Santarus Receives FDA Approval of UCERIS (Budesonide) for the Induction of Remission in Patients with Active, Mild to Moderate Ulcerative Colitis

SAN DIEGO--(BUSINESS WIRE)--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.

“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”

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.

Set forth below are tables reconciling the company’s adjusted EBITDA guidance to GAAP net income guidance for the years ending December 31, 2012 and 2013.


Santarus, Inc. Reconciliation of GAAP Net Income Guidance to Adjusted EBITDA Guidance ($ in millions)

		Years Ending December 31,
		2012	2013

GAAP net income		$12 - $14	$50 - $54
	Interest (income) expense	0	0
	Income tax expense	1	4
	Depreciation and amortization	6	7 - 8
	Stock-based compensation	6 - 7	12 - 13
	Stock issuance for regulatory milestone	4	0
Adjusted EBITDA		$29 - $32	$73 - $79

Important Safety Information About UCERIS

UCERIS is a prescription corticosteroid medicine used to help get mild to moderate ulcerative colitis under control. UCERIS is taken once daily in the morning with or without food for up to 8 weeks.

Do not take UCERIS if you are allergic to budesonide or any of the ingredients in UCERIS.
Before you take UCERIS, tell your doctor if you have liver 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 your doctor about all the medications you take, including prescription and over-the-counter vitamins and herbal supplements. UCERIS and other medicines may affect each other, causing side effects.
Do not eat grapefruit or drink grapefruit juice while taking UCERIS because these can increase the level of UCERIS in your blood.
Long-time use of UCERIS can cause you to have too much glucocorticosteroid medicine in your blood (hypercorticism). Tell your doctor if you have any of the following signs and symptoms of hypercorticism: acne, bruise easily, rounding of your face (moon face), ankle swelling, thicker or more hair on your body and face, a fatty pad or hump between your shoulders (buffalo hump), or pink or purple stretch marks on the skin of your abdomen, thighs, breasts, and arms.
When UCERIS is taken for a long period of time, the adrenal glands do not make enough steroid hormones. Tell your doctor if you are under stress or have any symptoms of adrenal suppression during treatment with UCERIS, including tiredness, weakness, nausea and vomiting, and low blood pressure.
UCERIS weakens your immune system. Taking medicines that weaken your immune system makes you more likely to get infections. Avoid contact with people who have contagious diseases such as chickenpox or measles while taking UCERIS. Tell your doctor about any signs or symptoms of infection, including fever, pain, aches, chills, feeling tired, or nausea and vomiting.
If you take certain other corticosteroid medicines to treat allergies (e.g., eczema, rhinitis), switching to UCERIS may cause your allergies to come back. Tell your doctor if any of your allergies become worse while taking UCERIS.
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. For additional information, talk to your healthcare provider and see the Full Prescribing Information including Patient Labeling.

About Ulcerative Colitis

Ulcerative colitis is a form of chronic inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the colon, which can interfere with the normal function of the colon. The disease typically starts to manifest in patients as young adults. Ulcerative colitis is an intermittent disease with periods of exacerbated symptoms, or flares, and periods that are relatively symptom-free. Although the symptoms of ulcerative colitis may resolve without treatment, the disease usually requires medication to go into remission. According to the Crohn’s and Colitis Foundation of America, as many as 700,000 people in the U.S. suffer from ulcerative colitis.

Conference Call

Santarus has scheduled an investor conference call regarding this announcement at 9:00 a.m. Eastern time (6:00 a.m. Pacific time) on January 15, 2013. Individuals interested in participating in the call may do so by dialing 866-819-7280 for domestic callers, or 678-374-2322 for international callers. A telephone replay will be available for 48 hours following the conclusion of the call by dialing 855-859-2056 for domestic callers, or 404-537-3406 for international callers, and entering reservation code 89526849. The live conference call also will be available by visiting the Investor Relations section of the company’s website at www.santarus.com and a recording of the call will be available on the company’s website for 14 days following the completion of the call.

About Santarus

Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company's current commercial efforts are focused on GLUMETZA^® (metformin hydrochloride extended release tablets) and CYCLOSET^® (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes, and on FENOGLIDE^® (fenofibrate) tablets, which is indicated as an adjunct to diet to reduce high cholesterol. In March 2013, the company plans to begin promoting UCERIS^™(budesonide) extended release tablets for the induction of remission of active, mild to moderate ulcerative colitis and ZEGERID^® (omeprazole/sodium bicarbonate) for the treatment of certain upper gastrointestinal disorders. Safety information and full prescribing information for Santarus’ products are available at www.santarus.com.

Santarus’ product development pipeline includes the investigational drug RUCONEST^®(recombinant human C1 esterase inhibitor) for treatment of acute attacks of hereditary angioedema. The company expects to submit a biologics license application (BLA) to the U.S. Food and Drug Administration for RUCONEST in the first half of 2013. Santarus is also developing rifamycin SV MMX^®, which is in Phase III clinical testing for treatment of travelers’ diarrhea. In addition, SAN-300, the company’s investigational monoclonal antibody, is in Phase I clinical testing. More information about Santarus is available at www.santarus.com.

Santarus cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. These forward-looking statements include statements regarding anticipated sales trends and financial results, the timing for commercial launch for UCERIS and the timing and outcome of various matters relating to Santarus' development products, including the submission of a BLA for RUCONEST.

The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans or objectives will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus’ business, including, without limitation: Santarus' ability to successfully launch UCERIS and generate revenues from UCERIS, ZEGERID, GLUMETZA and its other currently promoted commercial products and its authorized generic ZEGERID product; Santarus' ability to successfully advance the development of, obtain regulatory approval for and ultimately commercialize, its development-stage products, including the timing and outcome of the UCERIS Phase IIIb clinical study, the submission of the RUCONEST BLA and the second Phase III clinical study for rifamycin SV MMX; Santarus' ability to maintain patent protection for its products, including the difficulty in predicting the timing and outcome of ongoing patent litigation; Santarus' ability to achieve continued progress under its strategic alliances, and the potential for early termination of these agreements; Santarus' dependence on strategic partners for certain aspects of its development programs, including risks related to their financial stability; adverse side effects, inadequate therapeutic efficacy or other issues related to Santarus' products that could result in product recalls, market withdrawals or product liability claims; competition from other pharmaceutical or biotechnology companies and evolving market dynamics; other difficulties or delays relating to the development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus' products; fluctuations in quarterly and annual results; Santarus' ability to obtain additional financing as needed to support its operations or future product acquisitions; and other risks detailed in Santarus’ prior press releases as well as in prior public periodic filings with the Securities and Exchange Commission.

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Santarus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Santarus^®, FENOGLIDE^®, UCERIS^™, and ZEGERID^® are trademarks of Santarus, Inc. GLUMETZA^® is a trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. CYCLOSET^® is a trademark of VeroScience LLC. MMX^® is a trademark of Cosmo Technologies Limited. RUCONEST^® is a trademark of Pharming Group N.V.