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Santarus Receives FDA Approval Of UCERIS (Budesonide) For The Induction Of Remission In Patients With Active, Mild To Moderate Ulcerative Colitis

Stocks in this article: SNTS

Santarus, Inc. (NASDAQ: SNTS) announced today that the U.S. Food and Drug Administration (FDA) has approved UCERIS (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis. The company expects to commence the commercial launch of UCERIS in March 2013.

UCERIS contains budesonide, a corticosteroid, in a novel oral tablet formulation that utilizes proprietary MMX ® multi-matrix system colonic delivery technology. The approved dosing regimen for adult patients is one 9 mg tablet taken orally once daily in the morning for up to 8 weeks. UCERIS was developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A.

“The FDA approval of UCERIS provides an important new therapeutic option to patients and physicians for the treatment of active, mild to moderate ulcerative colitis,” said William J. Sandborn, M.D., chief, division of Gastroenterology, director, University of California San Diego (UCSD) IBD Center and professor of clinical medicine, UCSD Health System. “Specifically, UCERIS is indicated for use in the induction of remission of active disease, an acute phase of the disease often characterized by cramping, bloating, diarrhea, bleeding, fatigue, weight loss and frequent bowel movements.”

Gerald T. Proehl, president and CEO of Santarus, said, “We are pleased to provide a new option for patients to treat the active phase of mild to moderate ulcerative colitis. With the incremental revenue from UCERIS and continued growth in our marketed products, we anticipate another robust year of solid financial results for Santarus in 2013. We expect total revenues of $320 million to $325 million, representing significant double-digit growth over our 2012 revenue guidance.”

Mr. Proehl continued, “We are adding 85 new sales representatives, thereby increasing our total number of sales reps to 235, to facilitate a strong commercial launch of UCERIS. Our expanded commercial organization will promote both UCERIS and ZEGERID ® (omeprazole/sodium bicarbonate) to gastroenterologists in addition to promoting our three diabetes/metabolic products to endocrinologists and other physicians.”

Financial Outlook for 2012 and 2013

For the full year in 2012, Santarus expects to meet or exceed the financial guidance provided on its November 7, 2012 third quarter financial results conference call of:

  • Total revenues of approximately $210 million.
  • Net income of approximately $12 million to $14 million, which includes the impact of the approximately $4 million success-based regulatory milestone expense in the first quarter of 2012 related to UCERIS and a $10 million expense for the success-based clinical milestone for RUCONEST ® in the fourth quarter.
  • Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) of approximately $29 million to $32 million.

Santarus is introducing its financial outlook for full year 2013 as follows:

  • Total revenues of approximately $320 million to $325 million.
  • Net income of approximately $50 million to $54 million.
  • Adjusted EBITDA of approximately $73 million to $79 million.

Additional information for selected estimated expenses for 2013 is as follows:

  • License fees will include a $5 million expense for a success-based milestone assuming FDA acceptance for review of the RUCONEST Biologics License Application.
  • Research and development expenses of approximately $34 million to $38 million.
  • Selling, general and administrative expenses of approximately $131 million to $134 million, which include an incremental estimated $38 million to $40 million investment associated with the sales force expansion of 85 sales representatives and promotional and other costs associated with the UCERIS launch and ZEGERID relaunch.

Non-GAAP Financial Measures

In this press release, Santarus used adjusted EBITDA as a key operating metric and non-GAAP financial measure. The company believes that the presentation of this non-GAAP financial measure provides useful supplementary information to and facilitates additional analysis by investors. The company uses this non-GAAP financial measure in connection with its own budgeting and planning. This non-GAAP financial measure is in addition to, not a substitute for, or superior to, measures of financial performance prepared in conformity with GAAP.

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