Large
accelerated filer £
|
Accelerated
filer ý
|
Non-accelerated
filer £
|
Page
|
|||
SPECIAL
CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS
|
1
|
||
PART
I
|
|||
ITEM
1
|
Identity
of Directors, Senior Management and Advisers
|
2
|
|
ITEM
2
|
Offer
Statistics And Expected Timetable
|
2
|
|
ITEM
3
|
Key
Information
|
2
|
|
ITEM
4
|
Information
on the Company
|
18
|
|
ITEM
4A
|
Unresolved
Staff Comments
|
33
|
|
ITEM
5
|
Operating
and Financial Review and Prospects
|
33
|
|
ITEM
6
|
Directors,
Senior Management and Employees
|
46
|
|
ITEM
7
|
Major
Shareholders and Related Party Transactions
|
55
|
|
ITEM
8
|
Financial
Information
|
55
|
|
ITEM
9
|
The
Offer and Listing
|
56
|
|
ITEM
10
|
Additional
Information
|
58
|
|
ITEM
11
|
Quantitative
And Qualitative Disclosures About Market Risk
|
75
|
|
ITEM
12
|
Description
of Securities other than Equity Securities
|
76
|
|
PART
II
|
|||
ITEM
13
|
Defaults,
Dividend Arrearages and Delinquencies
|
77
|
|
ITEM
14
|
Material
Modifications to the Rights of Security Holders and Use of
Proceeds
|
77
|
|
ITEM
15
|
Controls
and Procedures
|
77
|
|
ITEM
16
|
Reserved
|
77
|
|
ITEM
16A
|
Audit
Committee Financial Expert
|
77
|
|
ITEM
16B
|
Code
of Ethics
|
77
|
|
ITEM
16C
|
Principal
Accountant Fees And Services
|
77
|
|
ITEM
16D
|
Exemptions
From The Listing Standards For Audit Committees
|
78
|
|
ITEM
16E
|
Purchases
Of Equity Securities By The Issuer And Affiliated
Purchasers
|
78
|
|
|
|||
PART
III
|
|||
ITEM
17
|
Financial
Statements
|
79
|
|
ITEM
18
|
Financial
Statements
|
79
|
|
ITEM
19
|
Exhibits
|
79
|
|
|
|||
SIGNATURES
|
80
|
||
|
Year
Ended December 31,
|
||||||||||||||||
|
2006
|
2005
|
2004
|
2003
|
2002
|
|||||||||||
|
(In
thousands, except share and per share amounts)
|
|||||||||||||||
Statements
of Operations Data:
|
||||||||||||||||
Revenues
|
|
|
|
|
|
|||||||||||
Reimbursed
out-of-pocket expenses
|
$
|
--
|
$
|
2,743
|
$
|
3,269
|
$
|
--
|
$
|
--
|
||||||
License
|
454
|
454
|
185
|
--
|
--
|
|||||||||||
454
|
3,197
|
3,454
|
--
|
--
|
||||||||||||
Cost
of Revenues
|
||||||||||||||||
Reimbursed
out-of-pocket expenses
|
--
|
2,743
|
3,269
|
--
|
--
|
|||||||||||
License
(with respect to royalties)
|
54
|
54
|
32
|
--
|
--
|
|||||||||||
54
|
2,797
|
3,301
|
||||||||||||||
Gross
Margin
|
400
|
400
|
153
|
--
|
--
|
|||||||||||
|
||||||||||||||||
Research
and development
|
||||||||||||||||
Research
and development costs
|
10,229
|
7,313
|
11,985
|
14,022
|
13,231
|
|||||||||||
Less
participations
|
--
|
--
|
--
|
3,229
|
75
|
|||||||||||
|
10,229
|
7,313
|
11,985
|
10,793
|
13,156
|
|||||||||||
In-process
research and development
|
--
|
1,783
|
--
|
--
|
--
|
|||||||||||
General
and administrative
|
5,576
|
5,457
|
4,134
|
3,105
|
3,638
|
|||||||||||
Business
development costs
|
641
|
227
|
810
|
664
|
916
|
|||||||||||
Operating
loss
|
(16,046
|
)
|
(14,380
|
)
|
(16,776
|
)
|
(14,562
|
)
|
(17,710
|
)
|
||||||
|
||||||||||||||||
Other
income (expense)
|
||||||||||||||||
Financial
and other income, net
|
1,141
|
443
|
352
|
352
|
597
|
|||||||||||
Taxes
on income
|
(227
|
)
|
(78
|
)
|
(49
|
)
|
(78
|
)
|
(27
|
)
|
||||||
|
||||||||||||||||
Loss
for the period
|
$
|
(15,132
|
)
|
$
|
(14,015
|
)
|
$
|
(16,473
|
)
|
$
|
(14,288
|
)
|
$
|
(17,140
|
)
|
|
Loss
per ordinary share
|
||||||||||||||||
Basic
and diluted
|
$
|
(0.08
|
)
|
$
|
(0.08
|
)
|
$
|
(0.12
|
)
|
$
|
(0.13
|
)
|
$
|
(0.15
|
)
|
|
Weighted
average shares outstanding
|
201,737,295
|
170,123,003
|
134,731,766
|
111,712,916
|
111,149,292
|
As
of December 31,
|
||||||||||||||||
|
2006
|
2005
|
2004
|
2003
|
2002
|
|||||||||||
|
(In
thousands)
|
|||||||||||||||
Balance
Sheet Data:
|
||||||||||||||||
Cash,
cash equivalents, bank deposits and trading
and marketable securities
|
$
|
25,347
|
$
|
13,360
|
$
|
22,924
|
$
|
22,262
|
$
|
35,706
|
||||||
Working
capital
|
22,694
|
11,385
|
20,240
|
19,967
|
33,396
|
|||||||||||
Total
assets
|
26,900
|
15,151
|
25,624
|
24,853
|
38,423
|
|||||||||||
Long-term
obligations
|
738
|
1,493
|
2,489
|
1,244
|
1,017
|
|||||||||||
Total
shareholders’ equity
|
22,760
|
11,252
|
19,602
|
20,608
|
34,830
|
·
|
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.
|
·
|
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. Investigational new drug application, or
IND,
enabling, good laboratory practice, or 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. In January 2007, the Phase I clinical trial - as
originally
designed - was completed. As no dose limiting toxicities have been
encountered, we decided to add up to two additional higher dose
cohorts to
the study. We expect to announce results from this study in the
second
quarter of 2007. 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. We
expect results from this trial shortly.
|
·
|
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 in advanced
stages
of optimization.
|
·
|
develop
Bicifadine for the treatment of neuropathic pain;
|
|
|
·
|
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
patent application directed to sustained release formulations of
Bicifadine.
|
·
|
A
patent application directed to the use of Bicifadine for treating
a
disability or reducing a functional impairment associated with
acute pain,
chronic pain, and/or neuropathic disorders.
|
·
|
A
patent application directed to the use of Bicifadine for preventing
and
treating neuropathic disorders, including, but not limited to,
diabetic
neuropathy, diabetic peripheral neuropathy, and neuropathy associated
with
alcoholism, sciatica, multiple sclerosis, spinal cord injury, chronic
low
back pain, HIV, cancer, etc.
|
·
|
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 Phase IV post-marketing studies to find out
more about
the drug’s long-term risks, benefits, and optimal use, or to test the drug
in different populations, such as
children.
|
·
|
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.
|
Year
Ended December 31,
|
||||||||||||||||
|
2006
|
2005
|
2004
|
2003
|
2002
|
|||||||||||
|
(In
thousands, except share and per share amounts)
|
|||||||||||||||
Statements
of Operations Data:
|
||||||||||||||||
Revenues
|
|
|
|
|
||||||||||||
Reimbursed
out of-pocket-expenses
|
$
|
--
|
$
|
2,743
|
$
|
3,269
|
$
|
--
|
$
|
--
|
||||||
License
|
454
|
454
|
185
|
--
|
--
|
|||||||||||
454
|
3,197
|
3,454
|
--
|
--
|
||||||||||||
Cost
of Revenues
|
||||||||||||||||
Reimbursed
out-of-pocket expenses
|
--
|
2,743
|
3,269
|
--
|
--
|
|||||||||||
License
|
54
|
54
|
32
|
--
|
--
|
|||||||||||
54
|
2,797
|
3,301
|
||||||||||||||
Gross
Margin
|
400
|
400
|
153
|
--
|
--
|
|||||||||||
|
||||||||||||||||
Research
and development
|
||||||||||||||||
Research
and development costs
|
10,229
|
7,313
|
11,985
|
14,022
|
13,231
|
|||||||||||
Less
participations
|
--
|
--
|
--
|
3,229
|
75
|
|||||||||||
|
10,229
|
7,313
|
11,985
|
10,793
|
13,156
|
|||||||||||
In-process
research and development
|
--
|
1,783
|
--
|
--
|
--
|
|||||||||||
General
and administrative
|
5,576
|
5,457
|
4,134
|
3,105
|
3,638
|
|||||||||||
Business
development costs
|
641
|
227
|
810
|
664
|
916
|
|||||||||||
Operating
loss
|
(16,046
|
)
|
(14,380
|
)
|
(16,776
|
)
|
(14,562
|
)
|
(17,710
|
)
|
||||||
|
||||||||||||||||
Other
income (expense)
|
||||||||||||||||
Financial
and other income, net
|
1,141
|
443
|
352
|
352
|
597
|
|||||||||||
Taxes
on income
|
(227
|
)
|
(78
|
)
|
(49
|
)
|
(78
|
)
|
(27
|
)
|
||||||
|
||||||||||||||||
Loss
for the period
|
$
|
(15,132
|
)
|
$
|
(14,015
|
)
|
$
|
(16,473
|
)
|
$
|
(14,288
|
)
|
$
|
(17,140
|
)
|
|
|
||||||||||||||||
Loss
per ordinary share
|
||||||||||||||||
Basic
and diluted
|
$
|
(0.08
|
)
|
$
|
(0.08
|
)
|
$
|
(0.12
|
)
|
$
|
(0.13
|
)
|
$
|
(0.15
|
)
|
|
Weighted
average shares outstanding
|
201,737,295
|
170,123,003
|
134,731,766
|
111,712,916
|
111,149,292
|
As
of December 31,
|
||||||||||||||||
|
2006
|
2005
|
2004
|
2003
|
|
2002
|
||||||||||
|
(In
thousands)
|
|||||||||||||||
Balance
Sheet Data:
|
||||||||||||||||
Cash,
cash equivalents, bank deposits and trading
and marketable securities
|
$
|
25,347
|
$
|
13,360
|
$
|
22,924
|
$
|
22,262
|
$
|
35,706
|
||||||
Working
capital
|
22,694
|
11,385
|
20,240
|
19,967
|
33,396
|
|||||||||||
Total
assets
|
26,900
|
15,151
|
25,624
|
24,853
|
38,423
|
|||||||||||
Long-term
obligations
|
738
|
1,493
|
2,489
|
1,244
|
1,017
|
|||||||||||
Total
shareholders’ equity
|
22,760
|
11,252
|
19,602
|
20,608
|
34,830
|
·
|
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
|
$
|
469,000
|
$
|
441,000
|
$
|
28,000
|
$
|
--
|
$
|
--
|
||||||
Operating
leases
|
1,450,000
|
584,000
|
866,000
|
--
|
--
|
|||||||||||
Total
|
$
|
1,919,000
|
$
|
1,025,000
|
$
|
894,000
|
$
|
--
|
$
|
--
|
Years
ended December 31,
|
|||||||||||||
2006
|
2005
|
2004
|
Cumulative,
as
of
December
31, 2006
|
||||||||||
XTL-2125
|
|||||||||||||
Research
and development costs
|
$
|
2,936,000
|
$
|
3,367,000
|
$
|
3,232,000
|
$
|
12,301,000
|
|||||
Less
participations
|
--
|
--
|
--
|
(168,000
|
)
|
||||||||
2,936,000
|
3,367,000
|
3,232,000
|
12,133,000
|
||||||||||
XTL-6865
|
|||||||||||||
Research
and development costs
|
2,640,000
|
2,706,000
|
5,452,000
|
24,259,000
|
|||||||||
Less
participations
|
--
|
--
|
--
|
(2,540,000
|
)
|
||||||||
2,640,000
|
2,706,000
|
5,452,000
|
21,719,000
|
||||||||||
HepeX-B1
|
|||||||||||||
Research
and development costs
|
--
|
2,743,000
|
6,570,000
|
26,985,000
|
|||||||||
Less
participations
|
--
|
(2,743,000
|
)
|
(3,269,000
|
)
|
(10,173,000
|
)
|
||||||
|
--
|
--
|
3,301,000
|
16,812,000
|
|||||||||
Other
research and development programs2
|
|||||||||||||
Research
and development costs
|
4,653,000
|
1,240,000
|
--
|
35,586,000
|
|||||||||
Less
participations
|
--
|
--
|
--
|
(4,081,000
|
)
|
||||||||
4,653,000
|
1,240,000
|
--
|
31,505,000
|
||||||||||
Total
Research and development
|
|||||||||||||
Research
and development costs
|
10,229,000
|
10,056,000
|
15,254,000
|
99,131,000
|
|||||||||
Less
participations
|
--
|
(2,743,000
|
)
|
(3,269,000
|
)
|
(16,962,000
|
)
|
||||||
10,229,000
|
7,313,000
|
11,985,000
|
82,169,000
|
Name
|
Age
|
Position
|
Michael
S. Weiss
|
41
|
Chairman
of the Board of Directors
|
William
J. Kennedy, Ph.D
|
62
|
Non
Executive Director
|
Ido
Seltenreich (1)
|
35
|
Non
Executive and External Director
|
Vered
Shany, D.M.D (1)
|
42
|
Non
Executive and External Director
|
Ben
Zion Weiner, Ph.D
(1)
|
62
|
Non
Executive Director
|
Ron
Bentsur
|
41
|
Chief
Executive Officer
|
Bill
Kessler (1)
|
41
|
Director
of Finance
|
·
|
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,
|
||||||||||
2006
|
2005
|
2004
|
||||||||
Research
and Development
|
||||||||||
Israel
|
8
|
22
|
44
|
|||||||
U.S
|
18
|
19
|
8
|
|||||||
26
|
41
|
52
|
||||||||
Financial
and general management
|
||||||||||
Israel
|
4
|
4
|
7
|
|||||||
U.S
|
2
|
--
|
--
|
|||||||
6
|
4
|
7
|
||||||||
Business
development
|
||||||||||
Israel
|
--
|
--
|
--
|
|||||||
U.S
|
1
|
1
|
1
|
|||||||
1
|
1
|
1
|
||||||||
Total
|
33
|
46
|
60
|
|||||||
Average
number of full-time employees
|
40
|
54
|
58
|
Amount
and nature of beneficial ownership
|
|||||||||||||
|
Ordinary
shares
beneficially
owned
excluding
options
|
Options1
exercisable
within
60 days
of February
28, 2007
|
Total
ordinary
shares
beneficially
owned
|
Percent
of
ordinary
shares beneficially
owned
|
|||||||||
Michael
S. Weiss
Chairman
of the Board
|
--
|
3,083,3332
|
3,083,333
|
1.38
|
%
|
||||||||
William
Kennedy
Director
|
--
|
25,0003
|
25,000
|
*
|
|||||||||
Ben
Zion Weiner
Director
|
--
|
666,6672
|
666,667
|
*
|
|||||||||
Ido
Seltenreich
Director
|
250,0004
|
--
|
250,000
|
*
|
|||||||||
Vered
Shany
Director
|
--
|
--
|
--
|
--
|
|||||||||
Ron
Bentsur
Chief
Executive Officer
|
48,220
|
777,7825
|
826,002
|
*
|
|||||||||
Bill
Kessler
Director
of Finance
|
--
|
--
|
--
|
--
|
|||||||||
All
directors and executive officers as a group
(7 persons)
|
298,220
|
4,552,782
|
4,851,002
|
2.16
|
%
|
||||||||
-------------------------------------
|
(1)
|
Options
to purchase ordinary shares
|
(2)
|
At
an exercise price of $0.354 per ordinary share, expiring July 31,
2010.
|
(3)
|
20,000
options at an exercise price of $0.354 per ordinary share, expiring
July
31, 2015 and 5,000 options at an exercise price of $0.325 per ordinary
share, expiring July 31, 2016.
|
(4)
|
Held
under a blind trusteeship arrangement with a
third-party.
|
(5)
|
At
an exercise price of $0.774 per ordinary share, expiring March
15,
2016.
|
British
Pence (p)
|
US
Dollar
|
||||||
Last
Six Calendar Months
|
High
|
Low
|
High
|
Low
|
|||
February
2007
|
21.75
|
19.50
|
0.43
|
0.38
|
|||
January
2007
|
24.25
|
14.25
|
0.47
|
0.28
|
|||
December
2006
|
16.00
|
14.25
|
0.31
|
0.28
|
|||
November
2006
|
19.00
|
14.75
|
0.37
|
0.29
|
|||
October
2006
|
18.00
|
11.75
|
0.35
|
0.23
|
|||
September
2006
|
16.00
|
12.00
|
0.31
|
0.23
|
|||
Financial
Quarters During the Past Two Full Fiscal Years
|
|||||||
Fourth
Quarter of 2006
|
19.00
|
11.75
|
0.37
|
0.23
|
|||
Third
Quarter of 2006
|
24.00
|
12.00
|
0.47
|
0.23
|
|||
Second
Quarter of 2006
|
40.75
|
23.50
|
0.80
|
0.46
|
|||
First
Quarter of 2006
|
45.00
|
34.25
|
0.88
|
0.67
|
|||
Fourth
Quarter of 2005
|
53.00
|
42.00
|
1.04
|
0.82
|
|||
Third
Quarter of 2005
|
61.75
|
38.00
|
1.21
|
0.74
|
|||
Second
Quarter of 2005
|
40.50
|
36.00
|
0.79
|
0.70
|
|||
First
Quarter of 2005
|
43.50
|
26.00
|
0.85
|
0.51
|
|||
Last
Five Full Financial Years
|
|||||||
2006
|
45.00
|
11.75
|
0.88
|
0.23
|
|||
2005
|
61.75
|
26.00
|
1.21
|
0.51
|
|||
2004
|
32.25
|
13.00
|
0.63
|
0.25
|
|||
2003
|
18.75
|
5.75
|
0.37
|
0.11
|
|||
2002
|
64.00
|
11.50
|
1.25
|
0.23
|
|
New
Israeli Shekel
|
US
Dollar
|
|||||
Last
Six Calendar Months
|
High
|
Low
|
High
|
Low
|
|||
February
2007
|
1.86
|
1.59
|
0.44
|
0.38
|
|||
January
2007
|
2.02
|
1.12
|
0.48
|
0.27
|
|||
December
2006
|
1.34
|
1.03
|
0.32
|
0.24
|
|||
November
2006
|
1.57
|
1.24
|
0.37
|
0.29
|
|||
October
2006
|
1.40
|
0.96
|
0.33
|
0.23
|
|||
September
2006
|
1.31
|
1.04
|
0.31
|
0.25
|
Financial
Quarters Since Listing
|
|||||||
Fourth
Quarter of 2006
|
1.57
|
0.96
|
0.37
|
0.23
|
|||
Third
Quarter of 2006
|
2.03
|
1.04
|
0.48
|
0.25
|
|||
Second
Quarter of 2006
|
3.37
|
2.03
|
0.80
|
0.48
|
|||
First
Quarter of 2006
|
3.66
|
2.86
|
0.87
|
0.68
|
|||
Fourth
Quarter of 2005
|
4.38
|
3.44
|
1.04
|
0.82
|
Full
Financial Years Since Listing
|
|||||||
2006
|
3.66
|
0.96
|
0.87
|
0.23
|
US
Dollar
|
||
Last
Six Calendar Months
|
High
|
Low
|
February
2007
|
4.35
|
3.90
|
January
2007
|
4.99
|
2.69
|
December
2006
|
3.30
|
2.70
|
November
2006
|
3.69
|
2.85
|
October
2006
|
3.40
|
2.22
|
September
2006
|
3.02
|
2.08
|
Financial
Quarters Since Listing
|
||
Fourth
Quarter of 2006
|
3.69
|
2.22
|
Third
Quarter of 2006
|
4.43
|
2.08
|
Second
Quarter of 2006
|
7.50
|
4.40
|
First
Quarter of 2006
|
8.12
|
6.13
|
Fourth
Quarter of 2005
|
9.50
|
7.10
|
Full
Financial Years Since Listing
|
||
2006
|
8.12
|
2.08
|
·
|
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.
|
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; and
|
·
|
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.
|
·
|
a
citizen or resident of the US;
|
·
|
a
corporation created or organized under the laws of the US, the
District of
Columbia, or any state; or
|
·
|
a
trust or estate, treated, for US 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 US
dollar.
|
·
|
You
must include the gross amount of the dividend, not reduced by the
amount
of Israeli tax withheld, in your US taxable income.
|
·
|
You
may be able to claim the Israeli tax withheld as a foreign tax
credit
against your US 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 US (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 US
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 US tax attributable
to your net foreign source passive income. Additionally, if we
pay
dividends at a time when 50% or more of our stock is owned by US
persons,
you may be required to treat the part of the dividend attributable
to US
source earnings and profits as US source income, possibly reducing
the
allowable credit.
|
·
|
A
US 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 US holder has not held the ordinary shares for at least
16 days
of the 31-day period beginning on the date which is 15 days before
the
ex-dividend date or, alternatively, to the extent the US holder
is under
an obligation to make related payments with respect to substantially
similar or related property. Any days during which a US 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 XTL 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 US 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 and 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 US holder upon the disposition of, as well as
income
recognized upon receiving certain excess distributions on the ordinary
shares would be taxable as ordinary income;
|
·
|
the
US holder would be required to allocate the excess distribution
and/or
disposition gain ratably over such US holder's entire holding period
for
such ordinary shares;
|
·
|
the
amount allocated to each year other than the year of the excess
distribution 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
US holder would be required to file an annual return on IRS Form
8621 for
the years in which distributions were received on and gain was
recognized
on dispositions of, our ordinary shares; and
|
·
|
any
US holder who acquired the ordinary shares upon the death of the
shareholder would not receive a step-up to market value of his
income tax
basis for such ordinary shares. Instead such US 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-US holder
of a
trade or business in the US and, in the case of a resident of a
country
which has a tax treaty with the US, the item is attributable to
a
permanent establishment in the US;
|
·
|
the
Non-US holder is subject to tax under the provisions of US tax
law
applicable to US expatriates; or
|
·
|
the
individual non-US holder is present in the US for 183 days or more
in the
taxable year of the disposition and certain other conditions are
met.
|
|
2006
|
2005
|
|||||
|
(in
thousands)
|
||||||
Audit
fees
|
$
|
166
|
$
|
161
|
|||
Audit-related
fees
|
150
|
74
|
|||||
Tax
fees
|
63
|
46
|
|||||
Total
|
$
|
379
|
$
|
281
|
Exhibit
Number
|
Description
|
3.1
|
Articles
of Association†
|
4.1
|
Form
of Share Certificate (including both Hebrew and English
translations)
|
4.2
|
Form
of American Depositary Receipt (included in Exhibit 4.3)
†
|
4.3
|
Deposit
Agreement, dated as of August 31, 2005, by and between XTL
Biopharmaceuticals Ltd., The Bank of New York, as Depositary,
and each
holder and beneficial owner of American Depositary Receipts issued
thereunder†
|
4.5
|
Form
of Director and Senior Management Lock−up Letter^
|
10.12
|
1998
Share Option Plan dated October 19, 1998†
|
10.13
|
1999
Share Option Plan dated June 1, 1999†
|
10.14
|
1999
International Share Option Plan Dated June 1, 1999†
|
10.15
|
2000
Share Option Plan dated April 12, 2000†
|
10.16
|
2001
Share Option Plan dated February 28, 2001†
|
10.17
|
Letter
of Understanding, dated August 5, 2005, relating to the License
Agreement
dated June 2, 2004 between Cubist Pharmaceuticals, Inc. and XTL
Biopharmaceuticals Ltd.†
|
10.19
|
Employment
Agreement, dated August 1, 1999, between XTL Biopharmaceuticals
Ltd. and
Jonathan Burgin†
|
10.20
|
Employment
Agreement, dated as of January 3, 2006, between XTL Biopharmaceuticals
Ltd. and Ron Bentsur^
|
10.21
|
Agreement,
dated August 1, 2005, between XTL Biopharmaceuticals Ltd. and
Michael S.
Weiss†
|
10.22
|
Form
No. 1 of Director Service Agreement†
|
10.23
|
Form
No. 2 of Director Service Agreement†
|
10.24
|
Form
No. 3 of Director Service Agreement†
|
10.25
|
Form
No. 4 of Director Indemnification Agreement†
|
10.26
|
License
Agreement Between XTL Biopharmaceuticals Ltd. and VivoQuest,
Inc., dated
August 17, 2005†
|
10.27
|
Asset
Purchase Agreement Between XTL Biopharmaceuticals Ltd. and VivoQuest,
Inc., dated August 17, 2005†
|
10.28
|
Form
of Securities Purchase Agreement, dated March 17, 2006, by and
among XTL
Biopharmaceuticals Ltd., and the purchasers named
therein^
|
10.29
|
Form
of Registration Rights Agreement, dated March 22, 2006, by and
among XTL
Biopharmaceuticals Ltd. and the purchasers named
therein^
|
10.30
|
Form
of Ordinary Share Purchase Warrants, dated March 22, 2006, issued
to the
purchasers under the Securities Purchase Agreement^
|
10.31
|
Escrow
Agreement, dated March 22, 2006, by and among XTL Biopharmaceuticals
Ltd.,
the Placement Agents named therein, and JPMorgan Chase Bank,
N.A., as
escrow agent^
|
10.32
|
License
Agreement between XTL Development, Inc. and DOV Pharmaceutical,
Inc.,
dated January 15, 2007.
|
10.33
|
Employment
Agreement, dated as of January 1, 2006, between XTL Biopharmaceuticals
Ltd. and Bill Kessler.
|
21.1
|
List
of Subsidiaries†
|
31.1
|
Certification
of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a),
as
adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002, dated
March 22, 2007.
|
31.2
|
Certification
of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a),
as
adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002, dated
March 22, 2007.
|
32.1
|
Certification
of Chief Executive Officer and Chief Financial Officer pursuant
to 18
U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act
of 2002, dated March 22,
2007.
|
XTL
BIOPHARMACEUTICALS LTD.
(Registrant)
|
||
|
|
|
Date: March 22, 2007 | Signature: | /s/ Ron Bentsur |
Ron Bentsur |
||
Chief Executive Officer |
Page
|
||||
Report
of Independent Registered Public Accounting Firm
|
F-2
|
|||
Consolidated
Balance Sheets as of December 31, 2006 and 2005
|
F-4
|
|||
Consolidated
Statements of Operations for the years ended
December
31, 2006, 2005 and 2004, and the period from
March
9, 1993 to December 31, 2006
|
F-5
|
|||
Statements
of Changes in Shareholders’ Equity for the
years
ended December 31, 2006, 2005 and 2004, and the period from
March
9, 1993 to December 31, 2006
|
F-6
|
|||
Consolidated
Statements of Cash Flows for the years ended
December
31, 2006, 2005 and 2004, and the period from
March
9, 1993 to December 31, 2006
|
F-10
|
|||
Notes
to the Consolidated Financial Statements
|
F-12
|
December
31
|
|||||||
2006
|
2005
|
||||||
Assets
|
|
||||||
CURRENT
ASSETS:
|
|
||||||
Cash
and cash equivalents
|
4,400
|
13,360
|
|||||
Short-term
bank deposits
|
20,845
|
—
|
|||||
Trading
securities
|
102
|
—
|
|||||
Property
and equipment (held for sale) -- net
|
18
|
—
|
|||||
Deferred
tax asset
|
29
|
—
|
|||||
Other
receivables and prepaid expenses
|
702
|
431
|
|||||
Total
current assets
|
26,096
|
13,791
|
|||||
EMPLOYEE
SEVERANCE PAY FUNDS
|
98
|
449
|
|||||
RESTRICTED
LONG-TERM DEPOSITS
|
172
|
110
|
|||||
PROPERTY
AND EQUIPMENT -- net
|
490
|
762
|
|||||
INTANGIBLE
ASSETS -- net
|
25
|
39
|
|||||
DEFERRED
TAX ASSET
|
19
|
—
|
|||||
Total
assets
|
26,900
|
15,151
|
|||||
Liabilities
and shareholders’ equity
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable and accrued expenses
|
3,003
|
2,007
|
|||||
Deferred
gain
|
399
|
399
|
|||||
Total
current liabilities
|
3,402
|
2,406
|
|||||
LIABILITY
IN RESPECT OF EMPLOYEE
|
|||||||
SEVERANCE
OBLIGATIONS
|
340
|
695
|
|||||
DEFERRED
GAIN
|
398
|
798
|
|||||
COMMITMENTS
AND CONTINGENCIES (Note 7)
|
|||||||
Total
liabilities
|
4,140
|
3,899
|
|||||
SHAREHOLDERS’
EQUITY:
|
|||||||
Ordinary
shares of NIS 0.02 par value (authorized: 300,000,000
as
of December 31, 2006 and 2005; issued and outstanding:
220,124,349
as of December 31, 2006 and 173,180,441 as of
December
31, 2005)
|
1,072
|
864
|
|||||
Additional
paid in capital
|
136,611
|
110,179
|
|||||
Deficit
accumulated during the development stage
|
(114,923
|
)
|
(99,791
|
)
|
|||
Total
shareholders’ equity
|
22,760
|
11,252
|
|||||
Total
liabilities and shareholders’ equity
|
26,900
|
15,151
|
/s/
Michael Weiss
|
/s/
Ron Bentsur
|
|
Michael
Weiss
|
Ron
Bentsur
|
|
Chairman
of the Board of Directors
|
Chief
Executive Officer
|
|
Year
ended December 31
|
Period
from
March
9, 1993*
to
December 31,
|
||||||||||||
2006
|
2005
|
2004
|
2006
|
||||||||||
REVENUES:
|
|||||||||||||
Reimbursed
out-of-pocket expenses
|
—
|
2,743
|
3,269
|
6,012
|
|||||||||
License
|
454
|
454
|
185
|
1,093
|
|||||||||
454
|
3,197
|
3,454
|
7,105
|
||||||||||
COST
OF REVENUES:
|
|||||||||||||
Reimbursed
out-of-pocket expenses
|
—
|
2,743
|
3,269
|
6,012
|
|||||||||
License
(with respect to royalties)
|
54
|
54
|
32
|
140
|
|||||||||
54
|
2,797
|
3,301
|
6,152
|
||||||||||
GROSS
MARGIN
|
400
|
400
|
153
|
953
|
|||||||||
RESEARCH
AND DEVELOPMENT COSTS
|
|||||||||||||
(includes
non-cash stock option compensation of $173, $112 and $30, in 2006,
2005
and 2004, respectively)
|
10,229
|
7,313
|
11,985
|
93,119
|
|||||||||
LESS
- PARTICIPATIONS
|
—
|
—
|
—
|
10,950
|
|||||||||
10,229
|
7,313
|
11,985
|
82,169
|
||||||||||
IN
- PROCESS RESEARCH AND
|
|||||||||||||
DEVELOPMENT
COSTS
|
—
|
1,783
|
—
|
1,783
|
|||||||||
GENERAL
AND ADMINISTRATIVE
|
|||||||||||||
EXPENSES
(includes
non-cash stock option
|
|||||||||||||
compensation
of
$1,992, $2,641 and $2, in 2006, 2005 and 2004,
respectively)
|
5,576
|
5,457
|
4,134
|
34,588
|
|||||||||
BUSINESS
DEVELOPMENT COSTS
|
|||||||||||||
(includes
non-cash stock option compensation of $15, $10 and $0, in 2006, 2005
and
2004, respectively)
|
641
|
227
|
810
|
5,154
|
|||||||||
OPERATING
LOSS
|
16,046
|
14,380
|
16,776
|
122,741
|
|||||||||
FINANCIAL
AND OTHER INCOME -
net
|
1,141
|
443
|
352
|
8,284
|
|||||||||
LOSS
BEFORE INCOME TAXES
|
14,905
|
13,937
|
16,424
|
114,457
|
|||||||||
INCOME
TAXES
|
227
|
78
|
49
|
466
|
|||||||||
LOSS
FOR THE PERIOD
|
15,132
|
14,015
|
16,473
|
114,923
|
|||||||||
BASIC
AND DILUTED LOSS PER
|
|||||||||||||
ORDINARY
SHARE
|
$
|
0.08
|
$
|
0.08
|
$
|
0.12
|
|||||||
WEIGHTED
AVERAGE NUMBER OF
|
|||||||||||||
SHARES
USED IN COMPUTING
|
|||||||||||||
BASIC
AND DILUTED LOSS PER
|
|||||||||||||
ORDINARY
SHARE
|
201,737,295
|
170,123,003
|
134,731,766
|
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, 2003:
|
||||||||||||||||
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
|
|||||||||||
Exercise
of employee stock options in 2003
|
—
|
—
|
854,100
|
4
|
—
|
|||||||||||
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, 2003
|
—
|
—
|
112,019,464
|
594
|
89,303
|
Accumulated
other comprehensive income (loss)
|
Deficit
accumulated during the development stage
|
Total
|
||||||||
CHANGES
DURING THE PERIOD
|
||||||||||
FROM
MARCH 9, 1993 (DATE OF
|
||||||||||
INCORPORATION)
TO DECEMBER 31, 2003:
|
||||||||||
Comprehensive
loss:
|
||||||||||
Loss
for the period
|
—
|
(69,303
|
)
|
(69,303
|
)
|
|||||
Net
unrealized loss
|
14
|
—
|
14
|
|||||||
Comprehensive
loss
|
14
|
(69,303
|
)
|
(69,289
|
)
|
|||||
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
|
|||||||
Exercise
of employee stock options in 2003
|
—
|
—
|
4
|
|||||||
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, 2003
|
14
|
(69,303
|
)
|
20,608
|
Ordinary
shares
|
Additional
|
|||||||||
Number
of
|
paid
in
|
|||||||||
shares
|
Amount
|
capital
|
||||||||
BALANCE
AT DECEMBER 31, 2003 -
|
||||||||||
brought
forward
|
112,019,464
|
594
|
89,303
|
|||||||
CHANGES
DURING 2004:
|
||||||||||
Comprehensive
loss:
|
||||||||||
Loss
for the period
|
—
|
—
|
—
|
|||||||
Net
unrealized gain
|
—
|
—
|
—
|
|||||||
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
|
|||||||
CHANGES
DURING 2006:
|
||||||||||
Comprehensive
loss - loss for the period
|
—
|
—
|
—
|
|||||||
Non-employee
stock option compensation expenses
|
—
|
—
|
7
|
|||||||
Employee
stock option compensation expenses
|
—
|
—
|
2,173
|
|||||||
Exercise
of stock options
|
277,238
|
1
|
96
|
|||||||
Issuance
of share warrants, net of $681 share
issuance expenses
|
—
|
—
|
4,565
|
|||||||
Issuance
of shares, net of $2,956 share
issuance expenses
|
46,666,670
|
207
|
19,591
|
|||||||
BALANCE
AT DECEMBER 31, 2006
|
220,124,349
|
1,072
|
136,611
|
Accumulated
other comprehensive income (loss)
|
Deficit
accumulated during the development stage
|
Total
|
||||||||
BALANCE
AT DECEMBER 31, 2003 -
|
||||||||||
brought
forward
|
14
|
(69,303
|
)
|
20,608
|
||||||
CHANGES
DURING 2004:
|
||||||||||
Comprehensive
loss:
|
||||||||||
Loss
for the period
|
—
|
(16,473
|
)
|
(16,473
|
)
|
|||||
Net
unrealized gain
|
(14
|
)
|
—
|
(14
|
)
|
|||||
Comprehensive
loss
|
(14
|
)
|
(16,473
|
)
|
(16,487
|
)
|
||||
Non-employee
stock option compensation 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
|
||||||
CHANGES
DURING 2006:
|
||||||||||
Comprehensive
loss - loss for the period
|
—
|
(15,132
|
)
|
(15,132
|
)
|
|||||
Non-employee
stock option compensation expenses
|
—
|
—
|
7
|
|||||||
Employee
stock option compensation expenses
|
—
|
—
|
2,173
|
|||||||
Exercise
of stock options
|
—
|
—
|
97
|
|||||||
Issuance
of share warrants, net of $681 share
issuance expenses
|
—
|
—
|
4,565
|
|||||||
Issuance
of shares, net of $2,956 share
issuance expenses
|
—
|
—
|
19,798
|
|||||||
BALANCE
AT DECEMBER 31, 2006
|
—
|
(114,923
|
)
|
22,760
|
Year
ended December 31
|
Period
from
March
9, 1993 (a)
to
December 31,
|
||||||||||||
2006
|
2005
|
2004
|
2006
|
||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|||||||||||
Loss
for the period
|
(15,132
|
)
|
(14,015
|
)
|
(16,473
|
)
|
(114,923
|
)
|
|||||
Adjustments
to reconcile loss to net cash used in
|
|||||||||||||
operating
activities:
|
|||||||||||||
Depreciation
and amortization
|
243
|
242
|
319
|
3,072
|
|||||||||
Linkage
difference on restricted deposits
|
(10
|
)
|
3
|
—
|
(7
|
)
|
|||||||
Acquisition
of in process research and development
|
—
|
1,783
|
—
|
1,783
|
|||||||||
Loss
(gain) on disposal of property and equipment
|
(57
|
)
|
6
|
1
|
(39
|
)
|
|||||||
Increase
(decrease) in liability in respect of employee
severance
obligations
|
8
|
(159
|
)
|
30
|
1,236
|
||||||||
Impairment
charges
|
—
|
26
|
—
|
380
|
|||||||||
Loss
(gain) from sales of investment securities
|
—
|
—
|
13
|
(410
|
)
|
||||||||
Other
income related to exchange of shares
(see
Note 10d)
|
(100
|
)
|
—
|
—
|
(100
|
)
|
|||||||
Gain
from trading securities
|
(2
|
)
|
—
|
—
|
(2
|
)
|
|||||||
Stock
option based compensation expenses
|
2,180
|
2,763
|
32
|
5,458
|
|||||||||
Gain
on amounts funded in respect of employee
severance
pay funds
|
(1
|
)
|
(6
|
)
|
(4
|
)
|
(92
|
)
|
|||||
Deferred
tax asset
|
(48
|
)
|
—
|
—
|
(48
|
)
|
|||||||
Changes
in operating assets and liabilities:
|
|||||||||||||
Decrease
(increase) in other receivables
|
|||||||||||||
and
prepaid expenses
|
(178
|
)
|
418
|
(143
|
)
|
(609
|
)
|
||||||
Increase
(decrease) in accounts payable
|
|||||||||||||
and
accrued expenses
|
910
|
(1,127
|
)
|
133
|
2,917
|
||||||||
Increase
(decrease) in deferred gain
|
(400
|
)
|
(400
|
)
|
1,597
|
797
|
|||||||
Net
cash used in operating activities
|
(12,587
|
)
|
(10,466
|
)
|
(14,495
|
)
|
(100,587
|
)
|
|||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||||||||
Decrease
(increase) in short-term bank deposits
|
(20,845
|
)
|
10,136
|
7,193
|
(20,845
|
)
|
|||||||
Restricted
deposits
|
(52
|
)
|
—
|
46
|
(165
|
)
|
|||||||
Investment
in investment securities
|
—
|
—
|
—
|
(3,363
|
)
|
||||||||
Proceeds
from sales of investment securities
|
—
|
—
|
722
|
3,773
|
|||||||||
Employee
severance
pay funds
|
(18
|
)
|
(50
|
)
|
(136
|
)
|
(909
|
)
|
|||||
Purchase
of property and equipment
|
(21
|
)
|
(38
|
)
|
(180
|
)
|
(4,042
|
)
|
|||||
Proceeds
from disposals of property and equipment
|
103
|
27
|
5
|
252
|
|||||||||
Acquisition
in respect of license and purchase of assets
|
—
|
(548
|
)
|
—
|
(548
|
)
|
|||||||
Net
cash provided by (used in) investing activities
|
(20,833
|
)
|
9,527
|
7,650
|
(25,847
|
)
|
Year
ended December 31
|
Period
from
March
9, 1993 (a)
to December
31,
|
||||||||||||
2006
|
2005
|
2004
|
2006
|
||||||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|||||||||||
Issuance
of share capital and warrants -
net of
share
issuance expenses
|
24,363
|
—
|
15,430
|
128,734
|
|||||||||
Exercise
of share warrants and stock options
|
97
|
1,511
|
19
|
2,100
|
|||||||||
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
|
24,460
|
1,511
|
15,449
|
130,834
|
|||||||||
NET
INCREASE (DECREASE) IN CASH AND
|
|||||||||||||
CASH
EQUIVALENTS
|
(8,960
|
)
|
572
|
8,604
|
4,400
|
||||||||
BALANCE
OF CASH AND CASH EQUIVALENTS
|
|||||||||||||
AT
BEGINNING OF PERIOD
|
13,360
|
12,788
|
4,184
|
—
|
|||||||||
BALANCE
OF CASH AND CASH EQUIVALENTS
|
|||||||||||||
AT
END OF PERIOD
|
4,400
|
13,360
|
12,788
|
4,400
|
|||||||||
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
|
136
|
49
|
107
|
457
|
|||||||||
Interest
paid
|
—
|
—
|
—
|
350
|
a. |
General:
|
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 Statement of Financial Accounting Standards
(“SFAS”) No. 7 “Accounting and Reporting by Development Stage
Enterprises.”
|
2) |
Through
December 31, 2006, the Company has incurred losses in an aggregate
amount
of United States $114.9 million. Such losses have resulted from the
Company’s activities as a development stage company. It is expected that
the Company will be able to finance its operations from its current
reserves through 2007. Continuation of the Company’s current operations
after utilizing its current cash reserves during 2008 is dependent
upon
the generation of additional financial resources either through agreements
for the commercialization of its product portfolio or through external
financing. See Note 7.
|
3) |
The
consolidated financial statements are prepared in accordance with
generally accepted accounting principles in the United States (“US
GAAP”).
|
4) |
The
preparation of the financial statements, in conformity with US GAAP,
requires management to make estimates and assumptions that affect
the
reported amounts of assets and liabilities and the disclosure of
contingent assets and liabilities, at the date of the financial
statements, and the reported expenses during the reporting periods.
Actual
results may vary from these
estimates.
|
b. |
Functional
currency
|
c. |
Principles
of consolidation
|
d. |
Impairment
of long-lived and intangible
assets
|
e. |
Cash
equivalents
|
f. |
Marketable
securities
|
g. |
Property
and equipment
|
%
|
||
Laboratory
equipment
|
10-20
|
|
(mainly
15)
|
||
Computers
|
33
|
|
Furniture
and office equipment
|
6-15
|
h. |
Intangible
assets
|
i. |
Deferred
income taxes
|
j. |
Research
and development costs and
participations
|
k. |
Revenue
recognition
|
l. |
Business
development costs
|
m. |
Loss
per share (“LPS”)
|
n. |
Comprehensive
loss
|
o. |
Stock-
based compensation
|
Year
ended
December 31 |
Period
from
March
9, 1993*
to
December 31,
|
||||||
2004
|
2004
|
||||||
($
in thousands except per share amounts)
|
|||||||
Loss
for the period, as reported
|
16,473
|
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
|
6,355
|
|||||
Loss
- pro-forma
|
16,712
|
91,648
|
Basic
and diluted loss per share:
|
|||||||
As
reported
|
0.12
|
||||||
Pro-forma
|
0.12
|
||||||
*
Incorporation date, see Note 1a.
|
p. |
Recently
issued accounting pronouncements in the United
States:
|
q. |
Reclassifications
|
December
31
|
|||||||
2006
|
2005
|
||||||
($
in thousands)
|
|||||||
Deferred
revenue
|
907
|
1,361
|
|||||
Less
- Deferred expenses related to Yeda
|
110
|
164
|
|||||
Deferred
gain
|
797
|
1,197
|
(1) |
the
Company issued the fair value equivalent of $1,391,000 of its ordinary
shares (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,
$25.0 million of which will be due upon or following regulatory approval
or actual product sales, and payable in cash or ordinary shares at
the
Company’s election. No contingent consideration has been paid pursuant to
the license agreement as of the balance sheet date, because none
of the
milestones have been achieved. The contingent consideration will
be
recorded as part of the acquisition costs in the future; and
|
(3) |
the
Company agreed to make royalty payments on future product
sales.
|
($
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
|
|||||||
2006
|
2005
|
||||||
($
in thousands)
|
|||||||
Property
and equipment
|
|||||||
Cost:
|
|||||||
Laboratory
equipment
|
1,281
|
1,960
|
|||||
Computers
|
227
|
232
|
|||||
Leasehold
improvements
|
572
|
698
|
|||||
Furniture
and office equipment
|
156
|
238
|
|||||
2,236
|
3,128
|
||||||
Accumulated
depreciation and amortization:
|
|||||||
Laboratory
equipment
|
895
|
1,333
|
|||||
Computers
|
202
|
217
|
|||||
Leasehold
improvements
|
572
|
697
|
|||||
Furniture
and office equipment
|
77
|
119
|
|||||
1,746
|
2,366
|
||||||
490
|
762
|
b. |
Under
the provisions of SFAS 144, the Company’s management reviewed the carrying
value of certain property and equipment (primarily laboratory equipment),
and recorded an impairment charge in an amount of $26,000 for the
year
ended December 31, 2005. See Note 9.
|
c. |
Depreciation
totaled $229,000, $238,000 and $319,000 for the years ended December
31,
2006, 2005 and 2004, 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
with Section 14 of the Law, mandating that upon termination of such
employee’s employment, the Company shall release to the employee all
amounts accrued in its insurance policies with respect to such employee.
Accordingly, the Company remits each month to each of its employees’
insurance policies, the amounts required by the Law to cover the
severance
pay liability.
|
2) |
Insurance
policies for certain employees: the policies provide most of the
coverage
for severance pay and pension liabilities of managerial personnel,
the
remainder of such liabilities are covered by the
Company.
|
b. |
The
Subsidiary
|
c. |
Severance
expenses
|
d. |
Cash
flow information regarding the Company’s liability for employee rights
upon retirement:
|
1) |
For
the years ended December 31, 2006, 2005 and 2004, the Company contributed
to insurance companies, in respect of its severance obligations to
its
Israeli employees, $82,000, $166,000 and $276,000, respectively,
and
expects to contribute, in 2007, $48,000 to insurance companies in
respect
of its severance obligations to its Israeli
employees.
|
2) |
The
Company expects to pay future benefits to certain employees who will
reach
retirement, as follows:
|
($
in thousands)
|
||
2010
|
12
|
|
2011
|
—
|
|
2012-2016
|
55
|
|
67*
|
a. |
Share
Capital and Warrants
|
b. |
Stock
Option Plans:
|
1) |
The
Company maintains the following share option plans for its employees,
directors and consultants.
|
(a) |
1998
Share Option Plan
|
(b) |
1999
Share Option Plan
|
(c) |
1999
International Share Option Plan
|
(d) |
2000
Share Option Plan
|
(e) |
2001
Share Option Plan
|
(f) |
Non-Plan
Share 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
|
|||||||||||||||||||
2006
|
2005
|
2004
|
|||||||||||||||||
Weighted
|
Weighted
|
Weighted
|
|||||||||||||||||
Average
|
average
|
average
|
|||||||||||||||||
Number
|
exercise
price
|
Number
|
exercise
price
|
Number
|
exercise
price
|
||||||||||||||
$
|
$
|
$
|
|||||||||||||||||
|
|||||||||||||||||||
Balance
outstanding at beginning
of year
|
24,268,975
|
0.59
|
17,805,661
|
0.69
|
17,552,661
|
0.69
|
|||||||||||||
Changes
during the year:
|
|||||||||||||||||||
Granted
*
|
11,740,000
|
0.70
|
11,370,000
|
0.36
|
432,000
|
0.33
|
|||||||||||||
Exercised
**
|
(277,238
|
)
|
0.35
|
(3,786,825
|
)
|
0.40
|
(50,000
|
)
|
0.37
|
||||||||||
Reclassified***
|
(125,000
|
)
|
0.25
|
—
|
—
|
—
|
—
|
||||||||||||
Expired
|
(2,074,505
|
)
|
0.60
|
(153,285
|
)
|
0.95
|
(44,133
|
)
|
0.91
|
||||||||||
Forfeited
|
(1,056,994
|
)
|
0.57
|
(966,576
|
)
|
0.39
|
(84,867
|
)
|
0.56
|
||||||||||
Balance
outstanding at end
of year****
|
32,475,238
|
0.63
|
24,268,975
|
0.59
|
17,805,661
|
0.69
|
|||||||||||||
Balance
exercisable at end of year****
|
14,145,370
|
0.72
|
16,262,310
|
0.70
|
16,051,324
|
0.72
|
* |
In
2006, the exercise price of the options granted to employees was
greater
than, equal to, or less than the share price on the grant date
(see (a)
below). In 2005, the exercise price of options granted to the Company's
directors was equal to or less than the share price on the grant
date (see
(b) and (c) below). In 2004, the exercise price of options granted
to
employees and directors was equal to the share price on the grant
date
(see (d) below).
|
**
|
The
total intrinsic value of options exercised during 2006, 2005 and
2004 was
$167,000, $1,521,000 and $6,000, respectively.
|
*** |
In
2006, a former employee was engaged by the Company as a consultant.
The
options that were granted to that former employee have been reclassified
from options to an employee to options to a consultant.
|
**** |
The
aggregate intrinsic value as of December 31, 2006 is $33,000 for
outstanding options, and $21,000 for exercisable options.
|
Options
outstanding
|
Options
exercisable
|
||||||||||||||||||
Range
of
exercise
prices
|
Number
outstanding
|
Weighted-
average
remaining
contractual
life
(years)
|
Weighed-
average
exercise
price
|
Number
exercisable
|
Weighted-
average
remaining
contractual
life
(years)
|
Weighed-average
exercise
price
|
|||||||||||||
$0.100-$0.299
|
272,772
|
5.9
|
$
|
0.16
|
126,237
|
3.9
|
$
|
0.11
|
|||||||||||
$0.300-$0.399
|
11,290,000
|
3.6
|
$
|
0.35
|
3,771,667
|
3.6
|
$
|
0.35
|
|||||||||||
$0.400-$0.499
|
5,802,600
|
1.1
|
$
|
0.49
|
5,802,600
|
1.1
|
$
|
0.49
|
|||||||||||
$0.500-$0.699
|
3,625,000
|
9.5
|
$
|
0.60
|
—
|
—
|
$
|
—
|
|||||||||||
$0.700-$0.899
|
7,273,800
|
9.0
|
$
|
0.78
|
233,800
|
4.1
|
$
|
0.85
|
|||||||||||
$0.900-$1.100
|
2,936,066
|
1.5
|
$
|
1.02
|
2,936,066
|
1.5
|
$
|
1.02
|
|||||||||||
$2.110
|
1,275,000
|
3.7
|
$
|
2.11
|
1,275,000
|
3.7
|
$
|
2.11
|
|||||||||||
32,475,238
|
4.9
|
$
|
0.63
|
14,145,370
|
2.1
|
$
|
0.72
|
(a) |
In
March 2006, the Company’s board of directors granted the Company's Chief
Executive Officer (“CEO”) options to purchase a total of 7,000,000
ordinary shares at an exercise price equal to $0.774 per ordinary
share
(closing price of the last trading day prior to official appointment;
closing price on grant date was $0.784). These options are exercisable
for
a period of 10 years from the date of issuance, and granted under
the same
terms and conditions as the 2001 Plan. Of these, 2,333,334 options
shall
vest as follows: 777,782 options on the one-year anniversary of the
issuance of the options and 194,444 options at the end of each quarter
thereafter for the following two years. The balance of the options
shall
vest upon achievement of certain market conditions or performance
conditions (2,333,333 of the options shall vest upon achievement
of a
certain market capitalization or working capital condition and 2,333,333
of the options shall vest upon achievement of another market
capitalization or working capital condition). In addition, in the
event of
a merger, acquisition or other change of control or in the event
that the
Company terminates the CEO, 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 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 CEO’s options at any time. As of
December 31, 2006, none of the options granted to the CEO have vested.
The
compensation expenses for the options that vest upon achievement
of
certain market conditions or performance conditions are amortized
using
the graded method.
|
(b) |
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 ordinary share (which was
below
market price on the date of grant) . These options are exercisable
for a
period of five years from the date of issuance, and were granted
under the
same terms and conditions as the 2001 Plan. The options shall vest
upon
achievement of certain market conditions (in each case, 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, 2006, 3,083,333 options that were granted to the
Chairman
and 666,667 options that were granted to one of the Company's
non-executive directors are vested (the first market condition milestone
was reached and therefore 1/3 of the options were vested). The
compensation expenses are amortized using the graded method.
|
(c) |
In
August 2005, the Company granted to two of its non-executive directors
options to purchase a total of 60,000 ordinary shares each, having
an
exercise price equal to $0.853 per ordinary share (equal to the average
price per share, as derived from the Daily Official List of the London
Stock Exchange, in the three days preceding the date of such grant)),
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, with the future grants
being contingent on such non-executive directors being members of
the
Company's board of directors at such time (also see (a)
above).
|
(d) |
The
weighted average fair value of options granted during 2004, estimated
by
using the Black & Scholes option-pricing model, was $ 0.10. The fair
value of options was estimated on the date of grant, based on the
following weighted average assumptions: dividend yield of 0%; expected
volatility of 35%; risk-free interest rates (in dollar terms) of
2.9%; and
expected life of 2 to 4 years, depending on the vesting period of
the
options.
|
(e) |
For
the years ended December 31, 2006, 2005 and 2004, non-cash compensation
relating to options granted to employees and directors was $2,173,000
(of
which $170,000 was charged to research and development costs, $1,990,000
was charged to general and administrative expenses and $13,000 was
charged
to business development costs), $2,718,000 (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), and $0, respectively. The total compensation costs related
to
nonvested awards not recognized as of December 31, 2006 was $5,478,000,
and the weighted average period over which it is expected to be recognized
is 3.0 years.
|
(f) |
In
March 2006, the Board of Directors of the Company approved the grant
to
the Chairman and to a non-executive director, of options to purchase
9,898,719 and 750,000 ordinary shares, respectively. All of such
options
are subject to vesting of which one third is based on service period,
and
the remainder is based on achievement of certain milestones linked
to the
Company’s valuation on the public markets. These grants are subject to
shareholder approval. During 2006, the Company did not seek shareholder
approval, so the options had not been granted at December 31,
2006.
|
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
|
|||||||||||||||||||
2006
|
2005
|
2004
|
|||||||||||||||||
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
|
525,000
|
0.33
|
205,000
|
0.54
|
|||||||||||||
Changes
during the year:
|
|||||||||||||||||||
Granted*
|
120,000
|
0.29
|
—
|
—
|
320,000
|
0.20
|
|||||||||||||
Reclassified**
|
125,000
|
0.25
|
—
|
—
|
—
|
—
|
|||||||||||||
Expired
|
(10,000
|
)
|
0.50
|
—
|
—
|
—
|
—
|
||||||||||||
Balance
outstanding at
|
|
||||||||||||||||||
end
of year***
|
760,000
|
0.31
|
525,000
|
0.33
|
525,000
|
0.33
|
|||||||||||||
Balance
exercisable at
|
|
||||||||||||||||||
end
of year***
|
448,334
|
0.36
|
355,000
|
0.39
|
280,901
|
0.45
|
* |
The
options exercise price was equal to the share price on the grant
date.
|
** |
In
2006, a former employee was engaged by the Company as a consultant.
The
options that were granted to that former employee have been reclassified
from options to an employee to options to a consultant.
|
*** |
The
aggregate intrinsic value as of December 31, 2006 is $27,000 for
outstanding options, and $13,000 for exercisable
options.
|
Options
outstanding
|
Options
exercisable
|
||||||||||||||||||
Range
of
exercise
prices
|
Number
outstanding
|
Weighted-
average
remaining
contractual
life
(years)
|
Weighed-
average
exercise
price
|
Number
exercisable
|
Weighted-
average
remaining
contractual
life
(years)
|
Weighed-average
exercise
price
|
|||||||||||||
0.100-0.299
|
375,000
|
5.5
|
$
|
0.24
|
233,334
|
3.5
|
$
|
0.22
|
|||||||||||
0.100-0.299
|
170,000
|
*
|
$
|
0.20
|
—
|
—
|
$
|
—
|
|||||||||||
0.300-0.399
|
20,000
|
5.0
|
$
|
0.31
|
20,000
|
5.0
|
$
|
0.31
|
|||||||||||
0.500-0.699
|
195,000
|
5.0
|
$
|
0.54
|
195,000
|
5.0
|
$
|
0.54
|
|||||||||||
760,000
|
448,334
|
(a) |
The
Company used the Black & Scholes fair value option pricing model. The
following assumptions under this method on grant date were used in
2006:
weighted
average expected volatility of 49%; weighted average risk-free interest
rates (in dollar terms) of 4.6%, dividend yield of 0%, and weighed
average
expected life of 4.5 years. The weighted average fair value of options
granted during the year using the model was $0.13 per option.
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 using this model was
$0.30.
|
(b) |
For
the years ended December 31, 2006, 2005 and 2004, non-cash compensation
relating to options granted to consultants were $7,000 (of which
$3,000
was charged to research and development costs, $2,000 was charged
to
general and administrative expenses and $2,000 was charged to business
development costs), $45,000 (all of which was charged to research
and
development costs), and $32,000 (of which $30,000 was charged to
research
and development costs, and $2,000 was charged to general and
administrative expenses), respectively. The
total compensation costs related to nonvested awards not recognized
as of
December 31, 2006 was $14,000, and the weighted average period over
which
it is expected to be recognized is 2.2 years.
|
a. |
Royalty
Bearing Agreements:
|
1) |
Under
a Research and License agreement with Yeda Research and Development
Company Ltd. (“Yeda”), the Company is committed to pay royalty payments at
rates determined in the agreement not exceeding 3% of net sales,
or
royalty rates between 20% to 25% of sublicensing fees, for products
in
development and research under the agreement.
|
2) |
The
Company is committed to pay royalties to the Government of Israel
on
proceeds from sales of products in the research and development of
which
the Government participates by way of grants. At the time grants
were
received, successful development of the related projects was not
assured.
In the case of failure of a project that was partly financed as above,
the
Company is not obligated to pay any such royalties. Under the terms
of the
Company's funding from the Israeli Government, royalties of 3% -
5% are
payable on sales of products developed from projects so funded, up
to 100%
of the amount of the grant received by the Company (dollar linked),
and as
from January 1, 1999, with the addition of an annual interest based
on
Libor.
|
3) |
The
Company has provided for annual
grants, over the next two years, of options to a non-executive director.
The future grants are contingent on being a member of the board of
directors at such time (see Note
6(b)2c).
|
b. |
Operating
lease commitments:
|
1) |
The
Company leases its office space in Israel and the United States under
lease agreements that expire through 2009.
|
December
31,
2006
|
||||
($
in thousands)
|
||||
In
2007
|
569
|
|||
In
2008
|
447
|
|||
In
2009
|
419
|
|||
1,435
|
2) |
The
Company leases vehicles under the terms of certain operating lease
agreements that expire in 2007, aggregating $15,000. Vehicle lease
expense
for the years ended December 31, 2006, 2005 and 2004 were $41,000,
$76,000
and $84,000, respectively.
|
c. |
Research
and development agreement
commitments
|
d. |
Tax
Assessment
|
a. |
The
Company
|
Tax
benefits under the Israeli Law for the Encouragement of Industry
(Taxes),
1969
|
Tax
rates in Israel applicable to income from other
sources
|
US
Federal Income Tax
Consequences
|
b. |
The
Subsidiary
|
c. |
Current
tax losses for tax
purposes
|
1) |
Company
|
2) |
Subsidiary
|
2006
|
2005
|
2004
|
|||||||||||||||||
($
in thousands)
|
($
in thousands)
|
($
in thousands)
|
|||||||||||||||||
Company
|
Subsidiary
|
Company
|
Subsidiary
|
Company
|
Subsidiary
|
||||||||||||||
Net
income (loss) before income taxes
|
(15,363
|
)
|
458
|
(14,187
|
)
|
250
|
(16,582
|
)
|
158
|
||||||||||
Income
taxes
|
—
|
227
|
—
|
78
|
—
|
49
|
|||||||||||||
Net
income (loss) for the year
|
(15,363
|
)
|
231
|
(14,187
|
)
|
172
|
(16,582
|
)
|
109
|
d. |
Deferred
income taxes
|
2006
|
2005
|
2004
|
||||||||
|
($
in thousands)
|
|||||||||
Income
taxes for the reported year:
|
||||||||||
Current
|
275
|
78
|
49
|
|||||||
Deferred
(in respect of the reporting period)
|
(48
|
)
|
—
|
—
|
||||||
227
|
78
|
49
|
e. |
Tax
assessments
|
1) |
Income
taxes
|
2) |
Withholding
taxes - see Note 7d.
|
a. |
Short-term
bank deposits
|
b. |
Other
receivables and prepaid
expenses:
|
December
31
|
|||||||
2006
|
2005
|
||||||
($
in thousands)
|
|||||||
Prepaid
expenses
|
258
|
285
|
|||||
Employees
|
118
|
75
|
|||||
Value
added tax authorities
|
8
|
17
|
|||||
Interest
receivable
|
318
|
54
|
|||||
702
|
431
|
c. |
Accounts
payable and accrued
expenses:
|
Suppliers
|
941
|
657
|
|||||
Accrued
expenses
|
1,190
|
940
|
|||||
Income
taxes
|
143
|
—
|
|||||
Accrued
compensation and related liabilities
|
729
|
410
|
|||||
3,003
|
2,007
|
d. |
Financial
and other income - net:
|
March
9, 1993
|
|||||||||||||
Year
ended December 31
|
to
December 31,
|
||||||||||||
2006
|
2005
|
2004
|
2006
|
||||||||||
($
in thousands)
|
|||||||||||||
Interest
income
|
1,058
|
503
|
297
|
10,286
|
|||||||||
Interest
expense
|
—
|
—
|
—
|
(374
|
)
|
||||||||
Foreign
exchange differences-gain (loss)
|
2
|
(39
|
)
|
67
|
(1,755
|
)
|
|||||||
Gain
from trading securities*
|
2
|
—
|
13
|
1
|
|||||||||
Other
income*
|
100
|
— | — |
100
|
|||||||||
Other
expense
|
(21
|
)
|
(21
|
)
|
(25
|
)
|
26
|
||||||
1,141
|
443
|
352
|
8,284
|
a. |
Linkage
terms of balances in non-dollars
currency:
|
1) |
As
follows:
|
December 31,
2006
|
|||||||
Israeli
currency
|
Other
|
||||||
Unlinked
|
|||||||
($
in thousands)
|
|||||||
Assets
|
548
|
4
|
|||||
Liabilities
|
747
|
108
|
2) |
Data
regarding the changes in the exchange rate of the dollar and the
Israeli
CPI:
|
Year
ended December 31
|
||||||||||
2006
|
2005
|
2004
|
||||||||
Devaluation
(evaluation) of the Israeli currency
against the dollar
|
(8.21
|
)%
|
6.85
|
%
|
(1.6
|
)%
|
||||
Changes
in the Israeli CPI
|
(0.1
|
)%
|
2.4
|
%
|
1.2
|
%
|
||||
Exchange
rate of one dollar (at end of year)
|
NIS
4.225
|
NIS
4.603
|
NIS
4.308
|
b.
|
Fair
value of financial
instruments
|
c. |
Concentration
of credit risks
|