pSivida Corp. Reports Results for the Fourth Quarter and Fiscal Year Ended June 30, 2009
For the year ended
Revenues for the three and twelve month periods ended
“We are expecting the 2-year top line safety and efficacy data from the
ongoing Phase III Iluvien trials for the treatment of DME at the end of
this calendar year,” stated Dr.
Dr. Ashton continued, “We are entering an important and exciting phase
of development and our programs are progressing according to schedule.
With expected cash from our existing collaborations and planned spending
levels, we believe we can fund our operations as currently conducted
through
The Company’s lead development product, Iluvien®, is a tiny injectable
device that delivers the drug fluocinolone acetonide (FA) directly to
the back of the eye for up to three years. Iluvien, formerly known as
Medidur™ FA for DME, is licensed on a worldwide basis to Alimera, which
is conducting fully-enrolled Phase III clinical trials studying a low
dose and a high dose for the treatment of diabetic macular edema (DME).
Alimera expects that 24-month interim data from these clinical trials
will be available in late 2009, and we currently anticipate that Alimera
will file a New Drug Application (NDA) with the
Alimera is also sponsoring studies designed to assess the safety and efficacy of Iluvien in wet and dry age-related macular degeneration and retinal vein occlusion.
About
pSivida is a world leader in the development of tiny, sustained release,
drug delivery products that are administered by implantation, injection
or insertion. pSivida’s lead development product delivers fluocinolone
acetonide (FA) for the treatment of diabetic macular edema (DME). This
product candidate, formerly known as Medidur™ FA for DME, is licensed to
Alimera, which is conducting fully recruited Phase III clinical trials
and intends to commercialize the product under the name Iluvien®.
pSivida also has two products approved by the
pSivida owns the rights to develop and commercialize a modified form of silicon known as BioSilicon™, which has potential therapeutic applications. The most advanced BioSilicon product candidate, BrachySil™, delivers a therapeutic P32, a radioactive form of phosphorus used to treat cancer, directly to solid tumors. pSivida has completed an initial safety clinical trial of BrachySil for the treatment of pancreatic cancer and is nearing completion of a follow-on dose-ranging clinical trial.
pSivida’s intellectual property portfolio consists of 62 patent
families, over 100 granted patents, including patents accepted for
issuance, and over 200 patent applications. pSivida conducts its
operations from
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995: Various statements made in this release are
forward-looking, and are inherently subject to risks, uncertainties and
potentially inaccurate assumptions. 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: inability to raise capital;
continued losses and lack of profitability; inability to derive revenue
from Retisert; impairment of intangibles; fluctuations in the fair
values of certain outstanding warrants; fluctuations in operating
results; termination of license agreements; inability to obtain
regulatory approvals for products; inability to obtain partners to
develop and market products; competition; insufficient third-party
reimbursement for products; inability to protect intellectual property
or infringement of others’ intellectual property; failure to retain key
personnel; consolidation in the pharmaceutical and biotechnology
industries; failure to comply with laws and regulations; manufacturing
problems; risks and costs of international business operations;
volatility of stock price; possible dilution through exercise of
outstanding warrants and stock options; possible influence by Pfizer;
payment of registration penalties; nonpayment of dividends; and other
factors that may be described in our filings with the
| PSIVIDA CORP. AND SUBSIDIARIES | |||||||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||||||
| (Unaudited) | |||||||||||||||||||||
| (In thousands except per share amounts) | |||||||||||||||||||||
| Three Months Ended | Year Ended | ||||||||||||||||||||
| June 30, | June 30, | ||||||||||||||||||||
| 2009 | 2008 | 2009 | 2008 | ||||||||||||||||||
| Revenues: | |||||||||||||||||||||
| Collaborative research and development | $ | 3,186 | $ | 2,647 | $ | 12,002 | $ | 3,328 | |||||||||||||
| Royalty income | 37 | 56 | 160 | 148 | |||||||||||||||||
| Total revenues | 3,223 | 2,703 | 12,162 | 3,476 | |||||||||||||||||
| Operating expenses: | |||||||||||||||||||||
| Impairment of goodwill | - | 60,106 | - | 60,106 | |||||||||||||||||
| Research and development | 1,830 | 2,404 | 8,007 | 14,426 | |||||||||||||||||
| General and administrative | 1,448 | 5,342 | 8,791 | 13,951 | |||||||||||||||||
| Total operating expenses | 3,278 | 67,852 | 16,798 | 88,483 | |||||||||||||||||
| Loss from operations | (55 | ) | (65,149 | ) | (4,636 | ) | (85,007 | ) | |||||||||||||
| Other income (expense): | |||||||||||||||||||||
| Change in fair value of derivatives | (619 | ) | 1,164 | 959 | 8,357 | ||||||||||||||||
| Interest income | 7 | 114 | 162 | 648 | |||||||||||||||||
| Interest expense | - | - | - | (507 | ) | ||||||||||||||||
| Other income (expense), net | 46 | 48 | 53 | 356 | |||||||||||||||||
| Total other (expense) income | (566 | ) | 1,326 | 1,174 | 8,854 | ||||||||||||||||
| Loss before income taxes | (621 | ) | (63,823 | ) | (3,462 | ) | (76,153 | ) | |||||||||||||
| Income tax benefit | 87 | 244 | 951 | 483 | |||||||||||||||||
| Net loss | $ | (534 | ) | $ | (63,579 | ) | $ | (2,511 | ) | $ | (75,670 | ) | |||||||||
| Basic and diluted net loss per share: | $ | (0.03 | ) | $ | (3.48 | ) | $ | (0.14 | ) | $ | (4.17 | ) | |||||||||
| Weighted average common shares outstanding: | |||||||||||||||||||||
| Basic and diluted | 18,264 | 18,261 | 18,263 | 18,166 | |||||||||||||||||
| PSIVIDA CORP. AND SUBSIDIARIES | ||||||||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||||||||
| (Unaudited) | ||||||||||||||
| (In thousands) | ||||||||||||||
| June 30, | June 30, | |||||||||||||
| 2009 | 2008 | |||||||||||||
| Assets | ||||||||||||||
| Current assets: | ||||||||||||||
| Cash and cash equivalents | $ | 6,899 | $ | 15,609 | ||||||||||
| Other current assets | 1,228 | 2,081 | ||||||||||||
| Total current assets | 8,127 | 17,690 | ||||||||||||
| Intangible assets, net | 28,802 | 36,802 | ||||||||||||
| Other assets | 175 | 1,292 | ||||||||||||
| Total assets | $ | 37,104 | $ | 55,784 | ||||||||||
| Liabilities and stockholders' equity | ||||||||||||||
| Current liabilities: | ||||||||||||||
| Accounts payable and accrued expenses | $ | 1,836 | $ | 4,870 | ||||||||||
| Deferred revenue | 5,912 | 10,476 | ||||||||||||
| Derivative liabilities | 971 | 1,930 | ||||||||||||
| Total current liabilities | 8,719 | 17,276 | ||||||||||||
| Deferred revenue | 4,622 | 8,114 | ||||||||||||
| Deferred tax liabilities | 222 | 316 | ||||||||||||
| Total liabilities | 13,563 | 25,706 | ||||||||||||
| Stockholders' equity: | ||||||||||||||
| Capital | 248,518 | 247,646 | ||||||||||||
| Accumulated deficit | (227,048 | ) | (224,537 | ) | ||||||||||
| Accumulated other comprehensive income | 2,071 | 6,969 | ||||||||||||
| Total stockholders' equity | 23,541 | 30,078 | ||||||||||||
| Total liabilities and stockholders' equity | $ | 37,104 | $ | 55,784 | ||||||||||
Source:
Released by:
US Public Relations
Beverly Jedynak
President
Martin
E. Janis & Company, Inc
Tel: +1 (312) 943 1123
bjedynak@janispr.com
or
pSivida
Corp.
Brian Leedman
Vice President, Investor Relations
pSivida
Corp.
Tel: +61 8 9227 8327
brianl@psivida.com
