pSivida Corp. Reports Second Quarter Fiscal Year 2013 Results
"We are pleased with the progress of our lead development product, an
injectable micro-insert for posterior uveitis. We expect to begin Phase
III trials early next quarter on schedule," said Dr.
"Because our posterior uveitis product uses the same micro-insert as ILUVIEN®, which has received marketing authorizations in various EU countries for chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies, and delivers the same drug as our surgically implanted Retisert® product already approved for posterior uveitis, we expect our Phase III trials will show efficacy similar to Retisert but with a side-effect profile in uveitis patients comparable to that seen in DME patients. We are optimistic therefore that our micro-insert will be efficacious for posterior uveitis, but with fewer side effects and a favorable risk/benefit profile compared to Retisert," continued Dr. Ashton. "The U.S. Food and Drug Admnistration's (FDA) decision to allow us to reference much of the ILUVIEN data for DME, including the clinical safety data, from Alimera Sciences' already-completed pivotal Phase III clinical trials, has the potential to both simplify any future NDA submission and to shorten development time. We are planning to target enrollment of a total of 300 patients in our two trials, with a primary end point of recurrence of uveitis at 12 months."
"Our pre-clinical studies of applications of Tethadur™, our protein/anti-body delivery technology platform, continue to progress well. We believe Tethadur has the potential to provide sustained release of peptides and proteins in many therapeutic areas, and its use in certain ophthalmic applications is currently being evaluated under an agreement with a leading global biopharmaceutical company. A sustained delivery system for proteins and antibodies used in ophthalmic treatments could offer a significant clinical advantage because current therapies require injection into the eye every one or two months."
Alimera Sciences, pSivida's licensee for ILUVIEN for DME, has announced
plans for a direct commercial launch in three EU countries in 2013, with
Alimera has also reported that, based on a
Revenues for the fiscal 2013 second quarter were
Revenues for the six months ended
At
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: uncertainties
with respect to: Alimera's ability to finance, achieve additional
marketing approvals, successfully commercialize and achieve market
acceptance of, and generate revenues to pSivida from, ILUVIEN for DME in
the EU; Alimera's resubmission of its NDA for ILUVIEN for DME and its
ability to obtain regulatory approval for, and if approved, to finance,
successfully commercialize and achieve market acceptance of, and
generate revenues to pSivida from, ILUVIEN for DME in the U.S.;
financing and success of Phase III posterior uveitis trials including
efficacy, side effects and risk/benefit profile of the posterior uveitis
micro-insert; initiation, financing and success of Latanoprost Product
Phase II trials and exercise by Pfizer of its option; development of
products using Tethadur and BioSilicon; initiation and completion of
clinical trials and obtaining regulatory approval of product candidates;
adverse side effects; ability to attain profitability; ability to obtain
additional capital; further impairment of intangible assets;
fluctuations in operating results; decline in royalty revenues; ability
to, and to find partners to, develop and market products; termination of
license agreements; competition and other developments affecting sales
of products; market acceptance; protection of intellectual property and
avoiding intellectual property infringement; 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; absence of dividends; and other factors described in our filings
with the
|
|
||||||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||||||
| (Unaudited) | ||||||||||||||||||||
| (In thousands except per share amounts) | ||||||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||||||
|
|
|
|||||||||||||||||||
| 2012 | 2011 | 2012 | 2011 | |||||||||||||||||
| Revenues: | ||||||||||||||||||||
| Collaborative research and development | $ | 195 | $ | 204 | $ | 364 | $ | 1,665 | ||||||||||||
| Royalty income | 390 | 426 | 774 | 624 | ||||||||||||||||
| Total revenues | 585 | 630 | 1,138 | 2,289 | ||||||||||||||||
| Operating expenses: | ||||||||||||||||||||
| Research and development | 1,575 | 1,992 | 3,098 | 4,121 | ||||||||||||||||
| General and administrative | 1,658 | 1,451 | 3,278 | 3,512 | ||||||||||||||||
| Impairment of intangible assets | - | 14,830 | - | 14,830 | ||||||||||||||||
| Total operating expenses | 3,233 | 18,273 | 6,376 | 22,463 | ||||||||||||||||
| Loss from operations | (2,648 | ) | (17,643 | ) | (5,238 | ) | (20,174 | ) | ||||||||||||
| Other income (expense): | ||||||||||||||||||||
| Change in fair value of derivatives | - | 128 | - | 170 | ||||||||||||||||
| Interest income | 4 | 11 | 11 | 20 | ||||||||||||||||
| Other expense, net | (1 | ) | - | (2 | ) | (2 | ) | |||||||||||||
| Total other income | 3 | 139 | 9 | 188 | ||||||||||||||||
| Loss before income taxes | (2,645 | ) | (17,504 | ) | (5,229 | ) | (19,986 | ) | ||||||||||||
| Income tax benefit | 37 | 44 | 70 | 99 | ||||||||||||||||
| Net loss | $ | (2,608 | ) | $ | (17,460 | ) | $ | (5,159 | ) | $ | (19,887 | ) | ||||||||
| Net loss per share: | ||||||||||||||||||||
| Basic and diluted | $ | (0.11 | ) | $ | (0.84 | ) | $ | (0.23 | ) | $ | (0.96 | ) | ||||||||
| Weighted average common shares outstanding: | ||||||||||||||||||||
| Basic and diluted | 23,297 | 20,803 | 22,795 | 20,780 | ||||||||||||||||
|
|
|||||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||||
| (Unaudited) | |||||||||||
| (In thousands) | |||||||||||
|
|
June 30, | ||||||||||
| 2012 | 2012 | ||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash, cash equivalents and marketable securities | $ | 15,720 | $ | 14,571 | |||||||
| Other current assets | 1,090 | 1,388 | |||||||||
| Total current assets | 16,810 | 15,959 | |||||||||
| Intangible assets, net | 3,883 | 4,226 | |||||||||
| Other assets | 349 | 412 | |||||||||
| Total assets | $ | 21,042 | $ | 20,597 | |||||||
| Liabilities and stockholders' equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable and accrued expenses | $ | 1,299 | $ | 1,002 | |||||||
| Deferred revenue | 784 | 2,176 | |||||||||
| Total current liabilities | 2,083 | 3,178 | |||||||||
| Deferred revenue | 5,149 | 3,783 | |||||||||
| Total liabilities | 7,232 | 6,961 | |||||||||
| Stockholders' equity: | |||||||||||
| Capital | 269,726 | 264,452 | |||||||||
| Accumulated deficit | (256,917 | ) | (251,758 | ) | |||||||
| Accumulated other comprehensive income | 1,001 | 942 | |||||||||
| Total stockholders' equity | 13,810 | 13,636 | |||||||||
| Total liabilities and stockholders' equity | $ | 21,042 | $ | 20,597 | |||||||
US Public Relations
President
Tel: +1 (312) 943 1123
bjedynak@janispr.com
Vice President, Investor Relations
Tel: +61 (0) 41 228 1780
brianl@psivida.com
Source:
News Provided by Acquire Media
