EX-99.2 3 dex992.htm POWERPOINT PRESENTATION OF JANUARY 31, 2008 PowerPoint presentation of January 31, 2008
Salix Pharmaceuticals, Ltd.
The Name Gastroenterologists Trust
Exhibit 99.2


2
Forward-Looking Statement
Statements presented in this overview that are not historical facts are
forward-looking statements that involve risks and uncertainties that could
cause actual results to differ materially from projected results.
Factors that could cause actual results to differ materially include
anticipated write-offs and losses and our expectation to return to
profitability, intellectual property risks specifically patent protection,
competition from generic products and otherwise, the risks and
uncertainties of clinical trials and regulatory review, market acceptance of
approved products, and the need to acquire new products. These and other
relevant risks are detailed in the Company’s Securities and Exchange
Commission filings.


3
Generic Balsalazide
December 28, 2007
Office of Generic Drugs Approved
3 Generic Balsalazide Products
Salix Announced Watson Authorized Generic


4
Current Situation
Dramatic price erosion for COLAZAL
$125 million COLAZAL market now a $30-42 million
balsalazide market
Impact on price of future IBD products
Balsalazide tablet and granulated mesalamine
Substantial non-cash charge in 4Q07
Not profitable in 2008
Financial guidance to be provided March 3, 2008


5
Future Outlook
Based on current projections –
No need to raise money to execute business plan
Sufficient cash reserve to return to profitability
Expect to be cash flow positive in 2009
OSMOPREP and MOVIPREP well-positioned in a
growing market
TRx market growth of 18% in 2007*
Osmoprep/Moviprep TRx growth of 353% in 2007*
Expect products to be a $100 million franchise in approx. 3 years
Stable revenue from XIFAXAN and “Other Products”
*  Wolters Kluwer Health PHAST


6
Future Outlook
3 NDA approvals anticipated in 2008
Balsalazide tab, granulated mesalamine, and metoclopramide-ZYDIS
Focus 2008 R&D spend on largest potential indications
Rifaximin Irritable Bowel Syndrome (IBS) program
Mid-2008: Initiate Phase III trials
2008: Publication/presentation of Phase IIb data
Mid-2010: Anticipate NDA submission
Rifaximin Hepatic Encephalopathy (HE) program
Orphan Drug Designation
4Q08/1Q09 NDA submission
Potential 6 month review
Numerous products with patent coverage


7
Mission Statement
Salix Pharmaceuticals is committed to being the leading
U.S. specialty pharmaceutical company licensing,
developing and marketing innovative products to
health care professionals to prevent or
treat gastrointestinal disorders.


8
In-license selective late-stage/marketed product
candidates
U.S. gastroenterology focus
Reduce risk and capital commitment
Complete development and secure FDA approval
Sell products through specialty sales force
Establish franchise with U.S. gastroenterologists
Sell products that serve unmet needs
Strategy


9
An Overall Compelling
Market Opportunity
An influential and demanding target
audience (13,400 specialty physicians)
30.5 million patient visits annually
40 million prescriptions annually
$6 billion Rx sales annually
Source: Verispan PDDA and Wolters Kluwer Health (1/08)


10
History of Success
Product
Launches
NDA
Approvals
Metoclopramide-
ZYDIS
®
Vapreotide
acetate
Granulated
Mesalamine
Acquisitions
2007
2006
2005
2004
2003
2002
2001
2000


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Anticipated Approvals
INFLAMMATORY BOWEL DISEASE
Balsalazide tablet (1100 mg)
2Q08
Granulated mesalamine (1.5 gm)
4Q08
METOCLOPRAMIDE-ZYDIS
4Q08
RIFAXIMIN
Hepatic Encephalopathy (550 mg)
3Q09
Irritable Bowel Syndrome (550 mg)
Mid-2011


12


13
Xifaxan
Unique, Gastrointestinal-Specific Antibiotic
Broad spectrum
Reduced risks
No stable resistance
2004 FDA approval for treatment of travelers’
diarrhea
Patent coverage: May 24, 2024*
Orange Book listed
*Patent expiration dates listed herein are for US patents and
assume there are no patent term adjustments, extensions or
other events that could affect the term or scope of a patent.


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RIFAXIMIN Intellectual Property
Q2 2011
Q1 2009
Q3 2009
Q2 2010
2014
2016
3-28-11
HE
anticipated
filing
7 year orphan
exclusivity
HE
anticipated
approval
9-28-08
7-25-08
8-14-08
5-26-08
First possible
ANDA filing
(includes
paragraph 4
certification)
IBS
anticipated
approval
IBS
anticipated
filing
3 year
exclusivity
Patent
expiration
Patent
issued
Salix has 45 days to
respond and file
lawsuit
(entitled
up
to 30 month stay;
average is 28.5
months according to
Paragraph 4
database)
FDA has
60 days
to accept
the ANDA
ANDA
filer
(20 days to
inform
Salix)
30 month stay
expiration
RIFAXIMIN 550mg (HE)
5-26-06
5-22-24
RIFAXIMIN 550mg (IBS)
XIFAXAN 200mg (TD)
Polymorphous forms of RIFAXIMAN, processes for their production and use thereof in medicinal preparations


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Bowel Cleansing


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Improved Preps for Colonoscopy
OsmoPrep
Proprietary tablet formulation
Launched June 2006
Patent coverage: May 2013*
MoviPrep
Proprietary, state-of-the-art 2 liter liquid PEG with ascorbic acid
Launched October 2006
Patent coverage: September 2024*
Bowel Prep TRx Market Growth in 2007
Total market 18%
OsmoPrep/MoviPrep 353%
*Patent expiration dates listed herein are for US patents and
assume there are no patent term adjustments, extensions or
other events that could affect the term or scope of a patent.


17
Next Generation IBD Products
Balsalazide Tablet (1100mg)
PDUFA* action date –
May 16, 2008
Patent coverage: March 2018**
Expected launch July 2008
Granulated Mesalamine (375mg capsule)
PDUFA
action
date
4Q08
(estimate)
Patent coverage: April 2018**
Expected launch Jan/Feb 2009
*Prescription Drug User Fee Act
**Patent expiration dates listed herein are for US patents and
assume there are no patent term adjustments, extensions or other
events that could affect the term or scope of a patent.


18
Products in Development
Metoclopramide-ZYDIS
®
Gastroparesis/Gastroesophageal reflux
Expected approval 4Q08
Expected launch Jan/Feb 2009
Patent coverage: July 2017*
Vapreotide acetate
Treatment of acute esophageal variceal bleeding
»
Serious complication of late-stage liver cirrhosis
Ongoing confirmatory Phase III trial
Orphan Drug Designation
*Patent expiration dates listed herein are for US patents and
assume there are no patent term adjustments, extensions or other
events that could affect the term or scope of a patent.


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Capitalization –
9/30/07 (in millions)
48.6
Fully
diluted
common
shares
(Treasury
method)
47.2
Common shares outstanding
$15.0
Long term debt
$70.2
Cash, cash equivalents & investments
Actual


20
Current Run Rates for
Base Business
~ $28
Other Products
~$5**
Colazal
~ $60
MoviPrep
OsmoPrep
Visicol
~ $64
Xifaxan
(rifaximin)
Revenue Run Rate
(in millions)*
*Run rate based on current Rx data
**Estimate for 2008


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2008 Anticipated Milestones
Q2 2008
Q1 2008
Complete Rifaximin HE
Phase III enrollment
Balsalazide tablet
PDUFA action date
Digestive Disease
Week –
Rifaximin
IBS Phase IIb data
and balsalazide
tablet data
(abstracts
submitted)
Initiate Rifaximin
IBS Phase III trials
(Mid-2008)
Q3 2008
Launch balsalazide
tablet
American College
Gastroenterology –
Rifaximin IBS
Phase IIb data and
granulated
mesalamine data
(abstracts to be
submitted)
Q4 2008
Granulated mesalamine
PDUFA action date
(estimated)
Metoclopramide-ZYDIS
PDUFA action date
(estimated)
File Rifaximin HE NDA
(4Q08/1Q09)


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2009 Anticipated Milestones
File Rifaximin HE NDA (4Q08/1Q09)
Launch granulated mesalamine
Launch metoclopramide-ZYDIS
Compete Rifaximin IBS Phase III enrollment
Expect to be cash flow positive


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Salix Pharmaceuticals, Ltd.
The Gastroenterology Company
Providing products to gastroenterologists and their patients