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 July 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
document attached as Exhibit 99.1 to this Report on Form 6-K is 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; (v) the Registrant's Registration Statement on
Form F-3, Registration No. 333-141091; and (vi) the Registrant's
Registration Statement on Form F-3, Registration
No. 333-143225.
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:
July
31, 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 - June 30, 2007
Commentary
and Highlights; Worldwide License Agreement with Pfizer; Company
Redeems
Convertible Notes; Evaluation Agreement for Cardiovascular Drug
Delivery
|
| ASX/Media RELEASE |
31
July
2007
|
pSivida
Quarterly Cash Flow - June 30, 2007
Commentary
and Highlights
-
Worldwide License Agreement with Pfizer
--Company
Redeems Convertible Notes
-
Evaluation Agreement for Cardiovascular Drug Delivery
Boston,
MA. and Perth, Australia - pSivida Limited (ASX:PSD, NASDAQ:PSDV, Xetra:PSI)
announced that it has released its cash flow statement for the quarter ended
June 30, 2007.
Cash
Flow
The
cash
balance at June 30, 2007 was A$3.1m (US$2.7m) a decrease of A$4.3m (US$3.3m)
from the balance at March 31, 2007. During the quarter, net cash outflows from
financing activities were $A817k (US$685k) as a result of convertible note
redemptions partially offset by the net proceeds from equity financings. Net
cash inflows from investing activities were $A1.9m (US$1.5m) resulting from
the
sale of a subsidiary (AION) and net cash used in operating activities was $A5.3m
(US$4.4m).
In
July
2007, the Company raised approximately A$21.4m (US$18.4m) of net proceeds from
share placements including a A$7.5m
(US$6.5m)
investment by Pfizer raising their total investment in the Company to A$13.7m
(US$11.5m). The Company currently expects that it has sufficient cash to fund
operations for more than 12 months.
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 in ophthalmic
applications in April 2007. Under the terms of the agreement, pSivida will
receive up to approximately A$182m (US$155m) in development and sales related
milestones. Pfizer made an initial investment of A$6.1m (US$5.0m) in ordinary
shares of pSivida and subsequently made an additional A$7.5m (US$6.5m)
investment in American Depository Shares (ADSs) in July 2007. 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
Redeems all Convertible Notes
All
convertible notes have been redeemed enabling
the Company to move forward with a simpler capital structure.
Retisert®
Royalties
Royalty
revenue recorded in the June 2007 quarter totalled A$306k (US$257k), which
represents an increase of 83% compared to the same period in 2006 and an
increase of 9% compared to the previous quarter. The reported amount is less
than the actual revenues that would have been earned in this fiscal quarter
in
accordance with a royalty advance agreement the Company entered into with Bausch
& Lomb in June 2005. Under the terms of that agreement, Bausch and Lomb will
retain 100% of the next A$5.5m (US$4.7m) of royalties otherwise payable under
the license. Retisert®
is the
only FDA-approved treatment for posterior 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®
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.
Evaluation
Agreement for Cardiovascular Drug Delivery
pSivida
entered into a new evaluation agreement with an undisclosed large global medical
device company to evaluate cardiovascular
delivery of drugs using pSivida’s drug delivery technologies. This agreement
follows the expiration of the previous evaluation agreement with the same
medical
device company.
April
placement
In
April
2007, pSivida completed private placements to raise in the aggregate
approximately A$16.4m (US$13.4m) after expenses, including the A$6.1m (US$5.0m)
investment by Pfizer in connection with signing the Collaborative Research
and
License Agreement.
AION
Diagnostics Sold
In
April
2007, pSivida completed the sale of 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 first installment in cash on the closing date and at closing delivered
a A$1.9m (US$1.5m) Note, payable 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™ (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
Vice
President, 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@dr-reuter.eu
|
NOTES
TO EDITORS:
pSivida
is a global drug delivery 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 owns 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 has a worldwide collaborative research and license agreement
with Pfizer Inc. for other ophthalmic applications of the Medidur™
technology.
pSivida
owns the rights to develop and commercialize a modified form of silicon
(porosified or nano-structured silicon) known as BioSilicon™, which has
applications in drug delivery, wound healing, orthopedics, and tissue
engineering. The most advanced BioSilicon™ product, BrachySil™ 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®; the risk that the ophthalmic medical community in the
United States will fail to continue to accept Retisert® to treat
patients with uveitis; the risk that the product specific J-Code will fail
to
help patients get timely access to Retisert® or result in increased
sales of Retisert®; 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 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.