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Salix
Pharmaceuticals Ltd
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Nasdaq:SLXP
Salix
Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops
and markets prescription pharmaceutical products for the treatment of gastrointestinal
diseases. Salix's strategy is to in-license late-stage or marketed proprietary
therapeutic drugs, complete any required development and regulatory submission
of these products, and market them through the Company's 150-member gastroenterology
specialty sales and marketing team.
Salix
Pharmaceuticals Reports 4Q2006 And FY2006 Results
$208.5
Million Total Product Revenue Increases 35% Over 2005
Net
Income $31.5 Million: EPS $0.65
OSMOPREP™
and MOVIPREP® Approved and Launched
Bowel
Cleansing Franchise Achieves 20% Market Share
XIFAXAN®
Achieves 118% Year–Over–Year Growth in Prescription Demand
SANVAR®
License Agreement Signed
Clinical
Development Pipeline Advanced
RALEIGH,
NC, February 28, 2007 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today
announced financial and operating results for the fourth quarter and year
ended December 31, 2006.
Total
product revenue was $62.6 million for the fourth quarter of 2006, a year-over-year
increase of 23% compared to $50.7 million for the fourth quarter of 2005.
Total product revenue for 2006 was $208.5 million, a year–over–year increase
of 35%. VISICOL®, OSMOPREP™ and MOVIPREP®, combined, generated
revenue of $11.5 million for the fourth quarter of 2006, and $45.5 million
for the full year 2006. Revenue from these three products, which comprise
our bowel cleansing franchise, contributed 22% of 2006 total product revenue.
Our bowel cleansing franchise achieved 20% market share by the end of 2006.
XIFAXAN® revenue for the fourth quarter of 2006 was $18.7 million,
a 61% increase compared to the fourth quarter of 2005, and XIFAXAN revenue
for 2006 was $51.6 million, a 72% increase compared to 2005. COLAZAL®
generated revenue of $30.4 million for the fourth quarter of 2006 compared
to $30.8 million for the fourth quarter of 2005. COLAZAL generated revenue
of $103.5 million for 2006 compared to $110.3 million for 2005. This 6%
decrease in revenue compared to 2005 COLAZAL revenue reflects the normalization
of COLAZAL trade inventories over the course of 2006. Based on COLAZAL's
current price, the dollar value of 2006 prescriptions approximated $114
million.
Total
cost of products sold was $12.2 million for the fourth quarter and $41.4
million for the full year. Gross margin on total product revenue was 80.4%
for the fourth quarter and 80.1% for 2006, compared to 75.2% and 77.9%,
respectively, for the corresponding periods of 2005. Research and development
expenses were $15.8 million for the fourth quarter of 2006, compared to
$17.3 million for the prior year period. Research and development expenses
were $47.9 million for 2006, compared to $34.5 million for 2005. Selling,
general and administrative expenses were $19.1 million for the fourth quarter
of 2006 and $82.6 million for 2006, compared to $23.0 million and $70.8
million, respectively, for the corresponding periods of 2005. The Company
reported net income of $13.9 million, or $0.29 per share, fully diluted,
for the fourth quarter of 2006 and for the full year reported net income
of $31.5 million, or $0.65 per share, fully diluted.
Cash,
cash equivalents and investments were $76.5 million on December 31, 2006.
As of January 31, 2007 cash, cash equivalents and investments were approximately
$109 million and accounts receivables totaled approximately $17 million.
Commenting
on the performance of the Company, Adam Derbyshire, Senior Vice President
and Chief Financial Officer, stated, "Total product revenue for 2006 increased
35% to $208.5 million yielding net income of $31.5 million, or $0.65 per
share, fully diluted, with a 5% tax rate due to prior net operating loss
carry forwards. We are extremely pleased with our continuing robust growth,
particularly over the course of a year during which we invested in the
future of the Company by launching two products, acquiring one product,
advancing our pipeline of development projects and increasing our cash
reserves.
"The
demand for XIFAXAN, our most compelling long-term opportunity, continued
to increase during 2006. XIFAXAN sales totaled $51.6 million for the year,
a 72% increase over 2005. Our newly-launched bowel cleansing products -
OSMOPREP and MOVIPREP - performed extremely well and met all internal expectations.
Revenue from this new therapeutic franchise contributed $45.5 million or
22% of 2006 total product revenue. COLAZAL generated revenue of $103.5
million for 2006. As planned, COLAZAL's contribution as a percentage of
total product revenue incrementally decreased during 2006 due to the expansion
of our product portfolio with the launch of our bowel cleansing products
and as XIFAXAN sales continued to ramp. COLAZAL sales contributed 50% of
total product revenue for 2006 compared to 71% for 2005 and 84% for 2004.
We expect COLAZAL's contribution as a percentage of total product revenue
will continue to moderate going forward.
"For
2007 we anticipate that we will be able to deliver strong ongoing revenue
and EPS growth, and at the same time continue to build our business. We
believe total Company product revenue for 2007 will be approximately $260
million, including the contribution of recently acquired PEPCID® OS
(oral solution). This level of revenue represents top line year-over-year
growth of 25%. We believe we will be able to generate $0.85 in earnings
per share, fully diluted, assuming a 15% tax rate, for the year ending
December 31, 2007. This 2007 EPS of $0.85 represents a 31% increase compared
to 2006 earnings per share of $0.65, or, adjusting to equalize the 5% 2006
tax rate with the anticipated 15% 2007 tax rate, a 46% increase. We believe
our ability to grow revenue and EPS at these rates while continuing to
significantly strengthen our product portfolio distinguishes Salix from
many of its peers.
"Beginning
in the first quarter of 2006 and continuing throughout the year, we committed
an increased level of resources, almost $48 million, to expedite critical
R&D projects, primarily our COLAZAL life cycle management programs.
We are confident that this commitment to adequately fund the development
of key products and indications should be more than adequately rewarded
by increased commercial opportunity as these products come to market over
the next several years. Research and development expenditures totaled 23%
of revenue during 2006. We anticipate that R&D expenditures will be
approximately 25% of revenue in 2007 as we plan to file two NDAs and as
we continue to enroll patients in our ongoing late-stage clinical trials.
Selling, general and administrative expenses for 2006 totaled 40% of revenue,
reflecting costs associated with the June and October launches of OSMOPREP
and MOVIPREP. We anticipate that SG&A will moderate to approximately
35% of revenue for 2007. Research and development expenditures and SG&A
expenditures for 2008 will be similar to 2007 levels. Looking further ahead
to 2009 and beyond, we expect to generate significant leverage as R&D
and SG&A as a percentage of revenue should decrease in that time period." |