Exhibit 99.1
FOR IMMEDIATE RELEASE
Contact: Adam C. Derbyshire Mike Freeman
Vice President and Director, Investor Relations and
Chief Financial Officer Corporate Communications
919-862-1000 919-862-1000
SALIX PHARMACEUTICALS REPORTS
FIRST QUARTER 2002 FINANCIAL RESULTS
RALEIGH, NC, May 15, 2002 - Salix Pharmaceuticals, Ltd. (Nasdaq:SLXP) today
announced operating results for the first quarter of 2002. The Company reported
a net loss of $4.7 million, or $0.26 per share, for the first quarter of 2002.
Product revenues for the period were $6.2 million. Product revenues were derived
from sales of COLAZAL(R) (balsalazide disodium) Capsules 750 mg, the Company's
first-line therapy for the treatment of mildly to moderately active ulcerative
colitis. Cost of sales was $1.6 million for the first quarter of 2002. Gross
margin was 75% for the period.
Operating expenses were $11.1 million for the first quarter of 2002, compared to
$8.5 million for the prior year period. Selling, general and administrative
expenses were $7.0 million for the first quarter of 2002, compared to $5.6
million for the first quarter of 2001. Research and development expenses were
$2.5 million for the first three months of 2002, compared to $1.4 million for
the prior year period.
Cash and cash equivalents were $79.1 million on March 31, 2002.
Commenting on the quarter, Robert Ruscher, President and Chief Executive
Officer, stated, "COLAZAL sales, at $6.2 million for the first quarter of 2002,
are off to a solid start for the year. Over 34,000 COLAZAL prescriptions were
written during the first quarter of 2002, compared to just under 25,000 during
the fourth quarter of 2001. This represents a 37% quarter-over-quarter rate of
growth. We firmly believe that COLAZAL
represents a significant step forward in the treatment of inflammation
associated with ulcerative colitis and that COLAZAL sales will increase as our
sales force continues to meet face-to-face with gastroenterologists to discuss
and provide product samples of COLAZAL. Based upon information currently
available, we estimate that net COLAZAL sales for 2002 will be between $30 and
$35 million.
"With COLAZAL on the market, we are working to expand our product pipeline. On
February 25, 2002, the FDA accepted for filing the New Drug Application we
submitted seeking approval to market LUMENAX(TM) in the United States for the
treatment of travelers' diarrhea. LUMENAX represents our next effort to provide
products that meet the needs of gastroenterologists and their patients. We view
the travelers' diarrhea indication as the first step in our development plan for
LUMENAX. We believe that LUMENAX can be positioned as the "treatment of choice"
for GI infections and, to this end, we intend to develop this non-systemic,
broad-spectrum antibiotic to treat additional infections of the GI tract.
"We have spent the past 18 months building the Company's specialty sales force
and in-house product development team. During March, we raised approximately $57
million by means of a follow-on public offering and now believe we have
sufficient cash to fund opportunities to expand our business. With our
infrastructure in place, Salix now is focused on using the proceeds from the
offering to leverage its core business by maximizing the commercial potential of
COLAZAL and LUMENAX and by acquiring or in-licensing additional products.
Accordingly, by the end of the second quarter of 2002, we intend to initiate
Phase IV studies for COLAZAL and small, single-center studies to investigate the
utility of LUMENAX in the treatment of several additional indications. We also
will continue to actively seek and review product in-licensing opportunities for
late-stage and marketed products with third parties in both the U.S. and
Europe."
The Company will host a conference call at 10:00 a.m. EDT, on May 15, 2002 to
discuss the subjects of this press release. Interested parties may access the
conference call by way of web cast or telephone. The live web cast will be
available at
http://www.salixpharm.com. The web cast will be archived on the Company's web
- -------------------------
site through May 21.
The telephone numbers to access the conference call are (888) 857-6929 (U.S. and
Canada) or (719) 457-2600 (international.) A replay of the call will be
available from 1:00 p.m., EDT, May 15 through May 21. 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 355866.
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 the required development and
regulatory submission of these products, and market them through the Company's
60-member gastroenterology specialty sales force. Salix's first marketed product
is COLAZAL(R), an anti-inflammatory drug approved for the treatment of mildly to
moderately active ulcerative colitis. The Company launched the product in the
U.S. through its specialty sales force in January 2001. 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. Salix's next product candidate is LUMENAX(TM) (rifaximin), currently in
development for the potential treatment of infections of the lower
gastrointestinal tract. The Company submitted an NDA for rifaximin for the
treatment of travelers' diarrhea to the FDA on December 26, 2001. Salix trades
on the Nasdaq National Market under the ticker symbol "SLXP."
For more information please contact the Company at 919-862-1000 or visit our web
site at www.salixpharm.com.
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Table follows
Salix Pharmaceuticals, Ltd.
Condensed Consolidated Statement of Operations
Unaudited
(In thousands, except per share data)
Three Months Ended
March 31, March 31,
2002 2001
(unaudited) (unaudited)
---------------------------
Revenues:
Product Revenue $ 6,211 $ 3,290
Revenue from Collaborative Agreements -- 1,375
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Total Revenues 6,211 4,665
Operating Expenses:
Cost of Products Sold 1,566 786
License Fees and Costs Related to Collaborative Agreements 31 692
Research and Development 2,485 1,435
Selling, General and Administrative 6,978 5,558
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Total Costs and Expenses 11,060 8,471
Loss from operations (4,849) (3,806)
Interest and Other Income/(Expense), net 125 (91)
Income tax -- --
---------------------------
Net loss $ (4,724) $ (3,897)
Net loss per share $ (0.26) $ (0.28)
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Weighted average shares outstanding 17,895 13,711
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Salix Pharmaceuticals, Ltd.
Condensed Consolidated Balance Sheets
(In thousands)
March 31, December 31,
2002 2001
(unaudited) (audited)
-----------------------------
Assets
Cash and Cash Equivalents $ 79,140 $ 27,868
Accounts Receivable, net 1,815 2,378
Inventory 7,580 6,274
Other Assets 2,278 2,070
-----------------------------
Total Assets $ 90,813 $ 38,590
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Liabilities & Stockholders' Equity
Accounts Payable and Other Current Liabilities $ 7,495 $ 8,094
Deferred Revenue 2,852 2,902
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Total Current Liabilities 10,347 10,996
Common Stock 21 17
Additional Paid-in-Capital 131,052 73,461
Accumulated Deficit (50,607) (45,884)
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Total Stockholders' Equity 80,466 27,594
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Total Liabilities & Equity $ 90,813 $ 38,590
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Please Note: This press release contains forward-looking statements
regarding future events. These 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 risks
of regulatory review and clinical trials, the need to acquire additional
products and management of rapid growth. The reader is referred to the
documents that the Company files from time to time with the Securities
and Exchange Commission.