EX-99.1 2 dex991.htm PRESENTATION MATERIALS Presentation Materials
(NASDAQ: AUXL)
October/November 
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
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 completion of enrollment in the phase IIb trial for XIAFLEX for the treatment of Peyronie’s disease and the release of results
therefrom; 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 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
2008;
the
ability
to
fund
future
operations;
the
timing
of
conclusion
of
partnering
discussions
for
XIAFLEX
in
Europe;
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.


+
=
Late Stage
Blockbuster
Product
Opportunity
Fastest Growing
TRT product in
the U.S.
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 330 employees (~190 commercial)
I.P.O in July 2004
Currently approximately 41.4 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
Late Research
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 (fentanyl)


6
(NASDAQ: AUXL)
Anticipated News Flow Events
Anticipated News Flow Events
5
End of 2009:
XIAFLEX-
Results of Peyronie's
Phase IIb Study
H109:
XIAFLEX-Open Label Dupuytrens
Contracture 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
2010


7
(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
Dupuytren’s contracture
Peyronie’s disease
Well-characterized mode of action
Worldwide rights offer options
Build company
Partner and generate cash
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


8
(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


9
(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


10
(NASDAQ: AUXL)
Dupuytren’s Contracture—Unmet Medical Need
Dupuytren’s Contracture—Unmet Medical Need
Disease prevalence is estimated at 3%-6% among adult
Caucasians,  but occurs in all populations
Higher
prevalence
in
patients
of
northern-European
descent
Hereditary
component
in
approximately
40%
of
patients
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
Tubiana
2006.
Hueston 1963
3
Skoog 1948
4
Mikkelsen 1976
1
1
2
3
4


11
(NASDAQ: AUXL)
XIAFLEX—Potential to Revolutionize Treatment
XIAFLEX—Potential to Revolutionize Treatment
for Dupuytren’s Contracture
for Dupuytren’s Contracture


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


13
(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 -
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


14
(NASDAQ: AUXL)
Primary Endpoint Outcome Compares Favorably
Primary Endpoint Outcome Compares Favorably
To Surgery
To Surgery


15
(NASDAQ: AUXL)
4 Out Of 5 Dupuytren’s Contracture Patients
4 Out Of 5 Dupuytren’s Contracture Patients
Improved By   50%
Improved By   50%


16
(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


17
(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
0.12%
Ligament Injury
1  
0.04%
Total Tendon / Ligament
4
0.15%
Deep Vein Thrombosis
1
0.04%
Unconfirmed
Proliferation
of
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 July 31, 2008.
*one unconfirmed tendon injury was changed to confirmed tendonitis
Common adverse events and rates were consistent with prior
XIAFLEX trials


18
(NASDAQ: AUXL)
CORD I Key Takeaways
CORD I Key Takeaways
Primary endpoint of    5°
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


19
(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


20
(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


21
(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


22
(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)


23
(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.)


24
(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
Plaques show excessive collagen
deposition
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
1
2


25
(NASDAQ: AUXL)
Epidemiology—Peyronie’s Disease
Epidemiology—Peyronie’s Disease
Prevalence of Peyronie’s disease is estimated at 1 in 20
adult men
Actual prevalence higher based on autopsies
Prevalence rate increases with age
The average age of disease onset is 53 years
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
2
3
1


26
(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


27
(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


28
(NASDAQ: AUXL)
Promising Phase II Results: Patients With   25%
Promising Phase II Results: Patients With   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


29
(NASDAQ: AUXL)
Peyronie’s Phase IIb
Peyronie’s Phase IIb
Study Enrolling Patients
Study Enrolling Patients
Study designed to assess the safety and efficacy of XIAFLEX.
XIAFLEX will be administered two times a week every six weeks for up to
three treatment cycles (2 x 3)
~120 patients
~11 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 60°
versus > 60°).
Patients will be monitored for 36 weeks following first injection.
Enrollment expected to be complete in Q1 2009.


30
(NASDAQ: AUXL)
Peyronie’s Phase IIb
Peyronie’s Phase IIb
Study Design
Study Design
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.
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


31
(NASDAQ: AUXL)
Peyronie’s Phase IIb
Peyronie’s Phase IIb
Patient Reported Outcome
Patient Reported Outcome
(PRO)
(PRO)
Study is also designed to validate a 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.


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)
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)


35
(NASDAQ: AUXL)
Testim
®
1% Testosterone Gel:
Near-Term Growth Driver
Executing on Opportunities


36
(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


37
(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)


38
(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 2008 L12M: 
23.4%
Gel Segment Growth ($)
Gel Segment Growth ($)
Sep 2008 L12M: 
Sep 2008 L12M: 
23.4%
2007
700
$685
$563


39
(NASDAQ: AUXL)
$-
$5
$10
$15
$20
$25
$30
$35
0
20
40
60
80
100
120
140
Net Revs
TRX
Testim
®
®
quarterly net revenues and scripts
($ in millions)
Established Track Record of Consistent Growth
Established Track Record of Consistent Growth
Q3 2008 Net
Revenues
Y/Y Growth:
+24.2%
Q3 2008 Net
Q3 2008 Net
Revenues
Revenues
Y/Y Growth:
Y/Y Growth:
+24.2%
Q3 2008 TRX
YY Growth:
+24.7%
Q3 2008 TRX
Q3 2008 TRX
YY Growth:
YY Growth:
+24.7%
Source: Auxilium and IMS data


40
(NASDAQ: AUXL)
We Believe Testim Is Driving Growth in
Overall Gel Market
Source: IMS data
Testim Share of TRx of Gel Market
gel market share of
decile
8 -
10 PCPs (32.0%)
gel market share of decile
8 -
10 Urologists (41.6%)


41
(NASDAQ: AUXL)
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 received notice on Oct. 23,
2008; details of the notice are currently under legal review
ROW
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.


42
(NASDAQ: AUXL)
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
$46.4
3Q08 Financial Results and 2008 Guidance
3Q08 Financial Results and 2008 Guidance
($ Millions)
($ Millions)


43
(NASDAQ: AUXL)
Strategic Priorities
Strategic Priorities
Continue Development of XIAFLEX with a plan to:
1) vigorously defending Testim and continuing to support the
brand;
2) filing of the XIAFLEX BLA for Dupuytren’s contracture, which we
expect to achieve in early 2009;
3) continuing our pre-launch commercialization efforts for an
expected US launch of XIAFLEX in early 2010;
4) continuing enrollment in the Peyronie’s disease Phase IIb
trial,
which we expect will be completed in the first quarter of 2009;
5) concluding our partnering discussions for XIAFLEX in Europe.
Continue Driving Testim Growth


44
(NASDAQ: AUXL)
+
=
Late Stage
Blockbuster
Product
Opportunity
Fastest Growing
TRT product in
the U.S.
Poised for Growth