Irvine-based Ista Pharmaceuticals Inc. says it is set to turn its first full-year profit in its nearly 20-year existence.
Ista, which makes drugs for treating various eye ailments, said it expects an operating profit of $8 million to $10 million this year, excluding onetime charges, versus a projected loss of about $11 million in 2009.
The company is scheduled to report fourth-quarter results on Tuesday and said earlier this month that preliminary numbers show its 2009 revenue was $110.6 million, up 33% from a year earlier.
For 2010, the company expects sales of $147 million to $165 million, seeing growth in its anti-inflammatory drug Xibrom, related products and Bepreve, an itchy eye drug.
Analysts on average expect Ista to make $7.8 million this year before charges on sales of $148 million.
“Now we’ve covered all of the expenses and now we have monies dropping to the bottom line, so we expect to make money this year,” Chief Executive Vince Anido said.
Ista expects growth from a wider launch of Bepreve. The launch will extend into the middle of this year.
Ista projects that Bepreve, which is sold through ophthalmologists, optometrists and allergists, could generate $20 million in sales this year.
Bepreve was launched on a limited basis last fall to what Anido called the top 300 to 400 doctors who prescribe eye allergy drugs in the U.S.
“As doctors receive feedback and the calendar moves into the spring allergy season, we would expect Bepreve prescriptions to begin showing growth,” said Frank Pinkerton, an analyst with Atlanta investment bank SunTrust Robinson Humphrey Inc.
By the end of 2011, Bepreve could gain 5% of the prescription eye allergy market, which is valued at some $600 million yearly, Pinkerton said.
Bepreve will have competition from Alcon Inc.’s Patanol and Pataday, along with a pair of major prescription eye allergy drugs that are going off patent.
Those are Optivar, from Somerset, N.J.-based Meda Pharmaceuticals Inc., and Elestat, which is made by Inspire Pharmaceuticals Inc. of Durham, N.C.
Flagship Drug
Ista’s sales have been carried by flagship drug Xibrom, which is used twice daily for treating pain after cataract surgery.
Wall Street has liked the growth plan, sending Ista’s shares up 525% in 2009 after falling 90% in 2008 and 30% in 2007, following some setbacks.
Investors stand to benefit from Bepreve’s wider launch and a possible Food and Drug Administration approval for XiDay, a once-daily version of Xibrom, Pinkerton said.
“Ista is positioned in one of our favorite niche markets,” he said.
Investors have pulled back a little in 2010, with Ista’s stock down about 15% so far this year with a recent market value of about $130 million.
“There was a lot of fast money that came into the stock in anticipation of the Bepreve approval,” Ista’s Anido said. “So that money ran in, made its money (and) then went roaring back out. It’s not an uncommon event.”
Ista, which was started in 1992 as Advanced Corneal Systems Inc., is building up its sales staff. The drug maker previously said it would grow its sales force from 103 to 165 people to push the expanded allergy drug.
“Feb. 8 was our target date to have everybody out in the field because, typically, March is when we start seeing the first allergies kicking in,” Anido said.
Overall, Ista has 325 workers, half of whom are in OC.
Even though Ista has high hopes for Bepreve, sales have primarily grown because of Xibrom, which accounts for more than 75% of Ista’s revenue.
Updated drug XiDay is slated to launch before twice-daily Xibrom faces generic competition—although the company has said that it doesn’t expect to see a generic version for another two to three years.
Also on tap: a clinical trial for a lower-concentration version of Xibrom to treat dry eye, something Ista became interested in after a couple of doctors called Anido and told him that Xibrom helped their patients’ conditions improve faster.
Currently, the only FDA-approved drug for dry eye is Restasis, which Irvine-based Allergan Inc.
