InSite Vision Reports Second Quarter 2012 Financial Results
<0> InSite VisionLouis Drapeau, 510-747-1220Chief Financial OfficerorMedia and Investor inquiriesBCC PartnersMichelle Corral, 415-794-8662Karen L. Bergman, 650-575-1509 </0>
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 clinical trial.
“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.”
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 will host a conference call today beginning at 1:30 p.m. Pacific Time/4:30 p.m. Eastern Time to discuss its first quarter results.
Analysts and investors can participate in the conference call by dialing 888-713-4218 for domestic callers and 617-213-4870 for international callers using the pass code 78324903. A telephone replay will be available following the conclusion of the call by dialing 888-286-8010 for domestic callers and 617-801-6888 for international callers using the pass code 23185283.
The live conference call will also be webcast and available on the Investor Relations page of the company's website at . 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.
InSite Vision is advancing new ophthalmologic products for unmet eye care needs. The company’s product portfolio utilizes InSite Vision’s proven DuraSite bioadhesive polymer core technology, an innovative platform that extends the duration of drug retention on the surface of the eye, 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 (azithromycin ophthalmic solution) 1%, marketed in the U.S. by Merck, and Besivance (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch + Lomb. InSite Vision’s clinical-stage ophthalmic product pipeline includes AzaSite Plus and DexaSite for the treatment of eye infections, BromSite™ for pain and inflammation associated with ocular surgery, and ISV-101 for the treatment of dry eye disease. For further information on InSite Vision, please visit .
This news release contains certain statements of a forward-looking nature relating to future events, including the status of InSite’s clinical trials, including the timing of enrollment completion and announcement of top-line results from its DOUBle Phase 3 clinical trial and the expected timing of its Phase 3 BromSite clinical trial; the benefits of and prospects for InSite’s product candidates, and the potential event of default under the AzaSite Notes, including the statements in the quote from our Chief Executive Officer set forth above. Such statements entail a number of risks and uncertainties, including but not limited to: InSite’s ability to effectively design and conduct clinical trials for its product candidates, ability to meet the clinical endpoints for such trials and the timing thereof; InSite’s ability or willingness to use its cash to make payments under the AzaSite Notes; InSite’s ability to negotiate a favorable resolution with the holders of the AzaSite Notes to any event of default under the AzaSite Notes; InSite's reliance on third parties for the commercialization of its products including Merck and Bausch + Lomb and the effectiveness of the efforts of these third parties; the ability of InSite to maintain its corporate collaborations, particularly with Merck; the ability of InSite to enter into and maintain corporate collaborations for its product candidates; 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, InSite’s ability to successfully defend against UCSF’s appeal of the USPTOs decision in favor of InSite; InSite's ability to expand its product candidates and advance them through the clinic; InSite’s ability to effectively and on a timely basis enroll patients into its clinical trials and acquire materials used in its clinical trials and complete such clinical trials in a timely manner; 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; 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.