American
Depositary Shares, each representing
ten
Ordinary Shares, par value NIS 0.02
|
The
NASDAQ Capital Market
|
|
(Title
of Class)
|
(Name
of each exchange on which
registered)
|
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
|
16
|
|||
ITEM
4A
|
Unresolved
Staff Comments
|
26
|
|||
ITEM
5
|
Operating
and Financial Review and Prospects
|
26
|
|||
ITEM
6
|
Directors,
Senior Management and Employees
|
39
|
|||
ITEM
7
|
Major
Shareholders and Related Party Transactions
|
48
|
|||
ITEM
8
|
Financial
Information
|
48
|
|||
ITEM
9
|
The
Offer and Listing
|
48
|
|||
ITEM
10
|
Additional
Information
|
50
|
|||
ITEM
11
|
Quantitative
And Qualitative Disclosures About Market Risk
|
63
|
|||
ITEM
12
|
Description
of Securities other than Equity Securities
|
63
|
|||
PART
II
|
|||||
ITEM
13
|
Defaults,
Dividend Arrearages and Delinquencies
|
64
|
|||
ITEM
14
|
Material
Modifications to the Rights of Security Holders and Use of
Proceeds
|
64
|
|||
ITEM
15
|
Controls
and Procedures
|
64
|
|||
ITEM
16
|
Reserved
|
64
|
|||
ITEM
16A
|
Audit
Committee Financial Expert
|
64
|
|||
ITEM
16B
|
Code
of Ethics
|
64
|
|||
ITEM
16C
|
Principal
Accountant Fees And Services
|
65
|
|||
ITEM
16D
|
Exemptions
From The Listing Standards For Audit Committees
|
65
|
|||
ITEM
16E
|
Purchases
Of Equity Securities By The Issuer And Affiliated Purchasers
|
65
|
|||
PART
III
|
|||||
ITEM
17
|
Financial
Statements
|
66
|
|||
ITEM
18
|
Financial
Statements
|
66
|
|||
ITEM
19
|
Exhibits
|
67
|
|||
SIGNATURES
|
69
|
Year
Ended December 31,
|
||||||||||||||||
2007
|
2006
|
2005
|
2004
|
2003
|
||||||||||||
(In
thousands, except share and per share amounts)
|
||||||||||||||||
Statements
of Operations Data:
|
||||||||||||||||
Revenues
|
||||||||||||||||
Reimbursed
out-of-pocket expenses
|
$
|
—
|
$
|
—
|
$
|
2,743
|
$
|
3,269
|
$
|
—
|
||||||
License
|
907
|
454
|
454
|
185
|
—
|
|||||||||||
907
|
454
|
3,197
|
3,454
|
—
|
||||||||||||
Cost
of Revenues
|
||||||||||||||||
Reimbursed
out-of-pocket expenses
|
—
|
—
|
2,743
|
3,269
|
—
|
|||||||||||
License
(with respect to royalties)
|
110
|
54
|
54
|
32
|
—
|
|||||||||||
110
|
54
|
2,797
|
3,301
|
—
|
||||||||||||
Gross
Margin
|
797
|
400
|
400
|
153
|
—
|
|||||||||||
|
||||||||||||||||
Research
and development
|
||||||||||||||||
Research
and development costs
|
18,998
|
10,229
|
7,313
|
11,985
|
14,022
|
|||||||||||
Less
participations
|
56
|
—
|
—
|
—
|
3,229
|
|||||||||||
|
18,942
|
10,229
|
7,313
|
11,985
|
10,793
|
|||||||||||
In-process
research and development
|
—
|
—
|
1,783
|
—
|
—
|
|||||||||||
General
and administrative
|
5,582
|
5,576
|
5,457
|
4,134
|
3,105
|
|||||||||||
Business
development costs
|
2,008
|
641
|
227
|
810
|
664
|
|||||||||||
Operating
loss
|
(25,735
|
)
|
(16,046
|
)
|
(14,380
|
)
|
(16,776
|
)
|
(14,562
|
)
|
||||||
|
||||||||||||||||
Other
income (expense)
|
||||||||||||||||
Financial
and other income, net
|
590
|
1,141
|
443
|
352
|
352
|
|||||||||||
Income
taxes
|
206
|
(227
|
)
|
(78
|
)
|
(49
|
)
|
(78
|
)
|
|||||||
|
||||||||||||||||
Loss
for the period
|
$
|
(24,939
|
)
|
$
|
(15,132
|
)
|
$
|
(14,015
|
)
|
$
|
(16,473
|
)
|
$
|
(14,288
|
)
|
|
|
||||||||||||||||
Loss
per ordinary share
|
||||||||||||||||
Basic
and diluted
|
$
|
(0.11
|
)
|
$
|
(0.08
|
)
|
$
|
(0.08
|
)
|
$
|
(0.12
|
)
|
$
|
(0.13
|
)
|
|
Weighted
average shares outstanding
|
228,492,818
|
201,737,295
|
170,123,003
|
134,731,766
|
111,712,916
|
As
of December 31,
|
||||||||||||||||
2007
|
2006
|
2005
|
2004
|
2003
|
||||||||||||
(In
thousands)
|
||||||||||||||||
Balance
Sheet Data:
|
||||||||||||||||
Cash,
cash equivalents, bank deposits and trading
and marketable securities
|
$
|
12,977
|
$
|
25,347
|
$
|
13,360
|
$
|
22,924
|
$
|
22,262
|
||||||
Working
capital
|
8,532
|
22,694
|
11,385
|
20,240
|
19,967
|
|||||||||||
Total
assets
|
14,127
|
26,900
|
15,151
|
25,624
|
24,853
|
|||||||||||
Long-term
obligations
|
194
|
738
|
1,493
|
2,489
|
1,244
|
|||||||||||
Total
shareholders’ equity <
|
8,564
|
22,760
|
11,252
|
19,602
|
20,608
|
·
|
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 or personnel
of the
business;
|
·
|
our
inability to attract and retain management, key personnel and
other
employees necessary to conduct the business;
|
·
|
our
inability to maintain relationships with key third parties,
such as
alliance partners, associated with the business;
|
·
|
exposure
to legal claims for activities of the 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, specifically, the
timing of
completion and results from our clinical trials for
Bicifadine;
|
·
|
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.
|
·
|
complete
our Phase 2b program for Bicifadine for the treatment of diabetic
neuropathic pain;
|
·
|
advance
the development of Bicifadine towards approval in
diabetic neuropathic pain and possibly
in other
related indications
either alone or with a corporate partner;
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
1:
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
2:
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
3:
Studies establish safety and efficacy in an expanded patient population.
|
·
|
Phase
4:
The FDA may require Phase 4 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,
|
||||||||||||||||
2007
|
2006
|
2005
|
2004
|
2003
|
||||||||||||
(In
thousands, except share and per share amounts)
|
||||||||||||||||
Statements
of Operations Data:
|
||||||||||||||||
Revenues
|
||||||||||||||||
Reimbursed
out-of-pocket expenses
|
$
|
—
|
$
|
—
|
$
|
2,743
|
$
|
3,269
|
$
|
—
|
||||||
License
|
907
|
454
|
454
|
185
|
—
|
|||||||||||
907
|
454
|
3,197
|
3,454
|
—
|
||||||||||||
Cost
of Revenues
|
||||||||||||||||
Reimbursed
out-of-pocket expenses
|
—
|
—
|
2,743
|
3,269
|
—
|
|||||||||||
License
(with respect to royalties)
|
110
|
54
|
54
|
32
|
—
|
|||||||||||
110
|
54
|
2,797
|
3,301
|
—
|
||||||||||||
Gross
Margin
|
797
|
400
|
400
|
153
|
—
|
|||||||||||
|
||||||||||||||||
Research
and development
|
||||||||||||||||
Research
and development costs
|
18,998
|
10,229
|
7,313
|
11,985
|
14,022
|
|||||||||||
Less
participations
|
56
|
—
|
—
|
—
|
3,229
|
|||||||||||
|
18,942
|
10,229
|
7,313
|
11,985
|
10,793
|
|||||||||||
In-process
research and development
|
—
|
—
|
1,783
|
—
|
—
|
|||||||||||
General
and administrative
|
5,582
|
5,576
|
5,457
|
4,134
|
3,105
|
|||||||||||
Business
development costs
|
2,008
|
641
|
227
|
810
|
664
|
|||||||||||
Operating
loss
|
(25,735
|
)
|
(16,046
|
)
|
(14,380
|
)
|
(16,776
|
)
|
(14,562
|
)
|
||||||
|
||||||||||||||||
Other
income (expense)
|
||||||||||||||||
Financial
and other income, net
|
590
|
1,141
|
443
|
352
|
352
|
|||||||||||
Income
taxes
|
206
|
(227
|
)
|
(78
|
)
|
(49
|
)
|
(78
|
)
|
|||||||
|
||||||||||||||||
Loss
for the period
|
$
|
(24,939
|
)
|
$
|
(15,132
|
)
|
$
|
(14,015
|
)
|
$
|
(16,473
|
)
|
$
|
(14,288
|
)
|
|
|
||||||||||||||||
Loss
per ordinary share
|
||||||||||||||||
Basic
and diluted
|
$
|
(0.11
|
)
|
$
|
(0.08
|
)
|
$
|
(0.08
|
)
|
$
|
(0.12
|
)
|
$
|
(0.13
|
)
|
|
Weighted
average shares outstanding
|
228,492,818
|
201,737,295
|
170,123,003
|
134,731,766
|
111,712,916
|
As
of December 31,
|
||||||||||||||||
2007
|
2006
|
2005
|
2004
|
2003
|
||||||||||||
(In
thousands)
|
||||||||||||||||
Balance
Sheet Data:
|
||||||||||||||||
Cash,
cash equivalents, bank deposits and trading
and marketable securities
|
$
|
12,977
|
$
|
25,347
|
$
|
13,360
|
$
|
22,924
|
$
|
22,262
|
||||||
Working
capital
|
8,532
|
22,694
|
11,385
|
20,240
|
19,967
|
|||||||||||
Total
assets
|
14,127
|
26,900
|
15,151
|
25,624
|
24,853
|
|||||||||||
Long-term
obligations
|
194
|
738
|
1,493
|
2,489
|
1,244
|
|||||||||||
Total
shareholders’ equity <
|
8,564
|
22,760
|
11,252
|
19,602
|
20,608
|
· |
the
timing of expenses associated with product development and manufacturing
of the proprietary drug candidates within our portfolio and those
that may
be in-licensed, partnered or acquired, and specifically, the timing
of
completion and results from our clinical trials for Bicifadine;
|
· |
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
|
$
|
5,754,000
|
$
|
5,747,000
|
$
|
7,000
|
$
|
—
|
$
|
—
|
||||||
Operating
leases
|
990,000
|
527,000
|
463,000
|
—
|
—
|
|||||||||||
Total
|
$
|
6,744,000
|
$
|
6,274,000
|
$
|
470,000
|
$
|
—
|
$
|
—
|
Years
ended December 31,
|
|||||||||||||
2007
|
|
2006
|
|
2005
|
|
Cumulative,
as of December 31, 2007
|
|||||||
Bicifadine
(includes
$7.5 million initial upfront license fee)
|
$
|
13,476,000
|
$
|
—
|
$
|
—
|
$
|
13,476,000
|
|||||
DOS
|
4,056,000
|
4,653,000
|
1,240,000
|
9,949,000
|
|||||||||
Legacy
programs
|
|||||||||||||
XTL-2125
|
|||||||||||||
Research
and development costs
|
753,000
|
|
2,936,000
|
|
3,367,000
|
13,054,000
|
|||||||
Less
participations
|
—
|
—
|
—
|
(168,000
|
)
|
||||||||
753,000
|
2,936,000
|
3,367,000
|
12,886,000
|
||||||||||
XTL-6865
|
|||||||||||||
Research
and development costs
|
713,000
|
2,640,000
|
2,706,000
|
24,972,000
|
|||||||||
Less
participations
|
(56,000
|
)
|
—
|
—
|
(2,596,000
|
)
|
|||||||
657,000
|
2,640,000
|
2,706,000
|
22,376,000
|
||||||||||
HepeX-B1
|
|||||||||||||
Research
and development costs
|
—
|
—
|
2,743,000
|
26,985,000
|
|||||||||
Less
participations
|
—
|
—
|
(2,743,000
|
)
|
(10,173,000
|
)
|
|||||||
|
—
|
—
|
—
|
16,812,000
|
|||||||||
Other
research and development programs2
|
|||||||||||||
Research
and development costs
|
—
|
—
|
—
|
29,693,000
|
|||||||||
Less
participations
|
—
|
—
|
—
|
(4,081,000
|
)
|
||||||||
|
—
|
—
|
—
|
25,612,000
|
|||||||||
Total
legacy programs
|
1,410,000
|
5,576,000
|
6,073,000
|
77,686,000
|
|||||||||
Total
Research and development
|
|||||||||||||
Research
and development costs
|
18,998,000
|
10,229,000
|
10,056,000
|
118,129,000
|
|||||||||
Less
participations
|
(56,000
|
)
|
—
|
(2,743,000
|
)
|
(17,018,000
|
)
|
||||||
18,942,000
|
10,229,000
|
7,313,000
|
101,111,000
|
Name
|
Age
|
Position
|
||
Michael
S. Weiss
|
42
|
Chairman
of the Board of Directors
|
||
William
J. Kennedy, Ph.D
|
63
|
Non
Executive Director
|
||
Ido
Seltenreich (1)
|
36
|
Non
Executive and External Director
|
||
Vered
Shany, D.M.D (1)
|
43
|
Non
Executive and External Director
|
||
Ben
Zion Weiner, Ph.D
(1)
|
63
|
Non
Executive Director
|
||
Ron
Bentsur
|
42
|
Chief
Executive Officer
|
||
Bill
Kessler (1)
|
42
|
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,
|
||||||||||
2007
|
2006
|
2005
|
||||||||
Research
and Development
|
||||||||||
Israel
|
2
|
8
|
22
|
|||||||
US
|
16
|
18
|
19
|
|||||||
18
|
26
|
41
|
||||||||
Financial
and general management
|
||||||||||
Israel
|
4
|
4
|
4
|
|||||||
US
|
2
|
2
|
—
|
|||||||
6
|
6
|
4
|
||||||||
Business
development
|
||||||||||
Israel
|
—
|
—
|
—
|
|||||||
US
|
1
|
1
|
1
|
|||||||
1
|
1
|
1
|
||||||||
Total
|
25
|
33
|
46
|
|||||||
Average
number of full-time employees
|
29
|
40
|
54
|
Amount
and nature of beneficial ownership
|
|||||||||||||
|
Ordinary
shares
beneficially
owned
excluding
options
|
Options1
exercisable
within
60 days
of
February
29,
2008
|
Total
ordinary
shares
beneficially
owned
|
Percent
of
ordinary
shares
beneficially
owned
|
|||||||||
Michael
S. Weiss
Chairman
of the Board
|
—
|
3,083,333
|
2 |
3,083,333
|
1.0
|
%
|
|||||||
William
Kennedy
Director
|
—
|
56,667
|
3 |
56,667
|
*
|
||||||||
Ben
Zion Weiner
Director
|
—
|
666,667
|
4 |
666,667
|
*
|
||||||||
Ido
Seltenreich
Director
|
250,0005
|
—
|
250,000
|
*
|
|||||||||
Vered
Shany
Director
|
—
|
—
|
—
|
—
|
|||||||||
Ron
Bentsur
Chief
Executive Officer
|
201,010
|
2,180,558
|
6 |
2,381,568
|
*
|
||||||||
Bill
Kessler
Director
of Finance
|
50,000
|
250,000
|
7 |
300,000
|
*
|
||||||||
All
directors and executive officers as a group
(7 persons)
|
501,010
|
6,237,225
|
6,738,235
|
2.3
|
%
|
(1)
|
Options
to purchase ordinary shares.
|
(2)
|
At
an exercise price of $0.36 per ordinary share, expiring July 31,
2010.
|
(3)
|
40,000
options at an exercise price of $0.853 per ordinary share, expiring
July
31, 2015; 11,667 options at an exercise price of $0.325 per ordinary
share, expiring July 31, 2016; and 5,000 options at an exercise price
of
$0.204, expiring on July 31, 2007.
|
(4)
|
At
an exercise price of $0.354 per ordinary share, expiring July 31,
2010.
|
(5)
|
Held
under a blind trusteeship arrangement with a
third-party.
|
(6)
|
1,555,558
options at an exercise price of $0.774 per ordinary share, expiring
March
15, 2016; and 625,000 options at an exercise price of $0.315, expiring
January 14, 2018.
|
(7)
|
125,000
options at an exercise price of $0.60 per ordinary share, expiring
June
18, 2016; and 125,000 options at an exercise price of $0.315, expiring
January 14, 2018.
|
* |
Represents
Less than 1% of ordinary shares
outstanding.
|
Beneficial
owner
|
Number
of ordinary shares beneficially owned
|
Percent
of
ownership
|
|||||
Perceptive
Life Sciences Master Fund Ltd.1
|
52,383,260
|
17.9
|
%
|
1
Pursuant to a Form 4 filed with the SEC on
2/29/08.
|
|
US
Dollar
|
||||||
Last
Six Calendar Months
|
High
|
Low
|
|||||
February
2008
|
4.24
|
3.56
|
|||||
January
2008
|
3.59
|
2.91
|
|||||
December
2007
|
2.85
|
1.86
|
|||||
November
2007
|
2.13
|
1.66
|
|||||
October
2007
|
2.03
|
1.51
|
|||||
September
2007
|
2.44
|
1.25
|
|||||
Financial
Quarters During the Past Two Full Fiscal Years
|
|||||||
Fourth
Quarter of 2007
|
2.85
|
1.51
|
|||||
Third
Quarter of 2007
|
2.64
|
1.24
|
|||||
Second
Quarter of 2007
|
4.07
|
2.29
|
|||||
First
Quarter of 2007
|
4.99
|
2.71
|
|||||
Fourth
Quarter of 2006
|
3.69
|
2.22
|
|||||
Third
Quarter of 2006
|
4.54
|
2.08
|
|||||
Second
Quarter of 2006
|
7.50
|
4.40
|
|||||
First
Quarter of 2006
|
8.12
|
6.13
|
|||||
Full
Financial Years Since Listing
|
|||||||
2007
|
4.99
|
1.24
|
|||||
2006
|
8.12
|
2.08
|
1 |
Our
ADRs have been quoted on the NASDAQ Capital Market since December
3, 2007
and prior to that were quoted on the NASDAQ Global
Market.
|
New
Israeli Shekel
|
US
Dollar
|
||||||||||||
High
|
Low
|
High
|
Low
|
||||||||||
Last
Six Calendar Months
|
|||||||||||||
February
2008
|
1.47
|
1.32
|
0.40
|
0.36
|
|||||||||
January
2008
|
1.40
|
0.97
|
0.39
|
0.27
|
|||||||||
December
2007
|
0.99
|
0.73
|
0.27
|
0.20
|
|||||||||
November
2007
|
0.79
|
0.64
|
0.22
|
0.18
|
|||||||||
October
2007
|
0.78
|
0.67
|
0.21
|
0.18
|
|||||||||
September
2007
|
0.92
|
0.55
|
0.25
|
0.15
|
|||||||||
Financial
Quarters During the Past Two Full Fiscal Years
|
|||||||||||||
Fourth
Quarter of 2007
|
0.99
|
0.64
|
0.27
|
0.18
|
|||||||||
Third
Quarter of 2007
|
1.06
|
0.48
|
0.29
|
0.13
|
|||||||||
Second
Quarter of 2007
|
1.62
|
1.00
|
0.45
|
0.28
|
|||||||||
First
Quarter of 2007
|
2.02
|
1.12
|
0.56
|
0.31
|
|||||||||
Fourth
Quarter of 2006
|
1.57
|
0.96
|
0.43
|
0.26
|
|||||||||
Third
Quarter of 2006
|
2.03
|
1.04
|
0.56
|
0.29
|
|||||||||
Second
Quarter of 2006
|
3.37
|
2.03
|
0.93
|
0.56
|
|||||||||
First
Quarter of 2006
|
3.66
|
2.86
|
1.01
|
0.79
|
|||||||||
Full
Financial Years Since Listing
|
|||||||||||||
2007
|
2.02
|
0.48
|
0.56
|
0.13
|
|||||||||
2006
|
3.66
|
0.96
|
1.01
|
0.26
|
· |
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.
|
· |
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 certain conditions are
met.
|
· |
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.
|
|
2007
|
2006
|
|||||
|
(in
thousands)
|
||||||
Audit
fees
|
$
|
174
|
$
|
164
|
|||
Audit-related
fees
|
151
|
150
|
|||||
Tax
fees
|
21
|
63
|
|||||
Other
fees
|
21
|
11
|
|||||
Total
|
$
|
367
|
$
|
388
|
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^
|
|
10.13
|
1999
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.†
|
|
10.20
|
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
|
Securities
Purchase Agreement, dated March 17, 2006, by and among XTL
Biopharmaceuticals Ltd., and the purchasers named
therein
|
|
10.29
|
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^
|
|
10.32
|
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.*
|
|
10.34
|
Securities
Purchase Agreement, dated October 25, 2007, by and among XTL
Biopharmaceuticals Ltd., and the purchasers named
therein
|
|
10.35
|
Registration
Rights Agreement, dated October 25, 2007, by and among XTL
Biopharmaceuticals Ltd. and the purchasers named
therein
|
|
10.36
|
License
Agreement By and Between XTL Biopharmaceuticals
Ltd. and Presidio Pharmaceuticals, Inc. dated March 19,
2008
|
|
21.1
|
List
of Subsidiaries
|
23.1
|
Consent
of Kesselman & Kesselman, a member of PricewaterhouseCoopers
International Ltd, dated March 27, 2008
|
|
23.2
|
Consent
of Somekh Chaikin, a member firm of KPMG International, dated March
27,
2008
|
|
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 27, 2008
|
|
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 27, 2008
|
|
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 27, 2008
|
|
99.1
|
Report
of Management on Internal Control Over Financial Reporting dated
March 27,
2008
|
XTL
BIOPHARMACEUTICALS LTD.
(Registrant)
|
||
|
|
|
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, 2007 and 2006
|
F-5
|
Consolidated
Statements of Operations for the years ended December
31, 2007, 2006 and 2005, and the period from
March
9, 1993 to December 31, 2007
|
F-6
|
Consolidated
Statements of Changes in Shareholders’ Equity for the years
ended December 31, 2007, 2006 and 2005,
and
the period from March
9, 1993 to December 31, 2007
|
F-7
|
Consolidated
Statements of Cash Flows for the years ended December
31, 2007, 2006 and 2005, and the period from
March
9, 1993 to December 31, 2007
|
F-11
|
Notes
to the Consolidated Financial Statements
|
F-13
|
Kesselman
& Kesselman
Certified
Public Accountants
Trade
Tower, 25 Hamered Street
Tel
Aviv 68125 Israel
P.O
Box 452 Tel Aviv 61003
Telephone
+972-3-7954555
Facsimile
+972-3-7954556
|
Tel-Aviv,
Israel
|
|
|
/s/
Kesselman & Kesselman
|
|
March
27, 2008
|
|
|
Certified
Public Accountants (Isr.)
|
|
|
|
A
member of PricewaterhouseCoopers
International
Limited
|
December
31
|
|||||||
2007
|
2006
|
||||||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
2,377
|
4,400
|
|||||
Short-term
bank deposits
|
10,600
|
20,845
|
|||||
Trading
securities
|
—
|
102
|
|||||
Property
and equipment (held for sale) - net
|
—
|
18
|
|||||
Deferred
tax asset
|
—
|
29
|
|||||
Other
receivables and prepaid expenses
|
924
|
702
|
|||||
Total
current assets
|
13,901
|
26,096
|
|||||
Employee
severance pay funds
|
48
|
98
|
|||||
Restricted
long-term deposits
|
61
|
172
|
|||||
Property
and equipment - net
|
106
|
490
|
|||||
Intangible
assets - net
|
11
|
25
|
|||||
Deferred
tax asset
|
—
|
19
|
|||||
Total
assets
|
14,127
|
26,900
|
|||||
Liabilities
and shareholders’ equity
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
3,809
|
3,003
|
|||||
Deferred
gain
|
—
|
399
|
|||||
Other
current liabilities (Note 2)
|
1,560
|
—
|
|||||
Total
current liabilities
|
5,369
|
3,402
|
|||||
Liability
in respect of employee severance obligations
|
194
|
340
|
|||||
Deferred
gain
|
—
|
398
|
|||||
Commitments
and contingencies (Note 8)
|
|||||||
Total
liabilities
|
5,563
|
4,140
|
|||||
Shareholders’
equity:
|
|||||||
Ordinary
shares of NIS 0.02 par value (500,000,000 and 300,000,000
authorized,
292,654,785
and 220,124,349 issued and outstanding, at December 31, 2007
and
2006, respectively)
|
1,444
|
1,072
|
|||||
Additional
paid in capital
|
146,982
|
136,611
|
|||||
Deficit
accumulated during the development stage
|
(139,862
|
)
|
(114,923
|
)
|
|||
Total
shareholders’ equity
|
8,564
|
22,760
|
|||||
Total
liabilities and shareholders’ equity
|
14,127
|
26,900
|
/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,
|
||||||||||||
2007
|
2006
|
2005
|
2007
|
||||||||||
Revenues:
|
|||||||||||||
Reimbursed
out-of-pocket expenses
|
—
|
—
|
2,743
|
6,012
|
|||||||||
License
|
907
|
454
|
454
|
2,000
|
|||||||||
907
|
454
|
3,197
|
8,012
|
||||||||||
Cost
of revenues:
|
|||||||||||||
Reimbursed
out-of-pocket expenses
|
—
|
—
|
2,743
|
6,012
|
|||||||||
License
(with respect to royalties)
|
110
|
54
|
54
|
250
|
|||||||||
110
|
54
|
2,797
|
6,262
|
||||||||||
Gross
margin
|
797
|
400
|
400
|
1,750
|
|||||||||
Research
and development costs (includes
$7,500 initial upfront license fee in 2007 and also includes non-cash
stock option compensation of $141, $173, and $112, in 2007, 2006
and 2005,
respectively)
|
18,998
|
10,229
|
7,313
|
112,117
|
|||||||||
Less
- participations
|
56
|
—
|
—
|
11,006
|
|||||||||
18,942
|
10,229
|
7,313
|
101,111
|
||||||||||
In-process
research and development costs
|
—
|
—
|
1,783
|
1,783
|
|||||||||
General
and administrative expenses (includes
non-cash stock option compensation of $1,784, $1,992, and $2,641,
in 2007,
2006 and 2005, respectively)
|
5,582
|
5,576
|
5,457
|
40,170
|
|||||||||
Business
development costs
(includes stock appreciation rights compensation of $1,560 in 2007 and
also includes non-cash stock option compensation of $22, $15, and
$10, in
2007, 2006 and 2005, respectively)
|
2,008
|
641
|
227
|
7,162
|
|||||||||
Operating
loss
|
25,735
|
16,046
|
14,380
|
148,476
|
|||||||||
Financial
and other income, net
|
590
|
1,141
|
443
|
8,874
|
|||||||||
Loss
before income taxes
|
25,145
|
14,905
|
13,937
|
139,602
|
|||||||||
Income
taxes
|
(206
|
)
|
227
|
78
|
260
|
||||||||
Loss
for the period
|
24,939
|
15,132
|
14,015
|
139,862
|
|||||||||
Basic
and diluted loss per ordinary share
|
$
|
0.11
|
$
|
0.08
|
$
|
0.08
|
|||||||
Weighted
average number of shares used in computing basic and diluted loss
per
ordinary share
|
228,492,818
|
201,737,295
|
170,123,003
|
Preferred
shares
|
Ordinary
shares
|
||||||||||||
Number
of
|
Number
of
|
||||||||||||
shares
|
Amount
|
shares
|
Amount
|
||||||||||
Changes
during the period from March 9, 1993 (date of incorporation) to
December 31, 2004:
|
|||||||||||||
Comprehensive
loss - loss for the period
|
—
|
—
|
—
|
—
|
|||||||||
Employee
stock options expenses
|
—
|
—
|
—
|
—
|
|||||||||
Non-employee
stock option expenses
|
—
|
—
|
—
|
—
|
|||||||||
Exercise
of share warrants in 2000
|
—
|
—
|
1,499,980
|
7
|
|||||||||
Exercise
of share warrants in 2001
|
—
|
—
|
208,000
|
1
|
|||||||||
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
|
**
|
|||||||||
Exercise
of employee stock options in 2002
|
—
|
—
|
38,326
|
**
|
|||||||||
Exercise
of employee stock options in 2003
|
—
|
—
|
854,100
|
4
|
|||||||||
Exercise
of employee stock options in 2004
|
—
|
—
|
50,000
|
**
|
|||||||||
Issuance
of share capital in 1993, net of $912 issuance expenses
|
7,705,470
|
45
|
—
|
—
|
|||||||||
Issuance
of share capital in 1994, net of $22 issuance
expenses
|
717,500
|
5
|
—
|
—
|
|||||||||
Issuance
of share capital in 1996, net of $646 issuance expenses
|
6,315,810
|
49
|
—
|
—
|
|||||||||
Issuance
of share capital in 1998, net of $1,650 issuance expenses
|
26,319,130
|
139
|
—
|
—
|
|||||||||
Issuance
of share capital in 1999, net of $49 issuance
expenses
|
2,513,940
|
12
|
—
|
—
|
|||||||||
Issuance
of share capital in 2000
|
—
|
—
|
15,183,590
|
75
|
|||||||||
Issuance
of shares in 2004, net of $2,426 issuance expenses
|
—
|
—
|
56,009,732
|
247
|
|||||||||
Bonus
shares
|
7,156,660
|
41
|
19,519,720
|
97
|
|||||||||
Conversion
of preferred shares into ordinary shares
|
(50,744,110
|
)
|
(291
|
)
|
50,744,110
|
291
|
|||||||
Receipts
in respect of share warrants (expired in 1999)
|
—
|
—
|
—
|
—
|
|||||||||
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
|
|||||||||
Balance
at December 31, 2004
|
—
|
—
|
168,079,196
|
841
|
Deficit
|
||||||||||
accumulated
|
||||||||||
Additional
|
during
the
|
|||||||||
paid-in
|
development
|
|||||||||
capital
|
stage
|
Total
|
||||||||
Changes
during the period from March 9, 1993 (date of incorporation)
to December 31, 2004 :
|
||||||||||
Comprehensive
loss - loss for the period
|
—
|
(85,776
|
)
|
(85,776
|
)
|
|||||
Employee
stock options expenses
|
377
|
—
|
377
|
|||||||
Non-employee
stock option expenses
|
138
|
—
|
138
|
|||||||
Exercise
of share warrants in 2000
|
340
|
—
|
347
|
|||||||
Exercise
of share warrants in 2001
|
74
|
—
|
75
|
|||||||
Exercise
of employee stock options in 1999
|
**
|
—
|
**
|
|||||||
Exercise
of employee stock options in 2000
|
—
|
—
|
1
|
|||||||
Exercise
of employee stock options in 2001
|
26
|
—
|
26
|
|||||||
Exercise
of employee stock options in 2002
|
20
|
—
|
20
|
|||||||
Exercise
of employee stock options in 2003
|
—
|
—
|
4
|
|||||||
Exercise
of employee stock options in 2004
|
19
|
—
|
19
|
|||||||
Issuance
of share capital in 1993, net of $912 issuance expenses
|
5,545
|
—
|
5,590
|
|||||||
Issuance
of share capital in 1994, net of $22 issuance expenses
|
2,103
|
—
|
2,108
|
|||||||
Issuance
of share capital in 1996, net of $646 issuance expenses
|
5,314
|
—
|
5,363
|
|||||||
Issuance
of share capital in 1998, net of $1,650 issuance expenses
|
12,036
|
—
|
12,175
|
|||||||
Issuance
of share capital in 1999, net of $49 issuance expenses
|
1,189
|
—
|
1,201
|
|||||||
Issuance
of share capital in 2000
|
16,627
|
—
|
16,702
|
|||||||
Issuance
of shares in 2004, net of $2,426 issuance expenses
|
15,183
|
—
|
15,430
|
|||||||
Bonus
shares
|
(138
|
)
|
—
|
—
|
||||||
Conversion
of preferred shares into ordinary shares
|
—
|
—
|
—
|
|||||||
Receipts
in respect of share warrants (expired in 1999)
|
89
|
—
|
89
|
|||||||
Initial
public offering (“IPO”) of the Company’s shares under a prospectus dated
September 20, 2000, net of $5,199 issuance expenses
|
45,595
|
—
|
45,713
|
|||||||
Balance
at December 31, 2004
|
104,537
|
(85,776
|
)
|
19,602
|
Ordinary
shares
|
Additional
|
|||||||||
Number
of
|
paid
in
|
|||||||||
shares
|
Amount
|
capital
|
||||||||
Balance
at December 31, 2004 -
|
||||||||||
brought
forward
|
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 issuance expenses
|
—
|
—
|
4,565
|
|||||||
Issuance
of shares, net of $2,956 issuance expenses
|
46,666,670
|
207
|
19,591
|
|||||||
Balance
at December 31, 2006
|
220,124,349
|
1,072
|
136,611
|
|||||||
Changes
during 2007:
|
||||||||||
Comprehensive
loss - loss for the period
|
—
|
—
|
—
|
|||||||
Non-employee
stock option compensation expenses
|
—
|
—
|
13
|
|||||||
Employee
stock option compensation expenses
|
—
|
—
|
1,934
|
|||||||
Exercise
of stock options
|
45,416
|
**
|
4
|
|||||||
Issuance
of shares, net of $993 issuance expenses
|
72,485,020
|
372
|
8,420
|
|||||||
Balance
at December 31, 2007
|
292,654,785
|
1,444
|
146,982
|
Deficit
|
|||||||
accumulated
|
|||||||
during
the
|
|||||||
development
|
|||||||
stage
|
Total
|
||||||
Balance
at December 31, 2004 -
|
|||||||
brought
forward
|
(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 issuance expenses
|
—
|
4,565
|
|||||
Issuance
of shares, net of $2,956 issuance expenses
|
—
|
19,798
|
|||||
Balance
at December 31, 2006
|
(114,923
|
)
|
22,760
|
||||
Changes
during 2007:
|
|||||||
Comprehensive
loss - loss for the period
|
(24,939
|
)
|
(24,939
|
)
|
|||
Non-employee
stock option compensation expenses
|
—
|
13
|
|||||
Employee
stock option compensation expenses
|
—
|
1,934
|
|||||
Exercise
of stock options
|
—
|
4
|
|||||
Issuance
of shares, net of $993 issuance expenses
|
—
|
8,792
|
|||||
Balance
at December 31, 2007
|
(139,862
|
)
|
8,564
|
Period from
|
|||||||||||||
March 9, 1993 (a)
|
|||||||||||||
Year
ended December 31
|
to December 31,
|
||||||||||||
2007
|
2006
|
2005
|
2007
|
||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||||||||
Loss
for the period
|
(24,939
|
)
|
(15,132
|
)
|
(14,015
|
)
|
(139,862
|
)
|
|||||
Adjustments
to reconcile loss to net cash used in operating
activities:
|
|||||||||||||
Depreciation
and amortization
|
108
|
243
|
242
|
3,180
|
|||||||||
Linkage
difference on restricted deposits
|
(2
|
)
|
(10
|
)
|
3
|
(9
|
)
|
||||||
Acquisition
of in process research and development
|
—
|
—
|
1,783
|
1,783
|
|||||||||
Loss
(gain) on disposal of property and equipment
|
(40
|
)
|
(57
|
)
|
6
|
(79
|
)
|
||||||
Increase
(decrease) in liability in respect of employee severance
obligations
|
(70
|
)
|
8
|
(159
|
)
|
1,166
|
|||||||
Impairment
charges
|
105
|
—
|
26
|
485
|
|||||||||
Gain
from sales of investment securities
|
—
|
—
|
—
|
(410
|
)
|
||||||||
Other
income related to exchange of shares
|
—
|
(100
|
)
|
—
|
(100
|
)
|
|||||||
Loss
(gain) from trading securities
|
48
|
(2
|
)
|
—
|
46
|
||||||||
Stock
option based compensation expenses
|
1,947
|
2,180
|
2,763
|
7,405
|
|||||||||
Stock
appreciation rights compensation expenses
|
1,560
|
—
|
—
|
1,560
|
|||||||||
Gain
on amounts funded in respect of employee severance pay
funds
|
(2
|
)
|
(1
|
)
|
(6
|
)
|
(94
|
)
|
|||||
Deferred
tax asset
|
48
|
(48
|
)
|
—
|
—
|
||||||||
Changes
in operating assets and liabilities:
|
|||||||||||||
Decrease
(increase) in other receivables and prepaid expenses
|
(315
|
)
|
(178
|
)
|
418
|
(924
|
)
|
||||||
Increase
(decrease) in accounts payable and accrued expenses
|
892
|
910
|
(1,127
|
)
|
3,809
|
||||||||
Decrease
in deferred gain
|
(797
|
)
|
(400
|
)
|
(400
|
)
|
—
|
||||||
Net
cash used in operating activities
|
(21,457
|
)
|
(12,587
|
)
|
(10,466
|
)
|
(122,044
|
)
|
|||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||||||||
Decrease
(increase) in short-term bank deposits
|
10,245
|
(20,845
|
)
|
10,136
|
(10,600
|
)
|
|||||||
Decrease
(increase) in restricted deposits
|
113
|
(52
|
)
|
—
|
(52
|
)
|
|||||||
Investment
in investment securities
|
—
|
—
|
—
|
(3,363
|
)
|
||||||||
Proceeds
from sales of investment securities
|
—
|
—
|
—
|
3,773
|
|||||||||
Proceeds
from sales of trading securities
|
54
|
—
|
—
|
54
|
|||||||||
Employee
severance
pay funds
|
(17
|
)
|
(18
|
)
|
(50
|
)
|
(926
|
)
|
|||||
Purchase
of property and equipment
|
(65
|
)
|
(21
|
)
|
(38
|
)
|
(4,107
|
)
|
|||||
Proceeds
from disposals of property and equipment
|
308
|
103
|
27
|
560
|
|||||||||
Acquisition
in respect of license and purchase of assets
|
—
|
—
|
(548
|
)
|
(548
|
)
|
|||||||
Net
cash provided by (used in) investing activities
|
10,638
|
(20,833
|
)
|
9,527
|
(15,209
|
)
|
Period from
|
|||||||||||||
March 9, 1993 (a)
|
|||||||||||||
Year
ended December 31
|
to December 31,
|
||||||||||||
2007
|
2006
|
2005
|
2007
|
||||||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||||||||
Issuance
of share capital and warrants - net of share issuance
expenses
|
8,792
|
24,363
|
—
|
137,526
|
|||||||||
Exercise
of share warrants and stock options
|
4
|
97
|
1,511
|
2,104
|
|||||||||
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
|
8,796
|
24,460
|
1,511
|
139,630
|
|||||||||
NET
INCREASE (DECREASE) IN CASH AND
|
|||||||||||||
CASH
EQUIVALENTS
|
(2,023
|
)
|
(8,960
|
)
|
572
|
2,377
|
|||||||
BALANCE
OF CASH AND CASH EQUIVALENTS
|
|||||||||||||
AT
BEGINNING OF PERIOD
|
4,400
|
13,360
|
12,788
|
—
|
|||||||||
BALANCE
OF CASH AND CASH EQUIVALENTS
|
|||||||||||||
AT
END OF PERIOD
|
2,377
|
4,400
|
13,360
|
2,377
|
|||||||||
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, net of refunds
|
165
|
136
|
49
|
622
|
|||||||||
Interest
paid
|
4
|
—
|
—
|
354
|
(a) Incorporation
date, see Note 1a.
|
a. |
General
|
1) |
XTL
Biopharmaceuticals Ltd. (the “Company”) is
a biopharmaceutical company engaged in the acquisition and development
of
therapeutics for the treatment of unmet medical needs, particularly
diabetic neuropathic pain and hepatitis C. 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, 2007, the Company has incurred losses in an aggregate
amount
of US $139.9 million. Such losses have resulted from the Company’s
activities as a development stage company. Continuation of the
Company’s current operations and planned development activities after
utilizing its current cash reserves during 2009 is dependent upon
the
generation of additional financial resources either through agreements
for
the commercialization of its product portfolio or through external
financing.
|
3)
|
The
consolidated financial statements are prepared in accordance with
generally accepted accounting principles in the United States (“US
GAAP”).
|
4)
|
The
preparation of the financial statements, in conformity with US
GAAP,
requires management to make estimates and assumptions that affect
the
reported amounts of assets and liabilities and the disclosure of
contingent assets and liabilities, at the date of the financial
statements, and the reported expenses during the reporting periods.
Actual
results may vary from these
estimates.
|
b. |
Functional
currency
|
c. |
Principles
of consolidation
|
d. |
Impairment
of long-lived and intangible
assets
|
e. |
Cash
equivalents
|
f. |
Marketable
securities
|
g. |
Property
and equipment
|
%
|
|
Laboratory
equipment
|
10-20
|
(mainly
15)
|
|
Computers
|
33
|
Furniture
and office equipment
|
6-15
|
h.
|
Intangible
assets
|
i. |
Uncertainty
in income taxes
|
j. |
Deferred
income taxes
|
k.
|
Research
and development costs and
participations
|
l.
|
Revenue
recognition
|
m.
|
Business
development
costs
|
n. |
Loss
per share
|
o. |
Comprehensive
loss
|
p. |
Stock-
based compensation
|
Period from
March 9, 1993*
to December 31,
|
||||
($
in thousands except per share amounts)
|
2004
|
|||
Loss
for the period, as reported
|
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
|
6,355
|
|||
Loss
- pro-forma
|
91,648
|
q. |
Recently
issued accounting pronouncements in the United
States
|
a. |
License
Agreement with DOV Pharmaceutical,
Inc.
|
b. |
Transaction
Advisory Fee Structured in the Form of Stock Appreciation
Rights
|
(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
|
December
31
|
|||||||
2007
|
2006
|
||||||
($
in thousands)
|
|||||||
Deferred
revenue
|
—
|
907
|
|||||
Less
- Deferred expenses related to Yeda
|
—
|
110
|
|||||
Deferred
gain
|
—
|
797
|
a. |
Composition
of the assets, grouped by major classifications, is as
follows:
|
December
31
|
|||||||
2007
|
2006
|
||||||
($
in thousands)
|
|||||||
Property
and equipment
|
|||||||
Cost:
|
|||||||
Laboratory
equipment
|
119
|
1,281
|
|||||
Computers
|
220
|
227
|
|||||
Leasehold
improvements
|
141
|
572
|
|||||
Furniture
and office equipment
|
98
|
156
|
|||||
578
|
2,236
|
||||||
Accumulated
depreciation and amortization:
|
|||||||
Laboratory
equipment
|
115
|
895
|
|||||
Computers
|
172
|
202
|
|||||
Leasehold
improvements
|
141
|
572
|
|||||
Furniture
and office equipment
|
44
|
77
|
|||||
472
|
1,746
|
||||||
106
|
490
|
b.
|
The
Company had leased an aggregate of approximately 1,776 square meters
of
office and laboratory facilities in Rehovot, Israel, pursuant to
a lease
agreement that was set to expire in April 2007. On February 28,
2007, the
Company exercised an option to renew the lease and to downsize
the
facilities to 414 square meters of office space. Subsequent to
renewing
the lease in 2007, the Company determined to dispose of certain
unused
assets (primarily lab equipment). 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 “research and development costs” in the amount of $105,000 for
the year ended December 31, 2007.
|
c.
|
The
Company completed the disposition of its assets held for sale during
2007,
with $308,000 in proceeds from disposals of property and equipment
in
2007. As of December 31, 2007 and 2006, the Company’s unused assets
(primarily lab equipment) held for sale was $0 and $18,000,
respectively.
|
d.
|
Depreciation
totaled $94,000, $229,000 and $238,000 for the years ended December
31,
2007, 2006 and 2005, respectively.
|
a. |
The
Company
|
1) |
On
June 30, 2001, or subsequently on the date of employment, the Company
entered into an agreement with each of its Israeli employees 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 and XTL
Development
|
c. |
Severance
expenses
|
d. |
Cash
flow information regarding the Company’s liability for employee rights
upon retirement
|
1) |
For
the years ended December 31, 2007, 2006 and 2005, the Company contributed
to insurance companies, in respect of its severance obligations
to its
Israeli employees, $57,000, $82,000 and $166,000, respectively,
and
expects to contribute, in 2008, $33,000 to insurance companies
in respect
of its severance obligations to its Israeli
employees.
|
2) |
The
Company expects to pay $45,000 in future benefits to certain employees
who
will reach retirement during the years 2013-2017. As of December
31, 2007,
$35,000 of these future benefits have been funded by the Company
and are
included in “employee severance pay funds.” This
amount was determined based on each employee’s current salary and the
number of service years that will be accumulated upon each employee’s
retirement date. These amounts do not include amounts that might
be paid
to employees that will cease being employed by the Company prior
to the
normal retirement age.
|
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
|
|||||||||||||||||||
|
2007
|
2006
|
2005
|
||||||||||||||||
Number
|
Weighted
average
exercise
price
|
Number
|
Weighted
average
exercise
price
|
Number
|
Weighted
average
exercise
price
|
||||||||||||||
$
|
$
|
$
|
|||||||||||||||||
Balance
outstanding
at beginning of year
|
32,475,238
|
0.63
|
24,268,975
|
0.59
|
17,805,661
|
0.69
|
|||||||||||||
Changes
during the year:
|
|||||||||||||||||||
Granted1
|
9,620,000
|
0.36
|
11,740,000
|
0.70
|
11,370,000
|
0.36
|
|||||||||||||
Exercised2
|
(45,416
|
)
|
0.11
|
(277,238
|
)
|
0.35
|
(3,786,825
|
)
|
0.40
|
||||||||||
Cancelled
|
(9,250,000
|
)
|
0.35
|
—
|
—
|
—
|
—
|
||||||||||||
Reclassified3
|
—
|
—
|
(125,000
|
)
|
0.25
|
—
|
—
|
||||||||||||
Expired
|
(3,947,536
|
)
|
0.70
|
(2,074,505
|
)
|
0.60
|
(153,285
|
)
|
0.95
|
||||||||||
Forfeited
|
(417,339
|
)
|
0.60
|
(1,056,994
|
)
|
0.57
|
(966,576
|
)
|
0.39
|
||||||||||
Balance
outstanding
at year end4
|
28,434,947
|
0.62
|
32,475,238
|
0.63
|
24,268,975
|
0.59
|
|||||||||||||
Balance
exercisable
at year end4
|
12,477,311
|
0.72
|
14,145,370
|
0.72
|
16,262,310
|
0.70
|
1 |
In
2007, the exercise price of the options granted to employees
and directors
was greater than or equal to the share price on the grant date
(see (a)
and (c) below). In 2006, the exercise price of the options granted
to
employees and directors was greater than, equal to, or less than
the share
price on the grant date (see (b) and (c) below). In 2005, the
exercise
price of options granted to directors was equal to or less than
the share
price on the grant date (see (a) and (c) below).
|
2
|
The
total intrinsic value of options exercised during 2007, 2006
and 2005 was
$14,000, $167,000 and $1,521,000, respectively.
|
3
|
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.
|
4 |
The
aggregate intrinsic value as of December 31, 2007 is $27,000
for
outstanding options, and $25,000 for exercisable options.
|
Options
outstanding
|
Options
exercisable
|
||||||||||||||||||
Range
of
exercise
prices
|
Number
outstanding
|
Weighted-
average
remaining
contractual
life
(years)
|
Weighted-
average
exercise
price
|
Number
exercisable
|
Weighted-
average
remaining
contractual
life
(years)
|
Weighted-average
exercise
price
|
|||||||||||||
$0.100-$0.299
|
215,800
|
5.5
|
$
|
0.168
|
159,550
|
4.4
|
$
|
0.127
|
|||||||||||
$0.300-$0.399
|
11,640,000
|
2.8
|
$
|
0.359
|
3,760,000
|
2.6
|
$
|
0.359
|
|||||||||||
$0.400-$0.499
|
3,405,820
|
0.2
|
$
|
0.497
|
3,405,820
|
0.2
|
$
|
0.497
|
|||||||||||
$0.500-$0.699
|
3,207,661
|
8.3
|
$
|
0.600
|
845,161
|
7.9
|
$
|
0.600
|
|||||||||||
$0.700-$0.899
|
7,199,400
|
8.1
|
$
|
0.776
|
1,540,514
|
7.8
|
$
|
0.783
|
|||||||||||
$0.900-$1.100
|
1,491,266
|
0.9
|
$
|
1.007
|
1,491,266
|
0.9
|
$
|
1.007
|
|||||||||||
$2.110
|
1,275,000
|
2.7
|
$
|
2.110
|
1,275,000
|
2.7
|
$
|
2.110
|
|||||||||||
28,434,947
|
4.4
|
$
|
0.619
|
12,477,311
|
2.8
|
$
|
0.719
|
(a) |
In
December 2007, the
Company canceled 9,250,000 options that were granted to its Chairman
of
the Board (the “Chairman”) in August 2005, at an exercise price of $0.354
per share (the “Original Options”), and granted to the Chairman 9,250,000
options (the “New Options”) on the exact same remaining terms and
conditions as the Original Options (including the remainder of
the
exercise period of the Original Options), with the exception of
the
exercise price, which is equal to $0.36 per option (a price greater
than
the closing price on the date of grant of the New Options). Since
the
exercise price of the New Options are greater than the exercise
price of
the Original Options and were granted on the exact same remaining
terms
and conditions, in accordance with SFAS 123R, no incremental compensation
cost is recognized and the compensation cost continues to be recognized
according to the Original Options as described below. As of December
31,
2007, 3,083,333 options that were granted to the Chairman are vested
(the
first market condition milestone was reached and therefore 1/3
of the
options were vested).
|
(b) |
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 Company’s
ADRs on last
trading day prior to official appointment,
divided by ten;
closing price of the Company’s
ADRs on
grant date, divided by ten 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, 2007, 1,361,114 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
accelerated method.
|
(c) |
In
August 2007, the Company granted options to a non-executive director
to
purchase 20,000 ordinary shares, at an exercise price equal to
$0.204 per
ordinary share (a price equal to the closing price of the Company’s ADRs
on the grant date, divided by ten). The options are exercisable
for a
period of ten years from date of
grant.
|
(d) |
For
the years ended December 31, 2007, 2006 and 2005, non-cash compensation
relating to options granted to employees and directors was $1,934,000
(of
which $134,000 was charged to research and development costs, $1,778,000
was charged to general and administrative expenses and $22,000
was charged
to business development costs), $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), and $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),
respectively. The total compensation costs related to nonvested
awards not
recognized as of December 31, 2007 was $3,616,000, and the weighted
average period over which it is expected to be recognized is 2.1
years.
|
(e) |
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, at an exercise
price
of $0.713 per ordinary share. 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 and 2007, the Company did not seek shareholder approval,
so
the options have not been granted as of December 31,
2007.
|
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
|
|||||||||||||||||||
2007
|
2006
|
2005
|
|||||||||||||||||
Number
|
Weighted
average
exercise
price
|
Number
|
Weighted
average
exercise
price
|
Number
|
Weighted
average
exercise
price
|
||||||||||||||
$
|
$
|
$
|
|||||||||||||||||
Balance
outstanding at beginning of year
|
760,000
|
0.31
|
525,000
|
0.33
|
525,000
|
0.33
|
|||||||||||||
Changes
during the year:
|
|
||||||||||||||||||
Granted1
|
150,000
|
0.37
|
120,000
|
0.29
|
—
|
—
|
|||||||||||||
Reclassified2
|
—
|
—
|
125,000
|
0.25
|
—
|
—
|
|||||||||||||
Expired
|
—
|
—
|
(10,000
|
)
|
0.50
|
—
|
—
|
||||||||||||
Forfeited
|
(177,292
|
)
|
0.20
|
—
|
—
|
—
|
—
|
||||||||||||
Balance
outstanding at year end3
|
732,708
|
0.35
|
760,000
|
0.31
|
525,000
|
0.33
|
|||||||||||||
Balance
exercisable at year end3
|
507,708
|
0.35
|
448,334
|
0.36
|
355,000
|
0.39
|
1 |
The
options exercise price was equal to the share price on the grant
date.
|
2 |
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.
|
3 |
The
aggregate intrinsic value as of December 31, 2007 is $17,000 for
outstanding options, and $17,000 for exercisable
options.
|
Options outstanding
|
Options
exercisable
|
||||||||||||||||||
Range
of
exercise
prices
|
Number
outstanding
|
Weighted-
average
remaining
contractual
life
(years)
|
Weighted-
average
exercise
price
|
Number
exercisable
|
Weighted-
average
remaining
contractual
life
(years)
|
Weighted-average
exercise
price
|
|||||||||||||
0.100-0.299
|
367,708
|
2.8
|
$
|
0.239
|
292,708
|
1.2
|
$
|
0.227
|
|||||||||||
0.300-0.399
|
170,000
|
8.7
|
$
|
0.366
|
20,000
|
4.0
|
$
|
0.309
|
|||||||||||
0.500-0.699
|
195,000
|
4.0
|
$
|
0.538
|
195,000
|
4.0
|
$
|
0.538
|
|||||||||||
732,708
|
4.5
|
$
|
0.348
|
507,708
|
2.4
|
$
|
0.350
|
(a) |
The
Company used the Black & Scholes fair value option pricing model. The
following assumptions under this method on grant date were used
in 2007:
weighted
average expected volatility of 51%; weighted average risk-free
interest
rates (in dollar terms) of 4.5%, dividend yield of 0%, and weighted
average expected life of 3.0 years. The weighted average fair value
of
options granted during the year using the model was $0.14 per
option.
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 weighted
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.
|
(b) |
For
the years ended December 31, 2007, 2006 and 2005, non-cash compensation
relating to options granted to consultants were $13,000 (of which
$7,000
was charged to research and development costs, $6,000 was charged
to
general and administrative expenses and $0 was charged to business
development costs), $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),
and
$45,000 (all of which was charged to research and development costs),
respectively. The
total compensation costs related to nonvested awards not recognized
as of
December 31, 2007 was $11,000, and the weighted average period
over which
it is expected to be recognized is 1.4 years.
|
4) |
In
regards to the transaction advisory fee in the form of stock appreciation
rights see Note 2b.
|
a.
|
Royalty
and Contingent Milestone
Payments
|
1) |
The
Company has licensed the patent rights to its drug candidates from
others.
These license agreements require the Company to make contingent
milestone
payments to its licensors. In addition, under these agreements,
the
Company must pay royalties on sales of products resulting from
licensed
technologies.
|
2) |
On
December 31, 2007, the Company and Yeda mutually terminated the
Research
and License agreement dated April 7, 1993, as amended. As of December
31,
2007, and subject to certain closing conditions, all rights in
and to the
licensed technology and patents revert to Yeda (collectively the
“Yeda
Technology”).
|
3)
|
The
Company has provided for annual
grants, over the next year, 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 7(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 (see also Note 5).
|
2) |
The
Company leases vehicles under the terms of certain operating lease
agreements that expire in 2010, aggregating $43,000 ($20,000 in
2008,
$16,000 in 2009 and $7,000 in 2010). Vehicle lease expense for
the years
ended December 31, 2007, 2006 and 2005 were $15,000, $41,000 and
$76,000,
respectively.
|
c. |
Research
and development agreement
commitments
|
a. |
The
Company
|
Tax
rates in Israel applicable to income from other
sources
|
US
Federal Income Tax
Consequences
|
b.
|
The
Subsidiary and XTL
Development
|
c.
|
Current
tax losses for tax
purposes
|
1) |
Company
|
2) |
Subsidiary
and XTL Development
|
2007
|
2006
|
2005
|
|||||||||||||||||
($
in thousands)
|
($
in thousands)
|
($
in thousands)
|
|||||||||||||||||
Company
|
Subsidiaries1
|
Company
|
Subsidiaries1
|
Company
|
Subsidiaries1
|
||||||||||||||
Net
loss (income) before income taxes
|
10,354
|
14,791
|
15,363
|
(458
|
)
|
14,187
|
(250
|
)
|
|||||||||||
Income
taxes (benefit)
|
—
|
(206
|
)
|
—
|
227
|
—
|
78
|
||||||||||||
Net
loss (income) for the year
|
10,354
|
14,585
|
15,363
|
(231
|
)
|
14,187
|
(172
|
)
|
1 |
Subsidaries
include Subsidiary and XTL Development for the year ended December
31,
2007 and includes Subsidiary for the years ended December 31,
2006 and
2005.
|
|
2007
|
2006
|
2005
|
|||||||
Subsidiaries2
|
($
in thousands)
|
|||||||||
Income
taxes for the reported year:
|
||||||||||
Current
|
(254
|
)
|
275
|
78
|
||||||
Deferred
(in respect of the reporting period)
|
48
|
(48
|
)
|
—
|
||||||
(206
|
)
|
227
|
78
|
2 |
Subsidiaries
include Subsidiary and XTL Development for the year ended December
31,
2007 and includes Subsidiary for the years ended December 31,
2006 and
2005.
|
d.
|
Deferred
income taxes
|
December
31, 2007
|
December
31, 2006
|
||||||
($
in thousands)
|
|||||||
Deferred
tax assets:
|
|||||||
In
respect of tax loss carryforwards
|
38,003
|
28,801
|
|||||
Research
and development
|
2,206
|
2,902
|
|||||
Intangible
assets due to different amortization methods
|
2,890
|
247
|
|||||
Stock
appreciation rights compensation
|
624
|
—
|
|||||
Property
and equipment
|
63
|
19
|
|||||
Employee
related provisions
|
380
|
53
|
|||||
Other
temporary differences
|
3
|
726
|
|||||
Net
deferred tax asset, excluding valuation allowance
|
44,169
|
32,748
|
|||||
Less
valuation allowance
|
(44,169
|
)
|
(32,700
|
)
|
|||
Net
deferred tax assets
|
$
|
—
|
$
|
48
|
2007
|
2006
|
2005
|
||||||||
|
($
in thousands)
|
|||||||||
Balance
at the beginning of the year
|
32,700
|
25,239
|
23,584
|
|||||||
Change
during the year
|
11,469
|
7,461
|
1,655
|
|||||||
Balance
at end of year
|
44,169
|
32,700
|
25,239
|
e.
|
Reconciliation
of the theoretical tax expense to actual
expense
|
2007
|
2006
|
2005
|
||||||||
|
($
in thousands)
|
|||||||||
Loss
before income taxes as reported in the consolidated statement of
operations
|
25,145
|
14,905
|
13,937
|
|||||||
Computed
“expected” tax benefit
|
(7,292
|
)
|
(4,621
|
)
|
(4,739
|
)
|
||||
Increase
(decrease) in income taxes resulting from:
|
||||||||||
Change
in the balance of the valuation allowance for deferred tax assets
allocated to income tax expense (mainly in respect of carryforward
tax
losses)
|
11,469
|
7,461
|
1,655
|
|||||||
Permanent
differences
|
761
|
1,284
|
681
|
|||||||
Differences
in the basis of measurement for tax purposes (Israeli CPI) and
for
financial reporting purposes (dollar) and other
|
(4,404
|
)
|
(3,911
|
)
|
2,481
|
|||||
Effect
of foreign operations
|
(740
|
)
|
14
|
—
|
||||||
Income
taxes as reported
|
(206
|
)
|
227
|
78
|
f.
|
Tax
assessments
|
1)
|
Income
taxes
|
2)
|
Uncertain
tax positions
|
3)
|
Withholding
taxes
|
a. |
Short-term
bank deposits
|
b. |
Other
receivables and prepaid
expenses
|
December
31
|
|||||||
2007
|
2006
|
||||||
($
in thousands)
|
|||||||
Prepaid
expenses (research and development)
|
440
|
124
|
|||||
Prepaid
expenses (general and administrative)
|
113
|
134
|
|||||
Employees
|
—
|
118
|
|||||
Value
added tax authorities
|
21
|
8
|
|||||
Interest
receivable
|
61
|
318
|
|||||
Income
taxes receivable
|
270
|
—
|
|||||
Other
|
19
|
—
|
|||||
924
|
702
|
c. |
Accounts
payable and accrued
expenses
|
Suppliers
|
2,144
|
941
|
|||||
Accrued
expenses
|
1,116
|
1,190
|
|||||
Income
taxes
|
—
|
143
|
|||||
Accrued
compensation and related liabilities
|
549
|
729
|
|||||
3,809
|
3,003
|
d.
|
Financial
and other income - net
|
Year
ended December 31
|
March 9, 1993
to December 31,
|
||||||||||||
2007
|
2006
|
2005
|
2007
|
||||||||||
($
in thousands)
|
|||||||||||||
Interest
income
|
668
|
1,058
|
503
|
10,954
|
|||||||||
Interest
expense
|
(4
|
)
|
—
|
—
|
(378
|
)
|
|||||||
Foreign
exchange differences-gain (loss)
|
(10
|
)
|
2
|
(39
|
)
|
(1,765
|
)
|
||||||
Gain
(loss) from trading securities*
|
(48
|
)
|
2
|
—
|
(47
|
)
|
|||||||
Other
income*
|
—
|
100
|
—
|
100
|
|||||||||
Other
expense
|
(16
|
)
|
(21
|
)
|
(21
|
)
|
10
|
||||||
590
|
1,141
|
443
|
8,874
|
a.
|
Linkage
terms of balances in non-dollars
currency
|
1) |
As
follows:
|
December 31,
2007
|
|||||||
Israeli
currency
|
Other
|
||||||
|
|
|
Unlinked
|
|
|||
($
in thousands)
|
|||||||
Assets
|
144
|
5
|
|||||
Liabilities
|
313
|
50
|
2) |
Data
regarding the changes in the exchange rate of the dollar and the
Israeli
CPI:
|
Year
ended December 31
|
||||||||||
2007
|
2006
|
2005
|
||||||||
Devaluation
(evaluation) of the Israeli currency against the dollar
|
(8.97)%
|
|
(8.21)%
|
|
6.85%
|
|
||||
Changes
in the Israeli CPI
|
3.4%
|
|
(0.1)%
|
|
2.4%
|
|
||||
Exchange
rate of one dollar (at end of year)
|
NIS
3.846
|
NIS
4.225
|
NIS
4.603
|
b. |
Fair
value of financial
instruments
|
c. |
Concentration
of credit risks
|