pSivida Corp. Reports First Quarter Fiscal Year 2013 Results

  pSivida Corp. Reports First Quarter Fiscal Year 2013 Results

Business Wire

WATERTOWN, Mass. -- November 08, 2012

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 first quarter ended September 30,

“We are very pleased that the FDA has cleared us to proceed directly to two
pivotal Phase III clinical trials of our lead development product, an
injectable micro-insert for posterior uveitis,” said Dr. Paul Ashton,
President and CEO. “We intend these trials, which we plan to begin next year,
to form the basis for a future NDA submission. We are also pleased with the
progress and initial results of pre-clinical studies of applications of
Tethadur™, our protein/anti-body delivery technology platform.

“With respect to the posterior uveitis micro-insert, the FDA’s decision to
allow us to reference much of the ILUVIEN® data for diabetic macular edema
(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. Because this
development product uses the same micro-insert used in ILUVIEN for DME, which
delivers a smaller dosage of the same drug as our Retisert® product already
approved for posterior uveitis, we expect our 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, with a favorable
risk/benefit profile and fewer side effects compared to Retisert,” continued
Dr. Ashton.

Tethadur, the Company’s protein/anti-body delivery platform, has the potential
to provide sustained release of peptides and proteins in many therapeutic
areas and is currently being evaluated in ophthalmology under an agreement
with a leading global biopharmaceutical company. In the ophthalmic area, a
sustained delivery system like Tethadur for these types of molecules could
offer a significant clinical advance because they must currently be injected
into the eye every one or two months.

Regarding the European commercialization of ILUVIEN for DME, Alimera Sciences,
pSivida’s licensee, has announced a planned direct commercial launch in three
EU countries in 2013, with Germany expected in the first quarter, the United
Kingdom in the second quarter and France in the third quarter. ILUVIEN has
received marketing authorization in the United Kingdom, Austria, Portugal,
France and Germany, and has been recommended for marketing authorization in
Italy and Spain, for the treatment of vision impairment associated with
chronic DME considered insufficiently responsive to available therapies.
Alimera completed a $40 million financing to proceed with the direct
commercialization of ILUVIEN for DME in Germany, the U.K. and France. Alimera
has estimated that there are approximately one million people suffering from
DME in the seven EU countries where marketing authorization has either been
received or recommended.

Alimera also announced that it intends to resubmit the NDA for ILUVIEN for DME
to the FDA during the first quarter of 2013. Alimera further announced that
using data from its two previously completed pivotal Phase III clinical
trials, the resubmission will focus on the population of patients with chronic
DME, the same group 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 and 20% of net profits, as defined, from U.S. sales
of ILUVIEN by Alimera.

The investigator-sponsored Phase I/II dose-escalation study of pSivida’s
bioerodible, injectable latanoprost micro-insert for glaucoma and ocular
hypertension is ongoing. Pfizer has an exclusive option under various
circumstances to license the development and commercialization worldwide of
this micro-insert for human ophthalmic disease other than uveitis.

Revenues for the fiscal 2013 first quarter were $553,000 compared to $1.7
million for the first quarter a year earlier. The fiscal 2012 first quarter
included $1.1 million of revenue recognition from the termination of a 2008
nutraceutical field of use license. pSivida reported a net loss of $2.6
million, or $0.11 per share, for the first quarter ended September 30, 2012,
compared to a net loss of $2.4 million, or $0.12 per share, for the first
quarter of the prior year.

At September 30, 2012, cash, cash equivalents and marketable securities
totaled $17.6 million, reflecting $4.7 million in net proceeds from an August
registered direct offering of shares of common stock and warrants.

Today’s Conference Call Reminder

pSivida Corp. will host a live webcast and conference call today, November 8,
2012, 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 A replay of the call will be available approximately two
hours following the end of the call through November 15, 2012. 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 59823674.

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 DME, licensed to Alimera Sciences, Inc.,
has received marketing authorization in Austria, France, Germany, Portugal and
the U.K. and is awaiting authorization in Italy and Spain. 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.

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.

(In thousands except per share amounts)
                                              Three Months Ended
                                              September 30,
                                              2012         2011
Collaborative research and development        $ 169        $ 1,461
Royalty income                                  384          198
Total revenues                                 553        1,659  
Operating expenses:
Research and development                        1,523        2,129
General and administrative                      1,620        2,061
Total operating expenses                       3,143      4,190  
Loss from operations                           (2,590 )    (2,531 )
Other income (expense):
Change in fair value of derivatives             -            42
Interest income                                 7            9
Other expense, net                              (1     )     (2     )
Total other income                             6          49     
Loss before income taxes                        (2,584 )     (2,482 )
Income tax benefit                              33           55
Net loss                                      $ (2,551 )   $ (2,427 )
Net loss per share:
Basic and diluted                             $ (0.11  )   $ (0.12  )
Weighted average common shares outstanding:
Basic and diluted                              22,294     20,757 

(In thousands)
                                                  September 30,   June 30,
                                                  2012            2012
Current assets:
Cash, cash equivalents and marketable             $  17,646       $ 14,571
Other current assets                                 1,254          1,388
Total current assets                                 18,900         15,959
Intangible assets, net                               4,078          4,226
Other assets                                         361            412
Total assets                                      $  23,339      $ 20,597   
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued expenses             $  1,067        $ 1,002
Deferred revenue                                     2,395          2,176
Total current liabilities                            3,462          3,178
Deferred revenue                                     3,714          3,783
Total liabilities                                   7,176        6,961    
Stockholders' equity:
Capital                                              269,463        264,452
Accumulated deficit                                  (254,309 )     (251,758 )
Accumulated other comprehensive income               1,009          942
Total stockholders' equity                          16,163       13,636   
Total liabilities and stockholders' equity        $  23,339      $ 20,597   


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