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 April 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
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- ___.
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; (iii) the Registrant's
Registration Statement on Form F-3, Registration No. 333-135428; (iv)
the Registrant's Registration Statement on Form F-3, Registration
No. 333-141083; and (v) the Registrant's Registration Statement on
Form F-3, Registration No. 333-141091.
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:
April
30, 2007
| PSIVIDA LIMITED | ||
| |
|
|
| By: | /s/ Michael J. Soja | |
|
Michael J. Soja |
||
| Vice President, Finance and Chief Financial Officer | ||
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
ASX
Release: pSivida Quarterly Cash Flow - 31 March 2007 - Commentary
and
Highlights; Worldwide License Agreement with Pfizer; Company to Redeem
Convertible Notes
|
|
EXHIBIT
99.2:
|
Appendix
4C - Quarterly report for entities admitted on the basis of
commitments
|
| ASX/Media RELEASE |
30
April
2007
|
pSivida
Quarterly Cash Flow - 31 March 2007
Commentary
and Highlights
-
Worldwide License Agreement with Pfizer
-
Company to Redeem Convertible Notes
Boston,
MA. and Perth, Australia - pSivida Limited (ASX:PSD, NASDAQ:PSDV, Xetra:PSI)
is
pleased to announce that it has released its cash flow statement for the quarter
ended March 31, 2007.
Cash
Flow
The
cash
balance at March 31, 2007 was A$7.4m (US$6.0m) an increase of A$2.0m (US$1.6m)
from the balance at December 31, 2006. During the quarter, net cash inflows
from
financing activities were A$8.8m (US$7.0m) and net cash used for operating
activities during the quarter was $A6.8m (US$5.3m).
In
addition, as described more fully later in this release, in early April the
company raised an additional A$10.3 (US$8.5) of net proceeds from share
placements and A$6.1m
(US$5m) from
a
strategic investment by Pfizer.
Worldwide
Collaborative Research and License Agreement with Pfizer
pSivida
signed an exclusive worldwide Collaborative Research and License Agreement
with
Pfizer Inc. for pSivida’s controlled drug delivery technologies, including the
MedidurTM
technology, in ophthalmic applications in April 2007. Under the terms of the
agreement, pSivida will receive up to A$191m (US$155m) in development and sales
related milestones. Pfizer has invested A$6.1m (US$5.0m) in ordinary shares
of
pSivida, the proceeds of which, as previously disclosed, are
being held in the escrow described below until redemption of the Sandell
Note.
Pfizer
has also agreed to invest an additional A$6.1m (US$5.0m) in the future, subject
to certain conditions.
The
two companies will work together on a joint research program aimed at developing
ophthalmic products using pSivida’s sustained drug delivery technology. In
addition to the milestone payments described above, Pfizer will fund the cost
of
the joint research program. This
license agreement followed the completion of 12 months of evaluation of
pSivida’s drug delivery technologies by Pfizer. pSivida is free to license its
MedidurTM
drug delivery technology for non-ophthalmic applications.
pSivida
to redeem all Convertible Notes
The
Company has now deposited into escrow a total of A$16.4m
(US$13.6m), which is approximately sufficient to redeem the remaining principal
balance of all its remaining convertible debt. Assuming no additional
conversions of the Sandell Note into equity, the amount payable upon redemption
of the Sandell note will be approximately A$15.4m (US$12.8m). The Company also
anticipates issuing a redemption notice for the remaining balance of its
Subordinated Convertible Notes. Following conversions of A$6.5m (US$5.4m) of
these Notes to equity in April, the estimated amount of cash required to redeem
all the remaining Subordinated Notes assuming no additional conversions into
equity is A$1.1m (US900k).
pSivida
entered into an agreement with its principal institutional lender, Sandell
Asset Management Corp. (Sandell)
whereby Sandell
has agreed to close the December 29th,
2006
amendment to the Convertible Loan, which was announced on January 2nd,
2007
and in conjunction with the closing, pSivida will issue the previously disclosed
warrants to Sandell to acquire American Depository Shares and will redeem the
entire balance of the Sandell loan that has not been converted into equity
prior
to the redemption date. The company expects the redemption of the Note to occur
on or before September 28, 2007. The retirement
of the Company’s convertible debt should enable pSivida to move forward with a
much simpler capital structure and facilitate the Company’s future
development.
Retisert(R)
Royalties
Royalty
revenue recorded in the March quarter totalled A$281k (US$221k) which represents
an increase of 15% compared to the same period in 2006, and an increase of
9%
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. Under the terms of
that agreement, following the next A$327k (US$257k) of royalties payable to
the
Company, Bausch and Lomb will retain 100% of the next A$5.7m (US$4.8m) of
royalties otherwise payable under the license. Retisert(R)
is the
only FDA approved treatment for uveitis, a chronic eye disease and has been
marketed by Bausch & Lomb in the United States since June 2005.
A
product
specific J-Code for Retisert(R)
went
into effect on January 1, 2007, replacing the Medicare hospital outpatient
C-Code. The J-Code should be recognized by all health care insurers as they
add
this code to their respective billing systems and assist patients to get timely
access to this innovative therapy.
Additional
Highlights and Announcements for the Quarter and
Post-Quarter
Boston
based Managing Director appointed
Dr.
Paul
Ashton, located at the pSivida head office in Boston was appointed to the
position of Managing Director. Dr. Ashton’s appointment is part of the program
of consolidation of management and increased US focus of operations instituted
by the Board of Directors. Dr. Ashton was formerly the Company’s Executive
Director of Strategy. Concurrently, Dr. Roger Brimblecombe, Chairman of the
Board of Directors, retired from service to pSivida. Dr. David J. Mazzo was
appointed to succeed Dr. Brimblecombe as Non-executive Chairman of the Board.
Drug
delivery licensing agreement with Faber Research LLC
pSivida
entered into a licensing agreement with US-based Faber Research LLC to develop
pSivida’s proprietary DurasertTM,
ZanisertTM,
and
CODRUGTM
drug
delivery technologies for infectious diseases and diseases of the
ear.
A$11.5m
(US$9m) raised in April placement
pSivida
completed a private placement of 41 million fully paid ordinary shares issued
at
A$0.27 each to raise approximately A$11.0m (US$9.0m) before costs to United
States and European investors. Each two shares were issued with one free
attaching option at an exercise price of A$0.27 and a term of four years. The
issue price was equal to the five day volume weighted average closing price
of
pSivida’s ordinary shares on the ASX through
30th
March,
2007, which was the last trading day prior to the closing of the exclusive
worldwide Collaborative Research and License Agreement with Pfizer Inc.
Placements to U.S. investors were made pursuant to Regulation D under the U.S.
Securities Act and placements to non-U.S. investors were made pursuant to
Regulation S under that Act.
AION
Diagnostics sold
In
April,
2007, pSivida completed the sale of its entire holdings in its subsidiary,
AION
Diagnostics Inc. to GEM Global Yield Fund, a portfolio management company,
for a
purchase price of A$3.7m (US$3.0m), payable in two equal installments of A$1.9m
(US$1.5m). GEM paid the the first installment in cash on the closing date and
at
closing delivered a A$1.9m (US$1.5m) note payable no later than 12 months after
the closing date. pSivida has exclusively licensed the non-electronic imaging
diagnostic applications of its BioSiliconTM
technology to AION Diagnostics for which pSivida will receive royalties from
all
commercialized products.
Alimera
Sciences MedidurTM
Trial Exceeds 500 Patient Mark in Phase III Trial
Enrollment
Enrollment
for the Phase III global clinical trial, the FAME(TM) (Fluocinolone Acetonide
in
Diabetic Macular Edema) Study has exceeded 50 percent. FAME is a double masked,
randomized, multi-center study that will follow approximately 900 patients
in
the U.S., Canada, Europe and India for 36 months. The trial is studying the
safety and efficacy of the novel treatment currently referred to as
MedidurTM
for
diabetic macular edema (DME). MedidurTM,
a tiny,
injectable intravitreal insert, is being studied as a way to deliver a very
low
dose of fluocinolone acetonide, a corticosteroid, to the retina for up to three
years as a treatment for DME. Using a proprietary 25 gauge transconjunctival
injector system, an eye care professional injects the MedidurTM
insert
into the vitreous through a minimally invasive procedure in an outpatient
setting.
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(R)
is FDA approved for the treatment of uveitis. Vitrasert(R)
is FDA approved for the treatment of AIDS-related CMV Retinitis. Bausch &
Lomb own the trademarks Vitrasert(R)
and Retisert(R).
pSivida has licensed the technologies underlying both of these products to
Bausch & Lomb. The technology underlying Medidur(TM)
for diabetic macular edema is licensed to Alimera Sciences and is in Phase
III
clinical trials. pSivida has a worldwide collaborative research and license
agreement with Pfizer Inc. for ophthalmic applications of its drug delivery
technologies, including other ophthalmic applications of the Medidur(TM)
technology.
pSivida
owns the rights to develop and commercialize a modified form of silicon
(porosified or nano-structured silicon) known as BioSilicon(TM), which has
applications in drug delivery, wound healing, orthopedics, and tissue
engineering. The most advanced BioSilicon(TM) product, BrachySil(TM) delivers
a
therapeutic, P32 directly to solid tumors and is presently in Phase II clinical
trials for the treatment of pancreatic cancer.
pSivida’s
intellectual property portfolio consists of 71 patent families, 99 granted
patents, including patents accepted for issuance, and over 300 patent
applications.
pSivida conducts its operations from 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 (
PSI).
pSivida is a founding member of the NASDAQ Health Care Index and the Merrill
Lynch Nanotechnology Index.
This
release 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: the
risk
that Bausch & Lomb will fail to maintain or increase its promotional
activity related to Retisert(R);
the
risk that the ophthalmic medical community in the United States will fail to
continue to accept Retisert(R)
to treat
patients with uveitis; the risk that the product specific J-Code will fail
to
help patients get timely access to Retisert(R)
or
result in increased sales of Retisert(R);
the
risk that we will not be able to raise
additional funds at favourable terms or at all; the risk that we fail to reduce
corporate overhead, the risk that the company’s operational changes fail
to bring about cost savings or make more efficient use of resources;
the
risk
that we may not meet any of the milestones in the Pfizer agreement or may not
successfully develop or commercialize the products under development; the risk
that Pfizer terminates the license agreement; the risk that we will not be
able
to exploit our drug delivery technologies outside of the eye; the risk that
our
evaluation agreements for our products may not produce favorable results and/or
result in license agreements; the risk that we will be unable to repay all
amounts outstanding under our convertible notes or other liabilities; the risk
that Faber may not commercialize any pSivida technology for infectious diseases
or diseases of the ear; the risk that AION may not commercialize any products
for which pSivida would receive a royalty; risks with respect to the efficacy
of
pSivida's drug delivery technology; and risks with respect to the final results
of the FAME clinical trials. 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, 24/10/2005
|
Name
of entity
|
|
pSivida
Limited
|
|
ABN
|
Quarter
ended (“current quarter”)
|
|
|
78
009 232 026
|
31
March 2007
|
Consolidated
statement of cash flows
|
Cash
flows related to operating activities
|
Current
quarter
$A’000
|
Year
to date
(9
months)
$A’000
|
||||||||
|
1.1
|
Receipts
from customers
|
1,250
|
1,813
|
|||||||
|
1.2
|
Payments
for(a)
staff costs
|
(1,449 |
)
|
(3,976 |
)
|
|||||
|
(b)
advertising and marketing
|
- | - | ||||||||
|
(c)
research and development
|
(2,583 |
)
|
(9,196 |
)
|
||||||
|
(d)
leased assets
|
- | - | ||||||||
|
(e)
other working capital
|
(3,663 |
)
|
(9,061 |
)
|
||||||
|
1.3
|
Dividends
received
|
-
|
-
|
|||||||
|
1.4
|
Interest
and other items of a similar nature received
|
64
|
183
|
|||||||
|
1.5
|
Interest
and other costs of finance paid
|
(321
|
)
|
(714
|
)
|
|||||
|
1.6
|
Income
taxes paid
|
-
|
-
|
|||||||
|
1.7
|
Other
|
5
|
5
|
|||||||
|
Net
operating cash flows
|
(6,697
|
)
|
(20,946
|
)
|
||||||
| + See chapter 19 for defined terms. | |
| 24/10/2005 |
Appendix
4C Page
1
|
Appendix
4C
Quarterly
report for entities
admitted
on the basis of commitments
|
Current
quarter
$A’000
|
Year
to date
(9
months)
$A’000
|
|||||||||
|
1.8
|
Net
operating cash flows (carried forward)
|
|
(6,697
|
)
|
(20,946
|
)
|
||||
|
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
|
-
-
-
(24)
-
|
-
-
-
(96)
-
|
|||||||
|
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
|
(24
|
)
|
(96
|
)
|
||||||
|
1.14
|
Total
operating and investing cash flows
|
(6,721
|
)
|
(21,042
|
)
|
|||||
|
Cash
flows related to financing activities
|
||||||||||
|
1.15
|
Proceeds
from issues of shares, options, etc.
|
11,516
|
15,325
|
|||||||
|
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
|
(1,777
(880
|
)
)
|
(6,171
(883
|
)
)
|
|||||
|
Net
financing cash flows
|
8,859
|
13,555
|
||||||||
|
Net
increase (decrease) in cash held
|
2,138
|
(7,487
|
)
|
|||||||
|
1.21
|
Cash
at beginning of quarter/year to date
|
5,380
|
15,447
|
|||||||
|
1.22
|
Exchange
rate adjustments to item 1.20
|
(121
|
)
|
(563
|
)
|
|||||
|
1.23
|
Cash
at end of quarter
|
7,397
|
7,397
|
|||||||
| + See chapter 19 for defined terms. | |
| 24/10/2005 |
Appendix
4C Page
2
|
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
|
198
|
|||||
|
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
|
Financing
facilities available
Add
notes as necessary for an understanding of the position. (See AASB 107 paragraph
50(a)).
|
Amount
available
$A’000
|
Amount
used
$A’000
|
|||||||||
|
3.1
|
Loan
facilities
|
-
|
23,116
|
|||||||
|
3.2
|
Credit
standbyarrangements
|
-
|
-
|
|||||||
| + See chapter 19 for defined terms. | |
| 24/10/2005 |
Appendix
4C Page
3
|
Appendix
4C
Quarterly
report for entities
admitted
on the basis of commitments
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
|
4,597
|
4,698
|
|||||||
|
4.2
|
Deposits
at call
|
2,800
|
682
|
|||||||
|
4.3
|
Bank
overdraft
|
-
|
-
|
|||||||
|
4.4
|
Other
(provide details)
|
|
-
|
-
|
||||||
|
Total:
cash at end of quarter (item
1.23)
|
7,397
|
5,380
|
||||||||
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. | |
| 24/10/2005 |
Appendix
4C Page
4
|
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: 30 April 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.
|
| · |
20.1-
reconciliation of cash flows arising from operating activities to
operating profit or loss
|
| · |
40(b),(d)-
itemised disclosures relating to acquisitions and
disposals
|
| · |
46-
policy for classification of cash items
|
| · |
48-
disclosure of restrictions on use of cash
|
| 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. | |
| 24/10/2005 |
Appendix
4C Page
5
|