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 first fiscal quarter ended
September 30, 2015.
Development of Medidur™ for posterior uveitis, pSivida’s lead
product candidate, advanced signifcantly in the first quarter of
fiscal 2016. pSivida now plans to file a New Drug Application
(NDA) for Medidur based on six-month efficacy data from its two
Phase III trials, rather than 12-month data from one trial and
six-month data from the second, after the U.S. Food & Drug
Administration (FDA) advised pSivida that this data will be
acceptable for review by the agency. Because all patients in the
first Phase III trial completed six months of follow-up in
September 2015, pSivida now expects to report top-line results from
the first Phase III trial in December 2015. Enrollment
in the second trial continues on schedule, with a planned NDA for
Medidur in the first half of 2017. pSivida has begun discussions
with the MHRA (Medicines and Healthcare Products Regulatory Agency)
to determine the requirements for approval in the EU.
Top-line results from a three-year, ongoing
investigator-sponsored study of low and high doses of Medidur
showed a statistically significant reduction in recurrence of
uveitis (p=0.014), which is also the primary endpoint in pSivida’s
Phase III trials, and a statistically significant improvement in
visual acuity (p=0.014) at the last follow-up visit in eyes treated
with Medidur compared to those that were not treated with Medidur
(pSivida is studying only the low dose). pSivida also
reported that, in its first Phase III trial, 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) at three months of
follow-up. Because initial IOP elevation is an indication of
the likelihood of subsequent clinically significant IOP increases,
a key safety measure, the minimal difference at three months
suggests favorable results for the safety of Medidur in the Phase
III trials.
“We look forward to reporting the top-line results from our
first Phase III trial, which we now expect to be available at the
end of this year,” said Paul Ashton, Ph.D., President and CEO
of pSivida.
pSivida is working on expanding the use of its patented
Durasert™ technology platform beyond ophthalmology. pSivida and
Hospital for Special Surgery, the leading specialty hospital for
orthopedics and rheumatology, have been collaborating to develop an
implant for the treatment of pain associated with severe knee
osteoarthritis (OA). This implant is comprised of a screw with an
embedded Durasert device that is surgically implanted in the knee.
The implant is designed to deliver a corticosteroid directly to the
joint on a sustained basis to provide long-term pain relief and
thereby delay or eliminate the need for knee replacement surgery.
Following promising pre-clinical data showing maintenance of
sustained drug levels in the knee, the principal investigator filed
an investigational new drug (IND) application and is awaiting
information from the FDA as to any additional requirements it may
have for initiating the clinical trial. “Knee OA is the primary
reason for knee replacement surgery, with over 700,000 performed
last year in the U.S. alone. These numbers are expected to increase
with projected increases in aging and overweight populations. The
potential to provide sustained treatment of the pain associated
with severe knee OA and avoid knee replacement with a simple
implant procedure is very exciting,” said Dr. Ashton.
pSivida continued to make good progress in its programs to use
its Durasert technology to create treatments for additional chronic
eye diseases age-related macular degeneration (AMD) and glaucoma,
both of which have known drug treatments and represent very
significant market potentials. pSivida initiated a pre-clinical
program evaluating the use of Durasert to deliver off-patent or
soon-to-be off-patent anti-cancer drugs that inhibit VEGF and PDGF
to treat wet and dry AMD, the leading cause of vision loss in
people age 60 and older. pSivida also was successful in
optimizing the ability of Tethadur to deliver antibodies in in
vitro studies. “Higher molecule loading capacity and enhanced
antibody stability are critical attributes for sustained antibody
delivery to a small cavity like the eye for an extended period so
we are very pleased with our success in achieving these attributes
in the lab. We are moving on to confirmatory testing of Tethadur.
We are targeting INDs for both AMD and Tethadur products in
the next year,” said Dr. Ashton.
“We had $24.0 million in cash at September 30, 2015. That
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 FY 2016 First Quarter.
Revenues for the quarter ended September 30, 2015 totaled $466,000
compared to $25.3 million for the prior year quarter. The decrease
was primarily due to the ILUVIEN FDA approval milestone earned in
September 2014.
Operating expenses for the three months ended September 30, 2015
totaled $5.4 million compared to $4.5 million a year earlier. The
increase was primarily attributable to higher CRO costs for the
Medidur clinical development program.
Income tax benefit of $41,000 for the three months ended
September 30, 2015 compared to income tax expense of $226,000 for
the three months ended September 30, 2014. The prior year quarter
included $260,000 of federal alternative minimum tax expense based
on projected 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
were earned in both periods.
Net loss for the quarter ended September 30, 2015 was $4.9
million, or $0.17 per share, compared to net income of $20.6
million, or $0.67 per diluted share, for the prior year
quarter.
At September 30, 2015, cash, cash equivalents and marketable
securities totaled $24.0 million.
Today’s Conference Call
Reminder.
pSivida Corp. will host a live webcast and
conference call today, November 5, 2015, at 4:30pm 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 12, 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
67983411.
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 Medidur 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
endpoint of both trials is recurrence of posterior uveitis at six
months, 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. As the last 6-month follow-up visit for patients in this
trial occurred in September 2015, top-line data is expected in
December 2015. The second trial will enroll up to 150 patients in
approximately 15 centers in India. We plan to seek FDA approval of
Medidur based on 6-month data from the two Phase III trials and a
short-duration utilization study of our redesigned proprietary
inserter, together with data referenced from the Phase III trials
of ILUVIEN for DME.
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 sustained-release treatments for back-of-the-eye
diseases. The most recent, ILUVIEN®, a micro-insert for diabetic
macular edema, licensed to Alimera Sciences, is currently 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 being independently developed,
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 Tethadur™ to deliver drugs and biologics
to treat wet and dry age-related macular degeneration, glaucoma,
osteoarthritis and other diseases. To learn more about pSivida
please visit www.psivida.com and connect on Twitter, LinkedIn,
Facebook and Google+.
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; ability to use 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.
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|
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|
PSIVIDA CORP. AND SUBSIDIARIES |
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
(Unaudited) |
|
(In thousands except per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
|
|
|
|
|
September 30, |
|
|
|
|
|
|
|
2015 |
|
|
|
2014 |
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
Collaborative research and development |
|
$ |
180 |
|
|
$ |
25,081 |
|
|
|
|
Royalty
income |
|
|
286 |
|
|
|
226 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
466 |
|
|
|
25,307 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research
and development |
|
|
3,482 |
|
|
|
2,784 |
|
|
|
|
General and
administrative |
|
|
1,968 |
|
|
|
1,734 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses |
|
|
5,450 |
|
|
|
4,518 |
|
|
|
|
|
|
|
|
|
|
|
|
(Loss)
income from operations |
|
|
(4,984 |
) |
|
|
20,789 |
|
|
|
Interest
and other income |
|
|
10 |
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss)
income before income taxes |
|
|
(4,974 |
) |
|
|
20,792 |
|
|
|
Income tax
benefit (expense) |
|
|
41 |
|
|
|
(226 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss)
income |
|
$ |
(4,933 |
) |
|
$ |
20,566 |
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss)
income per common share: |
|
|
|
|
|
|
|
Basic |
|
$ |
(0.17 |
) |
|
$ |
0.70 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
$ |
(0.17 |
) |
|
$ |
0.67 |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding: |
|
|
|
|
|
|
|
Basic |
|
|
29,416 |
|
|
|
29,323 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
29,416 |
|
|
|
30,765 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PSIVIDA CORP. AND SUBSIDIARIES |
|
|
CONDENSED CONSOLIDATED BALANCE
SHEETS |
|
|
(Unaudited) |
|
|
(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
June 30, |
|
|
|
|
|
|
|
2015 |
|
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities |
$ |
24,005 |
|
|
$ |
28,535 |
|
|
|
|
Other
current assets |
|
1,158 |
|
|
|
1,303 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
current assets |
|
25,163 |
|
|
|
29,838 |
|
|
|
Intangible
assets, net |
|
1,713 |
|
|
|
1,925 |
|
|
|
Other
assets |
|
|
584 |
|
|
|
604 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
27,460 |
|
|
$ |
32,367 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts
payable and accrued expenses |
$ |
2,960 |
|
|
$ |
3,315 |
|
|
|
|
Deferred
revenue |
|
33 |
|
|
|
33 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
current liabilities |
|
2,993 |
|
|
|
3,348 |
|
|
|
Deferred
revenue |
|
5,587 |
|
|
|
5,596 |
|
|
|
Deferred
rent |
|
|
57 |
|
|
|
55 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
8,637 |
|
|
|
8,999 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
Capital |
|
|
293,503 |
|
|
|
293,089 |
|
|
|
|
Accumulated
deficit |
|
(275,599 |
) |
|
|
(270,666 |
) |
|
|
|
Accumulated
other comprehensive income |
|
919 |
|
|
|
945 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
stockholders' equity |
|
18,823 |
|
|
|
23,368 |
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
27,460 |
|
|
$ |
32,367 |
|
|
|
|
|
|
|
|
|
|
|
Martin E. Janis & Company, Inc.
Beverly Jedynak
President
+1 312 943 1123
M: +1 773 350 5793
bjedynak@janispr.com
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