EX-99.1 2 dex991.htm PRESENTATION MATERIALS Presentation materials
1
March 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, 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 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
•Decision from FDA on priority review
(approx. 60 days post-BLA filing on
Feb. 27)
•
Dupuytren's Contracture safety data
available (post-BLA filing)
•
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
•
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
-
5
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
•
BLA filed on Feb. 27, 2009
°

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
O
O

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
Dupuytren’s 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
•
Safety profile should compare favorably to surgery
–
No systemic exposure and no systemic allergic 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
–
RA is 1% of adult population
•
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
1
2
3

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
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

23
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

24
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

25
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
>
Actual
prevalence
may
be
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
3
2
1

26
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

27
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

28
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%

29
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. 30º
to 60º
versus > 60º).
•
Patients will be monitored for 36 weeks following first
injection.

30
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.

31
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.

32
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

33
Annually, >210,000 Peyronie’s
Candidates
Could Exist between U.S. and Europe
Source: 2006 Auxilium research and analysis

34
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)

35
Testim
®
1% Testosterone Gel:
Near-Term Growth Driver

36
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

37
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)

38
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 ($)
Jan 2009 L12M: 
25.6%

39
Testim
®
®
Quarterly Net Revenues and Scripts
($ in millions)
Continuing Track Record of Consistent
Revenue Growth
2008 Net
Revenues
Y/Y Growth:
+31.0%
2008 TRX
Y/Y Growth:
+26.5%
Source: Auxilium and IMS data
$26M
$42.8M
$68.9M
$95.7M
$125.2M

40
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

41
2009
Q4 ’08      2008
Guidance
Revenues
$34.8
$125.4
$150-155
R&D Expense
$14.6
$54.5
$49-53
SG&A Expense
$24.4
$89.5
$116-121
Net Loss
($12.1)
($46.3)         ($50-55)
Stock –
Based
Comp Expense
$3.7
$11.7
$16-19
Cash & Cash Equivalents
$113.9
Q4 ‘08 Financial Results and
2009 Guidance ($ Millions)
Currently approximately 42.4 million shares issued & outstanding. Additional 5.5 million shares subject to issuance
from stock options & warrants

42
Strategic Priorities in 2009
•
Continue
our
pre-launch
commercialization
efforts
and,
if
FDA grants a priority review for the XIAFLEX BLA for
Dupuytren’s contracture, be prepared to launch in ~60
days after anticipated approval date;
•
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.

43
Focused on Sustainable Long-term Growth
Testim
XIAFLEX Dupuytren’s
XIAFLEX Peyronie’s
XIAFLEX New Indications
XIAFLEX New Territories

44
Sell-side coverage
•
Jonathon Aschoff-
Brean
Murray
•
Scott Henry-
Roth
•
Salveen Kochnover-
Collins Stewart
•
Kimberly Lee-
Pacific
Growth
•
Lucy Lu-
Citigroup
•
Aaron Mishel-
TWP
•
John Newman-
Oppenheimer
•
Josh Schimmer-
FTN
•
Eric Schmidt-
Cowen
•
Joe Schwartz-
Leerink
Swann
•
David Steinberg-
Deutsche Bank
•
Marshall Urist-
Morgan
Stanley
•
Thomas Wei-
Piper
Jaffray
•
Eun
Yang-
Jefferies

45
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

46
Notes

47
Notes

48
March 2009
(NASDAQ: AUXL)