0001193125-11-135559.txt : 201105110001193125-11-135559.hdr.sgml : 2011051120110511123440ACCESSION NUMBER:0001193125-11-135559CONFORMED SUBMISSION TYPE:8-KPUBLIC DOCUMENT COUNT:28CONFORMED PERIOD OF REPORT:20110511ITEM INFORMATION:Regulation FD DisclosureITEM INFORMATION:Financial Statements and ExhibitsFILED AS OF DATE:20110511DATE AS OF CHANGE:20110511

FILER:

COMPANY DATA:COMPANY CONFORMED NAME:CADENCE PHARMACEUTICALS INCCENTRAL INDEX KEY:0001333248STANDARD INDUSTRIAL CLASSIFICATION:PHARMACEUTICAL PREPARATIONS [2834]IRS NUMBER:000000000FISCAL YEAR END:1231

FILING VALUES:FORM TYPE:8-KSEC ACT:1934 ActSEC FILE NUMBER:001-33103FILM NUMBER:11831029

BUSINESS ADDRESS:STREET 1:12481 HIGH BLUFF DRIVESTREET 2:SUITE 200CITY:SAN DIEGOSTATE:CAZIP:92130BUSINESS PHONE:8584361400

MAIL ADDRESS:STREET 1:12481 HIGH BLUFF DRIVESTREET 2:SUITE 200CITY:SAN DIEGOSTATE:CAZIP:92130

8-K1d8k.htmFORM 8-K

Form 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section13 or 15(d) of the

Securities Exchange Act of1934

Date of Report (Date of earliest event reported): May11, 2011

Cadence Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

Delaware001-3310341-2142317

(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))

Item7.01.Regulation FD Disclosure.

Theodore R. Schroeder, President and Chief Executive Officer of Cadence Pharmaceuticals, Inc. (Cadence), and other executiveofficers will be presenting the information attached as Exhibit 99.1 to this Current Report on Form 8-K at various upcoming meetings beginning May11, 2011.

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 forpurposes of Section18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference to Items 7.01 and 9.01 in such filing to this Current Report on Form 8-K.

By filing this information, Cadence makes no admission as to the materiality of any information in this report. The information containedin the 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, fromtime 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 updatingmay be made through the filing of other reports or documents with the Securities and Exchange Commission, through press releases or through other public disclosure.

Item9.01.Financial Statements and Exhibits.

(d)Exhibits.

Exhibit
Number

Description of Exhibit

99.1Corporate Presentation, dated May11, 2011

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: May11, 2011

EXHIBIT INDEX

Exhibit
Number

Description of Exhibit

99.1Corporate Presentation, dated May11, 2011

EX-99.12dex991.htmCORPORATE PRESENTATION

Corporate Presentation

Improving the lives of hospitalized patientsCadence Pharmaceuticals, Inc.Corporate PresentationMay 11, 2011Exhibit 99.1

2This presentation includes forward-looking statements, which are based on ourcurrent beliefs and expectations. Such statements include, withoutlimitation, statements regarding: the anticipated U.S. market opportunity for OFIRMEV; our projections regarding the number of formulary approvals of OFIRMEV; our belief thatwe can rapidly accelerate sales of OFIRMEV; the potential for us toultimately acquire Incline Therapeutics, Inc. or other product candidates; and our strategy forbuilding a long-term hospital pain franchise. You are cautioned not to place undue reliance on these forward-lookingstatements, which speak only as of the date hereof. Ouractualfutureresultsmaydiffermateriallyfromourcurrentexpectationsduetotherisksanduncertaintiesinherentinour business. These risks include our dependence on the successful commercialization ofOFIRMEV; the potential that delays in achieving formulary acceptance forOFIRMEV at a substantial number of targeted accounts may decrease the market potential for OFIRMEV; our ability to generate revenues from OFIRMEV; our abilityto ensure an adequate and continued supply of OFIRMEV; our ability tosuccessfully enforce our marketing exclusivities and intellectual property rights, and to defend our patents; the potential product liability exposure associated withOFIRMEV; the risk that we may not be able to raisesufficientcapitalwhenneeded,oratall;andotherrisksdetailedunderRiskFactorsandelsewhereinourAnnual Report on Form 10-K for the period ended December 31, 2010, and our otherfilings made with the Securities and Exchange Commission from time to time. All forward-looking statements are qualified in their entirety by thiscautionary statement, which is made under the safe harbor provisions ofSection 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. Forward-looking statementsCADENCEandOFIRMEVaretrademarksofCadencePharmaceuticals,Inc.. IONSYSis a trademark of Incline Therapeutics, Inc.2011 Cadence Pharmaceuticals, Inc. All rights reserved.

3Cadence:investment highlightsHospital-focused specialty pharmaceutical companyOFIRMEVlaunched with broad pain and fever indication in January 2011

Rapid formulary adoption demonstrated

Established hospital sales team provides a core platform for theacquisition of additional products

Management team with significant hospital commercial experienceOption to acquire Incline Therapeutics

IONSYStransdermal PCA system

Opportunity to leverage OFIRMEV sales forceStrong balance sheet

4OFIRMEV: product overviewOFIRMEV (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 byBMSinEuropesince2002asPerfalgan

U.S. Commercial launch : January 17, 2011PERFALGANisatrademarkofBristolMyersSquibbCompany.

5OFIRMEV: indication supports messageBroad Indication

Mild to moderate pain

Moderate to severe pain with adjunctive opioids

Reduction of fever

Adults and children 2 and olderMessage

Significant pain relief

Reduced opioid consumption*

Improved patient satisfaction

Established safety profile* Clinical benefit of opioid reduction not demonstrated

6OFIRMEV:strong foundation for commercial successEffective 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

General Surgery DRG $23,000

OFIRMEV may help reduce post surgical ambulation time, and time to extubation in the ICU

Significant pain relief

Reduced opioid consumption*

Improved patient satisfactionExperienced Hospital Sales ForceEconomicValue* Clinical benefit of opioid reduction not demonstrated

7OFIRMEV:strong early launch indicators*Rapid formulary adoption

On formulary in 675 hospitals in first 15 weeks of launch

Mix of formulary wins is representative of overall target market

Includes major academic medical centers and large community healthcare systemsMost hospitals approved OFIRMEV without restriction

Allows access across the hospital by range of physiciansPhysician support and early experience positive

Physician support strong driver of formulary success

Physician feedback:

Significant pain relief

Utilization of less opioids

Improved patient experience* Launch through April 30, 2011

8OFIRMEV: vial sales off to strong startVial* Sales of Comparable New Hospital Product Launches Over Last 5 Years020,00040,00060,00080,000100,000120,000123456789101112Month Post LaunchOFIRMEV(1-11)TEFLARO(1-11)DORIBAX(10-07)CLEVIPREX(9-08)VAPRISOL(3-06)VIBATIV(10-09)LUSEDRA(11-09)ENTEREG (doses)(06-08)CALDOLOR(9-09)Average(Excl OFIRMEV)* # of doses are shown for Entereg, which is an oral productOFIRMEV vs Avg: 546%OFIRMEV Rank: 1 Source: Wolters Kluwer Pharma Solutions, Source PHAST Institution. Based on Cadence comparison to other selected product launches in hospital market over period March 2006 March 2011

9Limitations of other IV pain therapiesSedationNauseaVomitingConstipationHeadacheCognitive impairmentRespiratory depressionOpioidsNSAIDsBlack Box WarningBleedingGI complicationsKidney complicationsCardiovascular risksProlonged recoveryIncreased length of stay Higher costs to the institutionLimited use

10Pain IntensityCurrent US ApproachCurrent EU ApproachSevereOpioidsIVacetaminophen+ opioidsModerateOpioidsIVacetaminophen+/-opioids*MildOpioidsIVacetaminophenMulti-modal analgesia: the norms* First post operative analgesic drug, then add opioids if necessary

11Sinatra, et al. Anesthesiology, V 102, No. 4, April 2005.IV acetaminophenplacebop-valueWeighted sums of pain relief over 6hrs6.62.2 20 years

District Sales Managers > 9 years

24OFIRMEV: economic valuePlacebo-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)

DecreasedtimeinPACU(post-anesthesiacareunit)(6)

Decreased time to ambulation (7)

DecreasedtimetoextubationinICU(8)* Note: (1-5) Clinical benefitof opioid reduction was not demonstrated References: (1) Sinatra, 2005; (2)Viscusi, 2008; (3) Gimbel, 2008; (4) Atef, 2007; (5) Hong, 2010a; (6) Salihoglu, 2009; (7) Ohnesorge, 2009; (8) Memis, 2010

25Cadence: financial position12 MonthsEnded12/31/10(MM)3 Months Ended 3/31/11 (MM)Operating expenses $ 54.9$ 22.7 Cash, cash equivalents & short-term investments $134.1$109.0 (1)Shares outstanding 63.163.3(1)Does not include a $5.3 million upfront payment received in April 2011 under a datalicense agreement with Terumo

26OFIRMEV: product overviewOFIRMEV (acetaminophen) injection

Proprietary IV acetaminophen formulation

First and only IV formulation of acetaminophen approved in the United States

New Class of IV AnalgesicOFIRMEV launched with broad pain and fever indication in January 2011

Rapid formulary adoption demonstrated; 675 approvals by April 30

Management team with significant hospital commercial experience

Established hospital sales team provides a core platform for the acquisition of additional products

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