May 2 2012
InSite Vision Incorporated (OTCBB:INSV) today reported financial results
for the quarter ended March 31, 2012. Total revenues for the first
quarter of 2012 were $2.3 million, a decrease of $0.8 million from the
same quarter of 2011. InSite Vision had cash, cash equivalents and
short-term investments of $22.3 million as of March 31, 2012, reflecting
cash usage of $4.1 million in the quarter. During the first quarter of
2012, $2.1 million of cash was used for the AzaSite Plus™ and
DexaSite™ Phase 3 DOUBle clinical trial.
"The first quarter was one of progress against our product development
objectives to advance innovative ophthalmic therapeutics that we believe
will provide a meaningful benefit to patients," said Timothy Ruane,
InSite's Chief Executive Officer. "Enrollment in the Phase 3 DOUBle
clinical study of AzaSite Plus and DexaSite for the treatment of
blepharitis continues to go smoothly. We have recently conducted highly
productive meetings with the Food and Drug Administration to discuss the
regulatory path forward for both BromSite and DexaSite, which we expect
will move forward into Phase 3 clinical trials later this year. However,
we continue to be disappointed in Merck's commercialization results for
AzaSite as our royalties are down significantly from a year ago. We are
in communications with Merck to identify and develop a strategy designed
to restore AzaSite prescription growth as soon as possible."
Corporate and Commercial Highlights
AzaSite® (azithromycin ophthalmic solution) 1% royalties
for the first quarter of 2012 were $1.9 million compared to $2.7
million in same period of 2011. 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. AzaSite is approved for the treatment of bacterial
InSite recorded approximately $400 thousand in royalty revenues
associated with Besivance® (besifloxacin ophthalmic
suspension) 0.6%, compared to $200 thousand in same period of 2011.
Besivance is marketed globally by Bausch + Lomb for the treatment of
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
April 26, 2012, InSite had enrolled 515 patients in the DOUBle study
and expects to complete the trial and announce top-line results in
late 2012 or early 2013. 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 pivotal trial.
In February, InSite announced that following a discussion with the
FDA, the company will conduct a Phase 3 study of DexaSite against the
DuraSite vehicle to confirm DexaSite's efficacy against belpharitis.
The DexaSite study will be conducted in parallel with the ongoing
DOUBle study. InSite plans to begin this trial in the second half of
In February, InSite completed an end-of-Phase 2 meeting with the FDA
to discuss the Phase 3 protocol for BromSite™ (ISV-303), InSite's
product candidate for the treatment of post-surgical ocular
inflammation. The company plans to initiate a Phase 3 program
evaluating BromSite against the DuraSite vehicle this year with
results expected in early 2013.
In January 2012, the University of California, San Francisco (UCSF)
filed an appeal of the judgment in favor of InSite by the United
States Patent and Trademark Office (USPTO), which confirmed
inventorship of InSite's U.S. Patent Nos. 6,239,113 and 6,569,443
protecting AzaSite. InSite will continue to defend its patents
vigorously and believes that the UCSF appeal is without merit.
First Quarter 2012 Results Summary
Total revenues decreased by $0.8 million to $2.3 million for the first
quarter of 2012 compared to $3.1 million in the same period in 2011. The
decrease was primarily due to a 30 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
Research and development expenses for the first quarter of 2012 were
$4.0 million compared to $1.2 million in the same period in 2011. The
increase was primarily related to the DOUBle Phase 3 clinical trial.
General and administrative expenses for the first quarter of 2012 were
$1.4 million compared to $1.2 million in the same period in 2011. The
difference was primarily related to slightly higher personnel-related
costs due to an increase in headcount to support InSite's late-stage
clinical development activity. The change in fair value of warrant
liability resulted in income of $1.0 million in the first 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 first quarter of 2012 was $4.8 million, or $0.04 per
share, compared to a net loss of $2.4 million, or $0.03 per share, in
the first quarter of 2011.
InSite Vision Incorporated