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Page 1 Sepracor Inc. Company Overview – November 12, 2009 Adrian Adams President and CEO

Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

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Page 1: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

Page 1

Sepracor Inc.Company Overview – November 12, 2009

Adrian Adams

President and CEO

Page 2: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

2Disclaimer Regarding Forward-looking Statements

The statements made in this presentation material are forward-looking statements based on management’s assumptions and beliefs in light of information available up to the day of announcement, and involve both known and unknown risks and uncertainties.

Actual financial results may differ materially from those presented in this document, being dependent on a number of factors.

Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.

Page 3: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

3

• Fully integrated, research-based pharmaceutical company• Current therapeutic focus: Respiratory & CNS

• Primary care and specialty marketing with drug discovery and development infrastructure

• R&D pipeline: early-, mid-, and late-stage assets

• Six products available in the U.S.• LUNESTA®, XOPENEX® Inhalation Solution, XOPENEX HFA® and BROVANA®

• Ciclesonide franchise – includes OMNARIS® Nasal Spray and ALVESCO® HFA Inhalation Aerosol

• Royalty income from three major partnered products• ALLEGRA®, CLARINEX® and XYZAL®/XUSAL™

• Strong cash position

• 2008 total revenues of approximately $1.3 billion

Overview of Sepracor Inc.

Page 4: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

4Sepracor Inc. – 25 Years of Evolution

2005

launched in U.S.

launched in U.S.

2006

Sepracor becomes profitable

1996

Sepracor est. 1984 1991

ALLEGRA®

launched by HMRI

Sepracor launches

1999

Sepracor commits to self-development, self-commercialization strategy

2000

IPO

Isomer strategy launched

1989

Product LaunchesCorporate Development & LicensingFinancial

2002

CLARINEX®

launched by Schering-Plough

2007

launched in U.S.

Eisai licenses rights to eszopiclone for Japan

STEDESA™

rights licensed from BIAL

2008

Acquires rights to XOPENEX/ ipratropiumcombo. from Arrow

Oryx acquired

2009

launched in U.S.

3 ciclesonide candidates

licensed from

Nycomed

acquires Sepracor

Page 5: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

5Sepracor: Historical Financial Performance

0

200

400

600

800

1000

1200

1400

2000 2002 2004 2006 2008

Mill

ions

of D

olla

rs

-400

-300

-200

-100

0

100

200

300

400

500

600

2000 2002 2004 2006 2008

Total Revenue Growth 2000 - 2008 GAAP Net Income (Loss) 2000 - 2008

Prior periods have been adjusted to reflect the impact of the adoption on January 1, 2009 of FASB Staff Position No. APB 14-1, Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement) (“FSP APB 14-1”), FSP Emerging Issues Task Force No. 03-6-1, Determining Whether Instruments Granted in Share-Based Payment Transactions are Participating Securities (“FSP EITF 14-1”), and certain other immaterial adjustments as described in the Form 8-K filed with the SEC on May 14, 2009.

$(218.2)

$(283.8)$(310.6)

$148.8

$480.0

$85.2

$236

$373

$1183.1

$1292.3

CAGR 2000 –2008: 40.5%

Mill

ions

of D

olla

rs

Page 6: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

6Sepracor Employee Base

921319

236

252

162

Approximately 2,100 Employees

Sales

Commercial

Research & Development

General & Administrative

Canadian Operations

Page 7: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

7

592 773

Sepracor’s Product Portfolio by Contribution

2008 Product Revenues: ~$1.3 B

$0.0

$200.0

$400.0

$600.0

$800.0

$1,000.0

$1,200.0

$1,400.0

ROYALTIESSPIALVESCO®OMNARIS®BROVANA®XOPENEX HFA®XOPENEX® ISLUNESTA®

$600.3 M

$441.0 M

$74.2 M$57.3 M$77.0 M $11.1 M

$16.8 M

$14.6 M

Note: SPI revenues are for June to December 2008. ALVESCO revenues are for September to December 2008. OMNARIS revenues are for April to December 2008.

Milli

ons

of D

olla

rs

Page 8: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

8

Corporate / Commercial• Drive strong product portfolio performance with continued focus

on efficiencies, effectiveness and profitability• Generate efficiencies from corporate restructuring to continue to

achieve cost savings and build foundation for the future

Research & Development• Successfully execute high-priority R&D initiatives to strengthen

pipeline and enhance current franchises

Corporate Development & Licensing• Aggressively pursue corporate development and licensing

opportunities that enhance the portfolio and complement DSP’sstrategic direction

Financial• Deliver sustainable earnings momentum and enhanced

shareholder value

Corporate Priorities and Opportunities

Page 9: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

9

Achieve Financial Targets• Meet or exceed top- and bottom-line targets• Launch new direct-to-consumer campaigns for LUNESTA® and OMNARIS®

Nasal Spray

Focus on Profitability• Realize efficiencies from new commercial model implemented early 2009• Focus on contracting profitability• Maintain profitability of XOPENEX® Inhalation Solution and LUNESTA

Expand the Portfolio• ALVESCO® primary care physician launch• Prepare for STEDESA™ launch

Maximize Capabilities• Forecasting, incentives and targeting • Build relationship management platform for all brands• Commercial training and leadership development

Commercial: Overview of 2009 Priorities

Page 10: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

10

Context• Recent trends and macroeconomic environment impacting pharmaceutical market

• Reach and frequency model with multiple sales forces is losing momentum• Gain operating leverage with new model that supports current and future portfolio

• Foundation of changes began in 2008

Description• Commercial model organized into two business units (Primary Care and Specialty)

• Sales representatives have territory brand ownership with no mirrored territories and high accountability

Potential Benefits• Fosters entrepreneurial spirit and “fast-acting, high-performance” culture• Enables decision-making at lower levels in headquarters and field• Focus remains on important compliance issues

Sepracor’s Commercial Model

Page 11: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

11

BROVANA®

Sales RepresentativesXOPENEX® / ALVESCO®

Sales RepresentativesLUNESTA® / OMNARIS®

Sales Representatives Sales Representatives will be Market Driven

• Product, Disease State and Market Experts

• 100% Product Ownership and Accountability

• Pay for Performance

• Experts In Territory Analytics and Planning

Primary Care Physician (PCP)

Focus

94,000 Targets

755 Sales Representatives

Specialty Focus

43,000 Targets

295 Sales Representatives

Home Health Care & Specialty Focus

19,000 Targets

142 Sales Representatives

Product Ownership With Optimized Resources

Page 12: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

12

0

600

1,200

1,800

2,400

July - Sept 2008 July - Sept 2009

Improvement in Field Productivity Metrics

Source: IMS IPS, IMS NPA, Sepracor internal

Total Prescriptions (TRxs) / Representative

0

25

50

75

100

July-Sept 2008 July-Sept 2009

P1 Details / Representative

$0

$50,000

$100,000

$150,000

$200,000

$250,000

July - Sept 2008 July - Sept 2009

Net Sales / Representative

Improvement in Field Metrics• TRxs per representative up 37%• P1 details per representative up 24%• Net Sales per representative up 31%

+24%

Num

ber o

f Aud

ited

P1 D

etai

ls /

Rep

Net

Sal

es /

Rep

rese

ntat

ive +31%+37%

Num

ber o

f TR

xs/ R

epre

sent

ativ

e

Page 13: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

13

Therapeutic Overview• 30-40% of adults have some symptoms of insomnia within a year

• 15% of adults have chronic insomnia• Chronic insomnia is more prevalent with age and among women

U.S. Market Opportunity• Insomnia market size: $4B+, 5% annual growth

• Highly competitive market with established generic options

• 1/3 of the volume prescription and 2/3 over-the-counter; 90% of the sales from prescription and 10% from over-the-counter

LUNESTA• A non-narcotic sedative hypnotic indicated for sleep onset and sleep maintenance

• Activity on GABA-A receptor complex across α1, α2, and α3 receptor subtypes

LUNESTA®: Overview of Market and Product

Sources: National Center for Sleep Disorder Research, Decision Resources, IMS, Sepracor Internal

Page 14: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

14LUNESTA® Performance

Performance Update• Qtr3 ‘09 revenues of $127.3 M and

YTD revenues of $418.9 M• Overall insomnia market growth in

single digits, driven principally by generic zolpidem

Promotional Priorities• Promotional messages focus on the

“Science of Sleep (GABA receptor activity differentiation)”, particularly versus zolpidem

• Targeted promotional spend with emphasis on margin improvement

• Continue online direct-to-consumer and relationship management programs designed to drive dialogue between patients and physicians about LUNESTA and improve compliance with prescription drug therapy

Data sources: IMS NSP Monthly, Sepracor internal. Audited promotion spending include DTC spending, detailing spending, and retail value of samples. Full Q3’09 Audited promotional spending is not available.

0

20

40

60

80

100

120

140

160

180

Q1'07 Q2'07 Q3'07 Q4'07 Q1'08 Q2'08 Q3'08 Q4'08 Q1'09 Q2'09 Q3'09

Net Revenue Audited Promotional Spending

Dol

lars

in M

illio

ns

LUNESTA Net Revenue and Audited Promotional Spending ($M)

YTD denotes January through September 30, 2009

Page 15: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

15

Therapeutic Overview• Current asthma prevalence is 28 M people• 71% of patients are diagnosed

U.S. Market Opportunity• Current short-acting beta-agonist (SABA) market (moving average total Sept ‘09): $2.5B

• Annual Total Prescription growth rate: 4.4% • Seasonal and competitive market with generic options

• 78% of patients are prescribed inhalers• 26% of patients are prescribed nebulizers

XOPENEX Inhalation Solution and HFA Inhalation Aerosol

• A bronchodilator indicated for the treatment or prevention of acute bronchospasm in patients with reversible obstructive airway disease

• Only contains the therapeutically active (R)-isomer of albuterol

XOPENEX®: Overview of Market and Products

Sources: IMS, CDC, National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma (EPR – 3 -2007), U.S. Department of Health and Human Services, Sepracor Internal

Page 16: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

16

75

77

79

81

83

85

87

89

Qtr3 '08 Qtr3 '09

Qtr3 '08 Qtr3 '09

XOPENEX® - Stable Franchise Performance XO

PEN

EX I.

S. R

even

ues

$M

XOPENEX Inhalation Solution Revs.

+10.5%

$77.9

$86.1

0.0

5.0

10.0

15.0

20.0

25.0

30.0

Qtr3 '08 Qtr3 '09

Qtr3 '08 Qtr3 '09

XOPE

NEX

HFA

Rev

enue

s $M

XOPENEX HFA Inhalation Aerosol Revs.

+ 23.2%$18.5

$22.8

Performance UpdateXOPENEX® Inhalation Solution• Qtr3 ‘09 revenues of $86.1 M and YTD revenues of

$294.2 M• Increased contribution marginsXOPENEX HFA®

• Qtr3 ‘09 revenues of $22.8 M and YTD revenues of $57.7 M

• Increased contribution margins Promotional Priorities

• New “Asthma” Sales team gives additional focus to XOPENEX family

• Increased detailing to loyalists and pediatricians• Continued focus on unique single isomer chemical

structure• Drive patient starts with XoPack sample pack

YTD denotes January through September 30, 2009

Page 17: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

17

Therapeutic Overview• ~ 12 M people are diagnosed with chronic obstructive pulmonary disease (COPD)

• Risk factors include smoking, pollution and existing lung impairment

U.S. Market Opportunity• Large Total Prescription (TRx) market for COPD: 22 M TRxs (moving average total July ‘09)

• Untapped market opportunity: currently only 1 M patients are treated with nebulized therapy

• Only two long-acting beta-agonist (LABA) nebulized products available

• Significant market volume in Medicare and Home Health Care

BROVANA• An inhalation solution bronchodilator indicated for the maintenance treatment of COPD

• Clinical benefits include rapid onset and sustained bronchodilation

BROVANA®: Overview of Market and Product

Sources: IMS, CDC, NHLBI, Sepracor Internal

Page 18: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

18BROVANA® Volume Continues to Build

Data source: IMS DDD COT Monthly. BROVANA units received in mL then converted into package unitsdivided by 2. Q3’09 Units were estimated using weekly DDD data

BROVANA Performance• Q3 ‘09 revenues of $18.5 M and

YTD revenues of $56.2 M • Volume continues to build• Unrestricted access at 93% of

managed care lives • Improved share of voice and

awareness among targeted physicians

• Less restrictive Medicare coverage criteria for long-acting beta agonists became effective 12/1/09

Promotional Priorities• Specialty Markets Business Unit

provides greater focus for BROVANA

• Physician targeting focused on top prescribers

Uni

ts (0

00s)

0

500

1,000

1,500

2,000

2,500

3,000

3,500

4,000

4,500

5,000

Qtr3 '08 Qtr3 '09

RetailNon-Retail

+ 27%

BROVANA Retail and Non-Retail Unit Demand

YTD denotes January through September 30, 2009

Page 19: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

19

Therapeutic Overview• Allergic Rhinitis (AR) affects 65 M people• Most patients suffer from Perennial Allergic Rhinitis (PAR) or both PAR and Seasonal Allergic Rhinitis (SAR)

• Strong association between AR and other respiratory disorders

U.S. Market Opportunity• Current intranasal steroid (INS) market (moving average total Sept ‘09): ~ $2B

• Annual Total Prescription growth rate: 1-3% • Market is promotionally sensitive, which drives direct-to-consumer strategy

OMNARIS• An inhaled nasal steroid indicated for treatment of nasal symptoms of SAR in patients ≥ 6 yrs and PAR in patients ≥12 yrs

• Prodrug activated after nasal administration that provides significant improvement in total nasal symptom score (TNSS), within 24-48 hours

OMNARIS®: Overview of Market and Product

Sources: IMS, Sepracor Internal

Page 20: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

20

0

5

10

15

20

25

30

35

40

45

50

May-08

Jun-08

Jul-0

8Aug-0

8Sep

-08Oct-

08Nov-0

8Dec

-08Ja

n-09Feb

-09Mar-

09Apr-0

9May

-09Ju

n-09Ju

l-09

Aug-09

Sep-09

0.0%

0.2%

0.4%

0.6%

0.8%

1.0%

1.2%

1.4%

OMNARIS TRx OMNARIS TRx share

Launched New Commercial Model

DTC Launch

Performance Update• Qtr3 ‘09 revenues of $7.3 M and YTD

revenues of $22.3 M• Total Prescription volume and share

growth strong through spring allergy season

• Share growth during intranasal steroid low-season

• Patient awareness increasing through direct-to-consumer campaign

Promotional Priorities• Continue to drive uptake with key

specialists (e.g., allergists; ear, nose and throat specialists)

• Emphasis on consumer marketing as integral component of promotional strategy

Data source: IMS NPA Weekly. The INS Market is defined as the Inhaled Nasal Steroid Class (USC 28420).

OM

NA

RIS

TR

xSh

are

OM

NA

RIS

TR

xVo

l (00

0s)

Monthly OMNARIS Total Prescription (TRx) Volume and Share

OMNARIS® Nasal Spray - Continued Strong Uptake

YTD denotes January through September 30, 2009

Page 21: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

21

Therapeutic Overview• Current asthma prevalence 28 M people• 13 M people suffer from asthma attacks annually

• Therapy goals include reducing impairment by maintaining lung function

U.S. Market Opportunity• Current inhaled corticosteroid market (ICS) (moving average total Sept ‘09): ~ $1.4B

• Annual Total Prescription growth rate: 6% • Programs that educate prescribers and patients about the role of inflammation in chronic asthma can improve compliance with treatment guidelines

ALVESCO• An inhaled corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients ≥ 12 years old

ALVESCO®: Overview of Market and Products

Sources: IMS, CDC, National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma (EPR – 3 -2007), U.S. Department of Health and Human Services, Sepracor Internal

Page 22: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

22ALVESCO® Volume Continues to Build

Data source: IMS NPA Weekly. The ICS market is defined as Inhaled Bronchial Steroid (USC 28410), exclude Pulmicort Respules and Budesonide.

Performance Update• Positive prescription share and

volume growth during asthma “low” season

• Broader primary care launch began in Qtr1, positive impact to New Prescription trends

• Strong share growth among key specialists (e.g., allergists, pulmonologists)

Promotional Priorities• PCP promotional focus on site-

activated efficacy• Patient programs including starter

kits with co-pay reduction cards to encourage initial trial

• Continued use of other relationship management programs

Launch New Commercial Model

Launch of $0 Co-pay program

0

0.5

1

1.5

2

2.5

3

09/12

/0810

/17/08

11/21

/0812

/26/08

01/30

/0903

/06/09

04/10

/0905

/15/09

06/19

/0907

/24/09

08/28

/0910

/02/09

0.0%

0.2%

0.4%

0.6%

0.8%

1.0%

1.2%

ALVESCO TRx ALVESCO TRx Share

ALV

ESC

O T

Rx

Shar

e

ALV

ESC

O T

Rx

Vol (

000s

)

Weekly ALVESCO Total Prescription (TRx) Volume and Share

Page 23: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

23Sepracor’s Product Patent Portfolio

• XOPENEX® Inhalation Solution* – August 20, 2012**

• XOPENEX HFA® – last patent expires in 2024

• LUNESTA® – Qtr3 2014; assumes patent-term and pediatric extensions

• BROVANA® – last patent expires 2021

• OMNARIS® Nasal Spray – composition of matter patent expires in October 2017; last patent expires October 2020

• ALVESCO® HFA – composition of matter expires in October 2017; last patent expires May 2018

• STEDESA™ – patent-term extension could take composition of matter patent to late 2018/early 2019; additional patent applications are pending*Mylan (Dey) is currently selling a generic version of the XOPENEX Inhalation Solution concentrate formulation.

** Generic entry date per settlement.

Page 24: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

24Research and Development Update

R&D Priorities• Successfully execute high-priority R&D initiatives to

strengthen pipeline and enhance current franchises

Late-Stage Research and Development Assets

• STEDESA™ (eslicarbazepine acetate) for adjunctive treatment of epilepsy under FDA review

• OMNARIS® (ciclesonide) HFA for the treatment of allergic rhinitis in Phase III development

Page 25: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

25STEDESA™ Market Opportunity

Market• Approx. 2.7 M people in U.S. with epilepsy• U.S. epilepsy treatment mkt. est. $3.5 B

Target Profile• Efficacy

• Clear dose-response correlation• Marked, sustained seizure reduction

• Tolerability/Safety• Favorable tolerability and safety profiles• Relatively low risks regarding incidence of rash,

weight gain or hyponatremia in study population• Health Outcomes

• Significant improvements in quality of life over one-year treatment period

Regulatory Milestones• Submitted NDA to FDA on March 30, 2009• FDA action date January 30, 2010

Ongoing Development Program• U.S. Phase III adult monotherapy study initiated• Pediatric and additional indication programs of

Bipolar disorder and Neuropathic Pain are in planning stages

56

65

75

86

0

10

20

30

40

50

60

70

80

90

100

2002 2004 2006 2008

TRx

(

M

)

Anti-Epileptic Drugs* – Total Prescriptions (TRxs)

86 million Rxs in 2008 with a 7.5% CAGR ‘02-‘08

Sources: IMS NPA and IMS Healthplan analysis, 2006-2007, n=73,399 projected to U.S. insured population, Sepracor Internal

Page 26: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

26Eslicarbazepine Acetate Clinical Development Program

Phase III Combined Analysis

• 3 Phase III studies with common design testing doses of 400 mg, 800 mg and 1200 mg once-daily throughout a 12-week maintenance period

• Randomized, double-blind, placebo-controlled trials

• 1,049 adult patients with refractory partial-onset seizures ≥4 seizures per 28 days on a stable regimen of 1 to 3 concomitant AEDs

• Multinational program: 125 sites in 23 countries

150223239

Patients who completed 1 year (Total 612)

800 mg

76.1%

314

BIA-2093-301

800 mg

68.6%

325

BIA-2093-302

800 mg

Median dose of ESL

194

Number of patients enrolled (Total 833)

78.5%

Retention Rate (73.5%)

BIA-2093-303

Results from One-Year Open-Label Extension Study

Page 27: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

27Eslicarbazepine Acetate Phase III Results

Data on file – Phase III – Integrated Analysis studies 301, 302 and 303. QOLIE Scores from individual study 2093-301 Part 2.

Mean Relative (%) Reduction FromCombined Analysis

-45%

-40%

-35%

-30%

-25%

-20%

-15%

-10%

-5%

0%

Placebo 400 mg 800 mg 1200 mgN=286 N=195 N=282 N=272

*

* n.s. P≤0.0002 P≤0.0001

† ‡

Mean Quality of Life in EpilepsyInventory-31 (QOLIE-31) After 1-

Year Treatment or Discontinuation

p<0.0001

p<0.0001

52

53

54

55

56

57

58

59

60

61

Overall QoL Overall ScoreBaseline Last Assessment

Page 28: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

28OMNARIS® HFA for Allergic Rhinitis

OMNARIS HFA nasal aerosol

Opportunity• Intranasal corticosteroid market approximately $2 B• Approx. 20% of patients discontinue use of nasal

medications due to tolerability issues• Prior to chlorofluorocarbon (CFC) phase-out,

intranasal steroid aerosols represented approx. 25% of Total Prescription volume

Target Profile• Potential to be first available corticosteroid

formulated in a hydrofluoroalkane (HFA) nasal aerosol

• Formulation designed for no run-off or dripping, which is a common problem with most aqueous formulations

Development Timeline• Phase III SAR results complete• Initiate Phase III PAR Qtr3 2009• Potential NDA submission Qtr1 ‘11

Sources: IMS, Sepracor Internal

Automatic dose counter

Powerful spray delivers medication deep into nasal passages

Compact, portable device

Page 29: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

29

Study Design•Evaluated safety and efficacy of 80 mcg and 160 mcg of ciclesonide vs. placebo in patients with seasonal allergic rhinitis (SAR)

•707 adults and adolescents randomized over two weeks

Results•Primary efficacy endpoint: change from baseline in patient-reported AM and PM reflective total nasal symptom scores (TNSS) over two weeks (p<0.0001 for both doses)

•Key secondary endpoints:•Change from baseline in patient-reported AM and PM instantaneous TNSSover two weeks (p<0.0001 for both doses)

•Change from baseline in patient-reported AM and PM reflective total ocular symptom scores (P<0.001 for both doses)

•Overall adverse events for 80 mcg group and 160 mcg group comparable to placebo

OMNARIS® HFA Phase III SAR Study Results

Page 30: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

30

CD&L PrioritiesAggressively pursue corporate development and licensing opportunities

that enhance the portfolio and complement DSP’s strategic direction

STEDESA™™

Key Sepracor Partners

Corporate Development & Licensing (CD&L) Update

Out-licensed In-licensed

/ Ipratropim

Note: 3M is a technology partner of Sepracor

Page 31: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

31

Opportunities Assessed on a Non-Confidential and Detailed Basis: 281*

CDAs Executed/Detailed Evaluations of Confidential

Data: 104

Due Diligences Conducted: 34

Terms Exchanged or Bid Provided: 23

Transactions Executed: 10

*Includes products and companies, both public and private.

Current Priorities• Remain aggressive in pursuing licensing

opportunities

• Support DSP’s overall CD&L efforts

• Target attractive opportunities in CNS and other areas to complement pipeline

• Continue to build reputation as partner of choice

Current Priorities and Recent CD&L Activity (24 Months)

Page 32: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

32Financial Highlights Qtr3 and YTD 2009

Financial Update

Third Quarter 2009 Financial Results

January-September Year-to-Date 2009Financial Highlights

Page 33: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

332009 Continued Strong Non-GAAP Earnings Momentum

$0.00$0.05

$0.10

$0.15

$0.20

$0.25

$0.30

$0.35$0.40

Q3 2008 Q3 2009$0.00$0.50

$1.00

$1.50

$2.00

$2.50

$3.00

$3.50$4.00

YTD 2008 YTD 2009

$0.00

$0.50

$1.00

$1.50

$2.00

$2.50

YTD 2008 YTD 2009$0.00$0.10

$0.20

$0.30

$0.40

$0.50

$0.60

$0.70$0.80

Q3 2008 Q3 2009

Dol

lars

Non-GAAP EPS Qtr3 ‘08 vs. Qtr3 ‘09

$0.59

$0.10

Dol

lars

Non-GAAP EPS YTD ‘08 vs. YTD ‘09

$2.16

$0.70

+209%

Dol

lars

GAAP EPS Qtr3 ‘08 vs. Qtr3 ‘09

$0.25

$0.09

$3.43

$0.95

GAAP EPS YTD ‘08 vs. YTD ‘09

Dol

lars

YTD denotes January through September 30, 2009

+490%

Page 34: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

34Year-To-Date (YTD) Jan.-Sept. 30, 2009 Summary of Results (Non-GAAP)

$0.70$2.16Diluted EPS

116 M114 MShares Outstanding

9%8227%246Net Income

64%59047%435SG&A19%17817%161R&D

90%83591%843Margin

923927Revenue% of Rev.$ Millions% of Rev.$ Millions

YTD 2009 YTD 2008

Page 35: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

35Strong Balance Sheet Improvement

$-

$663 M

$186 M

$100 M

$134 M

$76 M$73 M

$48 M$46 M

Q308 Dec08 Dec08 Mar09 May09 May09 Sept Oct(est)

Oct(est)

Dec 08(2024)

Dec 08(2008)

Mar 09(2024)

Q3 08Debt

End of NovDebt

$148 M due 2010

$73 M due 2008

$442 M due 2024

w/put in 2009

No Debt by Year-

End 2009

No Debt by Year-

End 2009

Cash and short- and long-term investments were approximately $742 M at Sept. 30, 2009

Gain = $8.2 M

Gain = $4.3 MGain = $4.3 M

Gain = $0.8 M

May 09(2010)

May 09(2024)

* The remaining $186M of 2024 bonds and $100M of 2010 bonds are expected to be put back to the company in October and November respectively.

Oct 09*(2024)

Nov 09*(2010)

Page 36: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

362009 Financial Guidance Summary – Non-GAAP*

3.0%2.5%1.1%Cash Tax Rate

$148

$525 - $600

116 M

$2.10 - $2.70

$600$210

$1,150 - $1,250

Original 2009 Guidance

$550 - $600$766Cash & Equiv.

Debt (par value)

Shares Outstanding

EPS (fully diluted)

SG&AR&D

Revenue

$ in millionsexcept per share amounts

$100$530

114.5 M116 M

$2.55 - $2.90$1.63

$600$759$210$237

$1,225 - $1,275$1,292

Revised 2009 Guidance

(as of July 24, 2009)2008 Actual Results

*A reconciliation of GAAP to non-GAAP guidance calculations is located in the company’s second quarter 2009 earnings press release dated July 24, 2009, which can be found on Sepracor’s web site in the “For Investors” section.

Page 37: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

37Delivering on Our 2009 Corporate Objectives

Drive strong top-line product portfolio performance•Continued steady product performance

Generate efficiencies from corporate restructuring •Achieving cost-savings from our new commercial model

Advanced two high-priority R&D assets•Submitted STEDESA™ NDA to FDA for adjunctive treatment of epilepsy•Successfully completed OMNARIS® HFA Phase III study in seasonal allergic rhinitis and initiated Phase III perennial allergic rhinitis study in September

Aggressively pursue corporate development and licensing opportunities•Continuing to actively pursue opportunities in 2009, leveraging improved balance sheet

Deliver sustainable earnings momentum and enhanced shareholder value

•Delivering enhanced productivity and improved expense ratios

Page 38: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

38Key Benefits of DSP’s Acquisition of Sepracor

Establishes international platform • Access to fully integrated U.S. and Canadian pharmaceutical platforms

with a successful, experienced management team and talented employee base

• Extensive R&D organization with expertise in complementary therapeutic areas providing an enhanced pipeline of clinical candidates

Expands scale of pharmaceutical business• Established, successful commercial network in the U.S. and Canada• Significantly enhances sales capabilities

Reinforces product pipeline portfolio

Potential to accelerate penetration and maximize sales of lurasidone in the U.S.

Page 39: Sepracor Inc. Company Overview - November 12, 2009 · 2017-02-17 · Therapeutic Overview •Allergic Rhinitis (AR) affects 65 M people •Most patients suffer from Perennial Allergic

Page 39

Questions and Answers