Jul 31 2012
InSite Vision Incorporated (OTCBB:INSV) today reported financial results
for the quarter ended June 30, 2012. Total revenues for the second
quarter of 2012 were $1.8 million, a decrease of $1.3 million from the
same quarter of 2011. InSite Vision had cash, cash equivalents and
short-term investments of $17.6 million as of June 30, 2012, reflecting
cash usage of $4.7 million in the quarter, which included $2.2 million
for the AzaSite Plus™ and DexaSite™ Phase 3 DOUBle
"The first half of this year has been focused on clinical development
execution," said Tim Ruane, InSite's Chief Executive Officer. "The Phase
3 DOUBle clinical study of AzaSite Plus and DexaSite for the treatment
of blepharitis is accruing ahead of schedule and we are preparing to
initiate our Phase 3 clinical trial of BromSite for post-surgical pain
and inflammation. We anticipate a busy second half of the year as our
late-stage pipeline programs advance through pivotal studies."
Corporate and Commercial Highlights
Enrollment continues on track in InSite's Dual Ophthalmic agents Used
in Blepharitis (DOUBle) Phase 3 pivotal trial to evaluate AzaSite Plus
and DexaSite simultaneously for the treatment of blepharitis. As of
July 24, 2012, InSite had enrolled 826 patients in the DOUBle study
and expects to complete the trial and announce top-line results in
late 2012 or early 2013.
InSite's blepharitis product
candidates utilize the company's proprietary DuraSite platform to
extend the residence time of the drug beyond conventional eye drops.
AzaSite Plus is a fixed-dose combination of an antibiotic (1.0%
azithromycin) and an anti-inflammatory steroid (0.1% dexamethasone),
and DexaSite is a DuraSite formulation of 0.1% dexamethasone. The
DOUBle study seeks to enroll approximately 900 patients suffering from
moderate-to-severe blepharitis in a four-arm trial designed to
evaluate the efficacy and safety of both product candidates. InSite
Vision obtained a Special Protocol Assessment from the U.S. Food and
Drug Administration (FDA) in May 2011 for the design of the DOUBle
In the second quarter, InSite continued preparations for the Phase 3
clinical study of BromSite™ (bromfenac ophthalmic solution 0.075%) for
the treatment of post-surgical ocular inflammation. The company
selected Pharm-Olam International to serve as the contract research
organization for the study and completed manufacturing all clinical
trial supplies. The Phase 3 pivotal trial will evaluate BromSite
against the DuraSite vehicle for reducing post-surgical pain and
inflammation with results expected in late 2012 or early 2013.
InSite decided in the second quarter to delay the initiation of its
planned Phase 3 study of DexaSite until further notice in order to
conserve fiscal resources and focus on the execution of the Phase 3
DOUBLe and BromSite clinical trials.
AzaSite® (azithromycin ophthalmic solution) 1% royalties
for the second quarter of 2012 were $1.3 million compared to $2.6
million in same period of 2011. AzaSite is marketed in North America
by Merck for the treatment of bacterial conjunctivitis. The decline in
the AzaSite royalties is due to a continuing reduction in
prescriptions for AzaSite in the United States since the acquisition
of Inspire Pharmaceuticals by Merck in May 2011. The $1.3 million in
AzaSite royalties is not sufficient for our subsidiary to fully make
the interest payments due to the holders of the AzaSite Notes on
August 15, 2012. We could make-up this shortfall with our own cash
resources, but we have not yet made a decision to do so.
In the second quarter of 2012, InSite recorded $0.5 million in royalty
revenues associated with Besivance® (besifloxacin
ophthalmic suspension) 0.6%, compared to $0.3 million in same period
of 2011. Besivance is marketed globally by Bausch + Lomb for the
treatment of bacterial conjunctivitis.
Second Quarter 2012 Results Summary
Total revenues decreased to $1.8 million for the second quarter of 2012
compared to $3.1 million in the same period in 2011. The decrease was
primarily due to a 50 percent decrease in AzaSite royalties from Merck
compared to the same period last year. The decrease was partially offset
by a $0.2 million increase in royalties from net sales of Besivance.
Research and development expenses for the second quarter of 2012 were
$4.8 million compared to $1.4 million in the same period in 2011. The
increase was primarily related to the DOUBle Phase 3 clinical trial and
preparation for the BromSite Phase 3 clinical trial. General and
administrative expenses for the second quarter of 2012 were $1.4 million
compared to $1.5 million in the same period in 2011. The difference is
primarily due to legal expenses pertaining to patent litigation that
were incurred in 2011. The change in fair value of the warrant liability
resulted in non-cash income of $0.2 million in the second quarter of
2012. The income resulted from a decrease in the fair value warrant
liability, which was due to a decrease in the company's stock price.
Net loss for the second quarter of 2012 was $6.8 million, or $0.05 per
share, compared to a net loss of $2.8 million, or $0.03 per share, in
the second quarter of 2011.
InSite Vision Incorporated