Published: February 09, 2011
pSivida Corp. Reports Results for the Second Quarter Ended December 31, 2010
WATERTOWN, Mass. - (BUSINESS WIRE) - pSivida Corp. (NASDAQ: PSDV)(ASX: PVA), a leader in developing sustained
release, drug delivery products for treatment of back-of-the-eye
diseases, including the product candidate ILUVIEN for the treatment of
Diabetic Macular Edema (DME), today announced financial results for its
second quarter and six months ended December 31, 2010.
Revenues for the fiscal 2011 second quarter were $414,000 compared to
$3.4 million a year earlier. Revenues for the current quarter consisted
primarily of Retisert royalty income, for which payments resumed
following completion of an earlier agreement with Bausch & Lomb.
Substantially all of the $3.4 million of revenues in the prior year
quarter resulted from recognition of deferred revenue attributable to
the Company's amended collaboration agreement with Alimera Sciences,
Inc. Amortization of this deferred revenue was completed in the fiscal
2010 second quarter. The Company reported a consolidated net loss of
$2.7 million, or $0.15 per share, for the second quarter ended December
31, 2010, compared to a consolidated net loss of $24,000, or $0.00 per
share, for the second quarter of the prior year.
For the six months ended December 31, 2010, the Company reported a
consolidated net loss of $5.8 million, or $0.31 per share, compared to a
consolidated net loss of $1.6 million, or $0.09 per share, for the same
period of the prior fiscal year. Revenues for the six months ended
December 31, 2010 totaled $890,000 compared to $6.8 million for the six
months ended December 31, 2009.
Cash, cash equivalents and marketable securities totaled $14.6 million
at December 31, 2010 compared to $15.3 million at September 30, 2010.
Net cash used of $676,000 in the fiscal 2011 second quarter was lower
than recent quarters primarily due to the timing of receipt of $1.0
million of scheduled research funding payments. On January 24, 2011, the
Company completed the sale of 2,210,000 shares of common stock and
warrants to purchase 552,500 shares of common stock to institutional
investors for net proceeds of approximately $10.1 million.
On February 3, 2011, Alimera reported top-line results from the 36-month
readout from its completed Phase III pivotal clinical trials for ILUVIEN
for DME. Alimera has stated that it intends to provide 36-month data to
the FDA by March 31, 2011.
"We believe the top-line 3-year ILUVIEN data is promising, and look
forward to the FDA's action on ILUVIEN. If approved, pSivida will be
entitled to a $25.0 million milestone payment from Alimera and 20% of
profits (as defined) from the sales of ILUVIEN by Alimera," said Dr.
Paul Ashton, President and CEO of pSivida.
"Internal and collaborative product development based on our proprietary
drug delivery platforms continues to be a primary focus for pSivida.
Completion of the share offering in January further solidifies our
financial position and provides the resources to accelerate our
development programs," said Dr. Ashton.
Today's Conference Call Reminder
pSivida Corp. will host a live webcast and conference call today,
February 9, 2011, at 4:30 pm ET. The conference call may be accessed by
dialing (866) 356-4123 from the U.S. and Canada, or (617) 597-5393 from
international locations, passcode 42010443. The conference can also be
accessed on the pSivida Corp. website at www.psivida.com.
A replay of the call will be available approximately two hours following
the end of the call through February 16, 2011. The replay may be
accessed by dialing (888) 286-8010 within the U.S. and Canada or (617)
801-6888 from international locations, passcode 80133895.
About pSivida Corp.
pSivida is a world leader in the development of tiny drug delivery
products that are administered by implantation, injection or insertion
and provide sustained release of drugs on a controlled and level basis
for months or years. The Company uses these systems to develop
treatments for serious, unmet, medical needs. The Company's most
advanced product candidate, ILUVIEN, delivers fluocinolone
acetonide (FA) for the treatment of diabetic macular edema (DME). DME is
a leading cause of vision loss, affecting more than a million people in
the US alone, for which there is currently no FDA-approved drug therapy.
ILUVIEN is licensed to Alimera Sciences, Inc., which has completed Phase
III clinical trials and submitted a New Drug Application (NDA) with the
Food and Drug Administration (FDA) in June 2010 based on 24-month data.
In August 2010, the FDA granted Priority Review status for the NDA, and
in December 2010, the FDA issued a Complete Response Letter. In February
2011, Alimera reported 36-month top-line results from the completed
Phase III clinical trials. pSivida has two products approved by the FDA
for sustained release delivery of drug to treat chronic back-of-the-eye
diseases: Retisert for the treatment of posterior uveitis
and Vitrasert for the treatment of AIDS-related
cytomegalovirus (CMV) retinitis. pSivida has licensed both of these
products and the technologies underlying them to Bausch & Lomb
Incorporated. pSivida also has a worldwide collaborative research and
license agreement with Pfizer Inc. under which Pfizer may develop
additional ophthalmic products using certain of the Company's
technologies. pSivida's intellectual property portfolio consists of over
50 patent families, more than 100 granted patents, including patents
accepted for issuance, and more than 150 patent applications. pSivida
conducts its operations from Boston in the United States and Malvern in
the United Kingdom.
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: ability to
obtain additional capital uncertain; future losses; impairment of
intangibles; fluctuations in the fair values of certain outstanding
warrants; fluctuations in operating results; decline of royalty income
from Bausch & Lomb; Alimera's ability to obtain regulatory approval of
Iluvien including analysis of results through month 36 of the FAME
Study, safety and efficacy of ILUVIEN, controls and specifications
concerning the manufacturing, packaging and sterilization of ILUVIEN and
cGMP at manufacturers of ILUVIEN; Alimera's ability to successfully
commercialize ILUVIEN if approved; risk/benefit profile of ILUVIEN;
timeliness of approval, if any, of ILUVIEN and any limitations on uses
thereof; ability to complete clinical trials and obtain regulatory
approval of other product candidates; 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 publications; ability
to protect intellectual property or 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 through exercise of outstanding warrants and
stock options or future stock issuances; possible influence by Pfizer;
ability to pay any registration penalties; absence of dividends; and
other factors 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. Our
forward-looking statements speak only as of the dates on which they are
made. We do not undertake any obligation to publicly update or revise
our forward-looking statements even if experience or future changes
makes it clear that any projected results expressed or implied in such
statements will not be realized.
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PSIVIDA CORP. AND SUBSIDIARIES
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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(Unaudited)
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(In thousands except per share amounts)
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Three Months Ended
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Six Months Ended
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December 31,
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December 31,
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2010
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2009
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2010
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2009
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Revenues:
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Collaborative research and development
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$
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88
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$
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3,406
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$
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162
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$
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6,752
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Royalty income
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326
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27
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728
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64
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Total revenues
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414
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3,433
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890
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6,816
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Operating expenses:
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Research and development
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1,534
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1,728
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3,276
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3,528
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General and administrative
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2,001
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1,818
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4,170
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3,508
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Total operating expenses
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3,535
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3,546
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7,446
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7,036
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Loss from operations
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(3,121
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)
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(113
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)
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(6,556
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)
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(220
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)
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Other income (expense):
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Change in fair value of derivatives
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458
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83
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796
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(1,436
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)
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Interest income
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6
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-
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12
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2
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Other (expense) income, net
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(3
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)
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(4
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)
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(11
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)
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5
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Total other income (expense)
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461
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79
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797
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(1,429
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)
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Loss before income taxes
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(2,660
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)
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(34
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)
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(5,759
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)
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(1,649
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)
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Income tax (expense) benefit
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(35
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)
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10
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(44
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)
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34
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Net loss
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$
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(2,695
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)
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$
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(24
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)
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$
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(5,803
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)
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$
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(1,615
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)
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Net loss per share:
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Basic and diluted
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$
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(0.15
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)
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$
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-
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$
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(0.31
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)
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$
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(0.09
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)
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Weighted average common shares outstanding:
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Basic and diluted
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18,531
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18,317
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18,531
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18,305
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PSIVIDA CORP. AND SUBSIDIARIES
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CONDENSED CONSOLIDATED BALANCE SHEETS
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(Unaudited)
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(In thousands)
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December 31,
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June 30,
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2010
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2010
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Assets
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Current assets:
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Cash, cash equivalents and marketable securities
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$
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14,643
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$
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17,565
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Other current assets
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1,215
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1,469
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Total current assets
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15,858
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19,034
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Intangible assets, net
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22,681
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23,877
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Other assets
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149
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103
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Total assets
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$
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38,688
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$
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43,014
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Liabilities and stockholders' equity
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Current liabilities:
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Accounts payable and accrued expenses
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$
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1,022
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$
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1,545
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Deferred revenue
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81
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79
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Derivative liabilities
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514
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1,310
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Total current liabilities
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1,617
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2,934
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Deferred revenue
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8,305
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6,817
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Deferred tax liabilities
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222
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222
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Total liabilities
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10,144
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9,973
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Stockholders' equity:
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Capital
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251,714
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250,815
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Accumulated deficit
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(224,098
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)
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|
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(218,295
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)
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Accumulated other comprehensive income
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928
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521
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Total stockholders' equity
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28,544
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33,041
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Total liabilities and stockholders' equity
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$
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38,688
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$
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43,014
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US Public Relations
Martin E. Janis & Company, Inc
Beverly
Jedynak
President
Tel: +1 (312) 943 1123
bjedynak@janispr.com
or
pSivida
Corp.
Brian Leedman
Vice President, Investor Relations
Tel:
+61 8 9227 8327
brianl@psivida.com
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