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VIFOR PHARMA INVESTOR PRESENTATION PRESENTATION January 2019

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Page 1: PRESENTATION VIFOR PHARMA/media/Files/V/Vifor-Pharma/... · 2019-01-23 · presentation or the actual occurrence of the forecasted developments. You should not place undue reliance

VIFOR PHARMA

INVESTOR PRESENTATION

PRESENTATION

January 2019

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© Vifor Pharma January 2019 2

VIFOR PHARMA

OUR VISION

Global leader

in iron deficiency, nephrology

and cardio-renal therapies.

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© Vifor Pharma

ETIENNE JORNOD

EXECUTIVE CHAIRMAN

OF THE BOARD OF DIRECTORS

STEFAN SCHULZE

PRESIDENT OF THE EXECUTIVE

COMMITTEE & COO

COLIN BOND

CHIEF FINANCIAL OFFICER

EXPERIENCED LEADERSHIP TEAM

PROVEN TRACK RECORD

January 2019 3

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© Vifor Pharma

PROVEN TRACK RECORD

CORPORATE TIMELINE AND STRATEGY

2000 2010

2015

2020

BECOMING GLOBAL LEADER

IN IRON DEFICIENCY AND

ENTERING INTO NEPHROLOGY

BECOMING GLOBAL LEADER

IN NEPHROLOGY AND ENTERING

CARDIO-RENAL DISEASE AREA

• 2000: Venofer® US FDA approval

• 2007: Launch of Ferinject®

• 2008: Acquisition Aspreva

• 2008: Creation of EU affiliates

• 2009: Acquisition OM Pharma

• 2010: Creation of VFMCRP

• 2013: Injectafer® – FDA approval

• 2013: Launch of Velphoro®

• 2015: Mircera® license

• 2015: Veltassa® license

• 2016: Four licensing deals

• 2016: Relypsa acquisition

• 2017: Galenica Santé IPO

• 2017: Vadadustat license

• 2017: Veltassa® EU approval

• 2017: Mircera® license expansion

• 2018: CR845 license

BUILDING IRON PORTFOLIO

AND INTERNATIONAL EXPANSION

January 2019 4

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© Vifor Pharma

LEADING PORTFOLIO IN TARGET THERAPY AREAS

1) Pre-commercial products

Avacopan1) CCX1401)

1)

Vadadustat1)

January 2019 5

CR8451)

Iron

deficiency Nephrology Cardio-renal

Own

products

In-licensed

products

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© Vifor Pharma

THREE STRATEGIC GROWTH DRIVERS

Ferinject® Exploit the potential through market awareness

Veltassa® Build a blockbuster

Vifor Fresenius Medical Care Renal Pharma Grow and enhance value

January 2019 6

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© Vifor Pharma January 2019

FERINJECT®

A BLOCKBUSTER BY 2020

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

Europe US ROW

FAIR-HF

study

(cardio)

FERGI-COR

study

(gastro)

PREFER study

(fatigue)

New EU

guidelines:

nephro, cardio,

gastro, onco

FIND-CKD

study (ND-

CKD)

Injectafer®

approved

in the USA

CONFIRM-

HF study

(cardio)

New ESC

guidelines

(cardio)

EFFECT-HF

study

(cardio)

Intensifying

promotional

effort by

Daiichi

Sankyo

Launch in

CH, UK,

Spain

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

7

New EU

onco

guidelines

FERINJECT® IN-MARKET SALES1) (MCHF) 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

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%

January 2019 8

FERINJECT®

SIGNIFICANT MARKET OPPORTUNITY REMAINS1)

1) Based on Quarterly IQVIATM MIDAS® panel, GERS, Insight Health, Moving Annual Total (MAT) Q2 2017-18 2) 100 mg eq./1’000 population

Launch Date

2008

2011

2012

2008

2007

2009

2011

2008

2012

2013

2019

2021

Ferinject® volume per capita2) Ferinject® in-market volume growth

253

107

51

36

34

29

22

22

22

12

0

0

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© Vifor Pharma January 2019 9

FERINJECT®

THE BLOCKBUSTER PLAN

1) Study conducted by our US partner Daiichi Sankyo

Therapeutic

areas with high

unmet need

• Heart failure

• Patient blood management

• Gastroenterology

• Nephrology

Strong

partnerships

• Partnering with leading

companies

Geographic

expansion

• Japan (2019)

• China (2021)

• Key pharmerging markets

Life cycle

management

• AFFIRM-AHF

• HEART-FID1)

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© Vifor Pharma

2020 2021 2022 2023 2024

January 2019 10

1) Investigator initiated study, University of Hamburg 2) Study conducted by our US partner Daiichi Sankyo

FERINJECT®

EXPLOIT THE POTENTIAL

2019 2025

HEART-FID

completion2) U.S. Post-approval study

FAIR-HF2

completion1) Post-approval study

China launch

2021

AFFIRM-AHF

completion Post-approval study

EU guidelines*

update based on

AFFIRM AHF

U.S. guidelines*

update based on

HEART-FID

*Targeted guidelines:

Focus on cardiology, patient blood management, gastroenterology and nephrology

> CHF 2 billion

in-market sales

potential

Japan launch

H2 2019

U.S. label

update

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© Vifor Pharma January 2019 11

1) Pre-commercial products

VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA

THE RATIONALE

STRONG IRON AND PHARMA EXPERTISE

GLOBAL LEADER IN DIALYSIS

Avacopan1)

CCX1401)

55% Stake

45% Stake

Vadadustat1) CR8451)

1)

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© Vifor Pharma

Managed care expertise

Patient access (>300k patients)

Validation of innovation

Medications in FKC clinics1) become SoC2)

Sourcing of innovation

Evaluation of clinical assets

Acceptance of clinical risk

Regulatory and market access expertise

55% Stake

45% Stake

January 2019 12

VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA

SYNERGISTIC PARTNERSHIP

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

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

STRONG IRON AND PHARMA EXPERTISE

GLOBAL LEADER IN DIALYSIS

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© Vifor Pharma

VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA

CURRENT PORTFOLIO

January 2019 13

1) Pre-commercial products

CARDIO-RENAL

MANAGEMENT

MINERAL & BONE

MANAGEMENT

ANAEMIA

MANAGEMENT

KIDNEY

PROTECTION

Avacopan1)

1)

Vadadustat1)

CR8451)

CCX1401)

CKD-ASSOCIATED

COMPLICATIONS

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© Vifor Pharma

2020 2021 2022 2023 2024

January 2019 14

VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA

DELIVERING INNOVATION TO NEPRHOLOGY PATIENTS

2019 2025

Additional launches in

nephrology

CR845

launch

Vadadustat

launch

CCX140

launch

Avacopan / C3G Ph. II trial completion

CR845 / Uremic

Pruritus Ph. III trial completion

Vadadustat Ph. III trials

completion

> CHF 1bn

reported sales

Avacopan

launch

Avacopan / AAV Ph. III trial

completion

CCX140 / FSGS Ph. II trial completion

Rayaldee®

launch

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© Vifor Pharma

CURRENT INDICATIONS

January 2019

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

15

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© Vifor Pharma January 2019 16

NEPHROLOGY

LEADERSHIP OF THE WHOLE NEPHROLOGY CHAIN

CLINICAL / PRE-COMMERCIAL

IN-LICENSING DEALS AND PARTNERSHIPS

Avacopan

Vadadustat CR845

CCX140

PRE CLINICAL

DA

TA

GE

NE

RA

TIO

N

PARTNERSHIP

TRANSPLANTATION

COMMERCIAL

PRE DIALYSIS DIALYSIS

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© Vifor Pharma January 2019 17

VELTASSA®

OVERVIEW OF KEY FEATURES

1) SmPC = summary of product characteristics

RAASi enabling

Included in SmPC1) in Europe

Room temperature storage

US: 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 January 2019 18

VELTASSA® U.S. RAMP-UP

KEY CONSIDERATIONS

1) BrandImpact, Q1’17 2) Relypsa data on file

U.S. addressable market 3 million hyperkalemia patients

Awareness

Market access

Duration of treatment

Payers’ coverage

Nephrology: impact analysis ranked #11)

Prescribed by 89% of nephrologists2)

Currently ~4-5 months

67% Medicare coverage

Pricing Monthly gross price USD 820

Cardiology: Diamond study needed to unlock the cardiology space

Median out-of-pocket costs of $6 for all approved claims

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© Vifor Pharma

2020 2021 2022 2023 2024

January 2019 19

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

Guideline*

updates based on

AMBER results

Guideline*

updates based on

DIAMOND results

*Targeted guidelines:

European rollout

Japan launch

Zeria

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© Vifor Pharma January 2019

R&D INVESTMENTS

KEY CLINICAL TRIALS ONGOING

1) Iron overload; leveraging iron metabolism expertise 2) Study conducted by our US partner Daiichi Sankyo

PHASE 1 PHASE 2 PHASE 3 LIFE CYCLE MANAGEMENT

Own

Products

In-licensed

Products

Oral ferroportin

inhibitor1)

Avacopan (Q4 2019)

CCX140 (2020)

AFFIRM-AHF (Q4 2019)

AMBER (H1 2019)

DIAMOND (2022)

Vadadustat (2020)

20

CR845 (H2 2019)

Initiation mid-2019

HEART FID (2022)2)

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© Vifor Pharma

1) Half-year results 2018 2) Reported earnings after minorities adjusted for amortisation of intangible assets to normalise for the significant impact from the acquisition of Relypsa

FINANCIAL HIGHLIGHTS1)

January 2019 21

+23.4% +44.5%

2.66 80.0%

+29.3%

127.5

NET SALES EBITDA

CORE EPS2) (in CHF)

FERINJECT®/INJECTAFER®

NET DEBT (in million CHF) EQUITY RATIO

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© Vifor Pharma

In 2018 at constant exchange rates Vifor Pharma net sales are expected to grow

by more than 15% and reported EBITDA by more than 25%.

In 2020 net sales are expected to exceed CHF 2 billion and EBITDA to reach a high triple-digit

level.

For 2018 and 2019, the dividend is expected to be at the same level as for 2017. From 2020

onwards, the payout ratio is targeted at 35% of net income.

January 2019

GUIDANCE 2018

NET SALES AND EBITDA GUIDANCE INCREASED

22

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© Vifor Pharma

OUTLOOK 2019

CLINICAL TRIALS

MARKET ACCESS

Veltassa®: read-out of the AMBER study (H1 2019)

Veltassa®: initiation of the DIAMOND outcome study for RAASi enabling (Q1 2019)

Ferroportin inhibitor: initiation of phase-II study (mid-2019)

Avacopan: phase III ADVOCATE study readout (Q4 2019)

CR845: KALM-1 and KALM-2 study readouts (H2 2019)

Ferinject® launch in Japan (H2 2019)

Rayaldee® filing in Europe (H1 2019)

Expansion of footprint in China

Partnering the Japanese rights for CCX140

IN-LICENSING Completion of at least one additional bolt-on transaction during the course of 2019

January 2019 23

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© Vifor Pharma

CONTACT INFORMATION

Colin Bond – CFO

Phone: +41 58 851 83 53

Email: [email protected]

INVESTOR RELATIONS

Julien Vignot – Head of Investor Relations

Phone: +41 58 851 66 90

Email: [email protected]

Laurent de Weck – Investor Relations Manager

Phone: +41 58 851 80 95

Email: [email protected]

January 2019 24

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© Vifor Pharma

DISCLAIMER

Certain statements, beliefs and opinions in this presentation are forward-looking, which reflect the Company’s or, as

appropriate, the Company’s directors’ current expectations and projections about future events. By their nature, forward-

looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to

differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and

assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude

of factors including, but not limited to, changes in demand, competition and technology, can cause actual events,

performance or results to differ significantly from any anticipated development. Forward-looking statements contained

in this presentation regarding past trends or activities should not be taken as a representation that such trends or activities

will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update

or revisions to any forward-looking statements in this presentation as a result of any change in expectations or any change

in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the

Company nor its advisers or representatives nor any of its of their parent or subsidiary undertakings or any such person’s

officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors

nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this

presentation or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-

looking statements, which speak only as of the date of this presentation.

January 2019 25