- $15.2m received from Alimera in full payment of conditional note after
end of quarter.
WATERTOWN, Mass., May 12, 2010 (BUSINESS WIRE) --pSivida Corp. (NASDAQ: PSDV)(ASX: PVA)(FF: PV3), a drug delivery company
with two of the only three ophthalmic sustained release delivery
products approved by the FDA for treatment of back-of-the-eye diseases,
today announced financial results for its third quarter and nine months
ended March 31, 2010.
"I am very pleased with the progress on the development side. At the
recent ARVO conference, positive results of pre-clinical studies
indicated a key step toward the ability to use our bio-erodible
technology for the treatment of glaucoma and other degenerative eye
diseases. At the conference, there were nine presentations of our
technologies, three sponsored by us and our partners and another six by
independent researchers," said Dr. Paul Ashton, CEO of pSivida.
"I am also pleased with the significant improvement in our financial
condition. After the close of the quarter, the Company received $15.2
million from Alimera Sciences, Inc. in full payment of principal plus
accrued and unpaid interest on a conditional note. With this payment, we
project fiscal 2010 revenues of approximately $22.8 million and cash and
cash equivalents at June 30, 2010 of approximately $17 million, up from
approximately $7 million last year," added Dr. Ashton.
Financial Results
The Company reported a consolidated net loss of $2.7 million, or $0.15
per share, for the quarter ended March 31, 2010, compared to a
consolidated net loss of $636,000, or $0.03 per share, for the quarter
ended March 31, 2009.
Revenues totaled $515,000 for the three months ended March 31, 2010
compared to revenues of $3.2 million for the three months ended March
31, 2009. The revenue decrease was attributable to the completion on
December 31, 2009 of the Company's performance obligations under its
collaboration agreement with Alimera, through which date cash
consideration received from Alimera was being amortized to revenue.
For the nine months ended March 31, 2010, the Company reported a
consolidated net loss of $4.3 million, or $0.24 per share, compared to a
consolidated net loss of $2.0 million, or $0.11 per share, for the nine
months ended March 31, 2009. Revenues for the nine months ended March
31, 2010 were $7.3 million compared to revenues of $8.9 million for the
nine months ended March 31, 2009.
Cash and cash equivalents totaled approximately $4.0 million at March
31, 2010, a decrease of approximately $1.1 million compared to
approximately $5.1 million at December 31, 2009. Over the first 9 months
of fiscal 2010, net cash and cash equivalents decreased by $2.9 million.
Corporate Update
Alimera has reported its intent to file an NDA for Iluvien(R),
licensed by pSivida to Alimera, with the FDA in the second calendar
quarter of 2010 and to request Priority Review. If approved, Iluvien
would be the first ophthalmic drug therapy for Diabetic Macular Edema, a
potentially blinding eye disease that affects more than one million
people in the United States alone. Receiving Priority Review status
could result in a decision from the FDA by as early as the end of
calendar 2010 and, if positive, Alimera has indicated that first sales
of Iluvien could be as early as the first quarter of 2011.
"FDA approval of Iluvien would trigger a $25 million milestone payment
from Alimera," explained Dr. Ashton.
"We are continuing to advance our technologies toward the development of
additional products, both partnered through our ongoing collaboration
agreement with Pfizer, Inc. and internally. We are excited by the
opportunities in our pipeline," concluded Dr. Ashton.
Today's Conference Call Reminder
pSivida Corp. will host a live webcast and conference call today, May
12, 2010, at 4:30 pm ET. The conference call may be accessed by dialing
(800) 591-6945 from the U.S. and Canada, or (617) 614-4911 from
international locations, passcode 28745100. 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 May 19, 2010. The replay may be accessed by
dialing (888) 286-8010 within the U.S. and Canada or (617) 801-6888 from
international locations, passcode 15588389.
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's focus is the use of its technologies
to develop therapies 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 is conducting
fully-recruited Phase III clinical trials and has announced its plan to
file an New Drug Application (NDA) with the Food and Drug Administration
(FDA) in the second calendar quarter of 2010. pSivida has two products
approved by the FDA for sustained release delivery of drug to treat
chronic back-of-the-eye diseases: Retisert(R) for the treatment
of posterior uveitis and Vitrasert(R) 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 62 patent
families, over 100 granted patents, including patents accepted for
issuance, and over 200 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: maintaining
collaboration agreements with Alimera and Pfizer; modifications of
existing terms of collaboration agreements with Alimera and Pfizer;
achievement of milestones and other contingent contractual events;
ability to prove safety and efficacy of, and achieve regulatory
approvals for, and successfully commercialize Iluvien, BrachySil and
other products; ability to raise capital; ability to achieve
profitability; ability to derive revenues from Retisert; ability to
develop new products; impairment of intangibles; fluctuations in the
fair values of certain outstanding warrants; fluctuations in operating
results; termination of license agreements; ability to obtain partners
to develop and market products; competition; extent of third-party
reimbursement for products; product liability; ability to protect
intellectual property or infringement of others' intellectual property;
retention of key personnel; consolidation in the pharmaceutical and
biotechnology industries; compliance with laws; maintaining effective
internal control over financial reporting; manufacturing risks; risks
and costs of international business operations; 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; 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.
|
|
|
|
|
|
|
|
|
|
|
|
|
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, |
|
|
|
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
Collaborative research and development
|
|
$
|
490
|
|
|
$
|
3,136
|
|
|
$
|
7,242
|
|
|
$
|
8,816
|
|
|
|
Royalty income
|
|
|
25
|
|
|
|
27
|
|
|
|
89
|
|
|
|
123
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
515
|
|
|
|
3,163
|
|
|
|
7,331
|
|
|
|
8,939
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
1,680
|
|
|
|
1,892
|
|
|
|
5,208
|
|
|
|
6,177
|
|
|
|
General and administrative
|
|
|
1,698
|
|
|
|
2,052
|
|
|
|
5,206
|
|
|
|
7,343
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
3,378
|
|
|
|
3,944
|
|
|
|
10,414
|
|
|
|
13,520
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(2,863
|
)
|
|
|
(781
|
)
|
|
|
(3,083
|
)
|
|
|
(4,581
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of derivatives
|
|
|
226
|
|
|
|
22
|
|
|
|
(1,210
|
)
|
|
|
1,578
|
|
|
|
Interest income
|
|
|
-
|
|
|
|
22
|
|
|
|
2
|
|
|
|
155
|
|
|
|
Other income, net
|
|
|
4
|
|
|
|
(4
|
)
|
|
|
9
|
|
|
|
7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense)
|
|
|
230
|
|
|
|
40
|
|
|
|
(1,199
|
)
|
|
|
1,740
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
(2,633
|
)
|
|
|
(741
|
)
|
|
|
(4,282
|
)
|
|
|
(2,841
|
)
|
|
Income tax (expense) benefit
|
|
|
(72
|
)
|
|
|
105
|
|
|
|
(38
|
)
|
|
|
864
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(2,705
|
)
|
|
$
|
(636
|
)
|
|
$
|
(4,320
|
)
|
|
$
|
(1,977
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share:
|
|
$
|
(0.15
|
)
|
|
$
|
(0.03
|
)
|
|
$
|
(0.24
|
)
|
|
$
|
(0.11
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
|
18,480
|
|
|
|
18,262
|
|
|
|
18,363
|
|
|
|
18,262
|
|
|
|
|
|
|
|
|
|
|
PSIVIDA CORP. AND SUBSIDIARIES |
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
|
(Unaudited) |
|
(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
June 30, |
|
|
|
|
|
2010 |
|
2009 |
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
3,971
|
|
|
$
|
6,899
|
|
|
|
Other current assets
|
|
|
1,161
|
|
|
|
1,228
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
5,132
|
|
|
|
8,127
|
|
|
Intangible assets, net
|
|
|
24,674
|
|
|
|
28,802
|
|
|
Other assets
|
|
|
112
|
|
|
|
175
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$
|
29,918
|
|
|
$
|
37,104
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
$
|
1,520
|
|
|
$
|
1,836
|
|
|
|
Deferred revenue
|
|
|
79
|
|
|
|
5,912
|
|
|
|
Derivative liabilities
|
|
|
2,181
|
|
|
|
971
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
3,780
|
|
|
|
8,719
|
|
|
Deferred revenue
|
|
|
6,337
|
|
|
|
4,622
|
|
|
Deferred tax liabilities
|
|
|
222
|
|
|
|
222
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
10,339
|
|
|
|
13,563
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
Capital
|
|
|
250,422
|
|
|
|
248,518
|
|
|
|
Accumulated deficit
|
|
|
(231,368
|
)
|
|
|
(227,048
|
)
|
|
|
Accumulated other comprehensive income
|
|
|
525
|
|
|
|
2,071
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders' equity
|
|
|
19,579
|
|
|
|
23,541
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
|
$
|
29,918
|
|
|
$
|
37,104
|
|

SOURCE: pSivida Corp.
US:
Beverly Jedynak, President, Martin E. Janis & Company, Inc.
312-943-1123
bjedynak@janispr.com
or
Australia:
Brian Leedman, Vice President, Investor Relations, pSivida corp.
+61 8 9227 8327
brianl@psivida.com