pSivida Corp. (NASDAQ: PSDV, ASX: PVA), a leader in the
development of sustained release, drug delivery products for
treating eye diseases, today provided a Company update and
announced financial results for its fourth quarter and fiscal year
ended June 30, 2015.
Fiscal 2015 was a year marked by excellent progress toward
pSivida’s goal of becoming the leader in sustained release drug
delivery products in ophthalmology and beyond.
Phase III clinical trials for Medidur™ for posterior uveitis,
pSivida’s lead development product, continued on pace for an
expected NDA filing in the first half of 2017. Enrollment of the
first trial was completed in March 2015, and enrollment in the
second trial is ongoing. Medidur is designed to deliver three years
of treatment of posterior uveitis, a blinding eye disease, from a
single injection.
“We remain optimistic that Medidur will be safe and effective in
treating posterior uveitis. Recent top-line results from an
investigator-sponsored study and safety data from our first Phase
III trial have been very encouraging in this regard,” said Paul
Ashton, Ph.D., President and CEO of pSivida.
Top-line results from the investigator-sponsored study of low
and high doses of Medidur (pSivida is studying only the low dose)
showed a statistically significant reduction in recurrence of
uveitis (p=0.014) and a statistically significant improvement in
visual acuity (p=0.014) in eyes treated with Medidur compared to
those that were not treated with Medidur.
For all 129 enrolled patients in pSivida’s first Phase III trial
at three months of follow-up, only 5% more study eyes (2/3’s of
which received Medidur) experienced elevated intraocular pressure
(IOP) (over 21 mm Hg) than the fellow non-study eyes (none of which
received Medidur). This was consistent with the IOP safety data
earlier reported by pSivida for the first 105 patients at three
months follow-up.
pSivida expects that an investigational new drug application
(IND) will shortly be filed in the U.S. to commence an
investigator-sponsored study of an implant utilizing pSivida’s
patented Durasert™ technology to treat pain associated with severe
osteoarthritis of the knee. pSivida and Hospital for Special
Surgery, the leading specialty hospital for orthopedics and
rheumatology, have been collaborating on this product. It will
be surgically implanted in the knee to provide approximately six
months of sustained delivery of a corticosteroid directly to the
joint, designed to offer long-term pain relief and delay or
eliminate the need for knee replacement surgery. “With over 10
million cases of knee osteoarthritis and 700,000 knee replacement
surgeries last year in the U.S. alone and a population that is
aging and increasingly overweight, a product that would offer a new
treatment alternative for the pain of severe osteoarthritis of the
knee would be a very welcome clinical development,” said Dr.
Ashton.
pSivida also continued work on its pre-clinical programs focused
on creating products for chronic ophthalmic diseases and delivering
biologics using its core Durasert and Tethadur™technologies. “We
have seen excellent progress recently with both of these
technologies. We are particularly pleased at the advances we have
made in our development of Tethadur to deliver antibodies. With our
latest iteration of the technology, we have achieved higher
molecule loading capacity and enhanced antibody stability. These
are key elements for sustained delivery of biologics to a small
space such as the eye,” said Dr. Ashton. “We commenced a new
pre-clinical program to use Durasert to deliver drug to treat
age-related macular degeneration and continued to progress our
research with respect to other ophthalmic applications.”
ILUVIEN® for diabetic macular edema (DME), pSivida’s lead
licensed product, which is the same micro-insert as Medidur,
completed its first quarter of commercialization in the U.S. with
solid sales. ILUVIEN is also sold in the U.K., and was recently
launched in Portugal and relaunched in Germany. pSivida is entitled
to 20% of the net profits from sales of ILUVIEN by its licensee on
a country-by-country, quarter-by-quarter basis. “We believe the
three years of effective treatment from a single injection of
ILUVIEN should make it a very attractive treatment alternative in
the significant DME market, and we look forward to benefitting
through our profit participation,” said Dr. Ashton.
“Our $28.5 million in cash at the end of fiscal year 2015 marks
our highest year-end liquidity. It should give us the capital
resources to continue our planned product development programs,
including our two Medidur trials, into early 2017, even without any
potential future payments arising from ILUVIEN,” said Dr.
Ashton.
Results for the Fourth Quarter and FY 2015. Revenues for
the quarter ended June 30, 2015 totaled $409,000 compared to
$292,000 for the prior year’s fourth quarter. The increase was
primarily due to higher Retisert royalties.
Operating expenses for the three months ended June 30, 2015
totaled $5.6 million compared to $4.3 million a year earlier. The
increase was primarily attributable to higher CRO costs for the
Medidur clinical development program and higher professional
fees.
Net loss for the quarter ended June 30, 2015 was $5.1 million,
or $0.17 per share, compared to a net loss of $4.0 million, or
$0.14 per share, for the prior year quarter.
Revenues for the year ended June 30, 2015 totaled $26.6 million
compared to $3.5 million for the year ended June 30, 2014. The
increase reflected the $25.0 million milestone for FDA approval of
ILUVIEN recorded in the fiscal 2015 first quarter, partially offset
by an approximate $1.8 million reduction in revenues from funded
technology evaluation agreements.
Operating expenses for the year ended June 30, 2015 totaled
$20.1 million compared to $17.0 million for the same period of the
prior year, with the $3.1 million net increase primarily due to
increased CRO costs for the Medidur clinical development program as
well as increased professional fees and stock-based
compensation.
Income tax expense totaled $96,000 for the year ended June 30,
2015 compared to an income tax benefit of $130,000 for the year
ended June 30, 2014. Fiscal 2015 included $263,000 of federal
alternative minimum tax expense based on U.S. taxable income for
calendar year 2014, which was primarily attributable to the $25.0
million ILUVIEN FDA-approval milestone. Refundable foreign research
and development tax credits totaled $167,000 in fiscal 2015
compared to $130,000 in fiscal 2014.
Net income for the year ended June 30, 2015 totaled $6.3
million, or $0.21 per diluted share, compared to a net loss of
$13.4 million, or $0.49 per share, for the year ended June 30,
2014.
At June 30, 2015, cash, cash equivalents and marketable
securities totaled $28.5 million.
Today’s Conference Call Reminder
pSivida Corp. will host a live webcast and conference call
today, September 9, 2015, 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 September 16, 2015. 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 27613566.
About Posterior Uveitis. Posterior uveitis is a
chronic, non-infectious inflammatory disease affecting the
posterior segment of the eye, often involving the retina, which is
a leading cause of blindness in the developed and developing
countries. It afflicts people of all ages, producing swelling and
destroying eye tissues, which can lead to severe vision loss and
blindness. In the U.S., posterior uveitis affects approximately
175,000 people, resulting in approximately 30,000 cases of
blindness and making it the third leading cause of blindness in the
U.S.
Patients with posterior uveitis are typically treated with
systemic steroids but over time frequently develop serious side
effects that can limit effective dosing. Patients then often
progress to steroid-sparing therapy with systemic immune
suppressants or biologics, which themselves can have severe side
effects including an increased risk of cancer. Medidur is designed
to provide improved outcomes compared to standard of care, but with
a significant reduction in side effects.
About the Phase III Trials. pSivida is conducting
two Phase III trials to assess the safety and efficacy of Medidur
for the treatment of posterior uveitis. These are randomized,
sham-controlled, double-masked trials. The primary end point of
both trials is recurrence of posterior uveitis, with patients in
both trials followed for three years. The first Phase III Medidur
trial is fully enrolled with 129 patients in 16 centers in the U.S.
and 17 centers outside the U.S. The last 12-month follow-up visit
for patients in this trial is scheduled for March 2016, and
top-line data is expected in the second quarter of 2016. The second
trial will enroll up to 150 patients in approximately 15 centers in
India. We plan to seek approval of Medidur based on 12-month data
from the first Phase III trial, six-month data from the second
Phase III trial and data from a short-duration utilization study of
our redesigned proprietary inserter, together with data referenced
from the Phase III trials of ILUVIEN for DME. Pending favorable
results in our ongoing clinical trials and concurrence from
regulatory authorities regarding our proposed data package, we
expect to file an NDA in the first half of 2017.
About pSivida Corp. pSivida Corp. (www.psivida.com),
headquartered in Watertown, MA, is a leader in the development of
sustained release, drug delivery products for treating eye
diseases. pSivida has developed three of only four FDA-approved
treatments for back-of-the-eye diseases. The most recent, ILUVIEN®,
a micro-insert for diabetic macular edema, is licensed to Alimera
Sciences and sold in the U.S. and three EU countries. Retisert®, an
implant for posterior uveitis, is licensed to and sold by Bausch
& Lomb. pSivida’s lead product candidate, Medidur™, a
micro-insert for posterior uveitis, is currently in pivotal phase
III clinical trials with an NDA anticipated in the first half of
2017. pSivida’s pre-clinical development program is focused on
using its core platform technologies, Durasert™ and/or Tethadur™,
to deliver drugs and biologics to treat wet and dry age-related
macular degeneration (AMD), glaucoma, osteoarthritis and other
diseases.
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.
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
include uncertainties with respect to: our ability to achieve
profitable operations and access to capital; further impairment of
our intangible assets; fluctuations in our operating results;
declines in Retisert royalties; successful commercialization of,
and receipt of revenues from, ILUVIEN for DME; the effect of
pricing and reimbursement decisions on sales of ILUVIEN for DME;
consequences of fluocinolone acetonide side effects; safety and
efficacy results of Medidur Phase III trials, timing of filing and
acceptance of the Medidur NDA, if at all; fluctuations in our
operating results; ability to use of data in a U.S. NDA from trials
outside the U.S.; any exercise by Pfizer of its option with respect
to the latanoprost product; our ability to develop Tethadur to
successfully deliver large biologic molecules and develop products
using it; our ability to successfully develop product candidates,
initiate and complete clinical trials and receive regulatory
approvals; our ability to market and sell products; the success of
current and future license agreements; termination or breach of
current license agreements; effects of competition and other
developments affecting sales of products; market acceptance of
products; effects of guidelines, recommendations and studies;
protection of intellectual property and avoiding intellectual
property infringement; retention of key personnel; product
liability; industry consolidation; compliance with environmental
laws; manufacturing risks; risks and costs of international
business operations; legislative or regulatory changes; volatility
of stock price; possible dilution; absence of dividends; and other
factors described in our filings with the SEC. You should read
and interpret any forward-looking statements in light of these
risks. 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. You
should bear this in mind as you consider any 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 Year
Ended June 30, June 30, 2015 2014
2015 2014 Revenues: Collaborative research and
development $ 56 $ 6 $ 25,411 $ 2,155 Royalty income 353 286 1,154
1,318 Total revenues 409
292 26,565 3,473
Operating expenses: Research and development 3,198 2,306 12,088
9,573 General and administrative 2,411 2,000 8,056 7,468 Gain on
sale of property and equipment - (2 ) - (78 )
Total operating expenses 5,609 4,304
20,144 16,963 (Loss)
income from operations (5,200 ) (4,012 ) 6,421
(13,490 ) Other income, net: Interest income 7
3 19 6 Other (expense) income, net (1 ) (1 ) 3 (1 )
Total other income 6 2
22 5 (Loss) income before income
taxes (5,194 ) (4,010 ) 6,443 (13,485 ) Income tax benefit
(expense) 48 43 (96 ) 130 Net (loss)
income $ (5,146 ) $ (3,967 ) $ 6,347 $ (13,355 ) Net
(loss) income per share: Basic $ (0.17 ) $ (0.14 ) $ 0.22 $
(0.49 ) Diluted $ (0.17 ) $ (0.14 ) $ 0.21 $ (0.49 )
Weighted average common shares outstanding: Basic
29,412 29,256 29,378
27,444 Diluted 29,412 29,256
30,584 27,444
PSIVIDA
CORP. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE
SHEETS (Unaudited) (In thousands)
June 30, June 30, 2015
2014 Assets Current assets: Cash, cash
equivalents and marketable securities $ 28,535 $ 18,278 Other
current assets 1,303 1,064 Total current assets
29,838 19,342 Intangible assets, net 1,925 2,765 Other assets 604
564
Total assets $ 32,367 $ 22,671
Liabilities and stockholders' equity
Current liabilities: Accounts payable and accrued expenses $
3,315 $ 1,988 Deferred revenue 33 138 Total current
liabilities 3,348 2,126 Deferred revenue, less current portion
5,596 5,584 Deferred rent 55 37
Total
liabilities 8,999 7,747
Stockholders' equity: Capital 293,089 290,893 Accumulated
deficit (270,666 ) (277,013 ) Accumulated other comprehensive
income 945 1,044 Total stockholders' equity
23,368 14,924
Total liabilities and
stockholders' equity $ 32,367 $ 22,671
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150909006569/en/
Martin E. Janis & Company, Inc.Beverly Jedynak, President+1
312 943 1123M: +1 773 350 5793bjedynak@janispr.com
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