InSite Vision Reports Third Quarter 2013 Financial Results
Date : 11/12/2013 @ 4:03PM
Source : Business Wire
Stock : Insite Vision, Inc. (QB) (INSV)
Quote : 0.26 0.02 (8.33%) @ 2:03PM
InSite Vision Reports Third Quarter 2013 Financial Results
Print
Alert
Insite Vision, Inc. (QB) (USOTC:INSV)
Historical Stock Chart
1 Month : From Oct 2013 to Nov 2013
Click Here for more Insite Vision, Inc. (QB) Charts.
InSite Vision Incorporated (OTCBB:INSV) today reported financial results for the quarter ended September 30, 2013. Revenues for the third quarter of 2013 were $5.3 million compared to $12.1 million for the same period in 2012. Included in the third quarter of 2013 and 2012 were an additional $3.7 million and $9.3 million, respectively, in minimum royalty true-up payments from Merck on net sales of AzaSite. Net income for the third quarter of 2013 was $0.6 million, or less than $0.01 per share, compared to net income of $5.1 million, or $0.04 per share, in the third quarter of 2012.
“InSite is making good progress against our key objectives,” said Timothy Ruane, InSite’s Chief Executive Officer. “We completed our confirmatory Phase 3 study of BromSite for ocular inflammation and pain ahead of schedule and we look forward to reporting that data by year end. We also bolstered our IP portfolio with the receipt of a key patent for our DuraSite 2 platform, which will serve as the foundation for our future ophthalmic therapeutic candidates and is available for licensing to other ophthalmic companies to enhance their products.”
Recent Corporate and Commercial Highlights
In November 2013, InSite completed the confirmatory Phase 3 clinical trial of BromSite™ for the reduction of inflammation and pain after cataract surgery. This study enrolled 248 patients undergoing cataract surgery in a two-arm trial evaluating the efficacy and safety of BromSite against the DuraSite vehicle alone. BromSite combines a low dose (0.075%) of the non-steroidal anti-inflammatory drug (NSAID) bromfenac with InSite’s DuraSite drug delivery technology. Top-line results from this Phase 3 clinical study are expected before the end of 2013.
Results from InSite’s first Phase 3 pivotal trial demonstrated that treatment with BromSite achieved statistically significant superiority in reducing inflammation and pain compared to treatment with the DuraSite vehicle alone in patients following cataract surgery.
In October 2013, InSite announced that the United States District Court for the District of New Jersey upheld all four of the patents protecting AzaSite® (azithromycin 1% ophthalmic solution) in a patent infringement lawsuit against Sandoz Inc. On November 4, 2013, Sandoz filed an appeal of this decision to the United States Court of Appeals for the Federal Circuit. Sandoz filed an Abbreviated New Drug Application (ANDA) with the FDA in 2011 seeking to market a generic version of AzaSite before expiration of the patents covering AzaSite and its use.
InSite, Merck and Pfizer filed a similar lawsuit against Mylan Pharmaceuticals in June 2013. Mylan recently filed to market a generic version of AzaSite. Merck, with the assistance of InSite and Pfizer, intends to vigorously defend the five U.S. patents related to AzaSite.
On August 1, 2013, Merck notified the Company that it had ceased sales representative promotion of their ophthalmic products, including AzaSite, in the United States. The ophthalmic products, including AzaSite, will continue to be commercially available in the United States and physicians will be able to continue to prescribe the products for their patients. Merck’s obligation to make minimum royalty payments terminated on September 30, 2013.
In August 2013, the United States Patent and Trademark Office (USPTO) issued a patent on DuraSite® 2, the next-generation enhanced drug delivery system. DuraSite 2 provides a broad new platform for developing topically delivered ocular drugs with enhanced tissue penetration in order to improve efficacy and dosing convenience. The patent provides protection to 2029 for the delivery system and drugs that are formulated with DuraSite 2. InSite plans to use the DuraSite 2 platform in the development of all future pipeline products, and initiate a broad licensing program allowing partners exclusive and non-exclusive licensing and/or commercialization relationships.
In July 2013, InSite announced top-line results from the DOUBle Phase 3 clinical study, a multi-product trial evaluating AzaSite Plus™ and DexaSite™ in the treatment of moderate-to-severe blepharitis. While the trial did not meet the primary endpoint of complete resolution of all clinical signs and symptoms, AzaSite Plus and DexaSite demonstrated statistically significant improvements in clinical signs and symptoms of disease at Day 15.
We are in discussions with the U.S. Food and Drug Administration (FDA) to discuss the data from the clinical trial and determine the next steps in the development of these product candidates in the blepharitis indication.
Third Quarter 2013 Results Summary
Total revenues decreased to $5.3 million for the third quarter of 2013 compared to $12.1 million for the same period in 2012. Earned royalties from Merck for net sales of AzaSite were $1.1 million and $2.2 million for the third quarter of 2013 and 2012, respectively. Royalties from Merck included a $3.7 million minimum royalty true-up in the third quarter of 2013 and a $9.3 million minimum royalty true-up for the same period in 2012. The decrease in minimum royalties was primarily driven by an amendment to the payment terms of the Merck License in August 2012 such that Merck will pay on a quarterly basis, the higher of the pro-rata annual minimum royalty or the earned royalty for 2012 and 2013. As such, Merck paid an annual minimum royalty true-up payment in the third quarter of 2012, compared to a quarterly pro-rata share of the minimum royalty amount in the same period of 2013. The required minimum royalty for the fiscal year ended September 30, 2013 and 2012, the measurement period pursuant to the terms of the Merck License, was $19 million and $17 million, respectively. Merck’s obligation to make minimum royalty payments terminated on September 30, 2013. Revenues in the third quarter of 2013 also included $0.5 million from manufacturing equipment rental and the sale of azithromycin to Merck.
Research and development (R&D) expenses for the third quarter of 2013 were $2.5 million compared to $2.6 million in the same period in 2012. For the third quarter of 2013, program expenses were primarily related to costs of InSite’s second BromSite Phase 3 clinical trial. For the third quarter of 2012, program expenses were primarily related to costs of the first BromSite Phase 3 clinical trial and the AzaSite Plus/DexaSite DOUBle Phase 3 clinical study.
General and administrative (G&A) expenses for the third quarter of 2013 were $1.3 million compared to $1.6 million in the same period in 2012. The higher expenses in 2012 were attributable to legal expenses pertaining to patent litigation with the Regents of the University of California.
Net income for the third quarter of 2013 was $0.6 million, or less than $0.01 per share, compared to net income of $5.1 million, or $0.04 per share, in the third quarter 2012. Net income was higher in 2012 primarily due to additional minimum royalties received from Merck.
As of September 30, 2013, InSite had cash, cash equivalents and short-term investments of $11.4 million. Total cash usage in the third quarter of 2013 was $3.2 million.
