EX-99.1 2 dex991.htm PRESENTATION MATERIALS Presentation materials
(NASDAQ: AUXL)
January 2008
Exhibit 99.1


2
(NASDAQ: AUXL)
Safe Harbor Statement
Safe Harbor Statement
We
will
make
various
remarks
during
this
presentation
that
constitute
“forward-looking
statements”
for
purposes
of
the
safe
harbor
provisions
under
The
Private
Securities
Litigation
Reform
Act
of
1995,
including
statements
regarding
future
Testim
market
share,
prescriptions
and
sales
growth
and
factors
that
may
drive
such
growth;
size
and
growth
potential
of
the
testosterone
replacement
therapy
market
and
the
gel
segment
thereof
and
factors
that
may
drive
such
growth;
the
effect
of
the
Company’s
expansion
of
its
field
force;
the
protection
for
Testim
afforded
by
U.S.
Patent
No.
7,320,968,
the
value
of
extending
patent
protection
for
Testim
through
January
2025,
the
value
and
likelihood
that
patents
will
be
granted
from
the
continuation
and
divisional
applications
filed
by
Bentley
Pharmaceuticals,
Inc.;
the
pricing,
time
to
market,
size
of
market,
growth
potential
and
therapeutic
benefits
of
the
Company’s
product
candidates,
including
those
for
the
treatment
of
Dupuytren’s
contracture,
Peyronie’s
disease,
and
Frozen
Shoulder
syndrome;
interpretation
of
market
research
data;
competition
within
certain
markets
relevant
to
the
Company’s
product
candidates;
interpretation
of
clinical
results,
including
the
efficacy
and
tolerability
of
the
Company’s
product
candidates;
the
timing
of
the
commencement
and
completion
of
clinical
trials
and
the
timing
of
reporting
of
results
therefrom;
the
timing
of
manufacturing
scale
up
for
the
Company’s
product
candidates;
the
Company’s
ability
to
manufacture
XIAFLEX™
(clostridial
collagenase
for
injection
formerly
known
as
AA4500)
at
the
Company’s
Horsham
facility;
the
timing
of
the
completion
of
dosing
of
patients
in
phase
III
trials
for
XIAFLEX
for
the
treatment
of
Dupuytren’s
contracture;
the
timing
of
the
filing
of
the
Biologics
License
Application
for
approval
of
XIAFLEX
for
the
treatment
of
Dupuytren’s
contracture
and
the
approval
thereof;
the
timing
of
the
phase
IIb
trials
for
XIAFLEX
for
the
treatment
of
Peyronie’s
disease;
competitive
developments
affecting
the
Company’s
products
and
product
candidates,
including
generic
competition;
the
success
of
the
Company’s
development
activities;
the
Company’s
development
and
operational
goals
for
fiscal
2007;
the
ability
to
fund
future
operations;
and
the
Company’s
expected
financial
performance
during
2007
and
financial
milestones
that
it
may
achieve
for
2007,
including
2007
net
revenues,
research
and
development
spending,
selling,
general
and
administrative
expenses,
and
net
loss.
All
remarks
other
than
statements
of
historical
facts
made
during
this
presentation,
including
but
not
limited
to,
statements
regarding
future
expectations,
plans
and
prospects
for
the
Company,
statements
regarding
forward-looking
financial
information
and
other
statements
containing
the
words
“believe,”
“may,”
“could,”
“will,”
“estimate,”
“continue,”
“anticipate,”
“intend,”
“should,”
“plan,”
“expect,”
and
similar
expressions,
as
they
relate
to
the
Company,
constitute
forward-
looking
statements.
Actual
results
may
differ
materially
from
those
reflected
in
these
forward-looking
statements
due
to
various
factors,
including
general
financial,
economic,
regulatory
and
political
conditions
affecting
the
biotechnology
and
pharmaceutical
industries
and
those
discussed
in
the
Company’s
Annual
Report
on
Form
10-K
for
the
year
ended
December
31,
2006
and
the
Company’s
Quarterly
Report
on
Form
10-Q
for
the
period
ended
September
30,
2007
under
the
heading
“Risk
Factors”,
which
is
on
file
with
the
Securities
and
Exchange
Commission
(the
“SEC”)
and
may
be
accessed
electronically
by
means
of
the
SEC’s
home
page
on
the
Internet
at
http://www.sec.gov
or
by
means
of
the
Company’s
home
page
on
the
Internet
at
http://www.auxilium.com
under
the
heading
“Investor
Relations
-
SEC
Filings.”
There
may
be
additional
risks
that
the
Company
does
not
presently
know
or
that
the
Company
currently
believes
are
immaterial
which
could
also
cause
actual
results
to
differ
from
those
contained
in
the
forward-looking
statements.
Given
these
risks
and
uncertainties,
any
or
all
of
these
forward-looking
statements
may
prove
to
be
incorrect.
Therefore,
you
should
not
rely
on
any
such
factors
or
forward-looking
statements.
In
addition,
forward-looking
statements
provide
the
Company’s
expectations,
plans
or
forecasts
of
future
events
and
views
as
of
the
date
of
this
presentation.
The
Company
anticipates
that
subsequent
events
and
developments
will
cause
the
Company’s
assessments
to
change.
However,
while
the
Company
may
elect
to
update
these
forward-looking
statements
at
some
point
in
the
future,
the
Company
specifically
disclaims
any
obligation
to
do
so.
These
forward-looking
statements
should
not
be
relied
upon
as
representing
the
Company’s assessments
as
of
any
date
subsequent
to
the
date
of
this
presentation.


Fastest Growing
TRT product in
the U.S.
Late Stage
Company
Transforming
Product
Poised for Growth
+
=


4
(NASDAQ: AUXL)
Auxilium Pharmaceuticals, Inc.  (NASDAQ: AUXL)
Auxilium Pharmaceuticals, Inc.  (NASDAQ: AUXL)
Specialty biopharmaceutical company focused on Urologists,
Endocrinologists, Orthopedists and certain PCPs
Founded in 1999
Headquarters in Malvern, Pa.
Manufacturing in Horsham, Pa.
Approximately 290 employees (~190 commercial)
I.P.O in July 2004
Currently approximately 40.0 million shares issued & outstanding
Additional 7 million shares subject to issuance from stock options
& warrants
A component of the NASDAQ BIOTECH INDEX


5
(NASDAQ: AUXL)
Broad Pipeline Maturing in Coming Years
Broad Pipeline Maturing in Coming Years
Note:  Worldwide rights for all products available, except Testim where ex -U.S. rights have been licensed.
XIAFLEX™
(clostridial
collagenase for injection) was formally referred to as AA4500
5
6
Product
Testim®
gel
Approved in U.S.
Europe & Canada
XIAFLEX™
XIAFLEX™
XIAFLEX™
Transmucosal Film
AA4010
Transmucosal Film
Transmucosal Film
Market
Phase III
Phase II
Phase I
Pre-clinical
Late Research
Hypogonadism
Dupuytren’s Contracture
Peyronie’s Disease
Frozen Shoulder Syndrome
Overactive Bladder
Hormones and Urology
Pain


6
(NASDAQ: AUXL)
Anticipated News Flow Events
Anticipated News Flow Events
5
Jan 22:
Testim-Patent Issued
Q108/Q208:
XIAFLEX-Complete Peyronie's Animal Study
XIAFLEX-Initiate Peyronie's Phase IIb Studies
Q208:
XIAFLEX-Top- line Phase III (Double Blind) Data
H109:
XIAFLEX-Open Label Safety Data
Early 2009:
XIAFLEX-File BLA for Dupuytren's Contracture
6
6
Q409
Q309
Q209
Q109
Q408
Q308
Q208
Q108
Early 2010
XIAFLEX –
FDA Approval
In Dupuytren’s Contracture
Early
2010


XIAFLEX™
(clostridial
collagenase for injection)
A Company Transforming Opportunity


8
(NASDAQ: AUXL)
XIAFLEX –
XIAFLEX –
Company Transforming Opportunity
Company Transforming Opportunity
Potential to replace surgery in certain indications
Great fit for Specialty Biopharmaceutical Company
Worldwide rights offer options to build company or
generate cash
We believe there are approximately 450,000
potential patients annually in U.S. and EU for
Dupuytren’s & Peyronie’s indications -
> $1 Billion
opportunity, based on market research and
analysis
BLA for Dupuytren’s Contracture expected to file
in early 2009


9
(NASDAQ: AUXL)
XIAFLEX for Dupuytren’s
XIAFLEX for Dupuytren’s
Contracture
Contracture
Collagen accumulation in hand causes affected
fingers to become permanently flexed
Disease description
Patented through 2014; Orphan Drug Exclusivity for
7 years post approval
I.P. position
Surgery is only approved treatment -
expensive and
characterized by numerous complications
Current treatment
Enrollment in CORD I and CORD II completed in
December 2007
Last injections in CORD I and double blind portion of
Cord II expected in March 2008 –
Top line results in
Q2 2008
Clinical status
Prevalence estimated at 3-6% of Caucasian
populations -
highest among people of northern
European descent
Target population
Source: Badalamente, M. et al. J. Hand Surgery, September 2002


10
(NASDAQ: AUXL)
Potential to Revolutionize Treatment for Dupuytren’s
Potential to Revolutionize Treatment for Dupuytren’s
Contracture
Contracture
Current Treatment
XIAFLEX Treatment


11
(NASDAQ: AUXL)
Journal of Hand Surgery, July/Aug 2007-
Journal of Hand Surgery, July/Aug 2007-
Methods
Methods
Randomized, double-blind, placebo controlled
35 Patients (28 men, 7 women)
Mean Age was 61 ±
8.5 years
XIAFLEX Injections:
10,000 units dosing
Maximum 3 injections per joint at 4-6 week intervals
2:1 randomization vs. placebo
Primary Endpoint:
Contracture within 0 to 5°
of normal
Measured 30 days after last injection


12
(NASDAQ: AUXL)
Pivotal Phase III Study –
Pivotal Phase III Study –
Results
Results
XIAFLEX
Placebo
P-value
Primary End Point
21/23 (91%)*
0/12
< .001
-
MP Joint
12/14 (86%)
0/7
< .001
-
PIP Joint
9/9 (100%)
0/5
< .001
Secondary Joint
5/6 (83%)
0/3
.035
Median Time to
Success
8 Days
N/A
Mean # Injections
For Success
1.4
N/A
*  Success rates were 70% after a single injection


13
(NASDAQ: AUXL)
Pivotal Phase III Study –
Pivotal Phase III Study –
Other Findings
Other Findings
Adverse Events:
No Serious Adverse Events reported
Adverse events were mild to moderate, mostly local
reactions. Resolved within a mean of 3 weeks
No reports of loss of sensation or infections, and no skin
grafts required
In total, 54 / 62 (87%) joints achieved clinical success 
in the study and its open label extension
Recurrence Rates:
3 of 54 joints followed for 12 months
5 of 27 joints followed for 24 months


14
(NASDAQ: AUXL)
Dupuytren’s Clinical Plan ~ 725 total patients
Dupuytren’s Clinical Plan ~ 725 total patients
CORD I Study:
216 patients in at least 15 sites in the U.S.
Double blind placebo controlled, randomized in 2:1 ratio of active to
placebo
Primary endpoint is reduction in contracture to within 0 -
of normal
Secondary endpoints to measure clinical improvement and time to
success
Top Line data expected to be
available Q2 2008
CORD II Study:
60 patients, following protocol similar to U.S. trial
Top Line data expected to be available Q2 2008
Five Australian sites
Enrolled >300 patients in CORD I / II by December 2007
Open-label studies to generate additional safety data (n ~ 450 -
>300 patients enrolled by December 2007)


15
(NASDAQ: AUXL)
We believe:
There is a pent-up demand for non-surgical therapy
Surgeons and patients prefer non-invasive treatment
Each patient on average has 2.2 joints which will require
treatment; 49% have contractures in both hands
Early data indicates on average 1.4 vials of XIAFLEX required
per joint
2.2 joints per patient x 1.4 vials per joint = 3.1 vials per patient on
average
We believe XIAFLEX treatment can be priced competitively to
cost of surgery (~$5,000 in the U.S.)
Dupuytren’s Commercial Opportunity
Dupuytren’s Commercial Opportunity


16
(NASDAQ: AUXL)
Market Research Performed –
Market Research Performed –
Dupuytren’s
Dupuytren’s
Multiple prevalence data sets proved to be highly variable in
numbers of patients
Two rounds of quantitative primary research have been
commissioned by Auxilium on XIAFLEX for Dupuytren’s
contracture
A combined 571 Orthopedic Surgeons have been interviewed to
estimate market size (401 in U.S.; 170 in Europe) and 391 have
given feedback on potential usage of XIAFLEX (221 U.S.; 170
Europe)
Second study (n=444 total & 340 in depth) was designed to
provide 95% confidence level and 7.5% margin of error


17
(NASDAQ: AUXL)
Patients
Seeking
Treatment
~1,030,000
No Prior
Surgery
~540,000
Had Surgery
Previously
~490,000
Watchful
Waiting
~270,000
Medical/
Surgical
Treatment
~270,000
Medical/
Surgical
Treatment
~125,000
Watchful Wait/
In Follow Up
~365,000
XIAFLEX
Potential
Candidates
~240,000
240,000 Dupuytren’s Candidates In U.S. & Europe
240,000 Dupuytren’s Candidates In U.S. & Europe
Annually
Annually
Source: Auxilium research and analysis
~150,000 in U.S.
~ 90,000 in Europe
Prevalence      
3 –
6% of
Population
~13,500,000 to
27,000,000


18
(NASDAQ: AUXL)
XIAFLEX for Peyronie’s Disease
XIAFLEX for Peyronie’s Disease
Patented through 2019
Orphan Drug exclusivity for 7 years post approval
I.P.  position
Treated by urologists
Lacks good treatment options
PABA, Vitamin E, Verapamil ineffective
Surgery may shorten penis; cause scarring
Unmet need for non-surgical treatment
Current treatment
Promising efficacy data from open label phase II studies. 
Statistically significant improvement vs. baseline was
achieved in:
Correction of penile deviation (=
25% reduction in angle)
In sexual functioning
Clinical status
Affects men predominantly over 50
Target population
Plaque or hard scar area on the penis
Deformity of the penis during erection precludes
intercourse
Disease description
Source: Mulhall, J. et al, June 2004


19
(NASDAQ: AUXL)
Peyronie’s Clinical Plan
Peyronie’s Clinical Plan
Local effects / tolerability pre-clinical study outside of plaque
requested by FDA.  In life stage of animal study completed 4Q
2007.  Expect to send final report to FDA in 1H 2008.
Phase IIb dose ranging study expected to begin in Q2 2008, 
pending FDA review of animal study results
Patient Reported Outcome Survey likely to be primary endpoint. 
We plan to validate of the Survey during a phase IIb study.
File as a Supplemental BLA for Peyronie’s indication.  Will not be
filed before Dupuytren’s BLA approved.


20
(NASDAQ: AUXL)
Market Research Performed –
Market Research Performed –
Peyronie’s
Peyronie’s
Two rounds of quantitative primary research have
been commissioned by Auxilium on XIAFLEX for
Peyronie’s disease
A combined 575 Urologists have been interviewed to
estimate market size (415 in U.S.; 160 in Europe) and
383 have given feedback on potential usage of
AA4500 (223 U.S.; 160 Europe)
Second study (n=472 total & 333 in depth) was
designed to provide 95% confidence level and 7.5%
margin of error


21
(NASDAQ: AUXL)
Patients
Seeking
Treatment
~475,000
Surgery Not
Recommended
~365,000
Watchful
Waiting
~160,000
Medical or
Intralesional
Therapy
~205,000
Surgery
Recommended
~110,000
XIAFLEX
Potential
Candidates
~210,000
210,000 Peyronie’s Candidates In U.S. and Europe
210,000 Peyronie’s Candidates In U.S. and Europe
Annually
Annually
Source: Auxilium research
~135,000 in U.S.
~ 75,000 in Europe


22
(NASDAQ: AUXL)
XIAFLEX for Frozen Shoulder Syndrome
XIAFLEX for Frozen Shoulder Syndrome
Arthroscopic procedure or surgery
Current treatment
Early studies showed trend to efficacy and
tolerability at highest dose (10,000 units)
Additional phase II studies needed to assess
optimal dose, primary endpoints and dosing
regimen
Clinical status
Estimated 3% of people develop frozen shoulder
syndrome over their lifetime
Higher incidence among patients with diabetes (10-
20%) vs general population (2-5%)
Higher incidence among patients with insulin-
dependent diabetes (36%), with increased frequency
of bilateral shoulder involvement
Market research indicates ~700,000 patients visit
doctors in the U.S. every year
Most common in patients between 45 –
70 yrs
Target population
Diminished shoulder motion, characterized by
restriction in active and passive range of motion
Disease description
Source: Pearsall, A. Adhesive capsulitis. eMedicine. 2005 http://www.emedicine.com/pmr/topics372.htm


Testim
®
1% Testosterone Gel:
Near-Term Growth Driver
Executing on Opportunities


24
(NASDAQ: AUXL)
Testim®
Testim®
is the Fastest Growing Testosterone
is the Fastest Growing Testosterone
Replacement Therapy Gel
Replacement Therapy Gel
Proprietary, topical
1% testosterone gel
Once-a-day application
Favorable clinical and
commercial profile
Comparative studies support advantages 
Non-substitutable with Androgel
Broad prescription coverage
Growing prescriber loyalty


25
(NASDAQ: AUXL)
Male Hypogonadism (Testosterone Deficiency) Overview
Male Hypogonadism (Testosterone Deficiency) Overview
Recent study indicates 39% of U.S. males over 45 yrs are
hypogonadal
We estimate that less than 10% of affected population receives treatment
Diagnosis increasing through education and awareness
Signs/symptoms –
Brain Function
Libido and erections
Energy and vigor
Cognitive function
Sleep quality
Irritability and depressed mood
Signs/symptoms –
Body Composition
Muscle mass and strength
Bone mineral density
Male hair density and skin thickness
Fat mass –
abdominal obesity
Source: Mulligan T. et al. Int J. Clin Pract
2006


26
(NASDAQ: AUXL)
Clinical Results Show Testim
Clinical Results Show Testim
®
®
Changes Body Composition
Improves Sexual Activity
Sexual Activity
59%
Statistically significant
increases in sexual desire
Lean Body Mass         
4.8 lbs
Fat Mass
4.0 lbs
Bone Mineral Density  
2.6 %
12-month study
Placebo-controlled study, 90-day results
Source: Auxilium studies published in Journal of Clinical Metabolism & Review of Urology


27
(NASDAQ: AUXL)
Patient Benefits are Clinically Proven
Patient Benefits are Clinically Proven
Note:
Adjusted geometric means (CV
b
%) of a single-dose (50 mg testosterone), randomized,
complete crossover study of 29 hypogonadal men.
Total Testosterone
2,000
3,000
4,000
5,000
6,000
Mean AUC
0-24
(ng*h/dL)
Testim
AndroGel
Free Testosterone
0
50
100
150
200
250
Mean AUC
0-24
(ng*h/dL)
Testim
AndroGel
16 clinical studies involving approx. 1,800 patients
largest placebo-controlled study ever conducted
Clinical trial of Testim
®
vs. AndroGel
®
Testim provides 30% higher testosterone absorption (p<0.001)


28
(NASDAQ: AUXL)
Gels Fastest Growing TRT Segment
Gels Fastest Growing TRT Segment
Source: IMS data
($ in millions)
Gel
Patch
Oral
Injectables
$35
$117
$200
$287
$340
$383
$449
0
100
200
300
400
500
600
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
$459
$399
$302
$210
$77
$59
$49
$499
$118
$568
Gel Segment Growth ($)
Sep 2007 L12M: 
+25%
2007 YTD (Sep):
+26%
Gel Segment Growth ($)
Gel Segment Growth ($)
Sep 2007 L12M: 
Sep 2007 L12M: 
+25%
2007 YTD (Sep):
2007 YTD (Sep):
+26%


29
(NASDAQ: AUXL)
Testim
®
®
quarterly net revenues and scripts
($ in millions)
Established Track Record of Consistent Growth
Established Track Record of Consistent Growth
Q3 2007 Net
Revenues
Y/Y Growth:
+49%
Q3 2007 Net
Q3 2007 Net
Revenues
Revenues
Y/Y Growth:
Y/Y Growth:
+49%
Q3 2007 TRX
Y/Y Growth:
+33%
Q3 2007 TRX
Q3 2007 TRX
Y/Y Growth:
Y/Y Growth:
+33%
Source: Auxilium and IMS data
$-
$5
$10
$15
$20
$25
$30
0
20
40
60
80
100
120
Net Revs
TRX


30
(NASDAQ: AUXL)
Testim
Testim
®
®
Driving Growth in Market
Driving Growth in Market
Source: IMS data
Testim
®
Share of TRx of Gel Market
Strong market share with high-prescribing urologists;
39.4% gel market share of decile
8-10 Urologists in November 2007
1.0%
21.5%
0%
5%
10%
15%
20%
25%
Mar-03
Dec-07


31
(NASDAQ: AUXL)
U.S. Testim
®
patent (covering Hsieh Enhancers)
expires in June 2008
U.S. Patent # 7,320,968 covering method of use claims
for Testim issued January 22, 2008; expires 2025
Divisional application and continuations filed with
USPTO in late 2007 with a plan to protect additional
inventions and seek additional claims
New patent issued in Canada; expires 2023
New patent issued in Europe; expires 2023
Note: The referenced Testim patents are owned by Bentley Pharmaceuticals, Inc.
Testim Patent Coverage


Financials / Strategic Priorities


33
(NASDAQ: AUXL)
YTD
2007
Q3 ’07
Sept ’07
Guidance
Revenues
$26.2
$68.0
$92-96
R&D Expense
$9.8
$28.3
$40-44
SG&A Expense
$18.2
$53.9
$74-77
Net Loss
$6.9
$28.8
$39-43
Stock –
Based
Comp Expense
$1.6
$4.3
$7-9
Cash & short term investments
$82.5
2007 Financial Results and Revised Guidance
2007 Financial Results and Revised Guidance
($ Millions)
($ Millions)


34
(NASDAQ: AUXL)
Strategic Priorities
Strategic Priorities
Continue Development of XIAFLEX with a plan to:
Complete dosing in CORD I and double blind portion of CORD II in
Q1 2008, allowing for top line results to be announced in Q2 2008 &
be prepared to file BLA in early 2009
Continue market research activities; prepare commercial team
Continue development of XIAFLEX in Peyronie’s Disease and
Frozen Shoulder Syndrome indications
Continue Driving Testim Growth
Implement infrastructure and processes to allow for rapid
growth


35
(NASDAQ: AUXL)
Fastest Growing
TRT product in
the U.S.
Late Stage
Company
Transforming
Product
Poised for Growth
+
=