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, 2014.
pSivida’s lead licensed product ILUVIEN® has made significant
progress. It is scheduled to commence sales in the U.S. this
quarter following FDA approval in September for patients with
diabetic macular edema (DME) previously treated with a course of
corticosteroids without a clinically significant rise in
intraocular pressure. In the EU, ILUVIEN was launched in Portugal
in January and has been sold in the U.K. and Germany since 2013.
Since the fiscal 2015 first quarter, ILUVIEN has been approved in 8
more EU countries, bringing the total EU marketing approvals to 15
with two others pending, for treatment of vision impairment
associated with chronic DME considered insufficiently responsive to
available therapies. ILUVIEN has been sublicensed in Australia and
New Zealand. 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 and 20% of royalties and 33% of other
amounts from sublicenses of ILUVIEN.
“We are really looking forward to the upcoming launch of ILUVIEN
in the U.S. With its three-year treatment duration, ILUVIEN should
provide a valuable alternative for the treatment of DME patients
who now face injections as frequently as monthly with anti-VEGF
therapy, particularly the many patients whose disease is not
optimally managed with that therapy,” said Paul Ashton, Ph.D.,
President and CEO of pSivida.
During its fiscal 2015 second quarter, pSivida received the $25
million milestone payment as a result of the approval of ILUVIEN by
the U.S. Food and Drug Administration (FDA). “With over $35 million
in cash at the end of our second quarter, our cash resources
position us well to continue our product development programs into
2017 without any potential future contribution from ILUVIEN.”
pSivida’s lead development product, Medidur™ for the treatment
of posterior uveitis, is being tested in a pivotal Phase III trial.
Enrollment is expected to be completed around the end of March
2015. With a primary end-point of recurrence of disease at 12
months, top-line data from the trial is anticipated in the first
half of calendar 2016. The Company expects to review its plan with
the FDA this quarter to seek U.S. regulatory approval based on data
from this single trial, rather than two trials, together with
supplemental clinical data on pSivida’s proprietary inserter.
Medidur uses the same injectable, sustained-release micro-insert as
ILUVIEN for DME (same design, same drug, same polymer, same release
rate). The FDA has agreed that pSivida can use much of the data,
including clinical safety data, from the completed ILUVIEN Phase
III trials to support an application for Medidur.
pSivida’s pre-clinical development program is focused on its
Durasert™ and Tethadur™ platform technologies. Durasert is designed
to provide long-term sustained release of drugs. Different
generations of Durasert are the basis of pSivida’s three approved
products, as well as Medidur. Tethadur is designed to provide
sustained delivery of antibodies and other proteins. The Company’s
research is focused on back-of-the-eye diseases, including wet and
dry age-related macular degeneration (AMD) and glaucoma, as well as
osteoarthritis and other diseases.
“We continue to work on evolving our Durasert technology. We are
seeking to develop a micro-insert to deliver repurposed approved
drugs that have shown promise for the treatment of dry AMD. We are
working with the Hospital for Special Surgery to develop an implant
to provide sustained delivery of a steroid for the treatment of
osteoarthritis of the knee. We also continue development of our
Tethadur technology. We remain optimistic about the ability of
Tethadur to solve the challenge of sustained delivery of biologics,
which comprise many of today’s top-selling pharmaceuticals, most of
which must be delivered by frequent injections. We are working to
develop our own products where the perceived risk, cost and
opportunity are appropriate, while seeking to continue to leverage
our technologies through collaborative efforts where expertise
and/or cost make that a preferable product development
approach.”
Results for the FY2015 Second Quarter. Revenues for the
quarter ended December 31, 2014 totaled $521,000 compared to
$592,000 for the prior year’s second quarter. The decrease was due
to lower revenues from funded technology evaluation agreements,
partially offset by higher Retisert royalty income.
Operating expenses for the three months ended December 31, 2014
totaled $4.6 million compared to $4.1 million a year earlier. The
increase included CRO costs for the Medidur Phase III program and
stock-based compensation.
Net loss for the quarter ended December 31, 2014 was $4.1
million, or $0.14 per share, compared to a net loss of $3.5
million, or $0.13 per share, for the prior year quarter.
Revenues for the six months ended December 31, 2014 totaled
$25.8 million compared to $1.2 million for the six months ended
December 31, 2013. The increase reflected the $25.0 million
milestone for FDA approval of ILUVIEN recorded in the fiscal 2015
first quarter.
Operating expenses for the six months ended December 31, 2014
totaled $9.2 million compared to $8.4 million for the same period
of the prior year, with the increase primarily due to costs of the
Medidur clinical development program and stock-based
compensation.
Net income for the six months ended December 31, 2014 totaled
$16.5 million, or $0.54 per diluted share, compared to a net loss
of $7.2 million, or $0.27 per share for the six months ended
December 31, 2013.
At December 31, 2014, cash, cash equivalents and marketable
securities totaled $35.7 million. The Company’s quarterly cash burn
is expected to vary from quarter to quarter based on timing and
amounts of cash payments, including CRO payments, and cash receipts
under collaboration agreements.
Today’s Conference Call Reminder
pSivida Corp. will host a live webcast and conference call
today, February 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 February 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 75075675.
About pSivida Corp.
pSivida Corp., headquartered in Watertown, MA, is a leader in
the development of sustained release, drug delivery products for
treating eye diseases utilizing its core Durasert™ and Tethadur™
platform technology systems. pSivida’s lead product candidate,
Medidur™ for treatment of posterior uveitis, is being studied in a
pivotal Phase III clinical trial. Medidur uses the same injectable,
sustained release micro-insert as pSivida’s lead licensed product,
ILUVIEN® for the treatment of DME. ILUVIEN has been approved in the
U.S., is marketed in the U.K., Germany and Portugal and has
marketing authorization in 12 other EU countries, with two EU
approvals still pending. pSivida's other licensed product,
Retisert®, an implant that treats posterior uveitis, is sold in the
U.S. pSivida’s pre-clinical research is focused on ocular and
systemic delivery of biologics and drugs to treat wet and dry
age-related macular degeneration, 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: ability to achieve
profitable operations and access to capital; fluctuations in
operating results; further impairment of intangible assets; decline
in Retisert royalties; successful commercialization of, and receipt
of revenues from, ILUVIEN for DME; effect of pricing and
reimbursement decisions on sales of ILUVIEN for DME; consequences
of fluocinolone acetonide side effects; number of clinical trials
necessary to support an NDA for, and regulatory approval and
successful commercialization, of Medidur; development of the
Latanoprost Product and any exercise by Pfizer of its option;
ability of Tethadur to successfully deliver large biologic
molecules and development of products using Tethadur; ability to
successfully develop product candidates, complete clinical trials
and receive regulatory approvals; ability to market and sell
products; success of current and future license agreements;
termination of 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 together with 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 Six Months Ended December 31, December
31, 2014 2013 2014 2013
Revenues: Collaborative research and development $ 164 $ 300
$ 25,245 $ 473 Royalty income 357 292 583 716
Total revenues 521 592
25,828 1,189 Operating expenses:
Research and development 2,767 2,494 5,551 4,998 General and
administrative 1,870 1,711 3,604 3,522 Gain on sale of property and
equipment - (72 ) - (72 ) Total
operating expenses 4,637 4,133
9,155 8,448 (Loss) income from
operations (4,116 ) (3,541 ) 16,673 (7,259 ) Interest income 3 1 6
2 (Loss) income before income
taxes (4,113 ) (3,540 ) 16,679 (7,257 ) Income tax benefit
(expense) 38 26 (188 ) 56 Net
(loss) income $ (4,075 ) $ (3,514 ) $ 16,491 $ (7,201 )
Net (loss) income per share: Basic $ (0.14 ) $ (0.13 ) $
0.56 $ (0.27 ) Diluted $ (0.14 ) $ (0.13 ) $ 0.54
$ (0.27 ) Weighted average common shares
outstanding: Basic 29,367 26,953
29,345 26,435 Diluted 29,367
26,953 30,618 26,435
PSIVIDA CORP. AND SUBSIDIARIES CONDENSED
CONSOLIDATED BALANCE SHEETS (Unaudited) (In
thousands)
December 31, June 30, 2014 2014
Assets Current assets: Cash, cash equivalents and
marketable securities $ 35,686 $ 18,278 Other current assets 1,662
1,064 Total current assets 37,348 19,342
Intangible assets, net 2,301 2,765 Other assets 531 564
Total assets $ 40,180 $ 22,671
Liabilities and stockholders' equity Current
liabilities: Accounts payable and accrued expenses $ 2,204 $
1,988 Deferred revenue 69 138 Total current
liabilities 2,273 2,126 Deferred revenue 5,584 5,584 Deferred rent
48 37
Total liabilities 7,905
7,747
Stockholders' equity:
Capital 291,854 290,893 Accumulated deficit (260,522 ) (277,013 )
Accumulated other comprehensive income 943 1,044
Total stockholders' equity 32,275
14,924
Total liabilities and stockholders'
equity $ 40,180 $ 22,671
Martin E. Janis & Company, Inc.Beverly JedynakPresident+1
312 943 1123M: +1 773 350 5793bjedynak@janispr.com
Psivida Corp (ASX:PVA)
Historical Stock Chart
From Sep 2024 to Oct 2024
Psivida Corp (ASX:PVA)
Historical Stock Chart
From Oct 2023 to Oct 2024