has FINALLY turned the corner, IMO....?Let the reversal trend...

has FINALLY turned the corner, IMO....?

Let the reversal trend begin.

regards,


ASX/Media RELEASE 30 April 2008
pSivida Quarterly Cash Flow – March 31, 2008
Commentary and Highlights
- Reincorporation Plan Announced
- Medidur Collaboration Agreement Amended
- BrachySil Pancreatic Cancer Phase IIa Results
- Pfizer R&D Quarterly Payments Commence
Boston, MA. and Perth, Australia – pSivida Limited (ASX: PSD, NASDAQ: PSDV, FSE:
PSI) announced the filing of its Quarterly Cash Flow Statement for the quarter ended
March 31, 2008 with the ASX.
Cash Flow
The cash balance at March 31, 2008 was A$19.8m (US$18.2m), an increase of
A$8.6m (US$8.4m) from the balance at December 31, 2007. During the quarter, net
cash provided by operating activities was A$9.4m (US$8.5m) compared to net cash
used in operating activities of A$7.2m (US$6.4m) in the previous quarter. Gross cash
inflows from customers in the current quarter of A$14.4m (US$13.0m) consisted of
approximately A$13.3m (US$12.0m) received as part of the amended collaboration
agreement with Alimera Sciences, A$553k (US$500k) of research and development
funding from Pfizer and A$553k (US$500k) received from Intrinsiq Materials Cayman
Limited (Intrinsiq) in connection with the January 2008 license of nutraceutical and food
science applications of BioSilicon and sale of certain related assets. This compared to
gross cash inflows from customers of A$48k (US$43k) in the previous quarter. Cash
outflows from operating activities were approximately A$5.1m (US$4.6m) for the
current quarter compared to A$7.2m (US$6.4m) for the previous quarter. Primarily as a
result of the amended Alimera agreement, payments of Medidur development costs
decreased by approximately A$2.0m (US$1.8m) compared to the previous quarter.
Retisert®
Subsequent to March 31, 2008, Bausch and Lomb will retain the next US$3.3m
(A$3.6m) of Retisert® royalties otherwise payable to pSivida in accordance with an
advance royalty agreement the Company entered into in June 2005. Royalties
otherwise payable to pSivida for the quarter ended March 31, 2008 were US$371k
(A$410k), which represents a 31% decrease from US$541k (A$608k) for the quarter
ended December 31, 2007 and a 20% decrease from US$461k (A$587k) for the
quarter ended March 31, 2007. Retisert® is the only FDA-approved treatment for
posterior uveitis, a chronic eye disease.
Proposed reincorporation in the US
In April, the Company announced its proposal to reincorporate in the United States in
mid-2008, subject to Australian Federal Court and shareholder approvals. The
reincorporation is designed to make the Company a more attractive investment for
shareholders by increasing the potential scope and depth of the Company's
shareholder base and liquidity while maintaining strong ties with the Australian investor
base. After the reincorporation, the Company will maintain listings on the ASX,
NASDAQ and the Frankfurt Stock Exchange. The Company's current business,
operations, directors and management will not change as a result of the
reincorporation.
Medidur™ FA Collaboration Agreement Amendment
In March, the Company announced that Alimera Sciences and the Company amended
their license and collaboration agreement relating to Medidur™ FA, the Phase III
investigative treatment for diabetic macular edema (DME), and other Medidur products.
Alimera increased its equity in the future profits of Medidur FA from 50 to 80 percent in
exchange for consideration of up to approximately US$78m to pSivida.
DSMB again supports continuation of pivotal Phase III study of Medidur for DME
In March, the Company announced that an independent Data Safety Monitoring Board
(DSMB), after completing its review of available safety and efficacy data, recommended
that the pivotal Phase III clinical trials known as the FAME™ Study continue under the
current protocol, without change. The trial is studying the use of Medidur FA™ for the
treatment of DME.
BrachySil™ for Pancreatic Cancer Study Results
In January, the Company announced that the results of the Phase IIa clinical trial of
BrachySilTM for the treatment of advanced, inoperable pancreatic cancer were
presented at the American Society of Clinical Oncolgy-GI (ASCO-GI). Seventeen
patients were treated with BrachySil (32P - radioactive Phospherous combined with
BioSilicon®) directly into the tumor in combination with standard chemotherapy at two
major oncology hospitals in the UK and one in Singapore. The trial, designed as a
safety study, showed that BrachySilTM was easily administered and well tolerated, with
no clinically significant adverse events related to BrachySil. Data also showed disease
control in 82% of patients treated with BrachySilTM and an overall median survival time
of 309 days. A Phase IIb dose ranging study is expected to commence shortly.
Pancreatic cancer is the 4th highest cause of death by cancer in the US. Median
survival for people with inoperable primary pancreatic cancer or metastatic disease
(over 80% of pancreatic cancer patients) following diagnosis is typically less than 6
months using standard chemotherapy.
First R&D payments received from Pfizer
In February, the Company announced that it received US$500k as the first quarterly
research and development payment from Pfizer under the terms of the exclusive
worldwide Collaborative Research and License Agreement signed in April 2007 for
pSivida’s controlled drug delivery technologies in ophthalmic applications. Under the
terms of that agreement, pSivida will receive up to US$153.5m in development and
sales related milestones. Pfizer has invested US$11.5m in pSivida and is the
Company’s largest shareholder, holding approximately 10% of all outstanding shares. A
second quarterly payment was received in April.
pSiNutria business sold to Intrinsiq
In January, the Company announced that it licensed nutraceutical and food science
applications of BioSilicon, and sold certain related assets of pSiNutria Limited, a wholly
owned subsidiary of pSivida, to Intrinsiq. pSiNutria was established to develop
applications of the Company’s BioSiliconTM technology for the food industry and this
license and related sale of certain assets continues to sharpen the Company’s focus on
its core business – therapeutic delivery.
-ENDSReleased
by:
pSivida Limited
Brian Leedman
Vice President, Investor Relations
pSivida Limited
Tel: + 61 8 9227 8327
[email protected]
US Public Relations
Beverly Jedynak
President
Martin E. Janis & Company, Inc
Tel: +1 (312) 943 1123
[email protected]
European Public Relations
Eva Reuter
Accent Marketing Limited
Tel: +49 (254) 393 0740
[email protected]
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 AIDSrelated
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 (excluding
FA).
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 64 patent families, 113 granted patents, including patents accepted for
issuance, and over 280 patent applications. pSivida conducts its operations from 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
(PSI). pSivida is a founding member of the NASDAQ Health Care Index and the Merrill Lynch Nanotechnology Index.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various
statements made in this release are forward-looking and involve a number of risks and uncertainties. All statements that address
activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. The
following are some of the factors that could cause actual results to differ materially from the forward-looking statements:
achievement of milestones and other contingent contractual payment events; failure to prove efficacy for BrachySil; inability to
raise capital; continued losses and lack of profitability; inability to develop or obtain regulatory approval for new products;
inability to protect intellectual property or infringement of others’ intellectual property; inability to obtain partners to develop
and market products; termination of license agreements; competition; inability to pay any registration penalties; costs of
international business operations; manufacturing problems; insufficient third-party reimbursement for products; failure to retain
key personnel; product liability; inability to manage change; failure to comply with laws; failure to achieve and maintain
effective internal control over financial reporting; amortization or impairment of intangibles; issues relating to Australian
incorporation; potential delisting from ASX or NASDAQ; possible dilution through exercise of outstanding warrants and stock
options or future stock issuances; potential restrictions from capital raises; possible influence by Pfizer; and other factors that
may be described in our filings with the Securities and Exchange Commission. Given these uncertainties, readers are cautioned
not to place undue reliance on such forward-looking statements. We do not undertake to publicly update or revise our forwardlooking
statements even if experience or future changes make it clear that any projected results expressed or implied in such
statements will not be realized.