Santarus, Inc. announced that additional data from two pivotal clinical studies with UCERIS(R) (budesonide) extended release tablets will be featured in two poster presentations at the Digestive Disease Week(R) (DDW(R)) Meeting being held in Orlando, Fla. from May 18 -- 21, 2013. Su1219 -- Sandborn W, et al, Efficacy of Budesonide MMX(R) in Reduction of Symptoms in Patients with Mild-to-Moderately Active Ulcerative Colitis: A Pooled Analysis of the CORE I and CORE II Studies Su1220 -- Lichtenstein G R, et al, Budesonide MMX(R) 9 mg Induces Remission in Mild-to- Active Ulcerative Colitis Patients Regardless of Prior History of 5-ASA Therapy Important Safety Information. UCERIS is a prescription corticosteroid medicine used to help get mild to moderate ulcerative colitis control. UCERIS is taken once daily in the morning with or without food for up to 8 weeks. Do not take UCERIS if allergic to budesonide or any of the ingredients in UCERIS. Before one take UCERIS, tell the doctor if havliver problems, are planning to have surgery, have chickenpox or measles or have recently been near someone with chickenpox or measles, have or had a family history of diabetes, cataracts or glaucoma, have high blood pressure (hypertension), decreased bone mineral density (osteoporosis), stomach ulcers, any other medical condition, are pregnant or plan to become pregnant, or breastfeed or plan to breastfeed. Tell doctor about all the medications take, including prescription and over-the-counter vitamins and herbal supplements. UCERIS and other medicines may affect each other causing side effects. Long-time use of UCERIS can cause too much glucocorticosteroid medicine in blood (hypercorticism). Tell the doctor if any of the following signs and symptoms of hypercorticism: acne, bruise easily, rounding of face (moon face), The most common side effects with UCERIS are headache, nausea, decreased blood cortisol levels, stomach-area pain, tiredness, stomach or intestinal gas, bloating, acne, urinary tract infection, joint pain, and constipation. UCERIS is available by prescription only.

Santarus, Inc. announced unaudited consolidated earnings results for the first quarter ended March 31, 2013. For the quarter, the company reported total revenues of $79.440 million compared to $45.880 million a year ago. Income from operations was $19.870 million compared to $1.056 million a year ago. Income before income taxes was $19.808 million compared to $0.955 million a year ago. Net income was $18.715 million or $0.25 per diluted share compared to $0.627 million or $0.01 per diluted share a year ago. Non-GAAP adjusted earnings were $23.9 million or $0.32 per diluted share compared to $7.8 million or $0.12 per diluted share a year ago. The company has raised its financial outlook for full year 2013 as follows: total revenues of approximately $330 million to $340 million, compared with its prior estimate of total revenues of approximately $320 million to $325 million. Net income of approximately $57 million to $64 million, and diluted EPS of $0.72 to $0.81, increased from its prior estimates of net income of approximately $50 million to $54 million, and diluted EPS of $0.63 to $0.68. Non-GAAP adjusted earnings of approximately $81 million to $91 million and diluted non-GAAP adjusted EPS of $1.03 to $1.15, up from its prior estimates of non-GAAP adjusted earnings of approximately $73 million to $79 million and diluted non-GAAP adjusted EPS of $0.92 to $1.00. The EPS estimates assume 79 million fully diluted shares. Additional information for selected estimated expenses for 2013 is unchanged and is as follows: license fees will include a $5 million expense for a success-based milestone assuming FDA acceptance for review of the RUCONEST BLA. Research and development expenses of approximately $34 million to $38 million. SG&A expenses of approximately $131 million to $134 million, which include an incremental estimated $38 million to $40 million investment associated with the previously disclosed sales force expansion of 85 sales representatives and promotional and other costs associated with the UCERIS launch and ZEGERID relaunch.

Santarus, Inc. proposed to amend article fourth of the company’s amended and restated certificate of incorporation to increase the authorized common stock, par value $0.0001 per share, of the company from 100,000,000 shares to 200,000,000 shares; to approve an amendment and restatement of the Santarus, Inc. amended and restated 2004 equity incentive award plan to: extend the term of the plan through April 5, 2023, increase the number of shares reserved for issuance under such plan, satisfy the stockholder approval requirements of Section 162(m) of the internal revenue code, as amended (“Section 162(m)”) with respect to “performance-based” compensation under Section 162(m) (including approval of the material terms of the performance goals for awards that may be granted under the amended and restated 2004 equity incentive award plan as required under Section 162(m)), and make other technical or otherwise non-material revisions thereto.