American
Depositary Shares, each representing
|
None
|
two
Ordinary Shares, par value NIS 0.1
|
|
(Title
of Class)
|
(Name
of each exchange on which
registered)
|
11,913,805
American Depositary Shares
|
58,561,065
Ordinary Shares
|
¨ U.S.
GAAP
|
x International
Financial Reporting Standards as issued
|
¨ Other
|
by
the International Accounting Standards Board
|
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
|
22
|
ITEM
4A
|
Unresolved
Staff Comments
|
36
|
ITEM
5
|
Operating
and Financial Review and Prospects
|
36
|
ITEM
6
|
Directors,
Senior Management and Employees
|
54
|
ITEM
7
|
Major
Shareholders and Related Party Transactions
|
63
|
ITEM
8
|
Financial
Information
|
63
|
ITEM
9
|
The
Offer and Listing
|
64
|
ITEM
10
|
Additional
Information
|
66
|
ITEM
11
|
Quantitative
and Qualitative Disclosures About Market Risk
|
85
|
ITEM
12
|
Description
of Securities other than Equity Securities
|
86
|
PART
II
|
||
ITEM
13
|
Defaults,
Dividend Arrearages and Delinquencies
|
87
|
ITEM
14
|
Material
Modifications to the Rights of Security Holders and Use of
Proceeds
|
87
|
ITEM
15
|
Controls
and Procedures
|
87
|
ITEM
16
|
Reserved
|
88
|
ITEM
16A
|
Audit
Committee Financial Expert
|
88
|
ITEM
16B
|
Code
of Ethics
|
88
|
ITEM
16C
|
Principal
Accountant Fees And Services
|
88
|
ITEM
16D
|
Exemptions
From The Listing Standards For Audit Committees
|
89
|
ITEM
16E
|
Purchases
Of Equity Securities By The Issuer And Affiliated
Purchasers
|
89
|
ITEM
16G
|
Corporate
Governance
|
89
|
PART
III
|
||
ITEM
17
|
Financial
Statements
|
90
|
ITEM
18
|
Financial
Statements
|
90
|
ITEM
19
|
Exhibits
|
90
|
SIGNATURES
|
93
|
Year ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
U.S. dollars in thousands (except per share
data)
|
||||||||||||
Revenues
|
- | 5,940 | 907 | |||||||||
Cost
of revenues
|
- | 1,841 | 110 | |||||||||
Gross
profit
|
- | 4,099 | 797 | |||||||||
Research
and development costs
|
- | 11,722 | 11,500 | |||||||||
General
and administrative expenses (income)
|
(2,429 | )*) | 3,937 | 7,596 | ||||||||
Impairment
loss of intangible asset
|
- | 7,500 | - | |||||||||
Other
gains (losses), net
|
139 | 288 | (8 | ) | ||||||||
Operating
income (loss)
|
2,568 | (18,772 | ) | (18,307 | ) | |||||||
Finance
income
|
6 | 331 | 668 | |||||||||
Finance
costs
|
10 | 17 | 30 | |||||||||
Financial
income (costs), net
|
(4 | ) | 314 | 638 | ||||||||
Income
(loss) before taxes on income
|
2,564 | (18,458 | ) | (17,669 | ) | |||||||
tax
benefit
|
(23 | ) | (31 | ) | (206 | ) | ||||||
Net
income (loss) for the year attributable to equity holders of the
parent
|
2,587 | (18,427 | ) | (17,463 | ) | |||||||
Basic
and diluted earnings (loss) per share
(in U.S. dollars) **)
|
0.044 | (0.315 | ) | (0.382 | ) | |||||||
Weighted
average number of issued ordinary shares **)
|
58,561,065 | 58,553,864 | 45,698,564 |
*)
|
Including
reduced expenses which result from forfeiture of shares that were
contingent on the performance of the former chairman and CEO, see also
Note 16b to the financial
statements.
|
**)
|
After
taking into account the capital consolidation effected on June 22, 2009
(see note 16a(2) to the financial
statements).
|
As of December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
U.S. dollars in thousands
|
||||||||||||
Cash,
cash equivalents, bank deposits and trading and marketable
securities
|
412 | 2,924 | 12,977 | |||||||||
Working
capital
|
(151 | ) | 1,433 | 8,532 | ||||||||
Total
assets
|
715 | 3,402 | 23,378 | |||||||||
Long
term obligations
|
- | - | 131 | |||||||||
Total
shareholders' equity
|
7 | 1,474 | 17,878 |
Year ended December 31,
|
||||||||
2006
|
2005
|
|||||||
U.S.
dollars in thousands (except
per
share data)
|
||||||||
Revenues:
|
||||||||
Reimbursed
out-of-pocket expenses
|
- | 2,743 | ||||||
License
|
454 | 454 | ||||||
454 | 3,197 | |||||||
Cost
of revenues:
|
||||||||
Reimbursed
out-of-pocket expenses
|
- | 2,743 | ||||||
License
|
54 | 54 | ||||||
54 | 2,797 | |||||||
Gross
profit
|
400 | 400 | ||||||
Research
and development
|
10,229 | 7,313 | ||||||
In-process
research and development
|
- | 1,783 | ||||||
General
and administrative expenses
|
5,576 | 5,457 | ||||||
Business
development costs
|
641 | 227 | ||||||
Operating
loss
|
(16,046 | ) | (14,380 | ) | ||||
Financial
and other income, net
|
1,141 | 443 | ||||||
Income
taxes
|
(227 | ) | (78 | ) | ||||
Loss
for the period
|
(15,132 | ) | (14,015 | ) | ||||
Basic
and diluted loss per share
(in U.S. dollars) **)
|
(0.375 | ) | (0.412 | ) | ||||
Weighted
average number of issued ordinary shares **)
|
40,347,459 | 34,024,601 |
**)
|
After
taking into account the capital consolidation effected on June 22, 2009
(see note 16a(2) to the financial
statements).
|
As of December 31,
|
||||||||
2006
|
2005
|
|||||||
U.S. dollars in thousands
|
||||||||
Cash,
cash equivalents, bank deposits and trading and marketable
securities
|
25,347 | 13,360 | ||||||
Working
capital
|
22,694 | 11,385 | ||||||
Total
assets
|
26,900 | 15,151 | ||||||
Long
term obligations
|
738 | 1,493 | ||||||
Total
shareholders' equity
|
22,760 | 11,252 |
|
·
|
difficulty
in establishing or managing relationships with clinical research
organizations and physicians;
|
|
·
|
different
standards for the conduct of clinical trials and/or health care
reimbursement;
|
|
·
|
our
inability to locate qualified local consultants, physicians, and
partners;
|
|
·
|
the
potential burden of complying with a variety of foreign laws, medical
standards and regulatory requirements, including the regulation of
pharmaceutical products and treatment;
and
|
|
·
|
general
geopolitical risks, such as political and economic instability, and
changes in diplomatic and trade
relations.
|
|
·
|
obtaining
regulatory approvals to commence a clinical
trial;
|
|
·
|
reaching
agreement on acceptable terms with prospective contract research
organizations, or CROs, and trial sites, the terms of which can be subject
to extensive negotiation and may vary significantly among different CROs
and trial sites;
|
|
·
|
slower
than expected rates of patient recruitment due to narrow screening
requirements;
|
|
·
|
the
inability of patients to meet protocol requirements imposed by the FDA or
other regulatory authorities;
|
|
·
|
the
need or desire to modify our manufacturing
process;
|
|
·
|
delays,
suspension, or termination of the clinical trials due to the institutional
review board responsible for overseeing the study at a particular study
site; and
|
|
·
|
government
or regulatory delays or “clinical holds” requiring suspension or
termination of the trials.
|
|
·
|
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
including potential generic
competition;
|
|
·
|
the
level of off-label use of rHuEPO;
|
|
·
|
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 and/or partners' sales, marketing and distribution
efforts.
|
|
·
|
difficulty
and expense of assimilating the operations, technology or personnel of the
business;
|
|
·
|
our
inability to attract and retain management, key personnel and other
employees necessary to conduct the
business;
|
|
·
|
our
inability to maintain relationships with key third parties, such as
alliance partners, associated with the
business;
|
|
·
|
exposure
to legal claims for activities of the business prior to the
acquisition;
|
|
·
|
the
diversion of our management’s attention from our core business;
and
|
|
·
|
the
potential impairment of substantial goodwill and write-off of in-process
research and development costs, adversely affecting our reported results
of operations.
|
|
·
|
decreased
demand for a product;
|
|
·
|
injury
to our reputation;
|
|
·
|
inability
to continue to develop a drug candidate or
technology;
|
|
·
|
withdrawal
of clinical trial volunteers; and
|
|
·
|
loss
of revenues.
|
|
·
|
the
progress of our planned research
activities;
|
|
·
|
the
accuracy of our financial
forecasts;
|
|
·
|
the
number and scope of our planned 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 and near-term
working capital;
|
|
·
|
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.
|
|
·
|
initiate
a prospective, multi-center, double blind, placebo controlled Phase 1-2
clinical study intended to assess the safety and efficacy of rHuEPO when
given to patients with advanced MM;
|
|
·
|
advance
the development of rHuEPO towards approval as treatment of MM either alone
or with a corporate partner;
|
|
·
|
seek
to in-license or acquire additional
candidates.
|
|
·
|
Baz
R et al: A team from the Cleveland Clinic Myeloma Program analyzed
their experience with rHuEPO in MM patients. This retrospective analysis
provides data on 292 MM patients enrolled on different protocols between
1997 and 2003. The authors concluded that "rHuEPO was associated with
improved overall survival in this population of anemic MM patients with
SWOG stages II, III and IV." They summarized by saying that "a prospective
randomized trial is warranted to corroborate this finding" (Baz R et al:
Recombinant human erythropoietin is associated with increased overall
survival in patients with multiple myeloma (Acta Haematol 2007; 117:
162-7)).
|
|
·
|
Ludwig
H et al.: Forty two
patients with various types of cancers were treated with rHuEPO for their
anemia. The malignant diseases were: 18 multiple myeloma (MM), 10
myelodysplastic syndromes (MDS), 9 breast cancers and 5 colon cancers. The
median time period of treatment with rHuEPO was 16 weeks. The study was
designed to treat anemia (not the cancer). Response was defined as an
increase of the initial hemoglobin (Hb) level by at least 2 g/dl. The
response rates varied: 44.4% for breast cancer, 40% for colon cancer,
77.8% for MM, 10% for MDS. The median survival time of responders was 28.0
months as compared to only 9.2 months for non-responders. (Ludwig H et al;
Erythropoietin treatment for chronic anemia of selected hematological
malignancies and solid tumorsAnn Oncol 1993;
4:161-7).
|
|
·
|
Wallvik
J et al.: This Swedish group reports its experience with a
long-term follow-up of 68 MDS patients treated with rHuEPO. The median Hb
response duration was 15 months. The median overall survival time from
start of rHuEPO treatment was 26 months, significantly longer for
responders than for non-responders (49 vs. 18 months, p=0.018) (Wallvik J
et al.; Serum erythropoietin (EPO) levels correlate with survival and
independently predict response to EPO treatment in patients with
myelodysplastic syndromes. Eur J Haematol 2002; 68:
180-5).
|
|
·
|
is
intended to treat a serious or life-threatening
condition;
|
|
·
|
is
intended to treat a serious aspect of the condition;
and
|
|
·
|
has
the potential to address unmet medical needs, and this potential is being
evaluated in the planned drug development
program.
|
|
·
|
Phase 1: The drug is
administered to a small group of humans, either healthy volunteers or
patients, to test for safety, dosage tolerance, absorption, metabolism,
excretion, and clinical
pharmacology.
|
|
·
|
Phase 2: Studies are
conducted on a larger number of patients to assess the efficacy of the
product, to ascertain dose tolerance and the optimal dose range, and to
gather additional data relating to safety and potential adverse
events.
|
|
·
|
Phase 3: Studies
establish safety and efficacy in an expanded patient
population.
|
|
·
|
Phase 4: The FDA may
require Phase 4 post-marketing studies to find out more about the drug’s
long-term risks, benefits, and optimal use, or to test the drug in
different populations, such as
children.
|
|
·
|
slow
patient enrollment due to the nature of the clinical trial plan, the
proximity of patients to clinical sites, the eligibility criteria for
participation in the study or other factors, and the number of sites
participating in the trial;
|
|
·
|
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,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
U.S. dollars in thousands (except per share
data)
|
||||||||||||
Revenues
|
- | 5,940 | 907 | |||||||||
Cost
of revenues
|
- | 1,841 | 110 | |||||||||
Gross
profit
|
- | 4,099 | 797 | |||||||||
Research
and development costs
|
- | 11,722 | 11,500 | |||||||||
General
and administrative expenses (income)
|
(2,429 | )*) | 3,937 | 7,596 | ||||||||
Impairment
loss of intangible asset
|
- | 7,500 | - | |||||||||
Other
gains (losses), net
|
139 | 288 | (8 | ) | ||||||||
Operating
income (loss)
|
2,568 | (18,772 | ) | (18,307 | ) | |||||||
Finance
income
|
6 | 331 | 668 | |||||||||
Finance
costs
|
10 | 17 | 30 | |||||||||
Financial
income (costs), net
|
(4 | ) | 314 | 638 | ||||||||
Income
(loss) before taxes on income
|
2,564 | (18,458 | ) | (17,669 | ) | |||||||
Tax
benefit
|
(23 | ) | (31 | ) | (206 | ) | ||||||
Net
income (loss) for the year attributable to equity holders of the
parent
|
2,587 | (18,427 | ) | (17,463 | ) | |||||||
Basic
and diluted earnings (loss) per share
(in U.S. dollars) **)
|
0.044 | (0.315 | ) | (0.382 | ) | |||||||
Weighted
average number of issued ordinary shares
|
58,561,065 | 58,553,864 | 45,698,564 |
*)
|
Including
reduced-expenses which result from forfeiture of shares that were
contingent on the performance of the former chairman and former CEO, see
also Note 16b to the financial
statements.
|
**)
|
After
taking into account the capital consolidation effected on June 22, 2009
(see note 16a(2) to the financial
statements).
|
As of December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
U.S. dollars in thousands
|
||||||||||||
Cash,
cash equivalents, bank deposits and trading and marketable
securities
|
412 | 2,924 | 12,977 | |||||||||
Working
capital
|
(151 | ) | 1,433 | 8,532 | ||||||||
Total
assets
|
715 | 3,402 | 23,378 | |||||||||
Long
term obligations
|
- | - | 131 | |||||||||
Total
shareholders' equity
|
7 | 1,474 | 17,878 |
|
-
|
It
is technically feasible to complete the intangible asset so that it will
be available for use;
|
|
-
|
Management
intends to complete the intangible asset and use or sell
it;
|
|
-
|
There
is an ability to use or sell the intangible
asset;
|
|
-
|
It can be demonstrated how the
intangible asset will generate probable future economic
benefits;
|
|
-
|
Adequate
technical, financial and other resources to complete the development and
to use or sell the intangible asset are available;
and
|
|
-
|
The
expenditure attributable to the intangible asset during its development
can be reliably measured.
|
|
1.
|
Revenues
from transfer of rights to use development which include the Company's
involvement during the development period, are recognized on a
straight-line basis over the expected term of the
agreement.
|
|
2.
|
Revenues
from sale of DOS development rights to Presidio and rendering of ongoing
services by the Company are recognized as
follows:
|
|
a)
|
The
fair value of labor services by the Company's employees is recognized over
the service term.
|
|
b)
|
The
difference between the sale consideration and the fair value of labor
services is recognized at the date of transaction as revenues from sale of
DOS development rights.
|
|
3.
|
Interest
income is recognized on a periodic basis using the effective interest
method.
|
|
·
|
the
costs involved in closing the Bio-Gal transaction, including the required
financing;
|
|
·
|
the
accuracy of our financial
forecasts;
|
|
·
|
the
timing of the in-licensing, partnering and acquisition of new product
opportunities;
|
|
·
|
the
timing of expenses associated with product development and manufacturing
of the proprietary drug candidate that we have acquired from Bio-Gal Ltd.
and those that may be in-licensed, partnered or
acquired;
|
|
·
|
our
ability to achieve our milestones under licensing arrangements;
and
|
|
·
|
the
costs involved in prosecuting and enforcing patent claims and other
intellectual property rights.
|
Payment due by period (in thousands of US$)
|
||||||||||||||||||||
Contractual obligations
|
Total
|
Less than
1 year
|
1-3
years
|
3-5
years
|
More than
5 years
|
|||||||||||||||
Operating
leases
|
34.2 | 28.2 | 6 | — | — | |||||||||||||||
Total
|
34.2 | 28.2 | 6 | — | — |
Research
and Development Expenses in thousand US$
|
||||||||||||
Years
ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Bicifadine
|
11,038 | 5,976 | ||||||||||
DOS
|
— | 684 | 4,056 | |||||||||
Legacy
programs
|
||||||||||||
Research
and development costs
|
— | — | 1,524 | |||||||||
Less
participations
|
— | — | (56 | ) | ||||||||
Total
legacy programs
|
— | — | 1,468 | |||||||||
Total Research and
development
|
||||||||||||
Research
and development costs
|
— | 11,722 | 11,556 | |||||||||
Less
participations
|
— | — | (56 | ) | ||||||||
— | 11,722 | 11,500 |
Name
|
Age
|
Position
|
||
Amit
Yonay
|
40
|
Chairman
of the Board of Directors
|
||
Dafna
Cohen
|
40
|
Non
Executive and External Director
|
||
Jaron
Diament
|
42
|
Non
Executive and External Director
|
||
Marc
Allouche
|
36
|
Non
Executive Director
|
||
Boaz
Shweiger
|
35
|
Non
Executive Director
|
||
David
Grossman
|
35
|
Executive
Director and Chief Executive Officer
|
||
Ronen
Twito
|
|
35
|
|
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,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Research
and Development
|
||||||||||||
Israel
|
— | 2 | 2 | |||||||||
US
|
— | — | 16 | |||||||||
— | 2 | 18 | ||||||||||
Financial
and general management
|
||||||||||||
Israel
|
2 | 3 | 4 | |||||||||
US
|
— | 2 | 2 | |||||||||
2 | 5 | 6 | ||||||||||
Business
development
|
||||||||||||
Israel
|
— | — | — | |||||||||
US
|
— | 1 | 1 | |||||||||
— | 1 | 1 | ||||||||||
Total
|
2 | 8 | 25 | |||||||||
Average
number of full-time employees
|
3 | 14 | 29 |
Amount and nature of beneficial ownership
|
||||||||||||||||
Ordinary
shares
beneficially
owned
excluding
options
|
Options1
exercisable
within
60 days of
May 31,
2010
|
Total
ordinary
shares
beneficially
owned
|
Percent of
ordinary
shares
beneficially
owned
|
|||||||||||||
Amit Yonay2
Chairman of the
Board
|
— | 70,833 | 70,833 | * | ||||||||||||
Marc
Allouche2
Director
|
— | 70,833 | 70,833 | * | ||||||||||||
Dafna
Cohen
Director
|
— | — | — | — | ||||||||||||
Jaron
Diament
Director
|
— |
—
|
—
|
— | ||||||||||||
David
Grossman
Director
and Chief Executive Officer
|
— | — | — | — | ||||||||||||
Boaz
Shweiger2
Director
|
— | 70,833 | 70,833 | * | ||||||||||||
Ronen
Twito3
Chief
Financial Officer
|
— | 803,704 | 803,704 | 1.2 | % | |||||||||||
All
directors and executive officers as a group
(7 persons)
|
— | 1,016,203 | 1,016,203 | 1.6 | % |
(1)
|
Options
to purchase ordinary shares.
|
(2)
|
70,833
options at an exercise price of NIS 0.298 per ordinary share of NIS 0.1
par value, exercisable until March 1,
2020.
|
(3)
|
803,704
options at an exercise price of NIS 0.075 per ordinary share of NIS 0.1
par value, exercisable until June 23,
2019.
|
*
|
Represents
Less than 1% of ordinary shares
outstanding.
|
US Dollar
|
||||||||
|
High
|
Low
|
||||||
Last
Six Calendar Months
|
||||||||
June
2010 (until June 15)
|
0.08 | 0.06 | ||||||
May
2010
|
0.11 | 0.06 | ||||||
April
2010
|
0.13 | 0.11 | ||||||
March
2010
|
0.13 | 0.10 | ||||||
February
2010
|
0.14 | 0.12 | ||||||
January
2010
|
0.15 | 0.09 | ||||||
December
2009
|
0.15 | 0.09 | ||||||
Financial
Quarters During the Past Two Full Fiscal Years
|
||||||||
Second
Quarter of 2010 (until June 15)
|
0.13 | 0.06 | ||||||
First
Quarter of 2010
|
0.15 | 0.09 | ||||||
Fourth
Quarter of 2009
|
0.18 | 0.09 | ||||||
Third
Quarter of 2009
|
0.22 | 0.14 | ||||||
Second
Quarter of 2009
|
0.32 | 0.05 | ||||||
First
Quarter of 2009
|
0.20 | 0.05 | ||||||
Fourth
Quarter of 2008
|
3.55 | 0.04 | ||||||
Third
Quarter of 2008
|
4.96 | 2.95 | ||||||
Second
Quarter of 2008
|
3.93 | 2.90 | ||||||
First
Quarter of 2008
|
4.39 | 2.70 | ||||||
Full
Financial Years Since Listing
|
||||||||
2009
|
0.32 | 0.05 | ||||||
2008
|
4.96 | 0.04 | ||||||
2007
|
4.99 | 1.10 | ||||||
2006
|
8.17 | 2.00 |
1
|
Our
ADRs are quoted on the Pink Sheets since April 17, 2009. Our ADRs were quoted on the
NASDAQ Capital Market since December 3, 2007 until April 17, 2009 and
prior to that were quoted on the NASDAQ Global
Market.
|
New Israeli Shekel
|
US Dollar
|
|||||||||||||||
High
|
Low
|
High
|
Low
|
|||||||||||||
Last
Six Calendar Months
|
||||||||||||||||
June
2010 (until June 15)
|
0.262 | 0.162 | 0.069 | 0.042 | ||||||||||||
May
2010
|
0.294 | 0.199 | 0.077 | 0.052 | ||||||||||||
April
2010
|
0.318 | 0.283 | 0.083 | 0.074 | ||||||||||||
March
2010
|
0.370 | 0.300 | 0.097 | 0.079 | ||||||||||||
February
2010
|
0.359 | 0.303 | 0.094 | 0.079 | ||||||||||||
January
2010
|
0.407 | 0.275 | 0.107 | 0.072 | ||||||||||||
December
2009
|
0.410 | 0.262 | 0.107 | 0.069 | ||||||||||||
Financial
Quarters During the Past Two Full Fiscal Years
|
||||||||||||||||
Second
Quarter of 2010 (until June 15)
|
0.318 | 0.162 | 0.083 | 0.042 | ||||||||||||
First
Quarter of 2010
|
0.407 | 0.275 | 0.107 | 0.072 | ||||||||||||
Fourth
Quarter of 2009
|
0.468 | 0.262 | 0.123 | 0.069 | ||||||||||||
Third
Quarter of 2009
|
0.597 | 0.392 | 0.156 | 0.103 | ||||||||||||
Second
Quarter of 2009
|
1.285 | 0.200 | 0.336 | 0.052 | ||||||||||||
First
Quarter of 2009
|
0.345 | 0.095 | 0.090 | 0.025 | ||||||||||||
Fourth
Quarter of 2008
|
6.250 | 0.075 | 1.637 | 0.020 | ||||||||||||
Third
Quarter of 2008
|
8.700 | 5.065 | 2.278 | 1.326 | ||||||||||||
Second
Quarter of 2008
|
6.500 | 4.800 | 1.702 | 1.257 | ||||||||||||
First
Quarter of 2008
|
7.500 | 4.505 | 1.964 | 1.180 | ||||||||||||
Full
Financial Years Since Listing
|
||||||||||||||||
2009
|
1.285 | 0.095 | 0.336 | 0.025 | ||||||||||||
2008
|
8.700 | 0.075 | 2.278 | 0.020 | ||||||||||||
2007
|
10.20 | 2.275 | 2.671 | 0.596 | ||||||||||||
2006
|
18.50 | 4.645 | 4.844 | 1.214 |
|
·
|
a
breach of the office holder’s duty of care to the company or to another
person;
|
|
·
|
a
breach of the office holder’s fiduciary duty to the company, provided that
he or she acted in good faith and had reasonable cause to believe that the
act would not prejudice the company;
and
|
|
·
|
a
financial liability imposed upon the office holder in favor of another
person.
|
|
·
|
monetary
liability imposed upon him or her in favor of a third party by a judgment,
including a settlement or an arbitral award confirmed by the court;
and
|
|
·
|
reasonable
litigation expenses, including attorneys’ fees, actually incurred by the
office holder or imposed upon him or her by a court, in a proceeding
brought against him or her by or on behalf of the company or by a third
party, or in a criminal action in which he or she was acquitted, or in a
criminal action which does not require criminal intent in which he or she
was convicted; furthermore, a company can, with a limited exception,
exculpate an office holder in advance, in whole or in part, from liability
for damages sustained by a breach of duty of care to the
company.
|
|
·
|
any
amendment to the Articles of
Association;
|
|
·
|
an
increase of the company's authorized share
capital;
|
|
·
|
a
merger; and
|
|
·
|
approval
of interested party transactions that require shareholders
approval.
|
|
·
|
there
is a limitation on acquisition of any level of control of the company;
or
|
|
·
|
the
acquisition of any level of control requires the purchaser to do so by
means of a tender offer to the
public.
|
|
·
|
the
judgment was obtained after due process before a court of competent
jurisdiction, that recognizes and enforces similar judgments of Israeli
courts, and the court had authority according to the rules of private
international law currently prevailing in
Israel;
|
|
·
|
adequate
service of process was effected and the defendant had a reasonable
opportunity to be heard;
|
|
·
|
the
judgment is not contrary to the law, public policy, security or
sovereignty of the State of Israel and its enforcement is not contrary to
the laws governing enforcement of
judgments;
|
|
·
|
the
judgment was not obtained by fraud and does not conflict with any other
valid judgment in the same matter between the same
parties;
|
|
·
|
the
judgment is no longer appealable;
and
|
|
·
|
an
action between the same parties in the same matter is not pending in any
Israeli court at the time the lawsuit is instituted in the foreign
court.
|
|
·
|
where
a company's equity, as defined in the law, exceeds the cost of fixed
assets as defined in the Inflationary Adjustments Law, a deduction from
taxable income that takes into account the effect of the applicable annual
rate of inflation on the excess is allowed up to a ceiling of 70% of
taxable income in any single tax year, with the unused portion permitted
to be carried forward on a linked basis. If the cost of fixed assets, as
defined in the Inflationary Adjustments Law, exceeds a company's equity,
then the excess multiplied by the applicable annual rate of inflation is
added to taxable income; and
|
|
·
|
subject
to specified limitations, depreciation deductions on fixed assets and
losses carried forward are adjusted for inflation based on the increase in
the consumer price index.
|
|
·
|
a
citizen or resident of the US;
|
|
·
|
a
corporation created or organized under the laws of the US, the District of
Columbia, or any state; or
|
|
·
|
a
trust or estate, treated, for US federal income tax purposes, as a
domestic trust or estate.
|
|
·
|
have
elected mark-to-market accounting;
|
|
·
|
hold
our ordinary shares as part of a straddle, hedge or conversion transaction
with other investments;
|
|
·
|
own
directly, indirectly or by attribution at least 10% of our voting
power;
|
|
·
|
are
tax exempt entities;
|
|
·
|
are
persons who acquire shares in connection with employment or other
performance of services; and
|
|
·
|
have
a functional currency that is not the US
dollar.
|
|
·
|
You
must include the gross amount of the dividend, not reduced by the amount
of Israeli tax withheld, in your US taxable
income.
|
|
·
|
You
may be able to claim the Israeli tax withheld as a foreign tax credit
against your US income tax liability. However, to the extent that
25% or more of our gross income from all sources was effectively connected
with the conduct of a trade or business in the US (or treated as
effectively connected, with limited exceptions) for a three-year period
ending with the close of the taxable year preceding the year in which the
dividends are declared, a portion of this dividend will be treated as US
source income, possibly reducing the allowable foreign
tax.
|
|
·
|
The
foreign tax credit is subject to significant and complex limitations.
Generally, the credit can offset only the part of your US tax attributable
to your net foreign source passive income. Additionally, if we pay
dividends at a time when 50% or more of our stock is owned by US persons,
you may be required to treat the part of the dividend attributable to US
source earnings and profits as US source income, possibly reducing the
allowable credit.
|
|
·
|
A
US holder will be denied a foreign tax credit with respect to Israeli
income tax withheld from dividends received on the ordinary shares to
the extent the US holder has not held the ordinary shares for at
least 16 days of the 31-day period beginning on the date which is 15 days
before the ex-dividend date
or, alternatively, to the extent the US holder is under an obligation to
make related payments with respect to substantially similar or related
property. Any days during which a US holder has substantially diminished
its risk of loss on the ordinary shares are not counted toward meeting the
16-day holding period required by the
statute.
|
|
·
|
If
you do not elect to claim foreign taxes as a credit, you will be entitled
to deduct the Israeli income tax withheld from your XTL dividends in
determining your taxable income.
|
|
·
|
Individuals
who do not claim itemized deductions, but instead utilize the standard
deduction, may not claim a deduction for the amount of the Israeli income
taxes withheld.
|
|
·
|
If
you are a US corporation holding our stock, the general rule is that you
cannot claim the dividends-received deduction with respect to our
dividends. There is an exception to this rule if you own at least
10% of our ordinary shares (by vote) and certain conditions are
met.
|
|
·
|
gain
recognized by the US holder upon the disposition of, as well as income
recognized upon receiving certain excess distributions on the
ordinary shares would be taxable as ordinary
income;
|
|
·
|
the
US holder would be required to allocate the excess distribution and/or
disposition gain ratably over such US holder's entire holding period for
such ordinary shares;
|
|
·
|
the
amount allocated to each year other than the year of the excess
distribution or disposition and pre-PFIC years would be subject to tax at
the highest applicable tax rate, and an interest charge would be imposed
with respect to the resulting tax
liability;
|
|
·
|
the
US holder would be required to file an annual return on IRS Form 8621 for
the years in which distributions were received on and gain was recognized
on dispositions of, our ordinary shares;
and
|
|
·
|
any
US holder who acquired the ordinary shares upon the death of the
shareholder would not receive a step-up to market value of his income tax
basis for such ordinary shares. Instead such US holder beneficiary would
have a tax basis equal to the decedent's basis, if
lower.
|
|
·
|
the
item is effectively connected with the conduct by the Non-US holder of a
trade or business in the US and, in the case of a resident of a country
which has a tax treaty with the US, the item is attributable to a
permanent establishment in the US;
|
|
·
|
the
non-US holder is subject to tax under the provisions of US tax law
applicable to US expatriates; or
|
|
·
|
the
individual non-US holder is present in the US for 183 days or more in the
taxable year of the disposition and certain other conditions are
met.
|
Item
|
Associated Fee
|
Depositary Action
|
||
1.
|
Taxes
and other governmental charges
|
As
applicable
|
||
2.
|
Registration
fees in effect for the registration of transfers of shares generally on
the share register of XTL or foreign registrar and applicable to transfers
of shares to or from the name of the Depositary or its nominee or the
custodian or its nominee on the making of deposits or
withdrawals
|
As
applicable
|
||
3.
|
Expenses
incurred by the Depositary
|
• Cable,
telex and facsimile transmission (where expressly provided for
in the Deposit Agreement)
• Foreign
currency conversion into U.S. dollars
|
||
4.
|
$5.00
or less per 100 ADSs (or portion thereof)
|
Execution
and delivery of ADRs for distributions and dividends in shares and rights
to subscribe for additional shares or rights of any other nature and
surrender of ADRs for the purposes of withdrawal, including the
termination of the Deposit Agreement
|
||
5.
|
$0.02
or less per ADS (or portion thereof)
|
Any
cash distribution made pursuant to the Deposit Agreement, including, among
other things:
• cash
distributions or dividends;
• distributions
other than cash, shares or rights;
• distributions
in shares; and
• rights
of any other nature, including rights to subscribe for additional
shares.
|
||
6.
|
A
fee for the distribution of securities equal to the fee for the execution
and delivery of ADSs which would have been charged as a result of the
deposit of such securities
|
Distributions
of securities other than cash, shares or rights
|
||
7.
|
A
fee of $.02 or less per ADS (or portion thereof) for depositary services,
which will accrue on the last day of each calendar year, provided,
however, that no fee will be assessed to the extent a fee of $.02 was
charged pursuant to Item 5 above during that calendar year
|
As
applicable
|
||
8.
|
|
Any
other charge payable by the Depositary, any of the Depositary's agents,
including its custodian, or the agents of the Depositary's agents in
connection with the servicing of shares or other deposited
securities
|
|
As
applicable
|
2009
|
2008
|
|||||||
(in
thousands US$)
|
||||||||
Audit
fees
|
62 | 79 | ||||||
Audit-related
fees
|
- | 36 | ||||||
Tax
fees
|
- | 2 | ||||||
All
Other fees
|
8 | 22 | ||||||
Total
|
70 | 139 |
Exhibit
Number
|
Description
|
|
3.1
|
Articles
of Association†
|
|
4.1
|
Form
of Share Certificate (including both Hebrew and English translations).
*
|
|
4.2
|
Form
of American Depositary Receipt (included in Exhibit 4.3).
†
|
|
4.3
|
Deposit
Agreement, dated as of August 31, 2005, by and between XTL
Biopharmaceuticals Ltd., The Bank of New York, as Depositary, and each
holder and beneficial owner of American Depositary Receipts issued
thereunder. †
|
|
4.5
|
Form
of Director and Senior Management Lock−up Letter. ^
|
|
10.13
|
1999
Share Option Plan dated June 1, 1999. †
|
|
10.15
|
2000
Share Option Plan dated April 12, 2000. †
|
|
10.16
|
2001
Share Option Plan dated February 28, 2001. †
|
|
10.17
|
Letter
of Understanding, dated August 5, 2005, relating to the License Agreement
dated June 2, 2004 between Cubist Pharmaceuticals, Inc. and XTL
Biopharmaceuticals Ltd. †
|
|
10.20
|
Employment
Agreement, dated as of January 3, 2006, between XTL Biopharmaceuticals
Ltd. and Ron Bentsur. ^
|
|
10.21
|
Agreement,
dated August 1, 2005, between XTL Biopharmaceuticals Ltd. and Michael S.
Weiss. †
|
|
10.22
|
Form
No. 1 of Director Service Agreement. †
|
|
10.23
|
Form
No. 2 of Director Service Agreement. †
|
|
10.24
|
Form
No. 3 of Director Service Agreement. †
|
|
10.25
|
Form
No. 4 of Director Indemnification Agreement†
|
|
10.26
|
License
Agreement Between XTL Biopharmaceuticals Ltd. and VivoQuest, Inc., dated
August 17, 2005†
|
|
10.27
|
Asset
Purchase Agreement Between XTL Biopharmaceuticals Ltd. and VivoQuest,
Inc., dated August 17, 2005†
|
|
10.28
|
Securities
Purchase Agreement, dated March 17, 2006, by and among XTL
Biopharmaceuticals Ltd., and the purchasers named therein.
#
|
|
10.29
|
Registration
Rights Agreement, dated March 22, 2006, by and among XTL
Biopharmaceuticals Ltd. and the purchasers named therein.
#
|
|
10.30
|
Form
of Ordinary Share Purchase Warrants, dated March 22, 2006, issued to the
purchasers under the Securities Purchase Agreement. ^
|
|
10.32
|
License
Agreement between XTL Development, Inc. and DOV Pharmaceutical, Inc.,
dated January 15, 2007. *
|
|
10.33
|
Employment
Agreement, dated as of January 1, 2006, between XTL Biopharmaceuticals
Ltd. and Bill Kessler.
*
|
10.34
|
Securities
Purchase Agreement, dated October 25, 2007, by and among XTL
Biopharmaceuticals Ltd., and the purchasers named therein.
#
|
|
10.35
|
Registration
Rights Agreement, dated October 25, 2007, by and among XTL
Biopharmaceuticals Ltd. and the purchasers named therein.
#
|
|
10.36
|
License
Agreement By and Between XTL Biopharmaceuticals Ltd. and Presidio
Pharmaceuticals, Inc. dated March 19, 2008. #
|
|
10.37
|
Amended
and Restated License Agreement By and Between XTL Biopharmaceuticals Ltd.
and Presidio Pharmaceuticals, Inc. dated August 4, 2008.
&,>
|
|
10.38
|
Services
Agreement, dated as of October 15, 2008, by and among XTL
Biopharmaceuticals Ltd., Quoque Bioventures LLC and Antecip Bioventures
LLC. +
|
|
10.39
|
Stock
Appreciation Rights Agreement, dated as of October 15, 2008, by and among
XTL Biopharmaceuticals Ltd., XTL Development Inc., and Quoque Bioventures
LLC. +
|
|
10.40
|
Registration
Rights Agreement, dated as of October 15, 2008, by and among XTL
Biopharmaceuticals Ltd., XTL Development Inc., and Quoque Bioventures LLC.
+
|
|
10.41
|
Stock
Appreciation Rights Agreement, dated as of October 15, 2008, by and among
XTL Biopharmaceuticals Ltd., XTL Development Inc., and Antecip Bioventures
LLC. +
|
|
10.42
|
Registration
Rights Agreement, dated as of October 15, 2008, by and among XTL
Biopharmaceuticals Ltd., XTL Development Inc., and Quoque Bioventures LLC.
+
|
|
10.43
|
Asset
Purchase Agreement, dated as of March 18, 2009 between XTL
Biopharmaceuticals Ltd. and Bio-Gal Ltd. &, >
|
|
10.44
|
Research
and License Agreement Between Yeda Research and Development Company Ltd.,
Mor Research Applications Ltd., Biogal Ltd. (under its previous name
Haverfield Ltd.) and Biogal Advanced Biotechnology Ltd. dated January 7,
2002. &, >
|
|
10.45
|
Amendment
to Research and License Agreement Between Yeda Research and Development
Company Ltd., Mor Research Applications Ltd., Haverfield Ltd. and Biogal
Advanced Biotechnology Ltd. effective as of April 1, 2008. &,
>
|
|
10.46
|
Amended
and Restated Asset Purchase Agreement, Originally dated as of March 18,
2009, by among XTEPO Ltd. and Bio-Gal Ltd.
|
|
10.47
|
Share
Transfer Agreement, made as of December 31, 2009, by and among XTEPO
Ltd., XTL Biopharmaceuticals Ltd., and all of the shareholders and option
holders of XTL Biopharmaceuticals Ltd.
|
|
10.48
|
Notice
of Termination Agreement to Bicifadine License, dated March 4,
2010.
|
|
10.49
|
Employment
Agreement, dated as of January 18, 2010, between XTL Biopharmaceuticals
Ltd. and David Grossman.
|
|
10.50
|
Employment
Agreement, dated as of July 29, 2009, between XTL Biopharmaceuticals Ltd.
and Ronen Twito.
|
|
21.1
|
List
of Subsidiaries
|
|
23.1
|
Consent
of Kesselman & Kesselman, a member of PricewaterhouseCoopers
International Ltd, dated June 28, 2010.
|
|
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
June 28, 2010.
|
|
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
June 28, 2010.
|
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 June 28, 2010
|
XTL
BIOPHARMACEUTICALS LTD.
|
||
(Registrant)
|
||
Signature:
|
/s/ David Grossman
|
|
David
Grossman
|
||
Chief
Executive Officer
|
Page
|
|
Auditors'
Report
|
F-2
|
Consolidated
Financial Statements - in U.S. dollars:
|
|
Statements
of Financial Position
|
F-3
|
Statements
of Comprehensive Income
|
F-4
|
Statement
of Changes in Equity
|
F-5
|
Statement
of Cash Flows
|
F-6
- F-7
|
Notes
to Consolidated Financial Statements
|
F-8
- F-61
|
Kesselman
& Kesselman
Certified
Public Accountants
Trade
Tower, 25 Hamered Street
Tel
Aviv 68125 Israel
P.O
Box 452 Tel Aviv 61003
Telephone
+972-3-7954555
Facsimile
+972-3-7954556
|
December 31,
|
January 1,
|
||||||||||||||||||
2009
|
2008
|
2007
|
2007
|
||||||||||||||||
Note
|
U.S.
dollars in thousands
|
||||||||||||||||||
ASSETS
|
|||||||||||||||||||
CURRENT
ASSETS:
|
|||||||||||||||||||
Cash
and cash equivalents
|
5
|
412 | 2,924 | 2,377 | 4,400 | ||||||||||||||
Short-term
deposits
|
6
|
- | - | 10,600 | 20,845 | ||||||||||||||
Financial
assets at fair value through profit or loss
|
- | - | - | 102 | |||||||||||||||
Assets
held for sale
|
- | - | - | 18 | |||||||||||||||
Employee
benefit assets
|
13
|
- | 12 | - | - | ||||||||||||||
Accounts
receivable
|
7
|
33 | 305 | 654 | 609 | ||||||||||||||
Income
taxes receivable
|
72 | 49 | 270 | - | |||||||||||||||
Restricted
deposits
|
40 | 71 | - | - | |||||||||||||||
|
|||||||||||||||||||
|
557 | 3,361 | 13,901 | 25,974 | |||||||||||||||
NON-CURRENT
ASSETS:
|
|||||||||||||||||||
Restricted
deposits
|
- | - | 61 | 172 | |||||||||||||||
Employee
benefit assets
|
13
|
- | - | 16 | - | ||||||||||||||
Fixed
assets
|
9
|
23 | 41 | 106 | 490 | ||||||||||||||
Intangible
assets
|
10
|
- | - | 9,294 | 1,808 | ||||||||||||||
Other
investments
|
1b
|
135 | - | - | - | ||||||||||||||
Deferred
tax assets
|
- | - | - | 48 | |||||||||||||||
|
|||||||||||||||||||
|
158 | 41 | 9,477 | 2,518 | |||||||||||||||
|
|||||||||||||||||||
Total
assets
|
715 | 3,402 | 23,378 | 28,492 | |||||||||||||||
|
|||||||||||||||||||
LIABILITIES
AND EQUITY
|
|||||||||||||||||||
|
|||||||||||||||||||
CURRENT
LIABILITIES:
|
|||||||||||||||||||
Trade
payables
|
11
|
192 | 416 | 2,144 | 941 | ||||||||||||||
Other
accounts payable
|
12
|
516 | 1,058 | 1,665 | 1,834 | ||||||||||||||
Income
taxes payable
|
- | - | - | 143 | |||||||||||||||
Deferred
revenue
|
- | - | - | 399 | |||||||||||||||
Retirement
benefit obligation
|
13
|
- | 447 | - | - | ||||||||||||||
Liability
for share appreciation rights
|
14
|
- | 7 | 1,560 | - | ||||||||||||||
708 | 1,928 | 5,369 | 3,317 | ||||||||||||||||
NON-CURRENT
LIABILITIES:
|
|||||||||||||||||||
Retirement
benefit obligation
|
- | - | 131 | 223 | |||||||||||||||
Deferred
revenue
|
- | - | - | 398 | |||||||||||||||
- | - | 131 | 621 | ||||||||||||||||
EQUITY
ATTRIBUTABLE TO EQUITY HOLDERS OF THE PARENT:
|
16
|
||||||||||||||||||
Share
capital
|
1,445 | 1,445 | 1,444 | 1,072 | |||||||||||||||
Share
premium
|
139,786 | 139,786 | 139,577 | 131,153 | |||||||||||||||
Accumulated
deficit
|
(141,224 | ) | (139,757 | ) | (123,143 | ) | (107,671 | ) | |||||||||||
Total
equity
|
7 | 1,474 | 17,878 | 24,554 | |||||||||||||||
|
|||||||||||||||||||
Total
liabilities and equity
|
715 | 3,402 | 23,378 | 28,492 |
Amit
Yonay
|
David
Grossman
|
Ronen
Twito
|
||
Chairman
of the Board
|
Director
and CEO
|
CFO
|
Year
ended December 31,
|
|||||||||||||||
2009
|
2008
|
2007
|
|||||||||||||
Note
|
U.S.
dollars in thousands (except per share data)
|
||||||||||||||
Revenues
|
17
|
- | 5,940 | 907 | |||||||||||
Cost
of revenues
|
17
|
- | 1,841 | 110 | |||||||||||
Gross
profit
|
- | 4,099 | 797 | ||||||||||||
Research
and development costs
|
18
|
- | 11,722 | 11,500 | |||||||||||
General
and administrative expenses
|
19
|
(2,429 |
)*)
|
3,937 | 7,596 | ||||||||||
Impairment
loss of intangible asset
|
10
|
- | 7,500 | - | |||||||||||
Other
gains (losses), net
|
20
|
139 | 288 | (8 | ) | ||||||||||
Operating
income (loss)
|
2,568 | (18,772 | ) | (18,307 | ) | ||||||||||
Finance
income
|
21
|
6 | 331 | 668 | |||||||||||
Finance
costs
|
21
|
10 | 17 | 30 | |||||||||||
Financial
income (costs), net
|
(4 | ) | 314 | 638 | |||||||||||
Income
(loss) before taxes on income
|
2,564 | (18,458 | ) | (17,669 | ) | ||||||||||
tax
benefit
|
22
|
(23 | ) | (31 | ) | (206 | ) | ||||||||
Net
income (loss) for the year attributable to equity holders of the
parent
|
2,587 | (18,427 | ) | (17,463 | ) | ||||||||||
Basic
and diluted earnings (loss) per share
(in U.S. dollars) **)
|
23
|
0.044 | (0.315 | ) | (0.382 | ) |
*)
|
Including
reduced expenses which result from forfeiture of shares that were
contingent on the performance of the former chairman and CEO, see also
Note 16b.
|
**)
|
After
taking into account capital consolidation effected on June 22, 2009,
see Note 16a(2).
|
Year
ended December 31, 2009
|
|||||||||||||||||||
Share
capital
|
Share
premium
|
Accumulated
deficit
|
Total
|
||||||||||||||||
Note
|
U.S.
dollars in thousands
|
||||||||||||||||||
Balance
at January 1, 2009
|
1,445 | 139,786 | (139,757 | ) | 1,474 | ||||||||||||||
Net
income for the year
|
- | - | 2,587 | 2,587 | |||||||||||||||
Share-based
payment to employees and others
|
16
|
- | - | (4,180 | ) | (4,180 | ) | ||||||||||||
Transfer
to equity for liability for share appreciation rights
|
14
|
- | - | 126 | 126 | ||||||||||||||
Balance
at December 31, 2009
|
1,445 | 139,786 | (141,224 | ) | 7 |
Year
ended December 31, 2008
|
|||||||||||||||||||
Share
capital
|
Share
premium
|
Accumulated
deficit
|
Total
|
||||||||||||||||
Note
|
U.S.
dollars in thousands
|
||||||||||||||||||
Balance
at January 1, 2008
|
1,444 | 139,577 | (123,143 | ) | 17,878 | ||||||||||||||
Loss
for the year
|
- | - | (18,427 | ) | (18,427 | ) | |||||||||||||
Share-based
payment to employees and others
|
16
|
- | - | 1,813 | 1,813 | ||||||||||||||
Exercise
of options
|
16
|
1 | 32 | - | 33 | ||||||||||||||
Refund
of stamp duty on share issuance
|
- | 177 | - | 177 | |||||||||||||||
Balance
at December 31, 2008
|
1,445 | 139,786 | (139,757 | ) | 1,474 |
Year
ended December 31, 2007
|
|||||||||||||||||||
Share
capital
|
Share
premium
|
Accumulated
deficit
|
Total
|
||||||||||||||||
Note
|
U.S.
dollars in thousands
|
||||||||||||||||||
Balance
at January 1, 2007
|
1,072 | 131,153 | (107,671 | ) | 24,554 | ||||||||||||||
Loss
for the year
|
- | - | (17,463 | ) | (17,463 | ) | |||||||||||||
Issue
of shares
|
16
|
372 | 8,420 | - | 8,792 | ||||||||||||||
Share-based
payment to employees and others
|
16
|
- | - | 1,991 | 1,991 | ||||||||||||||
Exercise
of options
|
16
|
- | *) | 4 | - | 4 | |||||||||||||
Balance
at December 31, 2007
|
1,444 | 139,577 | (123,143 | ) | 17,878 |
*)
|
Less
than $ 1,000.
|
Year
ended December 31,
|
|||||||||||||||
2009
|
2008
|
2007
|
|||||||||||||
Note
|
U.S.
dollars in thousands
|
||||||||||||||
Cash flows from operating
activities:
|
|||||||||||||||
Net
income (loss) for the year attributable to equity holders of the
parent
|
2,587 | (18,427 | ) | (17,463 | ) | ||||||||||
Adjustments
to reconcile net income (loss) to net cash used in operating
activities (a)
|
(5,075 | ) | 7,849 | 3,543 | |||||||||||
Net
cash used in operating activities
|
(2,488 | ) | (10,578 | ) | (13,920 | ) | |||||||||
Cash flows from investing
activities:
|
|||||||||||||||
Decrease
(increase) in restricted deposit
|
6
|
31 | (10 | ) | 113 | ||||||||||
Decrease
in short-term bank deposits
|
10
|
- | 10,600 | 10,245 | |||||||||||
Purchase
of intangible assets
|
9
|
- | - | (7,500 | ) | ||||||||||
Purchase
of fixed assets
|
9,
20
|
- | (2 | ) | (65 | ) | |||||||||
Proceeds
from sale of fixed assets and held for sale assets
|
- | 327 | 308 | ||||||||||||
Other
investments
|
1b
|
(55 | ) | - | - | ||||||||||
Net
cash provided by (used in) investing activities
|
(24 | ) | 10,915 | 3,101 | |||||||||||
Cash flows from financing
activities:
|
|||||||||||||||
Proceeds
from issue of shares
|
16
|
- | - | 8,792 | |||||||||||
Refund
of stamp duty paid in 2004 for share issuance
|
- | 177 | - | ||||||||||||
Exercise
of options
|
16
|
- | 33 | 4 | |||||||||||
Net
cash provided by financing activities
|
- | 210 | 8,796 | ||||||||||||
Increase
(decrease) in cash and cash equivalents
|
(2,512 | ) | 547 | (2,023 | ) | ||||||||||
Cash
and cash equivalents at the beginning of the year
|
2,924 | 2,377 | 4,400 | ||||||||||||
Cash
and cash equivalents at the end of the year
|
412 | 2,924 | 2,377 |
Year
ended December 31,
|
||||||||||||||||
2009
|
2008
|
2007
|
||||||||||||||
Note
|
U.S.
dollars in thousands
|
|||||||||||||||
(a)
|
Adjustments to reconcile net income (loss) to net
cash used in operating activities:
|
|||||||||||||||
Income
and expenses not involving cash flows:
|
||||||||||||||||
Depreciation
and amortization
|
9,10
|
13 | 39 | 108 | ||||||||||||
Loss
(gain) on sale of fixed assets
|
20
|
5 | (288 | ) | (40 | ) | ||||||||||
Share
options granted to directors, employees and service
providers
|
16
|
(4,180 | ) | 1,813 | 1,991 | |||||||||||
Impairment
of intangible assets
|
10
|
- | 7,500 | - | ||||||||||||
Impairment
of fixed assets
|
9
|
- | - | 105 | ||||||||||||
Change
in intangible assets
|
10
|
- | 1,783 | - | ||||||||||||
Change
in retirement benefit obligation, net
|
13
|
(435 | ) | 320 | (108 | ) | ||||||||||
Change
in liability for share appreciation rights
|
14
|
119 | (1,553 | ) | 1,560 | |||||||||||
Change
in deferred taxes
|
22
|
- | - | 48 | ||||||||||||
Proceeds
from sale of securities at fair value through profit or loss,
net
|
- | - | 54 | |||||||||||||
Change
in fair value of financial assets at fair value through profit or
loss
|
- | - | 48 | |||||||||||||
Finance
costs on restricted deposit
|
- | - | (2 | ) | ||||||||||||
(4,478 | ) | 9,614 | 3,764 | |||||||||||||
Changes
in operating asset and liability items:
|
||||||||||||||||
Change
in deferred revenues
|
- | - | (797 | ) | ||||||||||||
Decrease
(increase) in accounts receivable
|
7
|
249 | 570 | (315 | ) | |||||||||||
Decrease
in other accounts payable
|
12
|
(542 | ) | (607 | ) | (312 | ) | |||||||||
Increase
(decrease) in trade payables
|
11
|
(304 | ) | (1,728 | ) | 1,203 | ||||||||||
(597 | ) | (1,765 | ) | (221 | ) | |||||||||||
(5,075 | ) | 7,849 | 3,543 | |||||||||||||
(b)
|
Additional information on cash flows from
operating activities:
|
|||||||||||||||
Interest
received
|
3 | 390 | 921 | |||||||||||||
Interest
paid
|
- | 3 | 4 | |||||||||||||
Refund
of taxes on income
|
- | 262 | - | |||||||||||||
Payment
of taxes on income
|
- | 2 | 165 |
(c)
|
Non-cash
investing activities for the year ended December 31, 2009 total at
approximately $ 80 thousand and it derives from deferred charges in
connection with Bio-Gal (Xtepo) transaction which were recorded in the
line item "other investments" (see Note 1b
below).
|
NOTE
1:-
|
GENERAL
|
|
a.
|
A
general description of the Company and its
activity:
|
b.
|
In
furtherance to the restructuring plan, in March 2009, the Company entered
into an asset purchase agreement with Bio-Gal Ltd. for the rights to use a
patent on Recombinant Erythropoietin ("EPO") for the prolongation of
multiple myeloma patients' survival and improvement of their quality of
life. In accordance with agreement, the Company will issue Bio-Gal
Ordinary shares representing just under 50% of the issued share capital of
the Company at closing date. In addition, the Company will make milestone
payments of $ 10 million in cash upon the successful completion of a
Phase 2b clinical trial. The Company's Board may, in its sole discretion,
issue additional shares to Bio-Gal in lieu of such cash payment. The
Company is also obligated to pay 1% royalties on net sales of the
product.
|
NOTE
1:-
|
GENERAL
(cont)
|
|
1.
|
The
completion of a successful fundraising by the Company or Xtepo at any time
after the successful completion of the phase 2 of an amount of minimum $ 2
million.
|
|
2.
|
Six
months from the successful completion of phase
2.
|
|
c.
|
In
2005, the Company acquired patent rights and other assets of VivoQuest
Inc. ("VivoQuest"), covering a compound library, which includes certain
compounds for the development of the DOS. Part of these rights was sold
during 2008 to Presidio.
|
|
d.
|
As
of December 31, 2009, the Company has accumulated losses in the amount of
approximately $ 141.2 million and equity in the amount of $ 7
thousand. The continuation of the Company's operations is dependent on
closing the Bio-Gal transaction and obtaining its funds or raising funds
from alternative sources.
|
NOTE
2:-
|
SIGNIFICANT
ACCOUNTING POLICIES
|
|
a.
|
Basis
of presentation of the financial
statements:
|
1.
|
Until
December 31, 2008, the consolidated financial statements of the Company
have been prepared in accordance with U.S.
GAAP.
|
1.
|
International
Financial Reporting Standards
(IFRS),
|
2.
|
International
Accounting Standards (IAS), and
|
3.
|
Interpretations
originated by the International Financial Reporting Interpretations
Committee (IFRIC) or the former Standing Interpretations Committee
(SIC).
|
2.
|
The
Company's financial statements as of December 31, 2009, 2008 and 2007
and January 1, 2007 and for each of the three years in the period
ended December 31, 2009 have been prepared in accordance with IFRS
and Interpretations originated by the International Financial Reporting
Interpretations Committee (IFRIC) and include the additional disclosure in
accordance with the Israeli Securities Regulations (Annual Financial
Statements), 2010.
|
NOTE
2:-
|
SIGNIFICANT
ACCOUNTING POLICIES (Cont.)
|
|
3.
|
The
Group's operating cycle is 12
months.
|
4.
|
The
Company analyses the expenses recognized in the statement of comprehensive
income by classification based on the function of
expense.
|
Change in the
|
||||
exchange rate
|
||||
Year ended
|
of U.S. $ 1
|
|||
%
|
||||
December
31, 2009
|
(0.71 | ) | ||
December
31, 2008
|
(1.14 | ) | ||
December
31, 2007
|
(8.97 | ) | ||
December
31, 2006
|
(8.21 | ) | ||
Exchange rate
|
||||
As of
|
of U.S. $ 1
|
|||
NIS
|
||||
December
31, 2009
|
3.775 | |||
December
31, 2008
|
3.802 | |||
December
31, 2007
|
3.846 | |||
December
31, 2006
|
4.225 |
NOTE
2:-
|
SIGNIFICANT
ACCOUNTING POLICIES (Cont.)
|
d.
|
Fixed
assets:
|
%
|
|||
Laboratory
equipment
|
10
- 20
|
||
Computers
|
33
|
||
Office
furniture and equipment
|
6 -
16
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
2.
|
Recognition
and measurement:
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
-
|
it
is technically feasible to complete the intangible asset so that it will
be available for use;
|
-
|
management
intends to complete the intangible asset and use or sell
it;
|
-
|
there
is an ability to use or sell the intangible
asset;
|
-
|
it
can be demonstrated how the intangible asset will generate probable future
economic benefits;
|
-
|
adequate
technical, financial and other resources to complete the development and
to use or sell the intangible asset are available;
and
|
-
|
the
expenditure attributable to the intangible asset during its development
can be reliably measured.
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
1.
|
Revenues
from transfer of rights to use development which include the Group's
involvement during the development period, are recognized on a
straight-line basis over the expected term of the
agreement.
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
|
2.
|
Revenues
from sale of DOS development rights to Presidio and rendering of ongoing
services by the Company are recognized as
follows:
|
|
a)
|
The
fair value of labor services by the Group's employees is recognized over
the service term.
|
|
b)
|
The
difference between the sale consideration and the fair value of labor
services is recognized at the date of transaction as revenues from sale of
DOS development rights.
|
|
3.
|
Interest
income are recognized on a periodic basis using the effective interest
method.
|
1.
|
Basic
earnings per share is calculated by dividing income or loss attributable
to equity holders of the parent by the weighted average number of Ordinary
shares outstanding during the
period.
|
|
2.
|
For
the purpose of calculating diluted earnings or loss per share, the number
of Ordinary shares shall be the average Ordinary shares calculated in
basic earnings per share plus the weighted average number of shares that
would be issued on the conversion of all the dilutive potential shares
into shares. Potential Ordinary shares are taken into account as above
only when their conversion is dilutive (decreases the earnings or
increases the loss per share).
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
|
s.
|
New
and amended IFRS standards and IFRIC
interpretations:
|
|
a)
|
IAS
27 (revised), "Consolidated and Separate Financial Statements" ("IAS 27R")
(effective for annual periods beginning on or after July 1, 2009).
IAS 27R requires the effects of all transactions with non-controlling
interests to be recorded in equity if there is no change in control and
these transactions will no longer result in goodwill or gains and losses.
IAS 27R also specifies the accounting when control of the entity is lost.
Any remaining interest in the entity is remeasured to fair value, and a
gain or loss is recognized in profit or loss. The Company/Group will apply
IAS 27R prospectively to all transactions with non-controlling interests
from January 1, 2010.
|
|
b)
|
IFRS
3 (revised), "Business Combinations" ("IFRS 3") (effective for annual
periods beginning on or after July 1, 2009). The revised standard
continues to apply the acquisition method to business combinations, with
some significant changes. For example, all payments to purchase a business
are to be recorded at fair value at the acquisition date, with contingent
payments classified as debt subsequently remeasured through the statement
of income. There is a choice on an acquisition-by-acquisition basis to
measure the non-controlling interest in the acquiree at fair value or at
the non-controlling interest's proportionate share of the acquiree's net
assets. All acquisition-related costs should be expensed. The Company will
apply IFRS 3R prospectively to all business combinations from
January 1, 2010.
|
|
c)
|
IFRS
9, "Financial Instruments" ("IFRS 9"). IFRS 9 was issued in November 2009
and it represents the first milestone in the three stages planned
replacement of IAS 39, "Financial Instruments: Recognition and
Measurement" ("IAS 39"). The first issued part replaces the sections
of IAS 39 which deal with the classification and measurement of financial
assets. Below are summarized principles of IFRS
9:
|
|
-
|
Financial
assets are classified into one of the two following categories: fair value
and amortized cost. The decision to which category a financial asset
should be classified is made on initial recognition. This classification
is driven by the entity's business model for managing financial
instruments and the contractual characteristics of the cash flows from the
instrument.
|
|
-
|
A
hybrid contract with a financial asset host is classified in its entirety
into one of the above categories without separating the embedded
derivative from a host contract.
|
|
-
|
A
financial asset is measured after initial recognition at amortized cost
only if two criteria are met: (a) the objective of the business model is
to hold the financial asset for the collection of the contractual cash
flows; and (b) the contractual cash flows under the instrument solely
represent payments of principal and interest (in other words, the
instrument has only basic features of a
loan).
|
|
-
|
Financial
assets that are debt instruments not meeting the above criteria are
measured at fair value through profit or
loss.
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
|
-
|
Financial
assets that are equity instruments should be measured at fair value, as
follows:
|
|
i.
|
Equity
instruments held-for-trading should be measured at fair
value.
|
|
ii.
|
As
for other equity instruments, an entity has an option to choose on initial
recognition (irrevocable designation) to recognize subsequent changes in
fair value in other comprehensive income. If the above is chosen, there is
no recycling of fair value gains and losses to profit or loss even if the
instrument is disposed. However, dividends from such instruments will be
recognized in profit or loss. Such designation is on an
instrument-by-instrument basis. Equity instruments which were not
designated as above, should be measured at fair value through profit or
loss.
|
|
d)
|
Amendment
to IAS 7, "Cash Flows Statements" ("the amendment to IAS 7"). This
amendment is part of the IASB's annual improvements project published in
April 2009. This amendment requires that only expenditures that result in
a recognized asset in the statement of financial position can be
classified as investing activities. The amendment to IAS 7 is applied
retrospectively for annual periods beginning on or after January 1,
2010. Earlier application is permitted. The Group will apply this
amendment from January 1, 2010 and it is not expected to have a material
impact on the financial statements.
|
|
e)
|
Amendment
to IAS 38, "Intangible Assets" ("the amendment to IAS 38"). This amendment
is part of the IASB's annual improvements project published in April 2009.
The amendment to IAS 38 clarifies, among others, the requirements in IFRS
3 (revised), "Business Combinations" ("IFRS 3R") regarding the accounting
treatment of intangible assets acquired in a business combination. This
amendment permits the grouping of intangible assets as a single asset if
each asset has similar useful economic lives. The amendment to IAS 38 is
applied prospectively for annual periods beginning on or after
January 1, 2010. Earlier application is permitted. If an entity
applies IFRS 3 for an earlier period, the amendment to IAS 38 shall be
applied for that earlier period. The Group will apply the amendment to IAS
38 from January 1, 2010. At this stage, the impact, if any, on the
financial statements can not be
assessed.
|
|
f)
|
Amendment
to IAS 38, "Intangible Assets" ("the amendment to IAS 38"). This amendment
is part of the IASB's annual improvements project published in April 2009.
This amendment clarifies, among others, the description of valuation
techniques used when measuring the fair value of intangible assets
acquired in a business combination that are not traded in active markets.
The amendment to IAS 38 is applied prospectively for annual periods
beginning on or after January 1, 2010. Earlier application is
permitted. The Group will apply the amendment to IAS 38 from January 1,
2010. At this stage, the impact, if any, on the financial statements can
not be assessed.
|
NOTE
3:-
|
CRITICAL
ACCOUNTING ESTIMATES AND JUDGMENTS
|
|
a.
|
Share-based
payments as well as liability for share appreciation rights (see
Note 2n) - in evaluating the fair value and the recognition method of
share-based payment, the Company's management is to estimate, among
others, different parameters included in the computation of the fair value
of the options and the Company's results and the number of options that
will vest. Actual results and estimates to be made in the future may
significantly differ from current
estimates.
|
|
b.
|
Intangible
assets - in testing impairment of intangible assets of research and
development, the Company's management is to estimate, among others, the
probable endpoints of trials conducted by the Company, the commercial
technical feasibility of the development and the resulting economic
benefits. Actual results and estimates to be made in the future may
significantly differ from current
estimates.
|
|
c.
|
Taxes
on income and deferred taxes - the Group is subject to taxes in Israel and
in the U.S. Significant judgment is required by the Company's management
in determining the provision for income taxes. There are many transactions
and calculations in the ordinary course of the Group for which the
ultimate tax determination is uncertain. Where the final tax outcome of
these matters is different from the amounts that were initially recorded,
such differences will impact the current and deferred income taxes in the
period in which such determination is
made.
|
NOTE
4:-
|
FINANCIAL
INSTRUMENTS AND FINANCIAL RISK
MANAGEMENT
|
NOTE
4:-
|
FINANCIAL
INSTRUMENTS AND FINANCIAL RISK MANAGEMENT
(Cont.)
|
NOTE
4:-
|
FINANCIAL
INSTRUMENTS AND FINANCIAL RISK MANAGEMENT
(Cont.)
|
December 31,
|
January 1,
|
|||||||||||||||
2009
|
2008
|
2007
|
2007
|
|||||||||||||
U.S.
dollars in thousands
|
||||||||||||||||
Cash
at banks, short-term deposits and restricted deposits:
|
||||||||||||||||
AAA
|
- | 1,305 | 6,187 | 11,319 | ||||||||||||
AA+
|
440 | - | - | - | ||||||||||||
AA
|
- | 1,056 | 6,505 | - | ||||||||||||
AA-
|
10 | 632 | 341 | 14,088 | ||||||||||||
Cash
not in banks
|
2 | 2 | 5 | 10 | ||||||||||||
452 | 2,995 | 13,038 | 25,417 |
NOTE
5:-
|
CASH
AND CASH EQUIVALENTS
|
December 31,
|
January 1,
|
|||||||||||||||
2009
|
2008
|
2007
|
2007
|
|||||||||||||
U.S.
dollars in thousands
|
||||||||||||||||
Cash
at bank and on hand
|
358 | 2,700 | 2,314 | 473 | ||||||||||||
Short-term
bank deposits
|
54 | 224 | 63 | 3,927 | ||||||||||||
412 | 2,924 | 2,377 | 4,400 |
December 31,
|
January 1,
|
|||||||||||||||
2009
|
2008
|
2007
|
2007
|
|||||||||||||
U.S.
dollars in thousands
|
||||||||||||||||
NIS
|
81 | 24 | 55 | 228 | ||||||||||||
U.S.
dollar
|
331 | 2,897 | 2,316 | 4,172 | ||||||||||||
U.K.
Pound
|
- | 3 | 6 | - | ||||||||||||
412 | 2,924 | 2,377 | 4,400 |
NOTE
6:-
|
SHORT-TERM
DEPOSITS
|
NOTE
7:-
|
ACCOUNTS
RECEIVABLE
|
a.
|
Composition:
|
December 31,
|
January 1,
|
|||||||||||||||
2009
|
2008
|
2007
|
2007
|
|||||||||||||
U.S.
dollars in thousands
|
||||||||||||||||
Accrued
income
|
- | - | 61 | 317 | ||||||||||||
Government
authorities
|
8 | 69 | 21 | 8 | ||||||||||||
Prepaid
expenses
|
21 | 211 | 553 | 259 | ||||||||||||
Other
receivables
|
4 | 25 | 19 | 25 | ||||||||||||
33 | 305 | 654 | 609 |
|
b.
|
The
carrying amount of other accounts receivable which represent monetary
items is denominated in the following
currencies:
|
December 31,
|
January 1,
|
|||||||||||||||
2009
|
2008
|
2007
|
2007
|
|||||||||||||
U.S.
dollars in thousands
|
||||||||||||||||
NIS
|
8 | 2 | 40 | 12 | ||||||||||||
U.S.
dollar
|
4 | 92 | 61 | 338 | ||||||||||||
Total
|
12 | 94 | 101 | 350 |
NOTE
8:-
|
ADDITIONAL
INFORMATION ABOUT INVESTMENT IN
SUBSIDIARY
|
Name
and country of
incorporation
|
%
interest
held
|
Scope
of investments
|
Dividends
received
or
receivable
|
|||
XTL
Biopharmaceuticals Inc.,
|
100%
equity
|
31.12.2009
- $ (1,728) thousand
|
-
|
|||
incorporated
in Delaware
|
interest
and
|
31.12.2008
- $ (11,106) thousand
|
-
|
|||
voting
rights
|
31.12.2007
- $ 5,116 thousand
|
-
|
||||
1.1.2007 -
$ 702 thousand
|
-
|
NOTE
9:-
|
FIXED
ASSETS
|
|
a.
|
Composition
of fixed assets and accumulated depreciation, by major classes, and the
movement therein in 2009 are:
|
Cost
|
Accumulated depreciation
|
|||||||||||||||||||||||||||||||||||||||
Opening
|
Additions
|
Disposals
|
Closing
|
Opening
|
Additions
|
Disposals
|
Closing
|
Depreciated cost
|
||||||||||||||||||||||||||||||||
book
|
during the
|
during the
|
book
|
book
|
during the
|
during the
|
book
|
December 31,
|
||||||||||||||||||||||||||||||||
amount
|
year
|
year
|
amount
|
amount
|
year
|
year
|
amount
|
2009
|
2008
|
|||||||||||||||||||||||||||||||
U.S.
dollars in thousands
|
||||||||||||||||||||||||||||||||||||||||
Office
furniture and equipment (including computers)
|
162 | - | (24 | ) | 138 | 121 | 13 | (19 | ) | 115 | 23 | 41 | ||||||||||||||||||||||||||||
Leasehold
improvements
|
141 | - | (141 | ) | - | 141 | - | (141 | ) | - | - | - | ||||||||||||||||||||||||||||
303 | - | (165 | ) | 138 | 262 | 13 | (160 | ) | 115 | 23 | 41 |
Cost
|
Accumulated depreciation
|
|||||||||||||||||||||||||||||||||||||||
Opening
|
Additions
|
Disposals
|
Closing
|
Opening
|
Additions
|
Disposals
|
Closing
|
Depreciated cost
|
||||||||||||||||||||||||||||||||
book
|
during the
|
during the
|
book
|
book
|
during the
|
during the
|
book
|
December 31,
|
||||||||||||||||||||||||||||||||
amount
|
year
|
year
|
amount
|
amount
|
year
|
year
|
amount
|
2008
|
2007
|
|||||||||||||||||||||||||||||||
U.S.
dollars in thousands
|
||||||||||||||||||||||||||||||||||||||||
Office
furniture and equipment (including computers)
|
318 | 2 | (158 | ) | 162 | 216 | 28 | (123 | ) | 121 | 41 | 102 | ||||||||||||||||||||||||||||
Leasehold
improvements
|
141 | - | - | 141 | 141 | - | - | 141 | - | - | ||||||||||||||||||||||||||||||
Laboratory
equipment
|
119 | - | (119 | ) | - | 115 | - | (115 | ) | - | - | 4 | ||||||||||||||||||||||||||||
578 | 2 | (277 | ) | 303 | 472 | 28 | (238 | ) | 262 | 41 | 106 |
NOTE
9:-
|
FIXED
ASSETS (Cont.)
|
Cost
|
Accumulated depreciation
|
|||||||||||||||||||||||||||||||||||||||||||
Opening
|
Additions
|
Disposals
|
Closing
|
Opening
|
Additions
|
Disposals
|
Closing
|
Depreciated cost
|
||||||||||||||||||||||||||||||||||||
book
|
during the
|
during the
|
book
|
book
|
during the
|
during the
|
book
|
December 31,
|
January 1,
|
|||||||||||||||||||||||||||||||||||
amount
|
year
|
year
|
amount
|
amount
|
year
|
Impairment
|
year
|
amount
|
2007
|
2007
|
||||||||||||||||||||||||||||||||||
U.S.
dollars in thousands
|
||||||||||||||||||||||||||||||||||||||||||||
Office
furniture and equipment (including computers)
|
383 | 65 | (130 | ) | 318 | 279 | 33 | - | (96 | ) | 216 | 102 | 104 | |||||||||||||||||||||||||||||||
Leasehold
improvements
|
572 | - | (431 | ) | 141 | 572 | - | - | (431 | ) | 141 | - | - | |||||||||||||||||||||||||||||||
Laboratory
equipment
|
1,281 | - | (1,162 | ) | 119 | 895 | 61 | 105 | (946 | ) | 115 | 4 | 386 | |||||||||||||||||||||||||||||||
2,236 | 65 | (1,723 | ) | 578 | 1,746 | 94 | 105 | (1,473 | ) | 472 | 106 | 490 |
|
b.
|
Additional
information:
|
|
1.
|
In
2007, the Group's management examined the recoverable amount of fixed
assets and recorded an impairment of laboratory equipment of
$ 105 thousand. The impairment has been charged in research and
development costs.
|
|
2.
|
In
2009, depreciation of fixed assets of $ 13 thousand has been charged
in general and administrative expenses (2008 - $ 28 thousand and 2007
- $ 28 thousand) and no depreciation has been charged in research and
development costs (2008 - $ 0 thousand and 2007 - $ 66
thousand).
|
NOTE
10:-
|
INTANGIBLE
ASSETS
|
|
a.
|
On
November 18, 2008, the Company published the results of Phase 2b
clinical trial of Bicifadine for diabetic neuropathic pain which testified
that the therapeutic did not meet its endpoints and, therefore, the
development activity was ceased. On this date, an intangible asset of
$ 7.5 million representing the acquired development rights was
impaired, see also
Note 26d(4).
|
|
b.
|
As
part of the Company's license agreement with VivoQuest (see
Note 15a(3)), the Company allocated the acquisition cost to fixed
assets and intangible assets, based on the fair value at the date of
acquisition.
|
U.S. dollars
in thousands
|
||||
Fair
value of Company's shares issued upon acquisition
|
1,391 | |||
Cash
paid
|
400 | |||
Direct
acquisition costs
|
148 | |||
Total
acquisition cost
|
1,939 | |||
Assets
arising on acquisition:
|
||||
Fixed
assets
|
113 | |||
Intangible
assets:
|
||||
In-process
research and development assets
|
1,783 | |||
Employment
contracts with professional staff
|
43 | |||
Total
intangible assets
|
1,826 | |||
Total
assets arising on acquisition
|
1,939 |
NOTE
11:-
|
TRADE
PAYABLES
|
December
31,
|
January
1,
|
|||||||||||||||
2009
|
2008
|
2007
|
2007
|
|||||||||||||
U.S.
dollars in thousands
|
||||||||||||||||
Open
accounts
|
170 | 416 | 2,144 | 941 | ||||||||||||
Checks
payable
|
22 | - | - | - | ||||||||||||
Total
|
192 | 416 | 2,144 | 941 |
|
b.
|
The
carrying amount of other trade payables is denominated in the following
currencies:
|
December
31,
|
January
1,
|
|||||||||||||||
2009
|
2008
|
2007
|
2007
|
|||||||||||||
U.S.
dollars in thousands
|
||||||||||||||||
NIS
|
36 | 16 | 143 | 135 | ||||||||||||
U.S.
dollar
|
156 | 400 | 2,001 | 806 | ||||||||||||
Total
|
192 | 416 | 2,144 | 941 |
NOTE
12:-
|
OTHER
ACCOUNTS PAYABLE
|
a.
|
Composition:
|
December 31,
|
January 1,
|
|||||||||||||||
2009
|
2008
|
2007
|
2007
|
|||||||||||||
U.S.
dollars in thousands
|
||||||||||||||||
Employees
and payroll accruals
|
122 | 39 | 44 | 52 | ||||||||||||
Government
authorities
|
- | 8 | 23 | 33 | ||||||||||||
Accrued
expenses
|
394 | 1,003 | 1,570 | 1,683 | ||||||||||||
Other
|
- | 8 | 28 | 66 | ||||||||||||
Total
|
516 | 1,058 | 1,665 | 1,834 |
b.
|
The
carrying amount of other accounts payable is denominated in the following
currencies:
|
December 31,
|
January 1,
|
|||||||||||||||
2009
|
2008
|
2007
|
2007
|
|||||||||||||
U.S.
dollars in thousands
|
||||||||||||||||
NIS
|
132 | 87 | 109 | 381 | ||||||||||||
U.S.
dollar
|
384 | 971 | 1,556 | 1,453 | ||||||||||||
Total
|
516 | 1,058 | 1,665 | 1,834 |
NOTE
13:-
|
RETIREMENT
BENEFIT OBLIGATION
|
a.
|
According
to the effective labor laws and employment contracts in Israel and
overseas, the Company and the subsidiaries are obligated to pay
compensation and/or pension to employees who are dismissed and, under
certain circumstances, to employees who
retire.
|
b.
|
The
Company's obligation for pension payment in Israel and the Company's
obligation for compensation payments to employees in Israel for whom the
applicable obligation is pursuant to section 14 to the Severance Pay Law,
are covered by fixed contributions in defined contribution plans. The
amounts contributed as above are not reflected in the statements of
financial position. During 2009, all company's employees were covered
pursuant to section 14 to the severance pay
law.
|
c.
|
The
Company has an obligation to pay compensation to employees which is a
defined benefit plan for which compensation reserves and managers'
policies exist and the Group companies make contributions. The net amount
of compensation obligations included in the statement of financial
position as of December 31, 2009, 2008, 2007 and January 1, 2007 reflect
the difference between the pension obligation and the plan assets, as
outlined below.
|
December 31,
|
January 1,
|
|||||||||||||||
2009
|
2008
|
2007
|
2007
|
|||||||||||||
U.S.
dollars in thousands
|
||||||||||||||||
Present
value of fully or partially funded obligations
|
- | 27 | 33 | 219 | ||||||||||||
Fair
value of plan assets
|
- | (39 | ) | (49 | ) | (191 | ) | |||||||||
Present
value of unfunded obligations
|
- | (12 | ) | (16 | ) | 28 |
Year
ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
U.S.
dollars in thousands
|
||||||||||||
Balance
at the beginning of the year
|
27 | 33 | 219 | |||||||||
Current
service cost
|
- | - | 46 | |||||||||
Interest
cost
|
- | 2 | 8 | |||||||||
Benefits
paid
|
(39 | ) | (10 | ) | (165 | ) | ||||||
Actuarial
losses (gains)
|
12 | 2 | (75 | ) | ||||||||
Balance
at the end of the year
|
- | 27 | 33 |
NOTE
13:-
|
RETIREMENT
BENEFIT OBLIGATION (Cont.)
|
Year
ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
U.S.
dollars in thousands
|
||||||||||||
Balance
at the beginning of the year
|
39 | 49 | 191 | |||||||||
Expected
return on plan assets
|
- | 2 | 6 | |||||||||
Actuarial
gains (losses)
|
- | (2 | ) | 1 | ||||||||
Employer
contributions
|
- | - | 16 | |||||||||
Benefits
paid
|
(39 | ) | (10 | ) | (165 | ) | ||||||
Balance
at the end of the year
|
- | 39 | 49 |
Year
ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
U.S.
dollars in thousands
|
||||||||||||
Current
service cost
|
- | - | 46 | |||||||||
Interest
cost
|
- | 2 | 8 | |||||||||
Actuarial
losses (gains)
|
12 | 4 | (76 | ) | ||||||||
Expected
return on plan assets
|
- | (2 | ) | (6 | ) | |||||||
12 | 4 | (28 | ) |
December 31,
|
January 1,
|
|||||||||||||||
2009
|
2008
|
2007
|
2007
|
|||||||||||||
U.S.
dollars in thousands
|
||||||||||||||||
Discount
rate
|
- | 2.884 | 5.276 | 5.111 | ||||||||||||
Israeli
CPI rate
|
- | (0.4 | ) | 2.5 | 1.29 | |||||||||||
Expected
return on plan assets
|
- | 2.884 | 5.276 | 5.111 | ||||||||||||
Expected
employee turnover
|
- | 47.17 | 47.17 | 47.17 | ||||||||||||
Future
salary increases
|
- | (0.4 | ) | 2.5 | 1.29 |
NOTE
13:-
|
RETIREMENT
BENEFIT OBLIGATION (Cont.)
|
d.
|
The
group records a provision in its books relates to retirement agreements
signed with executive officers and employees. As of December 31, 2008 and
2007, the liability related to these agreements totaled $ 447 thousand and
$ 131 thousand, respectively. As of December 31 2009 the group has no
liability for retirement agreements other than the defined contribution
plans as aforementioned in b.
|
NOTE
14:-
|
LIABILITY
FOR SHARE APPRECIATION RIGHTS
|
NOTE
14:-
|
LIABILITY
FOR SHARE APPRECIATION RIGHTS
(Cont.)
|
NOTE
15:-
|
COMMITMENTS
AND CONTINGENT LIABILITIES
|
a.
|
Royalty
and contingent milestone payments:
|
1.
|
The
Company acquired patent rights from others. These license agreements
require the Company to make contingent milestone payments to its
licensors. In addition, under these agreements, the Company must pay
royalties on sales of products resulting from licensed
technologies.
|
2.
|
The
subsidiary is committed to pay an advisory fee (in cash or by issuance of
shares) to a third party in connection with the DOV transaction (see also
Note 14 above).
|
3.
|
During
September 2005, the Company licensed from VivoQuest perpetual, exclusive,
and worldwide rights to VivoQuest's intellectual property and technology,
covering a proprietary compound library, which includes VivoQuest's lead
hepatitis C compounds (the Diversity Oriented Synthesis, or DOS program).
In addition, the Company acquired from VivoQuest certain assets, including
VivoQuest's laboratory equipment, assumed VivoQuest's lease of its
laboratory space and certain research and development employees. The
Company executed this transaction in order to broaden its pipeline and
strengthen its franchise in infectious
diseases.
|
a)
|
the
Company issued the fair value equivalent of $1,391,000 of its Ordinary
shares (1,314,420 Ordinary shares (262,884 after the capital
consolidation), 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;
|
NOTE
15:-
|
COMMITMENTS
AND CONTINGENT LIABILITIES (Cont.)
|
|
b)
|
the
Company agreed to make additional contingent milestone payments triggered
by certain regulatory and sales targets, totaling up to $ 34 million,
$ 25 million of which will be due upon or following regulatory
approval or actual product sales, and payable in cash or Ordinary shares
at the Company's election. No contingent consideration has been paid
pursuant to the license agreement as of the balance sheet date, because
none of the milestones have been achieved;
and
|
|
c)
|
the
Company agreed to make royalty payments on future product
sales.
|
b.
|
Operating
lease commitments:
|
NOTE
15:-
|
COMMITMENTS
AND CONTINGENT LIABILITIES (Cont.)
|
c.
|
Contingent
liabilities:
|
NOTE
16:-
|
SHARE
CAPITAL, RESERVES AND RETAINED
EARNINGS
|
a.
|
Share
capital:
|
1.
|
Composition:
|
Number
of shares
|
Amount
|
|||||||||||||||||||||||||||||||
Authorized
|
Issued
and
outstanding
|
Authorized
|
Issued
and
outstanding
|
|||||||||||||||||||||||||||||
December
31,
|
December
31,
|
December
31,
|
December
31,
|
|||||||||||||||||||||||||||||
2009
|
2008
|
2009
|
2008
|
2009
|
2008
|
2009
|
2008
|
|||||||||||||||||||||||||
Thousand
|
U.S.
dollars in thousands
|
|||||||||||||||||||||||||||||||
Ordinary
shares of NIS 0.1 *)
|
700,000 | - | 58,561 | - | 18,543 | - | 1,445 | - | ||||||||||||||||||||||||
Ordinary
shares of NIS 0.02
|
- | 500,000 | - | 292,805 | - | 2,630 | - | 1,445 |
Number
of shares
|
Amount
|
|||||||||||||||||||||||||||||||
Authorized
|
Issued
and
outstanding
|
Authorized
|
Issued
and
outstanding
|
|||||||||||||||||||||||||||||
December
31,
|
January
1,
|
December
31,
|
January
1,
|
December
31,
|
January
1,
|
December
31,
|
January
1,
|
|||||||||||||||||||||||||
2007
|
2007
|
2007
|
2007
|
2007
|
2007
|
2007
|
2007
|
|||||||||||||||||||||||||
Thousand
|
U.S.
dollars in thousands
|
|||||||||||||||||||||||||||||||
Ordinary
shares of NIS 0.02
|
500,000 | 300,000 | 292,655 | 220,124 | 2,630 | 1,420 | 1,444 | 1,072 |
|
*)
|
Traded
on the Tel-Aviv Stock Exchange. As of December 31, 2009, Ordinary share of
NIS 0.1 was traded at
NIS 0.272.
|
2.
|
Ordinary
shares confer upon their holders voting rights and right to participate in
the shareholders' meeting, right to receive earnings and the right to
participate in the excess of assets upon liquidation of the
Company.
|
a)
|
that
the share capital of the Company be consolidated so that each 5 shares of
NIS 0.02 par value shall be consolidated into one (1) share of NIS
0.1 par value.
|
b)
|
that
the authorized share capital of the Company be increased from NIS
10,000,000 par value divided into 100,000,000 Ordinary shares of NIS 0.1
par value to NIS 70,000,000 divided into 700,000,000 Ordinary shares
of NIS 0.1 par value.
|
c)
|
that
the ADR ratio be amended from one (1) ADR representing two (2) Ordinary
shares of NIS 0.1 par value to one (1) ADR representing twenty (20)
Ordinary shares of NIS 0.1 par
value.
|
NOTE
16:-
|
SHARE
CAPITAL, RESERVES AND RETAINED EARNINGS
(Cont.)
|
|
d)
|
due
to the capital consolidation, the amount of share options granted before
the capital consolidation and the exercise price were adjusted
accordingly.
|
3.
|
In
November 2007, the Company completed a private placement of 72,485,020
Ordinary shares of NIS 0.02 par value (14,497,004 Ordinary shares of
NIS 0.1 par value after the capital consolidation) each at $ 0.135
per share. Total proceeds to the Company from this private placement were
approximately $ 8.8 million, net of offering expenses of
approximately $ 1
million.
|
b.
|
Share-based
payment:
|
1.
|
In
April 2007, the Company's Board granted 70,000 share options to employees
in the Group to purchase 70,000 Ordinary shares of NIS 0.1 each at an
exercise price equal to $ 1.87 per share. The fair value of all share
options using the Black-Scholes model was $ 1.0 per option on the
grant date and a total of $ 70 thousand for all options. The option
term is for a period of 10 years from the grant date. The options are
exercisable on a straight-line basis every anniversary of the grant date
over a four-year period.
|
2.
|
In
August 2007, the Company granted 4,000 share options to a director to
purchase 4,000 Ordinary shares of NIS 0.1 each at an exercise price
equal to $ 1.02 per share. The fair value of all share options using
the Black-Scholes model was $ 0.55 per option on the grant date and a
total of $ 2.2 thousand for all options. The option term is for a
period of 10 years from the grant date. The options are exercisable on a
straight-line basis every quarter of the grant date over a three-year
period.
|
NOTE
16:-
|
SHARE
CAPITAL, RESERVES AND RETAINED EARNINGS
(Cont.)
|
3.
|
In
January 2008, the Company's Board granted 859,060 share options to
employees in the Company to purchase 859,060 Ordinary shares of
NIS 0.1 each at an exercise price equal to $ 1.575 per share.
The fair value of all share options using the Black-Scholes model was
$ 0.9 per option on the grant date and a total of $ 770 thousand
for all options. The option term is for a period of 10 years from the
grant date.
|
a)
|
799,300
options of which one-quarter is exercisable immediately and the balance is
exercisable on a straight-line basis every anniversary of the grant date
over three years
|
b)
|
24,000
options are exercisable
immediately
|
c)
|
35,760
options are exercisable on a straight-line basis every anniversary of the
grant date over four years
|
4.
|
In
December 2007, the Company canceled 1,850,000 options (with
performance-related conditions) that were granted to the Chairman in
August 2005 to purchase 1,850,000 shares of NIS 0.1 each at an
exercise price equal to $ 1.77 per share and granted to the Chairman
1,850,000 new options to purchase 1,850,000 shares of NIS 0.1 each at
an exercise price equal to $ 1.8 per share. All other exercise terms
remained exactly the same as those of the cancelled options. The fair
value of all share options was between $ 2.315 and $ 2.98 per
option and a total of $ 4,916 thousand for all
options.
|
NOTE
16:-
|
SHARE
CAPITAL, RESERVES AND RETAINED EARNINGS
(Cont.)
|
5.
|
In
March 2008, the Company's Board granted 50,000 share options to employees
in the Company to purchase 50,000 Ordinary shares of NIS 0.1 each at
an exercise price equal to $ 1.595 per share. The fair value of all
share options using the Black-Scholes model was $ 0.95 per option on
the grant date and a total of $ 48 thousand for all options. The
option term is for a period of 10 years from the grant date. The options
are exercisable on a straight-line basis every anniversary of the grant
date over a four-year period.
|
6.
|
In
May 2008, the Company granted 8,000 share options to service providers of
the Company to purchase 8,000 Ordinary shares of NIS 0.1 each at an
exercise price equal to $ 1.55 per share. The fair value of all share
options using the Black-Scholes model was $ 0.75 per option on the
grant date and a total of $ 6 thousand for all options. The option
term is for a period of 10 years from the grant date. The options are
exercisable on a straight-line basis every anniversary of the grant date
over a two-year period.
|
7.
|
In
July 2008, the Company granted 60,000 share options to a director in the
Company to purchase 60,000 Ordinary shares of NIS 0.1 each at an
exercise price equal to $ 1.75 per share. The fair value of all share
options using the Black-Scholes model was $ 1.1 per option on the
grant date and a total of $ 65 thousand for all options. The option
term is for a period of 10 years from the grant date. The options are
exercisable on a straight-line basis every month of the grant date over a
three-year period.
|
8.
|
In
August 2008, the Company granted 4,000 share options to a director in the
Company to purchase 4,000 Ordinary shares of NIS 0.1 each at an
exercise price equal to $ 1.84 per share. The fair value of all share
options using the Black-Scholes model was $ 1.15 per option on the
grant date and a total of $ 4.5 thousand for all options. The option
term is for a period of 10 years from the grant date. The options are
exercisable on a straight-line basis every quarter of the grant date over
a three-year period.
|
NOTE
16:-
|
SHARE
CAPITAL, RESERVES AND RETAINED EARNINGS
(Cont.)
|
9.
|
In
October 2008, the Company granted 940,000 share options to directors in
the Company to purchase 940,000 Ordinary shares of NIS 0.1 each at an
exercise price equal to $ 0.99 per share (of which 700,000 share
options were granted to the Chairman). The fair value of all share options
using the Black-Scholes model was $ 0.32 per option to the Chairman
and $ 0.62 per option to other directors on the grant date and a
total of $ 376 thousand for all options. The option term is for a
period of 10 years from the grant
date.
|
a)
|
583,334
options are exercisable
immediately
|
b)
|
116,666
options are exercisable on a straight-line basis every month of the grant
date over six months
|
10.
|
In
July 2009, the Company's Board granted 1,400,000 share options (unlisted)
to s senior officer in the Company to purchase 1,400,000 Ordinary shares
of NIS 0.1 each at an exercise price equal to NIS 0.075 per
share. The fair value of all share options using the Black-Scholes model
was NIS 0.42079 per option on the grant date and a total of
NIS 589,106 for all options. The option term is for a period of 120
months from the grant date, such that 33.33% of the share options are
exercisable immediately after five months from the grant date and the
remaining 66.67% share options are exercisable on a straight-line basis
every month of the grant date over a three-year
period.
|
NOTE
16:-
|
SHARE
CAPITAL, RESERVES AND RETAINED EARNINGS
(Cont.)
|
Year ended December 31,
|
||||||||||||||||||||||||
2009
|
2008
|
2007
|
||||||||||||||||||||||
Options
|
Weighted
average
exercise price
|
Options
|
Weighted
average
exercise
price
|
Options
|
Weighted
average
exercise
price
|
|||||||||||||||||||
Outstanding
at beginning of year
|
6,165,036 | 2.63 | 5,833,531 | 3.07 | 6,647,048 | 3.11 | ||||||||||||||||||
Granted
|
1,400,000 | 0.02 | 1,985,060 | 1.31 | 1,954,000 | 1.80 | ||||||||||||||||||
Exercised
*)
|
- | - | (30,108 | ) | 1.10 | (9,083 | ) | 0.53 | ||||||||||||||||
Cancelled
|
- | - | - | - | (1,850,000 | ) | 1.75 | |||||||||||||||||
Expired
|
(2,607,217 | ) | 2.18 | (934,764 | ) | 3.03 | (789,507 | ) | 3.50 | |||||||||||||||
Forfeited
|
(2,817,105 | ) | 2.44 | (688,683 | ) | 2.03 | (118,927 | ) | 2.40 | |||||||||||||||
Outstanding
at end of year
|
2,140,714 | 1.70 | 6,165,036 | 2.63 | 5,833,531 | 3.07 | ||||||||||||||||||
Exercisable
at end of year
|
1,338,121 | 2.65 | 2,900,192 | 2.93 | 2,597,004 | 3.53 |
*)
|
Total
proceeds received from these exercises aggregated $ 33 thousand and
$ 4 thousand for the years ended December 31, 2008 and 2007,
respectively.
|
NOTE
16:-
|
SHARE
CAPITAL, RESERVES AND RETAINED EARNINGS
(Cont.)
|
Year
ended December 31, 2009
|
Year
ended December 31, 2008
|
|||||||||||||||||||||
Options
outstanding
at
end
of year
|
Range
of
exercise
prices
|
Weighted
average
remaining
contractual
life
|
Options
outstanding
at
end
of year
|
Range
of
exercise
prices
|
Weighted
average
remaining
contractual
life
|
|||||||||||||||||
1,400,000 | 0-0.500 | 9.6 | - | 0-0.500 | 10 | |||||||||||||||||
18,150 | 0.500-1.499 | 0.1 | 987,075 | 0.500-1.499 | 10 | |||||||||||||||||
200,425 | 1.500-1.995 | 2.5 | 2,916,903 | 1.500-1.995 | 1.7 | |||||||||||||||||
10,840 | 2.000-2.495 | 0.3 | 10,840 | 2.000-2.495 | 2.3 | |||||||||||||||||
220,459 | 2.500-3.495 | 0.2 | 473,058 | 2.500-3.495 | 2.7 | |||||||||||||||||
2,880 | 3.500-4.495 | 0.1 | 1,439,880 | 3.500-4.495 | 7.1 | |||||||||||||||||
77,960 | 4.500-5.500 | 0.1 | 82,280 | 4.500-5.500 | 0.9 | |||||||||||||||||
210,000 | 5.500-10.55 | 0.7 | 255,000 | 10.55-5.500 | 1.7 | |||||||||||||||||
2,140,714 | 6.6 | 6,165,036 | 4.3 |
Year
ended December 31, 2007
|
Year
ended December 31, 2006
|
|||||||||||||||||||||
Options
outstanding
at
end
of year
|
Range
of
exercise
prices
|
Weighted
average
remaining
contractual
life
|
Options
outstanding
at
end
of year
|
Range
of
exercise
prices
|
Weighted
average
remaining
contractual
life
|
|||||||||||||||||
116,702 | 0.500-1.499 | 5.5 | 163,555 | 0.500-1.499 | 5.9 | |||||||||||||||||
2,362,000 | 1.500-1.995 | 2.8 | 2,262,000 | 1.500-1.995 | 3.6 | |||||||||||||||||
681,164 | 2.000-2.495 | 0.2 | 1,160,520 | 2.000-2.495 | 1.1 | |||||||||||||||||
680,532 | 2.500-3.495 | 8.3 | 764,000 | 2.500-3.495 | 9.5 | |||||||||||||||||
1,439,880 | 3.500-4.495 | 8.1 | 1,454,760 | 3.500-4.495 | 9 | |||||||||||||||||
298,253 | 4.500-5.500 | 0.9 | 587,213 | 4.500-5.500 | 1.5 | |||||||||||||||||
255,000 | 10.55-5.500 | 2.7 | 255,000 | 10.55-5.500 | 3.7 | |||||||||||||||||
5,833,531 | 4.4 | 6,647,048 | 4.9 |
NOTE
17:-
|
REVENUES
AND COST OF REVENUES
|
a.
|
The
Company entered into a licensing agreement with Cubist Pharmaceuticals,
Inc. in June 2004, and as amended in August 2005, under which the Company
granted Cubist a license to commercialize clinical against hepatitis B. In
July 2007, Cubist terminated the
agreement.
|
b.
|
As
for revenues and cost of revenues in 2008 arising on the sale of the
development rights of DOS, see Notes 10b and
15a(3).
|
NOTE
18:-
|
RESEARCH
AND DEVELOPMENT COSTS
|
Year
ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
U.S.
dollars in thousands
|
||||||||||||
Salaries
and payroll accruals
|
- | 1,583 | 2,788 | |||||||||
Expenses
relating to options to employees and service providers
|
- | 54 | 149 | |||||||||
Laboratory
materials and production works
|
- | 602 | 1,525 | |||||||||
Clinical
trials
|
- | 8,473 | 3,610 | |||||||||
Subcontracted
work
|
- | - | 632 | |||||||||
Professional
services
|
- | 227 | 456 | |||||||||
Rent
and laboratory maintenance
|
- | 661 | 1,140 | |||||||||
Depreciation
and amortization
|
- | 11 | 80 | |||||||||
Impairment
of laboratory equipment
|
- | - | 105 | |||||||||
Other
|
- | 111 | 1,071 | |||||||||
- | 11,722 | 11,556 | ||||||||||
Less
- grants and participations
|
- | - | 56 | |||||||||
- | 11,722 | 11,500 |
NOTE
19:-
|
GENERAL
AND ADMINISTRATIVE EXPENSES
|
Year
ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
U.S.
dollars in thousands
|
||||||||||||
Salaries
and payroll accruals
|
428 | 1,307 | 1,198 | |||||||||
Expenses
relating to options to employees and service providers *)
|
(4,180 | ) | 1,759 | 1,842 | ||||||||
Patents
|
14 | 235 | 440 | |||||||||
Expenses
(income) relating to share appreciation rights
|
119 | (1,553 | ) | 1,560 | ||||||||
Directors'
fees
|
98 | 356 | 280 | |||||||||
Travel
abroad
|
8 | 17 | 85 | |||||||||
Foreign
services, public relation and travel
|
13 | 145 | 296 | |||||||||
Rent
and office maintenance
|
355 | 183 | 77 | |||||||||
Vehicle
maintenance
|
25 | 16 | 14 | |||||||||
Insurance
|
198 | 203 | 203 | |||||||||
Professional
services
|
378 | 1,029 | 1,233 | |||||||||
Depreciation
and amortization
|
13 | 28 | 28 | |||||||||
Other
|
102 | 212 | 340 | |||||||||
(2,429 | ) | 3,937 | 7,596 |
*)
|
Include
reduced expenses which result from forfeiture of share options that were
contingent on the performance of the former chairman and CEO, see also
Note 16b.
|
NOTE
20:-
|
OTHER
GAINS (LOSSES), NET
|
Year
ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
U.S.
dollars in thousands
|
||||||||||||
Gain
(loss) on sale of fixed assets
|
(5 | ) | 288 | 40 | ||||||||
Change
in fair value of financial assets at fair value through profit or
loss
|
- | - | (48 | ) | ||||||||
Other
income
|
144 | - | - | |||||||||
139 | 288 | (8 | ) |
NOTE
21:-
|
FINANCE
COSTS (INCOME), NET
|
Year
ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
U.S.
dollars in thousands
|
||||||||||||
Finance
costs:
|
||||||||||||
Interest
charge
|
2 | 3 | 4 | |||||||||
Exchange
differences
|
- | - | 9 | |||||||||
Management
fees and commissions
|
8 | 14 | 16 | |||||||||
Other
|
- | - | 1 | |||||||||
Total
finance costs
|
10 | 17 | 30 | |||||||||
Finance
income:
|
||||||||||||
Interest
income on bank deposits
|
3 | 251 | 668 | |||||||||
Exchange
differences
|
3 | 14 | - | |||||||||
Other
|
- | 66 | - | |||||||||
Total
finance income
|
6 | 331 | 668 | |||||||||
Finance
income (costs), net
|
(4 | ) | 314 | 638 |
NOTE
22:-
|
TAXES
ON INCOME
|
a.
|
Taxation
in Israel:
|
1.
|
Since
the 2008 tax year, the results for tax purposes of the Company are
measured in nominal values. Until the end of the 2007 tax year, the
results for tax purposes of the Company were adjusted for the changes in
the Israeli CPI pursuant to the Income Tax (Inflationary Adjustments) Law,
1985 ("the inflationary adjustments
law").
|
2.
|
Tax
rates:
|
NOTE
22:-
|
TAXES
ON INCOME (Cont.)
|
|
b.
|
Foreign
subsidiaries:
|
|
c.
|
Carryforward
tax losses and real loss on sale of marketable
securities:
|
NOTE
22:-
|
TAXES
ON INCOME (Cont.)
|
|
d.
|
Taxes
on income included in the statements of income for the years
presented:
|
1.
|
As
follows:
|
Year
ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
U.S.
dollars in thousands
|
||||||||||||
Current
taxes:
|
||||||||||||
Current
taxes on income for the year
|
- | 10 | - | |||||||||
Adjustments
in respect of prior years
|
(23 | ) | (41 | ) | (254 | ) | ||||||
(23 | ) | (31 | ) | (254 | ) | |||||||
Deferred
taxes
|
- | - | 48 | |||||||||
Tax
benefit
|
(23 | ) | (31 | ) | (206 | ) |
2.
|
Below
is a reconciliation between the "theoretical" tax expense, assuming that
all the income were taxed at the regular tax rate applicable to companies
in Israel (see a(2) above) and the taxes recorded in the statement of
comprehensive income in the reported
year:
|
2009
|
2008
|
2007
|
||||||||||
$ thousand
|
$ thousand
|
$ thousand
|
||||||||||
Income
(loss) before taxes on income, as reported in the statements of
income
|
2,564 | (18,458 | ) | (17,669 | ) | |||||||
Theoretical
tax (tax saving) on this income (loss)
|
667 | (4,984 | ) | (5,124 | ) | |||||||
Increase
(decrease) in taxes resulting from different tax rates for foreign
subsidiaries
|
85 | (1,138 | ) | (365 | ) | |||||||
Expenses
not deductible for tax purposes
|
2 | 405 | 761 | |||||||||
Tax
exempt income
|
(1,087 | ) | - | - | ||||||||
Increase
in taxes resulting from taxable losses in the reported year for which no
deferred taxes were recognized
|
333 | 5,727 | 4,776 | |||||||||
Taxes
in respect of prior year
|
(23 | ) | (41 | ) | (254 | ) | ||||||
Taxes
on income
|
(23 | ) | (31 | ) | (206 | ) |
NOTE
22:-
|
TAXES
ON INCOME (Cont.)
|
3.
|
Since
the balance of carryforward tax losses exceeds other temporary differences
(net), and considering that the Company can not assess with certainty that
it will have sufficient income in the future to allow the losses to be
used in the foreseeable future, in 2009, the Company did not record
deferred taxes on these losses.
|
e.
|
The
effect of the adoption of IFRS in Israel on the tax
liability:
|
|
f.
|
Tax
assessments:
|
NOTE
23:-
|
EARNINGS
PER SHARE
|
a.
|
Basic:
|
Year
ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Income
(loss) attributable to equity holders of the parent (U.S. dollars in
thousands)
|
2,587 | (18,427 | ) | (17,463 | ) | |||||||
Weighted
average number of issued Ordinary shares
|
58,561,065 | 58,553,864 | 45,698,564 | |||||||||
Basic
earnings (loss) per share (in U.S. dollars)
|
0.044 | (0.315 | ) | (0.382 | ) |
Year
ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
U.S.
dollars in thousands
|
||||||||||||
Total
income (loss) for the year attributable to equity holders of the parent
according to the statement of income used to determine basic earnings
(loss) per share
|
2,587 | (18,427 | ) | (17,463 | ) | |||||||
Total
net income (loss) used to determine diluted earnings (loss) per
share
|
2,587 | (18,427 | ) | (17,463 | ) |
Number
of shares
|
||||||||||||
Weighted
average number of shares used to determine basic earnings (loss) per
share
|
58,561,065 | 58,553,864 | 45,698,564 | |||||||||
Adjustment
for incremental shares due to exercise of share options
|
209,102 | - | - | |||||||||
Weighted
average number of shares used to determine diluted earnings (loss) per
share
|
58,770,167 | 58,553,864 | 45,698,564 | |||||||||
Diluted
earnings (loss) per share (in U.S. dollars)
|
0.044 | (0.315 | ) | (0.382 | ) |
NOTE
24:-
|
TRANSACTIONS
AND BALANCES WITH RELATED PARTIES
|
|
a.
|
Compensation
to interested parties:
|
Year
ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
U.S.
dollars in thousands
|
||||||||||||
Wages
and salaries to interested parties employed by the Group
*)
|
(1,219 | ) | 1,169 | 1,041 | ||||||||
Number
of individuals to whom the benefit relates
|
2 | 1 | 1 | |||||||||
Management
fees and commissions to interested parties employed by the
Group
|
- | - | - | |||||||||
Number
of individuals to whom the benefit relates
|
- | - | - | |||||||||
Compensation
to directors not employed by the Group **)
|
(2,569 | ) | 944 | 1,222 | ||||||||
Number
of individuals to whom the benefit relates
|
12 | 6 | 6 | |||||||||
Rentals
to other interested parties not employed by the Group
|
- | - | - | |||||||||
Number
of individuals to whom the benefit relates
|
- | - | - |
*)
|
Includes
reduced expenses in 2009 which result from forfeiture of shares that were
contingent on the performance of the former CEO, in amount of $ 1.45
million. The fair value of the benefit recorded due to Options granted to
the CEO for the years 2008 and 2007 was approximately $ 919 and $ 816,
respectively.
|
**)
|
Includes
reduced expenses in 2009 which result from forfeiture of shares that were
contingent on the performance of the former chairman, in amount of $ 2.65
million. The fair value of the benefit recorded due to Options granted to
the chairman for the years 2008 and 2007 was approximately $ 643 and $
946, respectively.
|
NOTE
24:-
|
TRANSACTIONS
AND BALANCES WITH RELATED PARTIES
(Cont.)
|
b.
|
Compensation
to key management personnel:
|
Year
ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
U.S.
dollars in thousands
|
||||||||||||
Salaries
and other short-term benefits
|
424 | 1,122 | 1,066 | |||||||||
Increased
termination benefits
|
- | - | - | |||||||||
Post-employment
benefits
|
76 | 410 | - | |||||||||
Other
long-term benefits
|
- | - | - | |||||||||
Share-based
payments
|
(4,059 | )*) | 1,769 | 1,865 | ||||||||
(3,559 | ) | 3,301 | 2,931 |
*)
|
Includes
reduced expenses which result from forfeiture of shares that were
contingent on the performance of the former chairman and CEO, see also
Note 16b.
|
NOTE
25:
|
EVENTS
AFTER THE BALANCE SHEET DATE
|
a.
|
Below
is information about the Company's engagement with
Bio-Gal:
|
1.
|
Following
the Board's approval of the engagement of the Company with Bio-Gal on
December 31, 2009, the Company published on January 14, 2010 an
extraordinary private placement , to acquire 100% of the issued and
outstanding shares of Xtepo Ltd. (a private company that was established
for the purpose of this transaction, and which the Bio Gal intellectual
property will be transferred into), by allocating 133,063,688 ordinary
shares of NIS 0.1 par value each of the Company representing after
their allocation 69.44% of the Company's issued and outstanding share
capital. On March 2, 2010 the extraordinary shareholders meeting approved
the Bio-Gal transaction (see also note 1b' regarding the contingent
conditions for the transaction
closing).
|
2.
|
On
February 28, April 26, and on June 28, 2010 the Company and Bio-Gal have
extended the term for the closing of the Bio-Gal transaction, which was
eventually set to August 31, 2010. The rest of the terms for the closing
remained unchanged.
|
NOTE
25:
|
EVENTS
AFTER THE BALANCE SHEET DATE
(Cont.)
|
b.
|
Below
is information about share-based payments granted after the balance sheet
date to directors in the Group, the CEO (who also acts as a director in
the Company) and to another
employee:
|
1.
|
On
January 18, 2010, the Company's Board approved to grant 450,000 share
options to directors in the Company to purchase 450,000 Ordinary shares of
NIS 0.1 each at an exercise price equal to NIS 0.298 per share.
Pursuant to the guidance of IFRS 2, the fair value of all share options at
the date when the Board accepted the resolution, using the Black-Scholes
model was approximately $ 36 thousand. The option term is for a
period of 10 years from the grant date. 33% of the options are exercisable
immediately and the remaining options are exercisable in 24 tranches every
month over a two-year period.
|
2.
|
On
January 18, 2010, the Company's Board approved to grant 1,610,000
share options to the Company's CEO to purchase 1,610,000 Ordinary shares
of NIS 0.1 each at an exercise price equal to NIS 0.075 per
share. Pursuant to the guidance of IFRS 2, the fair value of all share
options at the date when the Board accepted the resolution, using the
Black-Scholes model was approximately $ 136 thousand. The option term
is for a period of 10 years from the grant date. 33% of the options are
exercisable immediately and the remaining options are exercisable in 24
tranches every month over a two-year
period.
|
3.
|
On
January 26, 2010, the Company's Board granted 100,000 share options
to an employee in the Company to purchase 100,000 Ordinary shares of
NIS 0.1 each at an exercise price equal to NIS 0.1 per share.
The fair value of all share options using the Black-Scholes model was
NIS 0.36 per option on the grant date and a total of NIS 36
thousand for all options. The option term is for a period of 10 years from
the grant date. The options are exercisable in 24 tranches every quarter
over a three-year period.
|
c.
|
On
March 2, 2010, the shareholders annual general meeting of the Company
approved the terms of employment of Mr. David Grossman, the Company’s CEO
and Director. However, the terms of employment shall become effective only
upon the closing of the Bio-Gal
transaction.
|
d.
|
In
March 2010, the Company formally terminated the license agreement with
DOV, regarding the Bicifadine, and all rights under this agreement were
reverted to DOV, in coordination with
DOV.
|
NOTE
26:-
|
RECONCILIATION
BETWEEN U.S. GAAP AND IFRS
|
a.
|
Reconciliations
of the consolidated statements of financial position as of January 1,
2007 ("opening balance sheet"), December 31, 2007 and December 31,
2008.
|
b.
|
Reconciliations
of the consolidated statements of comprehensive income for the years ended
December 31, 2007 and
2008.
|
c.
|
Reconciliations
of certain equity items as of January 1, 2007, December 31, 2007
and December 31, 2008.
|
d.
|
Giving
explanations of the reconciliations carried out, as above, including a
description of the exemptions elected by the Company in the transition to
IFRS, in accordance with IFRS
1.
|
NOTE
26:-
|
RECONCILIATION
BETWEEN U.S. GAAP AND IFRS (Cont.)
|
a.
|
The
effect of the transition on the consolidated statements of financial
position:
|
January
1, 2007
|
December
31, 2007
|
December
31, 2008
|
|||||||||||||||||||||||||||||||||||||
US
GAAP
|
Effect
of
transition
to
IFRS
|
IFRS
|
US
GAAP
|
Effect
of
transition
to
IFRS
|
IFRS
|
US
GAAP
|
Effect
of
transition
to
IFRS
|
IFRS
|
|||||||||||||||||||||||||||||||
Item
|
U.S.
dollars in thousands
|
||||||||||||||||||||||||||||||||||||||
ASSETS
|
|||||||||||||||||||||||||||||||||||||||
CURRENT
ASSETS:
|
|||||||||||||||||||||||||||||||||||||||
Cash
and cash equivalents
|
4,400 | - | 4,400 | 2,377 | - | 2,377 | 2,924 | - | 2,924 | ||||||||||||||||||||||||||||||
Short-term
deposits
|
20,845 | - | 20,845 | 10,600 | - | 10,600 | - | - | - | ||||||||||||||||||||||||||||||
Employee
benefit assets
|
1
|
- | - | - | - | - | - | 40 | (28 | ) | 12 | ||||||||||||||||||||||||||||
Financial
assets at fair value through profit or loss
|
102 | - | 102 | - | - | - | - | - | - | ||||||||||||||||||||||||||||||
Assets
held for sale
|
18 | - | 18 | - | - | - | - | - | - | ||||||||||||||||||||||||||||||
Accounts
receivable
|
1,9
|
702 | (93 | ) | 609 | 924 | (270 | ) | 654 | 354 | (49 | ) | 305 | ||||||||||||||||||||||||||
Income
taxes receivable
|
9
|
- | - | - | - | 270 | 270 | - | 49 | 49 | |||||||||||||||||||||||||||||
Deferred
taxes
|
8
|
29 | (29 | ) | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||
Restricted
deposits
|
- | - | - | - | - | - | 71 | - | 71 | ||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||
26,096 | (122 | ) | 25,974 | 13,901 | - | 13,901 | 3,389 | (28 | ) | 3,361 | |||||||||||||||||||||||||||||
NON-CURRENT
ASSETS:
|
|||||||||||||||||||||||||||||||||||||||
Employee
benefit assets
|
1
|
98 | (98 | ) | - | 48 | (32 | ) | 16 | - | - | - | |||||||||||||||||||||||||||
Restricted
deposits
|
172 | - | 172 | 61 | - | 61 | - | - | - | ||||||||||||||||||||||||||||||
Fixed
assets
|
490 | - | 490 | 106 | - | 106 | 41 | - | 41 | ||||||||||||||||||||||||||||||
Intangible
assets
|
4,5
|
25 | 1,783 | 1,808 | 11 | 9,283 | 9,294 | - | - | - | |||||||||||||||||||||||||||||
Deferred
taxes
|
8
|
19 | 29 | 48 | - | - | - | - | - | - | |||||||||||||||||||||||||||||
804 | 1,714 | 2,518 | 226 | 9,251 | 9,477 | 41 | - | 41 | |||||||||||||||||||||||||||||||
Total assets
|
26,900 | 1,592 | 28,492 | 14,127 | 9,251 | 23,378 | 3,430 |
(28
|
) | 3,402 |
NOTE
26:-
|
RECONCILIATION
BETWEEN U.S. GAAP AND IFRS (Cont.)
|
January
1, 2007
|
December
31, 2007
|
December
31, 2008
|
|||||||||||||||||||||||||||||||||||||
US
GAAP
|
Effect
of
transition
to
IFRS
|
IFRS
|
US
GAAP
|
Effect
of
transition
to
IFRS
|
IFRS
|
US
GAAP
|
Effect
of
transition
to
IFRS
|
IFRS
|
|||||||||||||||||||||||||||||||
Item
|
U.S.
dollars in thousands
|
||||||||||||||||||||||||||||||||||||||
LIABILITIES
AND EQUITY
|
|||||||||||||||||||||||||||||||||||||||
CURRENT
LIABILITIES:
|
|||||||||||||||||||||||||||||||||||||||
Trade
payables
|
941 | - | 941 | 2,144 | - | 2,144 | 416 | - | 416 | ||||||||||||||||||||||||||||||
Other
accounts payable
|
1,9
|
2,062 | (228 | ) | 1,834 | 1,665 | - | 1,665 | 1,058 | - | 1,058 | ||||||||||||||||||||||||||||
Income
taxes payable
|
9
|
- | 143 | 143 | - | - | - | - | - | - | |||||||||||||||||||||||||||||
Employee
benefit liabilities
|
1
|
- | - | - | - | - | - | 523 | (76 | ) | 447 | ||||||||||||||||||||||||||||
Liability
for share appreciation rights
|
- | - | - | 1,560 | - | 1,560 | 7 | - | 7 | ||||||||||||||||||||||||||||||
Deferred
revenue
|
399 | - | 399 | - | - | - | - | - | - | ||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||
3,402 | (85 | ) | 3,317 | 5,369 | - | 5,369 | 2,004 | (76 | ) | 1,928 | |||||||||||||||||||||||||||||
NON-CURRENT
LIABILITIES:
|
|||||||||||||||||||||||||||||||||||||||
Employee
benefit liabilities
|
1
|
340 | (117 | ) | 223 | 194 | (63 | ) | 131 | - | - | - | |||||||||||||||||||||||||||
Deferred
revenue
|
398 | - | 398 | - | - | - | - | - | - | ||||||||||||||||||||||||||||||
738 | (117 | ) | 621 | 194 | (63 | ) | 131 | - | - | - | |||||||||||||||||||||||||||||
Total
liabilities
|
4,140 | (202 | ) | 3,938 | 5,563 | (63 | ) | 5,500 | 2,004 | (76 | ) | 1,928 | |||||||||||||||||||||||||||
EQUITY:
|
|||||||||||||||||||||||||||||||||||||||
Share
capital
|
1,072 | - | 1,072 | 1,444 | - | 1,444 | 1,445 | - | 1,445 | ||||||||||||||||||||||||||||||
Share
premium
|
136,611 | (5,458 | ) | 131,153 | 146,982 | (7,405 | ) | 139,577 | 149,089 | (9,303 | ) | 139,786 | |||||||||||||||||||||||||||
Accumulated
deficit
|
(114,923 | ) | 7,252 | (107,671 | ) | (139,862 | ) | 16,719 | (123,143 | ) | (149,108 | ) | 9,351 | (139,757 | ) | ||||||||||||||||||||||||
Total
equity
|
22,760 | 1,794 | 24,554 | 8,564 | 9,314 | 17,878 | 1,426 | 48 | 1,474 | ||||||||||||||||||||||||||||||
Total
liabilities and equity
|
26,900 | 1,592 | 28,492 | 14,127 | 9,251 | 23,378 | 3,430 | (28 | ) | 3,402 |
NOTE
26:-
|
RECONCILIATION
BETWEEN U.S. GAAP AND IFRS (Cont.)
|
b.
|
The
effect of the transition on the consolidated statements of comprehensive
income:
|
Year
ended
December
31, 2007
|
Year
ended
December
31, 2008
|
||||||||||||||||||||||||||
US
GAAP
|
Effect
of
transition
to
IFRS
|
IFRS
|
US
GAAP
|
Effect
of
transition
to
IFRS
|
IFRS
|
||||||||||||||||||||||
Par.
|
U.S.
dollars in thousands (except per share data)
|
||||||||||||||||||||||||||
Revenues
|
5
|
907 | - | 907 | 5,940 | - | 5,940 | ||||||||||||||||||||
Cost
of revenues
|
4
|
110 | - | 110 | 58 | 1,783 | 1,841 | ||||||||||||||||||||
Gross
profit
|
797 | - | 797 | 5,882 | (1,783 | ) | 4,099 | ||||||||||||||||||||
Research
and development costs
|
1,2,4
|
19,007 | (7,507 | ) | 11,500 | 11,748 | (26 | ) | 11,722 | ||||||||||||||||||
General
and administrative expenses
|
1,2,6
|
5,557 | 2,039 | 7,596 | 5,115 | (1,178 | ) | 3,937 | |||||||||||||||||||
Business
development expenses (income)
|
6
|
2,008 | (2,008 | ) | - | (1,102 | ) | 1,102 | - | ||||||||||||||||||
Impairment
loss of intangible asset
|
4
|
- | - | - | - | (7,500 | ) | (7,500 | ) | ||||||||||||||||||
Other
gains (losses), net
|
40 | (48 | ) | (8 | ) | 288 | - | 288 | |||||||||||||||||||
Operating
loss
|
(25,735 | ) | 7,476 | (18,307 | ) | (9,591 | ) | (9,181 | ) | (18,772 | ) | ||||||||||||||||
Finance
income
|
3
|
- | 668 | 668 | - | 331 | 331 | ||||||||||||||||||||
Finance
cost
|
3
|
- | 30 | 30 | - | 17 | 17 | ||||||||||||||||||||
Finance
income, net
|
3
|
590 | 48 | 638 | 314 | - | 314 | ||||||||||||||||||||
Loss
before taxes on income
|
(25,145 | ) | 7,476 | (17,669 | ) | (9,277 | ) | (9,181 | ) | (18,458 | ) | ||||||||||||||||
Tax
benefit
|
(206 | ) | - | (206 | ) | (31 | ) | - | (31 | ) | |||||||||||||||||
Comprehensive
loss for the year
|
(24,939 | ) | 7,476 | (17,463 | ) | (9,246 | ) | (9,181 | ) | (18,427 | ) | ||||||||||||||||
Basic
and diluted loss per share (in U.S. dollars) *)
|
(0.546 | ) | 0.164 | (0.382 | ) | (0.158 | ) | (0.157 | ) | (0.315 | ) |
*)
|
After
taking into account consolidation of shares effected on June 22,
2009, see Note 16a.
|
NOTE
26:-
|
RECONCILIATION
BETWEEN U.S. GAAP AND IFRS (Cont.)
|
c.
|
The
effect of the above reconciliations on the consolidated statements of
changes in equity:
|
Share
capital
|
Share
premium
|
Accumulated
deficit
|
Total
|
||||||||||||||||
Par.
|
U.S.
dollars in thousands
|
||||||||||||||||||
Balance
at January 1, 2007, U.S. GAAP
|
1,072 | 136,611 | (114,923 | ) | 22,760 | ||||||||||||||
Share-based
payment to employees and others
|
2
|
- | (5,458 | ) | 5,458 | - | |||||||||||||
Adjustments
of employee benefit liabilities
|
1
|
- | - | 11 | 11 | ||||||||||||||
Intangible
asset
|
4
|
- | - | 1,783 | 1,783 | ||||||||||||||
Balance
at January 1, 2007, IFRS
|
1,072 | 131,153 | (107,671 | ) | 24,554 |
Share
capital
|
Share
premium
|
Accumulated
deficit
|
Total
|
||||||||||||||||
Par.
|
U.S.
dollars in thousands
|
||||||||||||||||||
Balance
at December 31, 2007, U.S. GAAP
|
1,444 | 146,982 | (139,862 | ) | 8,564 | ||||||||||||||
Share-based
payment to employees and others
|
2
|
- | (7,405 | ) | 7,405 | - | |||||||||||||
Adjustments
of employee benefit liabilities
|
1
|
- | - | 31 | 31 | ||||||||||||||
Intangible
asset
|
4
|
- | - | 9,283 | 9,283 | ||||||||||||||
Balance
at December 31, 2007, IFRS
|
1,444 | 139,577 | (123,143 | ) | 17,878 |
Share
capital
|
Share
premium
|
Accumulated
deficit
|
Total
|
||||||||||||||||
Par.
|
U.S.
dollars in thousands
|
||||||||||||||||||
Balance
at December 31, 2008, U.S. GAAP
|
1,445 | 149,089 | (149,108 | ) | 1,426 | ||||||||||||||
Share-based
payment to employees and others
|
2
|
- | (9,303 | ) | 9,303 | - | |||||||||||||
Adjustments
of employee benefit liabilities
|
1
|
- | - | 48 | 48 | ||||||||||||||
Balance
at December 31, 2008, IFRS
|
1,445 | 139,786 | (139,757 | ) | 1,474 |
NOTE
26:-
|
RECONCILIATION
BETWEEN U.S. GAAP AND IFRS (Cont.)
|
|
d.
|
Explanations
of the transition to reporting under
IFRS:
|
|
1.
|
Retirement
benefit obligation:
|
NOTE
26:-
|
RECONCILIATION
BETWEEN U.S. GAAP AND IFRS (Cont.)
|
|
2.
|
Share-based
payments:
|
|
3.
|
Finance
income and costs:
|
NOTE
26:-
|
RECONCILIATION
BETWEEN U.S. GAAP AND IFRS (Cont.)
|
|
4.
|
Research
and development expenses:
|
5.
|
Revenue
recognition on disposal of intangible
assets:
|
NOTE
26:-
|
RECONCILIATION
BETWEEN U.S. GAAP AND IFRS (Cont.)
|
6.
|
Business
development expenses:
|
7.
|
Cumulative
comparative figures:
|
8.
|
Deferred
taxes:
|
9.
|
Income
taxes receivable and payable:
|