Despite $1.9 million net loss for fourth quarter, Ista reports strong full-year ophthalmic sales

IRVINE, Calif. — Ista Pharmaceuticals reported a net loss of $1.9 million, or $0.06 per share, for the fourth quarter of 2008, which was an improvement compared with a net loss of $9.9 million, or $0.30 per share, for the fourth quarter of 2007, the company announced.

For the full-year 2008, Ista posted a net loss of $30.7 million, or $0.93 per share, compared with a net loss of $38.2 million reported during the full-year 2007, according to a press release from the company.

Ista's fourth-quarter net revenue totaled $28.1 million, up from $19.2 million during last year's fourth quarter. For the full-year 2008, the company posted $83.1 million in net revenue, compared with $58.9 million reported last year.

Specifically, full-year net revenues from sales of Xibrom (bromfenac ophthalmic solution 0.09%) increased to $63 million, a 50% increase over $42.1 million in net revenues reported in 2007.

In addition, full-year net revenues from sales of Istalol (timolol maleate 0.5%) rose 29% to $14.6 million, and net revenues from sales of Vitrase (hyaluronidase) remained at $5.2 million, according to the release.

"In 2008, Ista became the fastest-growing and fifth-largest branded ophthalmic drug company in the U.S. Xibrom continues its strong growth trajectory, and Istalol ended the year with an upswing in prescriptions," Vicente Anido Jr., PhD, president and chief executive officer of Ista, said in the release.

At Dec. 31, Ista had cash and short-term investments of $53 million. The company expects to end 2009 with a cash balance of $35 million to $45 million, including cash drawn on its Silicon Valley Bank revolving credit facility, which will be subject to change because of fluctuations in working capital, the release said.

Ista expects net revenue of $92 million to $97 million for 2009, and its operating income to break even. Because of the influence of interest and related expenses, the company estimates its net loss for 2009 to fall between $7 million and $10 million.

"We expect results from our T-Pred studies in the second half of 2009 that will supplement our [new drug application] filing, and we will complete a confirmatory [phase 3] trial for Xibrom QD to support our [supplemental new drug application] filing," Dr. Anido said in the release.

"We also have initiated a clinical study with a lower concentration of Xibrom to treat dry eye syndrome. At the end of 2008, we completed a [phase 2b] clinical study for ecabet sodium and believe the recently announced positive results ... provide a clear path forward to the [phase 3] study designs and [new drug application] filing requirements. Based upon our further analysis of the ecabet sodium [trial] and results from our Xibrom lower concentration study, we will make a decision on which product or products in our dry eye franchise to move into [phase 3] trials, which could start as early as 2010," Dr. Anido said.