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VIFOR PHARMA INVESTOR PRESENTATION SEPTEMBER 2020

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Page 1: SEPTEMBER 2020 VIFOR PHARMA/media/Files/V/Vifor-Pharma/... · 2020. 9. 4. · Switzerland Australia Spain Sweden Italy UK France U.S. Japan3 China 2% 18% 31% 12% 42% 23% 23% 19% 0%

VIFOR PHARMA

INVESTOR PRESENTATION

SEPTEMBER 2020

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VIFOR PHARMA

SEPTEMBER 2020

OUR VISION

Global leader

in iron deficiency, nephrology

and cardio-renal therapies

2

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PROVEN TRACK RECORD

SEPTEMBER 2020

CORPORATE TIMELINE AND STRATEGY

1) Pre-commercial products 2) In-licensed from Akebia Therapeutics, Inc., subject to certain conditions and limited to the US dialysis market

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 of Aspreva

2008: Creation of EU affiliates

2009: Acquisition of OM Pharma

2010: Creation of VFMCRP

2013: Injectafer® – FDA approval

2013: Launch of Velphoro®

2015: Mircera® in-licensing

2015: Veltassa® in-licensing

2016: Four in-licensing deals

2016: Relypsa acquisition

2017: Galenica Santé IPO

2017: Vadadustat1 in-licensing2

2018: CR8451 in-licensing

2019: Invokana® co-promotion

2019: Joint venture with Evotec

Building iron portfolio

and international expansion

3

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LEADING PORTFOLIO IN TARGET THERAPY AREAS

SEPTEMBER 2020

1) Pre-commercial products 2) Subject to certain conditions and limited to the US dialysis market

Iron

deficiencyNephrology Cardio-renal

Own

products

In-licensed

products

Avacopan1Vadadustat1 2

CR8451Rayaldee®1

4

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19%

81%

50%50%

FERINJECT®/INJECTAFER®

GLOBAL LEADER IN THE I.V. IRON MARKET

SEPTEMBER 2020

GLOBAL MARKET LEADER

Source: quarterly IQVIATM MIDAS® panel, GERS, Insight Health, DLI, moving annual total Q1-2020, historical data at constant exchange rate (average 2019)

20202014

2’198

CHFm

933

CHFm

5

2017

1’437

CHFm

40%

60%

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16 38 58 81123 163

242

377

538

693

890

1’060

FERINJECT®

SEPTEMBER 2020

BLOCKBUSTER STATUS ACHIEVED ONE YEAR EARLIER

1) Based on quarterly IQVIATM MIDAS® panel, GERS, Insight Health, DLI, historical data at constant exchange rate (average 2019)

Europe US RoW

IN-MARKET SALES1

CHF MILLION

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2019

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

New EU

onco

guidelines

2018

6

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Switzerland

Australia

Spain

Sweden

Italy

UK

France

U.S.

Japan3

China

2%

18%

31%

12%

42%

23%

23%

19%

0%

0%

FERINJECT®

SEPTEMBER 2020

SIGNIFICANT MARKET OPPORTUNITY REMAINS1

1) Based on quarterly IQVIATM MIDAS® panel, GERS, Insight Health, moving annual total (MAT) Q4 2018-19, historical data at constant exchange rate (average 2019)2) 100 mg eq./1’000 population 3) Launched on 1 September 2020

Ferinject® volume per capita2Ferinject® in-market volume growth

253

127

46

41

39

29

29

17

0

0

7

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2021 2022 2023 2024

Life cycle

management

Indications

with high

unmet need

FERINJECT®

SEPTEMBER 2020

EXPLOIT THE POTENTIAL

1) Launched on 1 September 2020 2) Investigator initiated study, University of Hamburg 3) Study conducted by our US partner Daiichi Sankyo

2020 2025

HEART-FID

completion*3

U.S. Post-

approval study

FAIR-HF2

completion*2

Post-approval

study

Focus on heart failure, patient blood management and nephrology

*Targeted guidelines:

> CHF 2

billion

in-market

sales

(> CHF 1

billion

reported

sales)

U.S. label

update

Geographic

expansion

AFFIRM-AHF

completion*Post-approval

study

China approval

2021

Japan launch1

2020

8

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VIT-2763 (FERROPORTIN INHIBITOR)

SEPTEMBER 2020 9

TARGETING RARE BLOOD DISORDERS

1) US and EU combined estimate

First patient in VITHAL study in Q2 2020

Approx. 150’000

DISEASE

Unmet need

Addressable

patients1

Phase-II status

Oral small moleculeBlocks iron transport to

the blood

Mechanism similar to

hepcidin

BETA THALASSEMIA SICKLE CELL DISEASE

Pain crisis and and organ damageTransfusion burden and iron overload

Approx. 25’000

Study initiation expected in 2021

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NEPHROLOGY

SEPTEMBER 2020 10

LEADERSHIP OF THE WHOLE NEPHROLOGY CHAIN

1) In-licensed products 2) Joint commercialisation agreement with Janssen Pharmaceuticals Inc. 3) Subject to certain conditions and limited to the US dialysis market

CLINICAL / PRE-COMMERCIAL

IN-LICENSING DEALS AND PARTNERSHIPS

Avacopan1

Vadadustat1 3CR8451

PRE-CLINICAL

DA

TA

GE

NE

RA

TIO

N

PARTNERSHIP

TRANSPLANTATION

COMMERCIAL

PRE-DIALYSIS DIALYSIS

NephTheraRayaldee® 1

21

1

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AVACOPAN

SEPTEMBER 2020 12

NEW STANDARD OF CARE IN ANCA-AV

ANCA-AV = Anti-neutrophil cytoplasmic antibody-associated vasculitis1) Studies conducted by our partner ChemoCentryx, Inc.

July 2020

Filing of avacopan

in the US by

ChemoCentryx, Inc.

November 2019

Successful readout

of ADVOCATE1

phase-III study

H2 2020

Filing of avacopan

in Europe

End of 2020

Phase-II ACCOLADE1

study readout in

C3 Glomerulopathy

End 2021 / Early 2022

Launch of avacopan

in Europe

2020 2021

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CR845 / DIFELIKEFALIN

SEPTEMBER 2020 13

INNOVATION IN CKD-ASSOCIATED PRURITUS

CKD = Chronic kidney disease ESRD: End Stage Renal Disease

Significant impact on quality of life

THE DISEASE THE OPPORTUNITY

Favorable safety profile with no sign of addiction

Meaningful reduction in itch intensity and

improvements in itch-related quality of life

No pill burden

NDA submission in the US in H2 2020 No approved treatment in US and EU

~40% of ESRD patients have moderate to

severe pruritus

Only off-label treatments with poor evidence

and/or unfavorable safety profile

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VADADUSTAT

SEPTEMBER 2020 14

POTENTIAL NEW ORAL STANDARD OF CARE IN DIALYSIS

ESAs = Erythropoiesis-stimulating agents1) Fresenius Kidney Care (FKC): Fresenius Medical Care North America dialysis provider organization 2) Subject to certain conditions

License agreement

Positive INNO2VATE

Phase-III results

Next steps

Non-inferior to ESAs in efficacy and cardiovascular safety

Achieved pre-specified non-inferiority margin agreed with FDA

Filing in the US by Akebia Therapeutics, Inc.

License granted by Akebia Therapeutics, Inc. to sell vadadustat to

FKC clinics1 and other third party dialysis organisations in the US2

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NEPHROLOGY

SEPTEMBER 2020 15

GROWING SIGNIFICANTLY WITH HIGH UNMET NEED

CURRENT INDICATIONS

Polycystic kidney disease

Metabolic acidosis

Vascular calcification

Kidney stones

Hypernatremia

Fabry

aHUS

Acute kidney injury

β-Thalassemia renal disease

ANCA associated vasculitis

Uremic pruritus

C3G

Secondary hyperparathyroidism

Hyperphosphatemia

Hyperkalemia

Anaemia

Iron deficiency

PIPELINE INDICATIONS POTENTIAL INDICATIONS

Diabetic kidney diseaseKidney fibrosis

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45%

14%

41%

VELTASSA®

SEPTEMBER 2020 16

ABILITY TO BUILD MARKET AWARENESS

1) Monthly IQVIATM MIDAS® panel, GERS, InsightHealth, DLI, moving annual total Q2-2020. Average 2019 exchange rates have been applied.

20202016

182

CHFm

401

CHFm

KEY CHARACTERISTICS

Calcium-based, non-absorbed

52-weeks data available

Acute & chronic usage

Veltassa® Sodium zirconium cyclosilicate Other potassium binders

IN-MARKET SALES1

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VELTASSA®

SEPTEMBER 2020

ASSESSMENT OF LONG TERM POTENTIAL UNCHANGED

3 million USD 898

Monthly gross priceEstimated

hyperkalaemia patients

in the US

6 months

Targeted duration

of treatment

x x > USD 10 billion =

Potential market size

(net sales)

17

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H1

2019

H1

2020

%∆ vs.

H1 2020

Net Sales 913.3 922.5 +1.0%

Other Income 20.4 43.0 +110.9%

Gross Profit 560.3 589.5 +5.2%

EBITDA 254.6 305.1 +19.8%

Depreciation and amortisation -106.0 -170.1 -60.5%

EBIT 148.7 135.0 -9.2%

Financial result -8.9 -17.0 -91.9%

Income tax -13.8 -11.3 +18.5%

Net profit before NCI 126.0 106.7 -15.3%

Non-controlling interests -60.9 -38.8 36.3%

Net profit after NCI 65.2 67.9 4.3%

Core earnings1 per share 2.11 2.66 +26.1%

P&L OVERVIEW (IN CHF MILLION)

STRONG GROWTH IN CORE EPS

COVID-19 impact on

Ferinject®/Injectafer® and Veltassa®

offset by dialysis business

EBITDA of CHF 319.8 million or

+25.6% at constant exchange rate

Increase in depreciation and

amortisation driven by CCX140

impairment of CHF 56.2 million

Non-controlling interests impacted

by the CCX140 impairment

NCI = non-controlling interests1) Reported earnings after non-controlling interests adjusted for proportionate amortisation of intangible assets of CHF 104.9 million in H1 2020 (H1 2019: CHF 71.9 million)

SEPTEMBER 2020 18

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31 Dec

2019

30 Jun

2020

Change vs.

31 Dec 2019

Cash & cash equivalents 544.9 304.7 (240.2)

Trade & other receivables 471.9 481.7 9.8

Inventories 348.7 420.2 71.6

Financial investments & other assets 633.4 784.4 151.1

PPE1 & RoU

2 assets 351.0 351.4 0.3

Intangible assets 2’584.5 2’557.1 (27.5)

Assets 4’934.4 4’899.5 (34.9)

Current financial & lease liabilities 17.8 14.2 (3.5)

Other current liabilities 523.6 534.4 10.8

Non-current financial & lease liabilities 626.5 620.9 (5.6)

Other non-current liabilities 31.3 57.3 26.0

Shareholders' equity 3’735.3 3’672.8 (62.6)

Liabilities & shareholders' equity 4’934.4 4’899.5 (34.9)

BALANCE SHEET OVERVIEW (IN CHF MILLION)

STRONG EQUITY RATIO OF 75.0%

Decrease in cash & cash

equivalents due to dividend

payments

Increase in financial investments

driven by gain on ChemoCentryx

equity stake

Decrease in intangible assets

driven by CCX140 impairment and

usual amortisation, partly offset by

purchase of a priority review

voucher for CHF 107.7 million

1) Property, plant & equipment 2) Right-of-use

SEPTEMBER 2020 19

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2020

Opening cash & cash equivalents, 1 January 544.9

Operating activities 288.1

Net working capital (NWC) (116.6)

Interest, tax & other financial payments 1.1

Cash flow from operating activities 172.6

Milestones & BD&L1 investments (125.7)

Capex & others (27.1)

Cash flow from investing activities (152.8)

Dividends paid (219.6)

Financing & others (34.4)

Cash flow from financing activities (254.0)

Exchange rate effects (5.9)

Ending cash & cash equivalents, 30 June 304.7

Financial liabilities2 (537.6)

Net debt (232.9)

CASH FLOW OVERVIEW (IN CHF MILLION)

NET DEBT POSITION OF CHF 232.9 MILLION

Net working capital driven by higher

inventory and temporary increase of

account receivables from US sales

Milestone and BD&L investments driven by

acquisition of a priority review voucher

Dividend payments of CHF 129.6 million to

Vifor Pharma shareholders and CHF 90.0

million to Fresenius Medical Care

1) Business development and licensing 2) Excluding non-interest bearing financial liabilities and lease liabilities

SEPTEMBER 2020 20

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GUIDANCE 20201

1) Subject to no worsening of the situation due to COVID-19

In 2020, net sales are expected to grow in the range of 5% at

constant exchange rates, reported EBITDA is expected to grow

in the range of 20%.

SEPTEMBER 2020 21

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OUTLOOK

1) Licensed from ChemoCentryx, Inc. 2) By our partner Cara Therapeutics, Inc. 3) Study conducted by our partner ChemoCentryx, Inc.

CLINICAL TRIALS

MARKET ACCESS

Veltassa® partnering in China

Ferinject® launch in Japan

Avacopan1 filing in Europe

CR845 filing in the US2

BUSINESS

DEVELOPMENT At least one in-licensing, product acquisition or corporate transaction

Ferinject® phase-IV AFFIRM-AHF study readout

Avacopan phase-II ACCOLADE3 in C3 Glomerulopathy study readout

SEPTEMBER 2020 22

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CONTACT INFORMATION

SEPTEMBER 2020

Colin Bond Chief Financial Officer

Phone: +41 58 851 83 53

Email: [email protected]

Julien VignotHead of Investor Relations

Phone: +41 58 851 66 90

Email: [email protected]

Laurent de Weck Investor Relations Senior Manager

Phone: +41 58 851 80 95

Email: [email protected]

Investor relations

23

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DISCLAIMER

SEPTEMBER 2020

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.

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