EX-99.1 2 dex991.htm SLIDE PRESENTATION Slide Presentation
1
May 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 any
action by the U.S. Food and Drug Administration on the Biologics License Application for XIAFLEX™ (clostridial collagenase for injection – formerly referred to as
AA4500) for the treatment of Dupuytren’s contracture and the approval thereof; the timing of the availability of safety data from the clinical trials for XIAFLEX; the timing of
the release of results from the phase IIb trial for XIAFLEX for the treatment of Peyronie’s disease; 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 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 2009 and financial milestones that it
may achieve for 2009, including 2009 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, 2008 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.

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

4
•
FDA Approval In Dupuytren’s Contracture 
(PDUFA August  28, 2009)
•
12 month Dupuytren's Contracture safety
presentation at medical conference
•Publication of CORD I data in top-tier
medical journal
•
U.S. Dupuytren’s Contracture
Launch (~ 60 days post-approval)
•
Top-line results of
Peyronie's Phase IIb
Study (4Q09)
•
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
•
Significant 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
CORD I -
Largest Double-blind, Placebo-
controlled Trial in Dupuytren’s Contracture
•
Primary endpoint is reduction in contracture to within
0
-
58
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
•
12 month safety profile

13
CORD
I
-
1
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
°
°

14
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.

15
XIAFLEX Offers a Non-Invasive
Treatment for Dupuytren’s Contracture

16
XIAFLEX for Dupuytren’s Contracture
Key Clinical Takeaways
•
Efficacy should compare favorably to surgery
–
Primary endpoint of
5°
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
•
12 month percent recurrence comparable to earlier single center
study(~6%)
•
Safety profile should compare favorably to surgery
–
No systemic exposure and no systemic hypersensitivity reactions

17
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)

18
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
°
°

19
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
•
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
1,4
>
30% during 1st and 2nd postoperative years
>
55% in 10 years
•
We believe Dupuytren’s contracture is under-diagnosed
and under-treated
1
2
3
1

20
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

21
Source: 2006 Auxilium research and analysis
Annually, >240,000 Dupuytren’s Candidates
Could Exist between U.S. & EU

22
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 for surgery
•
No
non-invasive
competition
-
pricing
expected
to
be
comparable to surgery
•
Market development represents upside

23
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

24
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

25
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

26
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

27
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%

28
Peyronie’s Phase IIb Study Top-line Data
Expected in 4Q09
•
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 60
versus > 60 ).
•
Active dosing period has been completed.
–
Patients will be monitored for 36 weeks following first injection.
°
°
°

29
Peyronie’s Phase IIb Study Design
Arm
Study Drug
Plaque Modeling
Targeted Number
of Patients 
A
XIAFLEX
yes
45
B
Placebo
yes
15
C
XIAFLEX
no
45
D
Placebo
no
15
120
•
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.

30
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.

31
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

32
Annually,
>210,000 Peyronie’s Candidates
Could Exist between U.S. and Europe
Source: 2006 Auxilium research and analysis

33
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)

34
Testim
®
1% Testosterone Gel:
Near-Term Growth Driver

35
Testim
®
Maintains Double-Digit Growth in
Testosterone Replacement Therapy Market
*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

36
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)

37
Gels Continue to Drive Significant Growth in
TRT Marketplace
Source: IMS data
$35
$117
$200
$287
$340
$383
$449
$690
$563
$49
$59
$77
$118
$210
$302
$399
$459
$499
$568
$685
$819
0
100
200
300
400
500
600
700
800
900
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
Gel
Patch
Oral
Injectables
($ in millions)
Gel Segment Growth ($)
Mar 2009 L12M: 
26.7%

38
Testim®
Quarterly Net Revenues and Scripts
($ in millions)
Continuing Track Record of Consistent
Revenue Growth
1Q09 Net
Testim
Revenues
Y/Y Growth:
+24.7%
1Q09 TRX
Y/Y Growth:
+14.1%
Source: Auxilium and IMS data
$42.8M
$68.9M
$95.7M
$125.1M
$33.8M

39
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

40
2009
Q1 ’09      Q1 ‘08
Guidance
Revenues
$34.7
$27.1
$150-155
R&D Expense
$13.5
$13.2
$45-50
SG&A Expense
$26.4
$21.0
$120-130
Net Loss
($13.2)
($12.3)         ($55-60)
Stock –
Based
Comp Expense
$4.5
$2.1
$16-19
Cash & Cash Equivalents
$90.2
Q1 ‘09 Financial Results and
2009 Guidance ($ Millions)
Currently approximately 42.7 million shares issued & outstanding. Additional 6.2 million shares subject to issuance
from stock options & warrants

41
Strategic Priorities in 2009
•Continue our pre-launch commercialization efforts and be
prepared to launch in ~60 days after anticipated approval
date of August 28, 2009;
•
Release top-line data from the XIAFLEX Peyronie’s disease
Phase IIb trial, which we anticipate 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 grow scripts.

42
Focused on Sustainable Long-term Growth
Testim
XIAFLEX Dupuytren’s
XIAFLEX Peyronie’s
XIAFLEX New Indications
XIAFLEX New Territories

43
Management Contact
James E. Fickenscher/CFO
Auxilium Pharmaceuticals, Inc.
(484) 321-5900
jfickenscher@auxilium.com
William Q. Sargent Jr./ VP IR
Auxilium Pharmaceuticals, Inc.
(484) 321-5900
wsargent@auxilium.com

44
May 2009
(NASDAQ: AUXL)