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 January 2007
Commission
File Number 000-51122
pSivida
Limited
(Translation
of registrant’s name into English)
Level
12 BGC Centre
28
The Esplanade
Perth
WA 6000
Australia
(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 x 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
x
If
"Yes"
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): 82- ___.
The
documents attached as Exhibit 99.1 and Exhibit 99.2 to this Report on Form
6-K
are hereby incorporated by reference herein and into the following registration
statements: (i) the Registrant's Registration Statement on Form F-3,
Registration No. 333-132776; (ii) the Registrant's Registration Statement
on Form F-3, Registration No. 333-132777; and (iii) the Registrant's
Registration Statement on Form F-3, Registration
No. 333-135428.
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.
Date:
January
31, 2007
|
PSIVIDA
LIMITED
|
||
| |
|
|
| By: | /s/Michael J. Soja | |
|
Michael J. Soja |
||
| Vice President, Finance and Chief Financial Officer | ||
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
Press
Release: pSivida Quarterly Cash Flow - 31 December 2006 - Commentary
and
Highlights; Licensing negotiations with Global Pharma; Retisert® receives
Product Specific Bill Code
|
|
EXHBIBIT
99.2
|
ASX
Filing: Appendix 4C - Quarterly report for entities admitted on the
basis
of commitments
|
| ASX/Media RELEASE |
31
January
2007
|
pSivida
Quarterly Cash Flow - 31 December 2006
Commentary
and Highlights
-
Licensing negotiations with Global Pharma
-
Retisert®
receives
Product Specific Bill Code
Boston,
MA. and Perth, Australia - Global bio-nanotech company pSivida Limited (ASX:PSD,
NASDAQ:PSDV, Xetra:PSI) is pleased to release its quarterly cash flow statement
for the period ended December 31st,
2006.
Licensing
negotiations with Global Pharmaceutical Company
The
Company is presently negotiating exclusively
with a large global pharmaceutical company to license pSivida’s drug delivery
technologies in a significant market opportunity.
The
pharmaceutical company has agreed to make payments totalling US$990k (A$1.3m)
to
pSivida for the right to exclusively negotiate a licensing agreement with the
Company for a period of three months, and to fund the cost of a preclinical
study.
Licensing
negotiations follow completion of 12 months of evaluation of pSivida’s drug
delivery technologies by this Pharma.
Retisert
Royalties
Royalty
revenue recorded in the December quarter totalled A$218k (US$203k) which
represents an increase of 12% compared to the same period in 2005, and a decline
of 18% compared to the previous quarter. The reported amount is 50% of the
actual revenues that would have been earned in this fiscal quarter. The
reduction in royalties earned and collected is in accordance with a royalty
advance agreement the Company entered into with Bausch & Lomb in June 2005.
Although
the Retisert drug delivery device has been marketed by Bausch & Lomb in the
United States since June 2005, a product specific J-Code and Medicare Payment
Rate recently went into effect on January 1st,
2007.
This replaces the Medicare hospital outpatient C-Code and should streamline
the
process for Medicare rebate for both hospitals and physicians and help patients
get timely access to this innovative therapy.
Cash
Flow
Cash
at
the end of the quarter was A$5.4m (US$4.2m). The cash balance is affected by
a
number of items that have occurred in this and in prior quarters, including
cash
inflows from operating and financing sources as well as operating cash
outflows.
The
Company expects to close in this quarter a capital raising that includes the
sale of shares and warrants. Full details will be announced as and when that
transaction closes.
Board
and Operational Restructure
The
Company has appointed Dr. Paul Ashton as the new Managing Director based in
Boston, MA following the retirement from the Board of Dr. Roger Brimblecombe
as
Executive Chairman and Acting CEO, who had been appointed to this position
in a
temporary capacity. Dr. David Mazzo has been appointed the Non-Executive
Chairman of the Company and Dr. Roger Aston has been re-appointed to the Board
of Directors.
The
Company has made operational changes designed to bring about cost savings and
make more efficient use of resources
by
directing resources away from its earlier stage, higher risk research and
development activities and reducing spending in these areas. To this end, the
research operations located in our facilities in Malvern, UK have been reduced.
The Company is moving to reduce corporate overhead as it continues to move
its
head office from Perth, Australia to Boston, Massachusetts.
General
Meeting of Shareholders
The
Company has provided a Notice of a General Meeting to be held in Perth,
Australia at 3:00pm WST on February 20th,
2007.
Shareholders are encouraged to vote and to attend the meeting to consider the
alternatives for the future financing of the Company. The Directors will only
approve completion of those transactions that they believe are in the best
interests of the Company and existing shareholders. Shareholders are also
encouraged to attend to view a company presentation outlining the Company’s
recent activities and milestones.
Highlights
and Announcements for the Quarter and Post-Quarter
Boston
based Managing Director appointed
pSivida
announced the appointment of Dr. Paul Ashton to the position of Managing
Director located at the pSivida head office in Boston, MA. Dr. Ashton’s
appointment is part of the program of consolidation of management and increased
focus of operations instituted by the Board of Directors. Dr. Ashton was
formerly the Company’s Executive Director of Strategy and the terms and
conditions of his new appointment have not changed. Concurrently, Dr. Roger
Brimblecombe, the Chairman of the Board of Directors, retired from service
to
pSivida. Dr. David J. Mazzo was appointed to succeed Dr. Brimblecombe as
Chairman of the Board. Dr. Roger Aston was recently reappointed as a
Non-Executive Director of the Board.
Drug
delivery licensing agreement with Faber Research LLC
pSivida
announced that it had entered into a licensing agreement with US-based Faber
Research LLC to develop pSivida’s proprietary DurasertTM,
ZanisertTM,
and
Co-DrugTM
drug
delivery technologies for infectious diseases and diseases of the
ear.
pSivida
released from Loan Covenant
pSivida
announced that it had entered into an agreement with its principal institutional
lender whereby the lender agreed to a general forbearance and relief from
certain loan covenants for a temporary period ending by March 31st,
2007.
In return, the Company has issued to the lender warrants to purchase 1.5 million
ADSs over 5 years with an exercise price of US$2.00 per ADS and has agreed,
upon
receipt of required approvals, including shareholder approval, to issue
additional warrants to purchase 4.0 million ADSs over 5 years with an exercise
price of US$2.00 per ADS.
Big
Pharma licensing negotiations commences
pSivida
announced that it is negotiating exclusively with a major global pharmaceutical
company to grant a worldwide, royalty bearing license to make, use and sell
products using pSivida’s drug delivery technologies. The Pharma has agreed to
make payments totalling US$990k (A$1.3m) for the right to exclusively negotiate
a licensing agreement with pSivida for a period of three months and to fund
the
cost of a preclinical study. Licensing negotiations follow completion of 12
months of evaluation of pSivida’s drug delivery technologies by this
Pharma.
A$3.7m
raised in placement
pSivida
announced the placement of 14,230,768 fully paid ordinary shares issued at
26
cents each to raise A$3.7m (US$2.9m) before costs to Australian and European
investors. Each share was purchased with two free attaching options at an
exercise price of 26 cents and a term of four years.
Transdermal
Drug Delivery Program Collaboration with global electronics
company
pSivida
entered into a feasibility study agreement with a global electronics and
technology company
to evaluate BioSilicon™
technology (nano-structured silicon) for transdermal drug delivery
systems. During the study, the parties will evaluate biodegradable porous
silicon structures, including microneedles, for the controlled release of drugs
via the transdermal route.
First
patients implanted in European Pancreatic Cancer Study
The
first
patients have been implanted with BrachySil™
for the
treatment of inoperable pancreatic cancer at Guys & St Thomas’ Hospital in
London, a major centre for cancer therapy in the United Kingdom. The treatment
delivers BrachySil™
directly
to a tumor in the pancreas via endoscopic ultrasound (used to assist in locating
the delivery point). BrachySil™
is a
novel oncology product which comprises a combination of BioSilicon™
and the
isotope 32Phosphorus, a proven anti-cancer therapeutic. The targeted and
localized nature of the product could potentially provide oncologists with
an
effective and user-friendly treatment for this disease which has a high unmet
clinical need.
Initiation
of Phase II clinical study of novel ophthalmic product
The
Company initiated in September a Phase II clinical trial of Mifepristone (also
known as RU486) as an eye drop treatment for steroid associated elevated
intraocular pressure (IOP). The investigator sponsored trial is expected to
involve up to 45 patients in the United States. The Company will be supplying
clinical trial material for this study and has filed a patent application on
this product class. Elevated IOP may occur in patients receiving steroidal
treatment for chronic eye diseases.
This
release does not constitute an offer of any securities for sale or solicitations
of offers to buy any securities of the Company.
-ENDS-
Released
by:
|
pSivida
Limited
Brian
Leedman
Investor
Relations Director
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
Accent
Marketing limited
Eva
Reuter
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™ 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
intellectual property portfolio consists of 76 patent families, 95 granted
patents, including patents accepted for issuance, and over 300 patent
applications. pSivida conducts its operations from offices and facilities near
Boston in the United States, Malvern in the United Kingdom and Perth in
Australia
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.
This
document contains forward-looking statements that involve risks and
uncertainties including with respect to products and potential products,
including the successful development, marketing and commercialization of our
products and potential products, applications, regulatory approvals, the
potential size of certain markets, our ability to raise funds and potential
partnerships. 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:
Bausch
& Lomb’s failure to maintain or increase its promotional activity related to
Retisert; the failure of the ophthalmic medical community in the United States
to continue to accept Retisert to treat patients with uveitis; failure of the
product specific J-Code and Medicare reimbursement rate to streamline the
process for Medicare reimbursement or help patients get timely access to
Retisert or result in increased sales of Retisert; our inability to raise
additional funds at favourable terms or at all; the Company’s failure to reduce
corporate overhead; the Company’s failure to successfully move its head office
from Perth, Australia to Boston, Massachusetts over the coming months or at
all;
failure of the company’s operational changes to bring about cost savings or make
more efficient use of resources; failure of the Company to successfully
negotiate and sign a license agreement with the major global pharma on
advantageous terms or at all; failure of the pre-clinical study with the major
global pharma to produce favourable results; failure of the market for the
products/technology subject to the license negotiations with the global pharma
to be significant; the failure of Medidur™ for DME to represent a large
ophthalmic market opportunity; the failure of any funded development
collaborations to result in a fast-to-market solution for our pharma industry
partners or a value-generating opportunity for the Company; the failure of
our
clinical trials for the treatment of steroid-associated elevated intraocular
pressure; our failure to obtain required approvals to expand our the Phase
IIa
trial commenced at Guys & St Thomas’ Hospital in London to Singapore; our
failure to find partners to participate in and fund BioSilicon™ drug delivery
R&D programmes; our inability to achieve milestones and future developments
expected to lead to growth of the Company over the coming year; failure of
BrachySil™ to represent an effective and user-friendly treatment for pancreatic
cancer; failure of the company to obtain requisite shareholder approvals to
complete the issuance of the warrants to the Company’s lender; our inability to
repay the amended convertible notes and new convertible notes; failure of Faber
to develop pSivida’s drug delivery technologies for infectious diseases and
diseases of the ear; failure of the feasibility study agreement with the global
electronics and technology company to produce favourable results or result
in a
license agreement; our inability to develop proposed products, including without
limitation, in the drug delivery, wound healing, orthopedics, 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 program that is in Phase IIb clinical trials to provide a
valuable platform for the development and commercialization 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 multicenter efficacy and safety trials; failure of there
to
be optimization and standardization between our two pancreatic
cancer study centers; 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
4C
Quarterly
report for entities
admitted
on the basis of commitments
Rule
4.7B
Appendix
4C
Quarterly
report
for
entities admitted
on
the basis of commitments
Introduced
31/3/2000. Amended 30/9/2001
|
Name
of entity
|
|
pSivida
Limited
|
|
ABN
|
Quarter
ended (“current quarter”)
|
|
|
78
009 232 026
|
31
December 2006
|
Consolidated
statement of cash flows
|
Cash
flows related to operating activities
|
Current
quarter
$A’000
|
Year
to date
(6
months)
$A’000
|
|
|
1.1
|
Receipts
from customers
|
371
|
563
|
|
1.2
|
Payments
for (a)
staff costs
(b)
advertising and marketing
(c)
research and development
(d)
leased assets
(e)
other working capital
|
(1,381)
-
(2,737)
-
(2,242)
|
(2,527)
-
(6,613)
-
(5,398)
|
|
1.3
|
Dividends
received
|
-
|
-
|
|
1.4
|
Interest
and other items of a similar nature received
|
66
|
119
|
|
1.5
|
Interest
and other costs of finance paid
|
(63)
|
(393)
|
|
1.6
|
Income
taxes paid
|
-
|
-
|
|
1.7
|
Other
|
-
|
-
|
|
Net
operating cash flows
|
(5,986)
|
(14,249)
|
|
+
See
chapter 19 for defined terms.
| 30/9/2001 |
Appendix
4C Page
1
|
Appendix
4C
Quarterly
report for entities
admitted
on the basis of commitments
|
Current
quarter
$A’000
|
Year
to date
(6
months)
$A’000
|
||
|
1.8
|
Net
operating cash flows (carried forward)
|
(5,986)
|
(14,249)
|
|
Cash
flows related to investing activities
|
|||
|
1.9
|
Payment
for acquisition of:
(a)
businesses (item 5)
(b)
equity investments
(c)
intellectual property
(d)
physical non-current assets
(e)
other non-current assets
|
-
-
-
(25)
-
|
-
-
-
(72)
-
|
|
1.10
|
Proceeds
from disposal of:
(a)
businesses (item 5)
(b)
equity investments
(c)
intellectual property
(d)
physical non-current assets
(e)
other non-current assets
|
-
-
-
-
-
|
-
-
-
-
-
|
|
1.11
|
Loans
to other entities
|
-
|
-
|
|
1.12
|
Loans
repaid by other entities
|
-
|
-
|
|
1.13
|
Other
|
-
|
-
|
|
Net
investing cash flows
|
(25)
|
(72)
|
|
|
1.14
|
Total
operating and investing cash flows
|
(6,011)
|
(14,321)
|
|
Cash
flows related to financing activities
|
|||
|
1.15
|
Proceeds
from issues of shares, options, etc.
|
3,809
|
3,809
|
|
1.16
|
Proceeds
from sale of forfeited shares
|
-
|
-
|
|
1.17
|
Proceeds
from borrowings
|
-
|
8,586
|
|
1.18
|
Repayment
of borrowings
|
-
|
(3,302)
|
|
1.19
|
Dividends
paid
|
-
|
-
|
|
1.20
|
Other -
other financing costs
-
share issue costs
|
-
(3)
|
(4,394)
(3)
|
|
Net
financing cash flows
|
3,806
|
4,696
|
|
|
Net
increase (decrease) in cash held
|
(2,205)
|
(9,625)
|
|
|
1.21
|
Cash
at beginning of quarter/year to date
|
7,879
|
15,447
|
|
1.22
|
Exchange
rate adjustments to item 1.20
|
(294)
|
(442)
|
|
1.23
|
Cash
at end of quarter
|
5,380
|
5,380
|
+
See
chapter 19 for defined terms.
|
Appendix
4C Page 2
|
30/9/2001
|
Appendix
4C
Quarterly
report for entities
admitted
on the basis of commitments
Payments to directors of the entity and associates of the directors
Payments
to related entities of the entity and associates of the related
entities
|
Current
quarter
$A'000
|
||
|
1.24
|
Aggregate
amount of payments to the parties included in item 1.2
|
213
|
|
1.25
|
Aggregate
amount of loans to the parties included in item 1.11
|
-
|
|
1.26
|
Explanation
necessary for an understanding of the transactions
|
|
|
1.1 1.2(a)
Staff
costs include consultants and directors’ fees paid by
pSivida.
1.2(c)
Research
and development costs include all expenditure incurred by pSiMedica
and
pSiOncology along with research and development costs incurred by
pSivida
Inc.
|
||
Non-cash
financing and investing activities
|
2.1
|
Details
of financing and investing transactions which have had a material
effect
on consolidated assets and liabilities but did not involve cash
flows
|
|
N/A
|
|
2.2
|
Details
of outlays made by other entities to establish or increase their
share in
businesses in which the reporting entity has an
interest
|
|
N/A
|
+
See
chapter 19 for defined terms.
| 30/9/2001 |
Appendix
4C Page
3
|
Appendix
4C
Quarterly
report for entities
admitted
on the basis of commitments
Financing
facilities available
Add
notes as necessary for an understanding of the position. (See AASB 1026
paragraph 12.2).
|
Amount
available
$A’000
|
Amount
used
$A’000
|
||
|
3.1
|
Loan
facilities
|
-
|
23,788
|
|
3.2
|
Credit
standby arrangements
|
-
|
-
|
Reconciliation
of cash
|
Reconciliation
of cash at the end of the quarter (as shown in the consolidated statement
of cash flows) to the related items in the accounts is as
follows.
|
Current
quarter
$A’000
|
Previous
quarter
$A’000
|
|
|
4.1
|
Cash
on hand and at bank
|
4,698
|
1,358
|
|
4.2
|
Deposits
at call
|
682
|
6,521
|
|
4.3
|
Bank
overdraft
|
-
|
-
|
|
4.4
|
Other
(provide details)
|
-
|
-
|
|
Total:
cash at end of quarter (item
1.22)
|
5,380
|
7,879
|
|
Acquisitions
and disposals of business entities
|
Acquisitions
(Item
1.9(a))
|
Disposals
(Item
1.10(a))
|
||
|
5.1
|
Name
of entity
|
N/A
|
N/A
|
|
5.2
|
Place
of incorporation or registration
|
||
|
5.3
|
Consideration
for
acquisition
or disposal
|
||
|
5.4
|
Total
net assets
|
||
|
5.5
|
Nature
of business
|
||
+
See
chapter 19 for defined terms.
|
Appendix
4C Page 4
|
30/9/2001
|
Appendix
4C
Quarterly
report for entities
admitted
on the basis of commitments
Compliance statement
|
1
|
This
statement has been prepared under accounting policies which comply
with
accounting standards as defined in the Corporations Act (except to
the
extent that information is not required because of note 2) or other
standards acceptable to ASX.
|
|
2
|
This
statement does give a true and fair view of the matters
disclosed.
|
| Sign here: | Date: 31 January 2007 | ||
| (Company secretary) | |||
| Print name: | Aaron Finlay |
Notes
| 1. |
The
quarterly report provides a basis for informing the market how the
entity’s activities have been financed for the past quarter and the effect
on its cash position. An entity wanting to disclose additional information
is encouraged to do so, in a note or notes attached to this
report.
|
| 2. |
The
definitions in, and provisions of, AASB
107: Cash Flow Statements
apply to this report except for the paragraphs of the Standard set
out
below.
|
| · | 6.2 |
-
reconciliation of cash flows arising from operating activities to
operating
profit or loss
|
| · | 9.2 | - itemised disclosure relating to acquisitions |
| · | 9.4 | - itemised disclosure relating to disposals |
| · | 12.1(a) | - policy for classification of cash items |
| · | 12.3 | - disclosure of restrictions on use of cash |
| · | 13.1 | - comparative information |
| 3. |
Accounting
Standards. ASX
will accept, for example, the use of International Accounting Standards
for foreign entities. If the standards used do not address a topic,
the
Australian standard on that topic (if any) must be complied
with.
|
+
See
chapter 19 for defined terms.
| 30/9/2001 |
Appendix
4C Page
5
|