EX-99.1 2 dex991.htm PRESENTATION MATERIALS Presentation materials
1
January 2009
(NASDAQ: AUXL)
Exhibit 99.1


2
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
the
filing
of
the
Biologics
License
Application
for
approval
of
XIAFLEX™
(clostridial
collagenase
for
injection
formerly
referred
to
as
AA4500)
for
the
treatment
of
Dupuytren’s
contracture,
timing
of
FDA’s
decision
on
priority
review
and
the
approval
of
the
BLA;
the
timing
of
the
availability
of
safety
data
from
the
clinical
trials
for
XIAFLEX;
the
timing
of
the
completion
of
enrollment
in
the
phase
IIb
trial
for
XIAFLEX
for
the
treatment
of
Peyronie’s
disease
and
the
release
of
results
therefrom;
the
timing
of
the
launch
of
XIAFLEX
for
the
treatment
of
Dupuytren’s
contracture
in
the
U.S.;
the
timing
of
the
initiation
of
phase
III
for
XIAFLEX
for
the
treatment
of
Peyronie’s
disease;
the
Company’s
ability
to
manufacture
XIAFLEX
at
the
Company’s
Horsham
facility
in
sufficient
quantities
to
meet
several
years
of
global
launch
expectations
given
annual
capacity
at
current
yields;
the
timing
of
the
filing
by
Pfizer
of
the
Marketing
Authorization
Application
for
XIAFLEX
for
the
treatment
of
Dupuytren’s
contracture
in
the
European
Union;
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
CPEX
Pharmaceuticals,
Inc.;
the
economic
benefit
of
the
agreement
with
Ferring
Pharmaceuticals;
the
impact
of
the
filing
by
Upsher-Smith
Laboratories,
Inc.
of
an
ANDA
for
a
testosterone
gel;
the
Company’s
development
and
operational
goals
and
strategic
priorities
for
fiscal
2009;
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
and
the
Company’s
Quarterly
Report
on
Form
10-Q
for
the
period
ended
September
30,
2008
under
the
heading
“Risk
Factors”,
which
are
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
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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..


3
Focused on Sustainable Long-term Growth
Testim
XIAFLEX Dupuytren’s
XIAFLEX Peyronie’s
XIAFLEX New Indications
XIAFLEX New Territories


4
File BLA for Dupuytren's Contracture    
(early 2009)
Decision from FDA on priority review
(60 days post-BLA filing)
Dupuytren's Contracture safety data
available (post-BLA filing)
Complete enrollment
in
Peyronie’s Phase IIb
(1Q09)
Top-line results of
Peyronie's Phase IIb
Study (4Q09)
FDA Approval In Dupuytren’s   
Contracture (early 2010)
U.S. Dupuytren’s Contracture
Launch (2010)
Pfizer files MAA for Dupuytren’s 
Contracture in EU (2010)
Initiation of Peyronie's
Phase III Studies (2010)
Timing
Dupuytren’s
Peyronie’s
Anticipated XIAFLEX Events
2009
2010


5
Pipeline Continues to Advance
Note:  Seeking partners for Transmucosal film product candidates
PRODUCT
LATE RESEARCH      PRE-CLINICAL           PHASE I           PHASE II           PHASE III              MARKET  
TESTIM
®
GEL
XIAFLEX™
XIAFLEX™
XIAFLEX™
Transmucosal Film AA4010
Transmucosal Film
Transmucosal Film
Hypogonadism
Dupuytren’s Contracture
Peyronie’s Disease
Frozen Shoulder Syndrome
Overactive Bladder
Pain
Hormone & Urology


6
Strong Strategic Partner for XIAFLEX in EU
Validates Market Potential
Compelling economics for Auxilium:
Up-front payment of $75 million
$150 million tied to regulatory milestones
$260 million based on sales milestones
Increasing tiered royalties based on sales
of XIAFLEX in Pfizer’s territories
Primarily responsible for the global
development of XIAFLEX, including all
clinical & commercial manufacturing
and supply.
Exclusive rights to commercialize
XIAFLEX for Dupuytren’s contracture
and Peyronie’s disease
>
27 member countries of European Union
(EU) and 19 other European and
Eurasian countries
Primarily responsible for:
EU regulatory activities
All commercialization activities
Phase IV clinical development
First EU only partnership


7
XIAFLEX
Driver of Long-Term Growth
XIAFLEX product and packaging have not been approved by the FDA


8
XIAFLEX –
Unique, Late-Stage, Blockbuster
Opportunity
Potential to be the only effective non-surgical treatment for two high unmet needs:
Dupuytren’s contracture
Peyronie’s disease
Well-characterized mode of action
State of the art biological manufacturing facility
Worldwide rights generate and support growth
Build company in North America
Partnered with Pfizer in EU for Dupuytren’s and Peyronie’s
Opportunity to add additional indications
Rights for other territories or indications could generate additional cash
We believe there are at least 450,000 potential patients annually in U.S. and
EU for Dupuytren’s & Peyronie’s indications or > $1 Billion opportunity,
based on market research and analysis


9
Dupuytren’s Contracture is Debilitating for
Patients
Excessive collagen deposition in fascia of hand
Nodules represent early, active form
Cords develop over time, are palpable, and result in
contractures
Quality of life and daily activities can be significantly
affected
Surgery may be reserved for advanced disease due
to unpredictable results, complications, long recovery
and recurrence/additional surgeries


10
Current Treatment Options Require Invasive
Surgery with Significant Recuperation or
Are Unapproved and Ineffective
Surgery
Non-surgical options
>
Splinting
>
Physical therapy
>
Corticosteroids
Needle
fasciotomy/
aponeurotomy
Amputation


11
XIAFLEX Offers an Improved Mechanism of
Action
Clostridial collagenase is faster and more potent than human collagenase
Activity of XIAFLEX further enhanced by optimizing the ratio of collagenases
in the product
End products
Fast cleavage
Human collagenase
Human collagenase
(MMP)
(MMP)
Slow cleavage
XIAFLEX
XIAFLEX
End products


12
Thoroughly Researched Dupuytren’s Clinical
Program for XIAFLEX
Study Name
Country
Design
Treated
Patients (N)
DUPY-202
U.S.
DB
73
DUPY-303
U.S.
DB
35
DUPY-851/852
U.S.
DB
5
DUPY-853
U.S.
DB
17
U.S.
OL
CORD II
AUS
DB & OL
63
JOINT I
U.S.
OL
195
JOINT II
AUS/ EU
OL
379
Pharmacokinetics
U.S.
16
1082
CORD I
299


13
CORD I -
Largest Double-blind, Placebo-
controlled Trial in Dupuytren’s Contracture
Primary endpoint is reduction in contracture to within
0
5
o
of
normal
>
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
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
Database is locked


14
CORD I -
and 2°
Endpoint Outcomes
Should Compare Favorably To Surgery
60%
50%
40%
30%
20%
10%
0%
79.3% reduction in contracture
for XIAFLEX patients vs. 8.6%reduction
for placebo patients (p<0.001)
Baseline
Last
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
* P < 0.001 Comparison of XIAFLEX vs. Placebo
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
% of Patients Achieving Less
Than or Equal to 5 degrees
Contractures Post Treatment
XIAFLEX
(N=203)
Placebo
(N=103)
XIAFLEX
(N=203)
Placebo
(N=103)
XIAFLEX
(N=203)
Placebo
(N=103)
% of Patients Achieving At Least
50% reduction in Contracture
Post-treatment


15
XIAFLEX Phase III AE and SAE Rates Should
Compare Favorably To Surgical Complications
Common adverse events and rates were consistent with prior XIAFLEX trials
Serious Adverse Events
Number
Rate/Inj.
Tendon / Ligament:
Confirmed Tendon Rupture
3
0.12%
Ligament Injury
1  
0.04%
Total Tendon / Ligament
4
0.15%
Deep Vein Thrombosis
1
0.04%
Dupuytren’s Disease
1
0.04%
Complex Regional Pain Syndrome
1  
0.04%
Total
7  
0.27%
Note:  > 2,600 injections in approximately 1000 patients from CORD,  JOINT and PK studies as of October 29, 2008.


16
XIAFLEX Offers a Non-Invasive
Treatment for Dupuytren’s Contracture


17
Dupuytren’s Key Clinical Takeaways
Efficacy should compare favorably to surgery
Primary
endpoint
of
reached
with
statistical
significance in multiple studies
Secondary endpoints support commercial uptake
Less severe contractures responded better than more
severe contractures
MP joints responded better than PIP joints
Safety profile should compare favorably to surgery
No systemic exposure and no systemic allergic reactions


18
XIAFLEX I.P. Position for Dupuytren’s Contracture
U.S. Orphan Drug  granted on May 23, 1996 provides exclusivity 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 product and manufacturing
patent filed (if issued, expected expiry 2027)


19
XIAFLEX Supply Chain
API produced in Horsham, PA
2°-
8°C storage expected at launch
Annual capacity at current yield should be sufficient for several
years of global launch expectations
1 manufacturing train in use and validated; capacity
to expand for future demand
Fill and Lyophilization: Hollister-Stier; WA
FDA and EMEA-approved facility
Supplies U.S. and EU markets with injectable forms


20
Dupuytren’s Contracture –an Unmet Medical Need
1
Tubiana
2006.
2
Hueston
1963
3
Skoog
1948
4
Mikkelsen
1976
Disease prevalence is estimated at 3%-6% of adult Caucasian
population,
or
13.5
to
27
Million,
in
U.S.
and
EU,
but
occurs
in
all
populations
Higher
prevalence
in
patients
of
northern-European
descent
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
Recurrence
rate
in
surgical
patients
>
30% in 2 years
>
55% in 10 years
We believe Dupuytren’s contracture is under-diagnosed
and under-treated
1
1
3
4


21
Extensive Market Research Performed
with Dupuytren’s Surgeons
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


22
Source: 2006 Auxilium research and analysis
Annually, >240,000 Dupuytren’s Candidates
Could Exist between U.S. & EU


23
Commercial Target for Launch of XIAFLEX
in Dupuytren’s Contracture
Not Seeking Treatment
12.5-26 Million pts
Medical and
Surgical Treatment
395,000 pts
Watchful Waiting
635,000 pts
Stage I
Stage II
Stage III


24
Sustainable Blockbuster Market for
Dupuytren’s Contracture Anticipated
High disease prevalence
Based on literature, ~ 13.5M to 27M patients in U.S. and EU,
however only  ~1M patients annually seeking treatment in
U.S. and EU
Sustainable patient pool
New patients within an ageing population
Average of 2.2 joints affected at time of diagnosis
~ 50% of patients have bilateral disease
Disease progression to additional joints
High recurrence rate
No
non-invasive
competition
-
pricing
expected
to
be
comparable to surgery
Market development represents upside


25
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 is 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


26
Peyronie’s Disease -
an Unmet Medical Need
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
Prevalence of Peyronie’s disease is estimated at 1 in 20 adult men
1
>
Actual prevalence may be 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


27
Current Surgical Options-
Treatment of Last
Resort
The goal of surgery is simply to make the two sides of the penis
equal in size through reduction of the longer side
Post-surgically, graft or prosthetic may be required
Cost of surgery in U.S. is ~$10-12K
Patients are highly motivated to attempt other treatments first


28
Unapproved Treatments for Peyronie’s Disease
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


29
Promising
Phase
II
Data
with
25%
Reduction
in the Angle of Deviation for Most Patients
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%


30
Peyronie’s Phase IIb Study Enrollment
Expected to Complete in 1Q09
Study designed to assess the safety and efficacy with XIAFLEX.
XIAFLEX will be administered two times a week every
six weeks for up to three treatment cycles (2 x 3)
~120 patients
12 U.S. sites
Patients must be able to maintain a rigid erection and have a penile
contracture between 30 and 90 degrees.
Stratification occurs by the degree of penile curvature
(i.e. 30°
to 60º
versus > 60º).
Patients will be monitored for 36 weeks following first injection.
Top-line results expected in 4Q09.


31
Peyronie’s Phase IIb Study Design
120
15
no
Placebo
D
45
no
XIAFLEX
C
15
yes
Placebo
B
45
yes
XIAFLEX
A
Targeted Number
of Patients 
Plaque Modeling
Study Drug
Arm
Patients will be randomized in a 3:1 ratio of XIAFLEX to placebo
and
a 1:1 ratio to receive penile plaque modeling or no modeling.


32
Peyronie’s Phase IIb Trial Utilizes a Novel
Patient Reported Outcome (PRO)
Study is designed to validate Auxilium’s proprietary Peyronie’s Patient
Reported Outcome (PRO) questionnaire.
PRO
will
measure
four
domains
of
patients’
sexual
quality
of
life,
over
a 36 week period:
penile pain
Peyronie’s disease bother
intercourse discomfort
intercourse constraint
PRO likely to be used as a primary efficacy endpoint in Phase III
clinical trials.


33
Extensive Market Research Performed
with Peyronie’s
Surgeons
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


34
Annually,
>210,000
Peyronie’s
Candidates
Could
Exist
between
U.S.
and
Europe
Source: 2006 Auxilium research and analysis


35
XIAFLEX I.P. Position for Peyronie’s Disease
U.S. Orphan Drug granted on March 12, 1996 provides exclusivity for
7 years post-approval
Market Exclusivity in EU could be extended to 11 years on
approval of additional indication
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 product and manufacturing patent filed
(if issued, expected expiry 2027)


36
Testim
®
1% Testosterone Gel:
Near-Term Growth Driver


37
Testim
®
Remains the Fastest Growing
Testosterone Replacement Therapy Gel
*Mulligan T. et al. Int J. Clin Pract
2006
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 <10% of affected population
receives treatment
We believe diagnosis is increasing through
education and awareness


38
Patient Results Were Proven in Clinical Studies
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
Gels
Continue
to
Drive
Significant
Growth
in
TRT Marketplace
($ in millions)
Source: IMS data
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
$568
Gel Segment Growth ($)
Gel Segment Growth ($)
Nov 2008 L12M: 
Nov 2008 L12M: 
22.9%
2007
700
$685
$563


40
Testim
®
®
Quarterly Net Revenues and Scripts
($ in millions)
Continuing Track Record of Consistent
Revenue Growth
Q3 2008 Net
Revenues
Y/Y Growth:
+24.2%
Q3 2008 TRX
Y/Y Growth:
+24.7%
Source: Auxilium and IMS data
$26M
$42.8M
$68.9M
$95.7M
$90.6M YTD


41
Testim Patent Coverage
*Note: The referenced Testim patents are owned by CPEX Pharmaceuticals, Inc.
U.S.
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 U.S. PTO in late 2007
with a plan to protect additional inventions and seek additional
claims
Upsher-Smith Laboratories, Inc. filed an ANDA with paragraph IV
certification referring to the ’968 patent; AUXL filed lawsuit under
Hatch-Waxman on Dec. 4, 2008; 30 month stay expires June 2011
ROW
Patent issued in Canada; expires 2023
Patent issued in Europe; expires 2023
Patents granted and applications pending in numerous countries worldwide


42
2008
Q3 ’08      9M’
08
Guidance
Revenues
$32.6
$90.6
$120-125
R&D Expense
$13.3
$39.9
$52-56
SG&A Expense
$21.9
$65.1
$88-92
Net Loss
($10.1)
($34.1)        ($44-48)
Stock –
Based
Comp Expense
$3.2
$8.1
$9-11
Cash & Cash Equivalents
$46.4*
Q3 ‘08 Financial Results and
2008 Guidance ($ Millions)
Currently approximately 41.6 million shares issued & outstanding. Additional 6.4 million shares subject to issuance from stock options & warrants
*Prior to receipt of $75M upfront from Pfizer in 4Q08


43
Strategic Priorities in 2009
File the XIAFLEX BLA for Dupuytren’s contracture, which we expect
to achieve in early 2009;
Continue our pre-launch commercialization efforts for an anticipated
U.S. launch of XIAFLEX in early 2010;
Complete enrollment in the Peyronie’s disease Phase IIb trial, which
we expect will be completed in 1Q09, and release top-line data,
which we believe will occur in 4Q09;
Work diligently with Pfizer to prepare for a 2010 EU filing for
XIAFLEX in Dupuytren's contracture;
Vigorously defend Testim IP and continue to support the brand.


44
Focused on Sustainable Long-term Growth
Testim
XIAFLEX Dupuytren’s
XIAFLEX Peyronie’s
XIAFLEX New Indications
XIAFLEX New Territories


45
January 2009
(NASDAQ: AUXL)