Santarus Receives FDA Approval of UCERIS (Budesonide) for the Induction of
Remission in Patients with Active, Mild to Moderate Ulcerative Colitis
Commercial launch expected in March 2013
Company provides 2013 financial guidance
Conference call scheduled for 9:00 a.m. EST on January 15, 2013
SAN DIEGO -- January 14, 2013
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
*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
*Research and development expenses of approximately $34 million to $38
*Selling, general and administrative expenses of approximately $131 million
to $134 million, which include an incremental estimated $38 million to $40
million investment associated with the sales force expansion of 85 sales
representatives and promotional and other costs associated with the UCERIS
launch and ZEGERID relaunch.
Non-GAAP Financial Measures
In this press release, Santarus used adjusted EBITDA as a key operating metric
and non-GAAP financial measure. The company believes that the presentation of
this non-GAAP financial measure provides useful supplementary information to
and facilitates additional analysis by investors. The company uses this
non-GAAP financial measure in connection with its own budgeting and planning.
This non-GAAP financial measure is in addition to, not a substitute for, or
superior to, measures of financial performance prepared in conformity with
Set forth below are tables reconciling the company’s adjusted EBITDA guidance
to GAAP net income guidance for the years ending December 31, 2012 and 2013.
Reconciliation of GAAP Net Income Guidance to Adjusted EBITDA Guidance
($ in millions)
Years Ending December 31,
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
*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
*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
*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
UCERIS is available by prescription only. For additional information, talk to
your healthcare provider and see the Full Prescribing Information including
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.
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.
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.
Martha L. Hough
VP Finance & Investor Relations
Debra P. Crawford
Chief Financial Officer
Westwicke Partners, LLC
Stefan Loren, Ph.D. (email@example.com)
Robert Uhl (firstname.lastname@example.org)
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