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
issuance
of
a
patent
from
the
pending
U.S.
application
for
Testim;
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
candidatesincluding
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.


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


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
6
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
Pre-clinical
Late Research
Hypogonadism
Peyronie’s Disease
Frozen Shoulder Syndrome
Overactive Bladder
Hormones and Urology
Pain
Dupuytren’s Contracture
Phase
I


6
(NASDAQ: AUXL)
Anticipated News Flow Events
Anticipated News Flow Events
Q108:
Testim-Patent Issuance
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
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
Journal
of
of
Hand
Hand
Surgery,
Surgery,
July/Aug
July/Aug
2007-
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
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 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)
$-
$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
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


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;
38.3% gel market share of decile
8-10 Urologists in October 2007
1.0%
21.3%
0%
5%
10%
15%
20%
25%
Mar-03
Nov-07


31
(NASDAQ: AUXL)
Current Testim
®
patent in U.S. expires in June 2008
New patent issued in Canada; expires 2023
New patent issued in Europe; expires 2023
Notice of Issuance for U.S. application # 10/473,724
mailed on January 2, 2008; expect patent to issue
within a month
Divisional application and continuations filed with
USPTO in late 2007 to protect additional inventions
and seek additional claims
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
+
=