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| 8-K - FORM 8-K - CADENCE PHARMACEUTICALS INC | d279355d8k.htm |
 Improving the lives of hospitalized patients
Corporate Overview
January 2012
Exhibit 99.1 |
 2
This presentation includes forward-looking statements, which are based on our
current beliefs and expectations. Such statements include, without
limitation, statements regarding: the anticipated U.S. market opportunity for OFIRMEV; our projections regarding sales and the
number of formulary approvals of OFIRMEV, and the potential for those formulary
approvals to create early and broad market adoption and rapidly accelerate
sales of OFIRMEV; the potential for us to ultimately acquire Incline Therapeutics, Inc. or other product candidates; the
sufficiency
of
our
capital
resources
to
fund
our
operations;
all
of
our
financial
estimates;
and
our
strategy
for
building
a
long-term
hospital
pain franchise.
You are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. Our actual future
results may differ materially from our current expectations due to the risks and uncertainties inherent in our business. In addition, past
results and trends may not be indicative or a guarantee of future results or
trends. These risks include, but are not limited to: our dependence
on
the
successful
commercialization
of
OFIRMEV,
which
is
our
only
product;
our
ability
to
achieve
broad
market
acceptance
and generate revenues from sales of OFIRMEV; our ability to continue to increase
growth in sales of OFIRMEV; our ability to successfully enforce our
marketing exclusivities and intellectual property rights, and to defend the patents covering OFIRMEV, including our current
patent litigation; the potential product liability exposure associated with
OFIRMEV; the risk that we may not be able to raise sufficient capital
when
needed,
or
at
all;
and
other
risks
detailed
under
“Risk
Factors”
and
elsewhere
in
our
Annual
Report
on
Form
10-K
for
the
period
ended December 31, 2010, and our other filings made with the Securities and
Exchange Commission from time to time. All forward-looking statements
are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of
Section 21E of the Private Securities Litigation Reform Act of 1995 and we
undertake no obligation to revise or update this presentation to reflect
events or circumstances after the date hereof. Caution on forward-looking
statements CADENCE and OFIRMEV are trademarks of
Cadence Pharmaceuticals, Inc. ©
2011 Cadence Pharmaceuticals, Inc. All rights reserved.
®
® |
 3
Company Highlights
Specialty biopharmaceutical company, focused on developing and
commercializing proprietary therapeutics utilized in the hospital setting
–
Sustainable
core
business
of
OFIRMEV
®
with
opportunities
to
diversify
product portfolio
OFIRMEV -
a differentiated, new class of IV pain medication
–
Non-opioid, non-NSAID analgesic
–
Foundation for multi-modal approach to pain management
Strong uptake of hospital formulary adoption and positive physician
feedback
Solid revenue growth driven by a growing customer base, increasing re-
order rates and penetration in a variety of surgical settings
Experienced management team with a track record of commercializing
hospital-based products |
 4
Overview of Cadence
OFIRMEV
®
(IV Acetaminophen)
–
U.S. and Canadian rights licensed from Bristol Myers Squibb
–
FDA approved in Nov. 2010 and commercially launched Jan. 2011
with broad indications for management of pain and fever
–
Established
hospital
sales
team
with
extensive
relationships
and
years
of hospital sales experience
Option to acquire Incline Therapeutics
–
IONSYS™
transdermal PCA system
–
Represents a potentially significant commercial opportunity and an
excellent strategic fit with OFIRMEV
IONSYS™
is a trademark of Incline Therapeutics, Inc. |
 5
OFIRMEV
®
: product overview
OFIRMEV
®
(acetaminophen) injection
–
Proprietary IV acetaminophen formulation
–
First and only IV formulation of acetaminophen
approved in the United States
–
New class of IV medication
•
non-narcotic / opioid
•
non-NSAID
–
Same formulation of IV acetaminophen marketed
by
BMS
in
Europe
since
2002
as
Perfalgan
™
PERFALGAN™
is a trademark of Bristol Myers Squibb Company. |
 6
OFIRMEV
®
:
strong foundation for commercial success
•
Sales force average >10 years hospital selling experience
•
Extensive relationships, significant overlap with prior
territory
•
Substantial hospital commercial experience throughout
management
–
CEO > 25 years, CCO > 15 years, VP of Sales > 25 years
•
$10.75/ vial
•
Diagnosis-related group payment range for common
procedures: $12,000 -
$31,000
(5)
•
OFIRMEV may help reduce post surgical ambulation
time
(6)
and
time
to
extubation
in
the
ICU
(3)
•
Significant
pain
relief
•
Reduced
opioid
consumption*
-4
•
Improved patient satisfaction
1,2
* Clinical benefit of opioid reduction not demonstrated
References: (1) Sinatra, et al., 2005, (2) Data on file, (3) Memis, et al., 2010,
(4) Atef, et al., 2008 (5) Birkmeyer,et al., 2010 (6) Ohnesorge, et al.,
2009 Effective Pain
Control
Experienced
Hospital Sales
Force
Economic
Value
1
1 |
 7
OFIRMEV
®
: indication supports message
Broad Indication
•
Mild to moderate pain
•
Moderate to severe pain with adjunctive opioids
•
Reduction of fever
•
Adults and children 2 and older
Message
•
Significant pain relief
•
Reduced opioid consumption*
•
Improved patient satisfaction
•
Established safety profile
* Clinical benefit of opioid reduction not demonstrated
|
 8
Limitations of other IV pain therapies
Sedation
Nausea
Vomiting
Constipation
Headache
Cognitive impairment
Respiratory depression
Opioids
NSAIDs
Black Box Warning
Bleeding
GI complications
Kidney complications
Cardiovascular risks
Prolonged recovery
Increased length of stay
Higher costs to the institution
Limited use |
 9
Pain Intensity
Current US Approach
Current EU Approach
Severe
Opioids
IV
acetaminophen
+ opioids
Moderate
Opioids
IV
acetaminophen
+/-
opioids*
Mild
Opioids
IV
acetaminophen
Multi-modal analgesia:
the norms
* First post-operative analgesic drug, then add opioids if necessary
|
 10
Sinatra,
et
al.
Anesthesiology,
V
102,
No.
4,
April 2005.
placebo
IV acetaminophen
Placebo-controlled, total hip or total knee replacement
(n=49/52)
p<0.001
.
.
Sinatra Study:
pivotal acute pain clinical trial
* Post hoc analysis based on currently acceptable regulatory
endpoint ** Clinical benefit of opioid reduction was not demonstrated
IV acetaminophen
placebo
p-value
Sum of pain intensity differences over 24hrs*
-2.8
-242.3
<0.001
Weighted sums of pain relief over 6hrs
6.6
2.2
<0.05
41%
23%
<0.01
Morphine consumption over 24hrs**
38.3 mg(33%
)
57.4 mg
<0.001
Safety
IV acetaminophen comparable to placebo
Patient Satisfaction (Good/excellent – 24hrs) |
 11
Consistent opioid reduction across studies
*Reduction
in
number
of
patients
requiring
analgesic
rescue
with
ketorolac
and
fentanyl
1)
Sinatra, et all.,2005;
2)
Memis, et al., 2005;
3)
Viscusi, et al., 2005;
4)
Hong, et a., 2010
5)
Atef, et al., 2008
Pain Intensity
Opioid Reduction*
Time
p Value
Severe
33%
1
24h
<0.01
61%
2
24h
<0.05
Moderate
53%
3
0-6h
0.016
Mild
86%
4
24h
<0.001
78%
5
24h
<0.001 |
 12
OFIRMEV
®
:
economic
value
Placebo-controlled studies using IV acetaminophen demonstrated
results that may be associated with possible hospital cost savings:
–
Decreased opioid consumption *
•
Total hip/knee replacement
(1)
•
Total hip replacement
(2, 3)
•
Adult tonsillectomy
(4)
•
Endoscopic thyroidectomy
(5)
–
Decreased
time
in
PACU
(post-anesthesia
care
unit)
(6)
–
Decreased time to ambulation
(7)
–
Decreased time to extubation in ICU
(8)
* Note: Clinical
benefit of opioid reduction was not demonstrated
References: (1) Sinatra, et al., 2005; (2) Viscusi, et al., 2008; (3) Gimbel, et
al., 2008; (4) Atef, et al., 2007; (5) Hong, et al., 2010a; (6) Salihoglu,
et al., 2009; (7) Ohnesorge, et al., 2009; (8) Memis, et al., 2010
|
 13
The UK experience
UK treatment paradigms for moderate
and acute pain are similar to those in
the US
–
Higher opioid than NSAID usage
–
Multimodal pain therapy
Perfalgan, BMY’s IV acetaminophen
–
Launched in 2004
–
Most share taken from opioids,
some from NSAIDS
Used alone and in combination with
opioids
–
Multimodal therapy provides broader
market opportunity
UK Injectable Analgesics
(Unit Share of Market)
Source: IMS data, 2009
2004
2009
Opioids
Perfalgan
NSAIDS
89%
2%
35%
1%
9%
63% |
 14
Oral
opioids:
acetaminophen
combinations
dominate
Opioid-acetaminophen combinations
Opioid-only products
Opioid-NSAID combinations
74%
25%
1%
Source: IMS data, 2008.
74% of oral opioid doses sold in U.S. contain acetaminophen
Approximately 14.4 billion total doses sold in 2008
Acetaminophen + hydrocodone is the most frequently dispensed Rx
drug in the US (FDA, 2009) |
 15
Hospital
products:
multi-step
launch
process
Regulatory
Approval
Physician
Access
Formulary
Access
Sales |
 16
Stage III
Increase Doses Per
Patient
Stage II
Broaden Physician
Utilization
Stage I
Create Access
OFIRMEV
®
:
adoption
process |
 17
OFIRMEV
®
:
strong early launch indicators
Rapid formulary adoption
–
On formulary in approx. 1,580 hospitals*
–
Mix of formulary wins is representative of overall target market
–
Includes major academic medical centers and large community
healthcare systems
Most hospitals approved OFIRMEV with minimal or no restrictions
–
Allows access across the hospital by range of physicians
–
Minimally restricted to patients who cannot take oral medication
Physician support and early experience positive
–
Physician support strong driver of formulary success
–
Physician feedback:
•
Significant pain relief
•
Utilization of less opioids
•
Improved patient satisfaction
–
Over 400,000 patients treated**
* Launch through December 31, 2011
** Based on our estimate of 2.5 doses per patient |
 18
Revenue growth:
three main drivers
Growth in customer base
–
Number of unique customer accounts
in Q4 increased 23% from Q3 to
2,200+
Increase in frequency of product use
–
~1,600 of 2,200 hospitals reordered
product through end of Q4
Increase in average quantity of product
order per customer
–
Customer shift from adoption phase
toward use on broader patient
population
–
Anticipate increasing number of vials
per patient as adoption by surgeons
broadens
Product Revenue |
 19
Formulary
approvals
have
exceeded
Company
projections
through
Q4
2011
–
Approx. 1,580
hospital
formulary
approvals
achieved
through
December
31,
2011
Rapid Formulary Penetration
Source: Cadence Internal Data |
 20
OFIRMEV sales continue to accelerate
•
Q4
sales
exceeded
cumulative
sales
during
1
st
9
months
of
2011
Significant Sales Growth Through Q4
Source:
Wolters
Kluwer
Pharma
Solutions,
Source®
PHAST
Institution.
*December
sales
estimate
derived
from
Cadence
internal
data. |
 21
Significant Growth in New Customers
Significant growth in new and repeat customers each quarter
23%
growth
in
unique
accounts
ordering
OFIRMEV
®
in
Q4
33% increase in accounts that placed multiple orders in Q4
|
 22
Growing
demand:
consistent
order
frequency
growth
(est.) |
 23
Growing demand: average order size growing
steadily Note: Sales data as reported through 12/22/12
|
 24
Surgery penetration:
deepening penetration of a growing base of hospitals
* Assumptions:
# Patients
Treated
in
On-Formulary
Accts
=
Vial
Sales
in
On-Formulary
Accts
÷
2.5
vials/patient
Estimated U.S. Surgical Procedures = 30MM hospital-based surgical
procedures/yr. Estimated Procedures in On-Formulary Accts = [U.S.
Surgical Procedures] * [% Formulary penetration] Share
of
Procedures
=
#
Patients
Treated
in
On
Formulary
Accts
÷
Estimated
Procedures
in
On-Formulary
Accts
* Estimated 2.5 vials/patient and
30MM hospital-based surgical procedures/yr |
 25
OFIRMEV
®
: vial sales off to strong start
* # of doses are shown for Entereg and Dificid, which are oral products
** Cubicin monthly sales are averaged within each quarter
OFIRMEV vs Avg:
7.8X
OFIRMEV Rank:
1
Source: Wolters Kluwer Pharma Solutions, Source® PHAST Institution. Cubist
Pharmaceuticals, Inc. Form 10-Q reports. Based on Cadence comparison to other
selected product launches in hospital market over period March 2006 – Dec 2011.
|
 26
OFIRMEV
®
: strong revenue ramp
** Cubicin monthly sales are averaged within each quarter
OFIRMEV hospital sales growth compares favorably vs. recent launches
despite significantly lower price.
Source: Wolters Kluwer Pharma Solutions, Source® PHAST Institution. Cubist Pharmaceuticals, Inc.
Form 10-Q reports. Based on Cadence comparison to other selected product launches in
hospital market over period March 2006 – Dec 2011.
OPAT utilization from Cubist Corporate Presentation, Cubist.IP.9.06.
|
 27
Experienced Management & Commercial Team
CEO > 25 years
CFO > 25 years
CMO > 25 years
Commercial Team
CCO > 15 years commercial management experience
VP Sales > 25 years sales management experience
3 Regional Business Directors:
–
Avg. 21 years industry experience, 13 years hospital sales management
experience
18 District Sales Managers:
–
Avg. 16 years industry experience, 7 years hospital sales management
experience
147 Hospital Sales Specialists -
extensive hospital selling experience |
 28
Company Highlights
Specialty biopharmaceutical company, focused on developing and
commercializing proprietary therapeutics utilized in the hospital setting
–
Sustainable core business of OFIRMEV
®
with opportunities to diversify
product portfolio
OFIRMEV -
a differentiated, new class of IV pain medication
–
Non-opioid, non-NSAID analgesic
–
Foundation for multi-modal approach to pain management
Strong uptake of hospital formulary adoption and positive physician
feedback
Solid revenue growth driven by a growing customer base, increasing re-
order rates and penetration in a variety of surgical settings
Experienced management team with a track record of commercializing
hospital-based products |
 29
Cadence:
financial
position
12 Months
Ended
12/31/10
(MM)
9 Months
Ended
9/30/11
(MM)
Net Product Revenue
$ 0.0
$
5.6
Operating expenses
$ 54.9
$ 68.0
Cash, cash equivalents &
short-term investments
$134.1
$145.0
(1)
Shares outstanding
63.1
63.6
(1)
Pro forma cash including net proceeds of $77.3MM raised in an equity follow-on
offering in November 2011. |