pSivida Corp. Reports Third Quarter Fiscal Year 2013 Results

  pSivida Corp. Reports Third Quarter Fiscal Year 2013 Results

Business Wire

WATERTOWN, Mass. -- May 13, 2013

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 third quarter ended March 31, 2013.

“We are very pleased that the FDA has accepted Alimera Sciences’ recently
resubmitted New Drug Application for ILUVIEN® for chronic Diabetic Macular
Edema (DME) and has set a PDUFA target date of October 17, 2013. Approval in
the U.S. would entitle pSivida to a $25 million milestone payment from Alimera
and 20% of net profits, as defined, from U.S. sales of ILUVIEN by Alimera,”
said Dr. Paul Ashton, President and CEO of pSivida. “Further good news was
Alimera’s recent announcements of the commercial launch of ILUVIEN in Germany
and for private pay and privately insured patients in the U.K. Alimera also
reported that a simple patient access scheme for ILUVIEN is being evaluated by
the UK’s National Institute for Clinical Excellence (NICE), and, if accepted,
ILUVIEN would be funded throughout England and Wales by the National Health
System.”

“Concurrent with these exciting developments for ILUVIEN, we continue to move
forward with our own lead development product, an injectable micro-insert for
posterior uveitis, for which we expect to begin the first Phase III trial
shortly,” said Dr. Ashton. “Because this product uses the same micro-insert as
ILUVIEN for DME, the FDA has agreed that we can use much of the data,
including clinical safety data, from the completed ILUVIEN Phase III trials to
support the application for uveitis. This should shorten and simplify the
regulatory process. We are planning to target enrollment of a total of 300
patients in our two trials, with a primary end point of recurrence of uveitis
at 12 months.”

“We believe that our pre-clinical studies of applications of Tethadur™, our
protein/anti-body delivery technology platform, continue to progress very
well. Tethadur’s use in certain ophthalmic applications is currently being
evaluated under an agreement with a leading global biopharmaceutical company.
A sustained delivery system for proteins and antibodies used in ophthalmic
treatments could offer a significant clinical advantage because current
therapies require an injection into the eye every one or two months.”

“Our recent technology evaluation agreement with another major pharmaceutical
company to evaluate our drug delivery platforms in the ophthalmic space offers
another potential path forward to the development of new products.”

Revenues for the fiscal 2013 third quarter were $513,000 compared to $538,000
for the third quarter last year. The Company reported a net loss of $2.8
million, or $0.12 per share, for the third quarter ended March 31, 2013,
compared to a net loss of $2.7 million, or $0.13 per share, for the third
quarter of the prior year.

Revenues for the nine months ended March 31, 2013 totaled $1.7 million
compared to $2.8 million for the prior year period. Prior year revenues
included $1.1 million of revenue recognition from the termination of a 2008
field-of-use license. The Company reported a net loss of $8.0 million, or
$0.35 per share, for the nine months ended March 31, 2013, compared to a net
loss of $22.6 million, or $1.09 per share, for the same period of the prior
year. The prior year net loss included a $14.8 million impairment write-down
of the Company’s finite-lived intangible assets.

At March 31, 2013, cash, cash equivalents and marketable securities totaled
$13.7 million compared to $15.7 million at December 31, 2012.

Today’s Conference Call Reminder

pSivida Corp. will host a live webcast and conference call today, May 13,
2013, at 4:30 pm ET. The conference call may be accessed by dialing (877)
303-9236 from the U.S. and Canada, or (760) 666-3569 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 May 20, 2013. 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 68825398.

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™. The injectable, sustained release micro-insert
ILUVIEN® for the treatment of chronic Diabetic Macula Edema (DME), licensed to
Alimera Sciences, Inc., has received marketing authorization in Austria,
France, Germany, Portugal, the U.K. and Spain and is awaiting authorization in
Italy. ILUVIEN for DME has not been approved in the US. pSivida plans to
institute pivotal Phase III clinical trials for the treatment of posterior
uveitis with the same micro-insert as ILUVIEN for DME. An
investigator-sponsored clinical trial is ongoing for an injectable,
bioerodible micro-insert to treat glaucoma and ocular hypertension. pSivida's
FDA-approved product, Retisert® for the treatment of posterior uveitis, is
licensed to Bausch & Lomb.

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: Alimera’s ability to finance,
achieve additional marketing approvals, successfully complete pricing and
reimbursement discussions for, commercialize and achieve market acceptance of,
and generate revenues to pSivida from, ILUVIEN for 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.; financing and success
of planned Phase III posterior uveitis trials, including efficacy, side
effects and risk/benefit profile of the posterior uveitis micro-insert;
initiation, financing and success of Latanoprost Product Phase II trials and
exercise by Pfizer of its option; development of products using Tethadur and
BioSilicon and potential collaborations for those products; 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
revenues; 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; possible influence by Pfizer; 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. 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,
                                                                   
                          2013         2012           2013         2012
                                                                   
Revenues:
     Collaborative
     research and         $ 239        $ 158          $ 603        $ 1,823
     development
     Royalty income         274          380            1,048        1,004
                                                                
                                                                   
          Total            513        538          1,651      2,827   
          revenues
                                                                   
Operating expenses:
     Research and           1,587        1,508          4,685        5,629
     development
     General and            1,738        1,757          5,016        5,269
     administrative
     Impairment of          -            -              -            14,830
     intangible assets
                                                                
                                                                   
          Total
          operating        3,325      3,265        9,701      25,728  
          expenses
                                                                   
Loss from operations       (2,812 )    (2,727 )      (8,050 )    (22,901 )
                                                                   
Other income:
     Change in fair
     value of               -            -              -            170
     derivatives
     Interest income        3            10             14           30
     Other income           -            1              (2     )     (1      )
     (expense), net
                                                                
                                                                   
          Total other      3          11           12         199     
          income
                                                                   
Loss before income          (2,809 )     (2,716 )       (8,038 )     (22,702 )
taxes
Income tax benefit          15           30             85           129
                                                                
                                                                   
Net loss                  $ (2,794 )   $ (2,686 )     $ (7,953 )   $ (22,573 )
                                                                   
Net loss per share:
     Basic and diluted    $ (0.12  )   $ (0.13  )     $ (0.35  )   $ (1.09   )
                                                                   
Weighted average common
shares outstanding:
     Basic and diluted     23,297     20,803       22,960     20,787  
                                                                             
                                                                             
                                                                             

PSIVIDA CORP. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands)
                                                             
                                                   March 31,      June 30,
                                                   2013           2012
                                                                  
Assets
Current assets:
  Cash, cash equivalents and marketable            $ 13,697       $ 14,571
  securities
  Other current assets                               1,508          1,388
                                                                 
                                                                  
Total current assets                                 15,205         15,959
Intangible assets, net                               3,619          4,226
Other assets                                         296            412
                                                                 
                                                                  
Total assets                                       $ 19,120      $ 20,597   
                                                                  
Liabilities and stockholders' equity
Current liabilities:
  Accounts payable and accrued expenses            $ 1,792        $ 1,002
  Deferred revenue                                   893            2,176
                                                                 
                                                                  
Total current liabilities                            2,685          3,178
Deferred revenue                                     5,194          3,783
                                                                 
                                                                  
Total liabilities                                   7,879        6,961    
                                                                  
Stockholders' equity:
  Capital                                            270,038        264,452
  Accumulated deficit                                (259,711 )     (251,758 )
  Accumulated other comprehensive income             914            942
                                                                 
                                                                  
Total stockholders' equity                          11,241       13,636   
                                                                  
Total liabilities and stockholders' equity         $ 19,120      $ 20,597   

Contact:

US Public Relations
Martin E. Janis & Company, Inc
Beverly Jedynak
President
+1 (312) 943 1123
bjedynak@janispr.com
or
pSivida Corp.
Brian Leedman
Vice President, Investor Relations
+61 (0) 41 228 1780
brianl@psivida.com
 
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