Washington,
D.C. 20549
FORM
6-K
REPORT
OF
FOREIGN ISSUER
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For
the month of September 2006
Commission
File Number 000-51122
pSivida
Limited
(Translation
of registrant’s name into English)
Level
12
BGC Centre
28
The
Esplanade
Perth
WA
6000
(Address
of principal executive offices)
(Indicate
by check mark whether the registrant files or will file annual reports under
cover Form 20-F or Form 40-F).
Form
20-F
ý Form
40-F o
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(7):
Indicate
by check mark whether the registrant by furnishing the information contained
in
this Form is also thereby furnishing the information to the Commission pursuant
to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes
o No
ý
If
"Yes"
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): 82- ___.
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant,
pSivida Limited, has duly caused this report to be signed on its behalf by
the
undersigned, thereunto duly authorized.
| pSivida Limited | ||
| |
|
|
| Date: September 13, 2006 | By: | /s/ Aaron Finlay |
|
Aaron Finlay |
||
| Company Secretary | ||
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
RetisertTM
Wins International Award
|
|
EXHIBIT
99.2:
|
Appendix
4E: Preliminary Final Report Year ended 30 June
2006
|
| ASX/Media RELEASE |
13
September
2006
|
RetisertTM
Wins International Award
Boston,
MA. and Perth, Australia — Global
bio-nanotech company pSivida Limited (ASX:PSD, NASDAQ:PSDV, Xetra:PSI) is
pleased to announce that a paper describing the initial clinical work on its
lead ophthalmology product RetisertTM,
has
been awarded first prize in the field of Clinical Uveitis by the DUAG (Deutsche
Uveitis-Arbeitsgemeinschaft), the umbrella organisation of all German uveitis
patient interest groups.
The
awards are to honour the three best publications in peer-reviewed journals
from
the previous year that have made a significant contribution to the area of
clinical or basic science in uveitis research, as judged by an international
committee of some of the world’s leading uveitis specialists.
‘Long-term
follow-up results of a pilot trial of a fluocinolone acetonide implant to treat
posterior uveitis’ published in Ophthalmology 2005
and
co-authored by pSivida’s Director of Strategy, Dr Paul Ashton, was awarded first
prize in the field of ‘Clinical Uveitis’.
 |
Uveitis
is a leading cause of blindness
affecting an estimated ^175,000 people in the US, *200,000 persons
in the
EU and ^800,000 people worldwide.
Uveitis is a chronic auto-immune disease in which the body’s own defences
attack the inner lining of the eye (the uvea). Retisert™
is
the only FDA approved drug for this disease. Surgically implanted
into the
eye, Retisert™ is approved to release a constant amount of the drug,
fluocinolone
acetonide,
over a treatment period of 30
months.
|
pSivida
receives royalties from sales of Retisert™ which sells for US$18,250 and covered
in the United States by Medicare and Medicaid. Retisert™ was approved by the FDA
in late 2005 and licensed to Bausch
& Lomb (B&L). A dedicated Retisert™
website
was recently launched by B&L www.retisert.com.
*Source:
European Medicines Agency
^Source:
Bausch & Lomb
-ENDS-
Released
by:
|
pSivida
Limited
Brian
Leedman
Investor
Relations
pSivida
Limited
Tel:
+ 61 8 9226 5099
brianl@psivida.com
|
US
Public Relations
Beverly
Jedynak
President
Martin
E. Janis & Company, Inc
Tel:
+1 (312) 943 1100 ext. 12
bjedynak@janispr.com
|
European
Public Relations
Eva
Reuter
Accent
Marketing Limited
Tel:
+49 (254) 393 0740
e.reuter@e-reuter-ir.com
|
NOTES
TO EDITORS:
pSivida
is a global bio-nanotech company committed to the biomedical sector and the
development of drug delivery products. Retisert™ is FDA approved for the
treatment of uveitis. Vitrasert® is FDA approved for the treatment of
AIDS-related CMV Retinitis. Bausch & Lomb own the trademarks Vitrasert® and
Retisert™. pSivida has licensed the technologies underlying both of these
products to Bausch & Lomb. The technology underlying Medidur™, a treatment
for diabetic macular edema, is licensed to Alimera Sciences and is in Phase
III
clinical trials.
pSivida
owns the rights to develop and commercialise a modified form of silicon
(porosified or nano-structured silicon) known as BioSilicon™, which has
applications in drug delivery, wound healing, orthopaedics, and tissue
engineering. pSivida’s subsidiary, AION Diagnostics Limited is developing
diagnostic products and the subsidiary pSiNutria is developing food technology
products both using BioSilicon™.
pSivida’s
intellectual property portfolio consists of 70 patent families, 74 granted
patents and over 290 patent applications.
pSivida
conducts its operations from offices and facilities near Boston in the United
States, Malvern in the United Kingdom, Perth in Australia and Singapore.
pSivida
is listed on NASDAQ (PSDV),
the
Australian Stock Exchange (PSD)
and on
the Frankfurt Stock Exchange on the XETRA system (German Symbol:
PSI. Securities Code (WKN) 358705).
pSivida is a founding member of the NASDAQ Health Care Index and the Merrill
Lynch Nanotechnology Index.
The
Company's largest shareholder and a strategic partner is QinetiQ, a leading
international defence, security and Technology Company, formed in 2001 from
the
UK Government's Defence Evaluation & Research Agency (DERA). QinetiQ (QQ.)
was instrumental in discovering BioSiliconTM
and
pSivida’s strong relationship with QinetiQ includes access to its cutting edge
research and development facilities.
This
document contains forward-looking statements that involve risks and
uncertainties. The statements reference potential products, applications
and regulatory approvals. Although we believe that the expectations
reflected in such forward-looking statements are reasonable at this time, we
can
give no assurance that such expectations will prove to be correct. Given these
uncertainties, readers are cautioned not to place undue reliance on such
forward-looking statements. Actual results could differ materially from those
anticipated in these forward-looking statements due to many important factors
including: the failure of the company to successfully close a new issue of
convertible notes; the failure of the Company to obtain the requisite
shareholder approval to issue the new convertible notes; failure to obtain
shareholder approval for the issue of shares underlying the ADS conversion
and
the warrant issues under the new convertible notes; our inability to raise
additional funds at favourable terms or any terms; our inability to repay the
amended notes and new convertible notes; issues relating to share registration
in the U.S. that may delay our registration; our inability to develop proposed
products, including without limitation, in the drug delivery, wound healing,
orthopaedics, and tissue engineering, diagnostics and food technology fields;
failure of our evaluation agreements to result in license agreements; failure
to
develop applications for BioSilicon™ due to regulatory, scientific or other
issues; failure to complete negotiations for new centers for the BrachySil™
phase IIb clinical trial for inoperable primary liver cancer; failure of
our discussions with the FDA for BrachySil™ to continue or to lead to FDA
approval; failure of the BrachySil™ phase IIb clinical trial for inoperable
primary liver cancer to determine the optimal dose, provide key safety data
or
support future pivotal efficacy trials or product registration or approval;
failure of the BrachySil™ primary liver programme that is in phase IIb
clinical trials to provide a valuable platform for the development and
commercialisation of BrachySil™ for pancreatic cancer and other indications;
failure to commence phase IIa BrachySil™ trials for the treatment of
pancreatic cancer; failure of the findings of the pancreatic cancer
phase IIa trial to provide a platform for further multicentre efficacy and
safety trials; failure of there to be optimisation and standardisation
between our two pancreatic cancer study centres; failure of the
results of the Retisert™ for DME trial to be a good indicator of the results of
pSivida’s ongoing phase III Medidur™ for DME trial; failure of the Medidur™
trials in DME to show a very similar improvement in visual acuity and diabetic
retinopathy severity score as Retisert™ for DME; failure of Medidur™ to release
fluocinolone acetonide at the same rate as Retisert™; our inability to recruit
patients for the phase III Medidur™ for DME trial. Other reasons are
contained in cautionary statements in the Annual Report on Form 20-F filed
with
the U.S. Securities and Exchange Commission, including, without limitation,
under Item 3.D, "Risk Factors" therein. We do not undertake to update any oral
or written forward-looking statements that may be made by or on behalf of
pSivida.
Appendix
4E
Preliminary
final report
Year
ended 30 June 2006
Rule
4.3A
Appendix
4E
Preliminary
final report
|
Name
of entity:
|
|
PSIVIDA
LIMITED
|
|
ABN
or equivalent company reference:
|
Reporting
period:
|
Previous
corresponding period:
|
||
|
78
009 232 026
|
Year
ended 30 June 2006
|
Year
ended 30 June 2005
|
2.
Results for announcement to the market
|
$A
|
|||||||
|
2.1 Revenues
|
up
|
137.4%
|
to
|
|
1,967,582
|
||
|
2.2 Loss
for the period after tax
|
up
|
82.9%
|
to
|
|
(31,441,268)
|
||
|
|
|||||||
|
2.3 Net
loss for the period attributable to members
|
up
|
87.2%
|
to
|
|
(31,441,268)
|
||
|
2.4 Dividends
|
Amount
per security
|
Franked
amount per security
|
||||
|
Final
dividend
|
Nil
|
N/A
|
||||
|
Interim
dividend
|
Nil
|
N/A
|
||||
|
2.5 Record
date for determining entitlements to the
dividends
|
N/A
|
|||||
|
2.6 Brief
explanation of any of the figures reported above to enable the figures
to
be understood:
N/A
|
||||||
Page
1
Appendix
4E
Preliminary
final report
Year
ended 30 June 2006
3.
Consolidated income statement
|
Current
Year
|
Previous
Year
|
||||||
|
30
June 2006
|
30
June 2005
|
||||||
|
$
|
$
|
||||||
|
Revenue
|
1,967,582
|
828,976
|
|||||
|
Other
income
|
106,737
|
-
|
|||||
|
Selling,
general and administrative
|
(21,343,405
|
)
|
(11,729,566
|
)
|
|||
|
Research
and development
|
(17,855,265
|
)
|
(8,287,930
|
)
|
|||
|
Finance
costs
|
(4,544,084
|
)
|
(1,919
|
)
|
|||
|
Change
in fair value of derivative
|
3,407,915
|
-
|
|||||
|
Foreign
exchange gain/(loss)
|
724,811
|
(1,623,484
|
)
|
||||
|
Loss
before income tax
|
(37,535,709
|
)
|
(20,813,923
|
)
|
|||
|
Income
tax benefit
|
6,094,441
|
3,620,891
|
|||||
|
Loss
for the period
|
(31,441,268
|
)
|
(17,193,032
|
)
|
|||
|
Loss
attributable to minority interest
|
-
|
399,196
|
|||||
|
Loss
attributable to members of the parent entity
|
(31,441,268
|
)
|
(16,793,836
|
)
|
|||
| Basic loss per share (cents per share) | (10.3 | ) | (8.1 | ) | |||
| Diluted loss per share (cents per share) | (10.3 | ) | (8.1 | ) | |||
Page
2
Appendix
4E
Preliminary
final report
Year
ended 30 June 2006
4.
Consolidated balance sheet
|
Current
Year
|
Previous
Year
|
||||||
|
2006
|
2005
|
||||||
|
$
|
$
|
||||||
|
Current
Assets
|
|||||||
|
Cash
and cash equivalents
|
15,446,552
|
12,892,061
|
|||||
|
Trade
and other receivables
|
1,001,486
|
709,418
|
|||||
|
Other
|
632,154
|
322,933
|
|||||
|
Total
Current Assets
|
17,080,192
|
13,924,412
|
|||||
|
Non-Current
Assets
|
|||||||
|
Other
financial assets
|
-
|
-
|
|||||
|
Property,
plant and equipment
|
3,139,549
|
3,273,663
|
|||||
|
Goodwill
|
52,835,183
|
23,305,698
|
|||||
|
Other
intangible assets
|
162,107,106
|
51,362,329
|
|||||
|
Other
|
-
|
-
|
|||||
|
Total
Non-Current Assets
|
218,081,838
|
77,941,690
|
|||||
|
Total
Assets
|
235,162,030
|
91,866,102
|
|||||
|
Current
Liabilities
|
|||||||
|
Trade
and other payables
|
10,042,837
|
2,017,820
|
|||||
|
Borrowings
|
11,219,696
|
-
|
|||||
|
Other
financial liabilities
|
2,465,416
|
-
|
|||||
|
Provisions
|
192,920
|
29,879
|
|||||
|
Total
Current Liabilities
|
23,920,869
|
2,047,699
|
|||||
|
Non-Current
Liabilities
|
|||||||
|
Borrowings
|
3,940,092
|
-
|
|||||
|
Deferred
tax liabilities
|
34,024,901
|
10,122,656
|
|||||
|
Total
Non-Current Liabilities
|
37,964,993
|
10,122,656
|
|||||
|
Total
Liabilities
|
61,885,862
|
12,170,355
|
|||||
|
Net
Assets
|
173,276,168
|
79,695,747
|
|||||
|
Equity
|
|||||||
|
Issued
capital
|
231,518,913
|
107,883,835
|
|||||
|
Reserves
|
1,960,738
|
574,127
|
|||||
|
Accumulated
losses
|
(60,203,483
|
)
|
(28,762,215
|
)
|
|||
|
Total
Equity
|
173,276,168
|
79,695,747
|
|||||
Page
3
Appendix
4E
Preliminary
final report
Year
ended 30 June 2006
5.
Consolidated statement of changes in equity
|
Consolidated
|
||||||||||||||||||||||
|
Issued
capital
|
Foreign
currency translation reserve
|
Option
premium reserve
|
Employee
equity-settled benefits reserve
|
Accumu-lated
losses
|
Minority
interest
|
Total
|
||||||||||||||||
|
$
|
$
|
$
|
$
|
$
|
||||||||||||||||||
|
Balance
at 1 July 2004
|
49,957,982
|
-
|
-
|
39,689
|
(11,968,378
|
)
|
1,583,200
|
39,612,493
|
||||||||||||||
|
|
||||||||||||||||||||||
|
Loss
attributable to members of the parent entity
|
-
|
-
|
-
|
-
|
(16,793,837
|
)
|
-
|
(16,793,837
|
)
|
|||||||||||||
|
Exchange
differences arising on translation of foreign operations
|
-
|
(350,287
|
)
|
-
|
-
|
-
|
79,361
|
(270,926
|
)
|
|||||||||||||
|
Minority
interest share of loss
|
-
|
-
|
-
|
-
|
-
|
(399,196
|
)
|
(399,196
|
)
|
|||||||||||||
|
Total
recognised income and expense for the year
|
-
|
(350,287
|
)
|
-
|
-
|
(16,793,837
|
)
|
(319,835
|
)
|
(17,463,959
|
)
|
|||||||||||
|
Shares
issued, net of issue costs
|
57,925,853
|
-
|
-
|
-
|
-
|
-
|
57,925,853
|
|||||||||||||||
|
Share
options issued
|
-
|
-
|
292,828
|
591,897
|
-
|
-
|
884,725
|
|||||||||||||||
|
Reversal
of minority interest
|
-
|
-
|
-
|
-
|
-
|
(1,263,365
|
)
|
(1,263,365
|
)
|
|||||||||||||
|
Balance
at 30 June 2005
|
107,883,835
|
(350,287
|
)
|
292,828
|
631,586
|
(28,762,215
|
)
|
-
|
79,695,747
|
|||||||||||||
|
|
||||||||||||||||||||||
|
Balance
at 1 July 2005
|
107,883,835
|
(350,287
|
)
|
292,828
|
631,586
|
(28,762,215
|
)
|
-
|
79,695,747
|
|||||||||||||
|
|
||||||||||||||||||||||
|
Loss
attributable to members of the parent entity
|
-
|
-
|
-
|
-
|
(31,441,268
|
)
|
-
|
(31,441,268
|
)
|
|||||||||||||
|
Exchange
differences arising on translation of foreign operations
|
-
|
(2,413,770
|
)
|
-
|
-
|
-
|
-
|
(2,413,770
|
)
|
|||||||||||||
|
Total
recognised income and expense for the year
|
-
|
(2,413,770
|
)
|
-
|
-
|
(31,441,268
|
)
|
-
|
(33,855,038
|
)
|
||||||||||||
|
Shares
issued, net of issue costs
|
123,635,078
|
-
|
-
|
-
|
-
|
-
|
123,635,078
|
|||||||||||||||
|
Equity
portion of convertible note
|
-
|
-
|
1,706,592
|
-
|
-
|
-
|
1,706,592
|
|||||||||||||||
|
Share
options and warrants issued
|
-
|
758,837
|
1,334,952
|
-
|
-
|
2,093,789
|
||||||||||||||||
|
Balance
at 30 June 2006
|
231,518,913
|
(2,764,057
|
)
|
2,758,257
|
1,966,538
|
(60,203,483
|
)
|
-
|
173,276,168
|
|||||||||||||
Page
4
Appendix
4E
Preliminary
final report
Year
ended 30 June 2006
6.
Consolidated cash flow statement
|
Current
Year
|
Previous
Year
|
||||||
|
2006
|
2005
|
||||||
|
$
|
$
|
||||||
|
Cash
flows from operating activities
|
|||||||
|
Receipts
from customers
|
1,982,174
|
-
|
|||||
|
Payments
to all suppliers, employees and consultants
|
(10,867,201
|
)
|
(4,815,520
|
)
|
|||
|
Interest
received
|
574,582
|
667,310
|
|||||
|
Income
tax paid
|
-
|
-
|
|||||
|
Research
and development expenditure paid
|
(12,980,181
|
)
|
(8,318,054
|
)
|
|||
|
Income
received in advance
|
486,780
|
-
|
|||||
|
Other
income received
|
68,931
|
161,666
|
|||||
|
Interest
paid
|
(1,007,752
|
)
|
-
|
||||
|
Net
cash flows used in operating activities
|
(21,742,667
|
)
|
(12,304,598
|
)
|
|||
|
Cash
flows from investing activities
|
|||||||
|
Purchase
of property, plant and equipment
|
(1,554,681
|
)
|
(3,410,218
|
)
|
|||
|
Proceeds
from sale of property, plant and equipment
|
25,905
|
-
|
|||||
|
Net
cash paid for acquisition of business
|
(5,194,962
|
)
|
-
|
||||
|
Net
cash paid for increased interest in subsidiary
|
-
|
(4,644,964
|
)
|
||||
|
Net
cash flows used in investing activities
|
(6,723,738
|
)
|
(8,055,182
|
)
|
|||
|
Cash
flows from financing activities
|
|||||||
|
Proceeds
from issues of ordinary shares
|
11,945,604
|
3,666,500
|
|||||
|
Payment
of share issue costs
|
(883,867
|
)
|
(27,422
|
)
|
|||
|
Proceeds
from borrowings
|
20,500,500
|
-
|
|||||
|
Payment
of borrowing costs
|
(1,238,959
|
)
|
-
|
||||
|
Net
cash flows provided by financing activities
|
30,323,278
|
3,639,078
|
|||||
|
Net
increase/(decrease) in cash held
|
1,856,873
|
(16,720,702
|
)
|
||||
|
Cash
and cash equivalents at the beginning of the financial
year
|
12,892,061
|
31,350,656
|
|||||
|
Effects
of exchange rate changes on cash
|
697,618
|
(1,737,893
|
)
|
||||
|
Cash
and cash equivalents at the end of the financial
year
|
15,446,552
|
12,892,061
|
|||||
Page
5
Appendix
4E
Preliminary
final report
Year
ended 30 June 2006
7.
Dividends (in the case of a trust, distributions)
|
Date
the dividend (distribution) is payable
|
N/A
|
||
|
+Record
date to determine entitlements to the dividend (distribution) (ie,
on the
basis of proper instruments of transfer received by 5.00 pm if
+securities
are not +CHESS
approved, or security holding balances established by 5.00 pm or
such
later time permitted by SCH Business Rules if +securities
are +CHESS
approved)
|
N/A
|
||
|
If
it is a final dividend, has it been declared?
|
N/A
|
Amount
per security
|
Amount
per security
|
Franked
amount
per security at % tax (see note 4)
|
Amount
per security of foreign source dividend
|
|
|
Final
dividend:
Current
year
Previous year
|
Nil
Nil
|
N/A
N/A
|
N/A
N/A
|
|
Interim
dividend:
Current
year
Previous year
|
Nil
Nil
|
N/A
N/A
|
N/A
N/A
|
Total
dividend (distribution) per security (interim plus
final)
|
Current
year
|
Previous
year
|
||||
|
Ordinary
securities
|
N/A
|
N/A
|
|||
|
Preference
securities
|
N/A
|
N/A
|
|||
|
8.
The dividend or distribution plans shown below are in
operation.
|
|||||
|
N/A
|
|||||
|
The
last date(s) for receipt of election notices for the
+dividend
or distribution plans
|
N/A
|
||||
9.
Consolidated retained profits
|
Current
Year
|
Previous
Year
|
||||||
|
2006
|
2005
|
||||||
|
$
|
$
|
||||||
|
Accumulated
losses at the beginning of the financial period
|
(28,762,215
|
)
|
(11,968,379
|
)
|
|||
|
Net
loss attributable to members
|
(31,441,268
|
)
|
(16,793,836
|
)
|
|||
|
Accumulated
losses at end of financial period
|
(60,203,483
|
)
|
(28,762,215
|
)
|
|||
Page
6
Appendix
4E
Preliminary
final report
Year
ended 30 June 2006
10.
NTA backing
|
Current
Year
|
Previous
Year
|
||||||
|
2006
|
2005
|
||||||
|
Net
tangible asset backing per ordinary security
|
(10.5
cents
|
)
|
2.3
cents
|
||||
|
Net
asset backing per ordinary security
|
43.6
cents
|
36.3
cents
|
|||||
11.
Control gained over entities having material effect
|
Name
of entity (or group of entities)
|
Control
Delivery Systems Inc (subsequently renamed pSivida Inc)
|
|
|
Consolidated
loss from ordinary activities after tax of the controlled entity
(or group
of entities) since the date in the current period on which control
was
+acquired
|
($5,937,498)
|
|
|
Date
from which such profit has been calculated
|
30
December 2005
|
|
|
Loss
from ordinary activities after tax of the controlled entity (or group
of
entities) for the whole of the previous corresponding
period
|
($883,253)
|
|
Loss
of control of entities having material effect
|
Name
of entity (or group of entities)
|
N/A
|
|
| Consolidated profit (loss) from ordinary activities after tax of the controlled entity (or group of entities) for the current period to the date of loss of control |
$
|
|
|
Date
to which the profit (loss) has been calculated
|
||
|
Consolidated
profit (loss) from ordinary activities after tax of the controlled
entity
(or group of entities) while controlled during the whole of the previous
corresponding period
|
$
|
|
| Contribution to consolidated profit (loss) from ordinary activities from sale of interest leading to loss of control |
$
|
Page
7
Appendix
4E
Preliminary
final report
Year
ended 30 June 2006
12.
Material interests in entities which are not controlled
entities
The
economic entity has an interest (that is material to it) in the following
entities.
(If
the interest was acquired or disposed of during either the current or previous
corresponding period, indicate date of acquisition (“from dd/mm/yy”) or disposal
(“to dd/mm/yy”).)
|
Name
of entity
|
Percentage
of ownership interest
held
at end of period or date of
disposal
|
Contribution
to net profit (loss)
|
||
|
Equity
accounted associates and joint venture entities
|
Current
period
|
Previous
corresponding
period
|
Current
period
$A
|
Previous
corresponding
period
- $A
|
|
N/A
|
||||
|
Total
|
||||
|
Other
material
interests
N/A
|
||||
|
Total
|
||||
13.
Significant information
Any
other
significant information needed by an investor to make an informed assessment
of
the entity’s financial performance and financial position:
For
the
financial year ending 30 June 2006, the loss attributable to members of pSivida
is $31,441,268 (2005: $16,793,836). The operating loss includes $17,855,265
(2005: $8,287,930) (an average of $1,487,939 per month) of research and
development costs expended by pSiMedica and administrative expenses, including
amortisation of intangibles, financing costs, salaries and costs relating
to the
head office totalling $25,887,488 (2005: $11,731,485) (an average of $2,157,291
per month).
The
ratio
of Research and Development expenditure to total costs is 60.3% (2005: 59.5%)
after the deduction of unrealised foreign exchange losses, financing costs
and
amortisation of intangible assets from total costs.
On
25
July 2005 Dr David Mazzo was appointed as a Non-executive Director of the
Company, based in New Jersey, USA.
On
27
July 2005 Mr Michael Rogers was appointed as a Non-executive Director of
the
Company.
In
August
2005 pSivida raised US$4.3 million (A$5.6 million) before costs via the private
placement of 665,000 ADSs (American Depositary Shares) to predominantly US
investors at US$6.50 (A$8.48) each, with each ADS representing 10 ordinary
shares. New York based Securities Dealers, Hunting Party Securities Ltd placed
the ADSs, which were structured as a PIPE (Private Investment in Public Equity)
and limited to the aforementioned amount. The ADSs have an attached 1 for
10, 3
year warrant exercisable for US$12.50 per ADS. The ADSs will become tradable
on
NASDAQ upon filing of a registration statement by pSivida with the Securities
and Exchange Commission.
In
September 2005 pSivida’s manufacturing partner, QSA completed the construction
and validation of a state-of-the-art cleanroom facility, dedicated to the
supply
of pSivida’s lead cancer therapy BrachySil™, at QSA’s Auriga Medical™ facility
in Braunschweig, Germany. This GMP facility will fulfil the final process
in the
manufacture of BrachySil™ for future clinical and commercial use, and represents
the crucial final stage in establishing the manufacturing and supply
infrastructure to support BrachySil™ as it advances through clinical
trials.
Page
8
Appendix
4E
Preliminary
final report
Year
ended 30 June 2006
In
October 2005 pSivida entered into a definitive merger agreement to acquire
Control Delivery Systems Inc (CDS), a US based drug delivery company. The
acquisition is an integral part of pSivida’s on-going US growth strategy,
creating a global bio-nanotech company specialising in drug delivery, with
revenues from existing products and generating long-term value through its
diversified late-stage product portfolio. CDS’s portfolio of products and
product candidates includes two approved and marketed products, one Phase
III
product and other early-stage product candidates. This combination also provides
pSivida with an operating base in the Boston biotech hub, enhancing its overall
visibility as well as access to the US scientific and investment communities
and
brings additional development and regulatory expertise to pSivida’s management
team.
pSivida
completed the acquisition of CDS on 30 December 2005 following overwhelming
approval by pSivida shareholders at the AGM held in November 2005. On completion
of the acquisition CDS was renamed pSivida Inc and former CEO, Dr Paul Ashton
was appointed to the pSivida Board and as the Director of Strategy, based
in
Boston.
In
October 2005 Castlerigg Master Investments, a New York based institutional
investor, signed an agreement with pSivida to purchase US$15 million (A$20.5
million) of Subordinated Convertible Debentures convertible into pSivida
ADSs at
an initial conversion price of US$7.10 per ADS (A$0.95 per ordinary share).
The
proceeds of the issuance were received in November 2005 and are being used
for
the expanded development of pSivida’s platform technologies and ongoing working
capital requirements.
Also
in
October 2005 pSivida signed a licence with Beijing Med-Pharm Corporation
(BJGP:PK) for the clinical development, marketing and distribution of pSivida’s
lead product, BrachySilTM,
in
China. The Licence includes upfront and milestone payments in excess of US$2
million and royalties ranging up to 30%, depending upon the level of sales,
payable to pSivida by Beijing Med-Pharm. China has the highest incidence
of
primary liver cancer in the world with over 345,000 estimated new cases per
annum (Globocan), representing 55% of total worldwide cases. Beijing Med-Pharm
is the only non-Chinese company with pharmaceutical distribution rights in
China
via its purchase in December 2004 of Beijing Wanwei Pharmaceutical Ltd, a
pharmaceutical distributor covering the bulk of Beijing's hospitals. In an
historic event, this purchase was approved by the Ministry of Commerce of
the
People's Republic of China on October 18, 2005.
In
November 2005 Phase IIb clinical trials commenced with BrachySil™ (32-P
BioSilicon™) as a potential new brachytherapy treatment for inoperable primary
liver cancer (hepatocellular carcinoma, HCC). The first patients successfully
received treatment at Singapore General Hospital using a new fine-gauge needle
multi-injection device which enabled for the first time, larger and also
multiple tumours to be treated. The Company has been successful in the
preparation and approvals for the initiation of the planned European Phase
IIa
trials of BrachySil™ in pancreatic cancer, a disease of high unmet clinical need
and a significant potential market opportunity for this targeted oncology
therapy.
In
December 2005 pSivida seed funded pSiNutria Limited A$1.5 million (US$1.1
million) and granted a royalty-bearing exclusive licence for the use of
BioSiliconTM
as an
ingestible ingredient in food applications. pSiNutria will develop applications
of our silicon technology in the food industry and is also developing patentable
intellectual property using silicon in the food packaging area.
BioSiliconTM
applications in food primarily pertain to its biodegradability and optical
properties. Potential pSiNutria products being developed include products
to
detect pathogens in food, for food tracing, for food preservation, and products
to detect variations of temperature in food storage. These products may include
ingestible BioSiliconTM
which
will dissolve into silicic acid in the body or silicon used in modified
atmosphere packaging.
On
11
January 2006 Ms Heather Zampatti was appointed as a Non-executive Director
of
the Company. The appointment of Ms Zampatti to the pSivida board replaced
Ms
Alison Ledger who stepped down after 18 months of service.
The
Company announced a one for eight rights issue (“Rights Issue”) on 2 May 2006 at
an issue price of $0.60 per share. The issue price represented an approximately
18% discount to the 30 day volume weighted average closing price (“VWAP”) on the
ASX up to 1 May 2006, being the last trading day and a 7% discount to the
five
day VWAP. The Company concluded the rights issue on 13 June 2006, raising
a
total of $6.3 million through the issue of 10,515,811 shares.
Capital
raised from the placement of the shortfall was to primarily fund the phase
III
clinical trials of MedidurTM
for the
treatment of Diabetic Macular Edema (DME), and phase IIa clinical trials
of our
lead BioSiliconTM
product,
BrachySilTM
which is
being developed for the treatment of inoperable pancreatic cancer. pSivida
expects to receive a significantly greater return by funding the
MedidurTM
trials
under the Co-Development Agreement to receive a profit share with Alimera
Sciences rather than a straight royalty which would be payable if we did
not
co-fund the trials.
On
23 May
2006 the Company announced that Mr Michael Soja had been appointed Vice
President, Finance and Chief Financial Officer, and Ms Lori Freedman had
been
appointed Vice President, Corporate Affairs, General Counsel and Secretary.
Both Mr Soja and Ms Freedman are based at pSivida’s Boston facility in the
United States.
Page
9
Appendix
4E
Preliminary
final report
Year
ended 30 June 2006
As
at 30
June 2006 the consolidated cash position was $15,446,552 (2005: $12,892,061)
and
the Company had 397,036,107 (2005: 219,312,166) shares on issue.
Registration
Rights Agreements
During
the year ended 30 June 2006, we entered into registration rights agreements
with
purchasers of our equity securities in the PIPE, the purchaser of our
convertible note and former shareholders of CDS. These registration rights
agreements require us to register with the SEC the resale of ADSs issued
to such
persons. Our obligation to register ADSs in each of these transactions is
subject to a deadline, which may be extended in certain situations, and our
failure to meet this deadline results in monetary penalties against us as
follows:
| · |
With
respect to the PIPE, we were required to complete the registration
no
later than 19 February 2006. While we believe that the agreement
permits
us to delay registration through the date of this registration
statement,
we may be subject to monthly cash penalties equal to one percent
of the
PIPE purchase price, or US$43,225 (A$59,200), from February 19
until the
date the registration statement is declared
effective.
|
| · |
With
respect to the convertible note financing, we were required to
complete
the initial registration no later than 15 May 2006. Since that date
we have been paying and expect to continue to pay for each 30-day
period
from such date a cash penalty equal to one and one-half percent
of the
outstanding principal amount of the note until the registration
statement
is declared effective. From 15 May 2006 until 31 July 2006, that
penalty was equal to US$225,000 (A$308,200) per 30-day period,
and we were
required to make payments of US$577,500 (A$791,096) through that
period.
We will be required to make additional payments at the same rate
for the
period from 1 August 2006 until the completion of the amendment
documentation. Our failure to register the shares issuable under
the
convertible note and associated warrants by September 15, 2006 may
result in a retroactive increase of the penalties described above
to two
and one-half percent of the initial principal amount of the note
or
US$375,000 (A$513,700) per 30-day period. In addition, our failure
to
register such shares within 60 days of such date may result in
an event of
default under the note. Upon such an event of default, the holder
of the
note would have the right, until 30 days after the registration
statement
becomes effective to require us to repay the entire principal amount
of
the note plus accrued interest at a
premium.
|
| · |
We
were also required to complete the registration of ADSs issued
in
connection with our acquisition of CDS no later than 28 June 2006.
Our
agreement to register these ADSs requires that we pay cash penalties
equal
to one percent of the number of such ADSs multiplied by the deemed
value
of such ADSs at the time of closing, or $5.087 per ADS, for every
30-day
period until the registration statement becomes effective. Such
penalties
could amount to US$813,089 (A$1,113,700) per thirty day period.
We are
seeking a waiver of this payment requirement from the holders of
ADSs
issued in connection with the acquisition of CDS, however, such
persons
may not grant us such a waiver on reasonable terms or at
all.
|
14.
Foreign entities set of accounting standards used in compiling the report
(IAS)
N/A
15.
Commentary on the results for the period.
15.1
Earnings per security (EPS)
|
|
Current
Year
|
Previous
Year
|
|||||
|
2006
|
2005
|
||||||
|
Basic
EPS (cents per share)
|
(10.3
cents
|
)
|
(8.1
cents
|
)
|
|||
|
Diluted
EPS (cents per share)
|
(10.3
cents
|
)
|
(8.1
cents
|
)
|
|||
15.2
Returns to shareholders (Including distributions and buy
backs)
Page
10
Appendix
4E
Preliminary
final report
Year
ended 30 June 2006
|
Current
period $A
|
Previous
corresponding
period
- $A
|
|
|
Ordinary
securities
|
N/A
|
N/A
|
|
Preference
securities
|
N/A
|
N/A
|
|
Other
equity instruments
|
N/A
|
N/A
|
|
Total
|
N/A
|
N/A
|
|
The
+dividend
or distribution plans shown below are in operation.
|
||
|
N/A
|
||
|
The
last date(s) for receipt of election notices for the dividend or
distribution plans
|
N/A
|
|
| Any other disclosures in relation to dividends (distributions). | N/A | |
15.3
Significant features of operating performance
Refer
to
Item 13.
15.4
Segment Information
a)
Business Segment - Primary Segment
The
economic entity operates in only one business segment being the biotechnology
sector.
b)
Geographic Segment - Secondary Segment
|
Segment
revenues
|
Segment
assets
|
Acquisition
of segment assets
|
|||||||||||||||||
|
2006
|
2005
|
2006
|
2005
|
2006
|
2005
|
||||||||||||||
|
$
|
$
|
$
|
$
|
$
|
$
|
||||||||||||||
|
Australia
|
-
|
-
|
12,669,836
|
11,059,134
|
292,661
|
7,475
|
|||||||||||||
|
United
States
|
1,324,069
|
-
|
150,867,512
|
-
|
153,306,733
|
-
|
|||||||||||||
|
United
Kingdom
|
68,931
|
161,666
|
69,300,275
|
78,174,497
|
953,223
|
83,578,841
|
|||||||||||||
|
Singapore
|
-
|
-
|
2,201,143
|
2,278,670
|
19,147
|
20,836
|
|||||||||||||
|
Unallocated
|
574,582
|
667,310
|
123,264
|
353,801
|
26,208
|
49,444
|
|||||||||||||
|
Consolidated
|
1,967,582
|
828,976
|
235,162,030
|
91,866,102
|
154,597,972
|
83,656,596
|
|||||||||||||
15.5
Report on trends in performance
None
Page
11
Appendix
4E
Preliminary
final report
Year
ended 30 June 2006
| 15.6 |
|
Report
any factors which have affected the results during the reporting
period or
which are likely to affect results in the future, including those
where
the effect could not be
quantified.
|
Impacts
of adopting Australian equivalents to International Financial Reporting
Standards
The
consolidated entity changed its accounting policies on 1 July 2005 to comply
with A-IFRS. The transition to A-IFRS is accounted for in accordance with AASB
1, ‘First-time Adoption of Australian Equivalents to international Financial
Reporting Standards’, with 1 July 2004 as the date of transition, except for
financial instruments, where the date of transition is 1 July 2005.
An
explanation of how the transition from superseded policies to A-IFRS has
affected the consolidated entity’s financial position, financial performance and
cash flows is set out in the following tables and the notes that accompany
the
tables.
Effect
of A-IFRS on the balance sheet as at 1 July 2004
|
|
|||||||||||||
|
Notes
|
Superseded
policies
*
|
Consolidated
Effect
of
transition
to
A-IFRS
|
A-IFRS
|
||||||||||
|
$
|
$
|
$
|
|||||||||||
|
Current
assets
|
|||||||||||||
|
Cash
and cash equivalents
|
31,350,656
|
-
|
31,350,656
|
||||||||||
|
Trade
and other receivables
|
340,482
|
-
|
340,482
|
||||||||||
|
Other
|
38,958
|
-
|
38,958
|
||||||||||
|
Total
current assets
|
31,730,096
|
-
|
31,730,096
|
||||||||||
|
Non-current
assets
|
|||||||||||||
|
Property,
plant and equipment
|
669,699
|
-
|
669,699
|
||||||||||
|
Other
intangible assets
|
b
|
7,934,622
|
1,183,550
|
9,118,172
|
|||||||||
|
Other
|
32,641
|
-
|
32,641
|
||||||||||
|
Total
non-current assets
|
8,636,962
|
1,183,550
|
9,820,512
|
||||||||||
|
Total
assets
|
40,367,058
|
3,891,589
|
41,550,608
|
||||||||||
|
Current
liabilities
|
|||||||||||||
|
Trade
and other payables
|
1,938,115
|
-
|
1,938,115
|
||||||||||
|
Total
current liabilities
|
1,938,115
|
-
|
1,938,115
|
||||||||||
|
Total
liabilities
|
1,938,115
|
2,708,039
|
1,938,115
|
||||||||||
|
Net
assets
|
38,428,943
|
1,183,550
|
39,612,493
|
||||||||||
|
Equity
|
|||||||||||||
|
Issued
capital
|
49,957,982
|
-
|
49,957,982
|
||||||||||
|
Reserves
|
c,
d
|
78,220
|
(38,531
|
)
|
39,689
|
||||||||
|
Accumulated
losses
|
f
|
(13,190,459
|
)
|
1,222,081
|
(11,968,378
|
)
|
|||||||
|
Parent
entity interest
|
36,845,743
|
1,183,550
|
38,029,293
|
||||||||||
|
Total
minority interest
|
1,583,200
|
-
|
1,583,200
|
||||||||||
|
Total
equity
|
38,428,943
|
1,183,550
|
39,612,493
|
||||||||||
*
Reported financial position as at 30 June 2004.
Page
12
Appendix
4E
Preliminary
final report
Year
ended 30 June 2006
Effect
of A-IFRS on the income statement for the financial year ended 30 June
2005
|
Notes
|
Superseded
policies
*
|
Consolidated
Effect
of transition to
A-IFRS
|
A-IFRS
|
||||||||||
|
$
|
$
|
$
|
|||||||||||
|
Revenue
|
828,976
|
-
|
828,976
|
||||||||||
|
Selling,
general and administrative
|
b,
d, e
|
(6,041,362
|
)
|
(5,688,204
|
)
|
(11,729,566
|
)
|
||||||
|
Research
and development
|
(8,287,930
|
)
|
-
|
(8,287,930
|
)
|
||||||||
|
Finance
costs
|
(1,919
|
)
|
-
|
(1,919
|
)
|
||||||||
|
Foreign
exchange gain/(loss)
|
(1,623,484
|
)
|
-
|
(1,623,484
|
)
|
||||||||
|
|
|||||||||||||
|
Loss
before income tax
|
(15,125,719
|
)
|
(5,688,204
|
)
|
(20,813,923
|
)
|
|||||||
|
Income
tax benefit
|
a
|
-
|
3,620,891
|
3,620,891
|
|||||||||
|
Loss
for the period
|
(15,125,719
|
)
|
(2,067,313
|
)
|
(17,193,032
|
)
|
|||||||
|
Loss
attributable to minority interest
|
399,196
|
-
|
399,196
|
||||||||||
|
Loss
attributable to members of the parent entity
|
(14,726,523
|
)
|
(2,067,313
|
)
|
(16,793,836
|
)
|
|||||||
*
Reported financial results under previous Australian GAAP.
Effect
of A-IFRS on the balance sheet as at 30 June 2005
|
Notes
|
Superseded
policies
*
|
Consolidated
Effect
of
transition
to
A-IFRS
|
A-IFRS
|
||||||||||
|
$
|
$
|
$
|
|||||||||||
|
Current
assets
|
|||||||||||||
|
Cash
and cash equivalents
|
12,892,061
|
-
|
12,892,061
|
||||||||||
|
Trade
and other receivables
|
709,418
|
-
|
709,418
|
||||||||||
|
Other
|
322,933
|
-
|
322,933
|
||||||||||
|
Total
current assets
|
13,924,412
|
-
|
13,924,412
|
||||||||||
|
Non-current
assets
|
|||||||||||||
|
Property,
plant and equipment
|
|
3,273,663
|
-
|
3,273,663
|
|||||||||
|
Goodwill
|
e
|
8,588,228
|
14,717,470
|
23,305,698
|
|||||||||
|
Other
intangible assets
|
b
|
56,249,010
|
(4,886,681
|
)
|
51,362,329
|
||||||||
|
Total
non-current assets
|
68,110,901
|
9,830,789
|
77,941,690
|
||||||||||
|
Total
assets
|
82,035,313
|
9,830,789
|
91,866,102
|
||||||||||
|
Current
liabilities
|
|||||||||||||
|
Trade
and other payables
|
2,017,820
|
-
|
2,017,820
|
||||||||||
|
Provisions
|
29,879
|
-
|
29,879
|
||||||||||
|
Total
current liabilities
|
2,047,699
|
-
|
2,047,699
|
||||||||||
|
Non-current
liabilities
|
|||||||||||||
|
Deferred
tax liabilities
|
a
|
-
|
10,122,656
|
10,122,656
|
|||||||||
|
Total
non-current liabilities
|
-
|
10,122,656
|
10,122,656
|
||||||||||
|
Total
liabilities
|
2,047,699
|
10,122,656
|
12,170,355
|
||||||||||
|
Net
assets
|
79,987,614
|
(291,867
|
)
|
79,695,747
|
|||||||||
|
Equity
|
|||||||||||||
|
Issued
capital
|
107,883,835
|
-
|
107,883,835
|
||||||||||
|
Reserves
|
c,
d
|
20,761
|
553,366
|
574,127
|
|||||||||
|
Accumulated
losses
|
f
|
(27,916,982
|
)
|
(845,233
|
)
|
(28,762,215
|
)
|
||||||
|
Total
equity
|
79,987,614
|
(291,867
|
)
|
79,695,747
|
|||||||||
*
Reported financial position under previous Australian GAAP.
Effect
of A-IFRS on the cash flow statement
There
are
no material differences between the cash flow statement presented under
A-IFRS
and the cash flow statement presented under the superseded
policies.
Page
13
Appendix
4E
Preliminary
final report
Year
ended 30 June 2006
Notes
to the reconciliations of the income statement and balance
sheet
(a) Deferred
income tax
Under
superseded policies, the consolidated entity adopted tax-effect accounting
principles whereby income tax expense was calculated on pre-tax accounting
profits after adjustment for permanent differences. The tax-effect of timing
differences, which occur when items were included or allowed for income
tax
purposes in a period different to that for accounting purposes, were recognised
at current taxation rates as deferred tax assets and deferred tax liabilities,
as applicable.
Under
A-IFRS, deferred tax is determined using the balance sheet liability method
in
respect of temporary differences arising from differences between the carrying
amount of assets and liabilities in the financial statements and their
corresponding tax bases.
The
effect of the deferred tax adjustments on deferred tax balances is as
follows:
|
Consolidated
|
|||||||
|
1
Jul 2004
|
30
Jun 2005
|
||||||
|
$
|
$
|
||||||
|
Deferred
tax assets not recognised
under
previous AGAAP
|
2,708,039
|
5,611,096
|
|||||
|
Deferred
tax liabilities not recognised
under
previous AGAAP
|
(2,708,039
|
)
|
(15,733,752
|
)
|
|||
|
Net
increase in deferred tax balances
|
-
|
(10,122,656
|
)
|
||||
|
Financial
year ended
30
Jun 2005
|
||||
|
$
|
||||
|
Net
impact on deferred tax at beginning of period
|
-
|
|||
|
Impact
on loss for period
|
3,620,892
|
|||
|
Deferred
tax capitalised to goodwill
|
(13,743,548
|
)
|
||
|
Net
impact of deferred tax at end of period
|
(10,122,656
|
)
|
||
(b) Other
intangible assets
At
the
date of transition to A-IFRS, the Company elected to restate all business
combinations occurring from 1 December 2000, the date of the entity’s relisting
on the Australian Stock Exchange.
As
part
of this restatement, the Company has capitalised direct acquisition
costs
previously expensed under superseded policies on the acquisition of
a
controlling interest in pSiMedica Limited in May 2001 totalling $112,278,
resulting in an increase to intangibles of this amount on transition
(and also
applicable at 30 June 2005) and a corresponding decrease to accumulated
losses.
The
restatement of business combinations has also resulted in an increase
in other
intangible assets of $3,400,552 on transition (and also applicable
at 30 June
2005) as a result of the gross-up of intangible assets resulting from
changes to
deferred tax balances. An amortisation expense must also be charged
on the
additional intangible amount. This has resulted in a decrease in intangibles
of
$692,513 at transition and $1,003,517 at 30 June 2005. A corresponding
increase
to accumulated losses of $692,513 on transition, and an additional
amortisation
expense of $311,004 for the year ended 30 June 2005 has been
recorded.
Further,
under A-IFRS the consolidated entity has chosen to amortise its intangible
assets from the date of their recognition, which differs from superseded
policies whereby the consolidated entity did not amortise intangible
assets
until such time as they resulted in the generation of revenue. This
has resulted
in a decrease in intangibles of $1,636,767 at transition and $7,395,994
at 30
June 2005. A corresponding increase to accumulated losses of $1,636,767
on
transition, and an additional amortisation expense of $5,759,227 for
the year
ended 30 June 2005 has been recorded.
(c) Cumulative
exchange differences
At
the
date of transition, the consolidated entity elected to reset the foreign
currency translation reserve to zero. An amount of $78,220 was reclassified
from
the foreign currency translation reserve to accumulated losses on transition
(and also applicable at 30 June 2005), thereby reducing the balance
of reserves
by this amount.
Page
14
Appendix
4E
Preliminary
final report
Year
ended 30 June 2006
(d) Share-based
payments
As
at the
date of transition to A-IFRS, the consolidated entity has recognised an
increase
in the employee equity-settled payments reserve and a corresponding increase
in
accumulated losses of $39,689.
For
the
financial year ended 30 June 2005, share-based payments of $591,897 (of
which
$508,610 was included in employee benefit expenses and $83,287 in consultancy
fees) which were not recognised under the superseded policies were recognised
under A-IFRS, with a corresponding increase in the employee equity-settled
payments reserve.
These
adjustments had no material tax or deferred tax consequences.
(e) Goodwill
There
is
no goodwill at the date of transition to A-IFRS.
In
accordance with AASB 3 ‘Business Combinations’, the consolidated entity
recognised an increase of goodwill of $13,743,547 for the half-year ending
31
December 2004, and for the year ended 30 June 2005.
Further,
goodwill, which was amortised under superseded policies, is not amortised
under
A-IFRS from the date of acquisition for those business combinations restated.
The effect of this change is an increase in the carrying amount of goodwill
by
$442,692 and a decrease in net loss before tax of $442,692 for the half-year
ended and as at 31 December 2004 and an increase in the carrying amount
of
goodwill by $973,923 and a decrease in net loss before tax of $973,923
for the
financial year ended and as at 30 June 2005. There is no tax effect as
deferred
taxes are not recognised for temporary differences arising from goodwill
from
which amortisation is not deductible for tax purposes.
(f) Accumulated
losses
The
effect of the above adjustments on accumulated losses is as
follows:
|
Consolidated
|
||||||||||
|
Notes
|
1
Jul 2004
|
30
Jun 2005
|
||||||||
|
$
|
$
|
|||||||||
|
Income
tax benefit/expense
|
a
|
3,400,552
|
7,021,443
|
|||||||
|
Direct
acquisition costs capitalised
|
b
|
112,278
|
112,278
|
|||||||
|
Amortisation
of grossed-up intangible
|
b
|
(692,513
|
)
|
(1,003,517
|
)
|
|||||
|
Amortisation
of intangibles previously unamortised
|
b
|
(1,636,767
|
)
|
(7,395,994
|
)
|
|||||
|
Transfer
from foreign currency translation reserve
|
c
|
78,220
|
78,220
|
|||||||
|
Expensed
share-based payments
|
d
|
(39,689
|
)
|
(631,586
|
)
|
|||||
|
Goodwill
no longer amortised
|
e
|
-
|
973,923
|
|||||||
|
Total
adjustment to accumulated losses
|
1,222,081
|
(845,233
|
)
|
|||||||
|
Attributable
to members of the parent entity
|
1,222,081
|
(845,233
|
)
|
|||||||
|
Attributable
to minority interests
|
-
|
-
|
||||||||
|
1,222,081
|
(845,233
|
)
|
||||||||
|
Consolidated
|
||||||||||
|
Notes
|
1
Jul 2004
|
30
Jun 2005
|
||||||||
|
$
|
$
|
|||||||||
|
Direct
acquisition costs capitalised
|
b
|
112,278
|
112,278
|
|||||||
|
Expensed
share-based payments
|
d
|
(39,689
|
)
|
(460,477
|
)
|
|||||
|
Total
adjustment to accumulated losses
|
72,589
|
(348,199
|
)
|
|||||||
Page
15
Appendix
4E
Preliminary
final report
Year
ended 30 June 2006
Amendment
of terms of convertible
note with Castlerigg Master Investments
On
July
17, 2006, we announced an agreement revising the terms of the subordinated
convertible promissory note that we issued on November 16, 2005 to
an
institutional investor. The note continues to have a three year term and
bear 8% interest payable quarterly. We may make future interest payments
in the form of our NASDAQ-listed ADSs, or, at our sole option, we may
make such
payments in cash. The holder of the note can now require repayment of the
note in equal amounts of US$6.25 million on July 31, 2007 and July
31,
2008. The note is now convertible into ADSs at a conversion price of
US$2.00 per ADS, subject to adjustment based upon certain events or
circumstances, including, without limitation, if 108% of the market
price of
ADSs for the ten trading days ending April 30, 2007 is lower than the
current
conversion price. In connection with the amendments, we prepaid US$2.5
million of the outstanding principal note, and agreed to prepay US$1.0
million
in related penalties. The investor retains its existing warrants to
purchase
633,803 additional ADSs, exercisable for six years at a current exercise
price
of US$7.17 per ADS. In connection with the amendments, we have agreed with
the institutional investor to extend the deadline for the registration
statement
required by the registration rights agreement with the selling security
holder
to be declared effective by the Securities and Exchange Commission
through
September 15, 2006, with increased penalties if that deadline is missed.
We have also been released from the restrictions on future fundraising
transactions contained in the note documentation. We also granted the
investor an additional warrant to purchase 5.7 million ADSs exercisable
for five
years with an exercise price of US$1.80 per ADS and a security interest
in our
current royalties, subject to release of that security upon any disposition
by
us of the royalty stream.
Any
other information required to be disclosed to enable the reader to compare
the
information presented with equivalent information for previous periods. This
must include information needed by an investor to make an informed assessment
of
the entity’s activities and results.
N/A
16.
Compliance statement
This
report is based on accounts to which one of the following applies.
(Tick
one)
|
o
|
The accounts have been audited. |
o
|
The accounts have been subject to review. |
|
ü
|
The
accounts are in the process of being audited or subject to
review.
|
o
|
The accounts have not yet been audited or reviewed. |
17.
If the accounts have not yet been audited or subject to audit review and are
likely to be subject to dispute or qualification, a description of the likely
dispute or qualification:
N/A
18.
If the accounts have been audited or subject to review and are subject to
dispute or qualification, a description of the dispute or
qualification:
N/A
| Sign here: | ___________________________ | Date: 13 September 2006 | ||
| (Company Secretary) | ||||
Page
16
Appendix
4E
Preliminary
final report
Year
ended 30 June 2006
Print
name: Aaron
Finlay
Page
17