final orex 1 q16 deck 5 4 16 final
TRANSCRIPT
For investor purposes only
Orexigen First Quarter 2016
Earnings Conference Call
May 4th 2016
For investor purposes only
Forward Looking Statements
This presentation contains forward-looking statements about Orexigen Therapeutics, Inc. and Contrave®. Words such as “believes,” “anticipates,”
“plans,” “expects,” “indicates,” “will,” “should,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify
forward‐looking statements. These statements are based on the Company‘s current beliefs and expectations. These forward‐looking statements include
statements regarding: the potential for greater profitability and shareholder value through the sole ownership of U.S. rights to commercialize Contrave®
in the United States; the potential success of marketing and commercialization of Contrave in the United States; the potential for Contrave and
Mysimba® to achieve commercial success globally; the potential for Orexigen to enter into successful partnership arrangements for Contrave/Mysimba
in additional territories outside the United States; the potential growth of the anti-obesity market through 2018 and the potential growth of Orexigen’s
share of such market through 2018; the potential improvement in profitability per Contrave prescription by 2018; the potential for the Company to be
profitable by 2019; the potential for Orexigen to achieve commercial success for Contrave in the United States without a partner; the potential for
Contrave to achieve the prescription and profitability models in 2017 and 2018; the sales force capacity for Contrave; the Company’s strategic plans
and initiatives; and the potential to maintain and strengthen the intellectual property protection for Contrave/Mysimba globally. The inclusion of financial
modeling, forward‐looking statements and potential financing and transaction plans and terms should not be regarded as a representation by Orexigen
that any of its plans will be achieved. Actual results may differ materially from those expressed or implied in this presentation due to the risk and
uncertainties inherent in the Orexigen business, including, without limitation: our ability to successfully and timely transition the commercialization and
development responsibilities for Contrave from Takeda to the Company; the potential that the marketing and commercialization of Contrave/Mysimba
will not be successful, particularly, with respect to Contrave, in the U.S. following the transition from Takeda; the Company’s ability to obtain
partnerships and marketing authorization globally; additional analysis of the interim results or the final data from the terminated Light Study, including
safety-related data, and the additional CVOT may produce negative or inconclusive results, or may be inconsistent with the conclusion that the interim
analysis was successful; our ability to adequately inform consumers about Contrave; our ability to successfully commercialize Contrave with a specialty
sales force in the United States; the therapeutic and commercial value of Contrave/Mysimba; competition in the global obesity market, particularly from
existing therapies; the Company’s failure to successfully acquire, develop and market additional product candidates or approved products; the
estimates of the capacity of manufacturing and the company’s ability to secure additional manufacturing capabilities; our ability to obtain and maintain
global intellectual property protection for Contrave and Mysimba; legal or regulatory proceedings against Orexigen, as well as potential reputational
harm, as a result of misleading public claims about Orexigen; our ability to maintain sufficient capital to fund our operations for the foreseeable future;
the potential for a Delaware court to determine that one or more of the patents are not valid or that Actavis' proposed generic product is not infringing
each of the patents at issue; and other risks described in Orexigen’s filings with the Securities and Exchange Commission. You are cautioned not to
place undue reliance on these forward‐looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or
update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under
the heading "Risk Factors" in Orexigen's Current Report on Form 10-K filed with the Securities and Exchange Commission on February 26, 2016 and
its other reports, which are available from the SEC's website (www.sec.gov) and on Orexigen's website (www.orexigen.com) under the heading
"Investors." All forward‐looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor
provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
2
For investor purposes only
Indicated for use as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. Approved with the brand name Contrave® in the United States and Mysimba® in the European Union.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND
NEUROPSYCHIATRIC REACTIONS
Suicidality and Antidepressant Drugs
Not approved for use in the treatment of major depressive disorder or
other psychiatric disorders. Contains bupropion, the same active
ingredient as some other antidepressant medications (including, but not
limited to, WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, and
APLENZIN). Antidepressants increased the risk of suicidal thoughts and
behavior in children, adolescents, and young adults in short-term trials.
These trials did not show an increase in the risk of suicidal thoughts and
behavior with antidepressant use in subjects over age 24; there was a
reduction in risk with antidepressant use in subjects aged 65 and older.
In patients of all ages, monitor closely for worsening, and for the
emergence of suicidal thoughts and behaviors. Advise families and
caregivers of the need for close observation and communication with the
prescriber. Not approved for use in pediatric patients.
Neuropsychiatric Reactions in Patients Taking Bupropion for Smoking
Cessation
Serious neuropsychiatric reactions have occurred in patients taking
bupropion for smoking cessation. The majority of these reactions
occurred during bupropion treatment, but some occurred in the context
of discontinuing treatment. In many cases, a causal relationship to
bupropion treatment is not certain, because depressed mood may be a
symptom of nicotine withdrawal. However, some of the cases occurred
in patients taking bupropion who continued to smoke. Although not
approved for smoking cessation, observe all patients for
neuropsychiatric reactions. Instruct the patient to contact a healthcare
provider if such reactions occur.
Full Prescribing Information, including Medication Guide, for Contrave is available at http://www.contrave.com/. The Mysimba summary of product characteristics is available at ema.europe.eu.
3
®
For investor purposes only
Agenda
4
Mike Narachi, CEO
Overview of Recent Business Highlights
Dr. Tom Cannell, Executive VP and Chief Commercial Officer
U.S. Commercial Opportunity
Dr. Preston Klassen, Executive VP Global Development,
Overview of Postmarketing Development Programs
Jason Keyes, VP Finance
Q1 Financial Results & Guidance
For investor purposes only
Mike Narachi, CEO
Overview of Recent Business
Highlights
For investor purposes only
Orexigen is acquiring all U.S. rights to Contrave
Rare opportunity for non-competitive acquisition of most prescribed brand in a growing market at an ideal point in the product’s life cycle
Acquisition of U.S. rights significantly magnifies projected long-term profitability and opens multiple paths to shareholder value creation
U.S. commercialization of Contrave funded by sale of $165 million in convertible senior secured notes to investor syndicate led by The BaupostGroup L.L.C.
Orexigen believes that with this investment the company has sufficient capital to fund its US commercialization plan for Contrave and to achieve projected profitability for full year 2019
6
Acquisition of U.S. Contrave® (naltrexone HCl / bupropion HCl) rights transformational for Orexigen
For investor purposes only
Acquiring Contrave rights at this point in the product’s lifecycle is a tremendous opportunity
Takeda’s heavy investment in the launch yielded a great starting point for Orexigen
– 100,000 HCP’s have been called on to date, 1.1 million details delivered
– Many well trained speakers delivered hundreds of speaker programs to 25,000 program attendees
– Over 62,000 unique Contrave prescribers, 942,977 prescriptions filled
– High levels of aided and unaided awareness of Contrave
– Contrave is the leading national branded weight loss medicine
Highly valuable information from real market data is available to guide the next phase of commercialization
– Adoption patterns, promotion response, customer buying process, micro-segmenting, price-demand elasticity
7
For investor purposes only
Valeant commercialization and distributorship agreement for Central and Eastern Europe
Terms of the agreement
Valeant to commercialize and distribute Mysimba® in 19 Central and Eastern European countries
Orexigen to sell Valeant Mysimbatablets at agreed transfer price
Anticipate Q3 2016 commercial launch in five (of 19 partnered) countries
– Valeant placed their first firm order for Mysimba tablets
Agreement is with Orexigen Therapeutics Ireland Limited
8
For investor purposes only
Kwang Dong Distributorship Agreement is example of Orexigen’s preferred ROW partnership strategy
Terms of the agreement
Kwang Dong is responsible for obtaining regulatory approval and for all commercialization activities and expenses in South Korea
Orexigen will supply Contrave tablets to Kwang Dong for a $7 million upfront payment, approximately 35 – 40% of net sales, potential sales-based milestone payments, and other fees
Regulatory approval obtained in April 2016
– In anticipation of a commercial launch this quarter, Orexigen has shipped an initial order of Contrave tablets to Kwang Dong
– This shipment and a subsequent firm order for later in 2016 have a combined value to Orexigen of approximately $5.9 million
Agreement is with Orexigen Therapeutics Ireland Limited
9
For investor purposes only
Broad and Growing Patent Estate
2034
2031
2032
2029
2027
2027/29
2024
2024/25
Binge Eating (methods)
Major Depression (methods)
Visceral Fat (methods)
Titration (methods)
Tri-layer tablet (methods & compositions)
Insulin Sensitivity (methods & compositions)
Weber / Cowley (methods & compositions)
Pending Issued in some territories, pending in others
2030Nal SR Dissolution Profile (methods & compositions)
Dates reflect US patent expiration
Cardiovascular outcomes (methods)
Major Depression (methods)
10
2031Food Effect (methods)
For investor purposes only
Dr. Tom Cannell, Executive VP and Chief
Commercial Officer
U.S. Commercial Opportunity
For investor purposes only
600
700
800
900
1,000
1,100
1,200
1,300
Jan2014
Apr2014
Jul2014
Oct2014
Jan2015
Apr2015
Jul2015
Oct2015
Jan2016
Apr2016
Jul2016
Oct2016
Jan2017
Apr2017
Jul2017
Oct2017
Jan2018
Apr2018
Jul2018
Oct2018
TR
xs
Th
ou
sa
nd
s
Optimistic Pessimistic History
Source: IMS Monthly NPA; Orexigen estimates.Note: Anti-obesity products considered included Contrave®, Belviq®, Qysmia®, Saxenda®, Orlistat®, Phentermines and other generics in the ATC3 A08A market.
Anti-obesity market TRx forecast
+4%
+4%
2015 2016 2017 20182014
+10%9.4M
+12%
10.5M
+10%11.5M
10.8M
+10%12.6M
+4%11.4M
+10%13.9M
11.8M
We project 4-10% overall market growth
Upper Bound of Range Lower Bound of Range Historical
12
For investor purposes only
0%
2%
4%
6%
8%
10%
12%
14%
16%
Oct2014
Dec2014
Feb2015
Apr2015
Jun2015
Aug2015
Oct2015
Dec2015
Feb2016
Apr2016
Jun2016
Aug2016
Oct2016
Dec2016
Feb2017
Apr2017
Jun2017
Aug2017
Oct2017
Dec2017
Feb2018
Apr2018
Jun2018
Aug2018
Oct2018
Dec2018
TR
x S
ha
re
Optimistic Pessimistic History
13
0.4%
6.4%7.3%
7.2%
8.7%
7.6%
11.0%
10.0%
Source: IMS Monthly NPA; Orexigen estimates
2015 2016 2017 20182014
Contrave share forecast
We project 10-11% share by 2018
Upper Bound of Range Lower Bound of Range Historical
For investor purposes only
0
20
40
60
80
100
120
140
160
Oct2014
Dec2014
Feb2015
Apr2015
Jun2015
Aug2015
Oct2015
Dec2015
Feb2016
Apr2016
Jun2016
Aug2016
Oct2016
Dec2016
Feb2017
Apr2017
Jun2017
Aug2017
Oct2017
Dec2017
Feb2018
Apr2018
Jun2018
Aug2018
Oct2018
Dec2018
TR
xs
Th
ou
sa
nd
s
Optimistic Pessimistic History
14Source: IMS Monthly NPA; Orexigen estimatesNote: Values rounded.
Contrave TRx forecast
+25%
+33%
+39%
+20%
+19%
+21%830K
780K
1,110K
870K
1,540K
1,190K
Contrave TRx scenarios driven by market and share assumptions
2015 2016 2017 20182014
Upper Bound of Range Lower Bound of Range Historical
665k
For investor purposes only
U.S. Commercial Summary
15
Launch an effective and efficient U.S. commercial organization
1 Achieve strong growth of Contrave by differentiating versus generic amphetamines
2
Ex
ecu
tio
n
ex
ce
lle
nce
Improve G:N ratio through appropriate discount and pricing strategies
3
Inn
ova
tio
n Activate patients to drive proactive requests for new anti-obesity medicines
4 Leverage behavior modification to improve persistency and compliance
5 Drive reimbursement upside through innovative contracting strategies
6
Sources of Opportunity (Represent significant upside above guidance range)
Path to Profitability (Core strategies designed to drive guidance range)
For investor purposes only
Product lifecycles follow predictable phases
16
Sale
s
Time
Launch
Growth
Maintain
Maximize Profit
Launch an effective and efficient U.S. commercial organization
1
For investor purposes only
Case Study – Proscar (finasteride): Transition from a primary care sales force to a specialist organization
17
0
50
100
150
200
250
300
350
400
0
500
1,000
1,500
2,000
2,500
3,000
1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004
De
tail
s (
in 0
00
’s)
Pro
sca
rT
Rx
(in
00
0’s
)
TRx
DetailsAvg. 5.2
min/detail
Avg. 8.5
min/ detail
Relaunch
Sources: TRx - IMS Health Launch MVPDetails and Minutes - Encuity Research, Based on research panel using actual reported numbers. Established data collection since 1989 for the collection of reported interactions. Average minutes per detail based on total reported minutes divided per total reported detailsNote: Proscar launched 6/1992, LOE: 6/2006
63% increase
minutes/detail
Launch an effective and efficient U.S. commercial organization
1
Primary Care Specialty
For investor purposes only
We project a significant increase in time and quality with the right 18,000 physicians
18
Primary Care Sales Force
Dedicated SpecialtySales Force
Product discussions shared with 2-3 other products in portfolio
Single product discussions
Time Spent on Contrave
Source: Orexigen EstimatesNote: Estimated capacity allocation based on 2016 Contrave Co-Promo PDE commitments.
Launch an effective and efficient U.S. commercial organization
1
35% of 600K PDEs Estimated Capacity
Product Discussions
+7%
210,000224,000
Significant increase
in min/detail
For investor purposes only
Orexigen Commercial Leadership Team
19
Thomas Cannell
Executive Vice President
Chief Commercial Officer
2014 – 2015: Head, Global Human Health Operating Model
2012 – 2014: President & Managing Director, Canada
2010 – 2012: Chief Marketing Officer & Chief Strategy Officer, Japan
2008 – 2010: Senior Vice President, Head of U.S. Commercial Model
2006 – 2008: Senior Vice President and General Manager
2003 – 2006: Vice President, Sales
2001 – 2003: Executive Director, Marketing
1998 – 2001: National Sales Director
1994 – 1996: Regional Sales Director
1992 – 1994: Product Manager
1989 – 1992: Progressive Roles in Market Research & Strategic Planning
1987 – 1989: Sales Representative
Elizabeth Eastland
Vice President
Sales
2015 – 2016: Regional Business Leader
2012 – 2015: Executive Director, Marketing & Global Operations Roles
2008 – 2012: Director, Commercial Operations
2007 – 2008: Senior Director, Strategic Planning, New Commercial Model
2003 – 2007: Progressive U.S. Regional Sales Roles
1996 – 2003: Progressive Primary Care, Specialty & Managed Markets Roles
1989 – 1996: Progressive Marketing, Sales, and Communications Roles
Robert Griffing
Senior Vice President
Global Marketing
2013 – 2015: Vice President, Global Sale & Marketing
2012 – 2013: Vice President, Commercial Operations
2010 – 2012: National Sales Leader
2007 – 2010: Global Brand Leader
2005 – 2007: Senior Director, New Products
2003 – 2005: Senior Regional Business Director
1998 – 2003: Progressive Specialty & Primary Care Marketing Roles
1990 – 1998: Progressive Primary Care & Hospital Sales Roles
Brian Longstreet
Senior Vice President
Global Market Access and Development
2012 – 2016: Managing Director, MSD Ireland & Global Health Innovation Investment Fund
2010 – 2012: Vice President, Commercial Operations
2009 – 2010: Vice President, Managed Markets & Policy
2008 – 2009: Vice President, U.S. Managed Markets – Healthcare Systems
2005 – 2008: Executive Director, U.S. Managed Markets
2001 – 2005: Progressive U.S. Marketing Roles
1999 – 2001: Business Unit Director, United Kingdom
1989 – 1999: Progressive Specialty & Primary Care Sales and Managed Market Roles
Robert Yoder
Senior Vice President
Global Commercial Operations
2014 – 2015: Vice President, US Sales Operations
2013 – 2014: Vice President, Commercial Operations
2010 – 2013: Executive Director, Global Business Operations
2008 – 2010: Senior Director, National Business Planning
2007 – 2008: Senior Director, Field Operations & Implementation
2005 - 2007: Senior Region Director, Specialty and Hospital Sales
2000 – 2005: Director, Regional Business Planning
1987 – 2000: Progressive Sales and Sales Support Roles
Launch an effective and efficient U.S. commercial organization
1
For investor purposes only
15 Regional Sales Managers Hired
20Note: 1. Hiring of Regional Sales Managers is in the final stages; 2. Aggregate experience is over 300 years in sales across 15 RSMs.
Launch an effective and efficient U.S. commercial organization
1
21 average years of experience2
For investor purposes only
Leveraging Strategic Commercial Partners inVentiv Health
21
Launch an effective and efficient U.S. commercial organization
1
Sourcing,Recruiting &
Training
Sales Ops Support
CRM & Commercial
Systems
Fleet, Field Logistics
Hardware & Helpdesk
Commercial Call Center
• Experience: Previous experience with Orexigen leadership
• Small Pharma Support: Flexible with ability to work through unique needs of small pharma
• Proven Record: Proven track record and implementation experience
• Speed: Ability to move and build quickly as well as toggle to meet market needs
• Infrastructure: Leverage their existing commercial support framework
Advantages of Partnership Services Provided
For investor purposes only 22
Critical Path for U.S. Commercialization
Launch an effective and efficient U.S. commercial organization
1
Jan Feb Mar Apr May Jun Jul Aug Sep Oct
Rep
Cust
om
er
Faci
ng
Key E
nable
rsFoundation S
erv
ices
H.S.AH.S.A in Field | KOL Management
MCM
Gross2Net
Patient Education
Brand Strategy
B-MOD
Med Service
Supply Chain
Managed Markets
Pricing, HECON
Med Ed | Speaker Program
Quality
Strategy Sr Director interview
H.S.A Maps & Recruiting Cities
H.S.A Recruiting
H.S.A. Onboarding
H.S.A. Interviews Job Offers
Sr DrHired
SFSS Mgr Recruiting MgrInterviews
Rep Recruiting Cities
MgrHired Interviews Job Offers
KOL Lists
Rep in FieldRepOnboarding
Regulatory
MapsTargets
VP Interview
StrategyData Purchase MCM Plan
Acct Strategy
National Tiering MCM Tactics Call Center Build HCP TieringCall Center Live Tactics Phase II
Savings CardMarket Research
UnbrandedAgency RFP
Strategy
CTM Plan3PL RFP
State LicensePlanTrade Plan
NDA|IND Transferred to OREX
Speaker Bureau Selection
Speaker Selection & contracting
Speaker Training Programs Live
Market Research
3PL Selection
Distributor Contracts (Top 4)
Product at 3PL 1st
Shipment
Distributor Contracts (Others)
Regulatory Plan
MLR Committee
Rep Recruiting
AE Onboarding
Acct Transition
AERecruiting
1st Orex Labeled Product
Market Research Results HCP Phase II PlanPatientRFP
Launch Resource Plan
AOR RFP Patient Ed Plan
VP Hired
Nat’l Ad Board
Speaker Notification of TransitionMed Ed Strategy
PMR Requirements to FDA
PDAR Safety ReportPDAR SafetyReport
Speaker BureauRFP
Med Ed Policies
BrandPosition & Messaging
AORBranded MaterialsUnbranded Mtls
PDAR Quarterly Safety Report
1st OPDP Promo Mtl Submission
Contracts Transitioned
GMP Internal Audit
EDMS Go Live
Product Recall Vendor
Medical Call Center (MCC) Vendor
Selected
MCC Kick Off
MCC | PV LiveMed Info Processing
Safety DB Vendor Selected Medical/Safety
SOPs
BMOD Program
Patient Ed CampaignAOR Selection
Product Complaint Receipt & Processing
2017 Pricing Strategy
PRE-CLOSE TRANSITION RELAUNCH
Prepared for a
3Q Relaunch
For investor purposes only
Our engagement strategy will span multiple channels with commensurate level of investment per HCP
23
Targeted E-mail
Speaker Programs
Online Samples
Digital Campaign
Non-target Prescribers(~163,000)
Primary Targets(~18,000)
KOLs(~200)
• Account follow up as directed by field
• Coverage of vacancies
• Outbound calls & prospecting
• MCM programs and Digital campaigns
• Speaker programs• Community of practice
KOL influence• On-line sample access• Attendance at society
meetings
• Speaker support• Account follow up as
directed by field
• Engages key leaders in support of shared objectives
• Exhibits and society meeting participation
Field Sales Reps
Health Science Associates
Personal Promotion
MCM/Call CenterProfessional
Relations
Incre
asin
g in
ve
stm
en
t p
er
HC
P e
ng
ag
em
en
t
MCM Targets(~20,000)
Increasing call frequency
Tier 1
Tier 2
Tier 3
Non-personal Only1
Note: 1. Non-personal programs will overlap and may also cover Primary Targets
Launch an effective and efficient U.S. commercial organization
1
For investor purposes only
MCM Strategy
24
~20,000 MCM Targets
Benefits Realized
Increased HCP-specific engagement
Increased Contrave Prescriptions
Increased conversion to primary targets
Low initial investment with risk-sharing
Pre-existing relationships with HCPs
Access and expertise with various media
Proprietary engagement tools
MCM Contrave brand team
Our partner will use their existing network and platforms to increase the credibility of Contrave among target HCPs and drive use
Launch an effective and efficient U.S. commercial organization
1
Partner Attributes
• Digital campaigns• E-campaigns• Personalized portals• Speaker programs• Online samples
For investor purposes only
U.S. Commercial Summary
25
Launch an effective and efficient U.S. commercial organization
1 Achieve strong growth of Contrave by differentiating versus generic amphetamines
2
Ex
ecu
tio
n
ex
ce
lle
nce
Improve G:N ratio through appropriate discount and pricing strategies
3
Inn
ova
tio
n
Activate patients to drive proactive requests for new anti-obesity medicines
4 Leverage behavior modification to improve persistency and compliance
5 Drive reimbursement upside through innovative contracting strategies
6
Potential Upsides
Path to Profitability
For investor purposes only 26
Hypothalamus and Reward System
HypothalamusAppetite Regulatory Center
• Body temperature
• Thirst
• Sleep
• Hunger
Mesolimbic Dopamine CircuitReward System
• Opioid addiction / dependence
• Alcohol abuse / dependence
• Nicotine addiction / dependence
• Food cravings
Nonclinical studies suggest that naltrexone and bupropion have effects on two separate areas of the brain involved in the regulation of food intake: the hypothalamus (appetite regulatory center) and the mesolimbic dopamine circuit (reward system). The exact neurochemical effects of CONTRAVE® leading to weight loss are not fully understood.1
Source: 1. Contrave Package Insert.Note: For illustrative purposes only.
Contrave Prescribing Information
Achieve strong growth of Contrave by differentiating versus generic phentermines
2
For investor purposes only
Product attributes in the PIs may provide a key source of differentiation
27
The efficacy and safety of Contrave and phentermine have not been evaluated in a head-to-head clinical study.Source: 1. FDA Package Inserts for Contrave and phentermine; 2. U.S. Department of Health and Human Services, Center for Substance Abuse Treatment, Treatment Improvement Protocol Series 37 (2008); 3. U.S. Department of Justice, Drug Enforcement AdministrationOrange Book (February 2016); 4. Table adapted from the Drug Enforcement Agency (Drug Scheduling). Please see the PI for the complete indication.
Achieve strong growth of Contrave by differentiating versus generic phentermines
2
Contrave• Indicated as an adjunct to a reduced
calorie diet and increased physical activity for chronic weight management
Phentermine• A sympathomimetic amine anorectic
indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction
Weight Loss Adjunct Therapy
Contrave• Affects two separate areas of the
brain involved in the regulation of food intake (hypothalamus and reward system) based on nonclinical studies
Phentermine• Not established as a appetite
suppressant as other CNS or metabolic effects may be involved
Obesity Mechanism of Action
Contrave• Components not classified as
Schedule I to IV drugs
Phentermine• Related chemically and
pharmalogically to amphetamine and other stimulant drugs that have been extensively abused; a schedule IV substance1,2
Drug Class
No Medical Use Medical Use
Lack of accepted safety under
medical supervision
Schedule I Schedule II Schedule III Schedule IV Schedule V
HeroinLSD
OxycodoneHydromorphoneCocaineMethamphetamine
Opioids (Codeine combinations)KetamineAnabolic Steroids
DiazepamPhentermineFlenfluramineNiravam
Opioids (in limited quantities)DifenoxinPregabalinLacosamide
Psychological or Physical Dependence
For investor purposes only
OOP for patients with 3rd party coverage
28
Achieve strong growth of Contrave by differentiating versus generic phentermines
2
Commercial Pay
Phentermine $241
Contrave® $301,2
Belviq®* $503
Qysimia®* $603
Note: *All Belviq and Qsymia patients eligible for free trial (15 and 14 days respectively); 1. Average patient cost; 2. Effective April 29, 2016; 3. Monthly cost illustration based on current CVS retail price as of January 2016.
For investor purposes only
U.S. Commercial Summary
29
Launch an effective and efficient U.S. commercial organization
1 Achieve strong growth of Contrave by differentiating versus generic amphetamines
2
Ex
ecu
tio
n
ex
ce
lle
nce
Improve G:N ratio through appropriate discount and pricing strategies
3
Inn
ova
tio
n
Activate patients to drive proactive requests for new anti-obesity medicines
4 Leverage behavior modification to improve persistency and compliance
5 Drive reimbursement upside through innovative contracting strategies
6
Potential Upsides
Path to Profitability
For investor purposes only
G:N Discount Expected to Improve to 40-45% by 2018
30
Estimated Revenue Captured Estimated Discount
Cash Pay
Commercial Pay
1Q2016 2H2016 (proj.) 2017 (proj.)
Wit
h S
avin
gs C
ard
Wit
ho
ut
Sa
vin
gs
Ca
rd
Cash Pay
Commercial Pay
70% 64% 62%
7% 9% 10%
9% 11% 12%
14% 16% 16%
% Estimated Patient Mix by Segment by Year
Improve G:N ratio through appropriate discount and pricing strategies
3
2018 (proj.)
60%
11%
14%
15%
Source: Orexigen estimates
For investor purposes only
U.S. Commercial Summary
31
Launch an effective and efficient U.S. commercial organization
1 Achieve strong growth of Contrave by differentiating versus generic amphetamines
2
Ex
ecu
tio
n
ex
ce
lle
nce
Improve G:N ratio through appropriate discount and pricing strategies
3
Inn
ova
tio
n
Activate patients to drive proactive requests for new anti-obesity medicines
4 Leverage behavior modification to improve persistency and compliance
5 Drive reimbursement upside through innovative contracting strategies
6
Potential Upsides
Path to Profitability
For investor purposes only
112.3M Addressable market1
We focus on high value motivated, help-seeking, and committed patients to enable their weight loss journey
32
Patients are seen as motivated when they recognize that they are overweight and want to lose weight
46.1M Motivated patients
20.6M Motivated &
Help-seeking patients
14.1M Motivated, Help-
seeking, & Committed
patients
Motivated
Patients are seen as help-seeking when they visit a HCP specifically for weight
Motivated & Help-seeking
Motivated, Help-seeking, & Committed
Patients are seen as committed when they have tried diet and exercise
Note: 1. This consists of Orexigen models driven by people in the United States who have a BMI greater than 30 or a BMI between 27 and 30 who have at least one weight-related comorbidity based on WHO data.
Activate patients to drive proactive requests for new anti-obesity medicines
4
For investor purposes only
Patient insight: two separate areas of the brain are involved in the regulation of food intake
33
Objective: encourage patients to ask their doctor about new Rx medicines
that might be right for them
hypothalamus (appetite regulatory center)
mesolimbic dopamine circuit (reward system)
Activate patients to drive proactive requests for new anti-obesity medicines
4
For investor purposes only 34
Activate patients to drive proactive requests for new anti-obesity medicines
4
Early DTC Concepts – example of creative going to first round of market research
WIP
For investor purposes only
U.S. Commercial Summary
35
Launch an effective and efficient U.S. commercial organization for Contrave
1 Achieve strong growth of Contrave by differentiating versus generic amphetamines
2
Ex
ecu
tio
n
ex
ce
lle
nce
Improve G:N ratio through appropriate discount and pricing strategies
3
Inn
ova
tio
n
Activate patients to drive proactive requests for new anti-obesity medicines
4 Leverage behavior modification to improve persistency and compliance
5 Drive reimbursement upside through innovative contracting strategies
6
Potential Upsides
Path to Profitability
For investor purposes only
Complementary approach to behavior modification strategy will foster sustainable weight loss while improving persistency and compliance
36
Key Criteria for an Optimal BMOD Program
Exercise
BMOD
Diet
• Simple, easy to follow plan with individualized solutions
• Builds skills that lead to lifetime behavior changes
• Fosters personal accountability
• Significant short and long-term weight loss
• Helps patients maintain their diet and increase physical
activity to maintain weight loss
• Nutritional tips and diet to allow the patient to remain full
and avoid cravings (e.g., competency in making appropriate
food choices)
• Strategies for addressing real-world social challenges
• Coaches that motivate and support the patient through the
journey and strengthen the skills needed to lose weight
• Proven lifestyle-change techniques and supported by clinical
studies
Leverage behavior modification to improve persistency and compliance
5
For investor purposes only
U.S. Commercial Summary
37
Launch an effective and efficient U.S. commercial organization
1 Achieve strong growth of Contrave by differentiating versus generic amphetamines
2
Ex
ecu
tio
n
ex
ce
lle
nce
Improve G:N ratio through appropriate discount and pricing strategies
3
Inn
ova
tio
n
Activate patients to drive proactive requests for new anti-obesity medicines
4 Leverage behavior modification to improve persistency and compliance
5 Drive reimbursement upside through innovative contracting strategies
6
Potential Upsides
Path to Profitability
For investor purposes only
Evolving U.S. Managed Markets Contracting Strategies will maximize access and drive profitable demand
38
Phase II
Two-phase approach to maximize access & reimbursement within U.S. Managed Markets
• Gain/Maintain parity with other branded agents
• Focus on open access and typically Tier 3 coverage
• Opportunistically target opportunities in an evolving marketplace
• Leverage branded-leader status to strive for low branded co-pay status and broader reimbursement
• Develop and implement more innovative contracting approaches including partnering (HECON, risk-sharing, adherence/persistency initiatives)
• Increased emphasis on other Customer segments (employers, specialty clinics & pharmacies, and integrated delivery network, etc.)
Phase I Phase II
Develop a customized solution for each payer
Drive reimbursement upside through innovative contracting strategies
6
For investor purposes only
24.6%
41.6%
25.1%
8.6%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
Bra
nd
ed
Ma
rke
t S
ha
re
Branded share dominance is a platform for future success
39
Contrave
Belviq
Qsymia
Saxenda
Branded Anti-obesity Market – Weekly Share
Source: IMS Weekly NPA (Week Ending: April 15, 2016).
Drive reimbursement upside through innovative contracting strategies
6
For investor purposes only
U.S. Commercial Summary
40
Launch an effective and efficient U.S. commercial organization
1 Achieve strong growth of Contrave by differentiating versus generic amphetamines
2
Ex
ecu
tio
n
ex
ce
lle
nce
Improve G:N ratio through appropriate discount and pricing strategies
3
Inn
ova
tio
n
Activate patients to drive proactive requests for new anti-obesity medicines
4 Leverage behavior modification to improve persistency and compliance
5 Drive reimbursement upside through innovative contracting strategies
6
Potential Upsides
Path to Profitability
For investor purposes only
Dr. Preston Klassen, Executive VP
Global Development
Overview of Postmarketing
Development Programs
For investor purposes only
Managing all Postmarketing Development Program Requirements to FDA Final Report Study Deadlines
42
PMR 2017 2018 2019 2020 2021 2022 2024
DDI x
Juvenile Tox x
TQT x
Renal PK x
BE – Pediatric Formulation x
Hepatic PK x
Pediatric Phase III (Adolescents) x
Adolescent PK x
Drug Utilization x
Observational Database x
CVOT-2 x
Pediatric PK (Children) x
Pediatric Phase III (Children) x
For investor purposes only
Jason Keyes, VP Finance
Q1 Financial Results & Guidance
For investor purposes only
First Quarter 2016 Financial Results
44
Revenue of $5.0 million, including $2.6 million in royalties on net sales of Contrave and $2.4 million in collaborative income
Total operating expenses for the first quarter of 2016 were $28.4 million compared to $19.8 million for the first quarter of 2015
$233.1 million in cash, cash equivalents, restricted cash, and an additional $59.1 million in marketable securities, for a total of $292.2 million, as of March 31, 2016
For investor purposes only
Path to Profitability: Growing US and OUS gross profits expected to exceed operating expenses in full year 2019
45
Global gross profit expected to exceed $180 – 200M operating expenses by 2019
US gross profit of $140 – 230M
US Contrave net sales of $160 – 260M
OUS gross profit potential > $40M with expected launches
Kwang Dong to launch in South Korea 2Q 2016
Valeant expected to launch in Central and Eastern Europe in 3Q 2016
Additional OUS partnerships expected in 2016 and 2017: other EU countries, Mexico, Australia, Canada, Middle East and North Africa, Brazil
Gross Profit Expenses Total annual cash operating expenses of $180
– 200M in years 2017 - 2019
Sales & Marketing costs $80 – 100M per year
$35 – 45M in total marketing spend including potential DTC
External R&D costs for postmarketing studies
2016 – 2017: $15 – 20M per year
2018 – 2021: $50M average per year, driven by the CVOT
R&D costs significantly decrease after 2021
Balance of expenses associated with global manufacturing & supply chain, quality, regulatory affairs & safety, and administration
Expected to decline over time
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