pSivida Corp. Reports Second Quarter Fiscal Year 2013 Results

  pSivida Corp. Reports Second Quarter Fiscal Year 2013 Results

Business Wire

WATERTOWN, Mass. -- February 6, 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 second quarter ended December 31,
2012.

“We are pleased with the progress of our lead development product, an
injectable micro-insert for posterior uveitis. We expect to begin Phase III
trials early next quarter on schedule,” said Dr. Paul Ashton, President and
CEO. “We intend these trials to form the basis for a future NDA submission and
are excited about the role this product could play in treating this serious,
underserved disease. The investigator-sponsored Phase II clinical study of
this micro-insert in this disease has completed enrollment ahead of schedule
and has been expanded to allow the treatment of more patients.”

“Because our posterior uveitis product uses the same micro-insert as ILUVIEN®,
which has received marketing authorizations in various EU countries for
chronic diabetic macular edema (DME) considered insufficiently responsive to
available therapies, and delivers the same drug as our surgically implanted
Retisert® product already approved for posterior uveitis, we expect our Phase
III trials will show efficacy similar to Retisert but with a side-effect
profile in uveitis patients comparable to that seen in DME patients. We are
optimistic therefore that our micro-insert will be efficacious for posterior
uveitis, but with fewer side effects and a favorable risk/benefit profile
compared to Retisert,” continued Dr. Ashton. “The U.S. Food and Drug
Admnistration’s (FDA) decision to allow us to reference much of the ILUVIEN
data for DME, including the clinical safety data, from Alimera Sciences’
already-completed pivotal Phase III clinical trials, has the potential to both
simplify any future NDA submission and to shorten development time. 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.”

“Our pre-clinical studies of applications of Tethadur™, our protein/anti-body
delivery technology platform, continue to progress well. We believe Tethadur
has the potential to provide sustained release of peptides and proteins in
many therapeutic areas, and its 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 injection into the eye every one
or two months.”

Alimera Sciences, pSivida’s licensee for ILUVIEN for DME, has announced plans
for a direct commercial launch in three EU countries in 2013, with Germany
expected in the first quarter, and the United Kingdom and France later in the
year. ILUVIEN has received marketing authorization in the United Kingdom,
Austria, Portugal, France, Germany and Spain, and has been recommended for
marketing authorization in Italy, for the treatment of vision impairment
associated with chronic DME considered insufficiently responsive to available
therapies. Alimera has estimated that there are approximately one million
people suffering from DME in the 7 EU countries where marketing authorization
has either been received or recommended. pSivida is entitled to receive 20% of
net profits, as defined, on a country-by-country basis from sales of ILUVIEN
by Alimera.

Alimera has also reported that, based on a June 2012 meeting with the FDA, it
intends to respond in the first quarter of 2013 to issues raised by the FDA in
its Complete Response Letter using data from Alimera’s two previously
completed pivotal Phase III clinical trials, focusing on the population of
patients with chronic DME, the same indication for which marketing approval
for ILUVIEN has been granted in various EU countries. 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.

Revenues for the fiscal 2013 second quarter were $585,000 compared to $630,000
for the second quarter last year. The Company reported a net loss of $2.6
million, or $0.11 per share, for the second quarter ended December 31, 2012,
compared to a net loss of $17.5 million, or $0.84 per share, for the second
quarter 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.

Revenues for the six months ended December 31, 2012 totaled $1.1 million
compared to $2.3 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 $5.2 million, or
$0.23 per share, for the six months ended December 31, 2012, compared to a net
loss of $19.9 million, or $0.96 per share, for the same period of the prior
year.

At December 31, 2012, cash, cash equivalents and marketable securities totaled
$15.7 million compared to $17.6 million at September 30, 2012.

Today’s Conference Call Reminder

pSivida Corp. will host a live webcast and conference call today, February 6,
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 February 13, 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 95328173.

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
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: uncertainties with respect to: Alimera’s ability to finance,
achieve additional marketing approvals, successfully commercialize and achieve
market acceptance of, and generate revenues to pSivida from, ILUVIEN for DME
in the EU; Alimera’s resubmission of its NDA for ILUVIEN for DME and its
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 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;
initiation and completion of clinical trials and obtaining regulatory approval
of product candidates; 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           Six Months Ended
                         December 31,                 December 31,
                                                                   
                         2012         2011            2012         2011
                                                                   
  Revenues:
      Collaborative
      research and       $ 195        $ 204           $ 364        $ 1,665
      development
      Royalty income      390        426           774        624     
                                                                   
           Total          585        630           1,138      2,289   
           revenues
                                                                   
  Operating expenses:
      Research and         1,575        1,992           3,098        4,121
      development
      General and          1,658        1,451           3,278        3,512
      administrative
      Impairment of
      intangible          -          14,830        -          14,830  
      assets
                                                                   
           Total
           operating      3,233      18,273        6,376      22,463  
           expenses
                                                                   
  Loss from operations    (2,648 )    (17,643 )      (5,238 )    (20,174 )
                                                                   
  Other income
  (expense):
      Change in fair
      value of             -            128             -            170
      derivatives
      Interest income      4            11              11           20
      Other expense,      (1     )    -             (2     )    (2      )
      net
                                                                   
           Total other    3          139           9          188     
           income
                                                                   
  Loss before income       (2,645 )     (17,504 )       (5,229 )     (19,986 )
  taxes
  Income tax benefit      37         44            70         99      
                                                                   
  Net loss               $ (2,608 )   $ (17,460 )     $ (5,159 )   $ (19,887 )
                                                                   
  Net loss per share:
      Basic and          $ (0.11  )   $ (0.84   )     $ (0.23  )   $ (0.96   )
      diluted
                                                                   
  Weighted average
  common shares
  outstanding:
      Basic and           23,297     20,803        22,795     20,780  
      diluted

                                                               
  PSIVIDA CORP. AND SUBSIDIARIES
  CONDENSED CONSOLIDATED BALANCE SHEETS
  (Unaudited)
  (In thousands)
       
                                                   December 31,   June 30,
                                                   2012           2012
                                                                  
  Assets
  Current assets:
        Cash, cash equivalents and marketable      $ 15,720       $ 14,571
        securities
        Other current assets                        1,090        1,388    
                                                                  
  Total current assets                               16,810         15,959
  Intangible assets, net                             3,883          4,226
  Other assets                                      349          412      
                                                                  
  Total assets                                     $ 21,042      $ 20,597   
                                                                  
  Liabilities and stockholders' equity
  Current liabilities:
        Accounts payable and accrued expenses      $ 1,299        $ 1,002
        Deferred revenue                            784          2,176    
                                                                  
  Total current liabilities                          2,083          3,178
  Deferred revenue                                  5,149        3,783    
                                                                  
  Total liabilities                                 7,232        6,961    
                                                                  
  Stockholders' equity:
        Capital                                      269,726        264,452
        Accumulated deficit                          (256,917 )     (251,758 )
        Accumulated other comprehensive income      1,001        942      
                                                                  
  Total stockholders' equity                        13,810       13,636   
                                                                  
  Total liabilities and stockholders' equity       $ 21,042      $ 20,597   

Contact:

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