UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 14, 2012
Cadence Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware | 001-33103 | 41-2142317 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
12481 High Bluff Drive, Suite 200 San Diego, California 92130
(Address of principal executive offices, including zip code)
(858) 436-1400
(Registrants telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01. | Regulation FD Disclosure. |
Theodore R. Schroeder, President and Chief Executive Officer of Cadence Pharmaceuticals, Inc. (Cadence), and other executive officers will be presenting the information attached as Exhibit 99.1 to this Current Report on Form 8-K at various upcoming meetings beginning February 15, 2012.
In accordance with General Instruction B.2. of Form 8-K, the information under Items 7.01 and 9.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, whether made before or after the date hereof, except as expressly set forth by specific reference to Items 7.01 and 9.01 to this Current Report on Form 8-K in such filing.
By filing this information, Cadence makes no admission as to the materiality of any information in this report. The information contained in this report and the exhibit hereto is intended to be considered in the context of Cadences filings with the Securities and Exchange Commission and other public announcements that Cadence makes, by press release or otherwise, from time to time. Cadence undertakes no duty or obligation to publicly update or revise the information contained in this report or the exhibit hereto, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the Securities and Exchange Commission, through press releases or through other public disclosure.
Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
Exhibit |
Description of Exhibit | |
99.1 | Corporate Presentation, dated February 2012 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
CADENCE PHARMACEUTICALS, INC. | ||
By: | /s/ William R. LaRue | |
| ||
William R. LaRue | ||
Senior Vice President, Chief Financial Officer, Treasurer and Assistant Secretary |
Date: February 14, 2012
EXHIBIT INDEX
Exhibit Number |
Description of Exhibit | |
99.1 | Corporate Presentation, dated February 2012 |
Improving the lives of hospitalized patients
Corporate Overview
Exhibit 99.1
February 2012
|
2
Caution on forward-looking statements
CADENCE
®
and OFIRMEV
®
are trademarks of Cadence Pharmaceuticals, Inc.
©
2012 Cadence Pharmaceuticals, Inc. All rights reserved.
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.
|
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
Effective Pain
Control
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
1
Reduced opioid consumption*
1-4
Improved patient satisfaction
1,2
Experienced
Hospital Sales
Force
Economic
Value
* 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 |
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
Pain Intensity
Opioid Reduction*
Time
p Value
Severe
33%
24h
<0.01
61%
24h
<0.05
Moderate
53%
3
0-6h
0.016
Mild
86%
4
24h
<0.001
78%
5
24h
<0.001
Consistent opioid reduction across studies
2
1
*Reduction in number of patients requiring analgesic rescue with ketorolac and fentanyl 1) Sinatra, et al.,2005;
2)
Memis, et al., 2005;
3)
Viscusi, et al., 2005;
4)
Hong, et al., 2010
5)
Atef, et al., 2008 |
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 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 Decreased
time
in
PACU
(post-anesthesia
care
unit)
(6) |
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, BMYs 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
Sales
Regulatory
Approval
Physician
Access
Formulary
Access |
16
Stage III
Increase Doses Per
Patient
Stage II
Broaden Physician
Utilization
Stage I
Create Access
OFIRMEV
®
: adoption process |
17
OFIRMEV
®
Launch: broad and rapid adoption
In 2011
* Launch through December 31, 2011
** Based on our estimate of 2.5 doses per patient
1,580 hospital formulary approvals*
2,200 accounts ordered
Approximately 1.2 million vials distributed
Over 400,000 patients treated** |
18
OFIRMEV
®
:
strong early launch indicators
Rapid formulary adoption
On formulary in approximately 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 |
19
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 |
20
Formulary
approvals
have
exceeded
Company
projections
through
Q4
2011
Approximately 1,580 hospital formulary approvals achieved through December 31,
2011 Rapid Formulary Penetration
Source: Cadence Internal Data |
21
OFIRMEV sales continue to accelerate
Q4 sales exceeded cumulative sales during first 9 months of 2011
Significant Sales Growth Through Q4
Source: Wolters Kluwer Pharma Solutions, Source® PHAST Institution, Jan.25, 2012
|
22
Significant growth in new and repeat customers each quarter
Significant Growth in New Customers
23%
growth
in
unique
accounts
ordering
OFIRMEV
®
in
Q4
33% increase in accounts that placed multiple orders in Q4
|
23
Growing demand: consistent order frequency
growth |
24
Growing demand: average order size growing
steadily Note: Sales data as reported through 12/22/12
|
25
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. |
26
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:
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. |
27
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. |
28
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
Hospital Sales Specialists:
Approximately 140 territories
Extensive hospital selling experience |
29
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 |
30
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. |