WATERTOWN, Mass.--(BUSINESS WIRE)--
pSivida Corp. (NASDAQ: PSDV, ASX: PVA), a leader in the development of
sustained release, drug delivery products for treating eye diseases,
today announced financial results for its fourth quarter and fiscal year
ended June 30, 2014.
Advancing its strategy of becoming a specialty-pharma company, pSivida
continued enrollment of the Phase III trial for its lead product
candidate, Medidur™ for posterior uveitis, the third largest cause of
blindness in the U.S. The Company expects to complete enrollment by the
end of calendar Q1 2015. In a revised regulatory strategy, the Company
plans to seek U.S. approval for Medidur based on data from a single,
rather than two, Phase III trial, together with supplemental clinical
data on its proprietary inserter. Medidur uses the same injectable,
sustained-release micro-insert as ILUVIEN® for diabetic macular edema
(DME). The FDA has agreed that pSivida can use much of the data,
including clinical safety data, from the completed ILUVIEN Phase III
trials to support an application for Medidur.
"Our revised regulatory strategy for Medidur has the potential to
significantly accelerate the timing of approval of Medidur, reducing
overall development costs and advancing U.S. commercial availability. We
plan to meet with the FDA to confirm our strategy. Because Medidur
delivers the same drug as both ILUVIEN and Retisert® (our partnered,
FDA-approved insert for the treatment of posterior uveitis) but in the
lower dose delivered by ILUVIEN, we are optimistic that Medidur will
show efficacy comparable to Retisert, but with the more favorable
risk/benefit profile and decreased side effects of ILUVIEN," said Dr.
Paul Ashton, Ph.D., President and CEO of pSivida. "Interim data from an
investigator-sponsored study reported earlier supported this view.
Medidur would be our fourth approved product based on our Durasert™
platform technology."
The Company also continued to advance the pre-clinical development of
Tethadur™, its platform technology designed to provide sustained
delivery of peptides and proteins (including antibodies). The first
peer-reviewed, in-vitro data for Tethadur presented earlier this year
demonstrated the sustained delivery of Avastin® and the ability of
Tethadur to provide a wide range of antibody release rates.
"We are pleased with our studies of Tethadur to deliver biologics on a
sustained basis. We believe that our ability to control release rate by
varying the pore size and surface area of Tethadur could permit
sustained delivery of antibodies that currently must be delivered by
frequent injection," continued Dr. Ashton. "We see exciting
opportunities, alone and in conjunction with Durasert, to provide
sustained delivery of biologics, both directly to the target area to
treat conditions such wet and dry age-related macular degeneration (AMD)
and osteoarthritis, and on a systemic basis. We plan to report the
results of additional pre-clinical studies of Tethadur later in calendar
2014, which could be the basis for our first Investigatory New Drug
Application (IND) using Tethadur."
"We are very optimistic for our lead partnered product, ILUVIEN for DME.
The New Drug Application (NDA) was refiled earlier this year, with a
resulting Prescription Drug User Fee Act (PDUFA) goal date of September
26, 2014. Our licensee, Alimera Sciences, entered into labeling
discussions with the FDA, and we await the FDA's decision with
anticipation. We are entitled to a $25.0 million milestone payment if
ILUVIEN is approved by the FDA and 20% of any net profits from sales by
Alimera on a country-by-country basis."
"In Europe, ILUVIEN's geographic footprint continues to expand," noted
Dr. Ashton. ILUVIEN has now been approved in ten EU countries for the
treatment of chronic DME insufficiently responsive to available
therapies, and approval is pending in seven others. Alimera is selling
ILUVIEN in the U.K. and Germany and expects to launch in France and
Portugal in late 2014. ILUVIEN's sales in the U.K. and Scotland
responded favorably to regulatory action earlier this year making
ILUVIEN available through the National Heath Service (NHS) to patients
who have had cataract surgery. In addition, Australia and New Zealand
were added to ILUVIEN's potential reach with the execution of an
exclusive regulatory and distribution agreement for those countries.
"We enhanced our liquidity in the last fiscal year with the sale of
common stock, ending the year with $18.3 million," concluded Dr. Ashton.
Revenues for the year ended June 30, 2014 totaled $3.5 million compared
to $2.1 million for the prior fiscal year. The increase was primarily
attributable to recognition of $1.5 million of consideration from a
feasibility study agreement upon resolution of a contingency.
Operating expenses for the year ended June 30, 2014 totaled $17.0
million compared to $14.2 million for the year ended June 30, 2013. The
increase was principally due to research and development costs of the
Medidur Phase III clinical trial that commenced in the quarter ended
June 30, 2013.
Net loss for the year ended June 30, 2014 was $13.4 million, or $0.49
per share, compared to a net loss of $11.9 million, or $0.52 per share,
for the prior fiscal year.
Revenues for the quarter ended June 30, 2014 totaled $292,000 compared
to $492,000 for the quarter a year earlier. The Company reported a net
loss of $4.0 million, or $0.14 per share, for the quarter ended June 30,
2014, compared to a net loss of $3.9 million, or $0.17 per share, for
the same period of the prior year.
At June 30, 2014, cash, cash equivalents and marketable securities
totaled $18.3 million compared to $10.3 million at the same time last
year.
Today's Conference Call Reminder
pSivida Corp. will host a live webcast and conference call today,
September 9, 2014, at 4:30 pm ET. The conference call may be accessed by
dialing (877) 312-7507 from the U.S. and Canada, or (631) 813-4828 from
international locations. 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 September 16, 2014. The replay may be
accessed by dialing (855) 859-2056 within the U.S. and Canada or (404)
537-3406 from international locations, Conference ID number 97522257.
About pSivida Corp.
pSivida Corp., headquartered in Watertown, MA, is a leader in the
development of sustained release, drug delivery products for treating
eye diseases. pSivida is currently focused on treatment of chronic
diseases of the back of the eye utilizing its core technology systems,
Durasert™ and BioSilicon™, including Tethadur™. pSivida has instituted a
pivotal Phase III clinical trial of its lead product candidate, Medidur™
for treatment of the chronic, back-of-the-eye disease posterior uveitis.
Medidur uses the same injectable, sustained release micro-insert as
pSivida's lead licensed product, ILUVIEN® for the treatment of DME,
licensed to Alimera Sciences, Inc. ILUVIEN is marketed in the U.K. and
Germany, has also received marketing authorization in eight other EU
countries and is pending approval in seven more EU countries under the
Mutual Recognition Procedure, for the treatment of chronic DME
considered insufficiently responsive to available therapies. ILUVIEN for
DME is currently under review by the FDA with a PDUFA goal date of
September 26, 2014. pSivida's FDA-approved Retisert®, an implant which
provides long-term, sustained drug delivery to treat posterior uveitis,
is licensed to and sold by Bausch & Lomb Incorporated. pSivida's
pre-clinical research is focused on ocular and systemic delivery of
biologics and treatment of wet and dry age-related macular degeneration,
osteoarthritis and glaucoma.
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: the number of clinical trials necessary to seek FDA
approval for Medidur for posterior uveitis, which may depend on whether
or not the FDA approves ILUVIEN, and outcome of the clinical trial(s);
Alimera's ability to finance, achieve additional marketing approvals,
obtain adequate pricing and reimbursement for, successfully
commercialize and achieve market acceptance of, and generate revenues to
pSivida from, ILUVIEN for chronic DME in the EU; Alimera's 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.;
Alimera's ability to pay the $25.0 million milestone due upon FDA
approval; our ability to finance, complete and achieve a successful
outcome for clinical trials for, and file and achieve marketing
approvals for, Medidur, including achieving acceptable risk-to-benefit
and safety profiles in light of the CRL for ILUVIEN; ability of Tethadur
to successfully deliver proteins, peptides and other large biologic
molecules; ability to develop product candidates and products and
potential related collaborations; initiation and completion of clinical
trials and obtaining regulatory approval of product candidates;
continued sales of Retisert; adverse side effects; ability to attain
profitability; ability to obtain additional capital; further impairment
of intangible assets; fluctuations in operating results; decline in
royalty income; 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; absence of dividends; and other factors
described in our filings with the SEC. Given these uncertainties,
readers are cautioned not to place undue reliance on such
forward-looking statements. Should known or unknown risks materialize,
or should underlying assumptions prove inaccurate, actual results could
differ materially from past results and those anticipated, estimated or
projected in the 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.
Follow pSivida on social media:
Twitter: https://twitter.com/pSividaCorp
Facebook: https://www.facebook.com/pages/PSivida-Corp/544893792199562
LinkedIn: http://www.linkedin.com/company/psivida
Google+: https://plus.google.com/u/0/b/113754643626984244726/113754643626984244726/posts
The President's Blog: http://www.thechairmansblog.com/paul-ashton
For more information on pSivida, visit www.psivida.com.
PSIVIDA CORP. AND SUBSIDIARIES
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
(Unaudited)
|
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Year Ended
|
|
|
June 30,
|
|
|
June 30,
|
|
|
2014
|
|
2013
|
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Collaborative research and development
|
|
$
|
6
|
|
|
$
|
177
|
|
|
|
$
|
2,155
|
|
|
$
|
780
|
|
Royalty income
|
|
|
286
|
|
|
|
315
|
|
|
|
|
1,318
|
|
|
|
1,363
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
292
|
|
|
|
492
|
|
|
|
|
3,473
|
|
|
|
2,143
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
2,306
|
|
|
|
2,320
|
|
|
|
|
9,573
|
|
|
|
7,005
|
|
General and administrative
|
|
|
2,000
|
|
|
|
2,153
|
|
|
|
|
7,468
|
|
|
|
7,169
|
|
Gain on sale of property and equipment
|
|
|
(2
|
)
|
|
|
-
|
|
|
|
|
(78
|
)
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
4,304
|
|
|
|
4,473
|
|
|
|
|
16,963
|
|
|
|
14,174
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(4,012
|
)
|
|
|
(3,981
|
)
|
|
|
|
(13,490
|
)
|
|
|
(12,031
|
)
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net:
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
3
|
|
|
|
2
|
|
|
|
|
6
|
|
|
|
16
|
|
Other expense, net
|
|
|
(1
|
)
|
|
|
-
|
|
|
|
|
(1
|
)
|
|
|
(2
|
)
|
|
|
|
|
|
|
|
|
|
|
Total other income
|
|
|
2
|
|
|
|
2
|
|
|
|
|
5
|
|
|
|
14
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
(4,010
|
)
|
|
|
(3,979
|
)
|
|
|
|
(13,485
|
)
|
|
|
(12,017
|
)
|
Income tax benefit
|
|
|
43
|
|
|
|
32
|
|
|
|
|
130
|
|
|
|
117
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(3,967
|
)
|
|
$
|
(3,947
|
)
|
|
|
$
|
(13,355
|
)
|
|
$
|
(11,900
|
)
|
|
|
|
|
|
|
|
|
|
|
Net loss per share:
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$
|
(0.14
|
)
|
|
$
|
(0.17
|
)
|
|
|
$
|
(0.49
|
)
|
|
$
|
(0.52
|
)
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
|
29,256
|
|
|
|
23,297
|
|
|
|
|
27,444
|
|
|
|
23,044
|
|
PSIVIDA CORP. AND SUBSIDIARIES
|
CONDENSED CONSOLIDATED BALANCE SHEETS
|
(Unaudited)
|
(In thousands)
|
|
|
|
|
|
|
|
June 30,
|
|
June 30,
|
|
|
2014
|
|
2013
|
Assets
|
|
|
|
|
Current assets:
|
|
|
|
|
Cash, cash equivalents and marketable securities
|
|
$
|
18,278
|
|
|
$
|
10,273
|
|
Other current assets
|
|
|
1,064
|
|
|
|
2,191
|
|
|
|
|
|
|
Total current assets
|
|
|
19,342
|
|
|
|
12,464
|
|
Intangible assets, net
|
|
|
2,765
|
|
|
|
3,430
|
|
Other assets
|
|
|
564
|
|
|
|
355
|
|
|
|
|
|
|
Total assets
|
|
$
|
22,671
|
|
|
$
|
16,249
|
|
|
|
|
|
|
Liabilities and stockholders' equity
|
|
|
|
|
Current liabilities:
|
|
|
|
|
Accounts payable and accrued expenses
|
|
$
|
1,988
|
|
|
$
|
2,565
|
|
Deferred revenue
|
|
|
138
|
|
|
|
738
|
|
|
|
|
|
|
Total current liabilities
|
|
|
2,126
|
|
|
|
3,303
|
|
Deferred revenue, less current portion
|
|
|
5,584
|
|
|
|
5,246
|
|
Deferred rent
|
|
|
37
|
|
|
|
-
|
|
|
|
|
|
|
Total liabilities
|
|
|
7,747
|
|
|
|
8,549
|
|
|
|
|
|
|
Stockholders' equity:
|
|
|
|
|
Capital
|
|
|
290,893
|
|
|
|
270,438
|
|
Accumulated deficit
|
|
|
(277,013
|
)
|
|
|
(263,658
|
)
|
Accumulated other comprehensive income
|
|
|
1,044
|
|
|
|
920
|
|
|
|
|
|
|
Total stockholders' equity
|
|
|
14,924
|
|
|
|
7,700
|
|
|
|
|
|
|
Total liabilities and stockholders' equity
|
|
$
|
22,671
|
|
|
$
|
16,249
|
|
Martin E. Janis & Company, Inc.
Beverly Jedynak
President
+1-312-943-1123
M:
+1-773-350-5793
bjedynak@janispr.com
Source: pSivida Corp.
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