25.02.2008 13:00:00
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InSite Vision Completes $60 Million Non-Recourse Note Offering Secured by AzaSite(R) Royalties
InSite Vision Incorporated (AMEX:ISV) today announced that it has closed
a private placement to institutional investors of $60 million in
aggregate principal amount of non-convertible, non-recourse promissory
notes. The notes are secured by royalties to be paid from sales in the
United States and Canada of AzaSite®
(azithromycin ophthalmic solution) 1%, a drug licensed to and sold by
Inspire Pharmaceuticals for the topical treatment of bacterial
conjunctivitis (pink eye).
"This non-dilutive financing will help us to
transform InSite into a multiple product and sustainable company. We
believe this financing will accelerate our ability to advance our
current product candidates and bring them to market resulting in an
increased revenue stream within the next two to three years,”
said Kumar Chandrasekaran, Chairman and Chief Executive Officer. "We
are well-positioned to build a successful company with products that
will help our patients live better lives.” "It is important to note that once we have
repaid the notes, InSite will again receive all of the royalty payments
under the existing agreement with Inspire,”
said Louis Drapeau, Vice President and Chief Financial Officer.
The company also announced that it will terminate a shelf registration
statement filed in May 2007 in preparation for a potential public
offering of equity securities.
InSite Vision intends to use the proceeds of the placement to fund the
advancement of its pipeline products, including AzaSite Plus™,
AzaSite Otic™ and AzaSite Xtra™,
for general corporate purposes, as well as to potentially acquire
complementary businesses, products, technologies or other assets,
although InSite has no current agreements or commitments with respect to
any acquisitions.
The notes are non-recourse to InSite Vision and are not convertible into
InSite equity. The annual cash coupon rate on the notes is 16% with
interest payable quarterly beginning May 15, 2008. Interest and
principal will be paid back from revenue received from the royalties
from AzaSite sales in the United States and Canada. AzaSite revenue
resulting from sales in countries other than Canada and the United
States is not included in this transaction. Net proceeds to InSite from
the financing are approximately $50 million after transaction costs and
interest reserves.
When the AzaSite royalties received for any quarter exceed the interest
payments and certain expenses due that quarter, the excess will be
applied to the repayment of principal of the notes until the notes have
been paid in full. The notes may be redeemed at InSite’s
option, subject to the payment of a redemption premium for a certain
period of time.
The notes have not been and will not be registered under the Securities
Act of 1933 and may not be offered or sold in the United States absent
an applicable exemption from the registration requirements of the Act.
About InSite Vision and AzaSite
InSite Vision develops novel topical anti-infective products, including
AzaSite® (azithromycin ophthalmic solution)
1% which was launched in the United States in August 2007 by Inspire
Pharmaceuticals for the topical treatment of bacterial conjunctivitis
(pink eye). InSite Vision licensed AzaSite to Inspire Pharmaceuticals
which has exclusive rights to commercialize AzaSite in the United States
and Canada. As part of the agreement, Inspire paid InSite an upfront
license fee of $13 million and an additional $19 million milestone
payment when the product was approved by the Food and Drug
Administration (FDA) in April 2007. Inspire also pays a royalty on net
sales of AzaSite in the United States and Canada at a rate of 20% in the
first two years of commercialization and 25% thereafter.
Based on its proprietary azithromycin-DuraSite®
technology platform used for AzaSite, InSite is pursuing the expansion
of its portfolio of anti-infective ophthalmic products to include
AzaSite Plus and AzaSite Xtra which have product features with the
potential to provide significant advantages currently not available with
conventional treatment options. In addition, InSite is evaluating the
use of its azithromycin-DuraSite platform to develop topical
anti-infective products outside of the ophthalmology market beginning
with AzaSite Otic for ear infections.
Forward Looking Statements
This news release contains certain statements of a forward-looking
nature relating to future events, such as the use of proceeds from the
note financing; the benefits of the financing; InSite’s
corporate goals; InSite’s ability to use the
proceeds of the financing to accelerate the advancement of its current
product candidates and bring them to market resulting in an increased
revenue stream within the next two to three years; the expected date of
repayment of the notes; the expectation that InSite will receive the
royalties due under the Inspire agreement once the notes have been
repaid; the potential value of the Inspire royalty stream; and InSite’s
product pipeline and development initiatives. Such statements entail a
number of risks and uncertainties, including but not limited to: InSite
may apply the net proceeds from the financing to other corporate
purposes which may not provide the optimal rate of return to InSite and
its stockholders; InSite may not achieve its corporate goals; the
Inspire royalty stream may not be sufficient to repay the notes or to
repay the notes on the expected timeline; the Inspire license agreement
may be terminated and InSite may not be able to find a new partner or be
able to successfully market AzaSite itself, resulting in a default on
the notes and foreclosure by the investors in the financing; if there is
an event of default under the indenture pursuant to which the notes were
issued, the investors will have the right to obtain rights to AzaSite
under certain circumstances which would preclude InSite from receiving
the royalties or other payments received on AzaSite even after the notes
have been repaid; the royalty stream for AzaSite may not be as large as
estimated in the report prepared by InSite’s
royalty consultant. InSite Vision’s reliance
on third parties, including Inspire, for the commercialization of
AzaSite and its other products; the ability of InSite Vision to enter
into corporate collaborations for AzaSite outside the United States and
Canada and with respect to its other product candidates, including
AzaSite Plus; Inspire’s ability to
successfully market AzaSite in the United States and Canada; InSite
Vision’s ability to expand its technology
platform to include additional indications; InSite Vision’s
ability to maintain and develop additional collaborations and commercial
agreements with corporate partners, including those with respect to
AzaSite, AzaSite Plus, AzaSite Xtra and AzaSite Otic; and its ability to
adequately protect its intellectual property and to be free to operate
with regard to the intellectual property of others; and determinations
by the FDA, including those with respect to AzaSite Plus and AzaSite
Otic. 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.
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