[November 07, 2012] |
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Salix Pharmaceuticals Reports 3Q2012 Results
RALEIGH, N.C. --(Business Wire)--
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced financial and
operating results for the third quarter ended September 30, 2012 and
other business updates.
Total product revenue was $185.1 million for the third quarter of 2012,
a 27% increase compared to $146.2 million for the third quarter of 2011.
Total product revenue for the first nine months of 2012 was $537.3
million, a 39% increase compared to $385.3 million for the first nine
months of 2011. XIFAXAN® revenue for the third quarter of
2012 was $137.9 million, a 43% increase compared to $96.7 million for
the third quarter of 2011. XIFAXAN revenue for the first nine months of
2012 was $367.5 million, a 39% increase compared to $264.4 million for
the first nine months of 2011. APRISO® revenue for the
third quarter of 2012 was $19.7 million, a 31% increase compared to
$15.0 million for the third quarter of 2011. The combined revenue
contribution of our most recently-introduced products - RELISTOR®,
SOLESTA® and DEFLUX®- totaled $12.1 million for
the third quarter of 2012.
Total cost of products sold was $26.5 million for the third quarter of
2012 and $93.9 million for the first nine months of 2012, compared to
$24.1 million for the third quarter of 2011 and $67.9 million for the
first nine months of 2011. Gross margin on total product revenue was
85.7% for the third quarter of 2012 compared to 83.5% for the third
quarter of 2011, and 82.5% for the first nine months of 2012 compared to
82.4% for the first nine months of 2011. Research and development
expenses were $32.8 million for the third quarter of 2012 and $86.7
million for the first nine months of 2012, compared to $24.8 million and
$85.3 million, respectively, for the prior year periods. The increase in
research and development expenses for 2012 compared to 2011 is due
primarily to increased expenses related to our Phase 3 retreatment study
of rifaximin for irritable bowel syndrome with diarrhea. Selling,
general and administrative expenses were $61.5 million for the third
quarter of 2012 compared to $41.4 million for the prior year period and
$187.3 million for the first nine months of 2012 compared to $132.8
million for the prior year period. The increase in selling, general and
administration expenses for 2012 compared to 2011 is due primarily to
increased personnel costs related to our sales force expansion in 2012
and increased marketing expenses related to SOLESTA and XIFAXAN550 for
hepatic encephalopathy. The Company reported GAAP net income of $16.5
million, or $0.26 per share, fully diluted, for the third quarter of
2012 and $46.6 million, or $0.73 per share, fully diluted, for the
nine-month period ended September 30, 2012.
Net income on a non-GAAP basis, excluding the loss on extinguishment of
debt and non-cash adjustments related to the repurchase of a portion of
our 2028 Notes in March 2012, the intangible asset impairment charge and
change in acquisition-related contingent consideration that occurred in
September 2012, the difference between income taxes paid and income
taxes expensed, and non-cash depreciation, amortization, stock-based
compensation and convertible debt interest expense, was $59.7 million,
or $0.95 per share, fully diluted, for the three-month period ended
September 30, 2012 and $154.5 million or $2.43 per share, fully diluted
for the nine-month period ended September 30, 2012. We believe these
non-GAAP measures might provide investors additional relevant
information, in part for purposes of historical comparison. In addition,
we use these non-GAAP measures to analyze our performance in more detail
and with better historical comparability; however, you should be aware
that non-GAAP measures are not superior to, nor a substitute for, the
comparable GAAP measures. We have provided a reconciliation of these
measures to the most closely related GAAP measures in the accompanying
financial tables.
Cash and cash equivalents were $775.9 million as of September 30, 2012.
Adam Derbyshire, Executive Vice President and Chief Financial Officer,
stated, "XIFAXAN 550 mg continued to perform well during the third
quarter of 2012. During the quarter our XIFAXAN prescription business,
comprised of XIFAXAN 200 mg tablets and XIFAXAN 550 mg tablets,
demonstrated impressive growth, on a milligram basis, of 20% compared to
the third quarter of 2011. APRISO also demonstrated strong prescription
year-over-year growth of 24% for the third quarter of 2012 compared to
the third quarter of 2011. RELISTOR prescriptions increased 89%
year-over-year for the third quarter of 2012 compared to the third
quarter of 2011.
"We continue to believe total Company product revenue for 2012 will be
approximately $735 million, representing 36% growth over 2011 revenue.
We now believe we will be able to generate adjusted net income of
approximately $200 million, or $3.13 per share, fully diluted on the
non-GAAP basis described above for the full year ending December 31,
2012.
"The current annualized run rates, based on dollarizing the August 2012
prescription data for XIFAXAN, MOVIPREP/OSMOPREP, APRISO, RELISTOR
(U.S.) and our 'other products', are approximately $495 million, $108
million, $87 million, $32 million, and $48 million, respectively. In
line with the full year 2012 guidance provided above, for the fourth
quarter of 2012 we anticipate total Company product revenue should be
approximately $198 million and adjusted net income should be
approximately $46 million, or $0.72 per share, fully diluted, on the
non-GAAP basis described above."
Carolyn Logan, President and Chief Executive Officer, stated, "Our third
quarter growth was driven primarily by XIFAXAN 550, APRISO and RELISTOR.
XIFAXAN continues to grow sequentially, with prescriptions, on a
milligram basis, increasing 5% for the third quarter of 2012 compared to
the second quarter of 2012. APRISO also continued to exceed the
Company's expectations during the quarter. APRISO prescriptions
increased 4% during the third quarter of 2012 compared to the second
quarter of 2012. RELISTOR prescriptions increased 18% during the third
quarter of 2012 compared to the second quarter of 2012.
"During the third quarter our sales force continued launching SOLESTA®
- our first-in-class, biocompatible tissue bulking agent for the
treatment of fecal incontinence, or FI. Fecal incontinence is estimated
to affect approximately 15% of people in the United States over the age
of 50 and is the leading reason for admission to assisted living
facilities in the United States. Physicians and patients have shown
significant interest in the use of SOLESTA as an alternative to more
invasive treatment options in the treatment of FI. In early November the
Centers for Medicare and Medicaid Services (CMS) assigned SOLESTA a
unique HCPCS code of "L8605" for reimbursement purposes. This new code
will facilitate separate reimbursement for SOLESTA across multiple
settings of care. SOLESTA will be billed under the new code L8605
(Injectable Bulking Agent, Anal Canal) effective January 1, 2013.
"On July 27, 2012 the Company received from the FDA a Complete Response
Letter (CRL) requesting additional clinical data for our supplemental
New Drug Application (sNDA) for RELISTOR (methylnaltrexone bromide)
injection for subcutaneous use for the treatment of opioid-induced
constipation (OIC) in adult patients with chronic, non-cancer pain. On
October 5, 2012 Salix conducted an End-of-Review meeting with the FDA's
Division of Gastroenterology and Inborn Errors Products to better
understand the contents of the letter. The Division has expressed a
concern that there may be a risk associated with the chronic use of
mu-opioid antagonists in patients that are taking opioids for chronic
pain. In order to understand this potential risk, the Division has
communicated that a very large, well-controlled, chronic administration
trial will have to be conducted to assess the safety of any mu-opioid
antagonist prior to market approval for the treatment of patients with
OIC who are taking opioids for chronic, non-cancer pain. Salix has held
discussions with the Division and has expressed the view that the
post-marketing, clinical and preclinical data currently available for
RELISTOR adequately demonstrate an appropriate and expected safety
profile sufficient to permit the approval of the current sNDA.
"The Company plans to continue to work with the FDA to generate a
reasonable path forward that can be agreed upon by both parties for the
further development and regulatory review of RELISTOR. While it is not
possible to definitively determine the duration of our discussion with
the FDA regarding this matter, at this time we anticipate a path forward
could be reached with the FDA during 2013. Opioid induced constipation
is a debilitating and unmet medical need that occurs as a consequence of
opioid use in some patients that are taking opioids for chronic pain.
Currently, there are no FDA-approved therapies for OIC in chronic,
non-cancer pain. Before changing our plans for development of RELISTOR,
we intend to make every effort to gain approval for the expanded use of
RELISTOR to extend the benefit RELISTOR has provided to relieving OIC in
advanced illness patients since 2008 to meet the unmet medical need of
OIC in patients with chronic, non-cancer pain. Based on the information
discussed above, we reassessed the value of the indefinite lived
intangible asset related to the chronic, non-cancer pain indication and
recorded a non-cash charge to earnings of $41.6 million in the
three-month period ended September 30, 2012. We also reassessed the fair
value of the contingent consideration related to Relistor and recorded a
$33.0 million decrease in the contingent consideration that resulted in
a corresponding increase to earnings in the three-month period ended
September 30, 2012.
"In respect of the currently-approved subcutaneous formulation of
RELISTOR for OIC in patients with advanced illness who are receiving
palliative care, physician feedback indicates a significant need in the
marketplace for a treatment that targets the underlying cause of OIC
without impacting opioid-mediated analgesic effects on the central
nervous system. RELISTOR does this by displacing opioid binding in
tissues in the gastrointestinal tract. Since we introduced RELISTOR in
April 2011, an increasing number of physicians have begun to treat their
patients with advanced illness who are receiving palliative care with
RELISTOR as a solution to OIC when response to laxative treatment has
not been sufficient. In early November the Centers for Medicare and
Medicaid Services (CMS) assigned RELISTOR a unique Healthcare Common
Procedure Coding System, or HCPCS code, of "J2212" for reimbursement
purposes. We initially estimated peak year sales of RELISTOR for
advanced illness could reach $50 million. Based on RELISTOR's
performance over the past 18 months we are increasing our estimate of
peak year sales to approximately $100 million for this indication.
"We continue to anticipate an action by the FDA by the end of the first
quarter of 2013 on our NDA for Crofelemer 125 mg tablets for the
proposed indication of the control and symptomatic relief of diarrhea in
patients with human immunodeficiency virus (HIV)/acquired immune
deficiency syndrome (AIDS) on anti-retroviral therapy.
Both the FDA and Salix are continuing to work collaboratively to
progress this important product through its full review. To date, this
collaboration has resulted in substantial progress in handling topics
important to crofelemer as well as to future botanical products in
general. The primary focus of our collaboration is the production and
control of the crofelemer active pharmaceutical ingredient in order to
ensure compliance with the manufacturing and product quality
requirements of the Federal Food, Drug & Cosmetic Act. Both Salix and
the FDA are committed to a robust level of cooperation and data exchange
with the goal of providing crofelemer to patients suffering from the
very important unmet need of the indication for which we are seeking
approval. Our efforts to date have advanced both the chemical and the
regulatory science methods available to ensure the quality and clinical
usefulness of crofelemer and, potentially, other products that are of
botanical origin.
"On February 21, 2012 the Company initiated TARGET 3 - a Phase 3 study
to evaluate the efficacy and safety of repeat treatment with rifaximin
550 mg TID (three times daily) for 14 days in subjects with irritable
bowel syndrome with diarrhea (IBS-D) who respond to an initial treatment
course with rifaximin 550 mg TID for 14 days. During the third quarter
we continued to enroll a number of subjects sufficient to randomize
approximately 800 subjects (400 subjects per treatment group) into the
double blind retreatment phase of the study. We initiated patient
enrollment in TARGET 3 during the first half of 2012 and currently
anticipate securing a FDA decision regarding approvability during the
first half of 2014. We continue to strengthen our intellectual property
relating to rifaximin for the treatment of IBS-D. A method of treatment
patent regarding XIFAXAN550 for the treatment of IBS-D should issue
November 13, 2012 and should provide protection until 2029.
"In August Salix entered into an exclusive agreement with Alfa
Wassermann S.p.A. by which we licensed rights in the United States and
Canada to an extended intestinal release (EIR) formulation of rifaximin
for gastrointestinal and respiratory indications, including Crohn's
disease. The EIR formulation of rifaximin has been designed to provide
an efficient delivery of rifaximin by releasing the active drug
following passage through the stomach in order to provide a homogeneous
distribution of rifaximin in the intestinal tract. This EIR formulation
of rifaximin will be studied for its potential to target difficult to
treat diseases of the intestinal tract such as Crohn's disease. We
intend to initiate two Phase 3 trials during the first half of 2013 with
the goal of securing FDA approval to market EIR rifaximin for the
treatment of Crohn's disease.
"We received the rights to EIR formulation rifaximin products as part of
a restructuring of long-standing arrangements between Alfa Wassermann
and Salix for the development and commercialization of rifaximin
products in the United States and Canada for gastrointestinal and
respiratory indications. The restructuring does not affect arrangements
for the rifaximin products currently approved in the Salix territory,
nor for any product for treatment of irritable bowel syndrome that might
be approved in the future. Under the new arrangements, Salix has
provided Alfa Wassermann with rights to obtain a license to develop and
commercialize, outside the United States and Canada for gastrointestinal
and respiratory indications, formulations of rifaximin currently being
developed by Salix and other new formulations of rifaximin that Salix
may develop in the future.
"During the third quarter of 2012 the Company also continued to make
progress in the development of budesonide foam, a new formulation of
rifaximin and LUMACAN™. We anticipate completing patient enrollment in
our two budesonide foam Phase 3 trials by the end of 2012. Currently we
are targeting submission of the NDA for budesonide foam for the
treatment of moderate ulcerative proctitis or proctosigmoiditis during
the third quarter of 2013. Regarding our next generation formulation of
rifaximin, our pharmacokinetic study to assist in the characterization
of three prototype tablet formulations progressed during the third
quarter of 2012, and currently we intend to move forward with the
initiation of a clinical trial in the first half of 2013. Work continued
to progress on the development of LUMACAN oral formulation prototypes.
During the third quarter we initiated an exploratory study designed to
evaluate fluorescence kinetics of LUMACAN following enema administration
for precancerous and cancerous lesions, in respect of the quality, onset
and offset of fluorescence following administration of the enema. If the
enema administration is successful, we intend to proceed to orally
administered test formulations. We believe that LUMACAN, if approved,
has the potential to significantly improve earlier detection and
diagnosis of colon cancer.
"During the third quarter we received a paragraph IV notification from
Lupin Limited stating that Lupin had filed an ANDA application to seek
approval to market a generic version of APRISO. The notification letter
asserted non-infringement and invalidity of the Company's Orange
Book-listed U.S. Patent No. 6,551,620. On September 7, 2012 Salix and
Dr. Falk Pharma filed a patent infringement complaint against Lupin. The
filing of this suit imposes an automatic 30-month stay of approval of
Lupin's ANDA. We have full confidence in and continue to evaluate our
intellectual property protecting APRISO, and we intend to vigorously
enforce our intellectual property rights.
"Salix is built on a tremendous history of success - including the
approval of eight New Drug Applications, the acquisition/licensing of 16
products and the establishment of a top-ranked specialty sales force
since 2000. Our core business remains strong and continues to grow. Our
portfolio of marketed products is complemented by our impressive
pipeline of product candidates in development that should drive
additional revenue growth over the long term as they are commercialized.
Additionally, the Company continues to actively pursue additional
product opportunities to expand and broaden our product portfolio. We
are extremely pleased with the success we have achieved to date, and we
believe the Company is well-positioned to continue to succeed in our
mission of being the leading specialty pharmaceutical company licensing,
developing and marketing innovative products to healthcare professionals
to prevent or treat gastrointestinal disorders."
The Company will host a conference call at 5:00 p.m. ET, on Wednesday,
November 7, 2012. Interested parties can access the conference call by
way of web cast or telephone. The live web cast will be available at www.salix.com.
A replay of the web cast will be available at the same location. The
telephone numbers to access the live conference call are (877) 756-4253
(U.S. and Canada) or (706) 902-2163 (international.) The telephone
numbers to access the replay of the call are (855) 859-2056 or (800)
585-8367 (U.S. and Canada) or (404) 537-3406 (international). The access
code for the replay is 95498100.
About Salix
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina,
develops and markets prescription pharmaceutical products for the
prevention and treatment of gastrointestinal diseases. Salix's strategy
is to in-license late-stage or marketed proprietary therapeutic
products, complete any required development and regulatory submission of
these products, and market them through the Company's gastroenterology
specialty sales and marketing team.
Salix markets XIFAXAN® (rifaximin) tablets 200 mg and 550 mg,
MOVIPREP® (PEG 3350, Sodium Sulfate, Sodium Chloride,
Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral
Solution), OSMOPREP® (sodium phosphate monobasic monohydrate,
USP and sodium phosphate dibasic anhydrous, USP) Tablets, APRISO®
(mesalamine) extended-release capsules 0.375 g, METOZOLV® ODT
(metoclopramide HCl), RELISTOR® (methylnaltrexone bromide)
Subcutaneous Injection, SOLESTA®, DEFLUX®, PEPCID®
(famotidine) for Oral Suspension, Oral Suspension DIURIL® (Chlorothiazide),
AZASAN® (Azathioprine) Tablets, USP, 75/100 mg, ANUSOL-HC®
2.5% (Hydrocortisone Cream, USP), ANUSOL-HC® 25 mg
Suppository (Hydrocortisone Acetate), PROCTOCORT® Cream
(Hydrocortisone Cream, USP) 1% and PROCTOCORT® Suppository
(Hydrocortisone Acetate Rectal Suppositories) 30 mg. Crofelemer,
budesonide foam, RELISTOR® , LUMACAN™ and
rifaximin for additional indications are under development.
For full prescribing information and important safety information on
Salix products, including BOXED WARNINGS for OSMOPREP, AZASAN and
METOZOLV, please visit www.salix.com
where the Company promptly posts press releases, SEC filings and other
important information or contact the Company at 919 862-1000.
Salix trades on the NASDAQ Global Select Market under the ticker symbol
"SLXP".
For more information, please visit our Website at www.salix.com
or contact the Company at 919-862-1000. Follow us on Twitter
(@SalixPharma) and Facebook (www.facebook.com/SalixPharma).
Information on our Twitter feed, Facebook page and web site is not
incorporated in our SEC filings.
Please Note: The materials provided herein contain projections and
other forward-looking statements regarding future events. Such
statements are just predictions and are subject to risks and
uncertainties that could cause the actual events or results to differ
materially. These risks and uncertainties include, among others: the
unpredictability of the duration and results of regulatory review of New
Drug Applications and Investigational NDAs; generic and other
competition in an increasingly global industry; litigation and the
possible impairment of, or inability to obtain, intellectual property
rights and the costs of obtaining such rights from third parties in an
increasingly global industry; the cost, timing and results of clinical
trials and other development activities involving pharmaceutical
products; post-marketing approval regulation; market acceptance for
approved products; revenue recognition and other critical accounting
policies; and the need to acquire new products. The reader is referred
to the documents that the Company files from time to time with the
Securities and Exchange Commission.
Salix Pharmaceuticals, Ltd.
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Condensed Consolidated Statements of Operations
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(In thousands, except per share data)
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Three Months Ended
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Nine Months Ended
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September 30,
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September 30,
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September 30,
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September 30,
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2012
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2011
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2012
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2011
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(unaudited)
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(unaudited)
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(unaudited)
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(unaudited)
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Revenues:
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Net product revenues
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$
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185,132
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$
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146,247
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$
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537,271
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$
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385,306
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Costs and Expenses:
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Cost of products sold
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26,471
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24,056
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93,918
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67,884
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Amortization of product rights and intangible assets
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11,345
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2,890
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34,034
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8,017
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Research and development
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32,819
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24,814
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86,677
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85,294
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Selling, general and administrative
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61,543
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41,439
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187,266
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132,786
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Intangible asset impairment charge
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41,600
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-
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41,600
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-
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Change in acquisition-related contingent consideration
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(31,398
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)
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-
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(31,398
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)
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-
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Total costs and expenses
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142,380
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93,199
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412,097
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293,981
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Income from operations
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42,752
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53,048
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125,174
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91,325
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Loss on extinguishment of debt
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-
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-
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(14,369
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)
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-
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Interest expense
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(15,692
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)
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(8,080
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)
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(39,591
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)
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(23,932
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)
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Interest and other income
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279
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509
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10,409
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2,082
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Income before income tax
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27,339
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45,477
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81,623
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69,475
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Income tax expense
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10,803
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11,198
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35,000
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15,671
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Net Income
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$
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16,536
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$
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34,279
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$
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46,623
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$
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53,804
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Income per share, basic
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$
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0.28
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$
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0.58
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$
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0.79
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$
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0.92
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Income per share, diluted
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$
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0.26
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$
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0.55
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$
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0.73
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$
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0.89
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Shares used in computing net income per share, basic
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58,755
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59,076
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58,671
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58,573
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Shares used in computing net income per share, diluted
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62,983
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65,160
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63,689
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65,405
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Reconciliation of GAAP Amounts to Non-GAAP Amounts:
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(In thousands, except per share data)
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We are disclosing our non-GAAP Condensed Consolidated Statements
of Operations, as adjusted, to eliminate the impact of the $10.0
million Lupin payment that occured in February 2011, the loss on
extinguishment of debt and non-cash adjustments related to the
repurchase of a portion of our 2028 Notes in March 2012, the
intangible asset impairment charge and change in
acquisition-related contingent consideration that occurred in
September 2012, the difference between income taxes paid and
income taxes expensed, and non-cash depreciation, amortization,
stock-based compensation and convertible debt interest expenses
that occured in the three-month and nine-month periods ended
September 30, 2012 and 2011, respectively. We believe these
non-GAAP measures might provide investors additional relevant
information, in part for purposes of historical comparison. In
addition, we use these non-GAAP measures to analyze our
performance in more detail and with better historical
comparability; however, you should be aware that non-GAAP measures
are not superior to nor a substitute for the comparable GAAP
measures. A reconciliation of our non-GAAP measures to the
comparable GAAP measures follows.
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Three Months Ended
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Three Months Ended
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September 30,
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September 30,
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September 30,
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September 30,
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September 30,
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September 30,
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2012
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2012 - Non-GAAP Adjustments
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2012- Non-GAAP
as adjusted
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2011
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2011 - Non-GAAP Adjustments
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2011 - Non-GAAP
as adjusted
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(unaudited)
|
(unaudited)
|
(unaudited)
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(unaudited)
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(unaudited)
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(unaudited)
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Revenues:
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Net product revenues
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$
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185,132
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$
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-
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$
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185,132
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|
|
$
|
146,247
|
|
$
|
-
|
|
$
|
146,247
|
|
|
|
|
|
|
|
|
|
|
|
Costs and Expenses:
|
|
|
|
|
|
|
|
|
Cost of products sold
|
|
26,471
|
|
|
-
|
|
|
26,471
|
|
|
|
|
24,056
|
|
|
-
|
|
|
24,056
|
|
|
Amortization of product rights and intangible assets
|
|
11,345
|
|
|
(11,345
|
)
|
|
-
|
|
|
|
|
2,890
|
|
|
(2,890
|
)
|
|
-
|
|
|
Research and development
|
|
32,819
|
|
|
(1,455
|
)
|
|
31,364
|
|
|
|
|
24,814
|
|
|
(2,531
|
)
|
|
22,283
|
|
|
Selling, general and administrative
|
|
61,543
|
|
|
(5,824
|
)
|
|
55,719
|
|
|
|
|
41,439
|
|
|
(4,124
|
)
|
|
37,315
|
|
|
Intangible asset impairment charge
|
|
41,600
|
|
|
(41,600
|
)
|
|
-
|
|
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
Change in acquisition-related contingent consideration
|
|
(31,398
|
)
|
|
31,398
|
|
|
-
|
|
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
Total costs and expenses
|
|
142,380
|
|
|
(28,826
|
)
|
|
113,554
|
|
|
|
|
93,199
|
|
|
(9,545
|
)
|
|
83,654
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from operations
|
|
42,752
|
|
|
28,826
|
|
|
71,578
|
|
|
|
|
53,048
|
|
|
9,545
|
|
|
62,593
|
|
|
Loss on extinguishment of debt
|
|
-
|
|
|
-
|
|
|
-
|
|
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
Interest expense
|
|
(15,692
|
)
|
|
10,380
|
|
|
(5,312
|
)
|
|
|
|
(8,080
|
)
|
|
4,882
|
|
|
(3,198
|
)
|
|
Interest and other income
|
|
279
|
|
|
-
|
|
|
279
|
|
|
|
|
509
|
|
|
-
|
|
|
509
|
|
|
Income before income tax
|
|
27,339
|
|
|
39,206
|
|
|
66,545
|
|
|
|
|
45,477
|
|
|
14,427
|
|
|
59,904
|
|
|
Income tax expense
|
|
10,803
|
|
|
(3,969
|
)
|
|
6,834
|
|
|
|
|
11,198
|
|
|
-
|
|
|
11,198
|
|
|
|
|
|
|
|
|
|
|
|
Net Income, as adjusted
|
$
|
16,536
|
|
$
|
43,175
|
|
$
|
59,711
|
|
|
|
$
|
34,279
|
|
$
|
14,427
|
|
$
|
48,706
|
|
|
|
|
|
|
|
|
|
|
|
Income per share, basic
|
$
|
0.28
|
|
$
|
0.73
|
|
$
|
1.02
|
|
|
|
$
|
0.58
|
|
$
|
0.24
|
|
$
|
0.82
|
|
Income per share, diluted
|
$
|
0.26
|
|
$
|
0.69
|
|
$
|
0.95
|
|
|
|
$
|
0.55
|
|
$
|
0.22
|
|
$
|
0.77
|
|
Shares used in computing net income per share, basic
|
|
58,755
|
|
|
58,755
|
|
|
58,755
|
|
|
|
|
59,076
|
|
|
59,076
|
|
|
59,076
|
|
Shares used in computing net income per share, diluted
|
|
62,983
|
|
|
62,983
|
|
|
62,983
|
|
|
|
|
65,160
|
|
|
65,160
|
|
|
65,160
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
|
|
|
Nine Months Ended
|
|
|
|
September 30,
|
September 30,
|
September 30,
|
|
|
September 30,
|
September 30,
|
September 30,
|
|
|
2012
|
2012 - Non-GAAP Adjustments
|
2012- Non-GAAP
as adjusted
|
|
|
2011
|
2011 - Non-GAAP Adjustments
|
2011 - Non-GAAP
as adjusted
|
|
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
|
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Net product revenues
|
$
|
537,271
|
|
$
|
-
|
|
$
|
537,271
|
|
|
|
$
|
385,306
|
|
$
|
-
|
|
$
|
385,306
|
|
|
|
|
|
|
|
|
|
|
|
Costs and Expenses:
|
|
|
|
|
|
|
|
|
Cost of products sold
|
|
93,918
|
|
|
-
|
|
|
93,918
|
|
|
|
|
67,884
|
|
|
-
|
|
|
67,884
|
|
|
Amortization of product rights and intangible assets
|
|
34,034
|
|
|
(34,034
|
)
|
|
-
|
|
|
|
|
8,017
|
|
|
(8,017
|
)
|
|
-
|
|
|
Research and development
|
|
86,677
|
|
|
(3,997
|
)
|
|
82,680
|
|
|
|
|
85,294
|
|
|
(15,816
|
)
|
|
69,478
|
|
|
Selling, general and administrative
|
|
187,266
|
|
|
(15,990
|
)
|
|
171,276
|
|
|
|
|
132,786
|
|
|
(11,265
|
)
|
|
121,521
|
|
|
Intangible asset impairment charge
|
|
41,600
|
|
|
(41,600
|
)
|
|
-
|
|
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
Change in acquisition-related contingent consideration
|
|
(31,398
|
)
|
|
31,398
|
|
|
-
|
|
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
Total costs and expenses
|
|
412,097
|
|
|
(64,223
|
)
|
|
347,874
|
|
|
|
|
293,981
|
|
|
(35,098
|
)
|
|
258,883
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from operations
|
|
125,174
|
|
|
64,223
|
|
|
189,397
|
|
|
|
|
91,325
|
|
|
35,098
|
|
|
126,423
|
|
|
Loss on extinguishment of debt
|
|
(14,369
|
)
|
|
14,369
|
|
|
-
|
|
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
Interest expense
|
|
(39,591
|
)
|
|
25,262
|
|
|
(14,329
|
)
|
|
|
|
(23,932
|
)
|
|
14,334
|
|
|
(9,598
|
)
|
|
Interest and other income
|
|
10,409
|
|
|
(9,325
|
)
|
|
1,084
|
|
|
|
|
2,082
|
|
|
-
|
|
|
2,082
|
|
|
Income before income tax
|
|
81,623
|
|
|
94,529
|
|
|
176,152
|
|
|
|
|
69,475
|
|
|
49,432
|
|
|
118,907
|
|
|
Income tax expense
|
|
35,000
|
|
|
(13,333
|
)
|
|
21,667
|
|
|
|
|
15,671
|
|
|
-
|
|
|
15,671
|
|
|
|
|
|
|
|
|
|
|
|
Net Income, as adjusted
|
$
|
46,623
|
|
$
|
107,862
|
|
$
|
154,485
|
|
|
|
$
|
53,804
|
|
$
|
49,432
|
|
$
|
103,236
|
|
|
|
|
|
|
|
|
|
|
|
Income per share, basic
|
$
|
0.79
|
|
$
|
1.84
|
|
$
|
2.63
|
|
|
|
$
|
0.92
|
|
$
|
0.84
|
|
$
|
1.76
|
|
Income per share, diluted
|
$
|
0.73
|
|
$
|
1.69
|
|
$
|
2.43
|
|
|
|
$
|
0.89
|
|
$
|
0.76
|
|
$
|
1.64
|
|
Shares used in computing net income per share, basic
|
|
58,671
|
|
|
58,671
|
|
|
58,671
|
|
|
|
|
58,573
|
|
|
58,573
|
|
|
58,573
|
|
Shares used in computing net income per share, diluted
|
|
63,689
|
|
|
63,689
|
|
|
63,689
|
|
|
|
|
65,405
|
|
|
65,405
|
|
|
65,405
|
|
|
|
|
|
|
|
|
|
|
|
Salix Pharmaceuticals, Ltd.
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets
|
|
|
|
|
|
(In thousands)
|
|
September 30,
|
December 31,
|
|
|
|
|
|
|
2012
|
2011
|
|
|
|
|
|
|
|
|
(unaudited)
|
(audited)
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
$
|
775,903
|
|
$
|
292,814
|
|
|
|
|
|
|
|
Accounts receivable, net
|
|
213,766
|
|
|
151,207
|
|
|
|
|
|
|
|
Inventory, net
|
|
|
71,654
|
|
|
49,205
|
|
|
|
|
|
|
|
Other assets
|
|
|
759,578
|
|
|
819,743
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Assets
|
|
$
|
1,820,901
|
|
$
|
1,312,969
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity
|
|
|
|
|
|
|
|
Accounts payable and other liabilities
|
$
|
1,288,306
|
|
$
|
763,332
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
1,288,306
|
|
|
763,332
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock
|
|
|
59
|
|
|
59
|
|
|
|
|
|
|
|
Additional paid-in-capital
|
|
621,474
|
|
|
685,315
|
|
|
|
|
|
|
|
Other comprehensive loss
|
|
65
|
|
|
(111
|
)
|
|
|
|
|
|
|
Accumulated deficit
|
|
|
(89,003
|
)
|
|
(135,626
|
)
|
|
|
|
|
|
|
Total stockholders' equity
|
|
532,595
|
|
|
549,637
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Liabilities and Stockholders' Equity
|
$
|
1,820,901
|
|
$
|
1,312,969
|
|
|
|
|
|
|

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