pSivida Corp. Reports First Quarter Fiscal Year 2013 Results
"We are very pleased that the
"With respect to the posterior uveitis micro-insert, the FDA's decision to allow us to reference much of the ILUVIEN® data for diabetic macular edema (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. Because this development product uses the same micro-insert used in ILUVIEN for DME, which delivers a smaller dosage of the same drug as our Retisert® product already approved for posterior uveitis, we expect our 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, with a favorable risk/benefit profile and fewer side effects compared to Retisert," continued Dr. Ashton.
Tethadur, the Company's protein/anti-body delivery platform, has the potential to provide sustained release of peptides and proteins in many therapeutic areas and is currently being evaluated in ophthalmology under an agreement with a leading global biopharmaceutical company. In the ophthalmic area, a sustained delivery system like Tethadur for these types of molecules could offer a significant clinical advance because they must currently be injected into the eye every one or two months.
Regarding the European commercialization of ILUVIEN for DME, Alimera
Sciences, pSivida's licensee, has announced a planned direct commercial
launch in three EU countries in 2013, with
Alimera also announced that it intends to resubmit the NDA for ILUVIEN
for DME to the
The investigator-sponsored Phase I/II dose-escalation study of pSivida's bioerodible, injectable latanoprost micro-insert for glaucoma and ocular hypertension is ongoing. Pfizer has an exclusive option under various circumstances to license the development and commercialization worldwide of this micro-insert for human ophthalmic disease other than uveitis.
Revenues for the fiscal 2013 first quarter were
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
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| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||
| (Unaudited) | ||||||||||
| (In thousands except per share amounts) | ||||||||||
| Three Months Ended | ||||||||||
| September 30, | ||||||||||
| 2012 | 2011 | |||||||||
| Revenues: | ||||||||||
| Collaborative research and development | $ | 169 | $ | 1,461 | ||||||
| Royalty income | 384 | 198 | ||||||||
| Total revenues | 553 | 1,659 | ||||||||
| Operating expenses: | ||||||||||
| Research and development | 1,523 | 2,129 | ||||||||
| General and administrative | 1,620 | 2,061 | ||||||||
| Total operating expenses | 3,143 | 4,190 | ||||||||
| Loss from operations | (2,590 | ) | (2,531 | ) | ||||||
| Other income (expense): | ||||||||||
| Change in fair value of derivatives | - | 42 | ||||||||
| Interest income | 7 | 9 | ||||||||
| Other expense, net | (1 | ) | (2 | ) | ||||||
| Total other income | 6 | 49 | ||||||||
| Loss before income taxes | (2,584 | ) | (2,482 | ) | ||||||
| Income tax benefit | 33 | 55 | ||||||||
| Net loss | $ | (2,551 | ) | $ | (2,427 | ) | ||||
| Net loss per share: | ||||||||||
| Basic and diluted | $ | (0.11 | ) | $ | (0.12 | ) | ||||
| Weighted average common shares outstanding: | ||||||||||
| Basic and diluted | 22,294 | 20,757 | ||||||||
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| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||||
| (Unaudited) | ||||||||||
| (In thousands) | ||||||||||
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June 30, | |||||||||
| 2012 | 2012 | |||||||||
| Assets | ||||||||||
| Current assets: | ||||||||||
| Cash, cash equivalents and marketable securities | $ | 17,646 | $ | 14,571 | ||||||
| Other current assets | 1,254 | 1,388 | ||||||||
| Total current assets | 18,900 | 15,959 | ||||||||
| Intangible assets, net | 4,078 | 4,226 | ||||||||
| Other assets | 361 | 412 | ||||||||
| Total assets | $ | 23,339 | $ | 20,597 | ||||||
| Liabilities and stockholders' equity | ||||||||||
| Current liabilities: | ||||||||||
| Accounts payable and accrued expenses | $ | 1,067 | $ | 1,002 | ||||||
| Deferred revenue | 2,395 | 2,176 | ||||||||
| Total current liabilities | 3,462 | 3,178 | ||||||||
| Deferred revenue | 3,714 | 3,783 | ||||||||
| Total liabilities | 7,176 | 6,961 | ||||||||
| Stockholders' equity: | ||||||||||
| Capital | 269,463 | 264,452 | ||||||||
| Accumulated deficit | (254,309 | ) | (251,758 | ) | ||||||
| Accumulated other comprehensive income | 1,009 | 942 | ||||||||
| Total stockholders' equity | 16,163 | 13,636 | ||||||||
| Total liabilities and stockholders' equity | $ | 23,339 | $ | 20,597 | ||||||
US Public Relations
President
Tel: +1 (312) 943 1123
bjedynak@janispr.com
or
Vice President, Investor Relations
Tel:
+61 (0) 41 228 1780
brianl@psivida.com
Source:
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