pSivida Corp. Reports First Quarter 2014 Results

  pSivida Corp. Reports First Quarter 2014 Results

Business Wire

WATERTOWN, Mass. -- November 12, 2013

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 first quarter ended September 30, 2013.

“We made excellent progress this quarter in advancing our own pipeline of
products, including our lead development product, Medidur™ for posterior
uveitis, now in a Phase III trial, and in enhancing our capital with a $10.8
million public offering of our common stock,” said Dr. Paul Ashton, President
and CEO of pSivida. “We look forward to continued growth in acceptance and
sales in Europe of one of our licensed products, ILUVIEN® for chronic diabetic
macular edema (DME), already being sold in the U.K. and Germany and slated to
launch in France next year.

“The first of the two planned pivotal Phase III clinical trials for Medidur
for posterior uveitis has commenced and continues on schedule. We expect that
Medidur will treat posterior uveitis with an efficacy profile comparable to
Retisert®, our FDA-approved implant for posterior uveitis currently being sold
by Bausch & Lomb, and a side effect profile superior to Retisert. Interim data
from a small investigator-sponsored Phase I/II study of Medidur for posterior
uveitis patients were consistent with this hypothesis,” Dr. Ashton continued.
Posterior uveitis is an inflammatory disease of one of the layers of the eye.
In the U.S., posterior uveitis affects approximately 175,000 people and is
responsible for approximately 30,000 cases of legal blindness, making it the
third largest cause of blindness.

“We are pleased that the U.K.’s National Institute for Health and Care
Excellence (NICE) reversed its original views and issued final draft guidance
that would significantly expand the availability of ILUVIEN in the U.K. and
Wales. On issuance of final guidance expected this month, the U.K.’s National
Health Service will provide reimbursement under a patient access scheme
submitted by Alimera for pseudophakic patients (those who had previously
undergone cataract surgery) with chronic DME that is insufficiently responsive
to available therapies, a typically large subgroup of chronic DME patients,”
said Dr. Ashton. “However, we were very disappointed that our licensee Alimera
Sciences received a complete response letter from the FDA on October 17, 2013
regarding ILUVIEN for DME. We expect to learn more about the potential for
approval in the U.S. following a meeting of the Dermatologic and Ophthalmic
Drugs Advisory Committee scheduled by the FDA for January 27, 2014.

“Pre-clinical testing of potential products using Tethadur™, our second key
technology platform, continues to be encouraging. Tethadur has the potential
to deliver peptides, proteins and antibodies on a sustained basis to the eye.
This could be mission critical to the development of BioSimilars and
BioBetters for the treatment of ophthalmic disease in light of the importance
of biologics in treatment of these diseases,” continued Dr. Ashton. The use of
Tethadur in certain ophthalmic applications is being evaluated under a funded
evaluation agreement with a leading global biopharmaceutical company. Other
major pharmaceutical companies are evaluating pSivida’s technology platforms
in other ophthalmic applications under funded agreements.

Revenues for the quarter ended September 30, 2013 totaled $597,000 compared to
$553,000 for the prior year period. The increase was attributable to higher
Retisert royalty income from Bausch & Lomb.

Net loss for the quarter ended September 30, 2013 was $3.7 million, or $0.14
per share, compared to a net loss of $2.6 million, or $0.11 per share, for the
prior year quarter. The higher net loss in the first quarter of fiscal 2014
primarily reflected costs associated with the initiation of the Phase III
clinical trial for Medidur for posterior uveitis.

At September 30, 2013, cash, cash equivalents and marketable securities
increased to $16.5 million compared to $10.3 million at June 30, 2013,
reflecting the addition of $9.9 million in net proceeds from an underwritten
public offering of common shares.

“Going forward, we expect our quarterly cash burn will continue to show some
variability due to timing of clinical trial costs and payments from
collaborating companies,” said Dr. Ashton.

Today’s Conference Call Reminder

pSivida Corp. will host a live webcast and conference call today, November 12,
2013, 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 November 19, 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 97230646.

About the Clinical Trials/Studies

pSivida has initiated the first of two planned pivotal Phase III trials of
Medidur for the treatment of posterior uveitis. These trials are expected to
enroll a total of approximately 300 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
for ILUVIEN for DME conducted by Alimera.

The investigator-sponsored Phase I/II study of Medidur for posterior uveitis
is a three-year study that will evaluate the safety and efficacy of Medidur in
up to 12 patients with posterior uveitis. Interim results were measured on the
twelve month anniversary of the start of enrollment. Through this period, none
of the eyes receiving Medidur experienced a recurrence of uveitis and
inflammation was reduced in all of these eyes. In contrast, all (untreated)
control eyes had either a recurrence of uveitis or a worsening of
inflammation. Furthermore, at the last follow-up visit reported in interim
results, best corrected visual acuity (on the Early Treatment Diabetic
Retinopathy Study eye chart) improved by an average of more than nine letters
in treated eyes while untreated eyes declined by an average of one letter.
Interim data showed that Medidur was well tolerated, and the observed safety
profile was consistent with the short-term safety profile reported in clinical
studies of ILUVIEN in DME eyes. Only one eye receiving Medidur measured an
increase in intraocular pressure above the normal range.

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™, 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. pSivida has
instituted the first of two planned pivotal Phase III clinical trials for
Medidur™ for the treatment of posterior uveitis, a chronic back-of-the-eye
disease. 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.

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, obtain adequate pricing and
reimbursement for, successfully 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.; 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.

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
                                                September 30,
                                                               
                                                2013           2012
                                                               
Revenues:
Collaborative research and development          $ 173          $ 169
Royalty income                                    424            384
                                                              
                                                               
Total revenues                                   597          553    
                                                               
Operating expenses:
Research and development                          2,504          1,523
General and administrative                        1,811          1,620
                                                              
                                                               
Total operating expenses                         4,315        3,143  
                                                               
Loss from operations                             (3,718 )      (2,590 )
                                                               
Other income (expense):
Interest income                                   1              7
Other expense, net                                -              (1     )
                                                              
                                                               
Total other income                               1            6      
                                                               
Loss before income taxes                          (3,717 )       (2,584 )
Income tax benefit                                30             33
                                                              
                                                               
                                                               
Net loss                                        $ (3,687 )     $ (2,551 )
                                                               
Net loss per share:
Basic and diluted                               $ (0.14  )     $ (0.11  )
                                                               
Weighted average common shares outstanding:
Basic and diluted                                25,918       22,294 
                                                                        

PSIVIDA CORP. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands)
                                                             
                                                September 30,     June 30,
                                                2013              2013
                                                                  
Assets
Current assets:
Cash, cash equivalents and marketable           $  16,454         $ 10,273
securities
Other current assets                               2,658            2,191
                                                                 
                                                                  
Total current assets                               19,112           12,464
Intangible assets, net                             3,300            3,430
Other assets                                       323              355
                                                                 
                                                                  
Total assets                                    $  22,735        $ 16,249   
                                                                  
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued expenses           $  2,169          $ 2,565
Deferred revenue                                   688              738
                                                                 
                                                                  
Total current liabilities                          2,857            3,303
Deferred revenue                                   5,641            5,246
                                                                 
                                                                  
Total liabilities                                 8,498          8,549    
                                                                  
                                                                  
Stockholders' equity:
Capital                                            280,597          270,438
Accumulated deficit                                (267,345 )       (263,658 )
Accumulated other comprehensive income             985              920
                                                                 
                                                                  
Total stockholders' equity                        14,237         7,700    
                                                                  
Total liabilities and stockholders' equity      $  22,735        $ 16,249   

Contact:

In US:
Martin E. Janis & Company, Inc.
Beverly Jedynak
President
+1 312 943 1123
M: +1 773 350 5793
bjedynak@janispr.com
or
In Australia:
pSivida Corp.
Brian Leedman
Vice President, Investor Relations
+61 (0) 41 228 1780
brianl@psivida.com