To
|
To
|
|
The
Israel Securities Authority Ltd.
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The
Tel-Aviv Securities Stock Exchange Ltd. ("TASE")
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Through the Magna
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Through the Magna
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www.isa.co.il
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www.tase.co.il
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1.
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Introduction
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2.
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Condensed
information of the transaction's nature and main
terms
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2.1
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On
December 31st,
2009, the Company's Board approved the Company's engagement in an
agreement to acquire 100% of the shares of Xtepo Ltd. ("Xtepo"), a private
company incorporated in Israel on November 9, 2009, which holds an
exclusive license to use a patent for the Erythropoietin drug ("EPO"), by way of issuing
new shares of the Company in an extraordinary private placement pursuant
to the Israeli Securities Regulations (Private Placement of Securities in
a Listed Company), 2000 ("the Regulations") to the
shareholders of Xtepo 1
("the share swap
agreement"), such that after consummating the share swap agreement
as above, Xtepo's shareholders (together with their stake in the Company
prior to the share swap) will hold about 70.64% 2 of
the Company's issued and outstanding share capital and the balance of
about 29.36% will be held by the Company's shareholders (excluding Xtepo
shareholders). For details of Xtepo, see Appendix
A to this report.
|
1
|
For
more details of the shareholders in Xtepo, see paragraph 11
below.
|
2
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Xtepo's
shareholders were granted a right to invest in Xtepo pro rata to their
holdings.
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2.2
|
The
execution of the share swap agreement as above is contingent, among other
things, on obtaining the approval of the Company's general shareholders'
meeting for the execution of the extraordinary private placement as above
and on obtaining the approval of the Israeli Tax Authorities as detailed
below ("the record
date"). For more details of the share swap agreement's
prerequisites, see paragraph 13.1.1
below.
|
3.
|
The
extraordinary private placement optionees and their status as interested
parties
|
4.
|
The
terms, number and percentage of the Company's share capital of the offered
securities following the
allocation
|
|
4.1
|
On
the record date, the optionees will be allocated - 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 after the completion of the
transaction.
|
|
4.2
|
The
allocated shares will have rights that are equal in all respects to the
rights of existing Ordinary shares in the Company on the date of the
publication of this report and that confer upon their holders, among other
things, equal rights in participating and voting in the Company's general
meetings, receiving dividends or any other distribution and participating
in excess assets of the Company in the event of
liquidation.
|
5.
|
The
consideration for the offered
securities
|
6.
|
The
price of the Company's shares in the extraordinary private placement and
their quoted market price
|
|
6.1
|
The
price of the Company's share in the private placement is appox.
NIS 0.10 4.
The quoted market price of the Company's share as of March 18, 2009 (the
original transaction date) is NIS 0.205, which is 111% higher than
the price of the Company's share in the private
placement.
|
3
|
Mr.
Alex Rabinovitch holds shares of Xtepoboth directly and through a company
controlled by him.
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4
|
It
should be mentioned that the investors in Xtepoprior to the transaction
make their investments in U.S. dollars. Accordingly, the transaction is
according to a share price in U.S. dollars equivalent to $ 0.0262. As
of the date of this report, in relation to the foreign currency exchange
rate at January 14, 2009, this price reflects NIS 0.097 per
share.
|
|
6.2
|
It
should be mentioned that the price of the Company's share according to the
private placement is identical to the exercise price of the options
allocated to several investors in Xtepo5
which will be exercised after the prerequisites specified in paragraph
13.1.1 to this report are met, based, among other things, on a fairness
opinion attached as Appendix
B to this report which established that the swap ratios reflected
in the Company's share prices in the private placement are
fair.
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|
6.3
|
The
Company shares' quoted market price at January 14, 2009 is
NIS 0.287.
|
7.
|
The
names of the controlling shareholders in the Company, the interested
parties, the directors and/or officers in the Company with personal
interest in the private placement and the nature of the personal
interest
|
8.
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Announcement
of convening an extraordinary general meeting of the Company's
shareholders
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|
8.1
|
Pursuant
to the Companies Law, 1999 ("the Companies Law"), an
announcement is hereby provided of the convening of an extraordinary
general meeting of the Company's shareholders to be held on Tuesday
February 23rd,
2010 at 10:00 am at the law offices of Kantor & Co. on 14 Abba Hillel
Silver, 12th
floor, Ramat-Gan, Israel under the following
agenda:
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8.1.1
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The
approval of the share swap agreement including the extraordinary private
placement.
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8.2
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The meeting's venue
and date
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8.2.1
|
The
extraordinary general meeting will convene on Tuesday February 23, 2010 at
10:00 at the law offices of Kantor & Co. on 14 Abba Hillel Silver,
12th
floor, Ramat-Gan, Israel. A deferred meeting, if necessary, will convene
on Tuesday March 2nd,
2010 at the same place and time.
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|
8.2.2
|
In
the extraordinary general meeting, a legal quorum will constitute the
presence of at least two (2) shareholders, represented by themselves or by
their proxies, who hold or represent together at least 33.33% of the
voting rights in the Company. If at the elapse of thirty minutes from the
meeting's scheduled date, the legal quorum is not achieved, the meeting
will be automatically deferred to the same day of the following week, at
the same time and place as scheduled for the original meeting; or to a
different time or place as decided by the board of directors in an
announcement to the shareholders. If in such deferred meeting no legal
quorum is obtained within thirty minutes from the scheduled date, two
shareholders that are present by themselves or by a proxy will form a
legal quorum and the meeting will be entitled to discuss the issues on the
agenda.
|
5
|
For
details of the options granted to investors in Xtepo, see paragraph 13.1.1
to this report.
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8.2.3
|
The
date for establishing the shareholders' right to vote in the general
meeting, as stipulated in Section 182 to the Companies Law, is Sunday
January 24th,
2010 ("the meeting
participation record date").
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|
8.2.4
|
Any
existing shareholder of the Company on the record date, whether or not the
shares are registered in its name or are held by it through a member of
the Stock Exchange, is entitled to participate in the meeting by itself or
via a proxy. Pursuant to the Companies Regulations (Proof of Share
Ownership for Voting in General Meetings), 2000, a Company shareholder
whose shares are held by a member of the Stock Exchange will be able to
participate in said meeting by itself or via a proxy provided that an
original proof of Company share ownership on the meeting participation
record date is delivered to the Company before the meeting (to be obtained
by that member of the Stock Exchange). Any documents appointing proxies
("the letters of
appointment") as well as the original authorizations under which
the letters of appointment (if any) were signed must be deposited with the
Company's registered headquarters 48 hours prior to the date of the
meeting.
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|
8.2.5
|
A
written format of the voting paper and statements of position, if any, can
be found at the Israel Securities Authority's site at www.magna.isa.gov.il
and at the TASE's site at www.tase.co.il.
In addition, a shareholder may apply to the Company directly for receiving
the written format of the voting paper and statements of position, if any.
A member of the Stock Exchange will send, at no consideration, via e-mail,
a link to the written format of the voting paper and statements of
position, if any, to each shareholder that is not registered with the
Company's shareholders' registrar and whose shares are listed with that
member of the Stock Exchange, if the shareholder has notified the member
of the Stock Exchange of its wish and provided that the notice was made
with respect to a certain securities account and prior to the record date.
Any shareholder whose shares are listed with a member of the Stock
Exchange is entitled to receive proof of ownership from the relevant
member of the Stock Exchange at the member of the Stock Exchange's branch
or by mail to their address in return for payment of delivery fees only,
if so requested, and this application will be granted in advance to the
relevant securities account. Pursuant to the Companies Regulations (Voting
Paper and Statements of Position), 2005, that shareholder will vote on the
second part of the voting paper and specify the manner of voting and
deliver it to the Company or mail it via registered mail whereby the proof
of ownership must reach the Company's headquarters no later than 72 hours
prior to the meeting date.
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|
8.2.6
|
The
Company does not allow voting via the
internet.
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|
8.2.7
|
One
or more shareholders that hold at least 5% of total voting rights and also
hold such rate of total voting rights that are not held by the controlling
shareholder in the Company, as defined in Section 286 to the Companies
Law, are entitled to review the voting papers as detailed in Regulation 10
to the Companies Regulations (Voting Paper and Statements of Position),
2005.
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|
8.2.8
|
The
last date for producing statements of position is within ten days after
the meeting participation record date ("the last statement of position
date of delivery"), namely: Wednesday, February 3rd,,
2010 and the last date for producing the board of directors' response to
the statements of position is five days after the last statement of
position date of delivery, namely Monday, February 8th,
2010.
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|
8.3
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The required decision
passing majority
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|
8.3.1
|
The
passing of the decision mentioned in paragraph 8.1.1 above requires an
ordinary majority of the voting
participants.
|
9.
|
Review
of documents
|
To
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To
|
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The
Israel Securities Authority Ltd.
|
The
Tel-Aviv Securities Stock Exchange Ltd. ("TASE")
|
|
Through the Magna
|
Through the Magna
|
|
www.isa.co.il
|
www.tase.co.il
|
10.
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Introduction
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|
10.1
|
On
December 31, 2009 the Company's Board approved the Company's engagement in
an agreement to acquire 100% of the shares of Xtepo Ltd. ("Xtepo" 6),
a private Israeli company, which following the execution of the
transaction at hand will hold an exclusive license to use a patent for the
Erythropoietin drug ("EPO"), by way of issuing
133,063,688 Ordinary shares of NIS 0.1 par value each of
the Company ("the
allocated shares") in an extraordinary private placement pursuant
to the Israeli Securities Regulations (Private Placement of Securities in
a Listed Company), 2000 ("the Regulations") to the
shareholders of Xtepo7
("the share swap
agreement"), such that after consummating the share swap agreement
as above, Xtepo's shareholders (together with their stake in the Company
prior to the share swap) will hold about 70.64% 8 of
the Company's issued and outstanding share capital (disregarding the
holdings of the optionees in the Company prior to the transaction) and the
balance of about 29.36% will be held by the Company's shareholders
(excluding Xtepo shareholders). For details of Xtepo, see Appendix
A to this report.
|
|
10.2
|
The
execution of the share swap agreement as above is contingent, among other
things, on obtaining the approval of the Company's general shareholders'
meeting for the execution of the extraordinary private placement as above
and on obtaining the approval of the Israeli Tax Authorities as detailed
below ("the record
date"). For more details of the share swap agreement's
prerequisites, see paragraph 13.1
below.
|
6
|
A
company incorporated and registered in Israel on November 9,
2009.
|
7
|
For
more details of the shareholders in Xtepo, see paragraph 14.4
below.
|
8
|
Xtepo 's shareholders were
granted a right to invest in Xtepo pro rata to their
holdings.
|
11.
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Details
of the optionees
|
12.
|
The
terms, number and percentage of the Company's share capital of the offered
securities following the
allocation
|
|
12.1
|
According
to the terms of the extraordinary private placement and subject to the
fulfillment of the share swap agreement's prerequisites as specified
below, the optionees will be allocated 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 and about 65.71% of the Company's issued and outstanding share
capital on a fully diluted basis 9.
|
|
12.2
|
The
allocated shares as above will have rights that are equal in all respects
to the rights of existing Ordinary shares of NIS 0.1 par value each
of the Company on the date of the publication of this report and that
confer upon their holders, among other things, equal rights in
participating and voting in the Company's general meetings, receiving
dividends or any other distribution and participating in excess assets of
the Company in the event of
liquidation.
|
13.
|
The
overall transaction relating to the private
placement
|
|
13.1
|
The
Share Swap Agreement
|
|
(a)
|
The
issuance of an extraordinary private placement report with respect to the
allocated shares;
|
|
(b)
|
The
approval of the share swap agreement by the Company's general
meeting;
|
|
(c)
|
The
approval of the transaction by the Israeli Tax Authorities. For more
details, see paragraph 13.2 below;
|
|
(d)
|
The
approval of the TASE for listing the shares allocated to the
optionees;
|
|
(e)
|
Any
other legally required approval for executing the share swap
agreement;
|
|
(collectively,
"the
prerequisites").
|
9
|
Assuming
the exercise of all of the Company's convertible stock options and
securities.
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|
13.2
|
The
tax aspects relating to the
transaction
|
|
The
optionees have applied to the Israeli Income Tax Authority for a tax
exemption according to Sections 104b and 103t to the Israeli Income Tax
Ordinance. The optionees have committed towards each other to act to
achieve said tax exemption. As of the date of this report, said exemption
has not yet been obtained. The restrictions applicable pursuant to Section
104b to the Income Tax Ordinance currently prescribe as
follows:
|
|
a.
|
The
optionees will not transfer more than 10% of the Company's shares held by
them for a period of two years from the allocation date ("the restriction
period").
|
|
b.
|
Through
the end of the restriction period, the Company will not make a private
placement of shares or share rights at a rate of 25% or more of the
Company's share capital as of the allocation
date.
|
|
c.
|
Through
the end of the restriction period, the Company will not make any private
placements of public offerings of shares resulting in a cumulative holding
rate of less than 51% of each of the optionees compared to their holdings
on the allocation date.
|
|
Pursuant
to Section 103t to the Income Tax Ordinance, the parties will not be
subject to any tax liability whatsoever for the execution of the share
swap agreement. The tax exemption will be granted subject to obtaining a
pre-ruling from the Israeli Tax Authorities, to meeting the conditions and
restrictions as determined in the income tax pre-ruling and the conditions
and restrictions prescribed by the Income Tax Ordinance. The restriction
period will be two years from the end of the tax year in which the swap
transaction was carried out ("the restriction
period").
|
|
The
main conditions and restrictions prescribed by Section 103t to the Income
Tax Ordinance are as follows:
|
|
a.
|
The
main economic activities of each company participating in the swap
transaction will continue as they were prior to the
transaction.
|
|
b.
|
Most
of the assets (over 50%) that were held by the companies participating in
the swap transaction will not be sold (excluding an involuntary sale) and
will be used as customary in the companies' ordinary course of business.
For this purpose, those assets will be fixed assets. As for the intangible
asset to be assigned to Xtepo pursuant to the provisions of Section
104b(f) to the Income Tax Ordinance, this asset will not be sold for a
period of two years from the date of
transfer.
|
|
c.
|
Each
of the right owners in the companies participating in the swap transaction
holds during the restriction period all the rights it owned immediately
after the transaction and the right owners holding quoted rights will not
be included in the right owner quorum for the purpose of this paragraph
unless they were on the date of the transaction the controlling
shareholders in the Company/transferred company. Moreover, after the swap
transaction and during the restriction period, the Company will hold all
the rights in the transferred company (Xtepo) which it held on the swap
transaction date.
|
|
d.
|
Despite
the abovementioned, upon the occurrence of any of the events specified
below, it will not be viewed as a change in rights provided that at no
time during the restriction period were the rights of the Company's right
owners lower than 51% in each of the rights in the Company and that the
Company's rights will not be lower than 51% in each of the rights in the
transferred company:
|
|
1.
|
Securities
were offered to the public based on a
prospectus;
|
|
2.
|
A
sale of up to 10% of the total rights in the Company/transferred company
to non former right owners on the swap transaction date, subject to the
provisions of the Income Tax
Ordinance;
|
|
3.
|
Allocation
of shares in the Company/transferred company to non former right owners in
the Company/transferred company prior to the allocation at a rate not
exceeding 25% of the Company's share capital prior to the
allocation.
|
|
13.2.1
|
On
the record date and subject to the fulfillment of the share swap
agreement's prerequisites as specified above, the optionees will assign
10
their holdings in Xtepoto the Company in return for and against the
allocation of shares in the Company representing after their allocation
69.44% of the Company's issued and outstanding share
capital.
|
|
13.2.2
|
The
table below provides information of the interested parties in Xtepo prior
to the transaction:
|
Interested
party
|
Stake
in Xtepo (including rights owners)
|
Alex
Rabinovitch 11
|
30.81%
|
David
Bassa 12
|
16.31%
|
Shalom
Manova
|
12.91%
|
Pinchas
Ben Eliezer 13
|
7.01%
|
|
13.2.3
|
For
convenience purposes, the holding structure in the Company and in Xtepo
before and after the execution of the share swap transaction is presented
in the sketch below*:
|
10
|
The
optionees' entire shares in Xtepo as of the date of this report are held
in trust by Ronen Kantor Trustees Ltd. ("the share trustee") for
the optionees. Upon the completion of the transaction at hand, the share
trustee will assign the Xtepo shares to the Company against the allocation
of the shares to Eyal Rubin, CPA, Partner and Head of Tax Division at BDO
("the optionee
trustee") who will hold them for the optionees pursuant to the
provisions of Sections 104b and 103t to the Income Tax
Ordinance.
|
11
|
Mr.
Alex Rabinovitch holds shares of Xtepo both directly and through a company
under his control.
|
12
|
The
shares are held for Messrs. David Bassa and Shlomo Bassa in equal parts
through a company controlled by them and/or directly
held.
|
13
|
By
himself or through a company controlled by
him.
|
14.
|
The
Company's issued share capital, number and percentage of optionees' and
public holdings in the
Company
|
|
14.1
|
The
Company's authorized share capital as of the date of this report is NIS
70,000,000 million and consists of 700,000,000 Ordinary shares of
NIS 0.1 par value each.
|
|
14.2
|
The
Company's issued and outstanding share capital as of the date of this
report amounts to NIS 5.9 million, consisting of 58,561,065 Ordinary
shares of NIS 0.1 par value
each.
|
|
14.3
|
Immediately
following the private placement as detailed in paragraph 13 above, the
Company's issued and outstanding share capital will amount to
NIS 19,153 thousand, consisting of 191,624,753 Ordinary
shares of NIS 0.1 par value
each.
|
14
|
It
should be emphasized that the transfer of the holdings of the shareholders
in Xtepo to the Company and the allocation of Company shares to Xtepo
shareholders in return will be effected simultaneously subject to the
fulfillment of the prerequisites.
|
|
14.4
|
To
the best of the Company's knowledge, the holdings of the public and the
interested parties in the Company as of the date of this immediate report
and following the allocation of shares as above are as
follows:
|
Shareholder
name
|
Before
the allocation
|
After
the allocation
|
||||||
No.
of shares
|
Options
|
Holding
rate
|
Fully
diluted
|
No.
of shares
|
Options
|
Holding
rate
|
Fully
diluted
|
|
|
|
|||||||
Interested parties
|
|
|||||||
Alex
Rabinovitch 15
|
1,643,592
*
|
0
|
2.81%
|
2.37%
|
42,641,209
|
22.25%
|
21.06%
|
|
David
Bassa 16
|
21,705,987
|
11.33%
|
10.72%
|
|||||
Shalom
Manova
|
17,175,573
|
8.96%
|
8.49%
|
|||||
Xtepo shareholders that are
not
interested
parties
|
664,000
|
0
|
1.13%
|
0.96%
|
53,848,512
|
27.75%
|
26.27%
|
|
|
|
|||||||
Public
|
56,253,473
|
10,863,611
|
96.06%
|
96.67%
|
56,253,473
|
10,863,611
|
29.36%
|
33.15%
|
|
||||||||
Total
|
58,561,065
|
10,863,611
|
100%
|
100%
|
191,624,753
|
10,863,611
|
100%
|
100%
|
|
(*)
|
Together
with a relative.
|
15
|
Directly
or through a company wholly owned by
him.
|
16
|
The
shares are held for Messrs. David Bassa and Shlomo Bassa in equal parts
through a company controlled by them and/or
directly.
|
15.
|
The
consideration for the offered securities and its
determination
|
|
15.1
|
Subject
to the fulfillment of all the share swap agreement prerequisites, as
stated in paragraph 13.1.1 above, the Company will allocate the optionees
on the record date 133,063,688 Ordinary shares of NIS 0.1 par
value each of the Company representing 69.44% of the Company's issued and
outstanding share capital in return for and against all the Extipo shares
held by the optionees that represent 100% of Xtepo's issued and
outstanding share capital.
|
|
15.2
|
The
share price was determined after negotiations between the Company's
management and the optionees and is identical to the exercise price of the
options allocated to several investors in Xtepo18. It should be
stated that the share price is based, among other things, on a fairness
opinion attached as Appendix
B to this report which established that the swap ratios reflected
in the Company's share prices are
fair.
|
16.
|
The
price of the Company's shares in the extraordinary private placement and
their quoted market price
|
|
16.1
|
It
should be stated that according to the conditions of the share swap
transaction, the allocated shares will be allocated to the optionees in
consideration for their total holdings in Xtepo, reflecting NIS an amount
of 0.10 per share19.
|
|
16.2
|
The
average rate of the Company’s shares in the four months preceding the
publication date of the immediate report regarding the original
transaction signed on March 18, 2009 is NIS 0.18, approximately 85.6%
higher than the share price in the special private
offering.
|
17.
|
Names
of controlling shareholders in the Company, material shareholders,
directors and/or position holders and officers in the Company with
personal interest in the private allocation and substance of their
personal interest
|
|
To
the best of the Company’s knowledge, as of the date of this report, the
Company has no controlling shareholders. Also, to the best of the
Company’s knowledge, no position holder, officer or interested party in
the Company has a personal interest in the private allocation relating to
this report.
|
18.
|
Required
contingent approvals and
conditions
|
|
The
share swap transaction determines that its implementation is subject,
inter alia, to
fulfillment of the following contingent
conditions:
|
|
(a)
|
Publication
of a report on the special private offering regarding allocation of the
allocated shares;
|
|
(b)
|
Approval
of share swap transaction by the general shareholder meeting of the
Company;
|
|
(c)
|
Approval
by the Israel Tax Authority for implementation of the transaction; for
details see paragraph 13.2 above;
|
18
|
For details of the options granted to investors in
Xtepo, see paragraph 13.1 to this
report.
|
19
|
The
investors in Xtepo prior to the transaction invest in United States
dollars. Accordingly, the transaction relating to the present report is
stated in according to the share price in United States dollars, which is
equivalent to US$ 0.0262. As of the date of this report, regarding the
conversion rate as of January 14, 20109, this price reflects NIS 0.097 per
share.
|
|
(d)
|
Approval
by the Stock Exchange for registration of the allocated shares to the
optionees;
|
|
(e)
|
Any
other approval required for implementation of the share swap transaction
in accordance with relevant
legislation.
|
19.
|
Details
of transactions of the kind of the proposed agreement or transactions
similar thereto, between the Company and the controlling shareholders, or
in which the controlling shareholders held a personal interest, in the
last two years
|
|
To
the best of the Company’s knowledge, the Company has no controlling
shareholder. Also, to the best of the Company’s knowledge, there were no
similar transactions to the proposed agreement according to this immediate
report, in the two years preceding the date of approval of the proposed
agreement by the Company’s board of directors, between the Company and
between the controlling shareholders or in which the controlling
shareholders held a personal
interest.
|
20.
|
Limitations
or restrictions in implementation of transactions in respect of allocation
of shares to optionees
|
|
According
to Section 15C of the Securities Law, 1968, and the Securities Regulations
(Details Regarding Sections 15A – 15C of the Law), 2000, a public offering
will be deemed:
|
20.1
|
An
offering concurrently with trading on the stock exchange of the allocated
shares in the framework of this share swap transaction (“the shares”), not
exceeding six months from the date of the allocation (“the definitive
restricted period”).
|
20.2
|
An
offering concurrently with trading on the stock exchange of the shares,
not exceeding six continuous quarters, commencing as from the end of the
period stated in paragraph (a) above (“the drizzling period”),
subject to fulfillment of one of the following in each of the additional
periods in the drizzling period:
|
20.2.1
|
The
number of shares offered in each day of trading on the stock exchange
exceeded the average daily volume of trading on the stock exchange of the
Company’s shares in the period of eight weeks preceding the offering
date.
|
20.2.2
|
The
proposed number of the proposed shares, in each quarter exceeded 1% of the
Company’s issued and paid up share
capital.
|
|
“Issued and
paid up share capital” – except shares derived from realization or
conversion of convertible securities allocated until the date of the
offering and not yet realized or
converted.
|
20.2..3
|
The
above will apply also in respect of shares that will be acquired from the
optionee during the definitive restricted period or the drizzling period,
as stated, not according to a prospectus and not in the course of trading
on the stock exchange.
|
21.
|
Discussion
of board of directors regarding approval of offering, value determined for
shares and value of consideration in respect
thereof
|
|
The
Company’s board of directors approved this report at its meeting on
January 14th,
2010, in accordance with the
following:
|
a.
|
Xtepo’s
activity is in the sector of the Company’s traditional activity and
enables the Company to commence Stage 2 clinical trials of a drug with
material market potential.
|
b.
|
Xtepo
completed a capital raise so that the share swap transaction will enable
material improvement of the Company’s financial position and will enable
the Company’s continued business activity, including clinical
trials.
|
c.
|
Since
the Company’s securities are no longer traded on the Nasdaq,
implementation of an integrated transaction (activity and financing),
enabling the Company to focus on development of drugs, is attractive,
taking into account the financial position of relevant markets,
specifically in companies in the Company’s
sector.
|
d.
|
The
transaction is based on a professional opinion received by the Company
from an external appraiser, determining that “allocation of XTL shares to
Xtepo shareholders, after transfer of shares and IP assets – of Xtepo to
XTL – is reasonable and
appropriate”.
|
e.
|
In
accordance with the transaction scenario detailed in this report, a
liability in the amount of US$ 10 million was waived, compared to the
original transaction scenario signed in March 2009, and furthermore,
despite the fact that the Company’s shares were delisted from trading on
the Nasdaq, the current transaction scenario improves the Company's
situation compared to the original transaction
structure.
|
f.
|
In
light of the Company’s position immediately prior to implementation of the
transaction and lack of other viable alternatives, non-implementation of
the transaction may lead to the Company’s inability to operate and to
cessation of activity.
|
22.
|
Names
of directors that approved the special private
offering
|
|
At
the meeting of the Company’s board of directors convened on December
31st,
2009, at which submission of this report was approved, Amit Yonay
(chairman of the board of directors), David Grossman (director and CEO),
Boaz Shweiger (director), Marc Allouche (director), Dafna Cohen (director
for the public) and Jaron Diament (director for the public),
participated.
|
23.
|
Date
of implementation of special private
offering
|
|
As
of the determining date, and subject to fulfillment of the contingent
conditions, the Company will allocate to the optionees the allocated
shares concurrently with transfer of the optionees’ total holdings in
Xtepo to the Company.
|
24.
|
Announcement
regarding special general meeting of the Company’s
shareholders
|
24.1
|
In
accordance with the Companies Ordinance, announcement is hereby
transmitted regarding convention of an extraordinary meeting of the
Company’s shareholders, to be held on February 23rd,
2010, at 10:00, in the offices of Kantor & Co. Law Offices, Abba
Hillel Silver Street 14, Floor 12, Ramat Gan, Israel, with the following
agenda:
|
24.1.1
|
Approval
of share swap agreement including special private offering in accordance
therewith.
|
24.2
|
Location and date of
meeting
|
24.2.1
|
The
special general meeting will be convened on February 23rd,
2010,, at 10:00, in the offices of Kantor & Co. Law Offices, Abba
Hillel Silver Street 14, Floor 12, Ramat Gan, Israel. A deferred meeting
will be convened, if required, on Tuesday, March 2nd,
2010, at the same location and at the same
time.
|
24.2.2
|
A
legal quorum participating in the special general meeting, themselves or
by legal proxies, will constitute at least two (2) shareholders holding or
representing together at least 33.33% of the voting rights in the Company.
If, after 30 minutes from the date and time determined for the meeting a
legal quorum is not present, the meeting will be deferred automatically
until the dame day in the following week, at the same time and in the same
location determined for the original meeting; or to another day, hour or
location as determined by the board of directors in an announcement to the
shareholders. In the event that no legal quorum is present at the deferred
meeting, within 30 minutes from the date and time determined for the
deferred meeting, two shareholders present by themselves or by their legal
proxy will constitute a legal quorum and the extraordinary meeting will be
entitled to consider issues for which purpose the meeting was
convened.
|
24.2.3
|
The
determining date for entitlement of the shareholders to vote at the
general meeting, as stated in Section 182 of the Companies Law is January
24th,
2010 (“the determining date for entitlement to participate in the
meeting”).
|
24.2.4
|
All
shareholders in the Company as of the determining date for entitlement to
participate in the meeting, whether the shares are registered in the
holder’s name or whether the shareholder holds the shares through a stock
exchange member, are entitled to participate in the meeting, individually
or through a voting representative. In accordance with the Companies
Regulations (Determination of Share Holding for Purposes of Voting at
General Meeting), 2000, a shareholder in the Company holding shares
through a member of the stock exchange may participate in the general
meeting individually or through a voting representative, only in the event
that original confirmation is transmitted to the Company, prior to the
meeting, regarding ownership of the Company’s shares as of the determining
date for entitlement to participate in the meeting (such confirmation is
receivable from the stock exchange member). A document appointing a voting
representative (“the appointment document”), and original power of
attorney in accordance with which the appointment document was signed (if
such exists) should be transmitted to the Company’s registered offices up
to 48 hours prior to the date of the
meeting.
|
24.2.5
|
The
format of the voting document and the position announcement, if such
exist, may be found on the website of the Securities Authority, www.magna.isa.gov.il
and on the website of the Tel Aviv Stock Exchange, www.tase.co.il.
Also, a shareholder is entitled to contact the Company directly in order
to receive the format of the voting document and the position
announcement, if such exist. A stock exchange member will transmit,
without consideration, by electronic mail, a link to the format of the
voting document and position announcement, if such exist, to any
shareholder not registered in the listing of the Company’s shareholders
and whose shares are registered with the same stock exchange member, if
the shareholder informs the stock exchange member of his interest therein,
subject to transmission of the announcement regarding a specific
securities account and prior to the determining date. A shareholders whose
shares are registered with a stock exchange member is entitled to receive
confirmation of ownership from the stock exchange member through which the
shareholder’s shares are held, at a branch of the stock exchange member or
by post to the shareholder’s address, in consideration for postage fees
only, subject to the shareholder’s request, and submission of such request
in advance to a specific securities account. In accordance with the
Companies Regulations (Voting in Writing and Position Announcement), 2005,
shareholders will vote on Part 2 of the voting document, detailing the
method of the voting, and will transmit the document to the Company or
will send the document by registered mail, wherein the document will reach
the Company’s offices not later than 72 hours prior to the date of
convention of the general meeting.
|
24.2.6
|
The
Company does not enable voting by
Internet.
|
24.2.7
|
One
or more shareholders holding shares at a rate of 5% or more of total
voting rights, and holders of such rate out of the total voting rights not
held by controlling shareholders in the Company, As defined in Section 286
of the Companies Law, are entitled to review the voting documents as
detailed in Regulation 10 of the Companies Regulations (Voting in Writing
and Position Announcement), 2005.
|
24.2.8
|
The
final date for transmission of a position announcement is up to ten days
after the determining date for entitlement to participate in the
extraordinary meeting (“the final date for transmission of position
announcements”), i.e. Wednesday, February 3rd,
2010, and the final date for transmission of the board of directors’
response to the position announcements is five days after the final date
for transmission of position announcements, i.e. Monday, February 8rd,
2010.
|
24.3
|
Required majority for
decision
|
|
The
required majority for approval of the decision stated in paragraph 24.1.1
above is a regular majority of the participants in the
voting.
|
25.
|
Securities
Authority
|
|
Within
21 days from the date of submission of this issued report, the Israel
Securities Authority (“the Authority”) is entitled to instruct the Company
to provide, by a certain date, explanation, details, information, data and
documents regarding the agreement for the transaction relating to this
mediate report, and to instruct the Company to amend this immediate
report, in such manner and as such time as
determined.
|
|
In
the event of such instruction for amendment, the Authority or an employee
thereof is entitled to determine deferral of the date of the general
meeting until a date not earlier than three business days and not later
than 21 days from the date of publication of the amendment to the
immediate report.
|
26.
|
Review
of documents
|
|
Documents
relating to this immediate report may be reviewed at the offices of Kantor
& Co. Law Offices, Abba Hillel Silver Street 14, Floor 12, Ramat Gan,
Israel, during regular work hours and after advance coordination at
telephone 03-6133371.
|
27.
|
Company
representatives
|
|
The
Company’s representatives responsible for the immediate report are
Advocate Giora Gutman and/or Ronen Kantor, of Kantor & Co. Law
Offices, Abba Hillel Silver Street 14, Floor 12, Ramat Gan, Israel,
telephone 03-6133371.
|
1.
|
Xtepo’s activity and
description of its business
development
|
|
1.1
|
Terminology
|
Multiple
myeloma
|
Multiple
myeloma is a hematological cancer accounting for about 10% of all
hematological cancers and about 1% of all malignant diseases. This disease
is characterized by uncontrolled proliferation of plasma cells, a type of
white blood cells, in the bone marrow, thus leading to the formation of
malignant cell foci causing damage and partial bone
destruction This disease has a multi-focal (multiple) nature,
reflected by formation of multiple malignant cell foci. The malignant
cells and the proteins secreted by them are responsible for a series of
clinical manifestations and complications, including damage to the bones,
accompanied by pain and fractures, damage to the bone marrow and anemia,
susceptibility to infections, weakening of the immune system, nervous
system impairment, renal insufficiency, coagulation defects,
etc. Multiple myeloma is an incurable disease, with mean life
expectancy of the patients being about 3-5 years.
|
||
Plasma
cells
|
A
group of cells constituting about 2-5% of all white blood cells in the
human body. Plasma cells produce immunoglobulins, which are immune system
proteins serving as antibodies.
|
||
Erythropoietin-
EPO
|
A
hormone produced by the kidneys, the known function of which is
stimulation of red blood cell production in the bone
marrow.
|
||
Recombinant
Erythropoietin (Recombinant EPO)
|
A
genetically – engineered hormone usually designed for treatment of various
types of anemia, mainly anemia affecting patients suffering from renal
insufficiency (and treated with hemodialysis), as well as patients with
various types of malignant diseases accompanied by
anemia.
|
||
Autologous
stem cells
|
Stem
cells are undifferentiated cells, out of which the three types of blood
cells are formed. Most stem cells reside in the bone marrow; however, some
of them- called peripheral blood stem cells (PBSC)- are collected from the
bloodstream.
Autologous
transplantation – the patient receives stem cells from his own bone marrow
or peripheral blood.
|
||
Neuropathy/
Peripheral neuropathy
|
Functional
impairment of the nerves responsible for transmitting sensation from the
tips of the hands and feet. In mild cases, peripheral neuropathy may cause
tingling in hands and feet, while in severe cases, it may cause pain and
pricking sensation in all parts of the body, up to difficulties in limb
function and movement.
|
||
T-
Lymphocytes
|
White
blood cells, which are an important component of the immune system. These
cells act in various ways, and are responsible for assisting the body in
its fight against infections, malignant cells,
etc.
|
Anti-
cancer effect
|
Anti-
cancer effect is any effect causing the cancer cells to stop dividing and
multiplying, destroying the cells or “freezing” their growth and
spread.
|
||
Helsinki
committee
|
A
committee acting in accordance with People’s Health Regulations (Clinical
trials in human subjects), 1980, responsible for approving and supervising
clinical trials - for more information, see paragraph 2.10.1
below.
|
||
IRB
|
Institutional
Review Board – A committee equivalent to the Helsinki committee in the US
and other world countries.
|
||
FDA
|
Food
and Drug Administration – The US authority responsible for control and
regulation of drug development and registration in the
US.
|
||
EMEA
|
European
Medicines Agency – The European authority responsible for control and
regulation of drug development and registration in European Union
countries. EMEA currently includes about 30 member - countries.1
|
||
Serious
Adverse Events (SEA) or Serious Adverse Drug Reaction
|
Any
disturbing medical event, at any dose, which is either life threatening or
fatal, or requiring hospitalization or extension of current
hospitalization, or causing permanent disability or permanent functional
impairment.
|
||
Activity
|
Laboratory
or clinical results indicating clinical efficacy of the
drug.
|
||
Efficacy
|
Proof
of clinical effect of a drug in a human clinical trial.
|
||
Orphan
drug
|
A
special pathway for approval and marketing of medicinal agents by the FDA.
This pathway is designed to fulfill the need for the development of drugs
for unique populations, as well as for the treatment of relatively rare
and incurable diseases (in the US – diseases affecting 200,000 patients
(maximal number), in the European Union - diseases with an incidence of up
to 5 per 10,000 people). Recognition of a certain drug as an orphan drug
grants the manufacturer regulatory marketing exclusivity for a period of 7
years in the US and 10 years in the European Union.
|
||
Ethical
drug
|
A
patented drug; only its developer is authorized to manufacture and sell
it.
|
|
1.2
|
General
|
|
1.3
|
Xtepo’s
drugs
|
|
1.4
|
Drug development
procedure – General
description
|
|
(a)
|
Pre-clinical
phase – This phase includes animal studies designed to demonstrate
efficacy of the drug in animal models of the disease for which the drug is
indicated. The pre-clinical phase also includes experiments, performed
under stringent conditions, designed to examine whether the drug exerts
toxic side effects, and to evaluate its various features in animals. In
addition, the pre-clinical phase includes development of Good
Manufacturing Practice methods (GMP- a set of manufacturing requirements
with which the drug has to comply in order to be approved for future
administration to the patients).
|
|
(b)
|
Phase I – This
is the first clinical phase of drug development, during which a
preliminary examination is performed in human subjects, with the aim of
evaluating the safety and the maximal safe dosage of the drug. Tests of
drug distribution and duration of its retention in the bloodstream may
also be performed during this phase; these tests enable evaluation of the
bioavailability of the drug and other parameters. Phase I studies may be
carried out in either healthy volunteers or in
patients.
|
|
(c
)
|
Phase II – This
phase involves preliminary examination of drug efficacy in patients. In
addition, one of the aims of this phase is to determine the optimal
therapeutic dose of the drug. Its safety evaluations are ongoing
simultaneously. In many cases, several Phase II studies are performed:
Phase IIa study, the objective of which is proof of concept, and a more
extensive Phase IIb study, including a larger number of patients and study
centers, as compared to Phase IIa
study.
|
|
(d)
|
Phase III – The
most important phase of multinational, multicenter, randomized, placebo-
controlled and double- blind studies. This phase involves a larger number
of subjects (hundreds and even thousands), and is carried out in a large
number of medical centers worldwide, using a single dosage. The objective
of this phase is to prove the safety and efficacy of the drug in a large
number of patients in order to enable a more accurate simulation (compared
to earlier phases) of its use by physicians in clinical practice.
Following successful completion of this phase, applications for approval
of drug registration may be submitted to the relevant health
authorities.
|
2.
|
Xtepo’s field of
activity
|
3.
|
Financial information
with respect to Xtepo’s field of
activity
|
4.
|
General environment
and effect of external factors on Xtepo’s
activity
|
5.
|
General information on
the field of activity
|
|
5.1
|
Introduction
|
|
5.1.1
|
Prof. Mittelman’s
research study
|
5.2
|
Structure of Xtepo’s
field of activity and the changes occurring within
it
|
|
5.2.1
|
Multiple Myeloma
(MM)
|
|
5.2.2
|
Drug development
processes
|
|
5.3
|
Critical success
determinants in this field of
activity
|
|
5.4
|
Barriers at the
entrance to the field of
activity
|
5.5
|
Alternatives to the
development product and changes occurring in
them
|
|
5.6
|
Structure of the
competition in the field of activity and changes occurring in
it
|
|
5.6.1
|
General
|
|
5.6.2
|
Competition in the
cancer market
|
|
5.6.3
|
Ways of coping with
competition
|
6.
|
Intangible
assets
|
|
6.1
|
Patent licensing
agrrements
|
7.
|
Restrictions, valid
legislation and special constraints relevant to the field of
activity
|
|
7.1
|
Helsinki
committee
|
|
a)
|
The
expected advantages, for the subject and the company, justify the risk and
discomfort associated with the trial for the
subject;
|
|
b)
|
The
existing scientific and medical information justify performance of the
requested clinical trial;
|
|
c)
|
The
clinical study design is scientifically valid, enabling it to provide
answers to the question under investigation; it is presented in a clear,
detailed and accurate manner in the study
protocol;
|
|
d)
|
The
risk for the study subject is minimal, due to the use of correct methods,
and use of procedures already performed in humans or tested in animals, as
much as possible;
|
|
e)
|
The
study subjects will be chosen in accordance with inclusion/ exclusion
criteria specified in the study
protocol;
|
|
f)
|
Informed
consent form for the study including all the required information, as
specified in the procedure;
|
|
g)
|
Study
design including instructions with respect to patient’s privacy protection
and confidentiality of the data
collected;
|
|
h)
|
The
study design includes a proper mechanism of study
monitoring;
|
|
i)
|
The
sponsored has ensured proper insurance coverage for the study
subjects;
|
|
j)
|
The
sponsor and the investigator are capable of allocating the resources
required for adequate performance of the study, including qualified
personnel and the necessary
equipment;
|
|
k)
|
Adequate
performance of the study will not be harmed by the nature of commercial
agreement with the investigator and the institution in which the study is
performed;
|
|
l)
|
If
the study subjects, some or all, may be exposed to inadequate pressure or
influence in order to convince them to participate in the study –
appropriate measures were taken in order to prevent the above pressure or
to minimize the above influence.
|
7.2
|
Approval by FDA and
EMEA
|
8.
|
Essential
agreements
|
8.1
|
License agreement with
Bio- Gal
|
|
1.
|
Annual
license fee of one percent (1%) of the net sales of Xtepo and its
subcontractors.
|
|
2.
|
A
single payment upon the following conditions: (1) Sale of 50% or more of
Xtepo’s shares to a third party (2) Merging of Xtepo with a third party
(3) Sale or transfer of Xtepo’s strategic assets (hereafter: realization
event), with a value of 250,000 USD or 2.5% of the gross profit
of Xtepo from this event (the lowest of the
two).
|
|
3.
|
In
spite of the above, the parties have decided to agree that although
performance of the transaction according to this report is a realization
event, the appropriate payments will be postponed until the successful
completion of Phase II clinical trial, following which Xtepo will pay Yeda
a single sum of 250,000 USD, and additional 100,000 USD in case of raising
at least 2 million USD, and subject to successful completion of Phase II
clinical trial.
|
9.
|
Human
resources
|
|
9.1
|
Organizational
structure
|
10.
|
Taxation
|
10.1
|
Tax rates applicable
to Xtepo as an Israeli
company
|
11.
|
Aims and business
strategy
|
12.
|
Expected development
over the next year
|
13.
|
Discussion of risk
factors
|
13.1
|
Risks of the
field
|
|
13.1.1
|
Exposure to the
effects of regulation
|
|
13.1.2
|
Dependence on external
funding
|
|
13.1.3
|
Dependence on highly
professional and skilled
personnel
|
|
13.1.4
|
Dependence on
volunteers for the trial
|
|
13.1.5
|
Exposure to
lawsuits
|
|
13.1.6
|
Competitors
|
13.2
|
Risks
unique to the company
|
|
13.2.1
|
Development
failure
|
|
13.2.2
|
Relative dependence on
a key person
|
|
13.2.3
|
Protection of
intellectual property
|
|
13.2.4
|
Marketing and
sales
|
|
13.2.5
|
The
following table summarizes the risk factors, which may affect Xtepo’s
business activity and business outcomes, and Xtepo’s estimate of the
extent of effect for each risk
factor
|
Type
of risk
|
Brief
description
|
Extent
of effect on Xtepo’s business activity
|
||
High
|
Moderate
|
Low
|
||
Risks
of the field
|
Being
subjected to law and regulation
|
V
|
|
|
Dependence
on external funding
|
V
|
|
||
Dependence
on professional and skilled personnel
|
|
V
|
||
Dependence
on recruitment of study subjects
|
V
|
|
||
Possible
side effects of the drug, certainly during development – potential
lawsuits
|
|
V
|
||
Development
of competing drugs
|
|
V
|
||
Risks
unique to the company
|
Numerous
elements of uncertainty – insufficient results, delay or failure of the
drug – no guarantee of successful trial or absence of side
effects
|
V
|
|
|
Due
to the high dependence on patents and maintenance of intellectual
property, there may be potential violation of existing
patents.
|
|
V
|
||
In
the future, when Xtepo’s drugs reach the stage of manufacture, Xtepo will
be dependent on manufacturing facilities of other companies, since it has
no capacity of mass production of the drug.
|
|
V
|
1.1
|
General
|
·
|
We
read, analyzed and examined the data, records, legal memoranda and
documentation furnished to us in regard to the Transaction, Bio-Gal and
the Company.
|
·
|
We
reviewed public data, including inter alia the evolvement process of the
Company’s share price.
|
·
|
We
performed various calculations as detailed and required for assessing the
reasonableness of the merged companies’ value derived from the
Transaction.
|
·
|
We
held talks with the Company’s CEO, Mr. David Grossman and with the CFO,
Mr. Ronen Twito, who provided us with the data used in this
Opinion.
|
·
|
We
prepared a reasonableness test to examine the assumptions underlying the
value of the subject Transaction.
|
2.1
|
Description
of XTL Biopharmaceuticals Ltd.
|
1.
|
Bio-Gal’s
shareholders are to establish a new company incorporated in Israel
(hereafter: “Xtepo”), to which
Bio-Gal would assign its intellectual property (“IP”). The
shareholders’ holdings in Xtepo would be identical to those in Bio-Gal,
(in conformity with the exemption prescribed under Section 104B of the
Income Tax Ordinance).
|
2.
|
Xtepo
will raise capital from New Investors by way of issuingof warrants, when
the capital to be raised will be approximately $1.5 m. Once the capital
has been raised, the new investors (hereafter: “the New Investors”) will
hold a 42% stake in Xtepo, while Bio-Gal’s original investors (hereafter:
“the Original Investors”)
will hold a 58% stake in Xtepo. (The Investors and
Original Investors will hereafter be referred to as “Xtepo’s
Shareholders”).
|
|
Exercising
of the warrants depends on the approval of the shareholder
meeting.
|
3.
|
Description
of XTL– Bio-Gal Transaction (through
Xtepo):
|
1.
|
XTL
will purchase 100% of Xtepo by way of issuing new Company shares under a
private placement to Xtepo’s shareholders (hereafter: “Share Swap Transaction”).
After completing the Share Swap Transaction, Xtepo’s shareholders
would control about 70% of XTL’s share capital, whilst the balance would
be held by the Company’s existing shareholders whose holdings in the
Company, subsequent to the Share Swap Transaction and share allotment,
would be diluted.
|
2.
|
The
cash payment of $10 m. would be cancelled in accordance with the
milestones (based on development progress) as stipulated in the original
agreement.
|
3.
|
Furthermore,
pursuant to the Transaction, the Patent usage rights would be assigned to
Xtepo. In the context of assigning the Patent rights, XTL has undertaken
to guarantee all of Xtepo’s debts to Yeda and Mor (including a commitment
to maintain information secrecy as well as payment of 1% royalties on net
sales of the drug developed on the basis of the Patent), derived as a
result of the Patent Agreement, should the Transaction with Xtepo indeed
materialize.
|
4.
|
According
to a binding clause in the Agreement, Xtepo is under an obligation, should
Phase II of the EPO Clinical Trial succeed, to transfer to Yeda a lump sum
of $250 thousand, as well as a lump sum of $120 thousand, upon occurrence
of two events in the following
order:
|
|
·
|
Success
of EPO Phase II Clinical Trial
|
|
·
|
The
earlier of the Company raising $2 m. at least, or 180 days from date of
success of Phase II clinical trial, as
above.
|
·
|
We
analyzed the value of Xtepo prior to the merger, based on a $1.5 m.
capital infusion, against which 42.2% of Xtepo’s shares were allotted to
the New Investors (through the allotment of warrants). This allotment
reflects an aggregate Company value of approximately $3.5 m. The IP value
derived from this Transaction is $2.0
m.
|
·
|
Since,
according to the proposed Transaction, Xtepo’s shareholders are entitled
to 70% of XTL’s shares, the value of the new merged company (XTL + Xtepo)
is $5 m.
|
·
|
Thus,
the value of XTL obtained prior to the merger was $1.5 m. XTL’s equity as
of 31.3.2009 (close to the original transaction date) amounted to $0.6 m.,
composed mostly of a cash balance. Thus, in our opinion, given that this
concerns a public company traded in Tel Aviv and in the U.S. and bearing
in mind its equity, a value of $1.5 m. is reasonable and
fair.
|
$ millions
|
||||
Cash
investments in Xtepo
|
1.4725 | |||
Proportion
of shares obtained
|
42.24 | % | ||
Company
value derived from $1.5 m. infusion in Xtepo
|
3.5 | |||
IP
value obtained (company value less cash investment
|
2.0 | |||
XTL
value prior to merger
|
1.534 | |||
Merged
company value
|
5.021 | |||
Proportional
part for Xtepo’s shareholders
|
69.44 | % | ||
Proportional
part for XTL’s shareholders
|
30.56 | % |
$
Thousand
|
September
30, 2009
Reviewed
|
June
30,
2009
Reviewed
|
March
31,
2009
Management
Data
|
December
31,
2008
Audited
|
||||||||||||
Current Assets
|
||||||||||||||||
Cash
and cash equivalents
|
640 | 899 | 1,013 | 2,924 | ||||||||||||
Assets
o/a of employee benefits
|
- | - | 12 | 12 | ||||||||||||
Accounts
receivable
|
20 | 134 | 195 | 305 | ||||||||||||
Income
tax receivable
|
49 | 49 | 49 | 49 | ||||||||||||
Restricted
deposits
|
40 | 71 | 71 | 71 | ||||||||||||
Total
|
749 | 1,153 | 1,340 | 3,361 | ||||||||||||
Non-Current Assets
|
||||||||||||||||
Fixed
assets
|
29 | 32 | 36 | 41 | ||||||||||||
Other
long term investments
|
95 | - | - | - | ||||||||||||
Total
|
124 | 32 | 36 | 41 | ||||||||||||
Total
Assets
|
873 | 1,185 | 1,376 | 3,402 | ||||||||||||
Current Liabilities
|
||||||||||||||||
Trade
payables
|
228 | 169 | 316 | 416 | ||||||||||||
Other
accounts payable
|
405 | 777 | 420 | 1,058 | ||||||||||||
Employee
benefit liabilities
|
- | - | - | 447 | ||||||||||||
Liability
for share appreciation rights
|
- | 178 | 54 | 7 | ||||||||||||
Total
|
633 | 1,124 | 790 | 1,928 | ||||||||||||
Shareholders
equity
|
240 | 61 | 586 | 1,474 | ||||||||||||
Total
liabilities and equity
|
873 | 1,185 | 1,376 | 3,402 |
June
30,
2008
|
Sept
30,
2008
|
Dec
31,
2008
|
March
31,
2009
|
June
30,
2009
|
||||||||||||||||
Cash
and cash equivalents
|
65,314 | 56,410 | 56,839 | 44,499 | 41,635 | |||||||||||||||
Equity
|
56,546 | 47,182 | 47,204 | 40,349 | 39,353 | |||||||||||||||
Market
value*
|
86,033 | 119,076 | 22,625 | 36,318 | 39,364 | |||||||||||||||
Period
after (prior to) clinical
failure -months
|
-3.5 | -0.5 | 2.5 | 5.5 | 8.5 | |||||||||||||||
Market
value / equity
|
152 | % | 252 | % | 48 | % | 90 | % | 100 | % |
1.
|
Drug
for the treatment of Parkinson’s disease Phase
III
|
2.
|
Drug
for the treatment of schizophrenia Phase
II
|
3.
|
Proving
clinical performance criteria of a drug treatment for sleep maintenance
insomnia in healthy older
adults.
|
March
31,
|
June
30,
|
Sept
30,
|
Dec
31,
|
March
31,
|
||||||||||||||||
2008
|
2008
|
2008
|
|
2008
|
|
2009
|
||||||||||||||
Cash
and cash equivalents
|
106,499 | 89,621 | 72,698 | 60,083 | 46,384 | |||||||||||||||
Equity
book value
|
98,667 | 81,204 | 66,242 | 52,992 | 38,386 | |||||||||||||||
Market
value*
|
335,700 | 136,906 | 99,527 | 33,460 | 35,320 | |||||||||||||||
Period
after (prior to) clinical
failure -months
|
5.5- | 2.5- | 0.5 | 3.5 | 6.5 | |||||||||||||||
Market
value / equity
|
340 | % | 169 | % | 150 | % | 63 | % | 92 | % |
4.5
|
Bio-Gal’s
IP Value (transferred through
Xtepo)
|
·
|
Analysis
of similar IP sale transactions
|
·
|
Estimated
cash flows for property
|
Name
of
Company
|
Date
Established
|
Date
Sold
|
Proceeds
of
Sale
|
Total
Investment
in
Company
|
||||
Ester
Neurosciences
|
1997
|
2007
|
$15
m. plus a further $17 m. based on meeting targets
|
10
|
||||
Hamilton
Pharmaceuticals
|
1932
|
2007
|
$4.4
m. in shares plus a further $4 m. based on meeting targets
|
11
|
||||
Miikana
Therapeutics
|
2002
|
2005
|
$21
m. in shares plus a further $18 m. based on meeting
targets
|
8
|
||||
MacroChem
Corporation
|
1981
|
2009
|
$3
m.
|
100
|
3
Mittelman M, Zeidman A, Kanter P, Katz O, Oster H, Rund D,
Neumann D. Erythropoietin has an anti-myeloma effect - a hypothesis based
on a clinical observation supported by animal studies. Eur J Haematol.
2004 Mar;72(3):155-65
|
·
|
As
a condition for conducting the trials, the Company must obtain prior
approval from the competent authorities to perform medical tests on human
beings in each and every country where such tests are envisaged.
Furthermore, the product which the Company intends to develop and market
is a medical one, hence its production, sale and marketing is contingent
on obtaining a license in each country where marketing is contemplated. In
order to obtain such approval, the Company must comply with licensing
requirements, including safety conditions and quality control standards,
as prescribed by the authorities.
|
·
|
The
Company is exposed to the risk of competitors developing a similar drug to
the above.
|
·
|
The
patent for using the drug to treat patients suffering from anemia is
expected to expire in 2012-2013, when the drug will become generic.
Accordingly, there is the risk that certain countries will make off-label
use of the EPO; however such risk is qualified since the EPO has a “black
box” warning that deters people from taking the drug otherwise than
according to label.
|
·
|
Bio-Gal
has a preliminary plan to conduct Phase II clinical trials on some 50
patients. Should a situation arise whereby several drugs are
being developed during the Company’s trials, this could create
difficulties in recruiting patients for Phase II and Phase III. The need
for a substantial number of patients in the advanced stages of clinical
trials is a serious obstacle in developing a drug that could impact the
prospects and time frame for completing the development of Xtepo’s EPO
drug.
|
1.
|
Completion
of Phase II drug development and obtaining approvals for proceeding to
Phase III.
|
2.
|
Completion
of Phase III drug development
|
3.
|
Successful
completion by the Company of all trial and registration stages, and
launching the drug for worldwide
marketing.
|
4.
|
Recognizing
EPO as an “Orphan Drug”, enabling it to be exclusively marketed for 7 more
years after completing the development process and obtaining the necessary
approvals for producing and distributing the
drug.
|
a.
|
Interim
results of a clinical trial (if planned) - for instance, in the midst of a
trial phase. If the trial is planned for two years, the results
could be obtained within a year.
|
b.
|
Final
trial results – these could be obtained three months after
completion.
|
Success
Probability
|
Cumulative
Probability
|
|
Phase
I
|
62.5%
|
62.5%
|
Phase
II
|
35%
|
21.9%
|
Phase
III
|
68%
|
14.9%
|
File
|
90%
|
13.4%
|
Trial
Phase
|
Cost
of Trial ($ m.)
|
Period
up to Completion of
Trial
Phase
|
Phase
II
|
1.5
|
2.5
|
Phase
III
|
16
|
3.5
|
Company
name
|
Development
status
|
Down
payment
|
Royalty
rate
|
Competition
(high/low
level)
|
Potential
market
size
|
|||||
Montigen
Inc.
|
Number
of drugs in para-clinical trials
|
$18
m. ($9 m. cash and $9 m. in Supergen shares). Further payment
up to $22 m. upon attaining milestones
|
Apparently
there isn’t any
|
On
all levels – but still far from commercialization
|
$
billions.
|
|||||
Hunter-Fleming
|
2
drugs in 2 phases.
2
drugs in phase I. One in para-clinical
|
€ 8
m. after deducting debt
(amount
unknown) – in shares
|
Additional
€ 17 m. in shares after completing milestones
|
Great
competition
|
Vast
markets – Alzheimers, arthritis and more
|
|||||
Elbion
|
1
drug ready for phase II.
2
drugs in para-clinic
|
Approx.
$30 m.
|
|
Medium
|
|
|||||
Innovive
Pharmaceuticals, Inc.
|
4
drugs in clinical trials
|
$3
m. in CytRX shares
|
Not
known, but deal reaches $21.3 m. presumably accord. to
milestones.
|
Variable
(depends on drug)
|
$
billions.
|
|||||
Targanta
Therapeutics
|
Phase
3 successfully completed,
FDA
demands more completions
|
$42
m.
|
$95
m. before milestones
(inc.
attaining market targets not indicated)
|
Medium
competition
|
aprx.
$ 1 billion.
|
|||||
IDM
Pharma, Inc.
|
Phase
3 successfully completed; approval to market in Europe
|
$75
m.
|
No
royalties
|
Medium.
Orphan drug in Europe up to 2014
|
$
100
ms.
|
Parameter
|
Value
|
Source
|
Non-risk
interest rate
|
3.10%
|
Bank
of Israel
|
Market
premium
|
6.50%
|
Damodaran
|
Beta
|
1.12%
|
Damodaran
|
Addition
in respect of small company
|
9.83%
|
Ibbotson
|
Addition
in respect of specific risk for company
|
3.00%
|
|
Price
of equity capital
|
23.21%
|
|
Rounded
off price of capital
|
25%
|
XTL BIOPHARMACEUTICALS LTD. | |||
Date:
January 15, 2010
|
By:
|
/s/
David Grossman
|
|
David Grossman | |||
Chief Executive Officer |