Santarus Reports Fourth Quarter And Full Year 2011 Financial Results

Santarus, Inc. (NASDAQ: SNTS) today reported financial and operating results for the three and 12 month periods ended December 31, 2011.

Key financial results for the fourth quarter of 2011 include:

• Total revenues increased 65% to $42.6 million from $25.9 million for the fourth quarter of 2010
• Net income was $1.9 million, or $0.03 per diluted share, compared with a net loss of $2.1 million, or $0.03 per share, for the fourth quarter of 2010
• Cash, cash equivalents and short-term investments as of December 31, 2011 were $58.6 million

Business Highlights

Recent business highlights include the following:

• Entered into a settlement agreement with Lupin Ltd. and its subsidiary, Lupin Pharmaceuticals, Inc., granting Lupin the right to begin selling a generic version of GLUMETZA ^® (metformin hydrochloride extended release tablets) on February 1, 2016, or earlier under certain circumstances. The settlement agreement is subject to review by the U.S. Department of Justice and the Federal Trade Commission, as well as entry by the U.S. District Court for the Northern District of California of an order dismissing the litigation.
• Announced in February the U.S. Food and Drug Administration (FDA) acceptance for review of the company’s New Drug Application (NDA) for UCERIS ^™ (budesonide) tablets 9 mg for the induction of remission of mild to moderate active ulcerative colitis. Santarus expects the FDA will complete its review or otherwise respond to the UCERIS NDA by October 16, 2012.
• Initiated patient enrollment in a Phase IIIb clinical study with UCERIS to evaluate whether there is an incremental benefit in remission rate when UCERIS 9 mg is added to current oral aminosalicylate (5-ASA) therapy for patients with mild to moderate active ulcerative colitis not adequately controlled on background 5-ASA therapy.
• Presented new safety and efficacy data from an eight-week open-label study with UCERIS 9 mg in patients with mild or moderate active ulcerative colitis at the Crohn’s & Colitis Foundation’s Clinical & Research Conference 2011 Advances in Inflammatory Bowel Diseases.
• Reported retrospective analyses of integrated efficacy data and immuno-safety data from placebo-controlled and open-label clinical studies of our investigational pipeline drug RHUCIN ^® (recombinant human C1 inhibitor, or C1INH) in patients with hereditary angioedema. The data were presented in two oral presentations at the 2011 Biennial Meeting of the World Allergy Congress.
• Completed expansion of sales force to 150 sales representatives, providing for more effective targeted promotion of our marketed products.
• In February, began promotion of FENOGLIDE ^® (fenofibrate) tablets 40 mg and 120 mg, an FDA-approved product for the treatment of high cholesterol.
• Increased revolving line of credit with Comerica Bank from $25 million to $35 million with improved terms and extended the maturity to February 2015.

“Our strong fourth quarter financial performance caps a year of significant accomplishments, including a return to profitability while maintaining a solid cash position,” said Gerald T. Proehl, president and chief executive officer of Santarus. “Our outlook for 2012 is for revenue of approximately $200 million, which represents an increase of 68% over 2011. We also expect improved profits even with the inclusion of success-based milestone expenses. We believe Santarus is well positioned for future growth with an attractive portfolio of commercial products and a robust pipeline of investigational drugs focused on specialty markets.”

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