pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in developing
sustained release, drug delivery products for treatment of
back-of-the-eye diseases, today announced financial results for its
second quarter ended December 31, 2011.
At December 31, 2011, cash, cash equivalents and marketable securities
totaled $18.7 million compared to $21.3 million at September 30, 2011.
“We are continuing to advance our clinical stage product pipeline," said
Paul Ashton, President and CEO. “Although we were extremely disappointed
by the recent FDA action, ILUVIEN® for DME is currently at an advanced
stage in the European approval process, with Alimera reporting that a
decision is expected in the first half of 2012. We are also continuing
to progress development of our inserts to treat uveitis affecting the
posterior segment of the eye and to treat glaucoma and ocular
hypertension.”
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 the United States, posterior uveitis has been estimated to
affect approximately 175,000 people and to be responsible for
approximately 30,000 cases of blindness. An investigator-sponsored trial
for the insert for posterior uveitis opened in September 2011.
The Company’s proposed glaucoma and ocular hypertension 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 also pleased with the progress being made in our pre-clinical
programs and our technology evaluations,” said Dr. Ashton. “Our
Tethadur™ system (based on BioSilicon technology) designed to deliver
large biologic molecules, including peptides and proteins, on a
sustained basis continues to advance, as does the evaluation of our
Durasert™ technology in orthopedic applications. Additionally, in
November 2011, we signed a funded technology evaluation agreement with a
leading global pharmaceutical company to evaluate our bioerodible
Durasert drug delivery technology in ophthalmology.”
Revenues for the second quarter were $630,000 compared to $414,000 a
year earlier, primarily reflecting recognition of deferred collaborative
research and development revenues from the June 2011 amended and
restated Pfizer agreement and increased Retisert® royalty income. As a
result of the November 2011 complete response letter issued by the FDA
in response to Alimera’s resubmitted new drug application for ILUVIEN
for DME and the significant decrease of the Company’s share price at
December 31, 2011, the Company recorded a charge of $14.8 million for
the impairment of its finite-lived intangible assets in the quarter. The
Company reported a net loss of $17.5 million, or $0.84 per share, for
the second quarter ended December 31, 2011 compared to a net loss of
$2.7 million, or $0.15 per share, for the second quarter of the prior
year.
Revenues for the six months ended December 31, 2011 totaled $2.3 million
compared to $890,000 for the prior year period, primarily reflecting
recognition of deferred collaborative research and development revenues
from a terminated 2008 field-of-use license and from the restated Pfizer
agreement. The Company reported a net loss of $19.9 million, or $0.96
per share, for the six months ended December 31, 2011 compared to a net
loss of $5.8 million, or $0.31 per share, for the same period of the
prior year.
Today’s Conference Call Reminder
pSivida Corp. will host a live webcast and conference call today,
February 8, 2012, at 4:30 pm ET. The conference call may be accessed by
dialing (866) 383-8003 from the U.S. and Canada, or (617) 597-5330 from
international locations, passcode 28830453. 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 15, 2012. The replay may be
accessed by dialing (888) 286-8010 within the U.S. and Canada or (617)
801-6888 from international locations, passcode 58641406.
About pSivida Corp.
pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained
release, drug delivery products designed to deliver drugs at a
controlled and steady rate for months or years. pSivida is currently
focused on treatment of chronic diseases of the back of the eye
utilizing its core technology systems, Durasert™ and BioSilicon™.
ILUVIEN® for the treatment of Diabetic Macular Edema (DME), which is
licensed to Alimera Sciences Inc., is pSivida’s most advanced product
candidate and is currently under review by the Medicines and Healthcare
products Regulatory Agency in the U.K. and six other EU country
regulatory authorities under the decentralized procedure. An
investigator-sponsored Investigational New Drug application opened for
an injectable insert to treat posterior uveitis of the same design as
ILUVIEN for DME, and an investigator-sponsored trial is ongoing for an
injectable, bioerodible insert to treat glaucoma and ocular
hypertension. pSivida’s two FDA-approved products, Retisert® and
Vitrasert®, are implants that provide long-term, sustained drug delivery
to treat two other chronic diseases of the retina.
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
ILUVIEN for DME in the EU; 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 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 | | | Six Months Ended |
| | December 31, | | | December 31, |
| | | | | | | | |
|
| | 2011 | | 2010 | | | 2011 | | 2010 |
| | | | | | | | |
|
|
Revenues:
| | | | | | | | | |
|
Collaborative research and development
| |
$
|
204
| | |
$
|
88
| | | |
$
|
1,665
| | |
$
|
162
| |
|
Royalty income
| | |
426
| | | |
326
| | | | |
624
| | | |
728
| |
| |
| |
| | |
| |
|
| | | | | | | | |
|
|
Total revenues
| |
|
630
|
| |
|
414
|
| | |
|
2,289
|
| |
|
890
|
|
| | | | | | | | |
|
|
Operating expenses:
| | | | | | | | | |
|
Research and development
| | |
1,992
| | | |
1,534
| | | | |
4,121
| | | |
3,276
| |
|
General and administrative
| | |
1,451
| | | |
2,001
| | | | |
3,512
| | | |
4,170
| |
|
Impairment of intangible assets
| | |
14,830
| | | |
-
| | | | |
14,830
| | | |
-
| |
| |
| |
| | |
| |
|
| | | | | | | | |
|
|
Total operating expenses
| |
|
18,273
|
| |
|
3,535
|
| | |
|
22,463
|
| |
|
7,446
|
|
| | | | | | | | |
|
|
Loss from operations
| |
|
(17,643
|
)
| |
|
(3,121
|
)
| | |
|
(20,174
|
)
| |
|
(6,556
|
)
|
| | | | | | | | |
|
|
Other income (expense):
| | | | | | | | | |
|
Change in fair value of derivatives
| | |
128
| | | |
458
| | | | |
170
| | | |
796
| |
|
Interest income
| | |
11
| | | |
6
| | | | |
20
| | | |
12
| |
|
Other expense, net
| | |
-
| | | |
(3
|
)
| | | |
(2
|
)
| | |
(11
|
)
|
| |
| |
| | |
| |
|
| | | | | | | | |
|
|
Total other income
| |
|
139
|
| |
|
461
|
| | |
|
188
|
| |
|
797
|
|
| | | | | | | | |
|
|
Loss before income taxes
| | |
(17,504
|
)
| | |
(2,660
|
)
| | | |
(19,986
|
)
| | |
(5,759
|
)
|
|
Income tax benefit (expense)
| | |
44
| | | |
(35
|
)
| | | |
99
| | | |
(44
|
)
|
| |
| |
| | |
| |
|
| | | | | | | | |
|
| | | | | | | | |
|
|
Net loss
| |
$
|
(17,460
|
)
| |
$
|
(2,695
|
)
| | |
$
|
(19,887
|
)
| |
$
|
(5,803
|
)
|
| | | | | | | | |
|
|
Net loss per share:
| | | | | | | | | |
|
Basic and diluted
| |
$
|
(0.84
|
)
| |
$
|
(0.15
|
)
| | |
$
|
(0.96
|
)
| |
$
|
(0.31
|
)
|
| | | | | | | | |
|
|
Weighted average common shares outstanding:
| | | | | | | | | |
|
Basic and diluted
| |
|
20,803
|
| |
|
18,531
|
| | |
|
20,780
|
| |
|
18,531
|
|
| | | | | | | | | | | | | | | | |
|
| PSIVIDA CORP. AND SUBSIDIARIES |
| CONDENSED CONSOLIDATED BALANCE SHEETS |
| (Unaudited) |
| (In thousands) |
|
| |
| |
| | December 31, | | June 30, |
| | 2011 | | 2011 |
| | | |
|
| Assets | | | | |
| Current assets: | | | | |
|
Cash, cash equivalents and marketable securities
| |
$
|
18,680
| | |
$
|
24,128
| |
|
Other current assets
| | |
1,173
| | | |
1,238
| |
| |
| |
|
| | | |
|
|
Total current assets
| | |
19,853
| | | |
25,366
| |
|
Intangible assets, net
| | |
4,596
| | | |
21,564
| |
|
Other assets
| | |
499
| | | |
183
| |
| |
| |
|
| | | |
|
| Total assets | |
$
|
24,948
|
| |
$
|
47,113
|
|
| | | |
|
| Liabilities and stockholders' equity | | | | |
| Current liabilities: | | | | |
|
Accounts payable and accrued expenses
| |
$
|
912
| | |
$
|
1,650
| |
|
Deferred revenue
| | |
1,722
| | | |
3,212
| |
|
Derivative liabilities
| | |
-
| | | |
170
| |
| |
| |
|
| | | |
|
|
Total current liabilities
| | |
2,634
| | | |
5,032
| |
|
Deferred revenue
| | |
4,521
| | | |
4,635
| |
|
Deferred tax liabilities
| | |
-
| | | |
13
| |
| |
| |
|
| | | |
|
| Total liabilities | |
|
7,155
|
| |
|
9,680
|
|
| | | |
|
| | | |
|
| Stockholders' equity: | | | | |
|
Capital
| | |
263,683
| | | |
262,927
| |
|
Accumulated deficit
| | |
(246,810
|
)
| | |
(226,923
|
)
|
|
Accumulated other comprehensive income
| | |
920
| | | |
1,429
| |
| |
| |
|
| | | |
|
|
Total stockholders' equity
| |
|
17,793
|
| |
|
37,433
|
|
| | | |
|
| Total liabilities and stockholders' equity | |
$
|
24,948
|
| |
$
|
47,113
|
|
| | | | | | | |
|
