CADENCE PHARMACEUTICALS INC - FORM 8-K - EX-99.1 - CORPORATE PRESENTATION

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8-K - FORM 8-K - CADENCE PHARMACEUTICALS INC	d301888d8k.htm

Improving the lives of hospitalized patients

Corporate Overview

Exhibit 99.1

February 2012

Caution on forward-looking statements

CADENCE

and OFIRMEV

are trademarks of Cadence Pharmaceuticals, Inc.

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.

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

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.

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

BMS

Europe

since

2002

Perfalgan

™

PERFALGAN™ is a trademark of Bristol Myers Squibb Company.

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

•

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

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

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

Pain Intensity

Current US Approach

Current EU Approach

Severe

Opioids

acetaminophen

+ opioids

Moderate

Opioids

acetaminophen

+/-

opioids*

Mild

Opioids

acetaminophen

Multi-modal analgesia: the norms

* First post-operative analgesic drug, then add opioids if necessary

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)

Pain Intensity

Opioid Reduction*

Time

p Value

Severe

33%

24h

<0.01

61%

24h

<0.05

Moderate

53%

0-6h

0.016

Mild

86%

24h

<0.001

78%

24h

<0.001

Consistent opioid reduction across studies

*Reduction in number of patients requiring analgesic rescue with ketorolac and fentanyl

Sinatra, et al.,2005;

Memis, et al., 2005;

Viscusi, et al., 2005;

Hong, et al., 2010

Atef, et al., 2008

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

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

PACU

(post-anesthesia

care

unit)

(6)

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%

35%

63%

Oral opioids: acetaminophen combinations dominate

Opioid-acetaminophen combinations

Opioid-only products

Opioid-NSAID combinations

74%

25%

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)

Hospital products: multi-step launch process

Sales

Regulatory

Approval

Physician

Access

Formulary

Access

Stage III

Increase Doses Per

Patient

Stage II

Broaden Physician

Utilization

Stage I

Create Access

OFIRMEV

: adoption process

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**

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

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

Formulary

approvals

have

exceeded

Company

projections

through

2011

–

Approximately 1,580 hospital formulary approvals achieved through December 31, 2011

Rapid Formulary Penetration

Source: Cadence Internal Data

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

Significant growth in new and repeat customers each quarter

•

Significant Growth in New Customers

23%

growth

unique

accounts

ordering

OFIRMEV

33% increase in accounts that placed multiple orders in Q4

Growing demand: consistent order frequency growth

Growing demand: average order size growing steadily

Note: Sales data as reported through 12/22/12

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]

Procedures

Patients

Treated

Formulary

Accts

Estimated

Procedures

On-Formulary

Accts

*Estimated 2.5 vials/patient and

30MM hospital-based surgical procedures/yr.

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:

OFIRMEV Rank:

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.

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.

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

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

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.

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