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ISTA Pharmaceuticals Reports Second Quarter 2011 Financial Results

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mlkrborn   Friday, 07/29/11 03:18:20 PM
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ISTA Pharmaceuticals Reports Second Quarter 2011 Financial Results
Date : 07/28/2011 @ 4:05PM
Source : MarketWire
Stock : ISTA Pharmceuticals (ISTA)
Quote : 4.945 -2.255 (-31.32%) @ 1:50PM

ISTA Pharmaceuticals Reports Second Quarter 2011 Financial Results
Ista Pharmaceuticals, Inc. (MM) (NASDAQ:ISTA)
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ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA), today reported financial results and progress on key milestones for the quarter ended June 30, 2011.

Second Quarter 2011 Highlights

* Second quarter 2011 net revenues were $37.1 million, an increase of 6% over the second quarter of 2010.



* Revenues for ISTA's ophthalmic solution for ocular itching associated with allergic conjunctivitis, BEPREVE® (bepotastine besilate ophthalmic solution) 1.5%, almost doubled over the prior-year quarter, growing from $6.2 million to $12.2 million.



* In April 2011, ISTA announced positive, top-line results from its Phase 2 study of bepotastine besilate nasal spray for allergic rhinitis.



* Under generally accepted accounting principles in the United States (GAAP), net income for the second quarter ended June 30, 2011, was $12.8 million, or $0.25 per share, based on 50.2 million fully diluted shares, impacted primarily by a non-cash warrant valuation gain of $19.0 million resulting from a decrease in the Company's stock price in the quarter. On an adjusted cash basis, ISTA had a net loss of $4.2 million, or loss of $0.11 per share, based on 38.4 million shares outstanding.



"As a company, we consistently record 40% of our net revenues in the first half of the year and 60% in the second half. Our first half net revenues of $73.9 million clearly put us on track to achieve our 2011 annual revenue guidance of $175 million to $190 million," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals. "In the second quarter, as a result of a concentrated sales and marketing campaign during a rather severe spring allergy season, product revenues for BEPREVE, our prescription eye drops for ocular itching associated with allergic conjunctivitis, were up 97% over the prior-year quarter. We have established a solid second position behind the market leader with a product that brings fast, long-lasting relief to ocular allergy sufferers.

"Prior to the allergy season, we successfully converted more than 80% of the bromfenac franchise from twice-daily XIBROM™ to once-daily BROMDAY™ for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extractions. We discontinued XIBROM shipments in late February and refocused our selling efforts on BEPREVE. Midway into the second quarter, a generic competitor to twice-daily XIBROM was approved. While the sales force was dedicated to BEPREVE, our channel and managed care teams were working to strengthen our bromfenac franchise position within the ophthalmic non-steroidal anti-inflammatory drug (NSAID) market. Year-to-date June 2011, as compared to 2010, total prescriptions for ISTA's bromfenac franchise (BROMDAY and XIBROM) increased 6.5% and on a weekly basis, BROMDAY continues to capture share. While revenues for our bromfenac franchise were down in the second quarter over the prior-year quarter, now that the spring allergy season is over, our sales force is fully dedicated to building share with the only once-daily NSAID on the market. Overall, our commercial business has been highly effective this year and with recent managed care contract wins for both BEPREVE and BROMDAY, we have confidence that we can gain share in both the allergic conjunctivitis and NSAID markets in the second half."

Dr. Anido continued, "In terms of progress on our new product pipeline, in April, we announced positive, top-line results from our Phase 2 study of bepotastine besilate nasal spray for allergic rhinitis. We're in discussions with the U.S. Food and Drug Administration (FDA) on the clinical study designs for a bepotastine besilate/steroid combination nasal spray and plan to initiate a Phase 2 trial either during the Mountain Cedar Pollen season later this year or during spring allergy season early next year. Our recently initiated Phase 3 studies for low-concentration BROMDAY are now fully enrolled. We plan to announce results from the low-concentration BROMDAY studies in fourth quarter of this year and launch the product in late 2012 or early 2013.

"In a separate press release today, we reported the preliminary results for the first of two Phase 3 efficacy and short-term safety trials for REMURA™ for dry eye (WEST study), which showed that while REMURA was highly effective in treating a sign and symptom of dry eye versus baseline, it was not statistically significantly better than placebo, a common outcome in dry eye clinical studies. REMURA achieved statistical significance against placebo in the sign of conjunctival staining in a key female patient sub-population with moderate dry eye disease. Armed with this data, we expect to amend the statistical plan to appropriately focus the EAST study. In the fourth quarter of this year, we expect to report the Phase 3 results from the REMURA EAST study, which now is fully enrolled but the database has not been locked. The EAST data will be combined with the results of the WEST study, and the full dataset will determine the next steps for this program."

Financial Results

Net revenues for the second quarter ended June 30, 2011, were $37.1 million, or an increase of 6% over the same period in 2010. Net revenue growth was driven primarily by strong demand for BEPREVE, for ocular itching associated with allergic conjunctivitis, and ISTALOL®, a beta-blocking agent for the treatment of glaucoma.



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