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 August 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:
August
2, 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: Open Briefing - Capital Raising & Business
Milestones
|
| Corporate File Pty Ltd |
OPEN
BRIEFING
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|
| pSivida Limited |
Capital
Raising & Business
Milestones
|
Date
02.08.07
|
corporatefile.com.au
pSivida
Limited (ASX Code: PSD) announced in July 2007 the raising of A$24 million
(US$21 million) in private placements through the sale of NASDAQ traded ADSs
(American Depositary Shares), ordinary Australian shares and warrants. This
raising is in addition to the A$11 million (US$9 million) private placement
in
February, the A$11 million (US$9 million) private placement in April and the
A$6
million (US$5 million) share sale to Pfizer also in April. How have these
various raisings affected the risk profile of pSivida?
MD
Dr Paul Ashton
These
financings have raised approximately A$49 million (US$40 million) net of
expenses and significantly improved our financial position.
Because
of the cash we were able to raise in these private placements including the
sale
of shares to Pfizer as part of our global collaborative research and license
agreement with Pfizer, we were able to eliminate all of the Company’s debt -
some A$22 million (US$19 million), and had as at July 13, 2007, approximately
A$23 million (US$20 million) of cash.
Given
that a large proportion of the fund raisings have been sales to US buyers,
most
of the newly issued shares were issued in ADSs that are traded on NASDAQ. Since
the beginning of July, the dollar volume of trading on NASDAQ has been twice
as
large as the dollar volume traded on ASX, where one ADS is equal to ten ordinary
ASX shares. We believe that this shift in relative trading volume toward the
United States and the strategic shifting of our core operations to the United
States have made the Company more attractive to US and European institutional
investors.
Overall,
through these capital raisings, we have simplified the Company’s capital
structure and as a result we believe we have significantly reduced the amount
of
financial risk.
corporatefile.com.au
What
is
your current rate of cash burn? Do you expect this to vary much into the
foreseeable future?
MD
Dr Paul Ashton
For
the
Quarter ended June 30, 2007, our burn rate, which we define as our operating
cash outflows net of operating cash inflows, was approximately $A1.8 million
($US1.5 million),substantially less than the burn rate for the quarter ended
March 31, 2007. In the Quarter ended March 31 we had a monthly burn rate of
approximately A$2.2 million (US$1.7 million).
We
have
reduced our burn rate primarily through more than a 30% reduction of staff
and
we have rationalized projects to focus on activities that we believe will
generate commercial returns in the near to medium term. With the cash we now
have in the bank, we believe we are fully funded for more than 12 months. We
do
not expect there to be any further significant reduction in our burn rate during
the next two years partly because we expect to be funding two clinical trials.
However, to the extent that during that period we receive any milestone payments
from the Pfizer licensing agreement, or up front payments as part of future
collaborations our cash burn rate could be significantly reduced.
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| pSivida Limited |
Capital
Raising & Business
Milestones
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Date
02.08.07
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corporatefile.com.au
In
the
latest placement you raised A$7.5 million (US$6.5 million) from Pfizer which
is
in addition to the A$6.1 million (US$5.0 million) investment they made in April.
How many shares will Pfizer hold in total after this raising? What percentage
of
your shares on issue does this represent? What are the strategic implications
for pSivida of a large pharmaceutical company taking such a stake?
MD
Dr Paul Ashton
Pfizer’s
participation in the latest capital raising has lifted their shareholding to
the
equivalent of some 70 million ordinary shares, or approximately 10.2 percent
of
our issued capital. Pfizer is now the largest single shareholder in the Company
and a strategic partner.
Having
Pfizer take this stake is strategically very important for pSivida as is the
license agreement. On average it costs over US$800m to develop a new drug.
Under our license with Pfizer they are responsible for the full
development costs in addition to up to approximately US$155 development and
sales related milestone cash payments to pSivida. We believe this clearly
demonstrates commercial interest for our drug delivery
technologies.
corporatefile.com.au
When
do
you expect to complete recruitment for your Phase III trials of
MedidurTM
for
Diabetic Macular Edema (DME), and how long are the trials likely to take? What
progress has there been for MedidurTM
in
ophthalmic applications since you announced the licensing deal with Pfizer
in
April?
MD
Dr Paul Ashton
The
MedidurTM
for DME
trials jointly funded by our development partner Alimera Sciences, are now
at an
advanced stage and we will share with Alimera in the profits on future product
sales. We’ve recruited well in excess of 500 patients in this 900 persons study.
We expect to complete recruitment for this trial by the end of this calendar
year.
As
MedidurTM
is a
long-term drug delivery system, we will be assessing safety and efficacy at
two
years and continue to follow patients for three years. With this in mind, we
expect to file a New Drug Application, which begins the approval process with
the FDA in early 2010. We expect to have preliminary topline safety and efficacy
results available in late 2009. There are currently no FDA approved drug
treatments for diabetic eye disease that either stabilize
or effect improvement in the condition. The potential market size for DME
treatment is very large. Approximately one in ten people with diabetes suffer
from, or will develop this sight-threatening eye disease and analysts estimate
the market size in the United States alone at 500,000 treatable
cases.
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BRIEFING
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| pSivida Limited |
Capital
Raising & Business
Milestones
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Date
02.08.07
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Genentech
and its licensing partner, Novartis are currently developing Lucentis,
their product for the ‘wet’ form of age-related macular edema, for the treatment
of DME. While Lucentis has been very successful in its sales for AMD, generating
sales of A$174 million (US$153 million) in its first quarter of sales, and
with
predictions that sales could top US$1 billion in its first year on the market,
this AMD product requires injections as frequently as monthly directly to the
back of the eye for the duration of the treatment for the disease. We understand
that this will also be true for their proposed DME application. By contrast,
our
product, MedidurTM,
releases a drug at a constant rate over a period of up to three years from
a
single injection. This makes us optimistic that MedidurTM
may have
a competitive advantage over Lucentis if both products are available for
the treatment of DME.
As
for
progress and developments on the Pfizer licensing deal announced in April,
other
than their increased investment in the Company, there’s little detail I can add
at this stage.
corporatefile.com.au
How
has
enrolment progressed in your Phase IIa trials of BrachySilTM
for
pancreatic cancer? When are you likely to be able to report on meaningful trial
data?
MD
Dr Paul Ashton
Enrolment
in the BrachySilTM
trial
for pancreatic cancer which we are currently fully funding ourselves is
progressing well and we expect to complete recruitment of a 15 persons study
at
hospitals in London, Birmingham and Singapore very shortly. Pancreatic cancer
is
the fourth largest cause of cancer related deaths in the United States and
typically, the life expectancy of pancreatic cancer patients is short. We hope
to get three month follow-up data to report on by the end of this calendar
year.
corporatefile.com.au
You
recently announced the renewal of an evaluation agreement for your drug delivery
technologies with a global medical device company. Are you likely to announce
any similar agreements in the near term?
MD
Dr Paul Ashton
We
believe that the renewed evaluation agreement demonstrates that there is
interest in applications of our controlled release drug delivery systems,
particularly in the treatment of cardiovascular disease. As this new agreement
follows the expiry of a previous evaluation agreement with the same large
medical device company, this is an exciting development. We expect further
evaluation agreements for our drug delivery technologies in other applications
this year.
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| pSivida Limited |
Capital
Raising & Business
Milestones
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Date
02.08.07
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corporatefile.com.au
What
further milestones are you targeting in the 2007 calendar year?
MD
Dr Paul Ashton
Over
the
last nine months, we have achieved significant milestones and brought the
Company to a sound financial position. The Company has successfully transitioned
from a bio-nano materials science company to a drug delivery company with two
FDA-approved products, a late stage pipeline and several partnerships. We are
focused on driving the business forward and rebuilding value in our share price.
As
mentioned, in the remainder of this calendar year we expect to complete the
recruitment of our MedidurTM
for DME
Phase III trials, complete recruitment and release results from of our
BrachySilTM
Phase
IIa trials in pancreatic cancer. We also expect to be in a position to announce
further evaluation agreements for our multiple drug delivery technologies.
All
in all, we expect the second half of 2007 to be a pivotal period for
pSivida.
corporatefile.com.au
Thank
you
Paul.
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 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.
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BRIEFING
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| pSivida Limited |
Capital
Raising & Business
Milestones
|
Date
02.08.07
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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: 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 or
our
proposed products; 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 or partnerships
and the risk of our failure to otherwise establish partnerships; the risk that
other companies do not have a commercial interest in pSivida; failure to enter
into any additional evaluation agreements for our technologies; the risk that
we
will not be able to raise additional funds at favourable terms or at all; the
risk that the Company is not fully funded for more than 12 months; failure
to
have significantly reduced the amount of financial risk; failure of the
activities that the Company is currently focusing on to generate commercial
returns in the near to medium term; risks with respect to the efficacy of
pSivida's drug delivery technology; risks with respect to the final results
of
the Medidur for DME clinical trials; 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 or the phase II BrachySil trials for
pancreatic cancer or to complete recruitment for our Medidur for DME trial
by
the end of this calendar year or the BrachySil trials for pancreatic cancer
shortly; the risk that we do not have preliminary top line safety and efficacy
results available in late 2009; failure to file an NDA with the FDA for
Retisert™ for DME in early 2010; failure of our Medidur™ for DME product to have
a competitive advantage over our competitors; failure to have three month follow
up data for our BrachySil trials for pancreatic cancer by the end of this
calendar year; failure to develop applications for BioSiliconTM due to
regulatory, scientific or other issues; failure of the pSivida Inc’s products to
achieve expected revenues; failure to achieve cost savings generally; our
inability to penetrate the Uveitis or other markets; our inability to continue
to develop products currently in our pipeline or to continue to feed our
product pipeline; our failure to achieve our stated 2007 milestones or to
execute on our stated U.S. growth strategy. 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.
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