pSivida Corp. Reports Third Quarter 2014 Results

  pSivida Corp. Reports Third Quarter 2014 Results

 Now Plans to Seek US approval of Medidur for Posterior Uveitis Based on One
                               Phase III Trial

Business Wire

WATERTOWN, Mass. -- May 13, 2014

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 third quarter ended March 31, 2014.

The Company now plans to seek U.S. approval for its lead development product,
Medidur™ for posterior uveitis, based on data from one Phase III trial, with
supplemental clinical data about the Company’s proprietary inserter if
ILUVIEN® for chronic diabetic macular edema (DME) is approved by the U.S. Food
and Drug Administration (FDA). The Phase III trial has already begun, and
enrollment is continuing. Medidur uses the same injectable sustained release
micro-insert delivering the same dosage of the same drug as ILUVIEN, and
pSivida will be able to reference the ILUVIEN New Drug Application (NDA)
(including data from ILUVIEN’s clinical trials) in a Medidur NDA. Posterior
uveitis, an inflammatory disease of one of the inner lining the eye, affects
approximately 175,000 people in the U.S., and is the third largest cause of

“Our revised regulatory strategy for Medidur has the potential to
significantly accelerate U.S. commercial availability and reduce overall
development costs. We remain optimistic that the FDA will approve ILUVIEN,
which we believe will permit us to seek U.S. approval with data from a single
Phase III trial for Medidur along with clinical data about our proprietary
inserter. We plan to have a confirmatory meeting with the FDA with respect to
our regulatory strategy as more data become available,” said Dr. Paul Ashton,
President and CEO of pSivida .

The Company recently presented the first peer-reviewed, in-vitro data for
Tethadur™, pSivida’s technology designed to provide sustained delivery of
peptides, proteins and antibodies, demonstrating sustained delivery of Avastin
with Tethadur. The study concluded that the release rate of antibodies such as
Avastin is controllable over a wide range by adjusting the pore size and
surface area of Tethadur. The Company plans to report the results of
additional pre-clinical studies of Tethadur later in calendar 2014,
potentially positioning the Company to file an Investigatory New Drug
Application (IND).

“We are pleased with our studies of Tethadur to deliver biologics on a
sustained basis and see exciting opportunities for potential products,”
continued Dr. Ashton. The Company is studying a number of applications of
Tethadur to provide sustained delivery of biologics both systemically and
directly to the back of the eye. A leading global biopharmaceutical company is
evaluating the use of Tethadur in certain ophthalmic applications.

The NDA has been refiled for the Company’s lead licensed product, ILUVIEN for
chronic DME, and the FDA has set a Prescription Drug User Fee Act (PDUFA) goal
date of September 26, 2014. The resubmission responded to questions raised in
the FDA's October 2013 complete response letter, provided a safety update,
which included commercial experience with ILUVIEN in Europe, and addressed
deficiencies noted in the methods and controls used for the drug product at
the facility where ILUVIEN is manufactured. The Company’s licensee, Alimera
Sciences, entered into labeling discussions with the FDA.

ILUVIEN is commercially available to treat chronic DME insufficiently
responsive to available therapies in the U.K. and Germany and is expected to
be available in France in 2014. Following favorable regulatory action, ILUVIEN
is now covered for National Heath Service (NHS) patients with pseudophakic
eyes (those that have had cataract surgery) in the U.K. and Scotland, subject
to simple patient access schemes. ILUVIEN has marketing approvals in four
additional EU countries and Alimera has filed for approval in eleven more EU

Alimera recently entered into an exclusive agreement with Specialised
Therapeutics Australia (STA) for the distribution of ILUVIEN in Australia and
New Zealand. STA is responsible for regulatory and commercial matters,
including marketing approval and reimbursement, in those countries.

“We are very pleased that the outlook for ILUVIEN has continued to brighten.
Alimera has secured reimbursement in the U.K. and continued to expand
ILUVIEN’s geographic sales potential. We are particularly pleased with the
refiled NDA, the new PDUFA date of September 26, 2014 and labeling discussions
in the U.S.,” said Dr. Ashton. “We are entitled to a $25 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.” Alimera recently entered into
a loan agreement that provides for a $25 million advance to pay the milestone
if ILUVIEN is approved by the FDA on or before October 31, 2014 and certain
other conditions are met.

Revenues for the quarter ended March 31, 2014 totaled $2.0 million compared to
$513,000 for the prior year period, reflecting recognition in this year’s
quarter of $1.5 million under a completed feasibility study agreement.

Net loss for the quarter ended March 31, 2014 was $2.2 million, or $0.08 per
share, compared to a net loss of $2.8 million, or $0.12 per share, for the
prior year quarter. The reduced net loss in the third quarter of fiscal 2014
primarily reflected the recognition of revenues in the fiscal 2014 third
quarter noted above, partially offset by costs in the quarter associated with
the Phase III clinical trial of Medidur for posterior uveitis, which had not
commenced in last year’s third quarter.

Revenues for the nine months ended March 31, 2014 totaled $3.2 million
compared to $1.7 million for the nine months ended March 31, 2013. The Company
reported a net loss of $9.4 million, or $0.35 per share, for the nine months
ended March 31, 2014, compared to a net loss of $8.0 million, or $0.35 per
share, for the same period of the prior year.

At March 31, 2014, cash, cash equivalents and marketable securities totaled
$21.3 million compared to $15.7 million at December 31, 2013, primarily
reflecting approximately $6.9 million received from a March 2014 registered
direct offering of common stock.

Today’s Conference Call Reminder

pSivida Corp. will host a live webcast and conference call today, May 13,
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 A replay of the call will be available approximately two
hours following the end of the call through May 20, 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 40618782.

About the Clinical Trials

pSivida has initiated a Phase III trial of Medidur for the treatment of
posterior uveitis. If ILUVIEN for DME is approved by the FDA, pSivida plans to
seek US approval of Medidur based on this trial and additional clinical data
about pSivida’s proprietary inserter. The ongoing Phase III trial is expected
to enroll approximately 120 patients. The primary end point is the recurrence
of uveitis within 12 months. pSivida will be permitted to reference much of
the data, including the clinical safety data, from the clinical trials of
ILUVIEN for chronic DME. If ILUVIEN is not approved by the FDA, the Company
plans to file for FDA approval as originally planned.

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™. The injectable, sustained release micro-insert ILUVIEN®
for the treatment of chronic DME considered insufficiently responsive to
available therapies, licensed to Alimera Sciences, Inc., is marketed in the
U.K. and Germany and has also received marketing authorization in Austria,
France, Portugal, and Spain and is awaiting authorization in Italy. Alimera
has filed for ten additional EU country approvals through the Mutual
Recognition Procedure. Alimera resubmitted its NDA for ILUVIEN in March 2014
and the FDA has set a PDUFA goal date of September 26, 2014. pSivida has
instituted a Phase III clinical trial of Medidur™ for the treatment of
posterior uveitis, a chronic back-of-the-eye disease, which uses the same
micro-insert as ILUVIEN. An investigator-sponsored clinical trial is ongoing
for an injectable, bioerodible micro-insert to treat glaucoma and ocular
hypertension, a product candidate on which Pfizer Inc. has an option.
pSivida's FDA-approved Retisert®, licensed to Bausch & Lomb Incorporated,
provides long-term, sustained drug delivery to treat posterior uveitis.

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 support an NDA for Medidur; 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.; the ability to finance, complete
and achieve a successful outcome for Phase III trials for, and file and
achieve marketing approvals for, Medidur for posterior uveitis, including
achieving acceptable risk-to-benefit and safety profiles in light of the CRL
for ILUVIEN; initiation, financing and success of Latanoprost Product Phase II
trials and any exercise by Pfizer of its option; 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.

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(In thousands, except per share amounts)
                           Three Months Ended          Nine Months Ended
                           March 31,                   March 31,
                           2014         2013           2014         2013
Collaborative research     $ 1,676      $ 239          $ 2,149      $ 603
and development
Royalty income               316          274            1,032        1,048
Total revenues              1,992      513          3,181      1,651  
Operating expenses:
Research and development     2,269        1,587          7,267        4,685
General and                  1,946        1,738          5,468        5,016
Gain on sale of property     (4     )     -              (76    )     -
and equipment
Total operating expenses    4,211      3,325        12,659     9,701  
Loss from operations        (2,219 )    (2,812 )      (9,478 )    (8,050 )
Other income (expense),
Interest income              1            3              3            14
Other expense, net           -            -              -            (2     )
Total other income          1          3            3          12     
Loss before income taxes     (2,218 )     (2,809 )       (9,475 )     (8,038 )
Income tax benefit           31           15             87           85
Net loss                   $ (2,187 )   $ (2,794 )     $ (9,388 )   $ (7,953 )
Net loss per share:
Basic and diluted          $ (0.08  )   $ (0.12  )     $ (0.35  )   $ (0.35  )
Weighted average common
shares outstanding:
Basic and diluted           27,672     23,297       26,842     22,960 

(In thousands)
                                                   March 31,      June 30,
                                                   2014           2013
Current assets:
Cash, cash equivalents and marketable securities   $ 21,267       $ 10,273
Other current assets                                 1,195          2,191
Total current assets                                 22,462         12,464
Intangible assets, net                               2,940          3,430
Other assets                                         619            355
Total assets                                       $ 26,021      $ 16,249   
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued expenses              $ 1,964        $ 2,565
Deferred revenue                                     312            738
Total current liabilities                            2,276          3,303
Deferred revenue                                     5,388          5,246
Deferred rent                                        11             -
Total liabilities                                   7,675        8,549    
Stockholders' equity:
Capital                                              290,373        270,438
Accumulated deficit                                  (273,046 )     (263,658 )
Accumulated other comprehensive income               1,019          920
Total stockholders' equity                          18,346       7,700    
Total liabilities and stockholders' equity         $ 26,021      $ 16,249   


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