ISTA Pharmaceuticals Announces 2010 Financial Guidance
ISTA Expects 2010 Net Revenue of $147 to $165 Million
Company Anticipates 2010 Operating Income of $8 to $10 Million
Press Release Source: ISTA Pharmaceuticals, Inc. On Tuesday February 9, 2010, 9:00 am
IRVINE, Calif., Feb. 9 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) today announced financial guidance for the full year 2010. The Company expects net revenue will be approximately $147 to $165 million. In addition, ISTA's management anticipates reporting its first profitable year in 2010, with earnings per share for the full year expected to be at least $0.02, excluding any mark-to-market adjustments relating to warrants.
"2010 will mark ISTA's transition from a young development company to a financially independent commercial organization," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals. "By offering products with differentiated value propositions for both the physician and the patient and building a strong and motivated commercial team, we will have achieved this milestone five years after launching our first product, Istalol, which was closely followed by the launch of our flagship product, Xibrom. As we look to 2010 and beyond, Bepreve, Xibrom, XiDay, bepotastine nasal spray, and bromfenac for dry eye stand out as our long-term growth drivers, and we are excited about ISTA's future."
2010 Financial Outlook in Detail
We expect our net revenue for 2010 will be approximately $147 to $165 million. We continue to assume there will not be a generic competitor to Xibrom in 2010. We expect sales from our Xibrom franchise (including XiDay, assuming U.S. Food and Drug Administration (FDA) approval) to be in the range of $95 to $105 million and anticipate sales from Bepreve will be at least $20 million. As in previous years, our net sales are seasonal, with first quarter net sales typically being the lowest of the year and less than the prior quarter.
We expect our gross margin in 2010 will be in the range of 74% to 76%.
We expect R&D expenses to be approximately 18% to 22% of net revenue, depending upon the progress of our clinical programs. In 2010, we will focus our development activities on our bromfenac formulation as a treatment for dry eye disease and our nasal bepotastine formulation for nasal allergies. During 2010, we anticipate initiating our full-scale Phase 3 clinical program in dry eye disease, as well as the long-term safety study required by the FDA in advance of a New Drug Application (NDA) filing. To maximize our bepotastine franchise, we will complete our formulation work for bepotastine nasal and anticipate initiating the clinical program with this product as a treatment for nasal allergies in 2010.
We expect SG&A expenses for 2010 to be approximately 48% to 52% of net revenue.
We expect our operating income for 2010 will be $8 to $10 million.
We expect our net income for 2010 will be at least $1 million, or earnings per share of $0.02, excluding any mark-to-market adjustments relating to warrants. Once we are profitable, we expect our fully diluted common shares, including our outstanding shares of common stock, warrants and stock options on a treasury stock basis, will be approximately 49 million shares.
We expect our business to generate $6 to $10 million in cash in 2010.
As previously announced on February 1, 2010, the Company will issue full financial results for 2009 after market close on February 23, 2010. In conjunction, ISTA will host a conference call to discuss the 2009 results, as well as review the 2010 guidance and the Company's product development pipeline. Information for the call and webcast are available at www.istavision.com.
Xibrom (bromfenac ophthalmic solution)® 0.09%, Istalol® (timolol maleate ophthalmic solution) 0.5%, Bepreve™ (bepotastine besilate ophthalmic solution) 1.5%, and XiDay™ (bromfenac ophthalmic solution) are trademarks of ISTA Pharmaceuticals.
Full prescribing information for Bepreve™ is available on ISTA Pharmaceuticals' website at http://www.istavision.com/pdf/Bepreve_insert.pdf
Full prescribing information for Xibrom™ is available on ISTA Pharmaceuticals' website at www.istavision.com/pdf/XibromPI_XIB553.pdf
Full prescribing information for Istalol® is available on ISTA Pharmaceuticals' website at www.istavision.com/pdf/Istalol_Full_PI-ISL274.pdf