Ista Pharmaceuticals Inc (ISTA) SEC Filing 10-K Annual report for the fiscal year ending Saturday, December 31, 2011

Net revenues for the fourth quarter 2011 were $45.1 million, an increase of 9% over the third quarter of 2011, driven by sales of the twin pack for once-daily BROMDAY™ (bromfenac ophthalmic solution) 0.09% for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extractions and sales of BEPREVE^® (bepotastine besilate ophthalmic solution) 1.5%, ISTA’s ophthalmic solution for ocular itching associated with allergic conjunctivitis. Net revenues for year-end 2011 were $160.3 million, a 2.4% increase over full-year results for 2010 primarily driven by sales of BEPREVE.

Under generally accepted accounting principles in the United States (GAAP), for the fourth quarter and full-year 2011 the Company reported a net loss of $15.9 million and $56.6 million, respectively, primarily impacted by non-cash warrant valuation adjustments of $22.2 million and $47.1 million, respectively, resulting from an increase in the Company’s stock price in the fourth quarter and for the year ending 2011. On an adjusted cash basis, ISTA had net income for the fourth quarter and full-year 2011 of $11.8 million, or $0.25 per diluted share, and $6.2 million, or $0.13 per diluted share, respectively, based on 47.3 million and 48.2 million diluted shares outstanding.

During the fourth quarter ISTA announced positive preliminary results from the Company’s Phase 3 clinical program for PROLENSA™ (bromfenac ophthalmic solution), a lower concentration, new formulation of BROMDAY to treat pain and inflammation associated with cataract surgery. There were no serious drug-related ocular or systemic adverse events, and PROLENSA’s safety profile was found to be consistent with ISTA’s currently marketed topical non-steroidal anti-inflammatory (NSAID) compound, BROMDAY. Based upon these successful results, ISTA plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the first half of 2012, to gain approval to market PROLENSA in the U.S.