pSivida Corp. Reports Results for the Fourth Quarter and Fiscal Year Ended June 30, 2009
4:00 pm ET 09/24/2009- Business Wire
WATERTOWN, Mass.--(BUSINESS WIRE)--
Psivida Corp. (NASDAQ: PSDV) (ASX: PVA) (FF: PV3), a drug delivery
company with two of the only three ophthalmic sustained release delivery
products approved by the FDA for treatment of back of the eye diseases,
today announced financial results for its fourth quarter and fiscal year
ended June 30, 2009. For the quarter ended June 30, 2009, the Company
reported a consolidated net loss of $534,000, or $0.03 per share,
compared to a consolidated net loss of $63.6 million, or $3.48 per
share, for the quarter ended June 30, 2008. Results for the three months
ended June 30, 2008 included a $60.1 million charge for impairment of
goodwill. Revenues for the three months ended June 30, 2009 were $3.2
million compared to revenues of $2.7 million for the three months ended
June 30, 2008. Cash and cash equivalents totaled $6.9 million at June
30, 2009.
For the year ended June 30, 2009, the Company reported a consolidated
net loss of $2.5 million, or $0.14 per share, compared to a consolidated
net loss of $75.7 million, or $4.17 per share, for the year ended June
30, 2008, also reflecting the $60.1 million impairment charge. Revenues
for the year ended June 30, 2009 were $12.2 million compared to revenues
of $3.5 for the year ended June 30, 2008.
Revenues for the three and twelve month periods ended June 30, 2009 and
2008 were predominantly related to the Company's amended and restated
collaboration agreement with Alimera Sciences, Inc. (Alimera).
"We are expecting the 2-year top line safety and efficacy data from the
ongoing Phase III Iluvien trials for the treatment of DME at the end of
this calendar year," stated Dr. Paul Ashton, President and CEO of
pSivida. "These trials are being conducted by Alimera, and Alimera's
planned NDA filing remains on schedule for early calendar 2010.
Additionally, we are targeting BioSilicon as the second prong of our
drug delivery platform in addition to the Durasert technology system on
which Iluvien is based."
Dr. Ashton continued, "We are entering an important and exciting phase
of development and our programs are progressing according to schedule.
With expected cash from our existing collaborations and planned spending
levels, we believe we can fund our operations as currently conducted
through FDA approval of Iluvien. Beginning in April 2010, we are due to
receive monthly principal payments of $500,000 under a $15 million
conditional note issued by Alimera and, if Iluvien is approved, we are
due to receive a $25 million milestone payment and, once commercialized,
a 20% profit share."
The Company's lead development product, Iluvien(R), is a tiny injectable
device that delivers the drug fluocinolone acetonide (FA) directly to
the back of the eye for up to three years. Iluvien, formerly known as
Medidur(TM) FA for DME, is licensed on a worldwide basis to Alimera, which
is conducting fully-enrolled Phase III clinical trials studying a low
dose and a high dose for the treatment of diabetic macular edema (DME).
Alimera expects that 24-month interim data from these clinical trials
will be available in late 2009, and we currently anticipate that Alimera
will file a New Drug Application (NDA) with the FDA in early 2010. DME
is a potentially blinding eye disease that affects over one million
people in the United States. Currently there are no FDA-approved drugs
for the treatment of DME.
Alimera is also sponsoring studies designed to assess the safety and
efficacy of Iluvien in wet and dry age-related macular degeneration and
retinal vein occlusion. |
