Sandoz Company Presentation

44
Pioneering novel ways to drive access to medicine Company Presentation December 2016

Transcript of Sandoz Company Presentation

Page 1: Sandoz Company Presentation

Pioneering novel ways to

drive access to medicine

Company Presentation

December 2016

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Sandoz InternationalBusiness Use Only2

Sandoz reached 520

million patients

worldwide in 2015 and

we aspire to reach

ONE BILLION

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Sandoz International

Agenda

1. The global access challenge

2. Reaching patients worldwide

3. Leading where it matters

4. Targeting those in need

5. Uniquely positioned to win

6. Back-up slides

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The global access challenge

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Sustainable universal access is a

key global healthcare objective

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>400m >2 billion

~2 million

# of people who lack access

to essential health services

# of people who cannot access

the medicines they need

# of preventable deaths every year

due to tuberculosis and malaria

7.35 trillion

Global cost of healthcare (2013):

Almost double the amount spent

in 2000

Source: WHO: Health in 2015; Access to Medicine Index 2015

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Growing Populations

The global population continues to

grow...

6

+1bn

About 8.5 billion people are

expected to inhabit the planet

by the year 2030

2030by

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Rapid Aging

... and the world is also getting

older...

7

+500m

About 1.4 billion people worldwide are

projected to be 60 or older by the year 2030,

fueling a rise in chronic illness

60

by

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2030

over

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Increasing Healthcare Demand

... putting healthcare systems

under increasing pressure...

8

13T

If growth trends continue, global

healthcare outlays could rise to

USD 13 trillion by 2025

2025by

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... but access is about more than

just affordability

• World Health Organization (WHO) Sustainable Development Goals outline how to achieve Universal Health Coverage by 2030

• WHO says access comprises six main elements:• Effective pre-qualification for essential medicines

• Appropriate product selection (e.g. pricing policies)

• Improved coverage for noncommunicable diseases

• Appropriate use of medicines (adherence)

• Tackling antimicrobial resistance (AMR) and ensuring responsible use of medicines

• Addressing underserved clinical areas

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Source: WHO: Health in 2015

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Reaching patients worldwide

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Sandoz International

• We cover all major

needs, with ~1000

molecules and 50 bn

units per year

• We have a leading

pipeline of >800 projects

• We lead in areas from

generic CV1, CNS1, pain

and dermatology to

oncology and respiratory

Sandoz is a global leader with a

broad and innovative portfolio

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1. Cardiovascular; Central Nervous System

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We focus on making access to

medicine happen...

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• We reach patients worldwide with the

medicines they need

• We lead the field where it really matters

• We target communities most in need

Our Mission and Vision

Our integrated approach

• Our mission at Novartis is to discover new

ways to improve and extend people’s lives

• Our Vision is to be a trusted leader in

changing the practice of medicine

Our Purpose

• At Sandoz, we pioneer novel approaches to

help people access high-quality medicine

• This is how we help improve society’s ability

to support growing healthcare needs

• Find out more here:

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... and on keeping healthcare

systems sustainable

• The savings we generate help to keep healthcare

systems sustainable and free up funds for innovation

• In the US alone, use of our medicines saved an

estimated USD 85 bn over the past 10 years

• In the EU, generic medicines ensure equal access to

frontline treatments for more than 500 million people

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Source: Internal estimates based on GPhA: Generic Drug Savings in the US; Medicines for Europe: Generic Medicines Factsheet.

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Leading where it matters

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2015 Sandoz Financial Results1

USD at actual rates

Third party sales 9.157 billion

(+7% in cc)

Core operating income 1.659 billion

(+17%)

Core Return on Sales (ROS) 18.1%

Sandoz had strong 2015 sales

growth in all key business areas

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1. Audited sales as of end 2015; restated 2015 sales (unaudited) of 10.070 bn, including transfer of 19 mature brands from Novartis

Pharmaceuticals to Sandoz

6339772

1441

605

2015 sales per franchise, in million USD,

Total 2015 sales: USD 9.157 billion

Retail Generics Biopharma

Anti-Infectives Onco Injectables

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• Biologics have revolutionized modern medicine, but access remains limited

• As the pioneer of biosimilars, we are leading the change –and have been for 10 years

• >USD 100 bn worth of biologics will come off patent by 20201, enabling biosimilars to drive access

• We intend to continue leading the way, by launching five major biosimilars until 2020

We are the global pioneer and

leader in biosimilar medicines...

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1. Evaluate Pharma, 2015

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• Antibiotics are the cornerstone

of global healthcare systems

• As a global generic leader, we

play a critical role in keeping

healthcare sustainable

• We are committed to tackling

anti-microbial resistance

(AMR) and promoting rational

use of medicines

• WHO estimates that AMR

could lead to 10m more

deaths annually by 20501

...and the global leader in generic

antibiotic medicines

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1. Review on Antimicrobial Resistance, 2016

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Targeting those in need

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Our targeted access programs aim

to address three related areas

• Our business model is based on driving access, by reaching more

patients with the medicines they need

• We are committed to operating ethically and sustainably

• Our corporate responsibility work focuses on three main areas

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Access to medical

informationAccess to

medicines

Access to

medical capacity

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Noncommunicable

diseases (NCDs):

• 28 million people die annually from NCDs

in lower-income countries

• “Novartis Access” launched in 2015 to

enhance access to NCD treatments

• Portfolio offered at USD 1 per treatment

per month to public sector customers

Infectious diseases:

• Novartis Malaria Initiative has provided

>800m treatments to the public sector of

malaria-endemic countries since 2001

We focus on the medical needs of

lower-income countries...

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Maternal and child health:

• Sponsoring training for midwives

• Partnering with the United Nations to help prevent deaths from pneumonia

• Working with World Child Cancer to “even the odds”

Respiratory:

• Supporting European and African doctors who partner to improve asthma diagnosis and treatment

... and on promoting access to

medical information and training

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In 2016, we launched the Sandoz

“Healthcare Acccess Challenge”

Global Communications Onboarding ǀ November 3, 2016 ǀ Business Use Only22

• Despite significant advances made by

modern medicine, universal access to

healthcare is still arguably the single

largest unmet medical need

• Sandoz HACk – Healthcare Access

Challenge invites young people to “re-

imagine” access to healthcare by

finding solutions to local problems

• Six shortlisted finalists will develop

their ideas on OpenIDEO and pitch at

Wired Health (London, March 2016)

• Three winners will receive EUR 20,000

seed funding and mentoring from

Sandoz to bring their ideas to life

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Uniquely positioned to win

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Anti-infectives:

First

oral penicillin

Sandoz has a unique scientific

heritage with a history of “firsts”

1951 1980 2006 2010 2013 2015

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Biotechnology:

First recombinant interferon-alfa

Omnitrope:

First biosimilar, launched in Europe

Enoxaparin:

First USD 1 billion generic, launched in US

AirFluSal:

First-of-a-kind respiratory inhaler device launched in EU

Glatopa:

First US approval and launch of this complex generic multiple sclerosis treatment

Zarxio: First US biosimilar approved and launched under BPCIA pathway

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We are uniquely positioned within

Novartis

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Novartis

Pharmaceuticals

Innovative medicines* Eye care devicesGenerics and biosimilars

Novartis

OncologyAlconSandoz

• Novartis is the first company with global scale in both branded

pharmaceuticals and generics

• Sandoz is one of three industry-leading Novartis divisions

• Sandoz is growing rapidly and expanding into new fields, including

mature brands

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We believe that, together, we can

make a real difference for patients

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The Novartis workforce includes people

of 144 nationalities

Novartis employs 118,700 people worldwide

Our culture is defined by clear values:

Innovation, quality, collaboration,

performance, courage, and integrity

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Thank you

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Sandoz International

Disclaimer

This presentation contains forward-looking statements that can be identified by words such as “potential,” “expected,” “will,” “planned,” or similar terms, or by express or implied discussions regarding potential new products, potential new indications for existing products, or regarding potential future revenues from any such products; potential shareholder returns or credit rating; or regarding the potential completion of the announced transactions with GSK and Lilly, the potential completion of the announced transaction regarding the Novartis flu vaccines franchise, or regarding potential future sales or earnings of any of the businesses involved in the announced transactions, or of the Novartis Group, and regarding any potential strategic benefits, synergies or opportunities as a result of the announced transactions; or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any new products will be approved for sale in any market, or that any new indications will be approved for any existing products in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such products will achieve any particular revenue levels. Nor can there be any guarantee that the announced transactions will be completed in the expected form or within the expected time frame or at all. Neither can there be any guarantee that Novartis will be able to realize any of the potential strategic benefits, synergies or opportunities as a result of the transactions. Neither can there be any guarantee that Novartis or any of the businesses involved in the transactions will achieve any particular financial results in the future. In particular, management's expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally, including an unexpected failure to obtain necessary government approvals for the transactions, or unexpected delays in obtaining such approvals; the potential that the strategic benefits, synergies or opportunities expected from the transactions may not be realized or may take longer to realize than expected; the inherent uncertainties involved in predicting shareholder returns or credit ratings; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; the Company’s ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on the Company of the loss of patent protection and exclusivity on key products which commenced in prior years and will continue this year; unexpected manufacturing or quality issues; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, government investigations and intellectual property disputes; general economic and industry conditions; uncertainties regarding the effects of the persistently weak global economic and financial environment; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; uncertainties involved in the development of new healthcare products; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and ExchangeCommission. Novartis is providing the information in this presentation as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

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Back-up slides

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• Strategy

• Biopharmaceuticals

• Anti-Infectives

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Sandoz is a global leader in generic

and biosimilar medicines

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1 In the combined regions of North America, Europe, Japan and Australia 2 #1 in Gx market by volume

Therapeutic Areas

Unique experience and knowledge

Sandoz is #1 and the leader in

• Biosimilars1

• Anti-Infectives2

• Dermatology2

• Transplant / Immunosuppressants2

Geographies

Leadership in prioritized geographies

Sandoz leads in key markets

• #1 in Western Europe (incl. Germany)

• #1 in CEE (#2 in Russia)

• #3 in US

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We focus on six priorities to drive

profitable growth

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Sandoz 6 Priorities

6P R I O R I T I E S

Sustainable

Growth

4

Tech Ops

& Quality

6

D&R /

BD&L

5

Biosimilars

3

Patients, People &

Collaboration

1

Geographic

Focus

2

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Industry trends reinforce our choice

of priorities

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Ensure

customer

focus/ brand

management

Drive

geographic

focus

Focus on

supply, cost

and quality

Continuous

differentiated

new launch

pipeline

Capitalize on

the biosimilar

opportunity

Targeted

portfolio

expansion and

“value-added”

meds

Industry Trends

3 41 3

Focusing on

markets that count,

now and in future.

Making strategic

choices to

streamline the

organization

Leveraging

breadth of Novartis

capabilities to build

a compelling

customer value

proposition

Confirming future

TA and value-

added drivers to

build a competitive

and differentiated

portfolio

Optimizing

manufacturing

network to step-

change supply

reliability,

quality and

competitiveness

Revamping our

New Launch

engine to fuel

future growth.

Building proactive

BD, M&A and

strategic

partnerships

Reinforcing our #1

market position.

Building our best-

in-class pipeline.

Driving continued

double-digit growth

What we are focusing on at Sandoz

5 62 51 2

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Driving focus by restructuring low-margin

businesses:

• Ongoing commercial exit in Indonesia, exit in

Venezuela, exit / divestment of Frankfurt API

(7ACA) site

• “Fine-tuned” model: Argentina, Colombia,

Ecuador, India, Nordics, Pakistan, Portugal

Targeting resources and delivering growth in our two

critical segments:

Priority Focus markets

Significant part of our existing and future business

Priority Growth markets

Significant market opportunity and absolute growth

top and bottom line

Region Growth

We constantly fine-tune our

market models to drive growth

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Optimize / exit

Priority Focus

Priority Growth

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We performed solidly in Q3 2016,

despite fewer US launches

Sandoz financials YTD / Q3 20161

USD million at actual rates

1 Including Mature Brands transferred from Innovative Medicines Division

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YTD 2016 % change cc Q3 2016 % change cc

Net sales 7539 +2 2517 -1

OpInc 1080 +12 354 -9

ROS (%) 14.3 14.1

Core OpInc 1550 +4 530 +1

Core ROS (%) 20.6 +0.3 ppts 21.1 +0.2 ppts

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Q3 2016 growth drivers3rd party sales in USD million at actual rates

Our growth is driven by key markets

across regions

35

134

92

197

383

706

954

CEE & MEA

Western Europe

LatAm

APAC

North America

Total Sandoz 2,517

Anti-Infectives

-3%

+3%

+4%

-3%

+10%

-14%

-1%

Variance cc

Vs PY Q3

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1 US Q3 sales were -4% in Q3; CEE Q3 sales only were USD 276m (+9%); total Anti-Infectives sales,

including FDF sales under Sandoz name, were USD 339m (-2%).

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Biopharma1 is a major growth driver,

on track for USD 1 bn sales in 2016

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2

3

5

0

5

10

15

20

25

0 2 4 6 8 10 12

Months after launch

Zarxio

1. Biopharmaceuticals include biosimilars, biopharmaceutical contract manufacturing and Glatopa®

2. Ahead of Teva’s Granix® at same point in time post-launch. Third party data underestimates penetration due to gaps in coverage.

3. Share of 20mg glatiramer acetate market, based on volume and including customers not reported by IMS. Source: Sandoz, IMS NPA.

0

5

10

15

20

25

0 2 4 6 8 10 12

Granix

(Teva)

• Approx. 50% of annual

sales will be from US

• Zarxio® US exceeded

USD 100m since launch

Glatopa® approx. 40%

market share3

Market share filgrastim US1, %

Zarxio

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Molecule Agency Status

FDA Approved

EMA File accepted

FDA File accepted

EMA File accepted

EMA File accepted

FDA File pending

EMA File pending

FDA File pending

EMA File pending

FDA approved etanercept in August

as second Sandoz US biosimilar

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5

Committed to launching

major biosimilars in EU

and US by 2020

All trademarks are the property of their owner

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Market set for dramatic expansion,

driven by US and immunology

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1. Compound Annual Growth Rate

2. Source: EvaluatePharma, IMS, Market Reports, Sandoz

2013 2015 2020

Biosimilar market by geographyUSD billion

EU US Rest of world

+35%

2013 2015 2020

Biosimilar market by segmentUSD billion

Insulins OncologyEPO, G-CSF, hGH ImmunologyOther

+142%0.7 1

+35%

14

+62% +35%

N/A

+92%

CAGR1

2015-20

0.7 1

+62%

14

CAGR1

2015-20

+50%

+50%

+90%

2

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Biosimilar competitive environment is

dynamic – not all will stay the course

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Evolution of competitive landscape

Before 2015 2015 and after Key competitors are

partnering for:

• Commercial

capabilities

• Generic

capabilities

• Financial

resources

• Clinical expertise

• Manufacturing

networksOther

competitors

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Inhalers

Patches/

trandermals/

thin films

Innovative

solid

formulationsImplants

APICytotoxics

Hormones

Lyophilization

Injectables Ophthalmics

Dermatology

Broad

portfolio

Projects in

development~1000 >800

We also have a broad small-molecule

pipeline, driving our base business

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Our leading antibiotics business is

our largest global franchise

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90 million patients1

in 130 countries

around the world1

are treated with

Sandoz antibiotics

1. 2015 data

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• Biochemie founded in Kundl, Austria, in

1946 to produce and supply penicillin

for the Austrian population. The

research team achieves domestic

production of penicillin in 1948.

• In 1951 two researchers at Biochemie,

Brandl and Margreiter, break new

ground by discovering Pen V, the first

oral penicillin

• Sandoz Ltd. acquires Biochemie in

1963, representing the beginning of

large-scale production of antibiotics

• Sandoz is still the biggest producer of

Penicillin V in the world

We pioneered the use of quality

antibiotics after World War 2 ...

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... and have continued leading the

way ever since

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1946Foundation Biochemie

1948Penicillin production starts

1951Discovery of Pen V, first

oral penicillin

2002

Sandoz acquires Lek

Pharmaceuticals, Slovenia’s

largest pharmaceutical company

with a strong presence in Central

and Eastern Europe

2002

Launch of co-amoxiclav in US

1880 ... 1950 1960 1970 1980 1990 2000 2010 2020

1886

Dr. Alfred Kern and Edouard

Sandoz set up The Chemical

Company Kern & Sandoz in Basel

1895

Production of the first

pharmaceutical substance,

antipyrine, a fever-controlling agent

1963

Sandoz acquires

Biochemie and begins

the large-production of

antibiotics

2013

Sandoz opened new facilities

in Kundl, Austria, further

expanding the production of

sterile penicillin 1992

Launch of amoxicillin

clavulanate potassium

in Europe

1982

Construction of

Lendava (API

production site)

1989

Acquisition of Les

Franqueses (API

production site)

2003

Acquisition of Palafolls

API production plant

130 years of

pharmaceutical

experience

70 years of

experience in

antibiotics

1st to discover

the oral form

of Pen V 65

years ago24 years since

Sandoz first

launched amoxi-

clavulanic

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We partner with global NGOs to

ensure supply to patients worldwide

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• Sandoz is committed to expanding

access to more products in the portfolio

‒ Top products procured include Amoxicillin

DT and Amoxicillin trihydrate/Potassium

Clavulanate POS

• Sandoz is committed to making its

pediatric Amoxicillin treatment available

to developing countries; to date, 500 000

treatment courses have been delivered

to UNICEF. This commitment supports

the UN Commission on Life-Saving

Commodities for Women and Children,

which has called for an increase in the

production, distribution, and promotion

of amoxicillin dispersible tablets