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| 8-K - FORM 8-K - AUXILIUM PHARMACEUTICALS INC | d8k.htm |
 1
May 2011
(NASDAQ: AUXL)
Exhibit 99.1 |
 2
Safe Harbor Statement
We will make various remarks relating to our current plans, potential future events, and what we
believe to be the prospects for the Company during this conference call that constitute
forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities
Litigation Reform Act of 1995. Today our forward-looking statements will cover, among other
things, the Company’s expected financial performance, results and strategic priorities
during 2011; the design and methodology, and the timing to report results, of the phase III trials for
XIAFLEX for the treatment of Peyronie’s; the commercial success in the U.S. of XIAFLEX for
Dupuytren’s contracture; Pfizer’s ability to commercialize XIAPEX for
Dupuytren’s contracture in EU and Eurasian markets, including the timing or likelihood of additional launches in those
markets and our receipt of any applicable milestone payments from Pfizer; Asahi Kasei Pharma's ability
to develop, register for approval and commercialize XIAFLEX for Dupuytren's contracture and
Peyronie's disease in Japan; the potential for XIAFLEX to become the standard of care for the
treatment of Dupuytren’s and the size of the Dupuytren’s market; the ability to obtain reimbursement for XIAFLEX, developments in the
reimbursement process and the effect of the reimbursement process on the success of the XIAFLEX
launch, including the timing and likelihood of the issuance of a CPT code for XIAFLEX; the
long-term demand for XIAFLEX; the effect of the identified leading indicators on the success of the
XIAFLEX launch and future net revenues; timing of results from the long-term extension study of
XIAFLEX; additional Phase IV clinical trials for XIAFLEX; filing a Canadian New Drug
Submission; peer to peer dialogue programs for U.S. physicians and our U.S. patient education campaign;
the potential for XIAFLEX to be used in multiple indications and the success of efforts to advance any
such new indications; the likelihood and effect of competition in the testosterone replacement
therapy gel market; business development efforts and opportunities to build out the
Company’s pipeline; the timing and likelihood of the Company achieving profitability and
sustaining growth. 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 Auxilium's
Annual Report on Form 10-K for the year ended December 31, 2010 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 “For Investors - 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
Our Vision Is to Become a Rapidly Growing,
Profitable and Sustainable Biopharmaceutical
Company
Maximize Value of
Testim and XIAFLEX
Deliver on
Current Pipeline
Build Out
Pipeline in
Specialty
Therapeutic
Areas |
 XIAFLEX and Testim Are Global Product
Opportunities
U.S.
Canada
EU
Japan
Open
ROW
Open
Open
Territory
XIAFLEX
Testim
4 |
 Auxilium Has a 6 Year Net Revenue CAGR
of 39.4%
1Q11 XIAFLEX Net
Revenues $12.3M
(including $10.5M in
U.S. revenues)
1Q11 Testim Net
Revenues $46.1M, 4%
y/y growth
5 |
 6 |
 •
Excessive collagen in fascia of hand
•
Nodules or pits are an early, active
presentation
•
Rope-like cords develop in the finger
and result in contractures
•
Quality of life and daily activities
affected
•
Surgery has been reserved for
advanced disease due to the nature
of the disease, unpredictable results,
complications, long recovery time and
recurrence/additional surgeries
Dupuytren’s Contracture Is Debilitating for Patients
and Surgery Has Been the Standard of Care
Immediately post-operative
Intra-operative open fasciectomy
Pictures
courtesy
of
Dr.
Clayton Peimer
pre-operative open fasciectomy
7 |
 We
Believe XIAFLEX Is a Paradigm Changing Treatment
•
Simple, non-invasive injection of XIAFLEX
•
Established mechanism of action and selective for specific types of collagen
•
XIAFLEX’s post-approval profile is consistent with clinical trial
experience Pre XIAFLEX injection
30 days following XIAFLEX
injection
8 |
 9
Strategies for Establishing XIAFLEX as the
Standard of Care
•
Disseminate our excellent clinical efficacy and safety data;
•
Facilitate peer to peer dialogue with physicians and
reimbursement specialists;
•
Educate patients and health care providers who inject, as well
as those who refer to our target specialists, on a non-surgical
option;
•
Streamline the reimbursement process, and;
•
Activate a critical mass of experienced prescribers |
 10
XIAFLEX Launch Strategy is Tailored to
Customer Needs
•
~ 6,000 target physicians
–
Hand surgeons, plastic surgeons, orthopedic
surgeons, general surgeons, rheumatologists
•
~ 100 field based personnel
–
Sales reps, sales managers, and reimbursement
specialists
•
Medical science liaisons
–
Key opinion leader and regional opinion leader
support |
 11
We Believe the U.S. Dupuytren’s Opportunity Is
Significant
70,000 Surgical
2,3,4
Patients Annually
300,000 Diagnosed
Patients Annually
2,3,4
>1 Million Diagnosed
Patients
2,4
1.
Dupuytren’s
Disease
–
Tubiana,
LeClerq,
Hurst,
Badalamente,
Mackin
2.
SDI Claims Data Based Projections
3.
Medicare
Data
Based
Projections
(BESS
database
used,
Medicare
5%
database
also
used
to
validate
numbers)
4.
Auxilium Research (Patient Segmentation, Forecast Research, WK/AMA
Databases) Sources:
$350 Million
Market
Opportunity
$1 Billion
Annual Market
Opportunity
>$3 Billion Market
Opportunity |
 12
Launch Update Through
April 2011 |
 Leading Indicators Trending Positively
-
Cumulative enrollment & sites that have ordered XIAFLEX
13 |
 Sites Moving from Test Drive to Increasing
Usage
Injections per Site
14 |
 Quarterly XIAFLEX Revenue (in $ millions)
* Includes one-time revenue recognition change of $1.8 million
*
15 |
 16
We Expect the Global Dupuytren’s Market to
Develop in 2011 and 2012
U.S.
•
XIAFLEX specific J-code J0775 effective Jan. 1
•
U.S. CPT code guidance expected for Jan. 2012
•
Additional phase IV clinical trials
•
Increasing peer to peer dialogue programs for U.S.
physicians
•
Targeted U.S. patient education campaign planned
ROW
•
Pfizer launch of XIAPEX
®
in EU begins in 2011
•
Asahi Kasei development of XIAFLEX in Japan |
 Testim
®
1% Testosterone Gel
•
Indicated for testosterone replacement therapy in adult
males for hypogonadism
•
Launched in U.S. in 2003 and EU in 2006
•
>7 yrs of use with established safety and efficacy
>
~100M daily doses since launch
>
16 clinical studies involving approx. 1,800 patients
•
Applied once daily at 5-10mg
>
90% stay on starting dose of 5mg (one tube)
>
Simple application process
17 |
 18
Hypogonadism Is an Unmet Need and
Under-penetrated Market
•
39% of U.S. males over 45 yrs are
hypogonadal
1
>Less than 10% of affected population
receives treatment
•
Increasing physician and patient education
and awareness should result in increased
treatment
1
Mulligan T. et al. Int J. Clin Pract
2006 |
 19
Gels Continue to Drive Significant Growth in
TRT Marketplace
Source: IMS data
$35
$117
$198
$281
$334
$371
$439
$545
$685
$892
$1,149
$49
$59
$77
$118
$210
$302
$390
$451
$483
$554
$663
$810
$1,041
0
200
400
600
800
1,000
1,200
1,400
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
Gel
Patch
Oral
Injectables
($ in millions)
Gel Segment Growth ($)
Mar 2011 L12M:
27.8%
$1,329 |
 20
Testosterone Replacement Therapy Landscape
is Changing
•
New competition in 2011 should help
increase overall market
–
Axiron 2% solution
–
Fortesta 2% gel
–
Androgel 1.6% gel
•
Expected further increase in physician and
patient education and awareness |
 21
Delivering on Current Pipeline
PRODUCT
LATE RESEARCH
PRE-CLINICAL PHASE I PHASE II PHASE
III MARKET
TESTIM®
GEL
XIAFLEX®
XIAFLEX®
XIAFLEX®
Hypogonadism
Dupuytren’s contracture
Peyronie’s disease
Frozen Shoulder Syndrome |
 1
Smith BH. Am J Clin Pathol. 1966;45:670-678.
2
Somers KD, Dawson DM. J Urol. 1997;157:311-315.
•
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
Peyronie’s disease Is a Devastating Disorder
with No Approved Therapies
22 |
 23
1
Bella A. Peyronie’s Disease J Sex Med 2007;4:1527–1538
2
Lue TF, et al. Summary of the recommendations on sexual dysfunctions in men. J Sex
Med 2004;1:6–23. 3
Mulhall JP, et al. Subjective and objective analysis of the prevalence of
Peyronie’s disease in a population of men presenting for prostate
cancer screening. J Urol 2004;171:2350–3. 4
Smith BH. Am J Clin Pathol. 1966;45:670-678.
5
Lindsay MB, J Urol.
1991;146:1007-1009.
6
Nyberg L, J Urol.128: 48, 1982
•
Prevalence of Peyronie’s disease is estimated to be approximately
5% in adult men
1,2,3
>
Actual prevalence may be higher, based on autopsies
4
•
Prevalence rate increases with age
>
The average age of disease onset is 53 years
5
•
High association with other diseases such as:
>
Diabetes, erectile dysfunction (ED), Dupuytren’s contracture,
plantar fascial contracture, tympanosclerosis, gout, and Paget’s
disease
6
We believe Peyronie’s Disease Is Under-
diagnosed and Under-treated |
 24
Peyronie’s Disease Phase III Development
Program
Study
Type
~ #
Subjects
Sites
XIAFLEX:
Placebo
Duration
AUX-CC-803
Double-blind,
placebo controlled
400
~ 30 US
5 AUS
2:1
52 Wks
AUX-CC-804
Double-blind,
placebo controlled
400
~ 30 US
5 AUS
2:1
52 Wks
AUX-CC-802
Open Label
250
12 US
6 NZ
18 EU
N/A
36 Wks
AUX-CC-805
Pharmacokinetics
16
1 US
N/A
4 Wks
XIAFLEX 0.58 mg
Two injections per treatment cycle
24 to 72 hours between injections
Penile plaque modeling following each cycle
Up to 4 cycles at 6 week intervals
Co-primary endpoints of disease bother and penile curvature
|
 25
We Believe Changes to the Phase IIb Trial Design
Should Increase the Chance of Success in Phase III
•
4 cycles of therapy in the phase III trial
•
All patients receive modeling in the phase III trial
•
All patients must have greater than 12 months of
disease since diagnosis to enter the phase III trial
Mean net improvements in phase IIb penile
curvature and bother domain for modeling
arm would have met statistical significance
using phase III co-primary endpoint
requirements |
 26
Business Development Efforts Expected to
Focus on Building Out Pipeline
•
Leverage current infrastructure of Testim and
XIAFLEX field forces with marketed products
•
Seeking Phase II and later assets in Urology,
Endocrinology, Rheumatology, and Orthopedics
•
Niche products with specialty physician call
points also represent development opportunities |
 27
BTC Litigation Update
•
On Feb. 15, 2011, AUXL filed a complaint against BioSpecifics Technologies
Corp. (BTC) alleging that BTC has breached the parties’
Amended and Restated
Development and License Agreement dated as of December 11, 2008 by its
commencement of clinical trials for the use of injectable collagenase to treat
canine
lipomas
without
the
prior
knowledge
and
approval
of
the
parties’
Joint
Development Committee (JDC).
•
AUXL is seeking preliminary and permanent injunctions ordering BTC to, among
other things:
•
suspend its canine lipoma clinical trial known as Chien-803 and
•
refrain from initiating any new clinical trials related to collagenase, both until
such time as any such
trial
has
been
reviewed
and
approved
by
the
parties’
JDC
pursuant to the
terms of the Agreement.
•
AUXL also seeking a declaratory judgment as to the rights and responsibilities of
the JDC under the Agreement
•
Suit filed in the Court of Common Pleas, Chester County, Pennsylvania
•
Court ordered
that
papers
filed
with
the
court
were
to
be
deemed
under
seal and
not available to the public until further order |
 28
1Q 2011 Financial Results ($ Millions)
(Decr.)
1Q11
1Q10
$
%
Total Revenues
$58.4
$45.5
$12.9
28%
Cost of Goods Sold *
$11.3
$9.5
$1.8
19%
Gross Profit
$47.1
$36.0
$11.1
31%
% of Revenues
81%
79%
R & D Expense *
$15.8
$8.5
$7.3
86%
SG&A Expense *
$43.2
$36.1
$7.1
20%
Net Loss
($11.8)
($8.6)
($3.2)
(38%)
Earnings per share
($0.25)
($0.18)
($0.07)
36%
* Stock Based Comp
$4.3
$3.8
$0.6
15%
Cash & Cash
Equivalents
$130.9
Incr. / |
 29
2011 Guidance
Global Testim Revenues
$200 -
210 million
Xiaflex:
US Revenues
50 -
60 million
Ex US / Def Rev
9 -
11 million
Total Xiaflex
$59 -
71 million
Total Revenues
$259 -
287 million
R & D Expense
$60 -
70 million
S G & A Expense
$170 -
180 million
Net Income (Loss)
$(31) -
(41) million
Stock Base Comp Expense
$15 -
20 million |
 30
We Believe That Auxilium is Well-Positioned
for Long-Term Growth
•
Maximize XIAFLEX net revenues for Dupuytren’s
contracture in the U.S.;
•
Maximize global Testim revenues.
•
Support Pfizer in the launch of XIAPEX for Dupuytren’s
contracture in the EU;
•
Complete Peyronie’s disease phase III double-blind
studies, with top-line results anticipated in 2Q12; and,
•
Advance XIAFLEX new indication(s). |
 31
Our Vision Is to Become a Rapidly Growing,
Profitable and Sustainable Biopharmaceutical
Company
Maximize Value of
Testim and XIAFLEX
Deliver on
Current Pipeline
Build Out
Pipeline in
Specialty
Therapeutic
Areas |