
Leases (Continued)
|
In
February 2001, the Company entered into a four year sublease agreement
for
laboratory and office facilities in Valley Cottage, New York (the
“Valley
Cottage Sublease”). As part of the Valley Cottage Sublease, the Company
made a $2.7 million payment, which included a $1,069,200 prepayment
of
base rent through November 30, 2004, $1,071,830 for the purchase
of
leasehold improvements and $558,970 for equipment and furniture.
Rent
expense for the Valley Cottage Sublease amounted to approximately
$146,000, $146,000, $304,000 and $1,253,000 for the six months
ended June
30, 2005 and 2004, year ended December 31, 2004, and the period
from
September 29, 1998 (inception) to June 30, 2005,
respectively.
|
In
addition to the base rent, the Company is also required to pay
its pro
rata share of real estate taxes, insurance premiums and common
area costs
(“Additional Rental Charges”). Additional rent charges for the six months
ended June 30, 2005 and 2004, year ended December 31, 2004, and
the period
from September 29, 1998 (inception) to June 30, 2005 are $43,800,
$43,800,
$76,000 and $350,000, respectively. In November 2002, the Company
received
a rebate from the landlord of approximately $54,000 representing
an
adjustment of the additional rent for the period from April 2001
through
November 2002. Such amount was recorded as a reduction of the 2002
rent
expense.
|
In
connection with the Asset Purchase Agreement (Note 11), XTL
Biopharmaceuticals Ltd. has assumed the commitment to the Valley
Cottage
lease.
|
8. |
Commitments
and Contingencies (Continued):
|
(b) |
Convertible
Notes
|
During
2001 and 2002, the Company obtained additional financing through
the
issuance of short term convertible term notes (the “Bridge Notes”)
totaling approximately $10.4 million, which accrue interest at
a rate of
6% per year. Principal plus accrued interest on the Bridge Notes,
as
amended in November 2002 (the “November Amendment”), were due on December
31, 2003. The Bridge Notes, as amended, are convertible into the
Company’s
Preferred Stock as follows: (i) if the Company consummated a convertible
preferred stock financing with one or more investors, that is approved
by
certain of the holders of the Bridge Notes, on or before December
31, 2003
(the “Qualifying Financing”), then, simultaneously with the closing of
such Qualifying Financing, the outstanding principal and accrued
interest
on the Bridge Notes would be converted into shares of the new series
of
convertible preferred stock of the Company which is authorized
by the
Company in connection with the Qualifying Financing at a price
per share
equal to that paid by investors in the Qualifying Financing; or
(ii) if a
Qualifying Financing is not obtained by such date, the Bridge Notes
and
accrued interest would be converted into shares of the Company’s B
preferred at $2.625 per share. Although the November Amendment
extended
the due date of the Bridge Notes to December 31, 2003, all other
rights
and privileges of the holders of the Bridge Notes remained unchanged.
The
extension of the due date of the Bridge Notes specified in the
November
Amendment resulted in a substantial change in the Bridge Notes
in
accordance with EITF 96-19, “Debtor’s Accounting for a Modification or
Exchange of Debt Instruments.” Accordingly, the Company recognized a loss
on extinguishment of debt in the amount of $350,450, which represented the
difference between the fair value and carrying amount of the Bridge
Notes
at November 19, 2002, the date of the November Amendment. A total
of
approximately $4.9 million of the Bridge Notes were sold to five
related
parties. During March 2003, following a Qualifying Financing, all
Bridge
Notes were converted to shares of Series C Preferred Stock (see
Note
6).
|
8. |
Commitments
and Contingencies (Continued):
|
(b) |
Convertible
Notes (Continued)
|
In
connection with the sale of the Bridge Notes, the Bridge Note holders
received fully exercisable warrants (“Bridge Warrants”) to purchase shares
of the Company’s preferred stock sold in the next round of financing at
the price paid by investors in that round of financing or to purchase
shares of B Preferred at $2.625 per share as defined. A total of
659,421
Bridge Warrants were issued in 2001. As the result of the issuance
of
Series C Preferred Stock, as discussed in Note 7, the terms of
the 2001
Bridge Warrants were fixed, so that the 2001 Bridge Warrants holders
would
be able to purchase 3,243,517 shares of Series C Preferred Stock
at a
price of $0.53368 per share. An additional 605,714 Bridge Warrants
were
issued in 2002. Bridge Warrants expire after 10 years. According
to the
November Amendment, if the Company received at least $3.5 million
from
certain defined investors (the “Investors”) in debt or equity financing on
or before December 31, 2002, the Bridge Warrants issued in 2002
would
terminate and not be exercisable. The Company raised $4.1 million
from the
Investors as of December 31, 2002 and thus all 2002 Bridge Warrants
expired on that date. The aggregate fair value of the Bridge Warrants
issued in 2001 and 2002 on the dates of issue was $1,177,366 and
$475,987,
respectively, which was equal to the discount on the respective
Bridge
Notes. Such discount was amortized on a straight-line basis, which
approximates the interest method, over the original term of the
Bridge
Notes.
|
(c) |
Collaboration
Agreements
|
In
order to further its research and development efforts, the Company
has
entered into several consulting and collaboration agreements with
individuals, research institutes and
universities.
|
(i) |
Scientific
Advisors
|
8. |
Commitments
and Contingencies (Continued):
|
(i)
|
Scientific
Advisors (Continued)
|
During
2000, 2001, and 2002, the Company entered into consulting agreements
(the
“Scientists Agreements”) with each of the Scientists, which provide for
monetary compensation and the sale to each Scientist of shares
of the
Company’s Common Stock at $0.025 and $0.13125 per share which was the fair
value of the Company’s Common Stock on the date of sale in 2001 and 2002,
respectively. During 2004 and 2003, the Company entered into consulting
agreements which provided for monetary
compensation.
|
The
Company has recognized expenses with regard to the Scientists Agreements
totaling approximately $165,000, $114,000 and $208,000 for the
six months
ended June 30, 2005 and 2004 and the year ended December 31, 2004 and
$1,192,000 for the cumulative period from September 29, 1998 (inception)
to June 30, 2005. In addition, as discussed in Note 5, the Company
has
notes receivable of $66,500, $66,500 and $53,375 at December 31,
2003,
2002 and 2001, respectively, from the sale of Common Stock to the
Scientists. The Scientists Agreements expire after one year and
may be
extended upon mutual agreement of the Company and Scientists. Either
party
may terminate the Scientists Agreements upon thirty days written
notice.
As of December 31, 2004, all of the Scientists Agreements have been
verbally extended.
|
(ii) |
Hong
Kong University of Science and
Technology
|
Between
1999 and 2001, the Company and the Biotechnology Research Institute
(“BRI”) of the Hong Kong University of Science and Technology (“HKUST”)
entered into several collaboration
and license agreements,
whereby BRI would provide laboratory facilities and know-how to
enhance
the Company’s research efforts. During the years ended December 31, 1999,
2000 and 2001, the Company made payments to BRI under these agreements.
Total payments recognized by the Company during 2001 and 2002 were
approximately $38,000 and $84,000, respectively. During the year
ended
December 31, 2003, the parties decided to terminate all agreements
and at
December 31, 2003, there were no remaining obligations on the part
of
either party under these
agreements.
|
8. |
Commitments
and Contingencies (Continued):
|
(ii) |
Hong
Kong University of Science and Technology
(Continued)
|
In
June 2004, the Company and the Biotechnology Research Institute
(“BRI”) of
the Hong Kong University of Science and Technology (“HKUST”) entered into
a new collaboration agreements called “Screen Library” program. The
program will be carried out within 9 months from the effective
date June
2004 and can be extended for additional 6 months. Under the agreement,
the
Company agrees to pay HK$ 200,000 to BRI for conducting the screening
activity. As of December 31, 2004, no payment has been made to
BRI and the
Company has not recognized any expenses relating to this
agreement.
|
(iii) |
Aaron
Diamond AIDS Research
Center
|
In
February 2001, the Company entered into a research agreement with
the
Aaron Diamond AIDS Research Center (“Aaron Diamond”) to undertake a
collaborative research program, under which Aaron Diamond will
develop
assays for screening of mutually agreed upon natural and other
product
extracts, chemical compounds and libraries, provided by the Company,
for
human immunodeficiency virus (HIV) activity. The Company will retain
all
rights to any inventions or products arising from the research
program and
will have the right to obtain patents thereon. The term of the
Aaron
Diamond agreement is for a period of five years from the date of
execution, unless extended by written agreement between the parties,
except that either party may terminate the Aaron Diamond agreement
on
thirty days prior written notice. During the term of the Aaron
Diamond
agreement, the research program will be reviewed by the Company
on an
annual basis and the research continued subject to the approval
of the
Company. During the years ended December 31, 2001 and 2002, the
Company
approved budgets for the research program for one-year periods
ending
February 2002 and February 2003, respectively. For the years ended
December 31, 2003, 2002 and 2001, the Company recognized $161,000,
$499,000 and $410,000, respectively, as research and development
expenses
in connection with the Aaron Diamond agreement. The Aaron Diamond
agreement has not been extended beyond February
2003.
|
8. |
Commitments
and Contingencies (Continued):
|
(iv) |
Peking
University
|
(v) |
Inpharmatica
Ltd.
|
In
June 2004, the Company and Inphamatica Ltd. entered into a “service
agreement” whereby Inphamatica will undertaken certain services such as
screening services, profiling services, consultancy services, modelling
services and other. The service will be carried out over a fixed
period of
24 months commencing from June 1, 2004. The service fees shall
be paid in
accordance with payment schedule specified in the agreement. For
the years
ended December 31, 2004 and for the six months ended June 30, 2004
and
2005, the Company has recognized expenses with regard to the “service
agreement” totalling approximately $115,000, $nil, and $58,000,
respectively.
|
8. |
Commitments
and Contingencies (Continued):
|
(vi)
|
Beijing
Kaizheng Biotech Developing
Ltd.
|
In
March 2004, the Company and Beijing Kaizheng
Biotech
Developing Ltd. entered into a “Contract Screening Agreement”. The
screening program consists of individual projects whereby Kaizheng
will
provide research equipment, reagents and personnel to conduct its
screening program at its Beijing facility. The service will be
carried out
over a fixed period of 24 months commencing from June 1, 2004.
The Company
agrees to pay Kaizheng Project fees specified in applicable project
description. During 2004, the Company has not recognized any expenses
with
regard to this agreement.
|
(vii) |
Replizyme
Ltd.
|
In
February 2004, the Company and Replizyme Ltd. entered into a “Service
Agreement”. Replizyme will screen compounds from Vivoquest for activity
against Hepatitis C Polymerase. The maximum cost for these tests
is
approximately $6,000. During 2004, the Company has not recognized
any
expenses with regard to this
agreement.
|
(viii) |
New
York Medical College and David Frick,
PHD.
|
In
April 2004, the Company and New York Medical College entered into
a
“Material Transfer Agreement” whereby NYMC will perform material testings
for the Company. The Company agrees to pay NYMC $6,200 payable
in three
instalments as specified in the agreement. Payments for the years
ended
December 31, 2004 and for the six months ended June 30, 2004 and
2005,
which have been paid and recognized by the Company are $6,200,
$2,000 and
$nil, respectively.
|
8. |
Commitments
and Contingencies (Continued):
|
(ix)
|
University
of Colorado
|
In
April 2004, the Company and University of Colorado entered into
a
“Material Transfer Agreement” whereby The University of Colorado will
perform material testing’s for the Company. The Company agrees to pay
$5,000 payable in three instalments as specified in the agreement,
which
have been paid and recognized by the Company during
2004.
|
9. |
Stock
Plan:
|
On
September 23, 1999, the Company adopted the 1999 Stock Plan (the
“Plan’)
whereby the Board of Directors of the Company (the “Board”) may grant (i)
options to purchase shares of Common Stock (“Options”) or (ii) Common
Stock (“Grant Stock”) to employees, officers, and directors of and
consultants and advisors to the Company. The Plan provides for
the
issuance of up to 6,869,047
shares
of Common Stock. Such amount is subject to adjustment for stock
splits,
stock dividends and other capital adjustments, as defined. All
Options
granted under the Plan are intended to be non-qualified unless
specified
by the Board to be incentive stock options (“ISO”), as defined by the
Internal Revenue Code. ISO’s may only be granted to employees of the
Company and may not be granted at exercise prices below fair value
of the
Common Stock on the date of grant (110% of fair value for employees
who
own 10% or more of the Company). Nonqualified Options may be granted
to
participants at less than the fair value of the Common Stock on
the date
of grant. The Board determines the terms upon which the Options
vest as
well as the exercise price of each Option grant. Options usually
vest over
4 years. The Board determines whether shares of Grant Stock are
subject to
restrictions and the terms by which such restrictions vest. Unvested
shares of Grant Stock may be subject to forfeiture upon termination
of
employment or occurrence of other events. The period during which
an
Option may be exercised may not exceed ten years from the date
of grant
(five years for grants of ISO’s to employees who own 10% or more of the
Company) and under certain situations, the Option’s expiration date may be
accelerated. The Plan terminates on September 23,
2009.
|
9. |
Stock
Plan (Continued):
|
The
following table summarizes stock option activity from the inception
of the
plan through June 30, 2005:
|
Number
of
|
Average
|
Number
of
|
Average
|
||||||||||
Options
|
Exercise
|
Options
|
Exercise
|
||||||||||
Outstanding
|
Price
|
Exercisable
|
Price
|
||||||||||
Balance
outstanding at January 1, 2004
|
2,427,500
|
$
|
0.09
|
737,363
|
$
|
0.12
|
|||||||
2004:
Granted
|
390,000
|
0.13
|
|||||||||||
2004:
Forfeited
|
(105,000
|
)
|
(0.10
|
)
|
|||||||||
Balance
outstanding at June 30, 2004
|
2,712,500
|
0.10
|
632,363
|
0.12
|
|||||||||
2004:
Granted
|
620,000
|
0.13
|
|||||||||||
2004:
Forfeited
|
(87,000
|
)
|
(0.06
|
)
|
|||||||||
Balance
outstanding at December 31, 2004
|
3,245,500
|
0.11
|
933,019
|
0.08
|
|||||||||
Stock
options forfeited
|
(251,250
|
)
|
(0.09
|
)
|
|||||||||
Stock
options exercised
|
(13,750
|
)
|
(0.13
|
)
|
|||||||||
Balance
outstanding at June 30, 2005
|
$
|
2,980,500
|
$
|
0.13
|
768,019
|
0.11
|
9. |
Stock
Plan (Continued):
|
For
all periods presented, the exercise price of options granted to
employees
was equal to the fair value of the Company’s common stock on the date of
grant. At December 31, 2004, and June 30, 2005 3,623,547 and 3,888,547,
respectively, shares of Common Stock were available for future
grant under
the Plan.
|
The
following table summarizes stock option information as of June
30,
2005:
|
Options
Outstanding
|
Options
Exercisable
|
|||||||||||||||
Weighted
|
Weighted
|
Weighted
|
||||||||||||||
Range
of
|
Average
|
Average
|
Average
|
|||||||||||||
Exercise
|
Number
|
Remaining
|
Exercise
|
Number
|
Exercise
|
|||||||||||
Prices
|
Outstanding
|
Contractual
Life
|
Price
|
Exercisable
|
Price
|
|||||||||||
$
0.06
|
1,122,500
|
6.8
|
$
|
0.06
|
42,750
|
$
|
0.06
|
|||||||||
0.13
-0.13125
|
1,858,000
|
8.2
|
0.13
|
725,269
|
0.13
|
|||||||||||
$0.06-$0.13125
|
2,980,500
|
7.7
|
$
|
0.10
|
768,019
|
$
|
0.11
|
10. |
Income
Taxes:
|
Since
inception there had been no provision (benefit) for federal or
state
income taxes because the Company has incurred operating losses
and has
established valuation allowances equal to the total deferred tax
asset.
|
10. |
Income
Taxes (Continued):
|
The
tax effect of temporary differences and net operating losses as
of June
30, 2005 and December 31, 2004 are as
follows:
|
June
30,
|
December
31,
|
||||||
2005
|
2004
|
||||||
Deferred
tax assets and valuation allowance:
|
|||||||
Net
operating loss carryforwards
|
$
|
6,883,686
|
$
|
5,905,286
|
|||
Capitalized
costs
|
2,474,920
|
2,227,775
|
|||||
Depreciation
and amortization
|
313,836
|
304,138
|
|||||
Research
and experimentation tax credit carry forward
|
168,336
|
168,336
|
|||||
Valuation
allowance
|
(9,840,778
|
)
|
(8,605,535
|
)
|
|||
|
$ |
—
|
$
|
—
|
As
of December 31, 2004, the Company has available, for tax purposes,
unused
net operating loss carryforwards of approximately $14.8 million,
which
will expire between 2019 and 2022. Future ownership changes may
limit the
future utilization of these net operating loss carryforwards as
defined by
the federal and state tax codes.
|
11.
|
Subsequent
Events:
|
In
August 2005, the Company entered into an asset purchase agreement
(“Asset
Purchase Agreement”) to sell substantially all of its tangible operating
assets to XTL Biopharmaceuticals Inc. (“XTL Inc.”), a Delaware
corporation, in consideration for approximately $450,000 in ordinary
shares, of XTL Biopharmaceuticals Ltd., an Israeli corporation
(“XTL”),
and the parent of XTL Inc. In addition, pursuant to an interim
funding
letter, XTL Inc. provided $400,000 to the Company to cover operating
expenses prior to the closing of the transaction. The book gain
on sale of
the assets related to this transaction was approximately $434,000.
The
Company’s shares of common and preferred stock and convertible secured
promissory notes payable (see Note 5) were not part of this
transaction.
|
11.
|
Subsequent
Events (Continued):
|
In
August 2005, the Company also entered into a Licensing Agreement
(“License
Agreement”) with XTL, pursuant to which the Company granted to XTL
exclusive worldwide rights to the Company’s intellectual property and
technology. The terms of the License Agreement included an initial
upfront
license fee of approximately $941,000 which was paid in ordinary
shares of
XTL stock. The License Agreement also provides for additional milestone
payments triggered by certain regulatory and sales targets. These
milestone payments could total $34.6 million, $25.0 million of
which would
be due upon or following regulatory approval or actual products
sales, and
are payable in cash or ordinary shares of XTL at its election.
In
addition, the License Agreement requires that XTL make royalty
payments on
products sales.
|
The
Asset Purchase Agreement and the License Agreement with VivoQuest
was
completed in September 2005. None of these milestones have
been reached as of June 30,
2005.
|
All
shares of stock of XTL received in the Asset Purchase Agreement
and
License Agreement were subsequently sold for a net loss of approximately
$160,000, which loss has not been recorded in the attached financial
statements.
|
An
agreement regarding distribution of proceeds has been entered into
by the
Company whereas any proceeds from the asset sale, net of liabilities
and
costs of the Company shall be distributed in the ratio of 91.3%
to the
holders of the Convertible Secured Promissory Notes Payable (see
Note 5)
and 8.7% to the remaining incentive pool (employees of the Company
at the
time of the closing of the asset sale) pro rata in proportion to
their
option shares at the time of the closing. As of January 2006,
approximately $900,000 has been distributed in
total.
|
In
September 2005, the Company approved a plan to dissolve and liquidate
on
or before September 2006.
|