MOVIPREP Prescriptions Increase 81% Year-over-Year
XIFAXAN Prescriptions Increase 13% Year-over-Year
METOZOLV FDA Action Date September 11, 2009
Rifaximin NDA for Hepatic Encephalopathy Submitted June 24, 2009
Rifaximin IBS Phase 3 Results Expected late Q3/early Q4
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced financial and
operating results for the second quarter ended June 30, 2009.
Total product revenue was $52.2 million for the second quarter of 2009,
compared to $41.1 million for the second quarter of 2008. Total product
revenue for the first six months of 2009 was $97.0 million compared to
$75.3 million for the first six months of 2008. XIFAXAN®
revenue for the second quarter of 2009 was $26.3 million, a 46% increase
compared to the second quarter of 2008. XIFAXAN revenue for the first
six months of 2009 was $50.4 million compared to $34.8 million for the
first six months of 2008. MOVIPREP®, OSMOPREP® and
VISICOL®, which comprise our bowel cleansing product line,
generated revenue of $16.5 million for the second quarter of 2009,
compared to $15.7 million for the second quarter of 2008. Total product
revenue for our bowel cleansing product line was $29.2 million for the
first six months of 2009 and $26.0 million for the first six months of
2008.
Total cost of products sold was $11.4 million for the second quarter and
$21.3 million for the first six months of 2009. Gross margin on total
product revenue was 78.1% for the second quarter of 2009 compared to
82.7% for the second quarter of 2008 and 78.0% for the first six months
of 2009, compared to 80.9% the first six months of 2008. The lower gross
margins for 2009 relative to the comparable periods for 2008 were due to
a change in the product revenue mix. We expect gross margins for the
year ending December 31, 2009 to be 79% to 80%. Research and development
expenses were $22.8 million for the second quarter of 2009 and $42.9
million for the first six months of 2009, compared to $15.4 million and
$41.3 million, respectively for the prior year periods. Selling, general
and administrative expenses were $29.0 million for the second quarter of
2009 and $54.0 million for the first six months of 2009, compared to
$23.0 million for the second quarter of 2008 and $44.1 million for the
first six months of 2008. The Company reported a net loss of $15.3
million, or $0.32 per share, fully diluted, for the second quarter of
2009.
Cash and cash equivalents were $86.0 million on June 30, 2009.
Commenting on the performance of the Company, Adam Derbyshire, Executive
Vice President and Chief Financial Officer, stated, “We continue to be
extremely pleased with the ongoing robust growth of XIFAXAN, our most
compelling long-term opportunity, as well as our bowel cleansing
franchise. Combined product revenue from XIFAXAN and our bowel cleansing
products achieved year-over-year growth of 27% for the second quarter of
2009. We believe we are positioned to continue to build our business and
to deliver year-over-year increases in product revenue by: 1) growing
our currently marketed products, 2) securing the approval of additional
products and additional indications for rifaximin and 3) expanding our
portfolio of products via development activities, licensing and
acquisitions.
“Previously we stated that we would update 2009 revenue and loss per
share guidance if and when METOZOLV™ ODT is approved and launched to
physicians. Based on the facts and circumstances associated with the
anticipated launch of METOZOLV ODT we currently intend to recognize
METOZOLV ODT revenue based on prescription pull-through rather than
product shipment or sell-in to wholesalers. Based on a pull-through
methodology for METOZOLV ODT, 2009 total Company product revenue should
be approximately $230 million, representing 29% growth over 2008
revenue, and we should recognize a loss of approximately $0.90 per
share, fully diluted, for the year ending December 31, 2009. If the
facts and circumstances change, we might recognize METOZOLV ODT revenue
based on product shipment to wholesalers. Based on a sell-in methodology
for METOZOLV ODT, 2009 total Company product revenue could be
approximately $240 million, representing 34% growth over 2008 revenue,
and we could recognize a loss of approximately $0.70 per share, fully
diluted, for the year ending December 31, 2009.
“The current annualized run rates, based on dollarizing the latest
prescription data for XIFAXAN, our bowel cleansing product line and our
“other products” category are approximately $108 million, $80 million,
and $34 million, respectively. Additionally, we previously stated that
research and development expenses and selling, general and
administrative expenses for 2009 should be approximately $99 million and
$111 million, respectively. We now anticipate that R&D and S,G&A
expenses for 2009 should be approximately $93 million and $120 million,
respectively. The updated 2009 selling, general and administrative
guidance includes anticipated METOZOLV ODT launch expenses primarily
associated with the hiring of a second sales force comprised of 64 sales
representatives.
“The continuing growth of our business and broadening of our product
portfolio necessitates the expansion of our sales effort. During the
remainder of 2009 we will be hiring, training and launching the second
sales force comprised of 64 sales representatives. In the short term the
added impact of this second sales force, combined with the ongoing
efforts of our existing 96-member sales force, should serve to increase
the share of voice we will be able to capture in the ulcerative colitis
market and increase our ability to gain share in the bowel cleansing
market. Then, as METOZOLV ODT and other products and/or indications are
approved, the combined efforts of the two sales forces should generate
increased product revenue.
“For the third quarter of 2009 we anticipate total Company product
revenue will be approximately $60 million and should generate a loss of
approximately $0.30 per share, fully diluted.”
Carolyn Logan, President and Chief Executive Officer, stated, “XIFAXAN
prescription demand and sales continued to increase during the second
quarter of 2009, as they have every quarter since the product was
launched in 2004. We look forward to expanding the label and use of this
non-absorbed, gut-selective antibiotic in the U.S. market potentially
beyond the treatment of travelers’ diarrhea to bring relief to patients
suffering from other bacterial complications of the gut.
“The bowel cleansing market represents a dynamic and growing opportunity
for Salix. For the second quarter of 2009 prescription demand for our
bowel cleansing franchise increased 17% year-over-year. MOVIPREP
prescriptions increased 81% year-over-year, while OSMOPREP prescriptions
for the comparable period decreased 41%.
“The March 2009 introduction of APRISO, our once-a-day therapy for
ulcerative colitis, combined with the introduction of a competitive
once-a-day product in 2007, should transition the ulcerative colitis
market from a multi-dose per day market to a once-a-day market. During
APRISO’s first six months on the market, it continues to make progress
with respect to increasing share of new prescriptions and share of new
physician prescribers. We believe APRISO, with its unique Intellicor™
delivery system, should position Salix to compete very effectively in
the evolving ulcerative colitis market in the months and years to come.
We continue to believe peak year sales of APRISO should exceed $100
million.
“As previously announced, positive results of our Phase 3 study of the
use of rifaximin in the treatment of hepatic encephalopathy (HE) were
presented at the annual meeting of Digestive Disease Week on May 30 to
June 4, 2009. The 299-patient, multinational, randomized, double-blind,
placebo-controlled trial, was designed to assess the long-term (six
months) efficacy, safety and tolerability of rifaximin in maintaining
remission compared to placebo among patients with a history of HE. These
new data demonstrated that rifaximin significantly reduced the risk of
HE-related hospitalizations in patients with previous episodes of HE and
showed a highly significant reduction in the risk of breakthrough HE
during the six month study. One analysis showed that rifaximin
significantly reduced the risk of HE-related hospitalizations compared
to placebo (50% risk reduction, p=0.01) during the six month treatment
period. A second analysis showed that rifaximin treatment after
adjusting for significant prognostic factors (such as age, duration of
current verified remission, number of prior HE episodes and model for
end-stage liver disease [MELD] – that can contribute to breakthrough HE)
resulted in a 60% risk reduction demonstrating a highly significant
protective effect (p<0.0001) in preventing HE breakthrough. We are
extremely pleased with the results of our pivotal study and are
encouraged with the level of interest generated by these data.
“We submitted the hepatic encephalopathy NDA to the U. S. Food and Drug
Administration (FDA) on June 24, 2009. Rifaximin has been granted orphan
drug designation by the FDA for use in hepatic encephalopathy. We
believe that this designation will provide seven years of marketing
exclusivity in the United States if rifaximin gains approval from the
FDA for HE.
“Currently we estimate the U.S. commercial opportunity represented by
the HE market is approximately $600 million. Hepatic encephalopathy
occurs frequently in patients with cirrhosis as a result of their
end-stage liver disease. Typically the cirrhosis is caused by a number
of factors such as alcohol and/or drug abuse, chronic viral hepatitis
and autoimmune disease. Cirrhosis is a leading cause of death in the
United States. The number of cases of liver disease in the United States
and around the world is rapidly increasing with more than 7 million
people in the United States being diagnosed with chronic liver disease.
There are reported to be more than 100,000 patients in the United States
with overt HE.
“With respect to our development program for rifaximin in the treatment
of irritable bowel disease, we completed enrollment well ahead of
schedule, in May 2009, and exceeded our patient enrollment quota of 1200
in TARGET 1 and TARGET 2, our two 600-patient studies to assess the
efficacy, safety and tolerability of rifaximin 550 mg, dosed three times
daily, in the treatment of patients with non-constipation irritable
bowel syndrome. Currently, we expect top-line data should be available
late third quarter or early fourth quarter of 2009, and we are targeting
to submit the non C-IBS NDA during the first half of 2010. Once the data
are made public, assuming a positive outcome, we intend to begin the
process of identifying a commercial partner to promote rifaximin to
primary care physicians for the treatment of non C-IBS, if and when
approved.
“Irritable bowel syndrome is among one of the most common chronic
medical conditions and affects approximately 15% of adults in the United
States. Currently we estimate the U.S. commercial opportunity
represented by the non-C IBS market is approximately $2.2 billion.
“The FDA review of METOZOLV ODT progressed during the second quarter of
2009. The FDA accepted Wilmington Pharmaceutical’s complete response for
METOZOLV ODT and granted an action date of September 11, 2009.
“Last week Stage 1, the (dose selection stage), of the Phase 3 trial of
crofelemer for the treatment of chronic diarrhea in people living with
HIV, or HIV-associated diarrhea, was completed. Stage 2 (final stage) is
now underway with the objective to determine the proportion of
HIV-positive patients experiencing relief of diarrhea with crofelemer
compared to placebo. The protocol for this trial has been reviewed and
approved by the FDA as a Special Protocol Assessment, or SPA, and has
been granted fast track designation.
“Recently the Company entered into an agreement with AstraZeneca to
co-promote Nexium® (esomeprazole magnesium) for the treatment
of acid reflux disease, which in 2008 had net sales of $3.8 billion in
the United States. Beginning August 31, our current 96-member specialty
sales force will begin calling on targeted gastroenterologists to
promote Nexium for six months. This co-promotion should provide an
opportunity for our current sales force to gain better access with
certain physicians and to develop expertise in a new disease state, as
well as generating a small amount of additional revenue.
“We look forward to continued growth and expansion during 2009 and
beyond. We plan to continue to execute our business strategy by
in-licensing late-stage and marketed products, developing the products
in our pipeline and ensuring that our marketed products are provided
with the attention and support required to achieve success.”
The Company will host a conference call at 5:00 p.m. ET, on Monday,
August 10, 2009. 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 (888) 510-1783
(U.S. and Canada) or (719) 457-2621 (international.) 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 5354538.
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 gastroenterology
specialty sales and marketing team.
Salix markets XIFAXAN® (rifaximin) tablets 200 mg, OSMOPREP®
(sodium phosphate monobasic monohydrate, USP and sodium phosphate
dibasic anhydrous, USP) Tablets, MOVIPREP® (PEG 3350, Sodium
Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and
Ascorbic Acid for Oral Solution), VISICOL® (sodium phosphate
monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP)
Tablets, APRISO™ (mesalamine) extended-release capsules 0.375 g, 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. METOZOLV™ ODT
(metoclopramide), crofelemer, budesonide foam and rifaximin for
additional indications are under development.
For full prescribing information and important safety information on
Salix products, 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 web site at www.salix.com
. Information on our 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:
our need to return to profitability; the unpredictability of the
duration and results of regulatory review of New Drug Applications and
Investigational NDAs; the cost, timing and results of clinical trials
and other development activities involving pharmaceutical products;
market acceptance for approved products; generic and other competition;
litigation and the possible impairment of, or inability to obtain,
intellectual property rights and the costs of obtaining such rights from
third parties; 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.
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Statements of Operations
|
|
|
|
|
|
|
|
|
|
(In thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
Six Months Ended
|
|
|
|
|
June 30,
|
June 30,
|
|
June 30,
|
|
June 30,
|
|
|
|
|
2009
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
(unaudited)
|
|
(unaudited)
|
|
(unaudited)
|
|
(unaudited)
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
Net product revenues
|
|
$
|
52,234
|
|
|
$
|
41,071
|
|
|
$
|
97,008
|
|
|
$
|
75,325
|
|
|
|
Revenues from collaborative agreements
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
Total revenues
|
|
|
52,234
|
|
|
|
41,071
|
|
|
|
97,008
|
|
|
|
75,325
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and Expenses:
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold
|
|
|
11,411
|
|
|
|
7,114
|
|
|
|
21,316
|
|
|
|
14,370
|
|
|
|
Fees and costs related to license agreements
|
|
|
500
|
|
|
|
105
|
|
|
|
500
|
|
|
|
1,605
|
|
|
|
Amortization of product rights and intangible assets
|
|
|
2,501
|
|
|
|
2,271
|
|
|
|
5,003
|
|
|
|
4,542
|
|
|
|
Research and development
|
|
|
22,837
|
|
|
|
15,358
|
|
|
|
42,911
|
|
|
|
41,256
|
|
|
|
Selling, general and administrative
|
|
|
28,995
|
|
|
|
22,967
|
|
|
|
54,010
|
|
|
|
44,144
|
|
|
|
Total costs and expenses
|
|
|
66,244
|
|
|
|
47,815
|
|
|
|
123,740
|
|
|
|
105,917
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations
|
|
|
(14,010
|
)
|
|
|
(6,744
|
)
|
|
|
(26,732
|
)
|
|
|
(30,592
|
)
|
|
|
Interest and other income, net
|
|
|
(1,354
|
)
|
|
|
149
|
|
|
|
(2,645
|
)
|
|
|
610
|
|
|
|
Income (loss) before provision for income tax
|
|
|
(15,364
|
)
|
|
|
(6,595
|
)
|
|
|
(29,377
|
)
|
|
|
(29,982
|
)
|
|
|
Provision for income tax
|
|
|
47
|
|
|
|
(494
|
)
|
|
|
94
|
|
|
|
(1,104
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
(15,317
|
)
|
|
$
|
(7,089
|
)
|
|
$
|
(29,283
|
)
|
|
$
|
(31,086
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share, basic
|
|
$
|
(0.32
|
)
|
|
$
|
(0.15
|
)
|
|
$
|
(0.61
|
)
|
|
$
|
(0.65
|
)
|
|
Net income (loss) per share, diluted
|
|
$
|
(0.32
|
)
|
|
$
|
(0.15
|
)
|
|
$
|
(0.61
|
)
|
|
$
|
(0.65
|
)
|
|
Weighted average shares outstanding, basic
|
|
|
48,240
|
|
|
|
47,763
|
|
|
|
48,175
|
|
|
|
47,743
|
|
|
Weighted average shares outstanding, diluted
|
|
|
48,240
|
|
|
|
47,763
|
|
|
|
48,175
|
|
|
|
47,743
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Salix Pharmaceuticals, Ltd.
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets
|
|
|
|
|
|
|
|
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
December 31,
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
(unaudited)
|
|
(audited)
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
86,049
|
|
|
$
|
120,153
|
|
|
|
|
|
|
|
Accounts receivable, net
|
|
|
53,366
|
|
|
|
40,461
|
|
|
|
|
|
|
|
Inventory, net
|
|
|
19,605
|
|
|
|
17,311
|
|
|
|
|
|
|
|
Other assets
|
|
|
218,025
|
|
|
|
222,559
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Assets
|
|
$
|
377,045
|
|
|
$
|
400,484
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and other liabilities
|
|
$
|
137,210
|
|
|
$
|
135,083
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
137,210
|
|
|
|
135,083
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock
|
|
|
48
|
|
|
|
48
|
|
|
|
|
|
|
|
Additional paid-in-capital
|
|
|
421,415
|
|
|
|
417,698
|
|
|
|
|
|
|
|
Accumulated deficit
|
|
|
(181,628
|
)
|
|
|
(152,345
|
)
|
|
|
-
|
|
|
|
|
|
Total stockholders' equity
|
|
|
239,835
|
|
|
|
265,401
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Liabilities and Stockholders' Equity
|
|
$
|
377,045
|
|
|
$
|
400,484
|
|
|
|
|
|
Salix Pharmaceuticals
Adam C. Derbyshire, Executive Vice
President
and Chief Financial Officer or
G. Michael Freeman,
Associate Vice President,
Investor Relations and Corporate
Communications, 919-862-1000