Restricted. © Siemens Healthcare, 2016 All rights reserved.

Molecular

Services

guiding targeted

cancer therapies

Raimund Martin, Dir. Business Development HC SI MSV

2016-02-20 Page 2 HC xxx – xxx Restricted. © Siemens Healthcare, 2016 All rights reserved.

Example for implementation of Siemens new strategy to become THE enabler of healthcare providers

2016-02-20 Page 3 HC xxx – xxx Restricted. © Siemens Healthcare, 2016 All rights reserved.

• The Challenge - Selected trends in the

healthcare environment

• The mission for Siemens Healthineers

• An example - The role of Molecular Services

• The outlook – Integration of In-vitro

Diagnostics and Diagnostic Imaging

to guide therapy in lung cancer

Agenda

2016-02-20 Page 4 HC xxx – xxx Restricted. © Siemens Healthcare, 2016 All rights reserved.

Global Dynamics in Healthcare

Healthcare Trends

Demographic shift

Population growth

Rapid scientific progress

Staff shortage Shift to value-based

reimbursement Growing chronic

disease burden

Increasing cost pressure

Consumerism

Managing Health

Value-based healthcare

Consolidation

Building the critical mass

Industrialization

Doing more with less

Transformation of Healthcare Providers

2016-02-20 Page 5 HC xxx – xxx Restricted. © Siemens Healthcare, 2016 All rights reserved.

+ 2.4

Market Trends Population growth

United Nations, Department of Economic and Social Affairs, Population Division, 2013

Population growth by 2050 (in billions of people) pulation growth by 2050 (in billions of people)

2013: 7.2

5.9 1.3

2050: 9.6

8.2 1.4

World population

Emerging and developing countries

Industrialized countries

Consequence: In the fast-growing emerging and developing countries, the demand for professional, affordable entry-level healthcare solutions is intensifying.

2016-02-20 Page 6 HC xxx – xxx Restricted. © Siemens Healthcare, 2016 All rights reserved.

Decrease in social life

Loss of productive

time

Market Trends Rapid scientific progress

1: BVMed, https://www.bvmed.de/de/branche/innovationskraft/patente?pk_campaign=tsr_CHK&pk_kwd=startseite_tsr-aktuelles-gT_mi_patente viewed May 9, 2016

2: Siemens Healthcare Whitepaper: “Standardizing Quality of Care – How and why can standardization help healthcare providers …”, page 5

3: “Coping up with the Information Overload in the Medical Profession”, http://file.scirp.org/pdf/JBM_2015112613240843.pdf viewed May 9, 2016

4: “Information overload within the health care system: a literature review”, http://onlinelibrary.wiley.com/doi/10.1111/j.1471-1842.2004.00506.x/pdf viewed May 9, 2016

Consequence: While the recent technological advancement is tremendously helpful for medical consultants, it also generates an enormous volume and variety of data and therefore information overload which can likely cause a reduction in decision quality.3

Illness, Stress,

Tiredness

Reduced mental

capacity

Longer working

hours

Information overload causes4

12,474 MedTech

patent applications in 2015

worldwide1

>22 mio references

to journal articles in MEDLINE2

+ 11% growth

compared to 20141

> 1 mio entries

every year2

2016-02-20 Page 7 HC xxx – xxx Restricted. © Siemens Healthcare, 2016 All rights reserved.

Market Trends Growing chronic disease burden

1: WHO: „Noncommunicable diseases“; http://www.who.int/mediacentre/factsheets/fs355/en/, viewed April 4, 2016

2: WHO: “The global burden of chronic”; http://www.who.int/nutrition/topics/2_background/en/, viewed April 4, 2016

Consequence: The rising number of chronic diseases, e.g. due to ageing, rapid unplanned urbanization, and globalization of unhealthy lifestyles causes entire societies to think of interventions to prevent and control them.1 Healthcare providers have to increasingly deal with multimorbidity in patients and need to find approaches to strengthen early detection and timely treatment.

Number of people killed each year by chronic diseases2

Chronic disease contribution to global burden of disease2

38 mio

2012

52 mio

2030

46%

2001

57%

2020

Major chronic diseases1:

• Cardiovascular diseases

• Cancers • Respiratory diseases • Diabetes

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Market Trends Increasing cost pressure

1: Arnold & Porter LLP, “Medicare Proposes New Payment System for Clinical Lab Tests, But Leaves Many of Labs' Questions Unanswered”, Oct. 2015;

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-Regulations.html, viewed Jan 22, 2016

2: “American Hospital Association – Underpayments by Medicare and Medicaid, Fact Sheet”, http://www.aha.org/content/14/2012-medicare-med-underpay.pdf, viewed Jan 22, 2016

Medicare’s payment rates to clinical laboratories on the Clinical Lab Fee Schedule 1

Consequence: Due to decreasing financial resources, healthcare providers have to find new ways to keep healthcare costs per patients as low as possible while still delivering high-quality medical services. One of the first things to do will often be the improvement of clinical processes.

68% of hospitals received Medicaid payments

less than cost in 20122

69% of hospitals received Medicare payments

less than cost in 20122

$56 bn Combined underpayments

in 2012 (Medicare + Medicaid)2

Indepen-

dent labs

57% Hospitals

24%

Physician

offices

19%

2014: $7 bn total

Estimated future reduction

- $360 mio (- 4.5%)

- $2.94 bn (- 7.5%)

- $5.14 bn (- 6.43%)

In 2017

2017 – 2021

2017 – 2026

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Market Transformation Consolidation – Building the critical mass

USA today: 900 – 1000 USA 2020: 200 – 400

Growing number of national and multi-national

healthcare chains diversifying their business

vertically as well as horizontally

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Market Trends Shift to value-based reimbursement

Siemens Healthcare Whitepaper: “Improving Patient Outcomes – How to define, measure, and increase a positive and reimbursable outcome for patient care”

30 days Medicare reduces

provider compensation if patients are readmitted

within 30 days of discharge

$420 mio approx. 2,700 of the 3,400

Medicare contract hospitals will have cuts

totaling $420 million in fiscal 2016 due to such readmissions

80% of U.S. healthcare organizations

are at least investigating or piloting the transition to

value-based care

32% of U.S. healthcare leaders

see uncertainty about the revenue stream

as no.1 hurdle for the industry’s transition

to value-based care

from

fee-for-service

to

fee-for-value

e.g. Affordable Care Act (ACA) – U.S.

Consequence: As part of the move toward value-based care, patient outcomes are increasingly coming into the spotlight, partly in connection with the trend toward population health management.

2016-02-20 Page 11 HC xxx – xxx Restricted. © Siemens Healthcare, 2016 All rights reserved.

Agenda

• The Challenge - Selected trends in the

healthcare environment

• The mission for Siemens Healthineers

• An example - The role of Molecular Services

• The outlook – Integration of In-vitro

Diagnostics and Diagnostic Imaging

to guide therapy in lung cancer

Author | Department

Page 12 | Unrestricted © Siemens Healthcare GmbH, 2016

> €1 bn R&D spent

75 countries

with direct presence

> 209,000 patients

every hour2

Biggest supplier

of medtech

infrastructure

World market leader

in most businesses

> 46,000 employees

12,500 granted patents

globally

> 70% of critical clinical

decisions are influenced by the

type of technology we provide1

~ €13 bn revenue

Access for

1.08 bn people in developing

countries2

Who We Are

1 AdvaMedDX, “A Policy Primer on Diagnostics”, June 2011, page 3

2 Siemens AG, “Sustainable healthcare strategy - Indicators in fiscal 2014”, page 3-4

Author | Department

Page 13 | Unrestricted © Siemens Healthcare GmbH, 2016

Digital Health

Services

Future

1956 CLINISTIX − dry chemistry testing for glucose in urine

E.v. Behring W. C. Röntgen

1901

Nobel prize winners (Physics + Medicine)

1896 Industrially manufac- tured X-ray appliance for medical diagnostics

1998 First Siemens track-based laboratory automation system 1967

First real-time ultrasound scanner

1975 First Siemens CT scanner

1983 First Siemens MRI scanner

2008 Robotic-assisted angiography system

2009 Multi-modality 3D imaging network

2008 Digital

radiography, wireless flat

panel detector

2012 Wireless transducers for ultrasound

2014 “Free breathing”

CT scanning with dual X-ray

sources & detectors

Enterprise Services

Advanced Therapies

1999 First

intuitive medical IT

platform from

Siemens

2001 First PET/CT system from Siemens

2006 Diagnostic analyzer integrating four tech-nologies in one system

2005 First

Dual Source CT scanner

1957 Fully automated discrete chemistry analyzer for whole blood or serum

1982 First acridinium ester based chemilumin-escence immuno- assays

2015 Wide-angle image acquisition breast

tomosynthesis

2016 Liquid biopsy

2011 First integrated, simultaneous whole-body MRI and PET

Outcomes

Costs

2014 teamplay

2015 First Twin Robotic X-ray scanner for enhanced patient care and productivity

2016 Atellica1

Molecular Diagnostics

1: System under FDA review. Not available for sale. Any features listed are part of the development design goals. Future availability cannot be guaranteed

Our Innovations -

120 Years Track Record

2016-02-20 Page 14 HC xxx – xxx Restricted. © Siemens Healthcare, 2016 All rights reserved.

... offering the broadest and deepest portfolio

*Incubated within Business Function Strategy & Innovation

Image courtesy Diagnostic Imaging: CMRR, Minneapolis, MGH, Boston

Image courtesy Advanced Therapies: IHU Strasbourg, France

Outcomes

Costs

Diagnostic Imaging

We help achieve highest diagnostic quality and efficiency

• Computed Tomography • Magnetic Resonance • Molecular Imaging • Radiography & Fluoroscopy & Imaging IT

Advanced Therapies

We enable advanced therapeutic procedures

• Cardiology • Interventional Radiology • Radiation Oncology • Surgery

Laboratory Diagnostics

We enable clinical and workflow excellence in the lab

• Chemistry, Automation & Immunoassay • Hemostasis, Hematology

& Specialty Business

Point of Care

We provide critical patient information in-office and at the bedside

• Blood Gas • Diabetes • Urinalysis

Services

We help achieve best institutional performance

• Customer Services • Digital Health Services • Enterprise Services & Solutions

Ultrasound

We enable real-time access to decision-critical information

• Cardiology • Radiology • Obstetrics & Gynecology

Molecular Diagnostics (MDX)*

We provide accurate diagnosis and monitoring technologies

• PCR platform & assays • Virology & bacteriology

Molecular Services (MSV)*

We provide high quality molecular testing and knowledge services

• Liquid / Tissue based oncology testing • Companion Diagnostics • Bioinformatics

Author | Department

Page 15 | Unrestricted © Siemens Healthcare GmbH, 2016

Outcomes

Costs

Our Mission is to

Make Healthcare Providers Succeed

Enabling better outcomes

at lower costs

2016-02-20 Page 16 HC xxx – xxx Restricted. © Siemens Healthcare, 2016 All rights reserved.

Agenda

• The Challenge - Selected trends in the

healthcare environment

• The mission for Siemens Healthineers

• An example - The role of Molecular Services

• The outlook – Integration of In-vitro

Diagnostics and Diagnostic Imaging

to guide therapy in lung cancer

2016-02-20 Page 17 HC xxx – xxx Restricted. © Siemens Healthcare, 2016 All rights reserved.

Molecular technologies are in the process of revolutionizing oncology

Precision Medicine has the potential to

revolutionize current medical practice for

diagnosing, treating, and monitoring cancer

patients by analyzing specific genomic changes

in the tumor and applying an effective, targeted

therapy to individual patients.

Source: Seidel, Heukamp et al., Science Transl Med, 2013

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Key drivers for the accelerating adoption of molecular diagnostics

Source: 1Adopted from genome.gov/sequencing costs; 2Buffrey et al 2015; American Health & Drug Benefits

0

50

100

150

200

1995 2000 2005 2010 20152000 2005 2010 2015

$1,000

$100

$10

$0.1

$1

$10,000

Cost per Megabase DNA Sequence1 FDA Oncology Drug Approvals2

cost of next generation sequencing (NGS) as a key

technology for genomic profiling

number of targeted therapy options linked to

specific genomic tumor alterations

Rapidly falling… Increasing…

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Fundamental change in oncology: Genomic analysis as key to treatment success

Targeted therapies only work in

patients that harbor the

respective mutations

Therapeutic decision is driven by

molecular diagnostics

Seidel, Heukamp et al., Science Transl Med Oct 30, 2013 Seidel, Heukamp et al., Science Transl Med Oct 30, 2013

Pro

ba

bili

ty o

f su

rviv

al

2016-02-20 Page 20 HC xxx – xxx Restricted. © Siemens Healthcare, 2016 All rights reserved.

Therapeutically relevant mutations determine targeted therapy treatment in various cancer types

Adenocarcinoma (Lung)

Other?

Breast Cancer

KRAS

EGFR

ALK

BRAF

ERBB2 Other?

PIK3CA

PTEN

EGFR1

AKT

Head and Neck Carcinoma

CDKN2A

CCND1

PTEN

PIK3CA HRAS

Other?

EGFR/HER2

Epithelial Carcinoma

Other?

(Lung)

EGFR

ERBB2/3

FGFR

P13K

MAPK

TOR

Colorectal Carcinoma

KRAS

PTEN

KRAS+

PIK3CA

PIK3CA

ERBB2/3

Other?

NIRAS

BRAF

Melanoma

(PTEN and CDKN2A are frequently inactivated)

BRAF

Other?

KIT

NF1

NIRAS

RET / ROS / NRAS

Adopted from Garraway , L. JCO 2013

MEK1

MET PIK3CA

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The clinical challenge:

limited availability of cancer patient tissue …

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… with increasing number of therapeutically relevant genetic changes screened with different lab techniques

ALK BRAF

DDR2

EGFR

MET

PDL1

PTEN

RB1

RET

ROS1 TP53

FGFR

HER2

KRAS

Complex method spectrum:

• Sanger sequencing

• PCR

• FISH

• IHC

• NGS hotspot panels

Analysis often requests

sequential workflow/testing

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The perfect test should give a comprehensive genomic picture of the tumor – including ALL relevant structural alterations …

Amplification Deletion

c) Chromosomal copy-number alterations

Normal (copy number = 2)

b) Complex structural alterations („fusions“)

Normal Chromosome 2

Chromosome 2 - 11 translocation

Inversion

Insertion

Deletion

Substitution

a) Subtle sequence alterations

GAGA

CTCT

GATA

CTAT

GA - -

CT - -

GATTGA

CTAACT

TCTC

AGAG

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Hybrid capture-based NGS analysis supports informed decisions about targeted therapy

* Key technologies, assays, and services are for research use only. Not commercially available in US.

Not for use in diagnostic procedures. Future commercial availability cannot be guaranteed.

• One assay to detect ALL types of clinically relevant genomic alterations including point mutations,

small insertions/deletions, copy number alterations, and selected gene fusions

• Proprietary computational biology software to analyze and interprete data for their

therapeutic relevance

• Tumor specific genomic information from limited tissue material or blood

Laborsome FISH not required

Next generation sequencing

Hybrid capture of gene panel

DNA extraction from tumor (or plasma)

Analysis of structural alterations

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Analysis of circulating tumor DNA from “liquid biopsies” as potential game-changer

• Non-invasive comprehensive tumor profiling

on circulating tumor DNA (ctDNA) from

whole blood

• Painless and low-risk alternative to

a tissue biopsy

• Disease monitoring to control treatment

efficacy and emergence of resistance

• Detection of genetic alterations from

different tumor sites (tumor heterogeneity)

Graphic adopted from Crowley, E. et al. Nat. Rev. Clin. Oncol. 2013

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High end molecular testing services are the basis of our customer offerings*

* Key technologies, assays, and services are for research use only. Not commercially available in US.

Not for use in diagnostic procedures. Future commercial availability cannot be guaranteed.

Molecular services to detect all types of

therapeutically relevant genomic alterations

FFPE (tissue)

Whole blood

Clinical routine specimen

Comprehensive molecular

report provides a basis for

clinical decision making

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Our assay portfolio for therapy guidance covers both tissue and liquid biopsy based testing*

* Key technologies, assays, and services are for research use only. Not commercially available in US.

Not for use in diagnostic procedures. Future commercial availability cannot be guaranteed.

** Customized development efforts depend on assay content, analytical requirements, regulatory

requirements and minimal number of samples for cost effective adoption.

Pan-cancer Genomic Profiling of Circulating Tumor DNA from Whole Blood – 39 Genes

Includes: ALK, BRAF, EGFR, FGFR1+2+3,

KRAS, MET, NRAS, PIK3CA, RET, ROS1

NEOplus*

Pan-cancer Genomic Profiling of Tissue (FFPE) – 94 Genes

Includes: ALK, BRAF, BRCA1+2, EGFR,

FGFR1+2+3, KRAS, MET, NRAS, PIK3CA,

RET, ROS1

NEOliquid*

Detection of point mutations, small insertions

/ deletions, copy number alterations, and

selected gene fusions

Detection of point mutations, small insertions

/ deletions, copy number alterations, and

selected gene fusions

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We strive to provide high quality and cutting edge molecular services to our customers

• Provide high quality molecular testing and knowledge services

to help clinicians characterize disease and to support guidance

of therapies in precision medicine

• Support and enable our customers in molecular oncology from

laboratories and hospitals to physicians and medical experts

• Develop and offer cutting edge technologies to provide access

to the latest scientific knowledge for the clinical decision making

Molecular Services Mission

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Outlook: Monitoring of EGFR T790M with NEOliquid shows reduction in allelic frequency correlating to tumor regression

Gautschi et al.,J Thorac Oncol. 2015

A B C D EGFR T790M allele frequency in

plasma reduced during

treatment cycles (prior to

treatment (A), after 2 weeks

(B), after 4 weeks (C), after 6

weeks (D) with osimertinib).

6 weeks osimertinib

(3rd gen. tyrosine kinase

inhibitor) leads to tumor

regression

39% 0.48% 0.06% 0.03%

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Agenda

• The Challenge - Selected trends in the

healthcare environment

• The mission for Siemens Healthineers

• An example - The role of Molecular Services

• The outlook – Integration of in-vitro

Diagnostics and Diagnostic Imaging

to guide therapy in lung cancer

2016-02-20 Page 31 HC xxx – xxx Restricted. © Siemens Healthcare, 2016 All rights reserved.

Improved outcomes due to innovations in cancer care

• Improved overall 5 year survival in several major cancer

types such as breast cancer or prostate cancer – cancer as

a chronic disease ?

• Improvements can be attributed to implementation of

• early detection/screening

• Introduction of new classes of anticancer drugs such

as TKIs or Immunotherapies

• advances in applications of radiation oncology

• minimal invasive therapies

• advanced imaging and molecular diagnostics

• modern supportive therapy to control side effects of

therapy

• centralization and specialization e.g. therapy in cancer

centers/multidisciplinary care

• improved access to therapy

• Education programs e.g. by Cancer Societies

Cancer survival trends by cancer type in UK

Source: cruk.org/cancerstrats 2014

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Lung Cancer: high incidence – poor survival

due to late stage diagnosis

Globocan 2012, World

Inc

ide

nce

& M

ort

ali

ty

Cancer in Germany, RKI 2008

SEER Cancer Statistic review Stage

Lung Cancer Worldwide:

Incidence 1.830.000

Mortality 1.590.000

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Early detection of Lung Cancer by Low-Dose CT imaging - cutting down mortality

CS I CS II

CS III CS IV

Mortality: 53-69 % (5 y)

Mortality: 90-99 % (5 y)

Fraction (%)

Unselected patients 72-79

LD-CT screening 30

Fraction (%)

Unselected patients 18-27

LD-CT screening 69

Stage shift to lower stages by LD-CT screening

and reduction of mortality

Aberle et al., N. Engl. J. Med., 2011 Aug 4;365(5):395-409

Walter et al. Thorax, 2013

CS = clinical stage

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Evolution of diagnostic imaging methods From chest x-ray to high definition 3D Computed Tomography

Chest x-ray used to be the diagnostic method of choice, but has widely been replaced by

Computed Tomography, providing high resolution 3D images at radiation doses far below 1mSv (here 0.17msV)

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Image analysis with dedicated software workstations: Comparison and monitoring across multiple time points

H IM CR

• Compare up to 8 time points

• Quantify tumor growth rates between time points

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Functional imaging with PET-CT for non-invasive lesion characterization

Image courtesy of University of Tennessee, Knoxville, TN, USA

Protocol: 370 MBq (10 mCi) -. 150 minute uptake, 1 minute per bed, 5 bed positions, TrueV

Patient information: A 65-year-old female patient (94.1 kg) with lung carcinoma was evaluated for primary staging.

Clinical finding: Hypermetabolic primary tumor was visualized in the left lung base. Multiple glucose avid metastases were visualized in the mediastinal nodes, opposite lung, as well as upper- and mid-thoracic vertebrae and ribs. Please note the image quality, lesion contrast and low image noise in the 5-minute ultraHD•PET acquisition.

Obese patient with 5-minute

ultraHD•PET scan

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Radiation Oncology - implementing molecular tumor characteristics into therapy planning

PET-CT with different tracers in Lung Cancer

IMRT based on anatomical, functional and molecular characteristics

18F-FDG-PET 18F-FAZA-PET Overlay

Source: Bollineni et al, JNM, 2013

Source: Jouin et al, Bull Cancer, 2013

CT-only RT Planning

Dose Escalation for improved tumor control

based on Phase-matched PET/CT RT Planning

Courtesy of University of Tennessee, Knoxville, TN, USA

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Screening and improved diagnostic methods enable changing therapy from palliative to curative approach

Source: Mayoclinic.org

CS III-IV RTX+CTX

CTX

CS I-II Surgery

RFA, SBRT

CS III-IV RTX+CTX

CTX

CS I-II Surgery

RFA, SBRT

Without screening Majority of patients diagnosed in late stage,

Reveiving invasive or palliative treatment

72-79 % 18-27 % 30% 69 %

With screening More patients diagnosed in early stage,

leading to less invasive, more curative treatments

Robotic surgery for early stage NSCLC SBRT Stereotactic Body Radio Therapy

Source: Princess Margaret Cancer Center

Radiofrequency / Microwave / Cryo Ablation

Examples for less invasive therapies:

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Incorporating chemotherapies, immunotherapy and targeted therapies into the management of NSCLC in the future

Source: Thomas, A. et al Nature Reviews Clin Oncol (12), 2015

Role of NGS testing in advanced

oncology – way to precision medicine

• Next generation sequencing as gate

keeper in therapy decision making

and drug selection

• Tissue based testing or liquid biopsy

(preferred) as follow up test in case of

progressive disease or relapse to

select second line drug therapy

State-of-the-art Diagnostic Imaging

for staging and monitoring and

follow-up/surveillance

Potential decision algorithm in Lung Cancer Care - central role of NGS

Acco

mp

an

ied

by A

dva

nce

d Im

ag

ing

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Engineering success. Pioneering healthcare.

the future of healthcare

together

Now’s our time

to inspire