Salix Pharmaceuticals Reports
$59.8 Million Total Product Revenue: 43% Increase Over 2006
Net Income $2.8 Million: EPS $0.06
MOVIPREP® Patent Protection Granted to 2024
PEPCID® Oral Suspension Acquired
DIACOL™ Licensed to Dr. Falk Pharma for Europe
Xifaxan® and IBD Clinical Development Programs Progressing
RALEIGH, NC, May 8, 2007 – Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced financial and operating results for the first quarter ended March 31, 2007.
Total product revenue was $59.8 million for the first quarter of 2007, a year–over–year increase of 43% compared to $41.9 million for the first
quarter of 2006. MOVIPREP®, OSMOPREP™ and VISICOL® combined, generated revenue of $11.0 million
for the first quarter of 2007. Revenue from these three products, which comprise our bowel cleansing product line, contributed 18% of 1Q07 total product
revenue. Xifaxan® revenue for the first quarter of 2007 was $15.4 million, a 134% increase compared to the first quarter of 2006.
COLAZAL® generated revenue of $30.1 million for the first quarter of 2007 compared to $22.8 million for the first quarter of 2006.
The Company continued to make progress during the period in its effort to broaden and diversify its product line. The chart below reveals the
changing product mix of our revenue base:
| REVENUE CONTRIBUTION |
(First Quarter % of Total Product Revenue)
|
| Product |
2007 |
2006 |
2005 |
|
| COLAZAL |
50% |
55% |
83% |
| Xifaxan |
26% |
16% |
9% |
| Bowel Cleansing |
18% |
23% |
na |
| Other |
6% |
6% |
8% |
Total cost of products sold was $12.0 million for the first quarter. Gross margin on total product revenue was 79.9% for the first quarter of 2007 compared
to 80.2% for the first quarter of 2006. Research and development expenses were $21.8 million for the first quarter of 2007, compared to $10.1
million for the prior year period. Selling, general and administrative expenses were $21.4 million for the first quarter of 2007, compared to $19.4
million in the prior year period. The Company reported net income of $2.8 million, or $0.06 per share, fully diluted, for the first quarter of 2007.
Cash, cash equivalents and investments were $54 million on March 31, 2007.
Commenting on the performance of the Company, Adam Derbyshire, Senior Vice President and Chief Financial Officer, stated, "Total product revenue for the
first quarter of 2007 increased 43% to $59.8 million yielding net income of $2.8 million, or $0.06 per share, fully diluted, with a 17% tax rate due
to prior net operating loss carry forwards. Total product revenue for the quarter included five weeks of revenue for our newly–acquired PEPCID®
Oral Suspension and DIURIL® Oral Suspension. We look forward to the contribution of a full quarter of product revenue
from these products beginning in the next quarter.
"As planned, we invested substantial resources, approximately $21.8 million or 37% of revenue, in research and development efforts during the first quarter
of 2007. As previously stated, we expect R&D expenditures will be approximately 25% of revenue for the entire year of 2007. We continue to believe
that total product revenue for 2007 will be approximately $260 million and that we will be able to generate $0.85 in earnings per share, fully
diluted, assuming a 17% tax rate, for the year ending December 31, 2007. The 2007 EPS of $0.85 represents a 50% increase, on a tax–adjusted basis,
compared to 2006 EPS of $0.65. We believe our ability to significantly strengthen our product portfolio by means of product acquisition and label
expansion of existing products while continuing to grow revenue and EPS at these rates distinguishes Salix from many of its peers and bodes well
for our future."
Commenting on the Company and its performance, Carolyn Logan, President and Chief Executive Officer stated, "The solid year–over–year increase
in revenue for each of our three major therapeutic areas demonstrates our consistent ability to build and grow the business. Our bowel–cleansing
product line experienced an impressive 90% increase in prescriptions for 1Q2007 compared to 1Q2006. MOVIPREP, OSMOPREP and VISICOL at quarter
end commanded an impressive 23% share of the prescription bowel cleansing market and we anticipate our share of this important market will continue
to increase. Prescription demand for our bacteria–related disease product, Xifaxan, increased 77% over the past year. Year–over–year
demand for COLAZAL, the initial offering in our inflammatory bowel disease product line, grew 5.3% versus 3.8% for the 5–ASA market, in
terms of prescriptions. These three product lines provide a diversified and growing base for the Company's ongoing expansion and growth.
"MOVIPREP and OSMOPREP are performing very well in the bowel cleansing market. As we expected, the differentiating qualities of these products are creating
distinct advantages in the marketplace. Our ability to provide both a tablet agent and a two–liter liquid PEG agent is creating an unprecedented
opportunity for Salix to establish a leadership position. We capitalized on our increasing visibility and presence in this market during the quarter by joining with
Walgreens and the Colon Cancer Alliance to sponsor a nationwide colorectal screening education campaign. This collaboration
resulted in an estimated 32 million patient exposures to information regarding the benefits of screening and early detection of colorectal cancer.
"In January 2007 the United States Patent and Trademark Office issued a patent for MOVIPREP providing coverage to September 2024. The patent is listed
in the Orange Book and serves to further strengthen the intellectual property position of our product portfolio. In April 2007 we out–licensed
to Dr. Falk Pharma the exclusive rights to market DIACOL™ in Europe. The product is marketed in the United States under the trade
name OSMOPREP. We received a milestone payment of $1.5 million and, under the terms of the agreement, may receive up to $2.5 million in additional
payments. Additionally we will receive royalty payments based on product sales. DIACOL received approval in the United Kingdom in December 2006
and currently is under regulatory review in Germany. This licensing agreement demonstrates our strategy to grow our business by out–licensing
opportunities in territories outside of the United States while maintaining our focus on the U.S. market. We are pleased with this opportunity to
strengthen our relationship with Dr. Falk Pharma and to expand the commercial potential of our unique tablet bowel cleansing agent.
"Xifaxan demonstrated continued strong growth during the first quarter of 2007. During the period approximately 94,000 prescriptions were written for Xifaxan.
This level of prescription demand represents a 77% increase compared to the first quarter of 2006 and a 9% increase compared to the fourth quarter
of 2006. We are committed to maximizing the therapeutic potential of this GI–targeted antibiotic, and our development efforts to expand
the Xifaxan label are moving forward on several fronts. Patient enrollment continued during the first three months of 2007 in our late–stage,
multi–center registration trials in irritable bowel syndrome, hepatic encephalopathy, C. difficile–associated diarrhea and the
prevention of travelers' diarrhea. We anticipate a number of significant milestones associated with these trials – including the release of top line
clinical trial results and the submission of new drug applications – will generate news flow beginning in the third quarter 2007 and continuing
through late 2008/1H2009. We anticipate these efforts will result in the approval of a stream of new indications for Xifaxan beginning in late
2008 or early 2009 through early 2010. Targeted timeframes, based upon information currently available, for certain milestones are listed below:
| Xifaxan Clinical Development |
| Proposed Timelines |
| INDICATION |
Top line results |
NDA submission |
|
| Prevention travelers' diarrhea |
3Q07 |
1H2008 |
| Irritable bowel syndrome |
4Q07 |
end 2008/1H2009* |
| Hepatic encephalopathy |
time of filing |
mid 2008 |
| C. difficile–associated diarrhea |
time of filing |
mid 2008 |
* pending results of FDA "end of Phase II" meeting |
"The Company's work to investigate the utility of Xifaxan to treat a broad spectrum of gastrointestinal disorders continues to be complemented by a robust
level of work by independent investigators. Digestive Disease Week 2007, which will be held May 19–23, should provide a forum at which leading
researchers and clinicians will have the opportunity to discuss recent advances in the role of antibiotic therapy in GI disease.
"COLAZAL continued to gain position in the 5–ASA market during the first quarter of 2007. Over the past year COLAZAL prescription growth has outpaced
total 5–ASA prescription growth by 40%. We believe COLAZAL's unique, azo–bonded prodrug formulation of 5–ASA and its consequent
proven ability to rapidly gain complete symptom relief compared to other 5–ASA agents currently available should continue to make our product
a valued and sought–after treatment. Our work to strengthen and expand our inflammatory bowel disease franchise progressed during the first
three months of 2007. We completed patient enrollment in the Phase III placebo–controlled trial of balsalazide tablets during the quarter
and we now are preparing the NDA submission. We remain on schedule to release top–line data for the placebo–controlled trial at the end
of June and to submit the application at the end of July. In February we completed patient enrollment in the second Phase III six–month trial
of granulated mesalamine. Plans are on track to release top–line data on the two trials during the fourth quarter of 2007 and to submit the
NDA by the end of December 2007. We believe the addition of these products to our inflammatory bowel disease portfolio will broaden our reach and
scope in providing solutions for an unsatisfied market.
"In February we announced our purchase of the U.S. prescription rights to PEPCID Oral Suspension and DIURIL Oral Suspension. We are pleased with the opportunity
to add these trusted brands and revenue–producing products to our product portfolio. In the near term, the additional revenue generated
by these products should serve to fund ongoing product development efforts and, in the longer term, should contribute to growing earnings per share."
The Company will host a conference call to discuss the contents of this press release at 9:00 a.m. ET, on Tuesday, May 8, 2007. Interested parties may
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 conference call are (800) 238–9007 (U.S. and Canada) or (719) 457–2622 (international.) The access code
for the call is 2447315. A replay of the call will be available beginning at 12:00 noon ET. The telephone numbers to access the replay of the call
are (888) 203–1112 (U.S. and Canada) or (719) 457–0820 (international.) The access code for the replay is 2447315.
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.
COLAZAL® (balsalazide disodium) Capsules 750 mg, is an anti–inflammatory drug approved for the treatment of mildly to moderately active
ulcerative colitis. Safety and effectiveness of COLAZAL beyond 12 weeks has not been established. COLAZAL was well tolerated in clinical studies.
In clinical trials, patients reported the following adverse events most frequently: headache (8%); abdominal pain (6%); diarrhea (5%); nausea
(5%); vomiting (4%); respiratory infection (4%); and arthralgia (4%). Withdrawal from therapy due to adverse events was comparable to placebo.
Xifaxan® (rifaximin) tablets 200 mg are indicated for the treatment of patients (≥12 years of age) with travelers' diarrhea caused by noninvasive
strains of Escherichia coli. Xifaxan should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea
due to pathogens other than Escherichia coli. Xifaxan should be discontinued if diarrhea symptoms get worse or persist more than 24–48
hours and alternative antibiotic therapy should be considered. In clinical trials, Xifaxan was generally well tolerated. The most common side
effects (vs. placebo) were flatulence 11.3% (vs. 19.7%), headache 9.7% (vs. 9.2%), abdominal pain 7.2% (vs. 10.1 %) and rectal tenesmus 7.2% (vs.
8.8%).
OSMOPREP™ Tablets (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) are indicated for cleansing
of the colon as a preparation for colonoscopy in adults 18 years of age or older. Considerable caution should be advised before OSMOPREP Tablets
are used in patients with severe renal insufficiency, congestive heart failure, ascites, unstable angina, gastric retention, ileus, acute obstruction
or pseudo–obstruction of the bowel, severe chronic constipation, bowel perforation, acute colitis, toxic megacolon, gastric bypass or stapling
surgery, or hypomotility syndrome. Use with caution in patients with impaired renal function, patients with a history of acute phosphate nephropathy,
known or suspected electrolyte disturbances (such as dehydration), or people taking drugs that affect electrolyte levels. Patients with electrolyte
abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia should have their electrolytes corrected before treatment
with OSMOPREP Tablets.
MOVIPREP® (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution) is indicated
for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. MOVIPREP should be used with caution in patients
using concomitant medications that increase the risk of electrolyte abnormalities such as diuretics or angiotensin converting enzyme (ACE)–inhibitors
or in patients with known or suspected hyponatremia. MOVIPREP should also be used with caution in patients with severe ulcerative colitis,
ileus, gastrointestinal obstruction or perforation, gastric retention, toxic colitis, or toxic megacolon. In clinical trials, abdominal distension,
anal discomfort, thirst, nausea and abdominal pain were some of the most common adverse reactions to MOVIPREP administration. Vomiting occurred
less frequently.
Salix also markets VISICOL® Tablets (sodium phosphate monobasic monohydrate, USP, sodium phosphate dibasic anhydrous, USP), PEPCID®
OS, DIURIL® OS, AZASAN® (azathioprine 75mg and 100mg tablets, USP), Anusol–HC® 2.5% (hydrocortisone
Cream USP), Anusol–HC® 25 mg Suppository (Hydrocortisone Acetate), PROCTOCORT® Cream (Hydrocortisone
Cream USP) 1% and PROCTOCORT® Suppositories (Hydrocortisone Acetate Rectal Suppositories, 30 mg). SANVAR® IR (vapreotide
acetate), balsalazide tablets, granulated mesalamine and Xifaxan® for additional indications are under development.
For full prescribing information on Salix products, please visit www.salix.com.
Salix trades on the NASDAQ Global Select Market under the ticker symbol "SLXP".
For more information please visit our web site at www.salix.com or contact the Company at 919–862–1000. Information on our web site is not incorporated
in our SEC filings.
ANUSOL® is a trademark of Johnson & Johnson
AZASAN® is a trademark of AaiPharma Inc. and AaiPharma LLC
MOVIPREP® is a trademark of Norgine B.V.
PEPCID® and DIURIL® are trademarks of Merck & Co., Inc.
SANVAR® is a trademark of Debiopharm S. A.
Xifaxan® is a trademark of Alfa Wassermann Hungary LLC
Table Follows
###
First Quarter 2007 Statement - Unaudited (PDF 32KB)
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COLAZAL® (balsalazide disodium) Capsules 750 mg are indicated for the treatment of mildly to moderately active Ulcerative Colitis in patients 5 years of age and older.
COLAZAL does not relieve symptoms in all patients; your patients' results may vary. In four well-controlled clinical trials, patients receiving a COLAZAL dose of 6.75g/day most frequently reported the following events
(reporting frequency > 3%): headache (8%), abdominal pain (6%), diarrhea (5%), nausea (5%), vomiting (4%), respiratory infection (4%), and arthralgia (4%). Withdrawal from therapy due to adverse events was comparable to
placebo. In the pediatric trial, patients most frequently reported the following adverse events: headache (15%), abdominal pain upper (13%), abdominal pain (12%), vomiting (10%), diarrhea (9%), colitis ulcerative (6%),
nasopharyngitis (6%) and, pyrexia (6%). COLAZAL is contraindicated in patients with a hypersensitivity to salicylates or the components of COLAZAL capsules or balsalazide metabolites. The safety and effectiveness of
COLAZAL beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults have not been established.
Consult with your physician to see if this product is right for you.
For complete Prescribing Information, please click here.
Xifaxan® (rifaximin) Tablets are indicated for the treatment of patients (≥12 years of age) with travelers' diarrhea caused by non-invasive strains of
Escherichia coli. Xifaxan should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli. Xifaxan should be
discontinued if diarrhea symptoms get worse or persist more than 24-48 hours and alternative antibiotic therapy should be considered.
In clinical trials, Xifaxan was generally well tolerated. The most common side effects (vs. placebo) were flatulence 11.3% (vs. 19.7%), headache 9.7% (vs. 9.2%), abdominal pain 7.2% (vs. 10.1 %), rectal tenesmus 7.2%
(vs. 8.8%), defecation urgency 5.9% (vs. 9.2%) and nausea 5.3% (vs. 8.3%).
Consult with your physician to see if this product is right for you.
For complete Prescribing Information, please click here.
MoviPrep® (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution) is indicated for cleansing of the
colon as a preparation for colonoscopy in adults 18 years of age or older. MoviPrep is contraindicated in patients who have had a severe hypersensitivity reaction
to any of its components. MoviPrep should be used with caution in patients using concomitant medications that increase the risk of electrolyte abnormalities, in patients with known or suspected hyponatremia,
severe ulcerative colitis, ileus, gastrointestinal obstruction or perforation, gastric retention, toxic colitis, toxic megacolon, or glucose-6-phosphate dehydrogenase deficiency. In clinical trials, abdominal
distention, anal discomfort, thirst, nausea, and abdominal pain were the most common adverse reactions to MoviPrep administration. MoviPrep contains a maximum of 2.33 mg of phenylalanine per treatment.
Consult with your physician to see if this product is right for you.
For complete Prescribing Information, please click here.
OsmoPrep® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets are indicated for cleansing of the colon as a preparation for colonoscopy
in adults 18 years of age or older. Considerable caution should be advised before OsmoPrep is used in patients with severe renal insufficiency, congestive heart failure, ascites, unstable angina, gastric
retention, ileus, acute obstruction or pseudo-obstruction of the bowel, severe chronic constipation, bowel perforation, acute colitis, toxic megacolon, gastric bypass or stapling surgery, or hypomotility syndrome.
Use with caution in patients with impaired renal function, patients with a history of acute phosphate nephropathy, patients with a history of seizures or at higher risk of seizure, patients with higher risk of cardiac
arrhythmias, known or suspected electrolyte disturbances (such as dehydration), or people taking drugs that affect electrolyte levels. Patients with electrolyte abnormalities such as hypernatremia, hyperphosphatemia,
hypokalemia, or hypocalcemia should have their electrolytes corrected before treatment with OsmoPrep. OsmoPrep is contraindicated in patients with a known allergy or hypersensitivity to sodium phosphate salts or any of
its ingredients. In clinical trials, the most commonly reported adverse reactions (reporting frequency >3%) were abdominal bloating, nausea, abdominal pain, and vomiting. It is recommended that patients receiving
OsmoPrep be advised to adequately hydrate before, during, and after the use of OsmoPrep.
Consult with your physician to see if this product is right for you.
For complete Prescribing Information, please click here.