pSivida Corp. Reports Results for the Third Quarter Ended March 31, 2012
At
“The third quarter was an excellent quarter as ILUVIEN® received a
positive outcome from the Decentralized Procedure in the EU. ILUVIEN was
indicated for the treatment of vision impairment associated with chronic
diabetic macular edema (DME) considered insufficiently responsive to
available therapies. ILUVIEN has since received marketing authorization
in the
“We are also pleased with the progress in our pre-clinical programs and
our technology evaluations,” said Dr. Ashton. “In
“In collaboration with Pfizer, we are also continuing to progress development of our bioerodible insert to treat glaucoma and ocular hypertension,” said Dr. Ashton. The Company’s proposed product candidate is an injectable, bioerodible sustained release insert delivering latanoprost and is currently the subject of a dose-ranging study. The Company granted Pfizer an exclusive option under various circumstances to license the development and commercialization worldwide of this insert for human ophthalmic disease other than uveitis.
“We are continuing to pursue our independent development of an insert to
treat uveitis affecting the posterior segment of the eye,” Dr. Ashton
continued. The Company’s posterior uveitis product candidate uses the
same injectable micro insert as ILUVIEN for DME. The Alimera
collaboration agreement allows the Company to reference the ILUVIEN for
DME regulatory filings. In
Revenues for the third quarter were
Revenues for the nine months ended
Today’s Conference Call Reminder
About
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 anticipated results or other expectations expressed,
anticipated or implied in our forward-looking statements: Alimera’s
ability to obtain regulatory approval of and successfully commercialize
(alone or with others) ILUVIEN for DME in the EU and delays in any such
approval; actions with respect to regulatory approval of ILUVIEN for DME
in the U.S.; ability to obtain additional capital; ability to attain
profitability; adverse side effects; exercise by Pfizer of the
Latanoprost Product option; ability to complete clinical trials and
obtain regulatory approval of product candidates; further impairment of
intangible assets; fluctuations in operating results; decline in royalty
revenues; ability to find partners to develop and market products;
termination of license agreements; competition; market acceptance of
products and product candidates; reduction in use of products as a
result of future guidelines, recommendations or studies; ability to
protect intellectual property and avoid infringement of others’
intellectual property; retention of key personnel; product liability;
consolidation in the pharmaceutical and biotechnology industries;
compliance with environmental laws; manufacturing risks; risks and costs
of international business operations; credit and financial market
conditions; legislative or regulatory changes; volatility of stock
price; possible dilution; possible influence by Pfizer; ability to pay
any registration penalties; absence of dividends; and other factors
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 | Nine Months Ended | ||||||||||||||||
| March 31, | March 31, | ||||||||||||||||
| 2012 | 2011 | 2012 | 2011 | ||||||||||||||
| Revenues: | |||||||||||||||||
| Collaborative research and development | $ | 158 | $ | 56 | $ | 1,823 | $ | 218 | |||||||||
| Royalty income | 380 | 304 | 1,004 | 1,032 | |||||||||||||
| Total revenues | 538 | 360 | 2,827 | 1,250 | |||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | 1,508 | 1,737 | 5,629 | 5,013 | |||||||||||||
| General and administrative | 1,757 | 1,762 | 5,269 | 5,932 | |||||||||||||
| Impairment of intangible assets | - | - | 14,830 | - | |||||||||||||
| Total operating expenses | 3,265 | 3,499 | 25,728 | 10,945 | |||||||||||||
| Loss from operations | (2,727 | ) | (3,139 | ) | (22,901 | ) | (9,695 | ) | |||||||||
| Other income (expense): | |||||||||||||||||
| Change in fair value of derivatives | - | 334 | 170 | 1,130 | |||||||||||||
| Interest income | 10 | 7 | 30 | 19 | |||||||||||||
| Other income (expense), net | 1 | - | (1 | ) | (11 | ) | |||||||||||
| Total other income | 11 | 341 | 199 | 1,138 | |||||||||||||
| Loss before income taxes | (2,716 | ) | (2,798 | ) | (22,702 | ) | (8,557 | ) | |||||||||
| Income tax benefit | 30 | 113 | 129 | 69 | |||||||||||||
| Net loss | $ | (2,686 | ) | $ | (2,685 | ) | $ | (22,573 | ) | $ | (8,488 | ) | |||||
| Net loss per share: | |||||||||||||||||
| Basic and diluted | $ | (0.13 | ) | $ | (0.13 | ) | $ | (1.09 | ) | $ | (0.45 | ) | |||||
| Weighted average common shares outstanding: | |||||||||||||||||
| Basic and diluted | 20,803 | 20,177 | 20,787 | 19,072 | |||||||||||||
| PSIVIDA CORP. AND SUBSIDIARIES | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (Unaudited) | ||||||||
| (In thousands) | ||||||||
| March 31, | June 30, | |||||||
| 2012 | 2011 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash, cash equivalents and marketable securities | $ | 16,462 | $ | 24,128 | ||||
| Other current assets | 1,433 | 1,238 | ||||||
| Total current assets | 17,895 | 25,366 | ||||||
| Intangible assets, net | 4,451 | 21,564 | ||||||
| Other assets | 487 | 183 | ||||||
| Total assets | $ | 22,833 | $ | 47,113 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 1,124 | $ | 1,650 | ||||
| Deferred revenue | 1,465 | 3,212 | ||||||
| Derivative liabilities | - | 170 | ||||||
| Total current liabilities | 2,589 | 5,032 | ||||||
| Deferred revenue | 4,689 | 4,635 | ||||||
| Deferred tax liabilities | - | 13 | ||||||
| Total liabilities | 7,278 | 9,680 | ||||||
| Stockholders' equity: | ||||||||
| Capital | 264,062 | 262,927 | ||||||
| Accumulated deficit | (249,496 | ) | (226,923 | ) | ||||
| Accumulated other comprehensive income | 989 | 1,429 | ||||||
| Total stockholders' equity | 15,555 | 37,433 | ||||||
| Total liabilities and stockholders' equity | $ | 22,833 | $ | 47,113 | ||||
Source:
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 (0) 412 281 780
brianl@psivida.com
