o | REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
OR
|
||
x | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
For the fiscal year ended December 31, 2005 | ||
OR
|
||
o | TRANSITIONAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
Commission file number _________________________________________________________ |
316,556
American Depositary
Shares
|
173,180,441
Ordinary Shares
|
Large
accelerated filer £
|
Accelerated
filer £
|
Non-accelerated filer ý |
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
|
17
|
|
ITEM
5
|
Operating
and Financial Review and Prospects
|
31
|
|
ITEM
6
|
Directors,
Senior Management and Employees
|
43
|
|
ITEM
7
|
Major
Shareholders and Related Party Transactions
|
52
|
|
ITEM
8
|
Financial
Information
|
53
|
|
ITEM
9
|
The
Offer and Listing
|
54
|
|
ITEM
10
|
Additional
Information
|
55
|
|
ITEM
11
|
Quantitative
And Qualitative Disclosures About Market Risk
|
72
|
|
ITEM
12
|
Description
of Securities other than Equity Securities
|
72
|
|
PART
II
|
|||
ITEM
13
|
Defaults,
Dividend Arrearages and Delinquencies
|
73
|
|
ITEM
14
|
Material
Modifications to the Rights of Security Holders and Use of
Proceeds
|
73
|
|
ITEM
15
|
Controls
and Procedures
|
73
|
|
ITEM
16
|
Reserved
|
73
|
|
ITEM
16A
|
Audit
Committee Financial Expert
|
73
|
|
ITEM
16B
|
Code
of Ethics
|
73
|
|
ITEM
16C
|
Principal
Accountant Fees And Services
|
73
|
|
ITEM
16D
|
Exemptions
From The Listing Standards For Audit Committees
|
74
|
|
ITEM
16E
|
Purchases
Of Equity Securities By The Issuer And Affiliated
Purchasers
|
74
|
|
PART
III
|
|||
ITEM
17
|
Financial
Statements
|
75
|
|
ITEM
18
|
Financial
Statements
|
75
|
|
ITEM
19
|
Exhibits
|
75
|
|
SIGNATURES
|
77
|
Year
Ended December 31,
|
||||||||||||||||
2005
|
2004
|
2003
|
2002
|
2001
|
||||||||||||
(In
thousands, except per share amounts)
|
||||||||||||||||
Statements
of Operations Data:
|
||||||||||||||||
Revenues
|
|
|
|
|
|
|||||||||||
Reimbursed
out of pocket expenses
|
$
|
2,743
|
$
|
3,269
|
$
|
--
|
$
|
--
|
$
|
--
|
||||||
License
|
454
|
185
|
--
|
--
|
--
|
|||||||||||
3,197
|
3,454
|
--
|
--
|
--
|
||||||||||||
Cost
of Revenues
|
|
|
|
|
||||||||||||
Reimbursed
out of pocket expenses
|
2,743
|
3,269
|
--
|
--
|
--
|
|||||||||||
License
|
54
|
32
|
--
|
--
|
--
|
|||||||||||
2,797
|
3,301
|
--
|
--
|
--
|
||||||||||||
Gross
Margin
|
400
|
153
|
--
|
--
|
--
|
|||||||||||
|
|
|
|
|
|
|||||||||||
Research
and development
|
|
|
|
|
|
|||||||||||
Research
and development costs
|
7,313
|
11,985
|
14,022
|
13,231
|
12,187
|
|||||||||||
Less
participations
|
--
|
--
|
3,229
|
75
|
1,133
|
|||||||||||
|
7,313
|
11,985
|
10,793
|
13,156
|
11,054
|
|||||||||||
In-process
research and development
|
1,783
|
--
|
--
|
--
|
--
|
|||||||||||
General
and administrative
|
5,457
|
4,134
|
3,105
|
3,638
|
3,001
|
|||||||||||
Business
development costs
|
227
|
810
|
664
|
916
|
1,067
|
|||||||||||
|
|
|
|
|||||||||||||
Operating
loss
|
(14,380
|
)
|
(16,776
|
)
|
(14,562
|
)
|
(17,710
|
)
|
(15,122
|
)
|
||||||
|
|
|
||||||||||||||
Other
income (expense)
|
|
|
|
|
||||||||||||
Financial
income, net
|
443
|
352
|
352
|
597
|
2,448
|
|||||||||||
Taxes
on income
|
(78
|
)
|
(49
|
)
|
(78
|
)
|
(27
|
)
|
--
|
|||||||
|
|
|
|
|
||||||||||||
Net
loss
|
$
|
(14,015
|
)
|
$
|
(16,473
|
)
|
$
|
(14,288
|
)
|
$
|
(17,140
|
)
|
$
|
(12,674
|
)
|
|
|
|
|
||||||||||||||
Net
loss per ordinary share
|
|
|
||||||||||||||
Basic
and diluted
|
$
|
(0.08
|
)
|
$
|
(0.12
|
)
|
$
|
(0.13
|
)
|
$
|
(0.15
|
)
|
$
|
(0.11
|
)
|
|
Weighted
average shares outstanding
|
170,123,003
|
134,731,766
|
111,712,916
|
111,149,292
|
110,941,014
|
As
of December 31,
|
||||||||||||||||
2005
|
2004
|
2003
|
2002
|
2001
|
||||||||||||
(In
thousands, except per share
amounts)
|
Balance
Sheet Data:
|
||||||||||||||||
Cash,
cash equivalents, bank deposits and
marketable
securities
|
$
|
13,360
|
$
|
22,924
|
$
|
22,262
|
$
|
35,706
|
$
|
52,188
|
||||||
Working
capital
|
11,385
|
20,240
|
19,967
|
33,396
|
50,433
|
|||||||||||
Total
assets
|
15,151
|
25,624
|
24,853
|
38,423
|
55,106
|
|||||||||||
Long-term
obligations
|
1,493
|
2,489
|
1,244
|
1,017
|
526
|
|||||||||||
Total
shareholders’ equity
|
11,252
|
19,602
|
20,608
|
34,830
|
51,953
|
· |
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. IND-enabling GLP studies demonstrated that
XTL-2125
has favorable oral pharmacokinetics and a good safety profile in
multiple
animal species. In May 2006, we announced the initiation of a Phase
I,
placebo-controlled, dose escalation trial of XTL-2125 in chronic
HCV
patients. The compound was in-licensed by us from B&C Biopharm Co.,
Ltd., a Korean drug development company.
|
· |
XTL-6865
is
also being developed for the treatment of hepatitis C. XTL-6865 (formerly
known as the HepeX-C program) is a combination of two fully human
monoclonal antibodies (Ab68 and Ab65) against the hepatitis C virus
E2
envelope protein. The antibodies comprising XTL-6865 are expected
to
“trap” the virus in the patient’s serum and prevent the infection of
healthy liver cells. A single antibody version of this product was
tested
in a pilot clinical program that included both Phase I and Phase
II
clinical trials. In April 2005, we submitted an IND to the FDA in
order to
commence a Phase Ia/Ib clinical trial for XTL-6865, the dual-antibody
product. In September 2005, we announced the initiation of a Phase
Ia
clinical trial with XTL-6865 in patients with chronic hepatitis
C.
|
· |
DOS
is
a pre-clinical program focused on the development of novel hepatitis
C
small molecule inhibitors. Compounds developed to date inhibit HCV
replication in a pre-clinical cell-based assay with potencies comparable
to clinical stage drugs. These compounds are presently being optimized.
We
expect to identify the first clinical candidate from the Diversity
Oriented Synthesis, or DOS, program and start IND-enabling GLP-safety
studies with this clinical candidate in the second half of 2006.
|
· |
HepeX-B
is
being developed to prevent re-infection with hepatitis B, known as
HBV, in
liver transplant patients. HepeX-B is a mixture of two fully human
monoclonal antibodies, which bind to the HBV surface antigen, or
HBsAg. In
December 2005, data from the Phase IIb trial in liver transplant
patients
showed that patients treated with HepeX-B experienced no evidence
of viral
reinfection. Worldwide rights for HepeX-B were licensed to Cubist
in 2004,
in exchange for certain milestone payments and future royalties on
Cubist’s net sales. Cubist recently met with the FDA to discuss proposed
changes to the method of manufacture and formulation of HepeX-B.
Cubist is
expected to meet again with the FDA in the next few months to discuss
the
implications of these changes on the next stage of the clinical
program.
|
· |
continue
the clinical development of XTL-2125 and XTL-6865;
|
· |
identify
clinical candidates from our DOS program and advance them into clinical
development; and
|
· |
seek
to in-license or acquire additional
candidates.
|
·
|
A
Phase Ia/Ib Clinical Program in Patients with Chronic
HCV,
which
demonstrated the safety and tolerability of using single and multi-doses
of Ab68 up to 120mg for a 28 day dosing period. In terms of efficacy,
eight out of 25 patients had at least a 90% reduction in HCV-RNA
levels
from pre-treatment levels following administration of Ab68. These
trials
provided safety data, as well as a preliminary indication of anti-viral
activity in humans.
|
|
·
|
A
Phase IIa Clinical Trial with Ab68 Following Liver
Transplant,
which demonstrated the safety and tolerability of Ab68 up to 240mg
for a
12 week dosing period. The study was planned as a blinded,
placebo-controlled, dose-escalating study in a total of 24 liver
transplant patients receiving six different doses of Ab68 (20mg,
40mg,
80mg, 120mg, 240mg, and 480mg). Ab68 was administered once during
the
transplantation, then up to three times during the first 24 hours
following transplantation, then daily during the following six days,
and
then in decreasing frequency during the following eleven weeks. The
480mg
dose level was not tested due to a clinical hold as a result of an
intraoperative death of the first patient tested at the 480mg dose
level
(later determined by the medical examiner to be related to pulmonary
emboli (blood clots in the lung). The FDA later cleared the clinical
hold,
but we decided to discontinue the study and focus further development
efforts on the dual antibody product, XTL-6865. No other drug-related
serious adverse events were reported during this study.
|
|
|
During the period of daily dosing (the first seven days following the transplant), reduction in viral load from baseline were greater in the two highest dose groups (120 mg and 240 mg) compared to the placebo group. On day one following the transplant (when Ab68 was administered three times) the median reduction in viral load from baseline of the highest dose group (240mg) was 1-log (90%) greater than the placebo group. The 120mg and 240mg dose groups had a greater reduction in viral load than the placebo group during the first week when dosed daily. This effect was less evident when dosed less frequently than daily. This data provided additional evidence of anti-viral activity in immunosuppressed patients. It should be noted that the small number of patients in this pilot study did not allow us to draw statistical analysis. |
· |
to
generate humanized monoclonal antibodies, or hMAbs (the “Trimera hMAb
Technology”); and/or
|
· |
as
an animal model of human disease (the “Trimera Model Technology”).
|
· |
is
intended to treat a serious or life-threatening
condition;
|
· |
is
intended to treat a serious aspect of the condition;
and
|
· |
has
the potential to address unmet medical needs, and this potential
is being
evaluated in the planned drug development
program.
|
· |
Phase
I:
The drug is administered to a small group of humans, either healthy
volunteers or patients, to test for safety, dosage tolerance, absorption,
metabolism, excretion, and clinical pharmacology.
|
· |
Phase
II:
Studies are conducted on a larger number of patients to assess the
efficacy of the product, to ascertain dose tolerance and the optimal
dose
range, and to gather additional data relating to safety and potential
adverse events.
|
· |
Phase
III:
Studies establish safety and efficacy in an expanded patient population.
|
· |
Phase
IV:
The FDA may require a Phase IV to conduct post-marketing studies
for
purposes of gathering additional evidence of safety and
efficacy.
|
· |
slow
patient enrollment due to the nature of the clinical trial plan,
the
proximity of patients to clinical sites, the eligibility criteria
for
participation in the study or other
factors;
|
· |
inadequately
trained or insufficient personnel at the study site to assist in
overseeing and monitoring clinical trials or delays in approvals
from a
study site’s review board;
|
· |
longer
treatment time required to demonstrate efficacy or determine the
appropriate product dose;
|
· |
insufficient
supply of the drug candidates;
|
· |
adverse
medical events or side effects in treated patients;
and
|
· |
ineffectiveness
of the drug candidates.
|
Year
Ended December 31,
|
||||||||||||||||
2005
|
2004
|
2003
|
2002
|
2001
|
||||||||||||
(In
thousands, except per share
amounts)
|
Statements of
Operations Data:
|
||||||||||||||||
Revenues
|
|
|
|
|
|
|||||||||||
Reimbursed
out of pocket expenses
|
$
|
2,743
|
$
|
3,269
|
$
|
--
|
$
|
--
|
$
|
--
|
||||||
License
|
454
|
185
|
--
|
--
|
--
|
|||||||||||
3,197
|
3,454
|
--
|
--
|
--
|
||||||||||||
Cost
of Revenues
|
|
|
|
|
||||||||||||
Reimbursed
out of pocket expenses
|
2,743
|
3,269
|
--
|
--
|
--
|
|||||||||||
License
|
54
|
32
|
--
|
--
|
--
|
|||||||||||
2,797
|
3,301
|
--
|
--
|
--
|
||||||||||||
Gross
Margin
|
400
|
153
|
--
|
--
|
--
|
|||||||||||
|
|
|
|
|
|
|||||||||||
Research
and development
|
|
|
|
|
|
|||||||||||
Research
and development costs
|
7,313
|
11,985
|
14,022
|
13,231
|
12,187
|
|||||||||||
Less
participations
|
--
|
--
|
3,229
|
75
|
1,133
|
|||||||||||
|
7,313
|
11,985
|
10,793
|
13,156
|
11,054
|
|||||||||||
In-process
research and development
|
1,783
|
--
|
--
|
--
|
--
|
|||||||||||
General
and administrative
|
5,457
|
4,134
|
3,105
|
3,638
|
3,001
|
|||||||||||
Business
development costs
|
227
|
810
|
664
|
916
|
1,067
|
|||||||||||
|
|
|
|
|||||||||||||
Operating
loss
|
(14,380
|
)
|
(16,776
|
)
|
(14,562
|
)
|
(17,710
|
)
|
(15,122
|
)
|
||||||
|
|
|
||||||||||||||
Other
income (expense)
|
|
|
|
|
||||||||||||
Financial
income, net
|
443
|
352
|
352
|
597
|
2,448
|
|||||||||||
Taxes
on income
|
(78
|
)
|
(49
|
)
|
(78
|
)
|
(27
|
)
|
--
|
|||||||
|
|
|
|
|
||||||||||||
Net
loss
|
$
|
(14,015
|
)
|
$
|
(16,473
|
)
|
$
|
(14,288
|
)
|
$
|
(17,140
|
)
|
$
|
(12,674
|
)
|
|
|
|
|
||||||||||||||
Net
loss per ordinary share
|
|
|
||||||||||||||
Basic
and diluted
|
$
|
(0.08
|
)
|
$
|
(0.12
|
)
|
$
|
(0.13
|
)
|
$
|
(0.15
|
)
|
$
|
(0.11
|
)
|
|
Weighted
average shares outstanding
|
170,123,003
|
134,731,766
|
111,712,916
|
111,149,292
|
110,941,014
|
As
of December 31,
|
||||||||||||||||
2005
|
2004
|
2003
|
2002
|
2001
|
||||||||||||
(In
thousands, except per share
amounts)
|
Balance
Sheet Data:
|
||||||||||||||||
Cash,
cash equivalents, bank deposits and marketable securities
|
$
|
13,360
|
$
|
22,924
|
$
|
22,262
|
$
|
35,706
|
$
|
52,188
|
||||||
Working
capital
|
11,385
|
20,240
|
19,967
|
33,396
|
50,433
|
|||||||||||
Total
assets
|
15,151
|
25,624
|
24,853
|
38,423
|
55,106
|
|||||||||||
Long-term
obligations
|
1,493
|
2,489
|
1,244
|
1,017
|
526
|
|||||||||||
Total
shareholders’ equity
|
11,252
|
19,602
|
20,608
|
34,830
|
51,953
|
· |
the
timing of expenses associated with manufacturing and product development
of the proprietary drug candidates within our portfolio and those
that may
be in-licensed, partnered or acquired;
|
· |
our
ability to achieve our milestones under licensing
arrangements;
|
· |
the
timing of the in-licensing, partnering and acquisition of new product
opportunities; and
|
· |
the
costs involved in prosecuting and enforcing patent claims and other
intellectual property rights.
|
Payment
due by period
|
||||||||||||||||
Contractual
obligations
|
Total
|
Less
than
1
year
|
1-3
years
|
3-5
years
|
More
than
5
years
|
|||||||||||
Research
& development agreements
|
$
|
652,000
|
$
|
585,000
|
$
|
67,000
|
$
|
--
|
$
|
--
|
||||||
Operating
leases
|
2,067,000
|
720,000
|
921,000
|
426,000
|
--
|
|||||||||||
Total
|
$
|
2,719,000
|
$
|
1,305,000
|
$
|
988,000
|
$
|
426,000
|
$
|
--
|
Years
ended December 31,
|
|||||||||||||
2005
|
2004
|
2003
|
Cumulative,
as of December 31, 2005
|
||||||||||
XTL-2125
|
|||||||||||||
Research
and development costs
|
$
|
3,367,000
|
$
|
3,232,000
|
$
|
1,780,000
|
$
|
9,365,000
|
|||||
Less
participations
|
--
|
--
|
(168,000
|
)
|
(168,000
|
)
|
|||||||
3,367,000
|
3,232,000
|
1,612,000
|
9,197,000
|
||||||||||
XTL-6865
|
|||||||||||||
Research
and development costs
|
2,706,000
|
5,452,000
|
6,287,000
|
21,619,000
|
|||||||||
Less
participations
|
--
|
--
|
(1,459,000
|
)
|
(2,540,000
|
)
|
|||||||
2,706,000
|
5,452,000
|
4,828,000
|
19,079,000
|
||||||||||
HepeX-B1
|
|||||||||||||
Research
and development costs
|
2,743,000
|
6,570,000
|
4,036,000
|
26,985,000
|
|||||||||
Less
participations
|
(2,743,000
|
)
|
(3,269,000
|
)
|
(1,602,000
|
)
|
(10,173,000
|
)
|
|||||
|
--
|
3,301,000
|
2,434,000
|
16,812,000
|
|||||||||
Other
research and development programs2
|
|||||||||||||
Research
and development costs
|
1,240,000
|
--
|
1,919,000
|
30,933,000
|
|||||||||
Less
participations
|
--
|
--
|
--
|
(4,081,000
|
)
|
||||||||
1,240,000
|
--
|
1,919,000
|
26,852,000
|
||||||||||
Total
Research and development
|
|||||||||||||
Research
and development costs
|
10,056,000
|
15,254,000
|
14,022,000
|
88,902,000
|
|||||||||
Less
participations
|
(2,743,000
|
)
|
(3,269,000
|
)
|
(3,229,000
|
)
|
(16,962,000
|
)
|
|||||
7,313,000
|
11,985,000
|
10,793,000
|
71,940,000
|
Name
|
Age
|
Position
|
Michael
S. Weiss
|
40
|
Chairman
of the Board of Directors
|
William
J. Kennedy, Ph.D
|
61
|
Non
Executive Director
|
Ido
Seltenreich (1)
|
34
|
Non
Executive and External Director
|
Vered
Shany, D.M.D (1)
|
41
|
Non
Executive and External Director
|
Jonathan
R. Spicehandler, M.D
|
57
|
Non
Executive Director
|
Ben
Zion Weiner, Ph.D
(1)
|
62
|
Non
Executive Director
|
Ron
Bentsur
|
40
|
Chief
Executive Officer
|
Jonathan
Burgin (1)
|
44
|
Chief
Financial Officer
|
· |
first,
our audit committee reviews the proposal for
compensation;
|
· |
second,
provided that the audit committee approves the proposed compensation,
the
proposal is then submitted to our board of directors for review,
except
that a director who is the beneficiary of the proposed compensation
does
not participate in any discussion or voting with respect to such
proposal;
and
|
· |
finally,
if our board of directors approves the proposal, it must then submit
its
recommendation to our shareholders, which is usually done in connection
with our shareholders’ general
meeting.
|
· |
an
employment relationship;
|
· |
a
business or professional relationship maintained on a regular
basis;
|
· |
control;
and
|
· |
service
as an office holder, other than service as an officer for a period
of not
more than three months, during which the company first offered shares
to
the public.
|
· |
the
majority of shares voted at the meeting, including at least one-third
of
the shares held by non-controlling shareholders voted at the meeting,
vote
in favor of election of the director, with abstaining votes not being
counted in this vote; or
|
· |
the
total number of shares held by non-controlling shareholders voted
against
the election of the director does not exceed one percent of the aggregate
voting rights in the company.
|
Year
ended December 31,
|
||||||||||
2005
|
2004
|
2003
|
||||||||
Research
and Development
|
||||||||||
Israel
|
22
|
44
|
42
|
|||||||
U.S
|
19
|
8
|
5
|
|||||||
41
|
52
|
47
|
||||||||
Financial
and general management
|
||||||||||
Israel
|
4
|
7
|
6
|
|||||||
U.S
|
--
|
--
|
--
|
|||||||
4
|
7
|
6
|
||||||||
Business
development
|
||||||||||
Israel
|
--
|
--
|
--
|
|||||||
U.S
|
1
|
1
|
2
|
|||||||
1
|
1
|
2
|
||||||||
Total
|
46
|
60
|
55
|
|||||||
Average
number of full-time employees
|
54
|
58
|
68
|
Amount
and nature of beneficial ownership
|
|||||||||||||
|
Ordinary
shares
beneficially
owned
excluding
options
|
Options
exercisable
within
60 days
of
April
30,
2006
|
Total
ordinary
shares
beneficially
owned
|
Percent
of
ordinary
shares
beneficially
owned
(1)
|
|||||||||
Michael
S. Weiss
Chairman
of the Board
|
--
|
3,083,333
|
3,083,333
|
1.38
|
%
|
||||||||
William
Kennedy
Director
|
--
|
--
|
--
|
--
|
|||||||||
Jonathan
Spicehandler
Director
|
--
|
--
|
--
|
--
|
|||||||||
Ben
Zion Weiner
Director
|
--
|
666,667
|
666,667
|
0.30
|
%
|
||||||||
Ido
Seltenreich
Director
|
250,000
|
--
|
250,000
|
0.11
|
%
|
||||||||
Vered
Shany
Director
|
--
|
--
|
--
|
--
|
|||||||||
Ron
Bentsur
Chief
Executive Officer
|
--
|
--
|
--
|
--
|
|||||||||
Jonathan
Burgin
Chief
Financial Officer
|
20,000
|
1,382,053
|
1,402,053
|
0.63
|
%
|
||||||||
All
directors and executive officers as a group
(8 persons)
|
270,000
|
5,132,053
|
5,402,053
|
2.40
|
%
|
||||||||
|
|
Beneficial
owner
|
Number
of
ordinary
shares
beneficially
owned
(1)
|
Percent
of
ownership (1)
|
|||||
Bank
Julius Baer
|
15,219,644
|
8.8
|
%
|
||||
Perpetual
Income & Growth Investment Trust plc.
|
13,732,146
|
7.9
|
%
|
||||
British
Pence (p)
|
US
Dollar
|
||||||||||||
Last
Six Calendar Months
|
High
|
Low
|
High
|
Low
|
|||||||||
April
2006
|
40.75
|
36.25
|
0.74
|
0.65
|
|||||||||
March
2006
|
44.00
|
34.25
|
0.79
|
0.62
|
|||||||||
February
2006
|
40.25
|
35.25
|
0.73
|
0.64
|
|||||||||
January
2006
|
45.00
|
40.25
|
0.81
|
0.73
|
|||||||||
December
2005
|
48.25
|
42.00
|
0.87
|
0.76
|
|||||||||
November
2005
|
53.00
|
44.75
|
0.96
|
0.81
|
|||||||||
Financial
Quarters During the Past Two Full Fiscal Years
|
|||||||||||||
First
Quarter of 2006
|
45.00
|
34.25
|
0.81
|
0.62
|
|||||||||
Fourth
Quarter of 2005
|
53.00
|
42.00
|
0.96
|
0.76
|
|||||||||
Third
Quarter of 2005
|
61.75
|
38.00
|
1.11
|
0.69
|
|||||||||
Second
Quarter of 2005
|
40.50
|
36.00
|
0.73
|
0.65
|
|||||||||
First
Quarter of 2005
|
43.50
|
26.00
|
0.78
|
0.47
|
|||||||||
Fourth
Quarter of 2004
|
25.50
|
13.00
|
0.46
|
0.23
|
|||||||||
Third
Quarter of 2004
|
19.50
|
13.75
|
0.35
|
0.25
|
|||||||||
Second
Quarter of 2004
|
32.25
|
17.00
|
0.58
|
0.31
|
|||||||||
First
Quarter of 2004
|
27.25
|
16.25
|
0.49
|
0.29
|
|||||||||
Last
Five Full Financial Years
|
|||||||||||||
2005
|
61.75
|
26.00
|
1.11
|
0.47
|
|||||||||
2004
|
32.25
|
13.00
|
0.58
|
0.23
|
|||||||||
2003
|
18.75
|
5.75
|
0.34
|
0.10
|
|||||||||
2002
|
64.00
|
11.50
|
1.15
|
0.21
|
|||||||||
2001
|
153.00
|
33.50
|
2.76
|
0.60
|
|||||||||
New
Israeli Shekel
|
US
Dollar
|
||||||||||||
Last
Six Calendar Months
|
High
|
Low
|
High
|
Low
|
|||||||||
April
2006
|
3.37
|
3.02
|
0.75
|
0.67
|
|||||||||
March
2006
|
3.61
|
2.86
|
0.80
|
0.64
|
|||||||||
February
2006
|
3.35
|
2.93
|
0.74
|
0.65
|
|||||||||
January
2006
|
3.66
|
3.21
|
0.81
|
0.71
|
|||||||||
December
2005
|
3.94
|
3.44
|
0.87
|
0.76
|
|||||||||
November
2005
|
4.31
|
3.69
|
0.96
|
0.82
|
New
Israeli Shekel
|
US
Dollar
|
||||||||||||
High
|
Low
|
High
|
Low
|
||||||||||
Financial
Quarters Since Listing
|
|||||||||||||
First
Quarter of 2006
|
3.66
|
2.86
|
0.81
|
0.64
|
|||||||||
Fourth
Quarter of 2005
|
4.38
|
3.44
|
0.97
|
0.76
|
US
Dollar
|
|||||||
Last
Six Calendar Months
|
High
|
Low
|
|||||
April
2006
|
7.50
|
6.49
|
|||||
March
2006z
|
7.95
|
6.13
|
|||||
February
2006
|
7.23
|
6.39
|
|||||
January
2006
|
8.12
|
6.90
|
|||||
December
2005
|
8.84
|
7.10
|
|||||
November
2005
|
9.08
|
7.86
|
US
Dollar
|
|||||||
Financial
Quarters Since Listing
|
High
|
Low
|
|||||
First
Quarter of 2006
|
8.12
|
6.13
|
|||||
Fourth
Quarter of 2005
|
9.50
|
7.10
|
· |
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;
|
· |
subject
to specified limitations, depreciation deductions on fixed assets
and
losses carried forward are adjusted for inflation based on the increase
in
the consumer price index; and
|
· |
a
citizen or resident of the 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. Additional special rules
currently apply to taxpayers predominantly engaged in the active
conduct
of a banking, insurance, financing or similar business. Additionally,
if
we pay dividends at a time when 50% or more of our stock is owned
by 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, unless you elect to calculate
your
foreign tax credit separately with respect to XTLbio
dividends.
|
· |
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 30-day period beginning on the date which is 15 days before
the
ex-dividend date or 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 XTLbio dividends
in
determining your taxable income.
|
· |
Individuals
who do not claim itemized deductions, but instead utilize the standard
deduction, may not claim a deduction for the amount of the Israeli
income
taxes withheld.
|
· |
If
you are a 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 or value) and certain conditions are
met,
including that we were not a PFIC during the period you have held
our
ordinary shares.
|
· |
gain
recognized by the US holder upon the disposition of, as well as income
recognized upon receiving certain dividends on the ordinary shares
and/or
ADRs would be taxable as ordinary
income;
|
· |
the
US holder would be required to allocate such dividend income and/or
disposition gain ratably over such US holder's entire holding period
for
such XTLbio ordinary shares and/or
ADRs;
|
· |
the
amount allocated to each year other than the year of the dividend
payment
or disposition and pre-PFIC years would be subject to tax at the
highest
applicable tax rate, and an interest charge would be imposed with
respect
to the resulting tax liability;
|
· |
the
US holder would be required to file an annual return on IRS Form
8621
regarding distributions received on, gain recognized on dispositions
of,
our ordinary shares and/or ADRs;
and
|
· |
any
US holder who acquired the ordinary shares and/or ADRs upon the death
of
the shareholder would not receive a step-up to market value of his
income
tax basis for such ordinary shares and/or ADRs. Instead such 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 or, in the case of an individual, a fixed
place of
business, 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 sale and certain other conditions are
met.
|
2005
|
2004
|
||||||
(in
thousands)
|
|||||||
Audit
fees
|
$
|
161
|
$
|
81
|
|||
Audit-related
fees
|
74
|
121
|
|||||
Tax
fees
|
46
|
5
|
|||||
Total
|
$
|
281
|
$
|
207
|
Exhibit
Number
|
Description
|
|
1.1
|
Form
of Securities Purchase Agreement, dated March 17, 2006, by and among
XTL
Biopharmaceuticals Ltd., and the purchasers named
therein^
|
|
1.2
|
Form
of Registration Rights Agreement, dated March 22, 2006, by and among
XTL
Biopharmaceuticals Ltd. and the purchasers named
therein^
|
|
1.3
|
Form
of Ordinary Share Purchase Warrants, dated March 22, 2006, issued
to the
purchasers under the Securities Purchase Agreement^
|
|
1.4
|
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^
|
|
3.1
|
Articles
of Association†
|
|
4.1
|
Form
of Share Certificate†
|
|
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†
|
|
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
May 25, 2006.
|
|
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
May 25, 2006.
|
|
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 May 25, 2006.
|
XTL
BIOPHARMACEUTICALS LTD.
(Registrant)
|
||
|
|
|
Date: May 25, 2006 |
Signature:
|
/s/ Ron Bentsur |
Ron Bentsur |
||
Chief Executive Officer |
Page
|
|
Reports
of Independent Registered Public Accounting Firm
|
F-2
|
Consolidated
Balance Sheets as of December 31, 2005 and 2004
|
F-4
|
Consolidated
Statements of Operations for the years ended
|
|
December
31, 2005, 2004 and 2003, and the period from
|
|
March
9, 1993 to December 31, 2005
|
F-5
|
Consolidated
Statements of Changes in Shareholders’ Equity for
the
|
|
years
ended December 31, 2005, 2004, and 2003, and the period
from
|
|
March
9, 1993 to December 31, 2005
|
F-6
|
Consolidated
Statements of Cash Flows for the years ended
|
|
December
31, 2005, 2004 and 2003, and the period from March 9,
1993
|
|
to
December 31, 2005
|
F-10
|
Notes
to the Consolidated Financial Statements
|
F-12
|
December
31
|
|||||||
2005
|
2004
|
||||||
A
s s e t s
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and cash equivalents
|
13,360
|
12,788
|
|||||
Short-term
bank deposits
|
—
|
10,136
|
|||||
Accounts
receivable - trade
|
—
|
543
|
|||||
Accounts
receivable - other
|
431
|
306
|
|||||
T
o
t a l current assets
|
13,791
|
23,773
|
|||||
EMPLOYEE
SEVERANCE PAY FUNDS
|
449
|
830
|
|||||
RESTRICTED
LONG-TERM DEPOSIT
|
110
|
113
|
|||||
PROPERTY
AND EQUIPMENT, NET
|
762
|
908
|
|||||
INTANGIBLE
ASSETS, NET
|
39
|
—
|
|||||
T
o
t a l assets
|
15,151
|
25,624
|
|||||
Liabilities
and shareholders’ equity
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable and accruals
|
2,007
|
3,134
|
|||||
Deferred
gain
|
399
|
399
|
|||||
T
o
t a l current liabilities
|
2,406
|
3,533
|
|||||
LIABILITY
IN RESPECT OF EMPLOYEE
|
|||||||
SEVERANCE
OBLIGATIONS
|
695
|
1,291
|
|||||
DEFERRED
GAIN
|
798
|
1,198
|
|||||
COMMITMENTS
AND CONTINGENCIES (Note 7)
|
|||||||
T
o
t a l liabilities
|
3,899
|
6,022
|
|||||
SHAREHOLDERS’
EQUITY:
|
|||||||
Ordinary
shares of NIS 0.02 par value (authorized: 300,000,000
as
of December 31, 2005 and 2004; issued and outstanding:
173,180,441
as of December 31, 2005 and 168,079,196 as of
December
31, 2004)
|
864
|
841
|
|||||
Additional
paid in capital
|
110,179
|
104,537
|
|||||
Deficit
accumulated during the development stage
|
(99,791
|
)
|
(85,776
|
)
|
|||
T
o
t a l shareholders’ equity
|
11,252
|
19,602
|
|||||
T
o
t a l liabilities and shareholders’ equity
|
15,151
|
25,624
|
/s/
Michael Weiss
|
/s/
Ron Bentsur
|
|
Michael
Weiss
|
Ron
Bentsur
|
|
Chairman
of the Board of Directors
|
Chief
Executive Officer
|
|
Period
from
|
|||||||||||||
March
9, 1993*
|
|||||||||||||
Year
ended December 31
|
to
December 31,
|
||||||||||||
REVENUES:
|
2005
|
2004
|
2003
|
2005
|
|||||||||
Reimbursed
out-of-pockets expenses
|
2,743
|
3,269
|
—
|
6,012
|
|||||||||
License
|
454
|
185
|
—
|
639
|
|||||||||
3,197
|
3,454
|
—
|
6,651
|
||||||||||
COST
OF REVENUES:
|
|||||||||||||
Reimbursed
out-of-pockets expenses
|
2,743
|
3,269
|
—
|
6,012
|
|||||||||
License
(with respect to royalties)
|
54
|
32
|
—
|
86
|
|||||||||
2,797
|
3,301
|
—
|
6,098
|
||||||||||
GROSS
MARGIN
|
400
|
153
|
—
|
553
|
|||||||||
RESEARCH
AND DEVELOPMENT
|
|
||||||||||||
COSTS
(includes non-cash compensation
|
|||||||||||||
of
$112, $30 and $0, in 2005, 2004
|
|||||||||||||
and
2003, respectively)
|
7,313
|
11,985
|
14,022
|
82,890
|
|||||||||
L
E S S - PARTICIPATIONS
|
—
|
—
|
3,229
|
10,950
|
|||||||||
7,313
|
11,985
|
10,793
|
71,940
|
||||||||||
IN
- PROCESS RESEARCH AND
|
|||||||||||||
DEVELOPMENT
COSTS
|
1,783
|
—
|
—
|
1,783
|
|||||||||
GENERAL
AND ADMINISTRATIVE
|
|||||||||||||
EXPENSES
(includes non-cash
|
|||||||||||||
compensation
of $2,641, $2 and $0,
|
|||||||||||||
in
2005, 2004 and 2003, respectively)
|
5,457
|
4,134
|
3,105
|
29,012
|
|||||||||
BUSINESS
DEVELOPMENT COSTS
|
|||||||||||||
(includes
non-cash compensation of $10 in
|
|||||||||||||
2005,
and $0, in 2004 and 2003, respectively)
|
227
|
810
|
664
|
4,513
|
|||||||||
OPERATING
LOSS
|
14,380
|
16,776
|
14,562
|
106,695
|
|||||||||
FINANCIAL
INCOME -
net
|
443
|
352
|
352
|
7,143
|
|||||||||
LOSS
BEFORE INCOME TAXES
|
13,937
|
16,424
|
14,210
|
99,552
|
|||||||||
INCOME
TAXES
|
78
|
49
|
78
|
239
|
|||||||||
LOSS
FOR THE PERIOD
|
14,015
|
16,473
|
14,288
|
99,791
|
|||||||||
BASIC
AND DILUTED LOSS PER
|
|||||||||||||
ORDINARY
SHARE
|
$
|
0.08
|
$
|
0.12
|
$
|
0.13
|
|||||||
WEIGHTED
AVERAGE NUMBER OF
|
|||||||||||||
SHARES
USED IN COMPUTING BASIC
|
|||||||||||||
AND
DILUTED LOSS PER ORDINARY
|
|||||||||||||
SHARE
|
170,123,003
|
134,731,766
|
111,712,916
|
Preferred
shares
|
Ordinary
shares
|
Additional
|
||||||||||||||
Number
of
|
Number
of
|
paid-in
|
||||||||||||||
shares
|
Amount
|
shares
|
Amount
|
capital
|
||||||||||||
CHANGES
DURING THE PERIOD
|
||||||||||||||||
FROM
MARCH 9, 1993 (DATE OF
|
||||||||||||||||
INCORPORATION)
TO
DECEMBER
31, 2002 :
|
||||||||||||||||
Comprehensive
loss:
|
||||||||||||||||
Loss
for the period
|
—
|
—
|
—
|
—
|
—
|
|||||||||||
Net
unrealized loss
|
—
|
—
|
—
|
—
|
—
|
|||||||||||
Comprehensive
loss
|
—
|
—
|
—
|
—
|
—
|
|||||||||||
Employee
stock options expenses
|
—
|
—
|
—
|
—
|
377
|
|||||||||||
Non-employee
stock option expenses
|
—
|
—
|
—
|
—
|
106
|
|||||||||||
Exercise
of share warrants in 2000
|
—
|
—
|
1,499,980
|
7
|
340
|
|||||||||||
Exercise
of share warrants in 2001
|
—
|
—
|
208,000
|
1
|
74
|
|||||||||||
Exercise
of employee stock
options
in 1999
|
15,600
|
**
|
—
|
—
|
**
|
|||||||||||
Exercise
of employee stock
options
in 2000
|
—
|
—
|
162,500
|
1
|
—
|
|||||||||||
Exercise
of employee stock
options
in 2001
|
—
|
—
|
59,138
|
**
|
26
|
|||||||||||
Exercise
of employee stock
options
in 2002
|
—
|
—
|
38,326
|
**
|
20
|
|||||||||||
Issuance
of share capital in 1993 (net
of
$912 - issuance expenses)
|
7,705,470
|
45
|
—
|
—
|
5,545
|
|||||||||||
Issuance
of share capital in 1994 (net
of
$22 - issuance expenses)
|
717,500
|
5
|
—
|
—
|
2,103
|
|||||||||||
Issuance
of share capital in 1996 (net
of
$646 - issuance expenses)
|
6,315,810
|
49
|
—
|
—
|
5,314
|
|||||||||||
Issuance
of share capital in 1998 (net
of
$1,650 - issuance expenses)
|
26,319,130
|
139
|
—
|
—
|
12,036
|
|||||||||||
Issuance
of share capital in 1999 (net
of
$49 - issuance expenses)
|
2,513,940
|
12
|
—
|
—
|
1,189
|
|||||||||||
Issuance
of share capital in 2000
|
—
|
—
|
15,183,590
|
75
|
16,627
|
|||||||||||
Bonus
shares
|
7,156,660
|
41
|
19,519,720
|
97
|
(138
|
)
|
||||||||||
Conversion
of preferred shares into
ordinary
shares
|
(50,744,110
|
)
|
(291
|
)
|
50,744,110
|
291
|
—
|
|||||||||
Receipts
in respect of share warrants
|
||||||||||||||||
(expired
in 1999)
|
—
|
—
|
—
|
—
|
89
|
|||||||||||
Initial
public offering (“IPO”) of the
|
||||||||||||||||
Company’s
shares under a prospectus
|
||||||||||||||||
dated
September 20, 2000 (net of
|
||||||||||||||||
$ 5,199-issuance
expenses)
|
—
|
—
|
23,750,000
|
118
|
45,595
|
|||||||||||
BALANCE
AT DECEMBER 31, 2002
|
—
|
—
|
111,165,364
|
590
|
89,303
|
Deficit
|
||||||||||
Accumulated
|
accumulated
|
|||||||||
other
|
during
the
|
|||||||||
comprehensive
|
development
|
|||||||||
income
(loss)
|
stage
|
Total
|
||||||||
CHANGES
DURING THE PERIOD
|
||||||||||
FROM
MARCH 9, 1993 (DATE OF
|
||||||||||
INCORPORATION)
TO
DECEMBER
31, 2002 :
|
||||||||||
Comprehensive
loss:
|
||||||||||
Loss
for the period
|
—
|
(55,015
|
)
|
(55,015
|
)
|
|||||
Net
unrealized loss
|
(48
|
)
|
—
|
(48
|
)
|
|||||
Comprehensive
loss
|
(48
|
)
|
(55,015
|
)
|
(55,063
|
)
|
||||
Employee
stock options expenses
|
—
|
—
|
377
|
|||||||
Non-employee
stock option expenses
|
—
|
—
|
106
|
|||||||
Exercise
of share warrants in 2000
|
—
|
—
|
347
|
|||||||
Exercise
of share warrants in 2001
|
—
|
—
|
75
|
|||||||
Exercise
of employee stock
options
in 1999
|
—
|
—
|
**
|
|||||||
Exercise
of employee stock
options
in 2000
|
—
|
—
|
1
|
|||||||
Exercise
of employee stock
options
in 2001
|
—
|
26
|
||||||||
Exercise
of employee stock
options
in 2002
|
—
|
20
|
||||||||
Issuance
of share capital in 1993 (net
of
$912 - issuance expenses)
|
—
|
—
|
5,590
|
|||||||
Issuance
of share capital in 1994 (net
of
$22 - issuance expenses)
|
—
|
—
|
2,108
|
|||||||
Issuance
of share capital in 1996 (net
of
$646 - issuance expenses)
|
—
|
—
|
5,363
|
|||||||
Issuance
of share capital in 1998 (net
of
$1,650 - issuance expenses)
|
—
|
—
|
12,175
|
|||||||
Issuance
of share capital in 1999 (net
of
$49 - issuance expenses)
|
—
|
—
|
1,201
|
|||||||
Issuance
of share capital in 2000
|
—
|
—
|
16,702
|
|||||||
Bonus
shares
|
—
|
—
|
—
|
|||||||
Conversion
of preferred shares into
|
||||||||||
ordinary
shares
|
—
|
—
|
—
|
|||||||
Receipts
in respect of share warrants
|
||||||||||
(expired
in 1999)
|
—
|
—
|
89
|
|||||||
Initial
public offering (“IPO”) of the
|
||||||||||
Company’s
shares under a prospectus
|
||||||||||
dated
September 20, 2000 (net of
|
||||||||||
$ 5,199
-issuance expenses)
|
—
|
—
|
45,713
|
|||||||
BALANCE
AT DECEMBER 31, 2002
|
(48
|
)
|
(55,015
|
)
|
34,830
|
Ordinary
shares
|
Additional
|
|||||||||
Number
of
|
paid
in
|
|||||||||
shares
|
Amount
|
capital
|
||||||||
BALANCE
AT DECEMBER 31, 2002 -
brought
forward
|
111,165,364
|
590
|
89,303
|
|||||||
CHANGES
DURING 2003:
|
||||||||||
Comprehensive
loss:
|
||||||||||
Loss
for the period
|
—
|
—
|
—
|
|||||||
Net
unrealized gain
|
—
|
—
|
—
|
|||||||
Comprehensive
loss
|
—
|
—
|
—
|
|||||||
Exercise
of stock options
|
854,100
|
4
|
—
|
|||||||
BALANCE
AT DECEMBER 31, 2003
|
112,019,464
|
594
|
89,303
|
|||||||
CHANGES
DURING 2004:
|
||||||||||
Comprehensive
loss:
|
||||||||||
Net
loss
|
—
|
—
|
—
|
|||||||
Net
unrealized loss
|
—
|
—
|
—
|
|||||||
Comprehensive
loss
|
—
|
—
|
—
|
|||||||
Non-employee
stock option compensation expenses
|
—
|
—
|
32
|
|||||||
Exercise
of stock options
|
50,000
|
**
|
19
|
|||||||
Issuance
of shares, net of $2,426
share
issuance expenses
|
56,009,732
|
247
|
15,183
|
|||||||
BALANCE
AT DECEMBER 31, 2004
|
168,079,196
|
841
|
104,537
|
|||||||
CHANGES
DURING 2005:
|
||||||||||
Comprehensive
loss - loss for the period
|
— | — | — | |||||||
Non-employee
stock option compensation expenses
|
—
|
—
|
45
|
|||||||
Employee
stock option compensation expenses
|
—
|
—
|
2,718
|
|||||||
Exercise
of stock options
|
3,786,825
|
17
|
1,494
|
|||||||
Issuance
of ordinary shares in respect of license
|
||||||||||
and
purchases of assets (Note 3)
|
1,314,420
|
6
|
1,385
|
|||||||
BALANCE
AT DECEMBER 31, 2005
|
173,180,441
|
864
|
110,179
|
Deficit
|
||||||||||
Accumulated
|
accumulated
|
|||||||||
other
|
during
the
|
|||||||||
comprehensive
|
development
|
|||||||||
income
(loss)
|
stage
|
Total
|
||||||||
BALANCE
AT DECEMBER 31, 2002 -
|
||||||||||
brought
forward
|
(48
|
)
|
(55,015
|
)
|
34,830
|
|||||
CHANGES
DURING 2003:
|
||||||||||
Comprehensive
loss:
|
||||||||||
Loss
for the period
|
—
|
(14,288
|
)
|
(14,288
|
)
|
|||||
Net
unrealized gain
|
62
|
—
|
62
|
|||||||
Comprehensive
loss
|
62
|
(14,288
|
)
|
(14,226
|
)
|
|||||
Exercise
of stock options
|
—
|
—
|
4
|
|||||||
BALANCE
AT DECEMBER 31, 2003
|
14
|
(69,303
|
)
|
20,608
|
||||||
CHANGES
DURING 2004:
|
||||||||||
Comprehensive
loss:
|
||||||||||
Loss
for the period
|
—
|
(16,473
|
)
|
(16,473
|
)
|
|||||
Net
unrealized loss
|
(14
|
)
|
—
|
(14
|
)
|
|||||
Comprehensive
loss
|
(14
|
)
|
(16,473
|
)
|
(16,487
|
)
|
||||
Non-employee
stock option expenses
|
—
|
—
|
32
|
|||||||
Exercise
of stock options
|
—
|
—
|
19
|
|||||||
Issuance
of shares, net of $2,426
|
||||||||||
share
issuance expenses
|
—
|
—
|
15,430
|
|||||||
BALANCE
AT DECEMBER 31, 2004
|
—
|
(85,776
|
)
|
19,602
|
||||||
CHANGES
DURING 2005:
|
||||||||||
Comprehensive
loss - loss for the period
|
—
|
(14,015
|
)
|
(14,015
|
)
|
|||||
Non-employee
stock option compensation expenses
|
—
|
—
|
45
|
|||||||
Employee
stock option compensation expenses
|
—
|
—
|
2,718
|
|||||||
Exercise
of stock options
|
—
|
—
|
1,511
|
|||||||
Issuance
of ordinary shares in respect of license
|
||||||||||
and
purchases of assets (Note 3)
|
—
|
—
|
1,391
|
|||||||
BALANCE
AT DECEMBER 31, 2005
|
—
|
(99,791
|
)
|
11,252
|
Period
from
|
|||||||||||||
March
9, 1993 (a)
|
|||||||||||||
Year
ended December 31
|
to
December 31,
|
||||||||||||
2005
|
2004
|
2003
|
2005
|
||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||||||||
Loss
for the period
|
(14,015
|
)
|
(16,473
|
)
|
(14,288
|
)
|
(99,791
|
)
|
|||||
Adjustments
to reconcile loss to net cash used in operating
activities:
|
|||||||||||||
Depreciation
and amortization
|
242
|
319
|
440
|
2,829
|
|||||||||
Linkage
difference on restricted long-term deposits
|
3
|
—
|
—
|
3
|
|||||||||
Acquisition
of in process research and development
|
1,783
|
—
|
—
|
1,783
|
|||||||||
Loss
on disposal of property and equipment
|
6
|
1
|
2
|
18
|
|||||||||
Increase
(decrease) in liability in respect of employee severance
obligations
|
(159
|
)
|
30
|
129
|
1,228
|
||||||||
Impairment
charges
|
26
|
—
|
354
|
380
|
|||||||||
Loss
(gain) from sales of available for sale securities
|
—
|
13
|
(27
|
)
|
(410
|
)
|
|||||||
Stock
based compensation expenses (employee and non-employee)
|
2,763
|
32
|
—
|
3,278
|
|||||||||
Loss
(gain) on amounts funded in respect of employee severance pay
funds
|
(6
|
)
|
(4
|
)
|
5
|
(91
|
)
|
||||||
Changes
in operating assets and liabilities:
|
|||||||||||||
Decrease
(increase) in accounts receivable - trade
|
543
|
(543
|
)
|
—
|
—
|
||||||||
Decrease
(increase) in accounts receivable - other
|
(125
|
)
|
400
|
(440
|
)
|
(431
|
)
|
||||||
Increase
(decrease) in accounts payable and accruals
|
(1,127
|
)
|
133
|
499
|
2,007
|
||||||||
Increase
(decrease) in deferred gain
|
(400
|
)
|
1,597
|
—
|
1,197
|
||||||||
Net
cash used in operating activities
|
(10,466
|
)
|
(14,495
|
)
|
(13,326
|
)
|
(88,000
|
)
|
|||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||||||||
Decrease
in short-term deposits
|
10,136
|
7,193
|
14,724
|
—
|
|||||||||
Restricted
long-term deposits, net
|
—
|
46
|
(20
|
)
|
(113
|
)
|
|||||||
Investment
in available for sale securities
|
—
|
—
|
(71
|
)
|
(3,363
|
)
|
|||||||
Proceeds
from sales of available for sale securities
|
—
|
722
|
1,048
|
3,773
|
|||||||||
Employee
severance
pay funds
|
(50
|
)
|
(136
|
)
|
(112
|
)
|
(891
|
)
|
|||||
Purchase
of property and equipment
|
(38
|
)
|
(180
|
)
|
(81
|
)
|
(4,021
|
)
|
|||||
Proceeds
from disposals of property and equipment
|
27
|
5
|
2
|
149
|
|||||||||
Acquisition
in respect of license and purchase of assets
|
(548
|
)
|
—
|
—
|
(548
|
)
|
|||||||
Net
cash provided by (used in) investing activities
|
9,527
|
7,650
|
15,490
|
(5,014
|
)
|
Period
from
|
|||||||||||||
March
9, 1993 (a)
|
|||||||||||||
Year
ended December 31
|
to
December 31,
|
||||||||||||
2005
|
2004
|
2003
|
2005
|
||||||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||||||||
Issuance
of share capital - net of share issuance expenses
|
—
|
15,430
|
—
|
104,371
|
|||||||||
Exercise
of share warrants and stock options
|
1,511
|
19
|
4
|
2,003
|
|||||||||
Proceeds
from long-term debt
|
—
|
—
|
—
|
399
|
|||||||||
Proceeds
from short-term debt
|
—
|
—
|
—
|
50
|
|||||||||
Repayment
of long-term debt
|
—
|
—
|
—
|
(399
|
)
|
||||||||
Repayment
of short-term debt
|
—
|
—
|
—
|
(50
|
)
|
||||||||
Net
cash provided by financing activities
|
1,511
|
15,449
|
4
|
106,374
|
|||||||||
NET
INCREASE (DECREASE) IN CASH AND
|
|||||||||||||
CASH
EQUIVALENTS
|
572
|
8,604
|
2,168
|
13,360
|
|||||||||
BALANCE
OF CASH AND CASH EQUIVALENTS AT BEGINNING
OF PERIOD
|
12,788
|
4,184
|
2,016
|
—
|
|||||||||
BALANCE
OF CASH AND CASH EQUIVALENTS AT END OF
PERIOD
|
13,360
|
12,788
|
4,184
|
13,360
|
|||||||||
Supplementary
information on investing and financing
activities not involving cash flows:
|
|||||||||||||
Issuance
of ordinary shares in respect of license,
and purchase of assets
|
1,391
|
—
|
—
|
1,391
|
|||||||||
Conversion
of convertible subordinated debenture into shares
|
—
|
—
|
—
|
1,700
|
|||||||||
Supplemental
disclosures of cash flow information:
|
|||||||||||||
Income
taxes paid (mainly - tax advance in respect of excess
expenses)
|
49
|
107
|
161
|
321
|
|||||||||
Interest
paid
|
—
|
—
|
—
|
350
|
|||||||||
(a) Incorporation
date, see note 1a.
|
1)
|
XTL
Biopharmaceuticals Ltd. (“the Company”) was incorporated under the Israel
Companies Ordinance on March 9, 1993. The Company is a development
stage
company in accordance with Financial Accounting Standard (“FAS”) 7
“Accounting and Reporting by Development Stage Enterprises.”
The
Company is a biopharmaceutical company engaged in the acquisition,
development and commercialization of pharmaceutical products
for the
treatment of infectious diseases, particularly the prevention
and
treatment of hepatitis B and C.
The
Company licensed its product candidate HepeX-B to Cubist Pharmaceuticals,
Inc. (hereinafter “Cubist”) during 2004, see Notes 1k and 2 as to details
of the agreement.
During
September 2005, the Company licensed perpetually from VivoQuest
Inc.
(“VivoQuest”), a US privately-held company which is a development stage
enterprise, exclusive worldwide rights to VivoQuest’s intellectual
property and technology, covering a proprietary compound library,
including VivoQuest’s lead hepatitis C compounds. In addition, the Company
also acquired from VivoQuest certain assets, see Note 3.
The
Company has a wholly-owned subsidiary in the United States,
XTL
Biopharmaceuticals Inc. (“Subsidiary”), which was incorporated in 1999
under the law of the State of Delaware. The Subsidiary is primarily
engaged in development activities and business
development.
|
2)
|
The
consolidated financial statements of the Company are presented
on a going
concern basis, which contemplates the realization of assets and
satisfaction of liabilities in the normal course of business. The
Company
has experienced a significant loss from operations. For the year
ended
December 31, 2005, the Company incurred a net loss of $14 million
and had
an accumulated deficit of $100 million. These matters raise substantial
doubt about the Company’s ability to continue as a going concern.
The
Company’s ability to continue as a going concern will depend upon its
ability to raise additional capital in the short term. The Company
is
actively pursuing raising additional capital to fund its operations
although there is no assurance that such capital will be available
to the
Company. Failure to secure additional capital or to expand its
revenue
base would result in the Company depleting its available funds
and not
being able to pay its obligations when they become due. The accompanying
consolidated financial statements do not include any adjustments
to
reflect the possible future effects on the recoverability and
classification of assets or the amounts and
classification of liabilities that may result from the possible
inability
of the Company to continue as a going
concern.
|
3)
|
The
consolidated financial statements are prepared in accordance with
generally accepted accounting principles in the United States (“US
GAAP”).
|
4)
|
The
preparation of the financial statements, in conformity with US
GAAP,
requires management to make estimates and assumptions that affect
the
reported amounts of assets and liabilities and the disclosure of
contingent assets and liabilities, at the date of the financial
statements, and the reported expenses during the reporting periods.
Actual
results may vary from these
estimates.
|
%
|
|
Laboratory
equipment
|
10-20
|
(mainly
15)
|
|
Computers
|
33
|
Furniture
and office equipment
|
6-15
|
Using
previous
accounting
|
Impact
of the adoption of
FAS
123R
|
As
reported
|
|
Loss for the year |
12,130
|
1,885
|
14,015
|
Basic and diluted loss per ordinary share |
(0.07)
|
(0.08)
|
Period
from
|
||||||||||
March
9, 1993*
|
||||||||||
Year
ended December 31
|
to
December 31,
|
|||||||||
2004
|
2003
|
2004
|
||||||||
($
in thousands except per share amounts)
|
||||||||||
Loss
for the period, as reported
|
16,473
|
14,288
|
85,776
|
|||||||
Deduct:
stock- based employee
|
||||||||||
compensation
expense,
|
||||||||||
included
in reported loss
|
—
|
—
|
(483
|
)
|
||||||
Add:
stock-based employee
|
||||||||||
compensation
expense
|
||||||||||
determined
under fair value
|
||||||||||
method
for all awards
|
239
|
821
|
6,355
|
|||||||
Loss
- pro-forma
|
16,712
|
15,109
|
91,648
|
Basic
and diluted loss per share:
|
||||||||||
As
reported
|
0.12
|
0.13
|
||||||||
Pro-forma
|
0.12
|
0.14
|
December
31,
|
|||||||
2005
|
2004
|
||||||
($
in thousands)
|
|||||||
Deferred
revenue
|
1,361
|
1,815
|
|||||
Less
- Deferred expenses related to Yeda
|
164
|
218
|
|||||
Deferred
gain
|
1,197
|
1,597
|
(1) |
the
Company issued the fair value equivalent of $1,391,000 of its ordinary
shares for a total of 1,314,420 ordinary shares (calculated based
upon the
average of the closing prices per share for the period commencing
two days
before, and ending two days after the closing of the transaction),
made
cash payments of approximately $400,000 to cover VivoQuest’s operating
expenses prior to the closing of the Transaction, and incurred
$148,000 in
direct expenses associated with the
Transaction;
|
(2) |
the
Company agreed to make additional contingent milestone payments
triggered
by certain regulatory and sales targets, totaling up to $34.6 million,
$25.0 million of which will be due upon or following regulatory
approval
or actual product sales, and are payable in cash or ordinary shares
at the
Company’s election. No contingent consideration has been paid pursuant
to
the license agreement as of the balance sheet date, because none
of the
milestones have been achieved. The contingent consideration will
be
recorded as part of the acquisition costs in the future; and
|
(3) |
the
Company agreed to make royalty payments on future product
sales.
|
($
in thousands)
|
||||
Fair
value of the Company’s ordinary shares
|
1,391
|
|||
Cash
consideration paid
|
400
|
|||
Direct
expenses associated with the Transaction
|
148
|
|||
Total
purchase price
|
1,939
|
|||
($
in thousands)
|
||||
Tangible
assets acquired - property and equipment
|
113
|
|||
Intangible
assets acquired:
|
||||
In-process
research and development
|
1,783
|
|||
Assembled
workforce
|
43
|
|||
Total
intangible assets acquired
|
1,826
|
|||
Total
tangible and intangible assets acquired
|
1,939
|
a.
|
Composition
of the assets, grouped by major classifications, is as
follows:
|
December
31
|
|||||||
2005
|
2004
|
||||||
($
in thousands)
|
|||||||
Property
and equipment
|
|||||||
Cost:
|
|||||||
Laboratory
equipment
|
1,960
|
1,828
|
|||||
Computers
|
232
|
517
|
|||||
Leasehold
improvements
|
698
|
698
|
|||||
Furniture
and office equipment
|
238
|
269
|
|||||
3,128
|
3,312
|
||||||
Accumulated
depreciation and amortization:
|
|||||||
Laboratory
equipment
|
1,333
|
1,120
|
|||||
Computers
|
217
|
488
|
|||||
Leasehold
improvements
|
697
|
691
|
|||||
Furniture
and office equipment
|
119
|
105
|
|||||
2,366
|
2,404
|
||||||
762
|
908
|
b.
|
Under
the provisions of FAS 144, the Company’s management reviewed the carrying
value of certain laboratory equipment, and recorded an impairment
charge
in an amount of $ 26,000 in 2005. See Note 9.
During
2003, the Company’s management determined to put on hold early-stage
research activities, and consequently, to sell an asset used in
one of
these activities. Under the provisions of FAS 144, the Company’s
management reviewed the carrying value of this asset (original
cost
$ 415,000, depreciated amount - $ 354,000) and determined to
write it off. An impairment charge in an amount of $ 354,000 was
recorded.
|
c.
|
Depreciation
totaled $ 238,000, $ 319,000 and $ 440,000 for the years ended
December
31, 2005, 2004 and 2003,
respectively.
|
a. |
The
Company
|
1) |
On
June 30, 2001, the Company entered into an agreement with each
employee
implementing Section 14 of the Severance Compensation Act, 1963
(the
“Law”) and the General Approval of the Labor Minister issued in accordance
to the said Section 14, mandating that upon termination of such
employee’s
employment, the Company shall release to the employee all the amounts
accrued in its insurance policies. Accordingly, the Company remits
each
month to each of its employee’s insurance policy, the amounts required by
the law to cover the severance pay liability.
The
employee severance obligations covered by these contribution plans
are not
reflected in the financial statements, as the severance payment
obligation
has been irrevocably transferred to the severance
funds.
|
2) |
Insurance
policies for certain employees (senior managers): the policies
provide
most of the coverage for severance pay and pension liabilities
of
managerial personnel, the remainder of the liabilities are covered
by the
Company.
The
Company has recorded an employee severance obligation for the
amount that
would be paid if all those employees were dismissed at the balance
sheet
date, on an undiscounted basis, in accordance with Israeli labor
law. This
liability is computed based upon the number of years of service
multiplied
by the latest monthly salary. The amount of accrued severance
represents
the Company’s severance obligation in accordance with labor agreements in
force and based on salary components, which in management’s opinion,
create an entitlement to severance.
The
Company may only utilize the severance pay funds in the insurance
policies
for the purpose of disbursement of
severance.
|
b. |
The
Subsidiary
The
Subsidiary’s severance obligation is calculated based on the employment
agreements between the Subsidiary and its employees.
|
c. |
Severance
expenses
Severance
expenses (income) totaled $ (159,000), $ 30,000 and $ 129,000
for the
years ended December 31, 2005, 2004 and 2003, respectively.
Loss
(gain) on employee severance pay funds in respect of employee
severance
obligations totaled $(6,000), $(4,000), and $5,000 for the
years ended
December 31, 2005, 2004 and 2003, respectively.
|
d.
|
Cash
flow information regarding the Company’s liability for employee rights
upon retirement:
|
1) |
The
Company contributed in 2005, 2004 and 2003 to the insurance companies,
in
respect to its severance obligations to Israeli employees, $166,000,
$276,000 and $348,000, respectively, and expects to contribute,
in 2006, $
90,000 to the insurance companies in respect to its severance obligations
to Israeli employees.
|
2) |
The
Company expects to pay future benefits to certain employees who
will reach
retirement, as follows:
|
($
in thousands)
|
|
2010
|
9
|
2011-2015
|
59
|
68
|
a.
|
Share
Capital
As
of December 31, 2005, the Company’s ordinary shares are traded on the
London Stock Exchange (“LSE”) and on the Tel Aviv Stock Exchange (“TASE”).
The closing price per share, as of December 31, 2005 was 45p
on the LSE
($0.78) and NIS 3.64 on the TASE ($0.79). In addition, the
Company’s
ADRs
trade on the Nasdaq National Market, with each ADR representing
ten
ordinary shares. The closing price of the Company’s ADRs, as of December
31, 2005, was $7.74
On
September 20, 2000 the Company completed an IPO, as result
of which
20,900,000 ordinary shares of NIS 0.02 each have been issued.
The proceeds
of the issuance of shares in the amount of ₤ 31.3 million (before
deduction of share issue expenses) were received as $ 44.7
million. The
underwriters of the IPO were granted an over-allotment option.
Accordingly, on October 26, 2000, the Company issued 2,850,000
Ordinary
Shares of NIS 0.02 for a consideration of $ 6.2 million (before
deduction
of share issue expenses) at the price of ₤ 1.5 per share or $2.1 per share
(the IPO price) to meet over-allotments in connection with
the
placing.
On
August 2, 2004, the Company completed a Placing and Open Offer
for new
ordinary shares, as result of which 56,009,732 Ordinary shares
of NIS 0.02
each have been issued. The gross proceeds of the issuance of
shares
amounted to ₤9.8 million - $17.8 million (approximately ₤8.5 million -
$15.4 million, net of issuance costs).
On
September 21, 2005, the Company issued to VivoQuest Inc. the
fair value
equivalent of $1,391,000 of its ordinary shares for a total
of 1,314,420
ordinary shares (see Note 3).
|
b.
|
Stock
Option Plans:
|
1)
|
The
Company maintains the following share option plans for its employees,
directors and consultants.
The
Company’s board of directors administers its share option plans and has
the authority to designate all terms of the options granted under
the
Company’s plans including the grantees, exercise prices, grant dates,
vesting schedules and expiration dates, which may be no more
than ten
years after the grant date.
As
of December 31, 2005, the Company has granted to employees, directors
and
consultants options that are outstanding to purchase up to 24,793,975
ordinary shares, under the five share option plans discussed
below and
pursuant to certain grants apart from these plans also discussed
below.
|
(a)
|
1998
Share Option Plan
Under
a share option plan established in 1998, (“the 1998 Plan”), the Company
granted options to employees during 1998, which are held by a trustee
under section 3(i) of the Israeli tax ordinance, of which 3,884,810
are
outstanding and exercisable as of December 31, 2005 at an exercise
price
per share of $0.497.
The
option term is for a period of 10 years from grant date. If the
options
are not exercised and the shares not paid for by such date, all
interests
and rights of any grantee shall expire. These options were granted
for no
consideration. There are no options available for grant from this
plan.
|
(b)
|
1999
Share Option Plan
Under
a share option plan established in 1999, (“the 1999 Plan”), the Company
granted options to employees during 1999, which are held by a trustee
under section 3(i) of the Tax Ordinance, of which 955,920 are outstanding
and exercisable as of December 31, 2005, at an exercise price of
$0.497.
The
option term is for a period of 10 years from grant date. If the
options
are not exercised and the shares not paid for by such date, all
interests
and rights of any grantee shall expire. These options were granted
for no
consideration. There are no options available for grant from this
plan.
|
(c)
|
1999
International Share Option Plan
Under
an international share option plan established in 1999, (“the
International Plan”), the Company granted options to employees during 1999
and 2000, of which 1,380,000 are outstanding and exercisable as
of
December 31, 2005, at an exercise price between $0.497 and $1.10.
|
|
The
options granted thereunder are outstanding and exercisable until
October
2007. If the options are not exercised and the shares are not
paid for by
such date, all interests and rights of any grantee shall expire.
These
options were granted for no consideration. There are no options
available
for grant from this plan.
|
(d)
|
2000
Share Option Plan
Under
a share option plan established in 2000, (“the 2000 Plan”), the Company
granted options to employees during 2000, which are held by
a trustee
under section 3(i) of the Tax Ordinance, of which 855,300 are
outstanding
and exercisable as of December 31, 2005, at an exercise price
of $1.10.
The
option term is for a period of 10 years from grant date. If
the options
are not exercised and the shares not paid for by such date,
all interests
and rights of any grantee shall expire. These options were
granted for no
consideration. There are no options available for grant from
this plan.
|
(e)
|
2001
Share Option Plan
Under
a share option plan established in 2001, (“the 2001 Plan”), the Company
granted options to employees during
2001-2004,
including directors, according to which up to 11,000,000 options
were
available to be granted, of which 2,703,485 are outstanding
as of December
31, 2005, at an exercise price per share between $0.106 and
$0.931.
These
options were granted in accordance with section 102 of the
Tax Ordinance,
under the capital gains option set out in section 102(b)(2)
of the
ordinance.
The
option term is for a period of 10 years from grant date.
The options were granted for no consideration. The options
vest over a
four year period, with vesting occurring on the 2nd, 3rd and
4th
anniversary from the grant date, and in addition, the lock
up period of
the options is for two years from the date of grant. Compensation
expenses
are calculated based on the straight line method. As of December
31, 2005,
2,316,820 options are fully vested. As of December 31, 2005,
the remaining
number of options available for future grants in this pool
is 7,919,960.
|
(f)
|
Non-Plan
Share Options
In
addition to the options granted under the Company’s share option plans,
there are 15,014,460 outstanding options, and 7,224,460 exercisable
options, as of December 31, 2005, which were granted by the
Company to
employees, directors and consultants not under an option plan
during
1997-2005.
The options were granted at an exercise price per share between
$0.20 and
$2.11. The options expire between 2007 and 2015. The options
which were
granted during 2005, are from the Non-Plan
Share Options, see 2(a) and 2(b) below for the term of the
options.
|
2)
|
The
following table summarizes options granted to employees and directors
under the Company's stock option plans, as discussed
above:
|
Year
ended December 31
|
|||||||||||||||||||
2005
|
2004
|
2003
|
|||||||||||||||||
Weighted
|
Weighted
|
Weighted
|
|||||||||||||||||
Average
|
average
|
average
|
|||||||||||||||||
Number
|
exercise
price
|
Number
|
exercise
price
|
Number
|
exercise
price
|
||||||||||||||
$
|
$
|
$
|
|||||||||||||||||
Balance
outstanding at
|
|||||||||||||||||||
beginning
of year
|
17,805,661
|
0.69
|
17,552,661
|
0.69
|
19,891,823
|
0.71
|
|||||||||||||
Changes
during the year:
|
|||||||||||||||||||
Granted
*
|
11,370,000
|
0.36
|
432,000
|
0.33
|
824,900
|
0.13
|
|||||||||||||
Exercised
**
|
(3,786,825
|
)
|
0.40
|
(50,000
|
)
|
0.37
|
(854,100
|
)
|
0.01
|
||||||||||
Expired
and forfeited
|
(1,119,861
|
)
|
0.47
|
(129,000
|
)
|
0.68
|
(2,309,962
|
)
|
0.87
|
||||||||||
Balance
outstanding at
|
|||||||||||||||||||
end
of year***
|
24,268,975
|
0.59
|
17,805,661
|
0.69
|
17,552,661
|
0.69
|
|||||||||||||
Balance
exercisable at end
|
|||||||||||||||||||
of
year***
|
16,262,310
|
0.70
|
16,051,324
|
0.72
|
11,924,323
|
0.63
|
|
The
following table summarizes information about stock options granted
to
employees and directors outstanding and exercisable at December 31,
2005:
|
Options
outstanding
|
Options
exercisable
|
||||||||||||
Weighted
|
Weighted
|
||||||||||||
average
|
average
|
||||||||||||
Balance
at
|
remaining
|
|
Balance
at
|
remaining
|
|||||||||
December 31,
|
|
contractual
|
|
December 31,
|
contractual
|
||||||||
2005
|
life
|
2005
|
life
|
||||||||||
Number
|
In
years
|
Number
|
In
years
|
||||||||||
Exercise
prices:
|
|||||||||||||
$
0.106
|
355,523
|
6.4
|
102,658
|
4.4
|
|||||||||
$
0.250
|
125,000
|
7.7
|
41,667
|
7.7
|
|||||||||
$
0.315
|
6,200
|
1.0
|
6,200
|
1.0
|
|||||||||
$
0.354
|
11,250,000
|
4.6
|
3,750,000
|
4.6
|
|||||||||
$
0.365
|
1,045,120
|
1.1
|
1,045,120
|
1.1
|
|||||||||
$
0.482
|
19,600
|
4.2
|
15,600
|
3.5
|
|||||||||
$
0.486
|
9,900
|
0.6
|
9,900
|
0.6
|
|||||||||
$
0.497
|
6,180,070
|
2.5
|
6,180,070
|
2.5
|
|||||||||
$
0.766
|
108,800
|
5.1
|
108,800
|
5.1
|
|||||||||
$
0.851
|
150,200
|
5.8
|
103,733
|
5.6
|
|||||||||
$
0.853
|
120,000
|
9.6
|
—
|
—
|
|||||||||
$
0.931
|
1,928,262
|
4.1
|
1,928,262
|
4.1
|
|||||||||
$
1.10
|
1,695,300
|
3.0
|
1,695,300
|
3.0
|
|||||||||
$
2.110
|
1,275,000
|
4.7
|
1,275,000
|
4.7
|
|||||||||
|
24,
268,975
|
3.9
|
16,262,310
|
3.4
|
(a)
|
In
August 2005, the Company’s shareholders granted its Chairman of the Board
(the “Chairman”) and one of its non-executive directors, options to
purchase a total of 9,250,000 and 2,000,000 ordinary shares,
respectively,
at an exercise price equal to $0.354 per share (which was
below market
price) . These options are exercisable for a period of five
years from the
date of issuance, and granted under the same terms and conditions
as the
2001 Plan. The options shall vest upon achievement of certain
market
conditions (each 1/3 of the options will vest upon achievement
of a
certain market condition). In addition, with regard to the
Chairman, in
the event of a merger, acquisition or other change of control
or in the
event that the Company terminates the Chairman, either without
cause or as
a result of his death or disability, or he terminates his
agreement for
good reason, the exercisability of any of the options granted
to him
(9,250,000 options) that are unexercisable at the time of
such event or
termination shall accelerate and the time period during which
he shall be
allowed to exercise such options shall be extended by two
years from the
date of the termination of his agreement. Additionally, the
Company’s
board of directors shall have the discretion to accelerate
all or a
portion of the Chairman’s options at any time. As of December 31, 2005,
3,083,333 options that were granted to the Chairman and 666,667
options
that were granted to one of its non-executive directors are
vested (the
first milestone was reached and therefore 1/3 of the options
were vested).
The compensation expenses are amortized using the graded
method.
The
Company used a lattice model that incorporated a Monte
Carlo Simulation
method as the fair value option pricing model, which was
estimated by
management with the assistance of an independent third-party
appraiser.
The following assumptions under this method were used for
the stock
options granted: risk free interest rate of 4.6% (in dollar
terms),
expected volatility of 50%, dividend yield of 0%, and derived
expected
life of 1.43 to 4.37 years. The weighted average fair value
of options
granted during the year, estimated by using the Monte Carlo
Simulation
Method was $0.53 per option.
|
(b)
|
In
August 2005, the Company granted to two of its
non-executive directors a grant of 60,000 options each, having
an exercise
price equal to $0.853 per share (which was at market price),
vesting over
the three years from the date of grant. In addition, they also
provided
for an annual grant of 20,000 options each, for three years,
at an
exercise price equivalent to the then current closing price
of the
Company’s ADR’s on the Nasdaq National Market. The future grants are
contingent on them being members of the board of directors
at such time.
The
Company used a Black & Scholes model as the fair value option pricing
model. The following assumptions under the Black & Scholes model were
used for the stock option granted: expected
volatility of: 50%; risk-free interest rates (in dollar terms)
of: 4.6%,
dividend yield of 0% and expected life of 5 years (based
on management
estimation).
The
weighted average fair value of options using the Black & Scholes
model, granted during the year, estimated by using the model
was $0.42 per
option.
|
(c)
|
The
weighted average fair value of options granted during 2004
and 2003,
estimated by using the Black & Scholes option-pricing model, was $
0.10 and $ 0.07 for the year ended December 31, 2004, and
2003,
respectively. The fair value of options was estimated on
the date of
grant, based on the following weighted average assumptions:
dividend yield
of 0% for all relevant years; expected volatility of: 2004
- 35% and 2003
- 45%; risk-free interest rates (in dollar terms) of: 2004
- 2.9% and 2003
- 2.75%; and expected life of 2 to 4 years, for each of
the reported
years, depending on the vesting period of the options.
|
(d)
|
The non-cash compensation relating to options granted to employees and directors were $2,718,000 in 2005 (of which $67,000 was charged to research and development costs, $2,641,000 was charged to general and administrative expenses and $10,000 was charged to business development costs.). The total compensation costs related to nonvested awards not recognized as of December 31, 2005 is $3,408,000, and the weighted average period over which it is expected to be recognized is 3.6 years. |
3)
|
The
following table summarizes options granted to consultants (including
consultants and members of the scientific advisory board and
other
third-party service providers) under the Company's stock option
plans, as
discussed above:
|
Year
ended December 31
|
|||||||||||||||||||
2005
|
2004
|
2003
|
|||||||||||||||||
Weighted
|
Weighted
|
Weighted
|
|||||||||||||||||
average
|
average
|
average
|
|||||||||||||||||
Number
|
exercise
price
|
Number
|
exercise
price
|
Number
|
exercise
price
|
||||||||||||||
$
|
$
|
$
|
|||||||||||||||||
Balance
outstanding at beginning of year
|
525,000
|
0.33
|
205,000
|
0.54
|
205,000
|
0.54
|
|||||||||||||
Changes
during the year - granted*
|
—
|
—
|
320,000
|
0.20
|
—
|
—
|
|||||||||||||
Balance
outstanding at end of year**
|
525,000
|
0.33
|
525,000
|
0.33
|
205,000
|
0.54
|
|||||||||||||
Balance
exercisable at end of year**
|
355,000
|
0.39
|
280,901
|
0.45
|
205,000
|
0.54
|
* |
The
options exercise price was equal to the share price on the
grant
date.
|
** | The aggregate intrinsic value as of December 31, 2005 is $236,000 for outstanding options, and $137,000 for exercisable options. |
Options
outstanding
|
Options
exercisable
|
||||||||||||
Weighted
|
|
Weighted
|
|||||||||||
average
|
|
average
|
|||||||||||
Balance
at
|
remaining
|
Balance
at
|
remaining
|
||||||||||
December 31,
|
contractual
|
December 31,
|
contractual
|
||||||||||
2005
|
life
|
2005
|
life
|
||||||||||
Number
|
In
years
|
Number
|
In
years
|
||||||||||
Exercise
prices:
|
|||||||||||||
$
0.20
|
150,000
|
2.7
|
150,000
|
2.7
|
|||||||||
$
0.20
|
170,000
|
*
|
—
|
—
|
|||||||||
$
0.497
|
10,000
|
3.4
|
10,000
|
3.4
|
|||||||||
$
0.538
|
195,000
|
1.0
|
195,000
|
1.0
|
|||||||||
525,000
|
355,000
|
||||||||||||
*
Two years from date of regulators approval to sell in any geographic
location. The options were granted during 2004.
|
(a)
|
The
Company used the Black & Scholes fair value option pricing model. The
following assumptions under this method were used in
2005: expected
volatility of 50%, risk free interest rates (in dollars
terms) of 4.6% and
expected life of three years. The following assumptions
under this method
were used in 2004: expected volatility of 33%, risk free
interest rates
(in dollars terms) of 3.6% and expected life of five
years. The weighted
average fair value of options granted during 2004, estimated
by using the
Black & Scholes fair value option pricing model was $0.30 for
2004,
and $0.88 per option for 2005.
|
(b)
|
The
non-cash compensation relating to options granted to
consultants were
$45,000 in 2005 and were charged to research and development
costs. The
charges for non-cash compensation relating to options
granted to
consultants were $32,000 in 2004 (of which $30,000 was
charged to research
and development costs, and $2,000 was charged to general
and
administrative expenses). There is no compensation costs
related to
nonvested awards not recognized as of December 31,
2005.
|
a.
|
Royalty
Bearing Agreements:
|
1) |
Under
a Research and License agreement with Yeda Research and Development
Company Ltd. (“Yeda”), the Company is committed to pay royalty payments at
rates determined in the agreement not exceeding 3% of net sales,
or
royalty rates mainly between 20% to 25% of sublicensing fees,
for products
in development and research under such an agreement.
The
Company has entered into certain license agreements with third
parties in
respect of particular projects. In connection with such agreements,
the
Company may incur royalty and milestone obligations commitments
at varying
royalty rates not exceeding 5 % of future net sales or 25 %
of
sublicensing fees of products developed, based on such agreements.
Additionally,
the Company has undertaken to make contingent milestone payments
to
certain licensors of up to approximately $49.0 million over
the life of
the licenses, of which $34.0 million will be due upon or following
regulatory approval of the drugs (for contingent milestones
related to
VivoQuest’s purchase agreement which are included in these figures, see
Note 3).
In
some cases, these contingent milestone payments will only be
triggered
upon receipt of royalties on sales of related products and
in certain
cases will partially offset royalties the Company would otherwise
owe
those
licensors.
In addition, the Company is required to pay one of its licensors
an amount
of $100,000-$200,000 per year, as minimum royalties, during
the life of
the license. The Company may terminate at any time the agreement
with the
licensor upon advance notice of six months.
|
2) |
The
Company is committed to pay royalties to the Government of Israel
on
proceeds from sales of products in the research and development
of which
the Government participates by way of grants. At the time grants
were
received, successful development of the related projects was
not assured.
In the case of failure of a project that was partly financed
as above, the
Company is not obligated to pay any such royalties. Under the
terms of
Company's funding from the Israeli Government, royalties of 3%
- 5% are
payable on sales of products developed from projects so funded,
up to 100%
of the amount of the grant received by the Company (dollar linked);
as
from January 1, 1999 - with the addition of an annual interest
based on
Libor.
At
December 31, 2005, the maximum amount of the contingent liability
in
respect of royalties related to ongoing projects to the government
is
$3,778,000.
|
In
addition, the Company has received the approval of the Government
of Israel for the transfer of manufacturing rights of its HepeX-B
product,
under the terms of the agreement with Cubist (see Note 2).
As a
consequence, thereof, the Company is obligated to repay the
grants
received from the
Government
of Israel for the financing of the HepeX-B product from any
amounts
received by the Company from Cubist due to the sales of HepeX-B
product,
at a percentage rate, per annum, calculated based on the aggregate
amount
of grants received from the Government
of Israel divided by all amounts invested by the Company in
the research
and development activities of HepeX-B, and up to an aggregate
amount of
300% of the original amounts received for such project, including
interest
at the Libor rate. As of December 31, 2005, the aggregate amount
received
from the
Government
of Israel for the financing of the HepeX-B project including
interest and
Libor rate is equal to $4,213,000.
|
3) |
The
Company provided for annual
grants, over three years, of options to two of its non-executive
directors. The future grants are contingent on them being
members of the
board of directors at such time (see note
6(b)2b).
|
b.
|
Operating
lease
commitments:
|
1) |
The
Company leases its office space under lease agreements
that expire through
2009.
Future
minimum rental payments under these agreements are as
follows:
|
December
31, 2005
|
|
($
in thousands)
|
In
2006
|
667
|
In
2007
|
437
|
In
2008
|
450
|
In
2009
|
426
|
1,980
|
To
secure the lease agreement in Israel, the Company provided
a bank
guarantee. As of December 31, 2005, the guarantee is
secured by a pledge
on a long-term deposit amounting to $110,000 (December
31, 2004- $113,000)
linked to the Israeli Consumer Price Index (“CPI”), which is included in
the balance sheet as long-term deposit.
Rental
expenses for the years ended December 31, 2005, 2004
and 2003 were
$524,000, $394,000 and $427,000, respectively. The
Company has an option
to extend certain rental agreements for up to 5 years.
|
2) |
The
Company leases vehicles under the terms of certain
operating lease
agreements that expire through 2007. Future minimum
lease payments -
linked to the CPI - are as
follows:
|
December
31, 2005
|
|
($
in thousands)
|
In
2006
|
53
|
In
2007
|
34
|
87
|
Vehicle
lease expense for the years ended December 31,
2005, 2004 and 2003 were
$76,000, $84,000 and $105,000, respectively.
|
c.
|
Research
and development agreement commitments
The
Company has commitments to pay amounts aggregating $ 652,000,
in respect
of research and development costs (mainly to outside service
providers),
of which $585,000 relates to 2006 and $67,000 relates to
2007.
|
d.
|
Tax
Assessment
In
2005, the Company received an assessment from the Israeli
tax authorities
of approximately $730,000 (including fines and interest
expenses) related
to withholding taxes for the periods of 2001-2004.
The Company has
recorded an accrual to reflect the probable liability
associated with this
assessment, based on the opinion of management, which
is included as part
of general and administrative expenses.
|
a.
|
The
Company
Measurement
of results for tax purposes under the Income Tax (Inflationary
Adjustments) Law, 1985
Under
this law, results for tax purposes are measured in real
terms, having
regard to the changes in the CPI. The Company is taxed
under this
law.
Results
for tax purposes are measured on a real basis - adjusted
to reflect the
increase in the Israeli consumer price index (hereafter
- the CPI). As
explained in Note 1b, the financial statements are presented
in dollars.
The difference between the change in the Israeli CPI
and the NIS-dollar
exchange rate - both on annual and cumulative basis -
causes a difference
between taxable income and income reflected in these
financial statements
(see also Note
1i).
|
|
Tax
benefits under the Israeli Law for Encouragement
of Capital Investments,
1959
The
Company has been granted an “approved enterprise” status under the Israeli
Law for Encouragement of Capital Investments, 1959.
Income derived from
the approved enterprise during a period of 7 years
from the year in which
this enterprise first realizes taxable income, provided
the maximum period
to which it is restricted by the law has not elapsed,
is entitled to tax
benefits as follows:
Tax
exemption for two years and reduced tax rate for
the remaining eight
years. The Company has not yet incurred taxable income.
The reduced tax
rate is dependent upon the percentage of foreign-owned
holdings (10% -
25%). Since the Company is currently over 25% foreign
owned, it is
entitled to reduced tax rate of 25% .
The
Company has an “approved enterprise” plan from 2001. The expiration of
this plan is in 2015.
If
the Company subsequently
pays a dividend out of income derived from the “approved enterprise”
during the tax exemption period, it will be subject
to tax on the amount
distributed, including any company tax on these amounts,
at the rate which
would have been applicable had such income not been
exempt (25%).
The
entitlement to the above benefits is conditional
upon the Company
fulfilling the conditions stipulated by the law,
regulations published
there-under and the instruments of approval for the
specific investment in
approved enterprise. In the event of failure to comply
with these
conditions, the benefits may be cancelled and the
Company may be required
to refund the amount of the benefits, in whole or
in part, with the
addition of interest. The
Investment center is currently reviewing the Company’s final
implementation report and as a result, the Company
has not yet received a
final implementation approval with respect to its
“approved enterprise”
from the Investment Center. Additionally, given the
Company’s significant
amount of net-operating losses and the limitation
mentioned above to the
benefit period, there is no certainty, if and when
the Company would be
able to enjoy the tax benefits described above.
Tax
benefits under the Israeli law for the Encouragement
of Industry
(Taxation), 1969
The
Company qualifies as “industrial company” under the above law. In
accordance with this law the Company is entitled
to certain benefits
including accelerated depreciation on industrial
buildings and equipment,
a deduction of 12.5% per year of the purchase price
of a good-faith
acquisition of patent and certain other intangible
property
rights.
|
Tax
rates in Israel applicable to income from other
sources
The
income of the Company not eligible for “approved enterprise” benefits,
mentioned above (other than income from “approved enterprises”, see c.
below) is taxed at the regular rate. Through December 31, 2003,
the
corporate tax was 36%. The corporate tax rates for 2004 and thereafter
are
as follows: 2004 - 35%, 2005 - 34%, 2006 - 31%, 2007 - 29%, 2008
- 27%,
2009 - 26% and for 2010 and thereafter -
25%.
|
b.
|
The
Subsidiary
The
Subsidiary is taxed according to U.S. tax
laws.
|
c.
|
Current
tax losses for tax
purposes
|
1) |
Company
Income
tax of the Company is computed on the basis of the income
in Israeli
currency as determined for statutory purposes.
The
Company incurred losses for tax purposes from inception.
The
carryforward loss for tax purposes as of December 31, 2005
is
approximately $ 94 million (linked to the CPI), which may
be offset
against future taxable income generated from a business,
(including
capital gains from the sale of assets used in the business)
with no
expiration date.
|
2) |
Subsidiary
The
Subsidiary is remunerated under a cost plus agreement
with the Company.
The subsidiary has incurred taxable income and recorded
tax expenses and
is taxed under the applicable U.S. tax
laws.
|
|
The
following table summarizes the taxes on income for the Company
and its
subsidiary for 2005, 2004 and
2003:
|
2005
|
2004
|
2003
|
|||||||||||||||||
($
in thousands)
|
($
in thousands)
|
($
in thousands)
|
|||||||||||||||||
Company
|
Subsidiary
|
Company
|
Subsidiary
|
|
Company
|
Subsidiary
|
|||||||||||||
Net
income (loss) before
|
|||||||||||||||||||
income
taxes
|
(14,187
|
)
|
250
|
(16,582
|
)
|
158
|
(14,327
|
)
|
117
|
||||||||||
Income
Taxes
|
—
|
78
|
—
|
49
|
—
|
78
|
|||||||||||||
Net
income (loss) for the year
|
(14,187
|
)
|
172
|
(16,582
|
)
|
109
|
(14,327
|
)
|
39
|
d.
|
Deferred
income taxes
As
a result of the“approved
enterprise” status of the Company, the Company’s current tax rate is 0%,
and therefore no deferred tax assets have been included in these
financial
statements in respect of carryforward losses.
|
e.
|
Reconciliation
of the theoretical tax expense to actual tax expense
The
main reconciling item, between the statutory tax rate of the
Company and
the effective rate is the non-recognition of tax benefits from
carryforward
tax losses due to the uncertainty of the realization of such
tax benefits
(see above).
|
f.
|
Tax
assessments
|
1)
|
Income
taxes
The
Company received tax assessments for the years up to and including
the
1998 tax year.
The
Company’s tax returns until 2001are considered final. The Subsidiary
has
not been assessed for tax purposes since
incorporation.
|
2)
|
Withholding
taxes - see Note 7d.
|
a.
|
2005
Restructuring
In
2005, the Company implemented a restructuring plan designed to
focus its
resources on the development of its lead programs, with the goal
of moving
these programs through to clinical proof of concept. The 2005
restructuring included a 32 person reduction in the Company’s workforce,
31 of whom were in research and development and one of whom was
in general
and administrative. As part of the 2005 restructuring, the Company
took a
charge in 2005 of $168,000, relating to employee dismissal costs,
$163,000
of which was included in research and development costs and $5,000
of
which was included in general and administrative expenses.
As
of December 31, 2005, 28 employees have left the Company under
the 2005
restructuring plan and approximately $147,000 of dismissal costs
have been
paid. The other 4 employees left the Company in early 2006. As
of December
31, 2005, approximately $21,000 in employee dismissal obligations
are
included in accounts payable and accruals. The balance of these
obligations was paid in early 2006.
In
December 2005, as a result of the Company's restructuring, and
in
accordance with the provisions of FAS 144, the
Company reviewed the carrying value of certain lab equipment
assets, and
recorded an impairment charge in
research and development costs
in
an amount of $26,000 in 2005 (see also Note 4b).
|
b.
|
2003
Restructuring
In
2003, the Company implemented and completed a restructuring plan.
As a
result of this restructuring, the Company ceased all early-stage
discovery
research activities related to infectious diseases. The 2003
restructuring
included a 20-person reduction in its workforce in Israel, 18
of whom were
in research and development and two of whom were in general and
administrative. As part of the 2003 restructuring, the Company
took a
charge in 2003 of $74,000, relating to employee dismissal costs,
$58,000
of which was included in research and development costs and $16,000
of
which was included in general and administrative expenses. The
Company
paid all of these amounts in 2003. As part of the 2003 restructuring,
the
Company reevaluated its long-lived assets in accordance with
FAS No. 144,
and recorded a non-cash impairment charge of $354,000 of fixed
assets for
the year ended December 31, 2003 (see Note 4b).
|
a.
|
Short-term
bank deposits
The
deposits are denominated in dollars and bear a weighted average
annual
interest rate of 4.23 % as of December 31, 2005 (as of December
31, 2004 -
1.81%).
|
b.
|
Accounts
receivable - other:
|
December
31
|
|||||||
2005
|
2004
|
||||||
($
in thousands)
|
|||||||
Prepaid
expenses
|
285
|
165
|
|||||
Employees
|
75
|
24
|
|||||
Value
added tax authorities
|
17
|
101
|
|||||
Other
|
54
|
16
|
|||||
431
|
306
|
c.
|
Accounts
payable and
accruals:
|
Suppliers
|
655
|
1,108
|
|||||
Accrued
expenses
|
940
|
1,337
|
|||||
Institutions
and employees in respect of salaries
|
|||||||
and
related benefits
|
250
|
294
|
|||||
Provision
for vacation pay and recreation pay
|
160
|
385
|
|||||
Other
|
2
|
10
|
|||||
2,007
|
3,134
|
|
Statements
of operations:
|
d.
|
Research
and development
costs:
|
Period
from
|
|||||||||||||
March
9, 1993
|
|
||||||||||||
Year
ended December 31
|
to
December 31,
|
||||||||||||
2005
|
2004
|
2003
|
2005
|
||||||||||
($
in thousands)
|
|||||||||||||
Wages,
salaries and related benefits
|
|||||||||||||
(includes
non-cash compensation
|
|||||||||||||
of
$67 in 2005, and $0
|
|||||||||||||
in
2004 and 2003)
|
2,764
|
2,776
|
3,450
|
23,709
|
|||||||||
Outside
service providers
|
2,054
|
6,430
|
6,799
|
35,910
|
|||||||||
Lab
supplies
|
558
|
754
|
1,128
|
8,964
|
|||||||||
Consultants
(includes non-cash
|
|||||||||||||
compensation
of $45 in 2005,
|
|||||||||||||
$30
in 2004 and $0 in 2003)
|
531
|
549
|
494
|
3,725
|
|||||||||
Rent
and maintenance
|
752
|
725
|
866
|
4,756
|
|||||||||
Impairment
loss
|
26
|
354
|
380
|
||||||||||
Depreciation
and amortization
|
212
|
277
|
369
|
2,929
|
|||||||||
Other
|
416
|
474
|
562
|
2,517
|
|||||||||
7,313
|
11,985
|
14,022
|
82,890
|
e.
|
General
and administrative expenses:
|
|
|||||||||||||
Wages,
salaries and related benefits
|
|||||||||||||
(includes
non-cash compensation
|
|||||||||||||
of
$5 in 2005, and $0 in 2004
|
|||||||||||||
and
2003)
|
454
|
1,890
|
1,244
|
11,534
|
|||||||||
Corporate
communications
|
140
|
289
|
228
|
2,350
|
|||||||||
Professional
fees
|
890
|
647
|
564
|
4,405
|
|||||||||
Director
fees and related (includes
|
|||||||||||||
non-cash
compensation of $2,636
|
|||||||||||||
in
2005, and $0 in 2004 and 2003)
|
2,821
|
243
|
183
|
4,208
|
|||||||||
Rent
and maintenance
|
91
|
90
|
104
|
956
|
|||||||||
Communications
|
25
|
34
|
33
|
220
|
|||||||||
Depreciation
and amortization
|
30
|
42
|
70
|
619
|
|||||||||
Patent
registration fees
|
174
|
271
|
125
|
1,191
|
|||||||||
Other
|
832
|
628
|
554
|
3,529
|
|||||||||
5,457
|
4,134
|
3,105
|
29,012
|
f.
|
Business
development costs:
|
Wages,
salaries and related
|
|||||||||||||
benefits
(includes non-cash
|
|||||||||||||
compensation
of $10 in 2005,
|
|||||||||||||
and
$0 in 2004 and 2003)
|
171
|
410
|
408
|
2,672
|
|||||||||
Travel
|
22
|
36
|
136
|
764
|
|||||||||
Professional
fees
|
34
|
364
|
120
|
1,077
|
|||||||||
227
|
810
|
664
|
4,513
|
g.
|
Financial
income,
net:
|
March
9, 1993
|
|||||||||||||
Year
ended December 31
|
to
December 31,
|
||||||||||||
2005
|
2004
|
2003
|
2005
|
||||||||||
($
in thousands)
|
|||||||||||||
Financial
income:
|
|
||||||||||||
Interest
income
|
503
|
297
|
458
|
9,228
|
|||||||||
Foreign
exchange differences-gain
|
—
|
67
|
—
|
203
|
|||||||||
Gain
from available for sale securities
|
—
|
13
|
62
|
13
|
|||||||||
Other
|
—
|
—
|
—
|
156
|
|||||||||
503
|
377
|
520
|
9,600
|
||||||||||
Financial
expenses:
|
|||||||||||||
Foreign
exchange differences-loss
|
39 |
—
|
148 |
1,960
|
|||||||||
Interest
expense
|
—
|
—
|
374
|
||||||||||
Loss
from available for sale securities
|
—
|
—
|
—
|
14
|
|||||||||
Other
|
21
|
25
|
20
|
109
|
|||||||||
60
|
25
|
168
|
2,457
|
||||||||||
Financial
income, net
|
443
|
352
|
352
|
7,143
|
a.
|
Linkage
terms of balances in non-dollars
currency:
|
1)
|
As
follows:
|
December 31,
2005
|
|||||||
Israeli
currency
|
Other
|
||||||
Unlinked
|
|||||||
($
in thousands)
|
|||||||
Assets
|
934
|
122
|
|||||
Liabilities
|
987
|
45
|
|
The
above balances do not include Israeli currency balances linked
to the
dollar.
|
2)
|
Data
regarding the changes in the exchange rate of the dollar and
the Israeli
CPI:
|
Year
ended December 31
|
||||||||||
2005
|
2004
|
2003
|
||||||||
Devaluation
(evaluation) of the Israeli currency
against the dollar
|
6.85%
|
|
(1.6)%
|
|
(7.6)%
|
|
||||
Changes
in the Israeli CPI
|
2.4 %
|
|
1.2%
|
|
(1.9)%
|
|
||||
Exchange
rate of one dollar (at end of year)
|
NIS
4.603
|
NIS
4.308
|
NIS
4.379
|
b.
|
Fair
value of financial instruments
The
financial instruments of the Company consist of non-derivative
assets and
liabilities, included in working capital.
In
view of their nature, the fair value of these financial instruments
is
usually identical or close to their carrying
value.
|
c.
|
Concentration
of credit risks
Most
of the Company’s cash and cash equivalents and bank deposits at the
balance sheet dates were deposited with Israeli banks.
The Company is of
the opinion that the credit risk in respect of those balances
is
remote.
|