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CAPITAL MARKET DAY 2018 RADISSON BLU, ZURICH AIRPORT 4 OCTOBER 2018 PRESENTATION

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Page 1: PRESENTATION CAPITAL MARKET DAY 2018/media/Files/V/Vifor-Pharma/documents/en/... · capital market day 2018 radisson blu, zurich airport 4 october 2018 presentation

CAPITAL MARKET DAY

2018

RADISSON BLU, ZURICH AIRPORT

4 OCTOBER 2018

PRESENTATION

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CREATING THE FUTURE

Etienne Jornod

Executive Chairman

CAPITAL

MARKET DAY

2018

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© Vifor Pharma

MILESTONE 2020

WHAT IS NEXT?

WE ARE ON THE WAY

Central purchasing organisation

for pharmacists

Worldwide

pharmaceutical company

4 October 2018 3

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© Vifor Pharma

WE ARE BUILDING A FAST GROWING COMPANY

3 DRIVERS WITH BLOCKBUSTER POTENTIAL

4

Ferinject® Exploit the potential

Veltassa® Drive to blockbuster

Vifor Fresenius Medical Care Renal Pharma Launch products and enhance value

4 October 2018

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© Vifor Pharma

PHASE 1 PHASE 2 PHASE 3 COMMERCIAL PHASE 4

Vadadustat4)

Avacopan

CCX140

CR845

Ferroportin

inhibitor1)

AFFIRM-AHF

HEART-FID2)

Paediatric

AMBER

DIAMOND Anti-infectives

PIPELINE & LIFE CYCLE MANAGEMENT

DE-RISKED INVESTMENTS

20193)

2019

OW

N P

RO

DU

CT

S

IN-L

ICE

NS

ING

PR

OD

UC

TS

5 4 October 2018

1) Iron overload; leveraging iron metabolism expertise 2) Daiichi Sankyo clinical trial 3) Assumes CMA approval 4) U.S. Filing expected by the end of 2019

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© Vifor Pharma

WE KNOW HOW TO CREATE A

NEW MARKET!

4 October 2018 6

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FERINJECT®

4 October 2018

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© Vifor Pharma

1) Excluding the market share of Vifor Pharma products (0.6%).

Source: IQVIATM MIDAS® Quarterly panel, GERS, Insight Health, DN, DLI, Q2-2018. Average 2017 exchange rates have been applied.

GLOBAL I.V. IRON IN-MARKET SALES

MAT Q2-19961)

4 October 2018 8

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© Vifor Pharma

GLOBAL I.V. IRON IN-MARKET SALES

MAT Q2-2018

4 October 2018 9

Source: IQVIATM MIDAS® Quarterly panel, GERS, Insight Health, DN, DLI, Q2-2018. Average 2017 exchange rates have been applied.

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VELTASSA®

4 October 2018

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© Vifor Pharma

GLOBAL POTASSIUM BINDER IN-MARKET SALES

MAT Q2-20151)

4 October 2018 11

1) Excluding the market share of Sorbisterit (1.6%)

Source: IQVIATM MIDAS® Quarterly panel, GERS, Insight Health, DLI, Q2-2018. Average 2017 exchange rates have been applied.

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© Vifor Pharma

GLOBAL POTASSIUM BINDER IN-MARKET SALES

MAT Q2-2018

4 October 2018 12

Source: IQVIATM MIDAS® Quarterly panel, GERS, Insight Health, DLI, Q2-2018. Average 2017 exchange rates have been applied.

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© Vifor Pharma

GLOBAL I.V. IRON IN-MARKET SALES

MAT Q2 WORLDWIDE 1996

96 MILLION CHF

MAT Q2 WORLDWIDE 2018

1,698 MILLION CHF

VIFOR PHARMA

1,219 MILLION CHF

= 71.9%

4 October 2018 13

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© Vifor Pharma

175 MILLION CHF

225 MILLION CHF

VIFOR PHARMA

63 MILLION CHF

= 28%

GLOBAL POTASSIUM BINDER MARKET

MAT Q2 WORLDWIDE 2015

MAT Q2 WORLDWIDE 2018

4 October 2018 14

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VFMCRP

15

4 October 2018

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© Vifor Pharma

THE JOINT COMPANY

UNIQUENESS OF THE BUSINESS MODEL

THIS IS WHAT DIFFERENTIATES VIFOR PHARMA

FROM A TYPICAL PHARMA COMPANY.

REGULATORY CLINICAL R&D MEDICAL

AFFAIRS

4 October 2018 16

DIRECT ACCESS

TO THE PATIENT COMMERCIAL

Vadadustat

Avacopan CCX140

CR845

PRODUCTION

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© Vifor Pharma 17

1) Fresenius Kidney Care (FKC): Fresenius Medical Care North America dialysis provider organization

INCREDIBLE PENETRATION IN FKC CLINICS1)

AND OTHER CLIENTS

4 October 2018

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FINANCIAL AND CAPITAL

MARKET CONSIDERATION

18

4 October 2018

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© Vifor Pharma

4'540%

3'444%

2'657% 2'537%

2'236% 2'107% 2'022% 1'995%

1'060% 1'017%

Vifor Pharma AG LogitechInternational SA

Tecan Group AG Sika AG Kuehne + NagelInternational AG

Schindler HoldingAG

ChocoladefabrikenLindt & Spruengli

AG

Sonova HoldingAG

LEM Holding SA Cie FinanciereRichemont SA

VIFOR PHARMA VS. TOP SPI PERFORMERS

THE HIGHEST SHARE PRICE RETURN SINCE 1995

Source: Bloomberg

Note: share price increase from 01.09.1995 to 31.08.2018; excludes market capitalization below CHF 100m as of 01.09.1995.

4 October 2018 19

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© Vifor Pharma

OBJECTIVE 2025

WE ARE CONFIDENT TO DELIVER ON “MILESTONE 2020”

THE OBJECTIVE 2025 IS TO CONTINUE

TO GROW AT ONE OF THE FASTEST RATES IN

THE PHARMACEUTICAL INDUSTRY…

• NET SALES

• EBITDA

• NET PROFIT

«WE HAVE BEEN GROWING

EVERY YEAR

FOR 22 YEARS1)!»

1) Net profit before minorities, excluding non-cash one off effects and launch and ramp-up costs of Veltassa® in 2016 and 2017

4 October 2018 20

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STRATEGY 2025

Stefan Schulze

President of the Executive Committee & COO

CAPITAL

MARKET DAY

2018

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© Vifor Pharma 4 October 2018 22

STRATEGY 2025

EXPLOIT OUR COMPETITIVE ADVANTAGES

EXISTING GROWTH DRIVERS

Ferinject® – Exploit the potential

Veltassa® – Drive to blockbuster

VFMCRP – Launch products and enhance value

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© Vifor Pharma 4 October 2018 23

FERINJECT® / INJECTAFER

®

EXPLOIT THE POTENTIAL

2019 2025

HEART-FID

completion U.S. Post-approval study

FAIR-HF2

completion Post-approval study

China launch

2021

AFFIRM-AHF

completion Post-approval study

EU guidelines1)

update based on

AFFIRM AHF

U.S. guidelines1)

update based on

HEART-FID

1) Targeted guidelines:

Focus on cardiology, patient blood management, nephrology and gastroenterology

> CHF 2 billion

in-market sales

potential

Japan launch

H2 2019

U.S. label

update

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© Vifor Pharma

PATIENT BLOOD MANAGEMENT (PBM) – EU51)

4 October 2018 24

COMMENTS

• Patient focused approach to

blood management

• Medical benefit: i.v. iron

improves outcomes, including

mortality

• Economic benefit: reduction in

length of hospitalisation and

blood transfusion

• In-market sales opportunity of

> CHF 200m in EU5

IRON DEFICIENCY

SIGNIFICANT PBM OPPORTUNITIES

1) France, Germany, Italy, Spain and UK

Not treated Other i.v. iron Ferinject®

1’160K

96K

109K

1’365K1

With iron deficiency

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© Vifor Pharma

FERINJECT® IN-MARKET SALES

4 October 2018 25

A LEADING PRODUCT

• Most extensive clinical evidence

with 28 published RCTs1) and

7’034 patients treated in RCTs

• More than 8 million

patient-years experience2)

• Unique non-dextran-based

carboxymaltose shell

• Only high-dose i.v. iron to

demonstrate efficient iron

utilization in the body3)

LIFE CYCLE MANAGEMENT

SUPPORTING FUTURE GROWTH

1) Randomized clinical trials 2) Vifor Pharma analysis as of August 2018 3) Beshara, S et al. Br J Haematol 2003; 120:853-9

Europe U.S. ROW

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025

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© Vifor Pharma 4 October 2018 26

VELTASSA®

DRIVE TO BLOCKBUSTER STATUS

2019 2025

DIAMOND

completion Post-approval study

AMBER

completion Post-approval study

Label updates based on

DIAMOND results

Blockbuster

status

Guideline1)

updates based on

AMBER results

Guideline1)

updates based on

DIAMOND results

1) Targeted guidelines:

European rollout

Japan launch

Zeria

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© Vifor Pharma

U.S. – 3.0 MILLION PATIENTS

Total population: 327 million

4 October 2018 27

EU5 – 3.1 MILLION PATIENTS

Total population: 320 million

JAPAN – 1.3 MILLION PATIENTS

Total population: 127 million

HYPERKALEMIA MARKET OPPORTUNITY

BUILD MARKET AWARENESS

Source: Saito Y et al. PLoS ONE 12 (9): e0184402.. 2008 ESC Heart

Failure 2016; 3: 145–151

Source: from House AJKD Vol 72 | Iss 2 | August 2018 . De Nicola et

al Nephrol Dial Transplant (2016) 31: 335–336

Source: USRDS 2013 ADR, CDC

10.7

4.7

2.3 1.7

0.8 0.5

0

2

4

6

8

10

12

CKD 3-4 only CKD 3-4 with HF HF only

Total prevalence With hyperkalemia

11.5

4.8

2.4 1.8

0.8 0.5

0

2

4

6

8

10

12

14

CKD 3-4 only CKD 3-4 with HF HF only

Total prevalence With hyperkalemia

10.3

0.5 0.8 1.1

0.1 0.1 0

2

4

6

8

10

12

CKD 3-4 only CKD 3-4 with HF HF only

Total prevalence With hyperkalemia

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© Vifor Pharma

RESULTS EXPECTED

CLINICAL OBJECTIVES

STUDY

4 October 2018 28

LIFE CYCLE MANAGEMENT

UNLOCK FULL POTENTIAL WITH CLINICAL DATA

Strengthen evidence

of RAASi enabling

Beneficial effect on

blood pressure

AMBER DIAMOND

Beneficial effect on

morbidity and mortality

STRATEGIC OBJECTIVES Guideline updates U.S. label change &

guideline updates

H1 2019 2022

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© Vifor Pharma

EXPECTED GLOBAL MARKET EVOLUTION FOR PHARMACEUTICALS IN NEPHROLOGY

4 October 2018 29

PRESENCE IN NEPHROLOGY

BECOME A GLOBAL LEADER IN A FAST-GROWING MARKET

Source: EvaluatePharma 2017-22 CAGR of 10.3%, 2022-25 CAGR assumed unchanged, Vifor Pharma analysis

2.7%

2017

~$20bn >$40bn

2025

VFMCRP current market share

Rest of the nephrology market

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© Vifor Pharma 4 October 2018 30

1) Assumes Conditional Marketing Authorization approval

VFMCRP

BECOME AN INNOVATION LAUNCH ENGINE

2019 2025

RetacritTM

launch

Avacopan

launch1)

Additional launches in

nephrology

Vadadustat

launch

CR845

launch

CCX140

launch

CCX140 / FSGS Phase II trial

completion

CR845 / Uremic Pruritus Phase III trial completion

Avacopan / C3G Phase II trial

completion

Avacopan / ANCA AV Phase III trial

completion

Vadadustat Phase III trials

completion

Rayaldee®

launch

> CHF 1bn

reported sales

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© Vifor Pharma

CURRENT INDICATIONS

4 October 2018 31

NEPHROLOGY

NUMEROUS OPPORTUNITIES REMAIN

Polycystic kidney disease

Metabolic acidosis

Vascular calcification

Kidney stones

Hypernatremia

Fabry

aHUS

Diabetic nephropathy

Acute kidney injury

β-Thalassemia renal disease

FSGS

ANCA associated vasculitis

Uremic pruritus

C3G

Secondary hyperparathyroidism Hyperphosphatemia

Hyperkalemia

Anaemia

Iron deficiency

PIPELINE INDICATIONS POTENTIAL INDICATIONS

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© Vifor Pharma

COMMERCIAL

4 October 2018 32

NEPHROLOGY

LEADERSHIP ON THE WHOLE NEPHROLOGY CHAIN

CLINICAL PRE-COMMERCIAL

IN-LICENSING DEALS AND PARTNERSHIPS

Avacopan

Vadadustat CR845

CCX140

PRE DIALYSIS DIALYSIS

COMMERCIAL

PRE CLINICAL

DA

TA

GE

NE

RA

TIO

N

PARTNERSHIP

TRANSPLANTATION

COMMERCIAL

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© Vifor Pharma 4 October 2018 33

STRATEGY 2025

EXPLOIT OUR COMPETITIVE ADVANTAGES

1) Therapeutic areas

EXISTING GROWTH DRIVERS

Ferinject® – Exploit the potential

Veltassa® – Drive to blockbuster

VFMCRP – Launch products and enhance value

Licensing/acquisition across geographies & TAs1):

• Nephrology & Cardio-renal

• Gastroenterology

• Patient Blood Management

INORGANIC GROWTH – ADJACENT INDICATIONS

• Leverage U.S. commercial infrastructure

• Become EU partner of choice for non-European growth

companies

EXISTING INFRASTRUCTURE

• Exploit data & pay-for-performance (anaemia and

bone-mineral metabolism management, etc.)

• Replicate VFMCRP structure in other therapeutic areas

• Ferroportin inhibitor

NEW TECHNOLOGIES AND BUSINESS AREAS

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© Vifor Pharma

FERROPORTIN

INHIBITOR

4 October 2018 34

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© Vifor Pharma

• Diagnosis soon after birth

• Death at around 5 year old if left

untreated

• Approximately 13 to 15 million

patients worldwide

4 October 2018 35

• Bi-weekly blood transfusions

associated to unwanted iron load,

treated with iron chelators

• Iron chelators therapy bound with

potentially fatal chelator-

associated toxicities

• Current chelator market size of

approximately USD 1 billion,

expected to double by 2022

• VIT-2763 binding to ferroportin

expected to prevent excessive

iron release

• Iron transporter ferroportin key in

regulating and controlling iron

level in the blood

• Clinical Phase I started in March,

results expected at the end of

2018

FERROPORTIN INHIBITOR VIT-2763

HIGH UNMET NEED IN BETA-THALASSEMIA MAJOR

BETA-THALASSEMIA MAJOR CURRENT TREATMENT NEW APPROACH – VIT-2763

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© Vifor Pharma

2018 2027

4 October 2018

FERROPORTIN INHIBITOR VIT-2763

EXPECTED DEVELOPMENT TIMELINE

2023 2019 2020 2021 2022 2024 2025 2026

Filing

Launch

Phase III Phase II Phase I

36

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Part I – Ferinject®

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FERINJECT®

EXPLOITING THE POTENTIAL

Dario Eklund

Chief Commercial Officer

CAPITAL

MARKET DAY

2018

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© Vifor Pharma

GLOBAL I.V. IRON MARKET (MAT Q2 2018)1)

• Market totalled CHF 1’698 million, +15% versus prior year period

• Ferinject® growth represented 88% of the total market growth, with +32% versus prior year period

• Global market share of Ferinject® in value is 47% (54% in our top 10 markets)

16 38 58 81 123 163

240

374

535

692

850-880

4 October 2018 39

MAT = Moving annual total 1) Based on Quarterly IQVIATM MIDAS® panel, GERS, Insight Health, DLI, historical data at constant exchange rate (average 2017) 2) Estimate based on IQVIATM

FERINJECT®

BLOCKBUSTER BY 2020

Europe U.S. ROW

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018E2)

IN-MARKET SALES1)

CHF MILLION

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© Vifor Pharma

Switzerland

Australia

New Zealand

Sweden

Germany

Spain

France

UK

Italy

U.S.

Japan

China

5%

33%

47%

16%

16%

39%

16%

22%

53%

45%

0%

0%

40

Source: Quarterly IQVIATM MIDAS® panel, GERS, Insight Health

Launch Date

2008

2011

2012

2008

2007

2009

2011

2008

2012

2013

2019

2021

FERINJECT®

SIGNIFICANT MARKET OPPORTUNITY REMAINS

4 October 2018

Ferinject® Volume Per Capita (MAT Q2 2018) 100 mg eq./1’000 population

Ferinject® In-Market Volume Growth (MAT Q2 2017-18)

253

107

51

36

34

29

22

22

22

12

0

0

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© Vifor Pharma 4 October 2018

FERINJECT®

THE BLOCKBUSTER PLAN

41

Therapeutic

areas

• Heart Failure

• Patient Blood Management

• Nephrology

• Gastroenterology

Strong

partnerships

• Partnering with leading

companies

Geographic

expansion

• Japan

• China

• Key pharmerging markets

Life Cycle

Management

• AFFIRM-AHF

• HEART-FID1)

1) Daiichi Sankyo clinical trial

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Therapeutic area focus

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© Vifor Pharma

PATIENT DROP-OFF - EU5

4 October 2018 43

1) IRONOUT HF trial, JAMA. 2017;317(19):1958-1966

Source: CapSys patient drop-off analysis, April 2018, Countries included: DE, ES, FR, IT, UK

CHRONIC HEART FAILURE

HUGE OPPORTUNITY REMAINS

1

Not treated Oral iron Other i.v. iron Ferinject®

1’415K

386K 47K

84K

1’932K

With iron deficiency

Ferinject® addresses only

4% of all patients

Further generate and exploit

clinical data

Fastest growing indication in

Europe

Oral iron ineffective1)

Sales opportunity of

> CHF 450m

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© Vifor Pharma

Ferinject® addresses only

8% of all patients

Medical benefits for the

patients

Economic benefits for the

providers

Sales opportunity of

> CHF 200m

PATIENT DROP-OFF - EU5

4 October 2018 44

Source: Vifor Pharma analysis, Q1 2018, Countries included: DE, ES, FR, IT, UK

PATIENT BLOOD MANAGEMENT

OVER 1 MILLION PATIENTS OPPORTUNITY

1

Not treated Other i.v. iron Ferinject®

1’160K

96K 109K

1’365K

With iron deficiency

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© Vifor Pharma

STUDIES SHOW CONTRIBUTION TO IMPROVED OUTCOMES1)

4 October 2018 45

PATIENT BLOOD MANAGEMENT

ECONOMIC BENEFIT

1) Froessler B et al, Ann Surg. 2016 Jul;264(1):41-6; German costs data

1

Transfusions

EUR 76 Savings per patient

Hospital stay

EUR 1’050 Savings per patient

Iron therapy

EUR 340 Cost per patient

-

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Strong partnerships

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© Vifor Pharma 47

• 20+ year partnership with Daiichi

Sankyo

• Injectafer® high dose segment

sales leader

• 44.5% MAT1) Q2 2018 growth

of Injectafer® in local currency

• 2025 goal: blockbuster franchise

in the U.S. with Venofer® and

Injectafer®

U.S. I.V. IRON MARKET

GROWTH DRIVEN BY INJECTAFER®

Source: IQVIATM NPA Audit from 2013 to 2018 1) Moving annual total

4 October 2018

U.S. I.V. IN-MARKET SALES

$169 $184 $188 $195 $208 $214

$324 $318 $324 $322 $321 $320

$0 $24 $89

$181 $252

$364

0

250

500

750

1'000

MAT Q2-2013 MAT Q2-2014 MAT Q2-2015 MAT Q2-2016 MAT Q2-2017 MAT Q2-2018

Mil

lio

ns

Other i.v. irons Venofer Ferinject ® ®

US

D m

illio

n

Injectafer®

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© Vifor Pharma 4 October 2018 48

1) 3 months rolling share 2) Including low dose i.v. iron

Source: IQVIATM, volume in 100mg equivalents, data as of 09.2018

DAIICHI-SANKYO PARTNERSHIP

STRONG SUPPORT TO INJECTAFER® GROWTH

• Injectafer® is the fastest growing

i.v. iron in the U.S. market

• Injectafer® has gained volume

share from Feraheme® and

INFeD®

• INFeD® product shortage in Q2

2018

HIGH DOSE U.S. I.V. IRON PRODUCTS VOLUME SHARE

Vo

lum

e s

hare

1)

0%

10%

20%

30%

40%

50%

60%

70%

201

5-0

3

201

5-0

4

201

5-0

5

201

5-0

6

201

5-0

7

201

5-0

8

201

5-0

9

201

5-1

0

201

5-1

1

201

5-1

2

201

6-0

1

201

6-0

2

201

6-0

3

201

6-0

4

201

6-0

5

201

6-0

6

201

6-0

7

201

6-0

8

201

6-0

9

201

6-1

0

201

6-1

1

201

6-1

2

201

7-0

1

201

7-0

2

201

7-0

3

201

7-0

4

201

7-0

5

201

7-0

6

201

7-0

7

201

7-0

8

201

7-0

9

201

7-1

0

201

7-1

1

201

7-1

2

201

8-0

1

201

8-0

2

201

8-0

3

201

8-0

4

201

8-0

5

201

8-0

6

201

8-0

7

INFeD®

Shortage

Injectafer®

Feraheme®

INFeD®

Injectafer®2) January

2017

July

2018

Value share 29.5% 44.6%

Volume share 10.5% 20.5%

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© Vifor Pharma 4 October 2018 49

MAT = Moving annual total

Source: IQVIATM, U.S. claims data from 09.2018

SOURCE OF GROWTH IN THE U.S.

INJECTAFER® EXPANDING IN ALL THERAPEUTIC AREAS

VOLUME PER THERAPEUTIC AREA

Gastroenterology Hematology / Oncology Nephrology Ob / Gynecology Cardiology

0

100

200

300

400

500

600

700

800

MAT Q2 2017 MAT Q2 2018

Vo

lum

e in

th

ou

san

d 1

00m

g e

qu

ivale

nts

+57%

+38%

+41%

+74% +70%

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© Vifor Pharma 4 October 2018 50

INJECTAFER® AND VENOFER

®

BUILD A U.S. BLOCKBUSTER FRANCHISE

Maintain Venofer® leadership in dialysis and hospital

Strengthen Injectafer® market share leadership with hematology and oncology

specialists

Expand Injectafer® use with gastroenterology, cardiology, ob / gyn and

nephrology specialists

Execute clinical studies to create future growth opportunities

1

4

3

2

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Geographic expansion

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© Vifor Pharma 4 October 2018 52

1) Below 14ng/mL: National Health/Nutrition Survey conducted in 2009 in Japan (based on publication dated 23 July 2018)

FERINJECT® IN JAPAN

THE NEXT MAJOR LAUNCH

2018 2019

Expected launch by

Zeria Pharmaceuticals

Market access negotiation

in preparation

Two phase III clinical

trials completed

Ferinject® will have IDA label

(excluding dialysis)

Significant unmet patient needs in

Women’s Health and

Gastroenterology

Oral market

Only one i.v. low dose drug

Approx. 50% of women below 50

years old have low ferritin levels1)

Build awareness around high-dose

i.v. iron as the new standard therapy

Market access / pricing

MARKET OPPORTUNITIES CHALLENGES

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© Vifor Pharma 4 October 2018 53

1) Based on Quarterly IQVIATM MIDAS® panel, GERS, Insight Health, DLI 2) Southeast Asian J Trop Med Publi Health 2015 46(2) 306-21 3) As per Vifor Pharma internal research

FERINJECT® IN CHINA

SIGNIFICANT OPPORTUNITY IN PBM

2018 2019 2021 2020

Phase III clinical

trial initiation

Partner

selection

Phase III clinical

trial readout

Expected

launch

Significant medical unmet need

in patient blood management

~3-5 Mio patients per year with

IDA undergoing elective surgery3)

Second largest iron market globally

~ USD 200m1)

Estimated anaemia prevalence in

central and eastern China2) is

13.4% (so up to 180 Mio people)

Very competitive market

Fast changing environment

2017

MARKET OPPORTUNITIES CHALLENGES

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Life cycle management

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© Vifor Pharma 55

COMPREHENSIVE CLINICAL DATA GENERATION

CONTINUED FOCUS ON KEY DISEASE AREAS

Source: Vifor Pharma

> CHF 300m

invested so far in company-

sponsored trials

Two major heart failure trials

with > 4,000 enrolled patients

on-going

Additional 45 interventional

clinical studies completed

& 11 on-going

4 October 2018

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FERINJECT®

SERVING HEART FAILURE PATIENTS

Antonio Jordao

Regional Head Southern Europe

CAPITAL

MARKET DAY

2018

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© Vifor Pharma

PATIENT DROP-OFF EU5

1’932K

4 October 2018 57

Source: CapSys patient drop-off analysis, April 2018, countries included: DE, ES, FR, IT, UK

IRON DEFICIENCY IN CHRONIC HEART FAILURE

MAJORITY OF PATIENTS ARE LEFT UNTREATED

Not treated Oral iron Other i.v. iron Ferinject® With iron deficiency

1’415K

386K 47K

84K

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© Vifor Pharma

INCREASED MORTALITY2)-5)

4 October 2018 58

OTHER CONSIDERATIONS

• Up to 50% of patients with chronic

heart failure are iron deficient3)

• Iron deficiency in chronic heart failure

is associated with:

o Reduced quality of life1)6)7)

o Increased risk of hospitalisation2)

IRON DEFICIENCY IN CHRONIC HEART FAILURE

POOR OUTCOMES FOR THE PATIENTS

1) Enjuanes C et al. Int J cardiol 2014;174:268-75. 2) Martens P et al. Acta Cardiol 2018;73(2):115-23. 3) Klip IT et al. Am Heart J 2013;165(4):575-82. 4) Jankowska EA et al. Eur Heart J 2010;31:1872-80. 5) Yeo JT et al.

Eur J Heart Fail 2014;16:1125-32. 6) Wienbergen H et al. Am J Cardiol 2016;118(12):1875-80. 7) Comin-Colet J et al. Eur J Heart Fail 2013;15(10):1164-72.

100

80

60

40

20

0

0 1 2 3 4 5 6 7 8

Patients without iron deficiency

Patients with iron deficiency

P = 0.001

Time in study (years)

Cum

ula

tive s

urv

ival (%

)

Numbers at risk

Iron deficiency absent: Iron deficiency present:

753

753

386

343

104

100

63

49

40

33

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© Vifor Pharma

META-ANALYSIS – PATIENTS WITH EVENT

INCIDENCE PER 100 PATIENT-YEARS AT RISK

OBSERVATIONS

• Improves heart failure symptoms2)-4)

• Improves quality of life and exercise

capacity2)-4)

• Significant risk reduction in chronic

heart failure hospitalisations

4 October 2018 59

1) Anker SD et al. Eur J Heart Fail 2018;20(1):125-33 2) Ponikowski P et al. Eur Heart J 2016;37:2129-200. 3) Ponikowski P et al. Eur J Heart J 2015;36:657-68. 4) Anker SD et al. NEJM 2009;361:2436–48.

FERINJECT® USE IN CHRONIC HEART FAILURE

CLEAR CLINICAL BENEFITS TO PATIENTS

20

15

10

5

0 Placebo

34 (15.1)

Ferinject®

19 (6.3)

58%

hazard ratio

reduction1)

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© Vifor Pharma

4 October 2018 60

FERINJECT® EXPANSION IN CARDIOLOGY

THE SPANISH APPROACH

Awareness campaign

Education on diagnosis

and appropriate treatment

Focus on Ferinject®

differentiation

2014 – 2015

2015 – 2016

2017 onwards

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© Vifor Pharma

IN-MARKET SALES IN CARDIOLOGY IN SPAIN

96

207

360

0

50

100

150

200

250

300

350

400

450

MAT Q2-2016 MAT Q2-2017 MAT Q2-2018

Ferinject Venofer Other IV Iron

4 October 2018 61

FERINJECT® EXPANSION IN CARDIOLOGY

SUCCESSFUL APPROACH IN SPAIN

Source: Farma&Cia, Q2-2018, Vifor Pharma Data Analytics

Ferinject® CAGR

94%

® ® Other i.v. irons

Vo

lum

e in

th

ou

san

d 1

00m

g e

qu

ivale

nts

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© Vifor Pharma 4 October 2018 62

Source: CHF Psychodrama Market Research, K&A Brand Research, November 2017

FERINJECT® EXPANSION IN CARDIOLOGY

SPAIN AS A MODEL TO UNLOCK POTENTIAL IN EUROPE

Iron Deficiency Awareness Ferinject® Differentiation

Fe Ferinject®

Diagnosis and Treatment

Fe

50% prevalence of iron deficiency in

chronic heart failure patients

Focus on important heart-related

issues; iron deficiency perceived

as harmless by Cardiologists

Oral iron as easy and convenient

choice, even if ineffective

in chronic heart failure patients

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© Vifor Pharma

IMPORTANCE OF IRON IN HEART FAILURE

IRON DEFICIENCY AWARENESS

COMMERCIAL PROGRAM ROLLED OUT IN Q2 2018

4 October 2018 63

1) Hoes MF et al. Eur J Heart Fail 2018;20(5):910-19

IRON DEFICIENCY IMPAIRS CONTRACTILITY

OF HUMAN CARDIOMYOCYTES1)

Normal Cardiomyocytes

(in vitro)

Iron-deficient cardiomyocytes

(in vitro)

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© Vifor Pharma

Continuous online medical education on iron deficiency

4 October 2018 64

Integrated promotional program through digital channels

DIAGNOSIS AND TREATMENT

TARGETED INITIATIVES STARTED IN MAY 2018 IN EUROPE

MEDICAL EDUCATION DIGITAL AMPLIFICATION

7’500

Cardiologists

2018E

15’000

Cardiologists

2019E

8’500

Cardiologists

17’000

Cardiologists

2018E 2019E

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© Vifor Pharma

EFFICACY-HF

CURRENT EVIDENCE GENERATING NEW EVIDENCE

4 October 2018 65

FERINJECT® DIFFERENTIATION

GENERATING EVIDENCE OF UNIQUE BENEFIT

INCREASED

QUALITY OF LIFE

IMPROVED

EXERCISE CAPACITY

REDUCED RATE OF

HOSPITALISATION

DECREASE IN

MORBIDITY

DECREASE IN

MORTALITY

BENEFIT IN ACUTE

HEART FAILURE

FAIR-HF

CONFIRM-HF AFFIRM-AHF

HEART-FID

FAIR-HF2

EFFECT-HF FAIR-HFpEF

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© Vifor Pharma

IN-MARKET SALES IN CARDIOLOGY IN EU51)

239

467

740

0

200

400

600

800

1'000

1'200

MAT Q2-2016 MAT Q2-2017 MAT Q2-2018

Ferinject Venofer Other IV Iron

NEXT STEPS

• Awareness campaign rolled out

in Q3 2018

• Medical education and digital

amplification programs to accelerate

diagnosis and treatment

• Further strengthen guidelines with

clinical trials

4 October 2018 66

FERINJECT® DRIVING GROWTH IN CARDIOLOGY

EARLY STAGE OF A SUCCESS STORY IN EUROPE

1) France, Germany, Italy, Spain and UK

Source: Farma&Cia, Q2-2018, Vifor Pharma Data Analytics

Ferinject® CAGR

76%

® ® Other i.v. irons

Vo

lum

e in

th

ou

san

d 1

00m

g e

qu

ivale

nts

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Professor Aryeh Shander

Emeritus Chair, Department of Anesthesiology, Critical Care Medicine, Hyperbaric Medicine and Pain Mngmt, Englewood Hospital, NJ, USA

Adjunct Clinical Professor, Department of Anesthesiology, Medicine and Surgery at Icahn School of Medicine at Mount Sinai, NY, USA

Clinical Professor, Department of Anesthesiology, Rutgers New Jersey Medical School, NJ, USA

PBM – A CALL FOR ACTION TO

IMPROVE PATIENT OUTCOMES

67

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• PBM extends to all patient populations

• PBM offers appropriate therapy for a disease or condition

• Anaemia management is central to PBM

• Modifiable risk factor

• PBM is based on improving patient outcomes

• All consistent with “Clinical Care” and “Good Clinical Practice”

68

WHY PATIENT BLOOD MANAGEMENT?

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TRANSFUSION IS THE ‘DEFAULT’ TREATMENT FOR

ALL ANEMIC PATIENTS

One treatment for all patients

One size (does not) fit all

Transfusions are associated with worse clinical outcomes

High risk with low benefit

Expensive therapy with low benefit = poor efficacy

Cure vs. Treatment

Transfusion a short term therapy

I.v. iron – a cure!

69

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248 203 192 149

1'183

726 606

507

3'514

2'694 2'579

2'070

0

500

1'000

1'500

2'000

2'500

3'000

3'500

4'000

EHMC RIH CHUV AKH Linz

US

D

Mean RBC product cost Mean cost per RBC txn Mean txn cost per surgical pt txed

70

AKH Linz, General hospital Linz; CHUV, Centre Hospitalier Universitaire Vaudois; EHMC, Englewood Hospital and

Medical Center; pt, patient; RIH, Rhode Island Hospital; txed, transfused; txn, transfusion

ACTIVITY-BASED COST OF TRANSFUSION

FROM A PROVIDER’S PERSPECTIVE

Shander A et al. Transfusion 2010;50:753–65

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Anthes E. Evidence-based medicine: Save blood, save lives. Nature. 2015;520(7545):24-6.

«TRANSFUSION ARE ONE OF THE MOST OVERUSED TREATMENTS

IN MODERN MEDICINE AT A COST OF BILLIONS OF DOLLARS»

71

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Johns Hopkins Health System PBM Program across five hospitals

Approximately 400% return on investment for PBM efforts (alone with blood product cost savings)

72

Frank SM et al. Anesthesiology 2017;127:754–64

POSITIVE IMPACT OF PBM IMPLEMENTATION

ON HOSPITAL COSTS

• Across the entire health system changes in

utilization (number of units per 1000 patients) are

shown over time

• Financial results

o $2,120,273 blood acquisition cost savings

o Reductions in transfused units per 1000 patients

– RBCs 455 to 365 ( 19.8%; P<0.0001)

Blo

od u

tilis

ation

(units/1

000 p

atients

)

500

400

300

200

100

0

RBCs

2014

2015

2016

2017

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74

Menitove J. Hematologist 2018;15(3)

THE WORLD IS CHANGING!

… due to patient

blood management!

RB

Cs u

nits,

mill

ions

18

1992

17

16

15

14

13

12

11

1994 1997 1999 2001 2004 2006 2008 2011 2013 2015

RBCs distributed RBCs transfused

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75

“Is the scientific use of safe and effective

medical and surgical techniques designed

to prevent anaemia and decrease bleeding

in an effort to improve patient outcome”

PATIENT BLOOD MANAGEMENT

Patient and medical condition (disease) focused

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76 Hofmann A. Oncologist 2011;16 Suppl 3:3-11; Spahn DR, Goodnough LT. Lancet 2013;381:1855–65; Isbister JP. Best Pract Clin Anaesthesiol 2013;27:69–84; Goodnough LT, Shander A. Anesthesiology 2012;116:1367–76

THE ANSWER: 3 PILLARS CONCEPT OF PBM!

Optimise red cell

mass

Minimise

blood loss &

bleeding

Optimise

reserve of

anaemia

Anemia

ID

Blood Loss

&

Bleeding

Transfusion

3. Optimise anaemia tolerance 2. Minimise Blood Loss 1. Optimise RBC Mass

Sixty-third World Health Assembly

Date: 17-21 May 2010

Location: Geneva, Switzerland

WHA63.12 adopted by resolution May 21, 2010:

„Bearing in mind that patient blood management means that before surgery every

reasonable measure should be taken to optimize the patient’s own blood volume, to

minimize the patient’s blood loss and to harness and optimize the patient-specific

physiological tolerance of anaemia following WHO’s guide for optimal clinical use

(three pillars of patient blood management)“

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© Vifor Pharma

GBD 2013 Mortality and Causes of Death Collaborators. Lancet 2015;385:117–171

1990 2013 1990 2013 Year Males Females

0.0

0.1

0.2

0.3

Pre

vale

nce (

pro

port

ion)

Malaria

Hookworm disease

Schistosomiasis

Other infectious diseases

Other neglected tropical diseases

Maternal haemorrhage

Uterine fibroids

Other gynaecological diseases

Sickle cell disorders

Thalassaemias

G6PD deficiency

Other haemoglobinopathies and haemolytic

anaemias

Iron-deficiency anaemia

Other endocrine, nutritional, blood and

immune disorders

Gastritis and duodenitis

Peptic ulcer disease

Chronic kidney disease (due to

diabetes mellitus)

Chronic kidney disease (due to

hypertension)

Chronic kidney disease (unspecified)

THE GLOBAL BURDEN OF ANAEMIA

In 2010, 68.36m YLD or

8.8% of all conditions were

attributable to anaemia

4 October 2018 77

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© Vifor Pharma

Up to 28 Million

anemic surgical patients

78

4 October 2018

ESTIMATION OF GLOBAL VOLUME OF SURGERY

Source: Thomas G Weiser, Scott E Regenbogen, Katherine D Thompson, Alex B Haynes, Stuart R Lipsitz, William R Berry, Atul A Gawande

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Fowler A.J. et al. Br J Surg (2015) 102: 1314

949’449 patients of 24 studies analyzed

39% of patients were anemic (WHO definition)

Anaemia was associated with Perioperative mortality - Odd Ratio (OR) 2.90 (2.30 – 3.68, p< 0.001) Acute kidney injury - OR 3.75 (2.95 – 4.76, p< 0.001) Infections - OR 1.93 (1.06 – 1.55, p< 0.01) Stroke in cardiac surgery - OR 1.28 (1.17 – 3.18, p< 0.01) RBC transfusion - OR 5.04 (4.12 – 6.17, p< 0.001)

META-ANALYSIS OF THE ASSOCIATION BETWEEN

PREOPERATIVE ANAEMIA AND MORTALITY AFTER SURGERY

Systematic review

79

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48

5

50

8

37

5

11

36

21

3

27

4

76

4

60

7

79

4

46

2

83

4

10

43

44

8

19

8

0

1

2

3

4

5

6

0

200

400

600

800

1000

1200

# o

f ca

se

s

OMR

n = 8108

NJ OMR - 2.89 %

3.54

1.51

1.23

PBM

COMPARING CORONARY MORTALITY RATES

80

Observed

Mortality

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THE BENEFIT OF PBM AND OPTIMAL ANAEMIA TREATMENT

EXAMPLE OF A STATE-WIDE PBM IMPLEMENTATION

81

Leahy MF et al. Transfusion 2017;57:1347-58

Clinical results/patient outcomes:

• In-hospital mortality 28%

• Length of hospital stay 15%

• Infection 21%

• Stroke 31%

Financial results over 6 years:

• $18’500,000 blood acquisition cost savings

• $80’000’000 to 100’000’000 activity-based cost

savings

Key measures indicators:

• Proportion admitted anaemic decreased from 20.8% to

14.4% (P=0.001)

• 41% reduction in blood product usage (P<0.001)

Improving outcomes while saving costs :

PBM in all emergency and elective medical and surgical patients in four tertiary hospitals in Western Australia

n=605,046

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REVIEW ARTICLE

Improving outcome of

trauma patients by

implementing patient

blood management Füllenbach C, Zacharowski K, and

Meybohm P

Curr Opin

Anaesthesiol. 2017,

30 (2):243-249

EDITORIAL

Promoting Safety,

Quality, and Value

through Patient

Blood Management Waters MD

Anesthesiology 2017,

127(5):738-740

REVIEW ARTICLE

Patient Blood

Management Equals

Patient Safety Zacharowski K. Spahn, DR

Anesthesiology 2016,

30(2):159-169

82

SPECIAL

COMMUNICATION

Promoting High-Value

Practice by Reducing

Unnecessary

Transfusions with a

Patient Blood

Management Program Sadana D, Pratzer A, Sher LJ, Saag

HS, Adler N, Volpicelli FM, Auron M,

Frank SM

JAMA Intern Med.

2018, 178(1):116-122

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• Addresses the high prevalence of anaemia

• Identifies Iron Deficiency Anaemia (IDA) as number one condition

• Strongly recommends the treatment with i.v. iron

• Oral iron ineffective in this population

CONSENSUS STATEMENT

International Consensus Statement on the Peri-Operative management od Anaemia and

Iron Deficiency

Munoz M et al

Anaesthesia. 2017, 72(2):233-247

83

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OPTIMAL ANAEMIA TREATMENT AND

THE BENEFIT OF PATIENT BLOOD MANAGEMENT

84 Source: references added in the notes

Pre-operative iron deficiency anaemia treatment

> 700 patients treated with Ferinject®

Post-operative iron deficiency anaemia treatment

> 500 patients treated with Ferinject®

Iron deficiency anaemia treatment in the intensive care unit

> 100 patients treated with Ferinject®

Key findings

Reduction of transfusion rate

Increase of Hb and iron store levels

Reduction of length of stay

Reduction of infection rates

Well tolerated treatment

Treatment of perioperative IDA with Ferinject® has been studied in 16 major studies with more than

1’300 patients, incl. RCTs, single-arm studies and observational studies

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OPPORTUNITIES FOR VIFOR PHARMA

• Become a leader in PBM through championing the anaemia cause

• Deliver a compelling message to regulators and payers

• Be on the forefront of this REAL change in paradigm

• Develop relationships with other non competing industry partners to

develop a comprehensive disease management approach

85

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Part II – Veltassa®

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VELTASSA® UPDATE

Patrick Treanor

President ad interim, Relypsa

CAPITAL

MARKET DAY

2018

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© Vifor Pharma 4 October 2018 88

VELTASSA®

OVERVIEW OF KEY FEATURES

1) SmPC = summary of product characteristics

RAASi enabling

Included in SmPC1) in Europe

Room temperature storage

U.S.: 3 months / EU: 6 months

High safety profile

Limited undesirable effects

Mode of action

Calcium-based, non-absorbed

Broad use

Acute & Chronic

52-weeks data

AMETHYST-DN study

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© Vifor Pharma

U.S.

4 October 2018 89

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© Vifor Pharma

VELTASSA® DEMAND PER BUSINESS DAY1)

NUMBER OF 30 COUNTS EQUIVALENT BOXES

HIGHLIGHTS

• One of the fastest growing drugs

in nephrology in last 10 years2)

• Year over year demand growth

of +81% (H1 2017 vs. H1 2018)

• All time high in demand reached

in August

0

100

200

300

400

500

600

700

Jan

-16

Fe

b-1

6

Ma

r-1

6

Ap

r-16

Ma

y-1

6

Jun

-16

Jul-

16

Au

g-1

6

Se

p-1

6

Oct-

16

Nov-1

6

Dec-1

6

Jan

-17

Fe

b-1

7

Ma

r-1

7

Ap

r-17

Ma

y-1

7

Jun

-17

Jul-

17

Au

g-1

7

Se

p-1

7

Oct-

17

Nov-1

7

Dec-1

7

Jan

-18

Fe

b-1

8

Ma

r-1

8

Ap

r-18

Ma

y-1

8

Jun

-18

Jul-

18

Au

g-1

8

4 October 2018 90

VELTASSA® DEMAND PER BUSINESS DAY

CONTINUOUS INCREASE

1) Internal data 2) EvaluatePharma

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© Vifor Pharma 4 October 2018 91

1) Sodium polystyrene sulfonate

Source: IQVIATM MIDAS® Quarterly panel Q2-2018, average 2017 exchange rates have been applied.

VELTASSA® U.S. MARKET SHARE

67.4% OF POTASSIUM BINDER MARKET

MAT Q2 2015

MAT Q2 2018

SPS1)

100%

32.1 Million CHF

86.1 Million CHF

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© Vifor Pharma

VELTASSA® PAYER COVERAGE

U.S. LIVES COVERED, %

HIGHLIGHTS

• ~24M lives added or

improved coverage for

Veltassa® since early 2018

• 55% of U.S. lives covered

without prior authorization

• Recent coverage expansion

increased Medicare Part D

coverage to 64%1)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

No

v-1

5

De

c-1

5

Jan-1

6

Feb

-16

Ma

r-1

6

Apr-

16

Ma

y-1

6

Jun-1

6

Jul-1

6

Aug-1

6

Sep-1

6

Oct-

16

No

v-1

6

De

c-1

6

Jan-1

7

Feb

-17

Ma

r-1

7

Apr-

17

Ma

y-1

7

Jun-1

7

Jul-1

7

Aug-1

7

Sep-1

7

Oct-

17

No

v-1

7

De

c-1

7

Jan-1

8

Feb

-18

Ma

r-1

8

Apr-

18

Ma

y-1

8

Jun-1

8

Jul-1

8

4 October 2018 92

VELTASSA® MEDICARE COVERAGE INCREASED

STRONG INCREASE FROM 44% TO 64%

1) Increase to at least 67% expected as of 1 January 2019

All lives 88%

Medicare 64%

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© Vifor Pharma

OUT-OF-POCKET (OOP) COSTS

IN PERCENT OF U.S. LIVES COVERED

HIGHLIGHTS

• Median OOP is $6 for all

approved claims

• ~50% of Veltassa® Medicare

claims are Low-Income

Subsidy (LIS)

75%

25%

$0-25

$26+

4 October 2018 93

VELTASSA® OUT-OF-POCKET COSTS

75% OF PATIENTS PAY $25 OR LESS

Source: Symphony Source Health Analytics Primary-Final Plan Benefit Design Report (July 2017-June 2018)

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© Vifor Pharma 94

NEPHROLOGISTS FEEDBACK

POSITIVE EXPERIENCES WITH VELTASSA®

Rated very highly by Nephrologists

Prescribers continue to expand usage

of Nephrologists believe

VELTASSA® is appropriate for

long-term treatment of

Hyperkalemia 94% 93%

89%

of Nephrologists believe

VELTASSA® is effective in

restoring K+ levels to target range

of Nephrologists have prescribed

VELTASSA® in the past three

months

Source: Relypsa data on file.

Over 10,750 physicians have

treated nearly 65,000 patients with

VELTASSA® since launch 65K

4 October 2018

Source: Based on a survey of 100 nephrologists conducted in August 2018 by Putnam Associates. Source: Based on a survey of 100 nephrologists conducted in August 2018 by Putnam Associates.

Source: Relypsa data on file.

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© Vifor Pharma

3 MILLION HYPERKALEMIA PATIENTS IN THE U.S.

4 October 2018 95

U.S. MARKET OPPORTUNITY

• 3 million potential patients

• Gross price of USD 820 per month

• Targeted duration of treatment: 6 months

• 10% treated with Veltassa®

= USD 1 billion in net sales (blockbuster)

Key drivers of success:

• Awareness ✓

• Access ✓

• Duration of treatment ✓

VELTASSA® U.S. RAMP-UP

KEY CONSIDERATIONS

Source: USRDS 2013 ADR, CDC

10.7

4.7

2.3 1.7

0.8 0.5

0

2

4

6

8

10

12

CKD 3-4 only CKD 3-4 with HF HF only

Total Prevalence With hyperkalemia

Pati

en

ts (

in m

illio

n)

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© Vifor Pharma

EUROPE

4 October 2018 96

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© Vifor Pharma

PATIENTS TREATED

4 October 2018 97

PATIENT FEEDBACK

VELTASSA® ROLLOUT IN EUROPE

OVERVIEW OF FIRST ACHIEVEMENTS

1) Pre-License Access Program

0

250

500

750

1000

Mar-18 Apr-18 May-18 Jun-18 Jul-18 Aug-18 Sep-18

Commercial & PLA1)

“Being diagnosed with high

potassium changed my life

completely. I was so scared

in the beginning, but now

there is hope.”

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© Vifor Pharma

Scotland Finland

4 October 2018 98

COMMERCIAL LAUNCH & REIMBURSEMENT

CURRENT STATUS

Switzerland Germany United Kingdom

Spain Italy France

Sweden Denmark

Norway Austria

REIMBURSEMENT

OBTAINED

REIMBURSEMENT

SUBMITTED

LAUNCHED

AVAILABLE

DELAYED

INITIAL

REJECTION

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© Vifor Pharma

GLOBAL APPROACH

TO DATA

GENERATION

4 October 2018 99

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© Vifor Pharma

RESULTS EXPECTED

ENROLLMENT

STUDY

4 October 2018 100

1) Chronic heart failure

LIFE CYCLE MANAGEMENT

UNLOCK FULL POTENTIAL WITH DATA

Enrolment of 290

patients completed

AMBER DIAMOND

Expected enrolment of

2’400 patients starting

Q1 2019

STRATEGIC OBJECTIVES

Increase accessible

patient pool U.S. label change

H1 2019 2022

Increase access to

patients with CHF1)

Guideline updates for

the management of

arterial hypertension

Guideline updates

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© Vifor Pharma

COMPETITIVE

UPDATE

4 October 2018 101

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© Vifor Pharma 4 October 2018 102

1) Veltassa® SmPC En. 2017 2) LokelmaTM SmPC En. 2018 3) Sanofi-Aventis, Resonium A SmPC, 2014, Kayexalate PI, 2010

* hypokalaemia, oedema ** 2 hours separation in FDA label *** U.S. PI advise 3-6 hour drug separation

VELTASSA®

A COMPELLING SAFETY/EFFICACY PROFILE

Novel therapeutic options Existing treatments

Veltassa® (patiromer)1) Sodium Zirconium

Cyclosilicate2)

Sodium Polystyrene

Sulphonate3)

No sodium content

Consistently well tolerated *

Drug-drug interactions 3 hours None** 3-6 hours***

Robust evidence for onset of effect

in 4-7 hrs

Onset of action 4-7 hours 2.2 hours 1-2 hours

1yr prospective data showing high tolerability

and efficacy

RAASi enablement in SmPC

Once-daily oral dose

Available dosages 8,4 g, 16,8 g, 25,2 g (sachets) 5 g, 10 g (sachets) 15 to 60 g per day (powder)

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© Vifor Pharma 4 October 2018 103

1) Stifel, Vifor Pharma Company Update, 22.05.2018

VELTASSA ®

FROM AN OUTSIDE PERSPECTIVE1)

LABEL FEATURE ANALYST’S PREFERENCE

Indication No difference

Limitations No difference

Mechanism Veltassa® - calcium exchange mechanism preferable to sodium

(concerns about increasing sodium levels, particularly in cardiology)

Dosage and

administration

Veltassa® - focus is on chronic management, clearer proposition, not convinced by

3x daily acute phase with LokelmaTM (potential confusion on positioning)

Dosage forms LokelmaTM (just) – slight preference, on lower volume of water, appears to be more

miscible powder

Storage LokelmaTM - no need for cold chain distribution

Warnings and

precautions

Veltassa® - similar potential impact on GI motility, but edema issue (sodium-related)

with LokelmaTM a key concern, requires more monitoring, changes to diet, diuretics

Adverse reactions No difference - more apparent GI issues with Veltassa®, offset by edema issues

with LokelmaTM

Drug interactions LokelmaTM – 2h interval better than 3h, although drug-drug interactions more

theoretical according to lab experiments

Clinical data No difference

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© Vifor Pharma

U.S.

• Strong demand continues

• Access improved to 88% of covered lives (Medicare 64%)

Product specific

• Extremely high satisfaction level from clinicians

• Uniquely differentiated versus competition

• Continued focus on building awareness

• Clinical studies focused on promoting benefits in cardiology

Europe

• Successful commercial launch in five countries

• Fragmented pricing & reimbursement process being systematically addressed

4 October 2018 104

VELTASSA® SUMMARY

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Importance of RAASi for HCPs and patients - Benefit of Veltassa® from a cardiologist point of view

Stefan D. Anker, MD PhD

Division of Cardiology & Metabolism:

Heart Failure, Cachexia and Sarcopenia

Dept of Cardiology & BCRT, Charité (CVK), Berlin, Germany

[email protected]

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The world of potassium

Nyirenda MJ, et al. BMJ 2009;339:bmj.b41114

• The most abundant cation in the body

• 98% intracellular

• Complex regulation of intracellular/extracellular

• Long-term K+ homeostasis mainly governed by renal

excretion

• Normal plasma K+ is tightly regulated despite variable

intake

• Disorders of K+ levels profoundly affect membrane

excitability and nerve, muscle and cardiac function

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Serum K+ Values

1. Rastegar A, et al. Postgrad Med J. 2001;77:759–64; 2. Einhorn LM, et al. Arch Intern Med. 2009;169:1156–62; 3. Kovesdy CP. Am J Med. 2015;128:1281–7.

K+, potassium.

Serum K+ levels (mEq/L)

3.0 3.5 4.0 4.5 5.0 5.5 6.0

Hypokalemia Normokalemia Hyperkalemia

MILD MODERATE SEVERE

6.5

Hypokalemia Normokalemia Hyperkalemia

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Mechanisms causing hyperkalemia

Causes

Excess potassium intake Potassium supplement

Enteral nutrition (e.g. whole protein formulas with high electrolyte content)

Potassium redistribution

Acidosis Hyperglycemia Insulin deficiency or resistance

Certain drugs, such as digoxin (toxicity) and succinylcholine

Strenuous exercise Hemolysis

Damage to tissue from rhabdomyolysis, burns, or trauma

Tumor lysis syndrome

Reduced potassium excretion

Impaired renal function Diabetes mellitus Heart Failure Obstructive uropathy

Diseases with low levels of or lack of response to aldosterone

Renin-angiotensin-aldosterone system (RAAS) inhibitors

Major causes of hyperkalaemia

www.stedmansonline.com (accessed 28.8.2015) www.nlm.nih.gov/medlineplus/mplusdictionary.html (accessed 28.8.2015)

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What are the risks associated with hyperkalaemia?

1. Alfonzo A, et al. UK Renal Association Clinical Practice Guidelines. 2014;

2. Xi L, et al. J Geriatr Cardiol. 2015;12:119–26.

* p=0.021

ECG, electrocardiogram.

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Elevated K+ is associated with an increase in all-cause mortality

Collins AJ, et al. Am J Nephrol. 2017;46:213–21.

An evaluation of medical records

demonstrated an increase in all-cause

mortality with elevated K+ in those

patients with comorbidities*

Co-morbidities included DM, HF,

CKD Stages 3–5, CVD or hypotension

Baseline serum K+ level (mEq/L)

Hyperkalaemia Normokalaemia Hypokalaemia

CKD, HF, DM CKD, HF DM Control group N=911,698

Shading surrounding lines indicates 95% confidence limits. *Evaluated through de-identified medical records (2007–2012) of individuals with ≥2 serum K+ readings (Humedica, Cambridge, MA). Spline analyses were performed to assess mortality at 0.1 mEq/L increments of serum K+ after adjusting for covariates and interactions. Patiromer clinical trials were not designed to measure mortality outcomes. CKD, chronic kidney disease; CVD, cardiovascular disease; DM, diabetes mellitus; HF, heart failure; K+, potassium

Predicted probability of mortality

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Patients with or without CKD who experience hyperkalaemia once, are at greater risk of recurrent hyperkalaemia events

Einhorn LM, et al. Arch Intern Med. 2009;169:1156–62.

50%

of patients with hyperkalaemia* had

2 or more recurrences within 1 year

Some patients experienced

>20 recurrent episodes within 1 year†

*Hyperkalaemia was defined as serum K+ ≥5.5 mEq/L (1 mEq/L = 1 mmol/L); †70 individuals (0.21%) had more than 20 episodes in 1 year. CKD, chronic kidney disease.

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Hyperkalaemia in heart failure patients increases as renal function declines

Go AS, et al. N Engl J Med 2004;351:1296–305.

eGFR: estimated glomerular filtration rate; MRA: mineralocorticoid receptor antagonist; WRF: worsening renal function. * Randomized Aldactone Evaluation Study: Double-blind trial in 1,658 patients with NYHA functional Class III or IV heart failure and ejection fraction ˂35% randomized to spironolactone 25mg (which could be titrated to 50mg) or placebo daily.

Ra

te o

f h

yp

erk

ala

em

ia

(% o

f p

atie

nts

)

6.08.5

6.7

13.315.4

25.6

18.2

30.2

0

5

10

15

20

25

30

35

Baseline eGFR ≥60 Baseline eGFR <60 No WRF WRF

Placebo Spironolactone

Intra-study change in renal function

Analysis based on RALES trial*

Baseline renal function

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All RAAS inhibitors increase serum K+ levels

dRi

ACEi

ARB

MRA

K+ retention

Na+/water uptake

Angiotensin I

AT1 receptor

Angiotensin II

Aldosterone production

Mineralocorticoid receptor

Angiotensinogen

ARNi

Rossignol P, et al. Circ Heart Fail 2014;7:51–58.

ACEi, angiotensin-converting-enzyme inhibitor; ARB, angiotensin receptor blocker; ARNi, angiotensin receptor-neprilysin inhibitor; dRi, direct renin inhibitor; HF, heart failure; MRA, mineralocorticoid receptor antagonist; RAAS, renin-angiotensin-aldosterone system.

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Hyperkalaemia is common with RAASi

Hyperkalemia Prevalence

(% of Patients)

Clinical Trials EMPHASIS-HF1 PARADIGM-HF2 SOLVD3 CHARM-Added4 RENAAL5 IDNT6

Serum K+ Level > 5.5 mEq/L > 5.5 mEq/L > 5.5 mEq/L > 6.0 mEq/L ≥5.5 mEq/L >6 mEq/L

Patient Population

HF with reduced EF HF with EF of 40%

or less HF with EF of 35%

or less

HF with EF of 40% or less and were treated with

ACEi Diabetic nephropathy Diabetic nephropathy

Pts were also taking spironolactone at baseline

11.8

16.0

6.4

4.0

10.8

18.6

7.2

17.0

2.5

1.0

5.1 6.0

0.0

5.0

10.0

15.0

20.0

EMPHASIS PARADIGM SOLVD CHARM-Added RENAAL IDNT

Eplerenone Placebo Enalapril LCZ696 Enalapril Placebo Candesartan Placebo Losartan Placebo Irbesartan Placebo

ACEi, angiotensin-converting enzyme inhibitor; EF, ejection fraction; HF, heart failure; Ks , potassium; Pts, patients; RAASi,renin-angiotensin-aldosterone system inhibitor.

1. Zannad F, et al. N Engl J Med. 2011;364:11-21. 2. McMurray JJ, et al. N Engl J Med. 2014;371:993-1004. 3. SOLVD Investigators, et al. N Engl J Med. 1991;325:293-302.

4. McMurray JJ, et al. Lancet. 2003;362:767-771. 5. Miao Y et al. Diabetologia. 2001;54:44-50. 6. Avapro [package insert]. Bridgewater, NJ: Sanofi-Aventis US LLC; 2014.

RAASi

Placebo

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Guidelines strongly recommend all RAASi to improve mortality and morbidity in HFrEF

HfrEF, heart failure with reduced ejection fraction; RAASi, renin–angiotensin–aldosterone system inhibitor.

EUROPE USA CANADA AUSTRALIA GLOBAL

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Hyperkalaemia frequently causes RAASi to be discontinued

In a quarter of patients with a serum K+ of >5.5 mEq/L ACEis/ARBs were reduced in dose or discontinued in a study of 194,456 patients*

*Geisinger Health Care database, retro-spective analysis of patients with outpatient visit and a blood pressure measurement in 44 counties in Pennsylvania in the time period of January to October 2011 ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; RAASi, renin–angiotensin–aldosterone system inhibitor. Chang AR, et al. Hypertension 2016;67:1181-8.

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Maximum RAASi dose is associated with a reduced incidence of mortality in the cardio-renal setting*

40

20

0

9.8%

20.3% 22.4%

13.7%

27.7% 30.1%

4.1% 8.2%

11.0%

CKD stages 3–4 Heart failure Total population

Pe

rce

nt

of

pa

tie

nts

(N=43’288 total patients

across dose categories)

(N=20’529 total patients

across dose categories)

(N=201’655 total patients

across dose categories)

Maximum dose

Discontinued

Submaximum dose

Epstein M, et al. Am J Manag Care 2015;21:S212–20.

* A large US database study including over 200’000 patients with the requirement of 1 RAAsi prescription within 12 months prior to July 1, 2009 CKD, chronic kidney disease; RAASi, renin-angiotensin-aldosterone system inhibitor.

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Guidelines recommend RAASi dose modifications with increasing serum K+

1. Yancy CW, et al. Circulation. 2016;134:e282–93; 2. Yancy CW, et al. Circulation. 2013;128:1810–52; 3. Ponikowski P, et al. Eur Heart J. 2016;37:2129–200;

4. Heart Failure Society of America, et al. J Card Fail. 2010;16:475–539; 5. KDIGO Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int Suppl. 2013;3;

6. National Institute for Health and Clinical Excellence. Chronic kidney disease (partial update): Early identification and management of chronic kidney disease in adults in primary and secondary care. 2014;

7. National Kidney Foundation. Guideline 11. http://www2.kidney.org/professionals/kdoqi/guidelines_bp/guide_11.htm. Accessed February 17, 2015.

Serum K+ threshold before change in RAASi guideline recommendation

>6.0

>5.5

>5.0

Serum K+ (mEq/L)

Most conservative Most aggressive

K/DOQI7: Discontinue ACEi/ARB if >5.5

ESC HFA3: Discontinue ACEi/ARB if >5.5;

Halve dose of MRA if >5.5

ACC/AHA HF2 and HFSA HF4:

MRA not recommended >5.0

K/DOQI7:

Halve dose of RAASi if >5.0

NICE CKD6: don’t routinely start

RAASi if >5.0

NICE CKD6: Stop RAASi if >6.0 ESC HFA3: Stop MRA if >6.0*

ACC/AHA/HFSA HF1, ESC HFA3:

ACEi/ARB use with caution >5.0

KDIGO Guidelines do not provide recommendations.5 *ESC HFA: Management of acute hyperkalaemia (>6.0) may require a short-term cessation of K+-retaining agents and RAASi, but this should be minimised and RAASi should be carefully reintroduced as soon as possible while monitoring K+ levels.3 ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; MRA, mineralocorticoid receptor antagonist; RAASi, renin-angiotensin-aldosterone system inhibitor.

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Patients who benefit the most from RAASi therapy are the patients at greatest risk of hyperkalaemia

Palmer BF et al. N Engl J Med. 2004;351:585-92.

CARDIO-RENAL PROTECTION

Prescribe or continue RAASi and accept the

presence of hyperkalaemia?

MANAGEMENT OF HYPERKALAEMIA

Avoid, discontinue or down-titrate RAASi

and lose the benefits on clinical outcomes?

RAASi, renin-angiotensin-aldosterone system inhibitor

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Why is the recognition and treatment hyperkalaemia increasingly important?

The incidence of hyperkalemia is increasing, and this is exacerbated by RAAS inhibitor use1–3

2010 2030

5.7M

8M

CHRONIC KIDNEY DISEASE

2009 2022

26M

46M

HEART FAILURE

US

Pa

tien

t N

um

be

rs

Reduced kidney function is the most

common cause of uncontrolled K+

Poor cardiac output leads to renal

insufficiency

A serum potassium level of ≥4.5 mEq/L is associated with mortality and arrhythmias

Unfortunately, current treatment have limitations

1. Einhorn LM, et al. Arch Intern Med 2009;169:1156–62; 2. Desai A, et al. Curr Heart Fail Rep. 2009;6:272-80; 3. Raebel MA, et al. J Gen Int Med 2010;25:326–33

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Patiromer is a novel, non-absorbed K+ binder

Li L, et al. J Cardiovasc Pharmacol Ther. 2016;21:456–65.

GI, gastrointestinal; K+, potassium.

Patiromer is a novel, spherical, non-absorbed polymer – High-capacity K+ binder – Average bead size (100 μM) is too large for Patiromer to be absorbed – Site of action is primarily from the colon where K+ is the most abundant cation

and residence time of the polymer is the longest – Calcium is the counter-exchange ion

High-capacity polymer Uniform, spherical patiromer beads

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Patiromer clinical studies

1. Huang I-Z, et al. J Am Soc Nephrol. 2010;21(Suppl):482A(F-PO1615); 2. ClinicalTrials.gov. NCT02033317. 3. Pitt B, et al. Eur Heart J. 2011;32:820–8;

4. Buysse J, et al. Future Cardiol. 2012;8:17–28; 5. Pitt B, et al. ESC Heart Fail. 2018;5:257−66; 6. Bakris GL, et al. JAMA. 2015;314:151–61;

7. Weir M, et al. N Engl J Med. 2015;372:211–21; 8. Weir M, et al. Presented at the American Society for Hypertension 2015, New York, NY: Abstract#LB-P-01;

9. Bushinsky DA, et al. Kidney Int. 2015;88:14–27; 10. Lesko LJ, et al. J Cardiovasc Pharmacol Ther. 2017;22:434–46; 11. Pergola P, et al. Am J Nephrol. 2017;46:323–32.

Proof of Concept

Prevention Treatment Post-US Approval

HF with/without CKD3,4

202

PEARL-HF

HK, CKD, T2DM, HTN6 205

(52-week safety & efficacy)

AMETHYST-DN

HK with CKD9

103

Effect of patiromer taken with or

without food11 401

(TOURMALINE)

CKD with HF5

204 HK with CKD7,8

301 (Phase 3 pivotal)

OPAL-HK

DDI Studies10

Healthy volunteers1

101

Haemodialysis subjects2

201

Healthy volunteers1

102

2008 2009 2010 2011 2013 2014 2015 2016

CKD, chronic kidney disease; DDI, drug–drug interaction; DN, diabetes nephropathy; HF, heart failure; HK, hyperkalaemia; HTN, hypertension; T2DM, type 2 diabetes mellitus.

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Populations studied in Patiromer trials

1. Data on file. Relypsa, Inc. Redwood City, CA; 2. Weir MR, et al. N Engl J Med. 2015;372(3):211–21;

3. Bakris G, et al. Poster presented at: ASN Kidney Week 2014; Philadelphia, PA; November 11-16, 2014; Poster SA-PO1099; 4. Vifor. Veltassa® Summary of Product Characteristics 2017.

*88% had ≥stage 3 CKD (29% had stage 4 CKD) **K+ 5.1 to <6.5 mEq/L ***60% >65 years of age (20% ≥75 years) CKD, chronic kidney disease; K+, potassium; RAASi, renin-angiotensin-aldosterone system inhibitor.

97% Hypertension1 88% CKD*1 49% Heart Failure1

73% Diabetes Mellitus1 60% over 65 Years***1,2 99.4% taking RAASi4

Wide range of severity of hyperkalaemia** 42% of subjects had a serum K+ ≥5.5 mEq/L at baseline2,3

8% of subjects had a serum K+ ≥6.0 mEq/L at baseline1

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Summary of Patiromer clinical studies

1. Bakris GL et al. JAMA. 2015;314:151-61; 2. Weir MR et al. N Engl J Med. 2015;372:211-21. 3. Pitt B et al. Eur Heart J. 2011;32:820

CHF, chronic heart failure; CKD, chronic kidney disease, DN, diabetic nephropathy, HF, heart failure; HK, hyperkalaemia; K+, potassium,; RAASi, renin-angiotensin-aldosterone system inhibitor; T2DM, type 2 diabetes mellitus * eGFR 15-59 mL/min/1.73 m²

• Lowest starting doses effective with minimal titration required • Long-term safety and efficacy data to support chronic use

• Significant and clinically meaningful serum K+ reduction, with maintenance

of serum K+ control and ability to keep patients on RAASi medications • Recurrence of HK on treatment withdrawal demonstrated need for long-

term chronic treatment

• In normokalaemic patients with CHF at risk of HK starting spironolactone

therapy, administration of patiromer compared with placebo: • Significantly reduced mean K+ levels

• Prevented hyperkalaemia

• Allowed a significantly greater percentage of patients to increase spironolactone doses to 50 mg/day

AMETHYST-DN (Phase II)1 52-week, open-label, randomized, dose-ranging study in patients with T2DM, CKD* and HK on ≥1 RAASi

OPAL-HK (Phase III):2 12-week, two-part, single-blind randomized withdrawal study in patients with HK and CKD* on ≥1 RAASi

PEARL-HF (Phase II):3 4-week, double-blind, randomized, placebo-controlled study in patients with HF and CKD* on ≥1 RAASi or with a history of HK with discontinuation of ≥1 RAASi

Design Results

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New studies for more evidence – AMBER

100% Resistant Hypertension 100% CKD 51% Heart Failure

47% Diabetes Mellitus 71% over 65 Years 99.3% taking RAASi4

Enabling spironolactone in

in patients with resistant hypertension for prevention of hyperkalaemia

Agarwal R et al. Am J Nephrol 2018;48:172–180

Baseline characteristics of first 146 patients Results are projected to be available in H1 / 2019

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Conclusion

• Elevate K+ levels are associated with poor outcome

• Hyperkalaemia is common and recurrent in CV diseases

• Current treatments for hyperkalaemia have limitations, in particular in the long-term management

• RAASi therapy is the cornerstone treatment in CV diseases

• Patiromer can treat hyperkalaemia and shows promise to enable optimal use of life-saving RAASi therapy

CV, cardiovascular; K+, potassium; RAASi, RAASi, renin-angiotensin-aldosterone system inhibitor .

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Part III – Vifor Fresenius

Medical Care Renal Pharma

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THE JOINT COMPANY

David Bevan

CEO, Vifor Fresenius Medical Care Renal Pharma

CAPITAL

MARKET DAY

2018

A UNIQUE PARTNERSHIP

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© Vifor Fresenius Medical Care Renal Pharma 4 October 2018 129

1) Pre-commercial products

THE JOINT COMPANY

THE RATIONALE

STRONG IRON AND PHARMA EXPERTISE

GLOBAL LEADER IN DIALYSIS

Avacopan1) CCX1401)

55% Stake

45% Stake

Vadadustat1)

CR8451)

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© Vifor Fresenius Medical Care Renal Pharma 4 October 2018 130

THE JOINT COMPANY

HIGHLY REPUTABLE DIRECTORS

1) Fresenius Medical Care North America

Etienne Jornod Executive Chairman

Stefan Schulze President of the Executive

Committee and COO

Colin Bond Chief Financial Officer

Rice Powell Chief Executive Officer

and Chairman

Michael Brosnan Chief Financial Officer

Frank Maddux Chief Medical Officer

FMCNA1)

David Bevan Chief Executive Officer

VFMCRP

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© Vifor Fresenius Medical Care Renal Pharma

Focus on pharma needs of nephrology patients – Global Leader

Access to patient data. Faster clinical trial execution

Faster uptake and utilisation

Partnership technically controlled by Vifor Pharma

Registered in Switzerland

Sourcing of innovation

Evaluation of clinical assets

Acceptance of clinical risk

Regulatory and market access expertise

4 October 2018 131

Managed care expertise

Patient access (>300k patients)

Validation of innovation

Medications in FKC clinics1) become SoC2)

THE JOINT COMPANY

VALUE BEYOND FINANCIALS

1) Fresenius Kidney Care (FKC): Fresenius Medical Care North America dialysis provider organization 2) Standard of care

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© Vifor Fresenius Medical Care Renal Pharma

CURRENT INDICATIONS

4 October 2018 132

NEPHROLOGY

NUMEROUS OPPORTUNITIES REMAIN

Polycystic kidney disease

Metabolic acidosis

Vascular calcification

Kidney stones

Hypernatremia

Fabry

aHUS

Diabetic nephropathy

Acute kidney injury

β-Thalassemia renal disease

FSGS

ANCA associated vasculitis

Uremic pruritus

C3G

Secondary hyperparathyroidism Hyperphosphatemia

Hyperkalemia

Anaemia

Iron deficiency

PIPELINE INDICATIONS POTENTIAL INDICATIONS

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© Vifor Fresenius Medical Care Renal Pharma 133

1) Fresenius Medical Care North America

THE SCIENTIFIC ADVISORY BOARD

A JOINT FOCUS ON INNOVATION

Frank Maddux Chief Medical Officer

FMCNA1)

Prof. Dr. Michel Burnier Vifor Pharma Board Member

Dr. of Internal Medicine and Nephrology

Stefan Wohlfeil Chief Medical Officer

Vifor Pharma

Andrin Cerletti Head Global Business Development

Vifor Pharma

Robert Kossman Chief Medical Officer

Renal Therapies Group, FMCNA1)

Ravi Thadhani Professor of Medicine

Harvard Medical School

4 October 2018

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© Vifor Fresenius Medical Care Renal Pharma 4 October 2018 134

THE SCIENTIFIC ADVISORY BOARD

INVOLVED IN ALL STAGES

External opportunities Pipeline products Marketed products

• Database screen of approx.

380 clinical stage assets per

year

• Pre due diligence on approx.

10 to 15 assets per year

• Full due diligence on approx.

5 to 6 projects per year

• Negotiations on approx. 1 to 3

deals per year

• Ensure VFMCRP operates as

a highly efficient launch engine

• Avacopan

• CCX140

• CR845

• Rayaldee®

• Vadadustat

• Optimise existing marketed

products

• Ferinject ®

• Mircera®

• RetacritTM

• Velphoro®

• Veltassa®

• Venofer ®

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© Vifor Fresenius Medical Care Renal Pharma

VIFOR

PHARMA

4 October 2018 135

UNIQUE PARTNERSHIP

PROCESS OF A SUCCESSFUL TRANSACTION – CR845

Pro

ject In

itia

tion

Due diligence

Unmet

need

analysis

Data

insights

Sharing of

experience

BD&L process

Commercial

insights

Ongoing oversight through

SAB1) members

FRESENIUS

MEDICAL

CARE

VFMCRP

Sig

nin

g

Joint Steering Committee &

Joint Development Committee

2017 2018 2019 2016

Key interaction with partner

1) Scientific advisory board

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SHAPING INNOVATION

Dr. Frank Maddux

Chief Medical Officer, Fresenius Medical Care North America

CAPITAL

MARKET DAY

2018

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© Vifor Fresenius Medical Care Renal Pharma

EMPLOYEES

Q2 2018

111,263

(-1% yoy)

of which ~70,000 in the U.S.

137

PATIENTS

Q2 2018

325,188

(+3% yoy)

of which ~201,000 in the U.S.

DIALYSIS CENTERS

Q2 2018

3,815

(+3% yoy)

of which 2,500 in the U.S.

FRESENIUS MEDICAL CARE

RENAL DISEASE POPULATION AND TRENDS

4 October 2018

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© Vifor Fresenius Medical Care Renal Pharma

EXPECTED TREND

4 October 2018 138

KEY DRIVERS

• Age, lifestyle and higher life

expectancy

• Increasing wealth and access

to medical treatments

• 10% of the U.S. population with

Chronic Kidney Disease

• Recognized as a public health

condition since 2006 by Centers

for Disease Control in the U.S.

• Strong growth in pharmerging

markets

CHRONIC KIDNEY DISEASE

GROWING PATIENT POPULATION

Note: based on FMC market and competitor survey 2015

3.5

6.0

2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025

Mil

lio

n o

f p

ati

en

ts

CAGR

5.5%

Actual FMC forecast VFMCRP Projection

Europe U.S. ROW

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© Vifor Fresenius Medical Care Renal Pharma

Chronic kidney disease (CKD) still highly prevalent:

• 10% of the world’s population is affected by CKD

• CKD kills more people than breast or prostate cancer

• Diabetes is the leading cause of kidney failure (44% of new cases)

• Obesity is linked closely with CKD (30% of people worldwide in 2018)

VFMCRP is best positioned to drive innovation and help patients live better lives.

4 October 2018 139

INSIGHT INNOVATIONS

RECLASSIFYING KIDNEY DISEASE

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© Vifor Fresenius Medical Care Renal Pharma

VIFOR FRESENIUS

MEDICAL CARE RENAL

PHARMA (VFMCRP)

140 4 October 2018

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© Vifor Fresenius Medical Care Renal Pharma 4 October 2018 141

1) Standard of care

VFMCRP

GROW AND ENHANCE VALUE

2010 2020 2015 2025

ESTABLISH BUILD PORTFOLIO ENHANCE VALUE

55% 45%

IDEA SOC1)

DRIVE INNOVATION

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© Vifor Fresenius Medical Care Renal Pharma

ESTABLISH

4 October 2018 142

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VENOFER® MARKET SHARE AT FKC CLINICS1)

4 October 2018 144

1) Fresenius Kidney Care (FKC): Fresenius Medical Care North America dialysis provider organization

VENOFER®

FIRST STEP IN BUILDING A SUCCESS STORY

50%

75%

100%

2008 2009 2010 2011 2012 2013 2015 2017 2018

HIGHLIGHTS

• >23m patient years experience

• Gold standard in dialysis

• Exclusivity for FMCNA in dialysis

in the U.S. since 2008

• Expected to remain a key part

of the dialysis treatment protocol

• Sold to other dialysis clinics

• Currently no iron sucrose similar

in the U.S.

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© Vifor Fresenius Medical Care Renal Pharma

PATIENTS TREATED WITH MIRCERA® AT FKC CLINICS BENEFITS OF MIRCERA®

Improved logistics

Easier dose preparation

90%+ of doses per electronic

algorithm

More patients in target range than

any other short acting ESA

Smoother path to stable dosing

Fewer dosing changes required

Adverse event rates low

4 October 2018 145

FMCNA Data from Clinical Data Analytics Assessment – Ofsthun, Stennett 2018

MIRCERA®

AT FKC CLINICS

UNPRECEDENTED SPEED OF CONVERSION

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© Vifor Fresenius Medical Care Renal Pharma

BUILD

146 4 October 2018

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© Vifor Fresenius Medical Care Renal Pharma 4 October 2018 147

1) Pre-commercial products 2) Only in dialysis

3) Profit sharing agreement in FMCNA dialysis clinics

VFMCRP

BUILD PORTFOLIO

2016 2015 2017

Mircera®/Roche U.S. License2)

Veltassa®/Relypsa License

(ex-U.S./Japan)

CCX140/

ChemoCentryx1) License (ex-U.S.)

RetacritTM/Pfizer U.S. License2)

Avacopan/

ChemoCentryx1) License (ex-U.S.)

EU Affiliates Acquisition from FMC

Rayaldee®/OPKO1) License

(Europe and other)

Vadadustat1) U.S. License for

FMC dialysis clinics

2018

CR845/Cara

Therapeutics1) License (ex-

U.S./Japan/South

Korea)3)

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© Vifor Fresenius Medical Care Renal Pharma

Breakthrough designation by FDA; Phase-III study ongoing in Uremic Pruritus

First sales expected in 2021/2022.

60%-70% of dialysis patients affected Primary target: Uremic Pruritus

No opioid addiction

Global rights except U.S., Japan and South Korea, profit share for the sales to FKC clinics1).

148

1) Fresenius Kidney Care (FKC): Fresenius Medical Care North America dialysis provider organisation

DIFELIKEFALIN/CR845 INJECTION

CKD-ASSOCIATED COMPLICATIONS

0.8

1.7

4 October 2018

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© Vifor Fresenius Medical Care Renal Pharma 4 October 2018 149

1) Pre-commercial products

VFMCRP

CURRENT PORTFOLIO

CARDIO-RENAL

MANAGEMENT

MINERAL & BONE

MANAGEMENT

ANAEMIA

MANAGEMENT

KIDNEY

PROTECTION

Avacopan1)

1)

Vadadustat1)

CR8451)

CCX1401)

CKD-ASSOCIATED

COMPLICATIONS

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© Vifor Fresenius Medical Care Renal Pharma

ENHANCE VALUE

150 4 October 2018

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© Vifor Fresenius Medical Care Renal Pharma 4 October 2018 151

VFMCRP

VISION

Global Leader in Nephrology

innovative patient-focused solutions.

The partner of choice

for renal pharmaceuticals and

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© Vifor Fresenius Medical Care Renal Pharma

SPEEDING UP THE IDEA TO STANDARD OF CARE PROCESS

4 October 2018 152

THE VFMCRP INNOVATION ECOSYSTEM

IDEA STANDARD

OF CARE

BASIC

RESEARCH

CLINICAL

TRIALS

REGULATORY

APPROVAL

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[]

4 October 2018 153

RANDOMIZED CONTROL TRIAL (RCT)

VS. REAL WORLD EVIDENCE (RWE)

Pharma data

(RCT, observational)

Electronic medical and

health records

Pharmacy

data

Mortality,

other registries

Hospital visits,

Service details Test results,

lab values,

Pathology results

Claim

databases

Social

Media

Consumer

Data

Real-World

Data (RWD)

Meaningful

questions

Fit-for-purpose

Validated

findings

Externally

Validated

findings

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© Vifor Fresenius Medical Care Renal Pharma

FMCNA CONVERTED PATIENTS TO VELPHORO®

JULY 2018 TO SEPTEMBER 2018

COMMENTS

• Program to migrate from calcium

based phosphate to non-calcium

based binders

• Referencing guidelines and

Velphoro® studies on the impact

of pill burden on adherence

• Panel Discussions and webinars

for nurses and dietitians

• Evidence base communications

with prescribing physicians

• Electronic algorithm to migrate

patients

4 October 2018 154

VELPHORO®

We

ek

ly c

on

ve

rsio

n d

uri

ng

ro

llo

ut

of

pro

gra

m

0

200

400

600

800

1000

1200

1400

28 29 30 31 32 33 34 35 36

Week number

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© Vifor Pharma

The Vifor Partnership: New Ideas, New Medicines.

Thomas J. Schall, PhD. President and Chief Executive Officer

October 2018

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© Vifor Pharma

FORWARD-LOOKING STATEMENTS

156

This presentation contains forward-looking statements from ChemoCentryx.

These statements relate to future events or our future financial performance or condition and involve known and unknown risks, uncertainties and other factors that could cause our actual results, levels of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties and other factors are described more fully in our periodic reports filed with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2017 filed with the SEC on March 12, 2018, particularly in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”.

This presentation also contains estimates, projections and other information concerning our industry, our business, and the markets for our drug candidates, as well as data regarding market research, estimates and forecasts prepared by our management. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information.

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© Vifor Pharma

CHEMOCENTRYX (CCXI): A DIFFERENTIATED APPROACH TO INHIBITING DISEASE-DRIVING CHEMOATTRACTANT SYSTEMS

157

Founded in 1997 by Dr. Thomas Schall, early

discover of ‘chemoattractant cytokine’

(chemokine) superfamily

Envisioned an entirely new approach for

autoimmune and inflammatory disease therapy

Precise mechanism; precision medicine:

inhibition of specific chemoattractant receptors

with orally-administered small molecules

Based in Mountain View, CA

NASDAQ listed since 2012

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NOVEL PRECISION THERAPEUTICS BY INHIBITING CHEMOATTRACTANT RECEPTORS

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A DIFFERENTIATED APPROACH TO INHIBITING DISEASE-DRIVING CHEMOATTRACTANT SYSTEMS

Highly Selective

Leaves Rest of Immune System Intact

Exclusive Focus

Small Molecules Highly-Selective

Broad Applicability

Leaves rest of immune system intact; No immunosuppression

Orally-administered, convenience, greater patient compliance

ChemoCentryx is a leader in chemoattractant system science

Approach applicable to Inflammatory, autoimmune diseases and cancer

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Establishing Strong Global Commercial Capabilities

CCXI retains commercial rights in the U.S.

Strategic commercial alliance with Vifor Pharma

Advanced Programs Focused on Orphan Diseases

Enrollment complete in landmark Phase III ADVOCATE trial in ANCA vasculitis

Extending the reach of avacopan –C3G trials ongoing; initiating clinical studies in hidradenitis suppurativa (HS) in US

Broad Pipeline of Unique, Orally-Administered, Small Molecule Therapeutics

Targeting indications with clear regulatory pathways and multi-billion dollar market potential

Robust clinical data generated with avacopan and CCX140

FROM BASIC SCIENCE TO COMMERCIALIZATION

Precision Approach Leads to Better Medicines

Leaves rest of the immune system intact

CCXI drug candidates selectively target a specific chemoattractant or chemokine receptor

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CCXI’S BROAD PIPELINE - DISCOVERY TO LATE STAGE DEVELOPMENT FROM NOVEL PLATFORM

THERAPEUTIC AREA INDICATION PHASE III PHASE II PHASE I PRECLINICAL

CKD, INCLUDING ORPHAN FOCAL SEGMENTAL GLOMERULOSCLEROSIS Chronic and Orphan Kidney Diseases

ANCA-ASSOCIATED VASCULITIS

Complement Inhibition in Orphan Diseases

C3 GLOMERULOPATHY

DRUG/ TARGET

Avacopan (formerly CCX168)/ C5aR

CCX140/CCR2

DIABETIC NEPHROPATHY, SUCCESSFULLY COMPLETED PHASE II

Other Inflammatory and Autoimmune Diseases

IBD: ULCERATIVE COLITIS

TH17 DRIVEN DISEASE, e.g. PUSTUALAR PSORIASIS

OTHER ONCOLOGY INDICATIONS

Immuno-Oncology ADVANCED PANCREATIC CANCER CCX872/ CCR2

CCX507/CCR9

CCX587/CCR6

HIDRADENITIS SUPPURATIVA

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AVACOPAN

Targeted Approach to Complement Diseases: A ‘Pipeline in a Drug’

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AVACOPAN: THE ONLY ORALLY-ADMINISTERED SMALL MOLECULE C5AR INHIBITOR

Targeting the Complement Pathway ‘Downstream’ is Best

Avacopan

Reason for black box warning for eculizumab

Does not block production of C5b-9 leaving host defense mechanism (MAC) in place

Preserves beneficial functions of C5L2 pathway

Avoids long-term biological consequences of upstream complement inhibition

C5aR

1.

2.

3.

1.

2.

3.

C5a Antibodies

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Rationale for Avacopan Auto Antibodies → Activation of Complement Cascade → Generation of C5a → C5a Binds C5a Receptor (C5aR) on Neutrophils C5aR-Activated Neutrophils Destroy Blood Vessels

Status Phase 3 ADVOCATE trial fully-enrolled; Top-line data expected in Q4 2019

ANTI-NEUTROPHIL CYTOPLASMIC AUTO-ANTIBODY (ANCA) VASCULITIS: A COMPLEMENT C5A ACTIVATED NEUTROPHIL-DRIVEN DISEASE

40K

~4,000 new cases per year in U.S.

Overview Prevalence

~5,000 new cases per year in EU

• Highly inflammatory and progressive autoimmune disease caused by the over-activation of the complement system; generation of C5a

• Kidney is a major target organ

• Characterized by recurring flares, accruing into irreversible organ system damage (end-stage renal disease) and death; relapse is common

• Significantly impacts multiple aspects of physical function, emotional well-being, and overall productivity

50K

Current Treatments

High-dose steroids for 6 months

Prednisone Methylprednisone

Immuno-suppressants

Cyclophosphamide OR Rituximab

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URGENT NEED TO MODERNIZE SOC IN ANCA VASCULITIS

Rapid induction of remission

Reduced side effects

Major Unmet Needs:

• Prevent damage and preserve renal function

• Prevent glucocorticoid-related toxicity and infection

Durable remission • Majority of patients at risk for

relapse for many years

* Little et al, 2010 Ann Rheum Dis 69:1036–1043, Flossmann et al 2011 Ann Rheum Dis 70:488–494.

Current ANCA Vasculitis High-Dose Steroid Standard of Care (SOC)

11-16% die within 1st year of diagnosis*

Greatest risk to patients in first year comes from steroid-induced infections

Current treatments contribute ~60% of the mortality rate*

Need to taper steroid = high relapse rate

Irreversible organ damage with relapse (especially in the kidney)

Steroids for 6 Months

Prednisone Methylprednisone

Cyclophosphamide

Rituximab

or

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AVACOPAN PROFOUNDLY INHIBITS COMPLEMENT-DRIVEN NEUTROPHIL ACTIVATION

1Birmingham Vasculitis Activity Score 2Estimated Glomerular Filtration Rate

o EMA PRIME designation and orphan medicinal product

designation

o SwissMedic orphan drug designation

o FDA Grant and orphan drug designation

o Intractable disease designation in Japan

ANCA Vasculitis Regulatory Designations for Avacopan:

Primary endpoint achieved

Rapid onset of action with avacopan treatment

Marked improvements in renal parameters

Patients feel better

Multi-center, randomized (1:1:1), double-blind Phase II trial in patients with newly diagnosed or relapsed ANCA Vasculitis

A. SOC Control Group = Placebo + High Dose Steroid (+ CYC/RTX)

B. Avacopan + Low Dose Chronic Steroid (1/3 of SOC) (+ CYC/RTX)

C. Avacopan + No Chronic Steroid (+CYC/RTX)

Significant lowering of proteinuria and shedding of kidney inflammation markers; decrease in eGFR2

Reduction in vasculitis activity score (BVAS1, a signs and symptoms index) at week 12 with avacopan

Disease remission by BVAS week 4

Statistically significant enhancement in quality of life; favorable safety profile

Phase II CLEAR Trial

Avacopan Efficacy Established in Phase II CLEAR Trial

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AVACOPAN PHASE II “CLEAR” TRIAL MET PRIMARY ENDPOINT

* Thickness of line indicates multiple patients achieved 100% improvement in BVAS

High Dose Steroids SOC Avacopan Treatment Groups

9 pts* 1 pt

BVAS individual participant data shows more rapid response and remission with avacopan compared to SOC

Rapid Remission (BVAS = 0):

29% avacopan + no steroid BVAS = 0 by week 4

Only 5% on steroid standard of care therapy

Treatment Groups # Patients

BVAS (Vasculitis Activity Score)1

Statistical Significance2

Total Avacopan Patients 36/43 -84% P = 0.002

Avacopan + low dose steroid

19/22 -86% P = 0.002

Avacopan + no steroid 17/21 -81% P = 0.01

High dose steroid standard of care (SOC)

14/20 -70% N/A

Primary Endpoint: Proportion of patients with BVAS response at week 12

1BVAS response defined ≥ 50% from baseline, and no worsening in any body system 2P values refer to comparison of avacopan to SOC for non-inferiority

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AVACOPAN: RAPID IMPROVEMENT IN RENAL PARAMETERS

Jayne et al, 2017 JASN doi: https://doi.org/10.1681/ASN.2016111179

Neutrophil counts normalize within days

**** P < 0.0001, *** P < 0.001, ** P < 0.01, * P < 0.05 for superiority of avacopan vs. steroid control group; LSM change from baseline

No requirement for chronic high dose steroids to stabilize kidney function

** P < 0.01, * P < 0.05 for avacopan vs. control

Proteinuria improves faster and at greater magnitude in avacopan groups vs. control

*** P < 0.001, ** P < 0.01, * P < 0.05 for superiority of avacopan vs. steroid control group; LSM change from baseline

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1 Prednisone / Methylprednisone

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AVACOPAN ENHANCES QUALITY OF LIFE IN ANCA VASCULITIS

Quality of Life After 12 Weeks of Avacopan Almost Same as General Population Controls

All Avacopan

Physical Functioning

General health perception

Vitality

Mental health

Bodily pain

Social functioning

Role emotional

Role Physical

Vitality

Avacopan + no steroid vs. general population controls2

Physical Functioning

Role Physical General health

perception

Mental health

Bodily pain

Social functioning

Role emotional

High-dose steroid1 group

Role Physical General health perception

Vitality

Mental health

Bodily pain

Social functioning

Role emotional

Physical Functioning

Significant improvement over 12 week dosing course 2Basu et al, 2014 Ann Rheum Dis 73:207–211

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AVACOPAN: LANDMARK PHASE III ADVOCATE TRIAL

Fully-enrolled, top-line data expected in Q4 2019

Avacopan, 30 mg twice daily

Placebo avacopan twice daily

RTX, 4 weeks or CYC, 12 weeks followed by AZA

RTX, 4 weeks or CYC, 12 weeks followed by AZA

Prednisone, 60 mg/day tapered to 0 over 21 weeks

Placebo to Prednisone Test Group

(N = 158)

Control SOC Group (N = 158)

52-week treatment period

Remission (based on BVAS)

at 26 Weeks

Sustained remission (based on BVAS)

at 52 Weeks

Two primary endpoints: (both analyzed after 52 weeks)

Time

1Potentially leading to greater separation of BVAS between SOC and Avacopan groups

+

B

VA

S R

em

issi

on

Sco

re

-

26 Weeks 52 Weeks

Avacopan Treatment (Test Group)

Control SOC Group

26 Weeks: Numerical Superiority / Non-Inferiority

Difference in Relapsed Patients

52 Weeks: Superiority

High rates of relapse over time associated with SOC1

4 Weeks

Rationale Behind ADVOCATE Design

1. Demonstrate effective,

rapid and sustained

remission of ANCA

vasculitis by BVAS

2. Eliminate need for

corticosteroids in standard

of care and associated

toxic side effects

Goals:

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OTHER OPPORTUNITIES FOR AVACOPAN

C3 Glomerulopathy (C3G) • Rare, life-threatening disease; affects young people; renal transplant not curative • Uncontrolled activation of the complement system leading to complement protein deposition in the kidney

(glomeruli), disrupting kidney function • No approved therapy • Huge economic burden on health care systems

• Potential registration-supporting trial with avacopan underway

Hidradenitis Suppurativa (HS): • Chronic disabling skin autoimmune disease that relentlessly progresses; with extremely painful

inflammatory nodules, boils or abscesses

• Neutrophil-driven disease where C5a involvement is validated

• C5a blockade with avacopan via C5aR offers a strong potential to control neutrophil activation

• Current incumbent therapy widely regarded as inadequate, yet sales in HS approach $1Bn US

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CCR2 INHIBITOR CCX140

Targeted Approach to Orphan Kidney Diseases Such as FSGS

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40K ~5,400 new cases

per year in U.S.

Overview

Rationale • Histologic lesion from glomerular injury affecting specialized kidney

filtering cells, especially podocytes; new science shows CCR2 in FSGS kidney and role for CCR2 in renal cell (podocyte) protection

• CCX140 has demonstrated a statistically significant reduction in proteinuria in previous Phase II clinical trial in DN patients

CCX140 FOR FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)

Prevalence

Current Treatments

40K

• Orphan disease of the kidney’s filtering units (glomeruli), and is characterized by serious scarring that leads to permanent kidney damage

• Presents with proteinuria, in which protein is found in the urine due to a breakdown of the normal filtration mechanism in the kidney

• One of the causes of a serious condition known as Nephrotic Syndrome and often leads to ESRD; Primary FSGS often associated with genetic mutation

No Approved Therapies • Non-specific treatment approaches include steroids to

control proteinuria or immuno-suppressants

Number of FSGS cases are rising more than any other cause of Nephrotic Syndrome

Status Two registration-supporting clinical trials underway

~1,500 new cases per year in EU

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CCX140: CLINICAL DEVELOPMENT IN FSGS

Trial #1: Nephrotic Syndrome Primary FSGS: • ≥ 3 gram/day baseline proteinuria

• First presentation or new flare following prior effective treatment

• *Significant decrease in proteinuria from baseline approvable endpoint

Trial #2: Sub-Nephrotic Primary FSGS • At least 1 gram/day baseline proteinuria

• Decrease in proteinuria from baseline anticipated accelerated approval endpoint

• Reduced in decline in eGFR anticipated full approval endpoint

Screening

(Biopsy-proven primary FSGS & assess proteinuria levels) 0

CCX140, Dose range from 5 mg QD to 15 mg BID (n=6 to 13)

12 24

Study Assessments – Reduction in Proteinuria from Baseline (weeks)

Trial #1: Nephrotic syndrome primary FSGS (≥ 3 gram/day baseline proteinuria)

Trial #2: Sub-nephrotic primary FSGS (at least 1 gram/day baseline proteinuria)

• Stratify by level of proteinuria and immunosuppressant treatment (yes/no)

Rescue if no partial response; otherwise continue

Expand to 30-50 patients for pivotal part 21

CCX140, 5 mg QD (n=10)

Placebo (n=10)

CCX140, 10 mg BID (n=10)

CCX140, 15 mg BID (n=10)

Highest safe dose ( 12 weeks open label)

1Pending favorable results

Screening

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EXCITING MOMENT IN THE EVOLUTION OF CCXI

EMA validates CMA application for avacopan in ANCA Vasculitis

Positive OS results with CCX872 in Pancreatic Cancer

Launch of Late-stage trials of avacopan in c3G and CCX140 in FSGS

Phase III ADVOCATE trial fully enrolled

Recent Achievements

Near-Term

o Continue to support Vifor market readiness activities in their territories

o Continue to promulgate development in ANCA, C3G, FSGS

o Initiate comprehensive placebo-controlled clinical program with avacopan in HS

o Strong cash reserves (>$200M Q2 2018 cash and investments)

Over the next 2 years

o Data from ADVOCATE, C3G, FSGS, HS clinical trials 2109-2020

o Potential commercial launch of avacopan in U.S.

o Continued expansion of pipeline into additional indications

o Cash through ADVOCATE pivotal data and filings

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The Vifor Partnership: A Formula for Success

October 2018