EX-99.1 2 dex991.htm PRESENTATION MATERIALS Presentation Materials
(NASDAQ: AUXL)
June 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
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
referred
to
as
AA4500)
at
the
Company’s
Horsham
facility;
the
timing
of
the
completion
of 
phase
III
trials
for
XIAFLEX
for
the
treatment
of
Dupuytren’s
contracture
and
the
reporting
of
results
therefrom;
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;
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
protection
for
Testim
afforded
by
U.S.
Patent
No.
7,320,968,
and
its
listing
in
the
Orange
Book,
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
absence
of
an
ANDA
for
the
generic
to
Testim;
the
Company’s
development
and
operational
goals
and
strategic
priorities
for
fiscal
2008;
the
ability
to
fund
future
operations;
and
the
Company’s
expected
financial
performance
during
2008
and
financial
milestones
that
it
may
achieve
for
2008,
including
2008
net
revenues,
research
and
development
spending,
selling,
general
and
administrative
expenses,
stock-based
compensation
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,
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
Blockbuster
Product
Opportunity
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 320 employees (~190 commercial)
I.P.O in July 2004
Currently approximately 41.2 million shares issued & outstanding
Additional 6.6 million shares subject to issuance from stock
options & warrants
A component of the NASDAQ BIOTECH INDEX


5
(NASDAQ: AUXL)
Broad Maturing Pipeline
Broad Maturing Pipeline
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
Product
Testim®
gel
Approved in U.S.
Europe & Canada
XIAFLEX™
XIAFLEX™
XIAFLEX™
Transmucosal Film
AA4010
Transmucosal Film
Transmucosal Film
Hypogonadism
Dupuytren’s Contracture
Peyronie’s Disease
Frozen Shoulder Syndrome
Overactive Bladder
Hormones and Urology
Pain
Phase III
Market
Phase II
Phase I
Pre-clinical
Late Research


6
(NASDAQ: AUXL)
Anticipated News Flow Events
Anticipated News Flow Events
Q308:
XIAFLEX-Initiate
Peyronie's
Phase
IIb
Study
H109:
XIAFLEX-Open
Label
Safety
Data
Early 2009:
XIAFLEX-File
BLA
for
Dupuytren's
Contracture
Early 2010
XIAFLEX
FDA
Approval In
Dupuytren’s
Contracture
Q409
Q309
Q209
Q109
Q408
Q308
2010


XIAFLEX™
(clostridial collagenase for injection)
Unique, Late-Stage Opportunity with Blockbuster
Potential


8
(NASDAQ: AUXL)
XIAFLEX-
XIAFLEX-
Unique, Late-Stage, Blockbuster
Unique, Late-Stage, Blockbuster
Opportunity
Opportunity
Potential to be first effective non-surgical treatment for two
high unmet needs
Late-Stage Phase III data for the treatment of Dupuytren’s
contracture -expect to file U.S. BLA in early 2009
We believe promising Phase II data in Peyronie’s disease
Well-characterized mode of action
Worldwide rights offer options to build company or
generate cash –
exploring EU partnering opportunities
now
We believe there are at least 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


9
(NASDAQ: AUXL)
Dupuytren’s Contracture—a Debilitating Condition
Dupuytren’s Contracture—a Debilitating Condition
Excessive collagen deposition
Nodules represent early, active
form
Cords develop over time, are
palpable, and result in
contractures
Debilitating effect on quality of life
Surgery may be reserved for
advanced disease due to
unpredictable results,
complications, long recovery and
recurrence/additional surgeries


10
(NASDAQ: AUXL)
Current Treatment Options Are Invasive or
Current Treatment Options Are Invasive or
Ineffective
Ineffective
Surgery
Non-surgical options
Splinting
Physical therapy
Corticosteroids
Needle
fasciotomy/
aponeurotomy
Amputation


11
(NASDAQ: AUXL)
Dupuytren’s Contracture—Unmet Medical Need
Dupuytren’s Contracture—Unmet Medical Need
Disease
prevalence
is
estimated
at
3%-6%
among
adult
Caucasians,
1
but
occurs
in
all
populations
Higher
prevalence
in
patients
of
northern-European
descent
1
Hereditary
component
in
approximately
40%
of
patients
2
On
average,
patients
have
2.2
affected
joints
at
the
time
of
diagnosis,
and
about
half
of
patients
have
bilateral
disease
3
Recurrence rate in surgical patients
4
30% in 2 years
55% in 10 years
We believe Dupuytren’s contracture is under-diagnosed and
under-treated
1
Tubiana
2006.
Hueston 1963
3
Skoog 1948
4
Mikkelsen 1976


12
(NASDAQ: AUXL)
XIAFLEX—Potential to Revolutionize Treatment
XIAFLEX—Potential to Revolutionize Treatment
for Dupuytren’s Contracture
for Dupuytren’s Contracture


13
(NASDAQ: AUXL)
XIAFLEX—Potential to Revolutionize
XIAFLEX—Potential to Revolutionize
Treatment for Dupuytren’s Contracture
Treatment for Dupuytren’s Contracture


14
(NASDAQ: AUXL)
91%
86%
100%
85%
0%
0%
0%
0%
20%
40%
60%
80%
100%
Pivotal Phase III Study (DUPY-303): Results*
Pivotal Phase III Study (DUPY-303): Results*
54/62 (87%) joints achieved 0°-5°
contracture 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
Mean number of injections for success was 1.4
Injections well tolerated with only local AEs
*The Journal of Hand Surgery.
2007;32(6).
* After up to three injections. Success rate was 70% after a single injection.
21/23
12/14
9/9
33/39
Primary joint
P<.001
MP joint
P<.001
PIP joint
P<.001
Non-Primary joints
0/12
0/7
0/5
XIAFLEX
Placebo


15
(NASDAQ: AUXL)
Most Patients Achieved Full Extension,
Most Patients Achieved Full Extension,
Regardless of Joint Affected or Severity
Regardless of Joint Affected or Severity
92%
78%
86%
61%
47%
53%
79%
60%
70%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
MP
PIP
Combined
10,000 units, approximately 0.58 mg.
Joint Type
Response rate by joint type and baseline joint severity
Studies 202-303-404 combined
Low severity
High severity
Total


16
(NASDAQ: AUXL)
CORD I Design
CORD I Design
Largest ever double-blind, placebo-controlled
trial in Dupuytren’s Contracture
randomized in 2:1 ratio of active to placebo
enrolled a 2:1 ratio of MP:PIP
enrolled 1:1 ratio of less severe to more severe joints
Primary
endpoint
is
reduction
in
contracture
to
within
0
-
5
o
of
normal
Secondary endpoints to measure clinical
improvement and time to success
50%
improvement
in
contracture
change in primary joint degree of contracture
3 month and 12 month safety profile


17
(NASDAQ: AUXL)
Primary Endpoint Outcome Compares Favorably
Primary Endpoint Outcome Compares Favorably
To Surgery
To Surgery


18
(NASDAQ: AUXL)
4 Out Of 5 Dupuytren’s Contracture Patients
4 Out Of 5 Dupuytren’s Contracture Patients
Improved By
Improved By
50%
50%


19
(NASDAQ: AUXL)
Contracture Reduction By Degrees Indicates Average
Contracture Reduction By Degrees Indicates Average
XIAFLEX Patient Achieves ~10°
XIAFLEX Patient Achieves ~10°
Of Contracture
Of Contracture


20
(NASDAQ: AUXL)
XIAFLEX Phase III AE and SAE Rates Should
XIAFLEX Phase III AE and SAE Rates Should
Compare Favorably To Surgical Complications
Compare Favorably To Surgical Complications
Serious Adverse Events
Number
Rate/Inj.
Tendon / Ligament:
Confirmed Tendon Rupture
3
0.14%
Unconfirmed Tendon Rupture
1
0.05%
Ligament Injury
1  
0.05%
Total Tendon / Ligament
5
0.24%
Deep Vein Thrombosis
1
0.05%
Complex Regional Pain Syndrome
1  
0.05%
Total
7  
0.33%
Note:  > 2,000 injections in approximately 850 patients from CORD,
JOINT and PK studies.
Common adverse events and rates were consistent with prior
XIAFLEX trials


21
(NASDAQ: AUXL)
CORD I Key Takeaways
CORD I Key Takeaways
Primary endpoint of
reached in 64% of patients
(p<0.001)
25 of 26 endpoints met with statistical significance
of <0.001, 1 of 26 was met with a p-value = 0.002
Of the 73 patients who didn’t respond, 44 received
less than 3 injections and 25 had no palpable cord
Primary joint contractures improved
50% in 4 out of 5
patients
82.2% of patients receiving XIAFLEX completed the
study with contractures
25°
Less severe contractures responded better than more
severe contractures
MP joints responded better than PIP joints
Safety profile compares favorably to surgery
No systemic exposure and no allergic reactions


22
(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; about half 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.
equates
to
$1,600
per
vial)
Dupuytren’s Commercial Opportunity
Dupuytren’s Commercial Opportunity


23
(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


24
(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 or 60%
of the
Medical/Surgical
Candidates
At least 240,000 Dupuytren’s Candidates In U.S. & Europe
At least 240,000 Dupuytren’s Candidates In U.S. & Europe
Annually
Annually
Source: 2006 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


25
(NASDAQ: AUXL)
Expected Pathway to BLA Filing in Early 2009
Expected Pathway to BLA Filing in Early 2009
Complete 12 month open-label safety follow up from
>100 CORD I patients originally randomized to
XIAFLEX
Complete open-label CORD II and JOINT I/II trials to
attain 1,000 patient exposure data
Finalize BLA filing (CMC, etc.)


26
(NASDAQ: AUXL)
XIAFLEX I.P. Position  for Dupuytren’s
XIAFLEX I.P. Position  for Dupuytren’s
Contracture
Contracture
U.S. Orphan Drug Exclusivity granted on May 23, 1996
for 7 years post approval
Market Exclusivity expected in EU for 10 years post-
approval
–Data protection granted for 8 years
Method of Use Patent in U.S. through 2014
Use Patent in France, UK, Sweden through 2018
–Pending in Germany and Denmark
Highly Purified Collagenase API  and manufacturing
patent filed (if issued, expected expiry 2027)


27
(NASDAQ: AUXL)
1. Smith BH. Am J Clin Pathol. 1966;45:670-678.
2. Somers KD, Dawson DM. J Urol. 1997;157:311-315.
Peyronie’s Disease—a Devastating Disorder
Peyronie’s Disease—a Devastating Disorder
Scarring phenomenon affecting the
tunica albuginea
1
Plaques show excessive collagen
deposition
2
Potential Symptoms
Pain with erection, penile
curvature/deviation, penile
shortening, indentations, and/or
erectile dysfunction
May experience difficulty with sexual
intercourse, loss of self-esteem, and
depression
There are no approved therapies
for the treatment of Peyronie’s
disease


28
(NASDAQ: AUXL)
Epidemiology—Peyronie’s Disease
Epidemiology—Peyronie’s Disease
Prevalence of Peyronie’s disease is estimated at 1 in 20
adult men
1
Actual prevalence higher based on autopsies
2
Prevalence rate increases with age
The average age of disease onset is 53 years
3
High association with other diseases such as:
Diabetes, erectile dysfunction (ED), Dupuytren’s
contracture, plantar fascial contracture,
tympanosclerosis,
gout,
and
Paget’s
disease
4
We believe Peyronie’s disease is under-diagnosed and
under-treated
1. Schwarzer
U, The prevalence of Peyronie’s disease: Results of a large survey.
BJU Int
2001;88:727–30;
Mulhall
et al: J Urology
2004:171: 2350 –
2353;Rhoden
et al: Int J. Impot
Res
2001 :13 : 291 –
293; La Pera
et al : EUR Urology
2001: 40
:525 –
530.
2. Smith BH. Am J Clin Pathol. 1966;45:670-678.
3. Lindsay MB, J Urol.
1991;146:1007–1009.
4. Nyberg L, J Urol.128: 48, 1982


29
(NASDAQ: AUXL)
Current Treatment—Surgical
Current Treatment—Surgical
The goal of surgery is simply to make the two sides of the
penis equal in size
Graft or prosthetic may be required
Cost of surgery in U.S. is ~$10-12K


30
(NASDAQ: AUXL)
Peyronie’s Disease—Unapproved Treatments
Peyronie’s Disease—Unapproved Treatments
Have Been Used With Little Reported Success
Have Been Used With Little Reported Success
Verapamil
Vitamin E
Colchicine
Potassium aminobenzoate (Potaba)
Tamoxifen
Interferon alpha-2a
Corticosteroids
Energy transfer treatment including
extracorporeal shock wave therapy (ESWT),
laser and ultrasound therapy, and
orthovoltage radiation


31
(NASDAQ: AUXL)
Promising Phase II Results: Patients With
Promising Phase II Results: Patients With
25%
25%
Reduction in the Angle of Deviation
Reduction in the Angle of Deviation
Study 1030
58%
53%
35%
0%
20%
40%
60%
80%
100%
Month 3
Month 6
Month 9
Study 1035
50%
100%
100%
89%
0%
20%
40%
60%
80%
100%
Week 6
Month 3
Month 6
Month 9


32
(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
XIAFLEX (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


33
(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 or
67% of
Medical/
Surgical
candidates
~210,000
At least 210,000 Peyronie’s Candidates In U.S. and Europe
At least 210,000 Peyronie’s Candidates In U.S. and Europe
Annually
Annually
Source: 2006 Auxilium research and analysis
~135,000 in U.S.
~ 75,000 in Europe
Prevalence      
1 in 20 Adult
Males


34
(NASDAQ: AUXL)
Peyronie’s Clinical Plan
Peyronie’s Clinical Plan
Phase IIb dose ranging study expected to begin in
Q3 2008
A proprietary Patient Reported Outcome (PRO)
questionnaire has been developed
To be validated in Phase IIb and likely to be used as a
primary efficacy endpoint in Phase III clinical trials
File as a Supplemental BLA for Peyronie’s
indication
Will not be filed before Dupuytren’s BLA approved.


35
(NASDAQ: AUXL)
XIAFLEX I.P.  Position for Peyronie’s
XIAFLEX I.P.  Position for Peyronie’s
Disease
Disease
U.S. Orphan Drug Exclusivity granted on March 12, 1996
for 7 years post approval
Market Exclusivity in EU could be extended to 11 years on
approval of additional indication
–Biosimilars
would need to generate extensive regulatory, safety,
and efficacy data
Method of Use Patent in U.S. through 2019
Use Patent Granted in France, UK, and Ireland (expiry 2020)
–Pending in Germany, Denmark, and Norway
Highly Purified Collagenase API and manufacturing patent
filed (if issued, expected expiry 2027)


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


37
(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
Recent study indicates 39% of U.S. males over 45 yrs
are hypogonadal*
We estimate that less than 10% of affected population
receives treatment
We believe diagnosis is increasing through education
and awareness
*Mulligan T. et al. Int J. Clin Pract
2006


38
(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)


39
(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
$568
Gel Segment Growth ($)
Apr 2008 L12M: 
23.6+%
Gel Segment Growth ($)
Gel Segment Growth ($)
Apr 2008 L12M: 
Apr 2008 L12M: 
23.6+%
2007
700
$685
$563


40
(NASDAQ: AUXL)
$-
$5
$10
$15
$20
$25
$30
0
20
40
60
80
100
120
Net Revs
TRX
Testim
®
®
quarterly net revenues and scripts
($ in millions)
Established Track Record of Consistent Growth
Established Track Record of Consistent Growth
Q1 2008 Net
Revenues
Y/Y Growth:
+47.2%
Q1 2008 Net
Q1 2008 Net
Revenues
Revenues
Y/Y Growth:
Y/Y Growth:
+47.2%
Q1 2008 TRX
YY Growth:
+31.2%
Q1 2008 TRX
Q1 2008 TRX
YY Growth:
YY Growth:
+31.2%
Source: Auxilium and IMS data


41
(NASDAQ: AUXL)
We Believe Testim Is Driving Growth in
Overall Gel Market
Source: IMS data
Testim Share of TRx of Gel Market
21.9%
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
Mar-03
May-08
Strong market share with high-prescribing urologists & PCP’s;
41.3% gel market share of decile 8-10 Urologists and 28.8% share with
decile 8 –
10 PCP’s in April 2008


42
(NASDAQ: AUXL)
U.S. Patent # 7,320,968 covering method of use claims for Testim
issued January 22, 2008; expires 2025
We believe no Paragraph III ANDA was filed prior to issuance of the
’968 patent, since five months have passed since listing in the
Orange Book
Divisional application and continuations filed with U.S. PTO 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
Patents granted and applications pending in numerous countries
worldwide
Testim Patent Coverage
Note: The referenced Testim patents are owned by CPEX Pharmaceuticals, Inc


Financials / Strategic Priorities


44
(NASDAQ: AUXL)
2008
Q1 ’07
Q1 ’08
Guidance
Revenues
$18.4
$27.1
$120-125
R&D Expense
$8.7
$13.2
$52-56
SG&A Expense
$17.2
$21.0
$88-92
Net Loss
($11.9)
($12.3)        ($44-48)
Stock –
Based
Comp Expense
$1.2
$2.1
$9-11
Cash & cash equivalents
$56.9
1Q08 Financial Results and 2008 Guidance
1Q08 Financial Results and 2008 Guidance
($ Millions)
($ Millions)


45
(NASDAQ: AUXL)
Strategic Priorities
Strategic Priorities
Continue Development of XIAFLEX with a plan to:
File Dupuytren’s BLA in early 2009
Initiate Phase IIb in Peyronie’s Disease in Q3 2008
Continue market research activities; prepare commercial
team
Continue development of XIAFLEX in Peyronie’s Disease
and Frozen Shoulder Syndrome indications
Continue Driving Testim Growth


46
(NASDAQ: AUXL)
Fastest Growing
TRT product in
the U.S.
Late Stage
Blockbuster
Product
Opportunity
Poised for Growth
+
=