Launching Oncology Therapies:

New Realities to Consider

Sujay KangoChief Commercial Officer

Infinity Pharmaceuticals, Cambridge, MA

Healthcare has improved survival:

More people living with cancer or cancer free

2

Increasing Number of Survivors in U.S.1

3

Million

in 1971

9.8

Million

in 2001

13.7Million

living with cancer

in 2012

1. Source: American Cancer Society

3

Are Today’s Treatments Enough?

• 1.6 Million New

Cases and 600,000

Deaths in 20141

• Every 10 minutes

someone in the

U.S. dies from a

blood cancer2

1. American Cancer Society; 2. Leukemia & Lymphoma Society, Facts and Statistics 2015.

• Many cancers are

still incurable e.g.

iNHL, CLL2

Over 800 Medicines in Development for Cancer1:

Majority Are Targeted Therapies

4

Bladder

Brain

Breast

Colorectal

Head & Neck

Hematological Malignancies

Kidneys

Leukemia

Liver

Lung

Lymphoma

Multiple Myeloma

Ovarian

Pancreatic

Prostate

Sarcoma

Skin

Solid Tumors

Stomach

Other

Unspecified

Medicines in Development for CancersPhase 1

Phase 2

Phase 3

Application

Submitted

1. Source: 2014 Cancer Report PhRMA.org

23

58

82

35

21

84

30

106

35

123

92

38

51

49

50

17

53

227

29

56

27

Over 70% of cancer pipeline may realize vision of

“personalized medicine”

5

73%

of cancer medicines in the

pipeline have the potential to be

personalized medicines

Personalized Medicine is Transforming Cancer Care

1. Source: 2014 Cancer Report PhRMA.org

Global Oncology Spend Reaches $100 Billion with a

modest growth of 6% over a 5 year period

6

2010-14 CAGR

Global 6.5%

2010 2011 2012 2013 2014

100

90

80

70

60

50

40

30

20

10

0

Spen

din

g U

S $

B

5.9%

15.5%

4.2%

5.8%

5.3%

US EUS Japan Pharmerging Rest of World

Source: IMS Health MDAS. Dec 2014

Global Oncology Drug Spending 2010-14

In Developed Markets Growth is driven by new

products and increased volume

7

2010 2011 2012 2013 2014

Abso

lute

Gro

wth

Const

US

$M

Protected Brands - Price

Non Original Brands

Protected Brands - Volume

Generics

LOE

Source: IMS MIDAS, Dec 2014; IMS Institute for Healthcare Informatics

Oncology Spending Growth Dynamics in Developed Markets 2010-14

OTC New Brands

10,000

8,000

6,000

4,000

2,000

0

-2,000

3,808

1,1661,350

4,5157,389

Targeted Therapies had ~double growth

(14.6% vs 6.5%) during the same period

8

2010 2011 2012 2013 2014

0

60

50

40

30

20

10

Spen

din

g U

S $

B

Developed Pharmerging Rest of World

Source: IMS Health MDAS. Dec 2014

Targeted Therapies Growth 2010-14

2010-14 CAGR

Global 14.6%

14.4%

19.0%

14.4%

Key Takeaways

• Despite significant progress, treatment advances vary across

cancer types1

– 5 year survival rate of lung cancer increased by 54% since 1975

• However, only 17.4% lung cancer patients survive at 5 years

– 5 year survival for AML is 25%

– 5 year survival for Myeloma is 46%

– 5 year survival for NHL is 70%

• Significant clinical benefit in select patient segments driven by– Targeted medicines, immuno-oncology, combinations, biomarkers

– Many molecules are in development for multiple indications including

less common malignancies

• Oncology therapies are a $100 Billion global market– Constitutes 1% of total healthcare spend

91. 2014 Cancer Report & SEER Fact Sheets 2. Global Oncology Trends Report by IMS

Key Implications To Consider

• Intensified competition—new MOAs, fast followers and or next

generation in class molecules– 45 NMEs launched 2010-2014; 10 in 2014 alone2

– Short lead time to maintain novel or in-class exclusivity

– Considerations on launch strategies and share

• Opportunities exist in oncology but successful product launches

will require:– Navigating the complex development landscape

– Changing market dynamics and

– Evolving stakeholder environment

10

Key Commercial Stakeholders:

Decision Making Influence Is Evolving

11

NEED

Informed decision

making & personal

choice

NEED

Outcome &

evidence based

partnerships

NEED

Holistic account

management and

specialized

knowledge

• NPs, PAs

• Pharmacist

• Reimbursement Mgrs

• Oncology Nurses

Community Hematologist/Oncology Practice Trends:

Evolving Dynamics Create New Opportunities

12

• Gaining therapeutic knowledge continues to be of key importance– Integrated support to improve outcomes, patient experience and

practice efficiency is welcomed

• Consolidation/Integration are rapidly changing the physician

practice – Access to industry is declining

– Practice level clinical pathways are becoming common

– 45% of practices currently use pathways for major solid tumors1

• Dispensing of specialty medicines– 33% or 1200/4200 International Oncology Network (ION) community

oncology practices result in 35,000 scripts per month2

1HIRC Market Research Report, 2014.2ION Solutions AmeriSource Bergen Company Data Presentation, 2015.

Payor Oversight Is Increasing

13

14

Common Payer Approach: Implement Pathways

Payer prioritization of tumor types for pathway implementationQ1: For which tumor types has your plan already developed pathways?

Q2: What are your plan’s next priorities for development of clinical pathways in oncology?

0

20

40

60

80

100

Breast Lung Colorectal MultipleMyeloma

Prostate MetastaticMelanoma

NonHodgkins

Lymphoma

10%

86%

33%

62%

38%

62%

19%

48%

38%

43%

29%

29%

29%

19%

Currently on Pathway High Priority for Pathway Development

15

Timeline of Targeted Opposition on Drug Pricing

CMS Pilot: Part B Payment Model Rule Proposal (released March 8, 2016 comments by May 9, 2016)

• Two phases of the proposal to be tested over next 5 years

– Phase I restructure ASP+6% payment model to ASP+2.5% plus a flat

fee of $16.80 which would increase at CPI annually

– Phase II is much broader and will test 5 value-based strategies

• discounting and eliminating cost-sharing,

• clinical decision support tool use,

• indications-based pricing,

• reference pricing, and

• manufacturer risk-sharing agreements

16

Key Global Market Access Trends

17

Reducing payer uncertainty

Innovative payment models and

Therapeutic guidelines could impact

combination therapy – even in less

restrictive markets (e.g. US)

Payers are increasing requirements on

comparator choices: H2H studies vs. SOC

“mandated” or strongly preferred

Use of RWE in absence of appropriate

comparators

Comparator selection during design of pivotal

studies needs to take into account market

access implications

Leverage indirect treatment comparisons

Evidence to justify comparator arm is key

Payers in markets with sophisticated HTAs

will only accept premium pricing for

treatments that address clear unmet needs

Showing significant OS and PFS improvements will be key. Consider alternatives for access to entire/broad population (e.g. select 1st line patients)

Payers are becoming more sophisticated in

referencing prices from a variety of countries Price bands &

Local/Reginal Strategies

Payers are concerned about the number of

branded novel agents & combination

therapies entering oncology

The economic

crisis

More refined

assessments of

added clinical

benefit

Increasing

prevalence of

structured HTA

Increasing

prevalence of

international

price

referencing

Theme ImplicationsTrend

Key Implication Of Payer/Access Trends: Pressure to

Demonstrate Value and Transparent Pricing

18

Value

Estimation

Purchase

Decision

Analysis

Global

Product

Optimization

• Create value

proposition

• Develop

initial price

assumptions

• Anticipate how

payers and other

key stakeholders

will interpret and

respond to the

value proposition

• Develop and test

initial price and

access

assumptions

• Identify and

quantify price

realization

tactics

• Provide global

pricing policy

recommendation

Patients Are Becoming More Informed

19

65% of American adults are on social media

28%71% 28% 26% 23%

Of these…

Sources: Huffington Post, Pew Research Center

75% of American adults seek health info online

Most common sources

• WebMD (56%)

• Wikipedia (31%)

• Health magazine websites (29%)

• Facebook (17%)

• YouTube (15%)

• Blog (13%)

• Patient communities (12%)

• Twitter (6%)

Sources: IMS Institute for Healthcare Informatics, Mashable

Discussion Topics by Patient Journey Stage

(Prostate Cancer Example1)

Diagnosis and Pre-

Treatment

• Tumor Markers 33%

• Skepticism 26%

• Chemo prevention 16%

• Biopsy 13%

Treatment

• Treatment Options 67%

• HCP visit 20%

• Alternative Treatments 6%

• Side Effects 6%

Living with Cancer

• Financial 43%

• Active surveillance 25%

• Emotional concerns 14%

• Informational needs 6%

22Global Oncology Trends Report 2015: IMS

Radiology exam 9%

Physical exam 3%

Remission 6%

Relapse 3%

Patient Trends and Implications

• Patient community is active and is seeking information

• Brand discussions do occur across platforms

• Patients are more empowered and beginning to shifting the

balance on decision making– Knowledge

– Increase out of pocket payments

– Co-insurance models

• Implications:– Key to understand patient needs, concerns and appropriate

engagement

23

Industry dynamics, a limited window for success, and launch uptake

correlation with long-term success increase the pressure to “get it right”

24

Impact of Year 1 on

Future Performance

73% Meet/Beat

Year 2

64% Meet/Beat

Year3

Impact of Year 1 on

Future Performance

15% Meet/Beat

Year 2

35% Meet/Beat

Year3

35%

Beat

Year 1 65%

Miss

Year 1

Though great launches often involve great products, superior launch

strategy, planning and execution always matter

Source: Evaluate Pharma World Preview. The Smart Cube. Deloitte Analysis. Revenue data obtained from DataMonitor;

forecast data obtained from analyst reports.

Note: Assessment is based on global revenue for ~50 drugs launched in 2007, 2008 and 2009 for top pharma companies

Critical to Develop Launch Strategy to Meet Today’s

Market Challenges and Opportunities

25

“Where to Play” “How to Win”

What sets of customers

should you invest in?

What should you do for

each set of customers?

Market

Definition

Business

Opportunity

Stakeholder

Prioritization

& Behavioral

Objectives

Segmentation

Desired

Customer

Experience

Value

Proposition

Positioning &

Messaging

Commercial

Model

CML Case Study:

Growth Driven by Approval of New Therapies

26

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

0

500

1,000

1,500

2,000

2,500

3,000 CML Sales (U.S.)Gleevec

Sprycel

Total Market

An

nu

al S

ale

s (

$ M

)

Source: EvaluatePharma.

June 2006

Sprycel

Launch

May 2001

Gleevec

Launch Oct 2007

Tasigna

Launch

Sep 2012

Bosulif Launch

(Ph+ CML)

Jan 2013

Iclusig Launch

Multiple Myeloma Case Study

27

“Those diagnosed in the last decade

had a 50% improvement in overall

survival (44.8 vs. 29.9 months)…we

demonstrate improved outcome of

patients with myeloma in recent years,

both in the relapsed setting as well as

at diagnosis.”

Improved survival in multiple myeloma

and the impact of novel therapiesShaji K.Kumar, S. Vincent Rajkumar, Angela Dispenzieri, Martha Q. Lacy,

Suzanne R. Hayman, Francis K. Buadi, Steven R. Zeldenrust, David Dingli,

Stephen J.Russell, John A. Lust, Philip R. Greipp, Robert A. Kyle, and Morie A. Gertz

Summary

• Opportunities exist in oncology therapy to meet unmet medical

needs BUT vary across malignancies

• Shape development plan early to ensure the program data will

meet or exceed high bar

• Stakeholder dynamics have evolved

• Revise the launch play book– Opportunity to apply lessons from EU & other HTA markets as US

market beginning to seek value-based arrangements

– Prioritize timing, investment mix and stakeholder plans

• Short exclusive time prior to competitive entrants gain market authorizations

• Traditional model of go-to-market and or HCP engagement may not be predictive

28

BACK UPS>>>>

29

Developing customer models guide us in identifying required

launch capabilities and matching the right resources

30

The Go-to-Market Model will be executed in a structured process of designing the customer engagement

model, defining the capabilities and resources required, and finally determining metrics

NAMD Letter to Congress – October 28, 2014

31

“Congress can exert downward

pricing on Sovaldi and similarly-

priced specialty drugs targeting

large patient populations. While

we recognize that direct price

controls would be a politically

volatile topic which could be

expected to encounter

substantial pushback, a strong

case can be made for the unique

circumstances of hepatitis C in

particular.”

Prices are reflective of multiple factors including clinical

value; these drivers are magnified in the biotech space

32

While a wide global price corridor is not unusual, issues like

international reference pricing are integral to global optimization

33

Sources: Database from Client, Redbook, FDA, The Medical Letter (http://secure.medicalletter.org/w1394d), NCI secondary research

PNH - Paroxysmal Nocturnal Hemoglobinuria HAE - Hereditary Angioedema SBS – Short Bowel Syndrome CF – Cystic Fibrosis

* Hemophilia prices are challenging to analyze based on wide variations in dosing and compliance with prophylactic treatments

Value

Estimation

Purchase Decision

Analysis

Global Product

Optimization

While a wide global price corridor is not unusual, issues like

international reference pricing are integral to global optimization

34

Source: IMS MIDAS, IMS Lifecycle, Price RX, l’Assurance Maladie, Lauer-Taxe, Gazzetta Ufficiale, BotPlusNet, MIMS and

Vertex research. Prices used in the calculation are for a course of therapy or annual, if chronic. Prices are current for EU

(assume relatively unchanged over time). For US: *Launch price or oldest Price RX value. † US WAC at launch, less than price

in some EU countries, but has risen 50% since launch (note also likely heavy net discounting in EU). FX rates also a factor

Value

Estimation

Purchase Decision

Analysis

Global Product

Optimization