INSV NEWS and CC today --
ALAMEDA, Calif., Nov 11, 2009 (BUSINESS WIRE) -- InSite Vision Incorporated
(OTCBB: INSV) today reported financial results for the quarter ended September< BR>30, 2009. Total revenue for the third quarter of 2009 was $2.2 million with a
net loss of $3.1 million, or $0.03 per share.
"We completed the third quarter with a solid cash position and increased product
revenues," said Louis Drapeau, InSite Vision's Chief Executive Officer. "AzaSite
sales have been growing steadily through the efforts of our partner Inspire
Pharmaceuticals, and beginning in the third quarter, our royalty rate on AzaSite
increased by five percent to 25 percent. In addition, this year we have
conserved fiscal resources, significantly reducing our costs as we evaluate
strategic opportunities and execute our 2009 business objectives."
Recent Accomplishments and Events
-- Prescriptions of AzaSite (azithromycin ophthalmic solution) 1%, InSite
Vision's product for the treatment of bacterial conjunctivitis, increased by 50
percent over the third quarter 2008.
-- Inspire Pharmaceuticals, InSite Vision's comm ercial partner for AzaSite in
the U.S. and Canada, increased production of AzaSite in response to a temporary
supply shortage of erythromycin ophthalmic ointment (0.5%). Erythromycin
ophthalmic ointment is a macrolide antibiotic routinely used in neonates for
prevention of ophthalmia neonatorum, a form of bacterial conjunctivitis that may
be contracted by newborns during delivery. Inspire estimated that $1.0 - $1.5
million of third quarter AzaSite revenue resulted from the shortage.
-- Beginning in August 2009, the royalty rate to InSite Vision on AzaSite sales
increased from 20 percent to 25 percent per the terms of InSite's agreement with
Inspire Pharmaceuticals.
-- Besivance(TM) (besifloxacin ophthalmic suspension) 0.6%, the second
commercial product to utilize InSite Vision's proprietary DuraSite(R) drug
delivery platform, is being marketed by InSite Vision's licensee, Bausch & Lomb
and their partner, Pfizer Inc, for the tre atment of bacterial conjunctivitis in
patients one year and older. Beginning in November 2009, InSite Vision will
receive a mid-single digit royalty from Bausch & Lomb on global net product
sales of Besivance.
-- Inspire Pharmaceuticals announced that enrollment is complete in one of two
Phase 2 clinical trials of AzaSite for the treatment of blepharitis. Two
randomized, placebo-controlled multi-center Phase 2 studies were initiated in
May 2009 to evaluate the safety and efficacy of AzaSite for the treatment of
blepharitis, an ocular disease characterized by inflammation of the eyelids. As
of November 5, 2009, target enrollment of 300 patients had been reached in the
four-week trial and 250 of 300 patients had been enrolled in the two-week trial.
Inspire Pharmaceuticals is targeting completion of enrollment in the two-week
trial in the first quarter of 2010.
-- InSite Vision continued its work with Piper Jaffray & Co. to identif y and
evaluate strategic opportunities. A number of existing and more recent
opportunities are under evaluation, and management will provide future updates,
as appropriate.
Third Quarter 2009 Results Summary
Revenues for the quarter ended September 30, 2009 were $2.2 million compared to
$1.0 million for the same period in 2008. Third quarter 2009 revenues included
royalties from Inspire Pharmaceuticals of $2.2 million for sales of AzaSite
compared to $0.9 million for the third quarter 2008. Royalties from Inspire
Pharmaceuticals increased by $1.3 million compared to the same period in 2008
principally due to a 92 percent increase in AzaSite revenues recorded by
Inspire.
Research and Development (R&D) expenses for the quarter ended September 30, 2009
were $1.0 million compared to $3.7 million in same period of 2008. Reduced R&D
spending in the third quarter of 2009 was primarily driven by the completion of
the first Pha se 3 trial of ISV-502 in late 2008. In addition, the company
incurred lower personnel-related expenses associated with the corporate
restructurings which occurred in December 2008 and March 2009.
General and Administrative (G&A) expenses were $1.4 million in the third quarter
of 2009, compared to $2.7 million for the same quarter in 2008. G&A expenses for
the third quarter decreased primarily due to legal and other expenses related to
the proxy contest in the third quarter of 2008. In addition, lower
personnel-related expenses associated with the corporate restructurings were
incurred.
InSite Vision had cash, cash equivalents and short-term investments of $26.7
million as of September 30, 2009. Total cash usage in the quarter ended
September 30, 2009 was $1.7 million.
Conference Call Today
InSite Vision will host a conference call today beginning at 4:30 p.m. Eastern
Time to discuss the company's third quarter results .
Analysts and investors can listen to the conference call by dialing (877)
407-0778 for domestic callers and (201) 689-8565 for international callers. A
telephone replay will be available following the conclusion of the call by
dialing (877) 660-6853 for domestic callers and (201) 612-7415 for international
callers. All callers will need to enter the account number 286 and conference ID
336735.
The live conference call will also be webcast and available on the Investor
Relations page of the company's website at www.insitevision.com. A copy of this
press release will be furnished to the Securities and Exchange Commission on a
Form 8-K and posted on the company's website prior to the call.
About InSite Vision
InSite Vision is committed to advancing new and superior ophthalmologic products
for unmet eye care needs. InSite Vision is recognized for the discovery and
development of novel ocular pharmaceutical products base d on its DuraSite(R)
bioadhesive polymer core technology, an innovative platform that extends the
duration of drug delivery on the eye's surface, thereby reducing frequency of
treatment and improving the efficacy of topically delivered drugs. The DuraSite
platform is currently leveraged in two commercial products for the treatment of
bacterial eye infections, AzaSite(R) (azithromycin ophthalmic solution) 1% and
Besivance(TM) (besifloxacin ophthalmic suspension) 0.6%. AzaSite is approved in
the United States and Canada and currently marketed by InSite Vision's partner,
Inspire Pharmaceuticals in the United States. InSite Vision has formed multiple
strategic licensing and distribution agreements with qualified partners to
market AzaSite in select countries in Asia and South America upon regulatory
approval in those regions. Besivance was approved by the U.S. Food and Drug
Administration in the second quarter 2009 and is being marketed by Bau sch & Lomb
and Pfizer Inc.
InSite Vision's ophthalmic product development pipeline also includes ISV-502
and additional product candidates leveraging the company's core technologies.
For further information on InSite Vision, please visit www.insitevision.com.
Forward-Looking Statements
This news release contains certain statements of a forward-looking nature
relating to future events, including the targeted completion date for enrollment
in Inspire's AzaSite blepharitis Phase 2 trials, statements regarding InSite's
review of its strategic options, InSite's plans to advance its AzaSite family of
products, and InSite's corporate goals. Such statements entail a number of risks
and uncertainties, including but not limited to: InSite's reliance on third
parties for the commercialization of its products; the ability of InSite to
enter into corporate collaborations for its product candidates; InSite's ability
to effectively purs ue its strategic options and to negotiate favorable terms
with respect thereto; InSite's ability to expand its technology platform to
include additional indications; InSite's ability to compete effectively, either
alone or through its partners, with other companies offering competing products
or treatments; InSite's ability to maintain and develop additional
collaborations and commercial agreements with corporate partners, including
those with respect to AzaSite; InSite's ability and willingness to commence
additional clinical trials with respect to ISV-502 and InSite's various other
product candidates and the results of such trials; its ability to adequately
protect its intellectual property and to be free to operate with regard to the
intellectual property of others and determinations of the U.S. Patent and
Trademark Office regarding same; and determinations by the U.S. Food and Drug
Administration. Reference is made to the discussion of these and other risk
factors detailed in InSite Vision's filings with the Securities and Exchange
Commission, including its annual report on Form 10-K and its quarterly reports
on Form 10-Q, under the caption "Risk Factors" and elsewhere in such reports.
Any forward-looking statements or projections are based on the limited
information currently available to InSite Vision, which is subject to change.
Although any such forward-looking statements or projections and the factors
influencing them will likely change, InSite Vision undertakes no obligation to
update the information. Such information speaks only as of the date of its
release. Actual events or results could differ materially and one should not
assume that the information provided in this release is still valid at any later
date.
InSite Vision Incorporated &n bsp;
;
Condensed Consolidated Statements of Operations
For the Three and Nine Months Ended September 30, 2009 and 2008
(in thousands, except per share amounts; unaudited) &nb sp;
&nb sp; Three months ended Nine months ended
September 30, September 30,
2009 2008 2009 2008
&nb sp;
Revenues $ 2,209 $ 960 $ 6,336 $ 12,196
Cost of revenues 316 167 798 376
Operating expenses:
Research and development 1,007 ; 3,694 4,550 12,722
General and administrative 1,425 2,724 4,626 6,293
Severance 0 0 369 0
Impairment 0 0 615 0
Total operating expenses 2,432&nb sp; 6,418 10,160 19,015
Loss from operations (539 ) (5,625 ) (4,622 ) (7,195 )
Interest (expense) and other income, net (2,513 ) (2,325 ) (7,485 ) (5,547 )
Net loss &n bsp; $ (3,052 ) $ (7,950 ) $ (12,107 ) $ (12,742 )
Net loss per share:
Basic $ (0.03 ) $ (0.08 ) $ (0.13 ) $ (0.13 )
Diluted $ (0.03 ) $ (0.08 ) $ (0.13 ) $ (0.13 )
Shares used to calculate net loss per share:
Basic 94,738 94,629 94,701 94,600
Diluted 94,738 94,629 94,701 94,600
Condensed Consolidated Balance Sheets
At September 30, 2009 and December 31, 2008 &nb sp;
(in thousands; unaudited)
September 30, December 31,
&nb sp; 2009 2008
Assets:
Cash, cash equivalents and short-term in vestments $ 26,749 $ 37,456
Receivables, prepaid expenses and other current assets 2,263 1,667
Property and equipment, net 381 1,479
Debt issuance costs, net &nb sp; 4,028 4,341
Total assets $ 33,421 $ 44,943
Liabilities and stockholders' deficit:
Accounts payable and accrued expenses $ 1,993 $ 2,876
Accrued interest & nbsp; 2,377 1,200
Deferred revenue 75 373
Long-term secured notes payable 60,000 60,000
Stockholders' deficit &nb sp; (31,024 ) (19,506 )
Total liabilities and stockholders' deficit $ 33,421 $ 44,943
SOURCE: InSite Vision
CONTACT:
InSite Vision
Louis Drapeau, Chief Executive Officer, 510-747-1220
mail@insite.com
or
Availe Communications
Ellen Rose, 650-387-8746 (Media Inquiries)
Copyright Business Wire 2009
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KEYWORD: United States
North America
California
INDUSTRY KEYWORD: Health
Biotechnology
Optical
Pharmaceutical
SUBJECT CODE: Earnings
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