pSivida Corp. Reports Second Quarter 2014 Results

  pSivida Corp. Reports Second Quarter 2014 Results

Business Wire

WATERTOWN, Mass. -- February 7, 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 second quarter ended December 31, 2013.

“We continued to advance our own pipeline of products. Enrollment continues on
schedule for our lead development product, Medidur™ for posterior uveitis, in
the first of two planned Phase III trials,” said Dr. Paul Ashton, President
and CEO of pSivida. “Our lead licensed product, ILUVIEN® for chronic diabetic
macular edema (DME), moved closer to potential marketing approval in the U.S.
and expanded availability in the EU.

“In posterior uveitis we believe that the trials will show an efficacy profile
of Medidur comparable to Retisert®, our FDA-approved implant for posterior
uveitis currently being sold by Bausch & Lomb, with a side effect profile
superior to Retisert. Preliminary data from a small investigator-sponsored
Phase I/II study of Medidur for posterior uveitis patients were consistent
with this hypothesis. Medidur, which uses the same micro-insert as ILUVIEN,
delivers a lower dosage of the same drug as Retisert,” Dr. Ashton continued.
Posterior uveitis, an inflammatory disease of one of the layers of the eye,
affects approximately 175,000 people in the U.S. Responsible for approximately
30,000 cases of legal blindness, posterior uveitis is the third largest cause
of blindness.

“We are very pleased that our licensee Alimera Sciences entered into labeling
discussions with the U.S. Food and Drug Administration (FDA) for ILUVIEN for
DME and plans to respond to the FDA's October 2013 Complete Response Letter
(CRL) in the first quarter of 2014. We understand Alimera will be providing
recent safety data from patients in the U.K. and Germany and addressing the
concerns raised by the FDA regarding the facility at which ILUVIEN for DME is
manufactured. Alimera reported that new clinical trials will not be required
by the FDA in connection with its review of ILUVIEN for DME prior to approval.
If approved, we will be entitled to a $25.0 million milestone payment from
Alimera and 20% of net profits on sales of ILUVIEN for DME by Alimera in the
U.S.

“We are also encouraged by the speed with which ILUVIEN has been made
available to U.K. National Health Service (NHS) facilities. Less than seven
weeks after the final guidance from the U.K.'s National Institute for Health
and Care Excellence (NICE) recommending ILUVIEN as a treatment option for
pseudophakic eyes (those that have had cataract surgery) with chronic DME
considered insufficiently responsive to available therapies, initial orders
were shipped to NHS hospitals and the first NHS patient was treated. Until
receipt of this guidance, ILUVIEN had been available in the U.K. only to
private pay and privately insured patients, but will now be available through
the NHS to this typically large subgroup of chronic DME patients, subject to a
patient access scheme.

“We continue to be encouraged by our studies of potential ophthalmic and
non-ophthalmic uses of Tethadur™, our second key technology platform designed
to provide sustained delivery of peptides, proteins and antibodies. The
importance of these biologics in treatment of ophthalmic disease makes
Tethadur a very promising technology,” 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 December 31, 2013 totaled $592,000 compared to
$585,000 for the prior year period. Increased collaborative research and
development revenue was offset by lower Retisert royalty income from Bausch &
Lomb.

Net loss for the quarter ended December 31, 2013 was $3.5 million, or $0.13
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 second quarter of fiscal 2014
primarily reflected costs associated with our Phase III clinical trial of
Medidur for posterior uveitis, which commenced in the quarter ended June 2013.

Revenues for the six months ended December 31, 2013 totaled $1.2 million
compared to $1.1 million for the six months ended December 31, 2012. The
Company reported a net loss of $7.2 million, or $0.27 per share, for the six
months ended December 31, 2013, compared to a net loss of $5.2 million, or
$0.23 per share, for the same period of the prior year.

At December 31, 2013, cash, cash equivalents and marketable securities totaled
$15.7 million compared to $16.5 million at September 30, 2013, reflecting
approximately $1.2 million received from an existing collaboration agreement
and approximately $1.25 million of net proceeds from sales of common stock
under pSivida’s at-the-market (ATM) offering program.

Today’s Conference Call Reminder

pSivida Corp. will host a live webcast and conference call today, February 7,
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
www.psivida.com. A replay of the call will be available approximately two
hours following the end of the call through February 14, 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 52647338.

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
of 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. Alimera is seeking
FDA approval for ILUVIEN for DME in the US. pSivida has instituted the first
of two planned pivotal Phase III clinical trials of 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          Six Months Ended
                           December 31,                December 31,
                           2013         2012           2013         2012
Revenues:
    Collaborative
    research and           $ 300        $ 195          $ 473        $ 364
    development
    Royalty income           292          390            716          774
                                                                 
                                                                    
         Total revenues     592        585          1,189      1,138  
                                                                    
Operating expenses:
    Research and             2,494        1,575          4,998        3,098
    development
    General and              1,711        1,658          3,522        3,278
    administrative
    Gain on sale of
    property and             (72    )     -              (72    )     -
    equipment
                                                                 
                                                                    
         Total operating    4,133      3,233        8,448      6,376  
         expenses
                                                                    
Loss from operations        (3,541 )    (2,648 )      (7,259 )    (5,238 )
                                                                    
Other income (expense),
net:
    Interest income          1            4              2            11
    Other expense, net       -            (1     )       -            (2     )
                                                                 
                                                                    
         Total other        1          3            2          9      
         income
                                                                    
Loss before income taxes     (3,540 )     (2,645 )       (7,257 )     (5,229 )
Income tax benefit           26           37             56           70
                                                                 
                                                                    
Net loss                   $ (3,514 )   $ (2,608 )     $ (7,201 )   $ (5,159 )
                                                                    
Net loss per share:
    Basic and diluted      $ (0.13  )   $ (0.11  )     $ (0.27  )   $ (0.23  )
                                                                    
Weighted average common
shares outstanding:
    Basic and diluted       26,953     23,297       26,435     22,795 


PSIVIDA CORP. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands)
                                                             
                                                   December 31,   June 30,
                                                   2013           2013
Assets
Current assets:
     Cash, cash equivalents and marketable         $ 15,721       $ 10,273
     securities
     Other current assets                            1,511          2,191
                                                                 
                                                                  
Total current assets                                 17,232         12,464
Intangible assets, net                               3,127          3,430
Other assets                                         460            355
                                                                 
                                                                  
Total assets                                       $ 20,819      $ 16,249   
                                                                  
Liabilities and stockholders' equity
Current liabilities:
     Accounts payable and accrued expenses         $ 1,380        $ 2,565
     Deferred revenue                                771            738
                                                                 
                                                                  
Total current liabilities                            2,151          3,303
Deferred revenue                                     6,069          5,246
                                                                 
                                                                  
Total liabilities                                   8,220        8,549    
                                                                  
Stockholders' equity:
     Capital                                         282,443        270,438
     Accumulated deficit                             (270,859 )     (263,658 )
     Accumulated other comprehensive income          1,015          920
                                                                 
                                                                  
Total stockholders' equity                          12,599       7,700    
                                                                  
Total liabilities and stockholders' equity         $ 20,819      $ 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
 
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