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VIFOR PHARMA INVESTOR PRESENTATION May 2020

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Page 1: VIFOR PHARMA/media/Files/V/Vifor... · • Room temperature storage VELTASSA® BUILDING THE HYPERKALAEMIA MARKET Source: quarterly IQVIATM MIDAS® panel, GERS, Insight Health, DLI,

VIFOR PHARMAINVESTOR PRESENTATION

May 2020

Page 2: VIFOR PHARMA/media/Files/V/Vifor... · • Room temperature storage VELTASSA® BUILDING THE HYPERKALAEMIA MARKET Source: quarterly IQVIATM MIDAS® panel, GERS, Insight Health, DLI,

© Vifor Pharma May 2020

VIFOR PHARMA

OUR VISION

Global leader

in iron deficiency, nephrology

and cardio-renal therapies.

2

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© Vifor Pharma

PROVEN TRACK RECORD

CORPORATE TIMELINE AND STRATEGY

20002010

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 in-licensing deals

• 2016: Relypsa acquisition

• 2017: Galenica Santé IPO

• 2017: Vadadustat1) license

• 2018: CR8451) license

• 2019: Invokana® co-promotion

• 2019: Joint venture with Evotec

BUILDING IRON PORTFOLIO

AND INTERNATIONAL EXPANSION

May 2020

1) Pre-commercial products

3

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© Vifor Pharma

LEADING PORTFOLIO IN TARGET THERAPY AREAS

1) Pre-commercial products

Avacopan1)Vadadustat1)

May 2020

CR8451)

Iron

deficiencyNephrology Cardio-renal

Own

products

In-licensed

products Rayaldee®1)

4

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© Vifor Pharma

THREE STRATEGIC GROWTH DRIVERS

Ferinject®

Exploit the potential through market awareness

Veltassa®

Build a blockbuster

Nephrology (VFMCRP1)) Expand leadership position

May 2020

1) Vifor Fresenius Medical Care Renal Pharma

5

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© Vifor Pharma

[T

May 2020

Source: quarterly IQVIATM MIDAS® panel, GERS, Insight Health, DLI, MAT Q4-2019, historical data at constant exchange rate (average 2019)

FERINJECT®

GLOBAL LEADER IN THE I.V. IRON MARKET

20191996

6

22%

50%

28%

2’131

CHFm

99

CHFm

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© Vifor Pharma

16 38 58 81123 163

242

377

538

693

890

1’060

May 2020

FERINJECT®

BLOCKBUSTER STATUS ACHIEVED ONE YEAR EARLIER

Europe US RoW

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

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

7

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© Vifor Pharma

Switzerland

Australia

Spain

Sweden

Italy

UK

France

U.S.

Japan

China

2%

18%

31%

12%

42%

23%

23%

19%

0%

0%

May 2020

FERINJECT®

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

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

253

127

46

41

39

29

29

17

0

0

8

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© Vifor Pharma

2021 2022 2023 2024

Life cycle

management

Indications

with high

unmet need

May 2020

1) Subject to reimbursement 2) Investigator initiated study, University of Hamburg 3) Study conducted by our US partner Daiichi Sankyo

FERINJECT®

EXPLOIT THE POTENTIAL

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

9

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© Vifor Pharma

NEPHROLOGY

HIGHLY DIVERSIFIED PORTFOLIO

May 2020

1) Pre-commercial products

MINERAL & BONE

MANAGEMENT

ANAEMIA

MANAGEMENT

KIDNEY

PROTECTION

Avacopan1)

Vadadustat1)

CR8451)

CKD-ASSOCIATED

COMPLICATIONS

Rayaldee®1)

10

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© Vifor Pharma

2020 2021 2022 2023 2024

May 2020

NEPHROLOGY

DELIVERING INNOVATION TO NEPRHOLOGY PATIENTS

2020 2025

Additional launches in nephrologyVadadustat

launch

> CHF 1bn

reported sales

Avacopan &

CR-845 launch

Rayaldee®

launch

12

Early stage development through NephThera, the joint venture with Evotec

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© Vifor Pharma

CURRENT INDICATIONS

May 2020

NEPHROLOGY

NUMEROUS OPPORTUNITIES REMAIN

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

13

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© Vifor Pharma May 2020

NEPHROLOGY

LEADERSHIP OF THE WHOLE NEPHROLOGY CHAIN

CLINICAL / PRE-COMMERCIAL

IN-LICENSING DEALS AND PARTNERSHIPS

Avacopan

VadadustatCR845

PRE-CLINICAL

DA

TA

GE

NE

RA

TIO

N

PARTNERSHIP

TRANSPLANTATION

COMMERCIAL

PRE-DIALYSIS DIALYSIS

14

NephTheraRayaldee®

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© Vifor Pharma

US nephrologists

May 2020

NEPHROLOGY

LEVERAGING US COMMERCIAL ORGANISATION

+

Invokana®

• First new treatment of diabetic kidney

disease in more than 20 years

• Royalties received on net sales

• Targeted population of 1.2 million

• Accretive latest end of 2020

15

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© Vifor Pharma May 2020 16

1) Birmingham Vasculitis Activity Score

NEPHROLOGY

AVACOPAN POSITIVE PHASE-III TRIAL RESULTS

Reduce glucocorticoid toxicity

Imp

rove r

en

al fu

ncti

on

• Week 26: BVAS1) remission

• Week 52: statistically superior

• Improved quality of life

• Increased risk of mortality

• High risk of infections

• Irreversible kidney damage

Standard of care

Avacopan

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© Vifor Pharma

[]

May 2020

NEPHROLOGY

STAGED, SUCCESS DEPENDENT PARTNERSHIP

NephThera

Generate target candidates Pre-clinical up to phase II Phase III to commercialisation

• World class discovery

• Unique kidney biobank

• Combines respective expertise

• Joint scientific committee

• Global commercial network

• Unique access to nephrology patients

17

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© Vifor Pharma

[]

46%

54%

May 2020

• Calcium-based, non-absorbed

• Limited undesirable effects

• 52-weeks data available

• RAASi enabling feature included in

SmPC1) in Europe

• Acute & chronic usage

• Room temperature storage

VELTASSA®

BUILDING THE HYPERKALAEMIA MARKET

Source: quarterly IQVIATM MIDAS® panel, GERS, Insight Health, DLI, MAT Q2-2019, historical data at constant exchange rate (average 2019) 1) SmPC = summary of product characteristics

20192015

18

179

CHFm

340

CHFm

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© Vifor Pharma

US MARKET OPPORTUNITY

May 2020

VELTASSA®

ASSESSMENT OF LONG TERM POTENTIAL UNCHANGED

3 million USD 898

Monthly gross priceEstimated

hyperkalaemia patients

6 months

Targeted duration

of treatment

x x > USD 10 billion =

Potential market size

(net sales)

19

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© Vifor Pharma

2020 2021 2022 2023 2024

May 2020

VELTASSA®

DRIVE TO BLOCKBUSTER STATUS

2020 2025

DIAMOND

completionPost-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

20

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© Vifor Pharma

FY

2018

FY

2019

Change

vs. 2018

Net sales 1’584.6 1’877.2 +18.5%

Other income 64.6 38.4 -40.4%

Cost of sales (648.7) (761.5) +17.4%

Gross profit 1’000.5 1’154.2 +15.4%

EBITDA 391.5 540.0 +37.9%

Depreciation and amortisation (164.1) (215.0) -31.0%

EBIT 227.4 325.0 +42.9%

Core earnings1)

per share2) 4.16 4.67 +12.2%

Average number of FTE3) 2’671 2’792 +4.5%

May 2020

P&L OVERVIEW (IN CHF MILLION)

1) Profit after minorities adjusted for amortisation of intangible assets (CHF 143.9 million in 2019) 2) Share amount of 64.9 million3) Full-time employees 4) Fresenius Kidney Care (FKC): Fresenius Medical Care North America dialysis provider organization

• EBITDA growth exceeding raised

full-year guidance

• Depreciation and amortisation

increase driven by the Mircera®

commercialisation rights extension

outside of FKC4) clinics and the new

leasing standard IFRS 16

• Core earnings per share increase by

23.2% when adjusted for FX gain in

2018 and IAS 19 impact in 2019

• Low FTE3) increase despite

investments in pipeline and clinical

21

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© Vifor Pharma

75.9

78.5

86.0

14.2

41.8

7.1

-10.9

292.6

+15.6%

+17.0%

+6.4

+89.9%

+12.0%

+46.2%

-4.9%

+18.5%

May 2020

NET SALES OVERVIEW (IN CHF MILLION)

GROWTH EXCEEDING GUIDANCE IN 2019

FY

2018

FY

2019

Ferinject®/Injectafer® 485.1 561.0

Mircera®/RetacritTM 461.3 539.8

Velphoro® 95.7 181.7

Venofer® 118.2 132.4

Veltassa® 90.5 132.3

Anti-infectives 112.1 119.2

Others 221.7 210.8

Net sales 1’584.6 1’877.2

Growth

in 2019

22

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© Vifor Pharma

31 Dec

2018

31 Dec

2019

Change

vs. 2018

Cash & cash equivalents 400.3 544.9 144.6

Trade & other receivables 509.0 471.9 (37.0)

Inventories 281.7 348.6 66.9

Financial investments & other assets 354.5 633.4 279.0

PPE1)

& RoU2)

assets 274.0 351.0 77.0

Intangible assets 2’676.0 2’584.5 (91.5)

Assets 4’495.5 4’934.4 438.9

Current financial & lease liabilities 116.2 16.8 (99.3)

Other current liabilities 478.3 524.5 46.3

Non-current financial & lease liabilities 492.4 626.5 134.1

Other non-current liabilities 44.1 31.3 (12.8)

Shareholders' equity 3’364.6 3’735.3 370.7

Liabilities & shareholders' equity 4’495.5 4’934.4 438.9

• Trade & other receivables

reduction despite strong top line

growth

• Financial investments increase

driven by the gain on the 18.3%

equity stake in ChemoCentryx

• Right-of-use assets mostly related

to the adoption of the new leasing

standard IFRS 16

May 2020

BALANCE SHEET OVERVIEW (IN CHF MILLION)

STRONG EQUITY RATIO OF 75.7%

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

23

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© Vifor Pharma

2019

Opening cash, 1 January 400.3

Operating activities 534.3

Net working capital 18.9

Income tax paid (28.3)

Cash flow from operating activities 524.8

Net investments in milestones & BD&L1) (86.0)

Capex & others (46.5)

Cash flow from investing activities (132.5)

Dividends paid (174.7)

Financing & others (63.7)

Cash flow from financing activities (238.5)

Exchange rate effects (9.3)-

Ending cash and cash equivalents, 31 December 544.9

Financial liabilities2) 539.2

Net cash 5.7

• Milestone and BD&L investments

mainly due to the extension of the

Mircera® commercialisation rights

outside of FKC3) clinics for 2020

• Dividend payments of CHF 129.7

million to Vifor Pharma shareholders

and CHF 45.0 million to Fresenius

Medical Care

• BBB- investment grade rating

assigned by S&P in September 2019

and Fitch Ratings in March 2020

May 2020 24

1) Business development & licensing 2) Excluding non-interest bearing financial liabilities and lease liabilities 3) Fresenius Kidney Care (FKC): Fresenius Medical Care North America dialysis provider organization

CASH FLOW OVERVIEW (IN CHF MILLION)

NET CASH POSITION OF CHF 5.7 MILLION

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© Vifor Pharma

GUIDANCE 20201)

1) Including OM Pharma and excluding any potential impact of COVID-19

May 2020 25

In 2020 at constant exchange rates, Vifor Pharma net sales are expected

to grow in the range of 10%, reported EBITDA is expected to grow

by more than 25%.

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© Vifor Pharma

OUTLOOK 2020

May 2020 26

CLINICAL TRIALS

MARKET ACCESS

Ferinject® launch in Japan, subject to reimbursement

Go-to-market strategy and filing in China for Ferinject®

Filing of Avacopan in Europe

BUSINESS

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

Ferinject® phase-IV AFFIRM-AHF study readout (H2 2020)

CR-845 phase-III KALM-2 study readout (April 2020)

Vadadustat phase-III INNO2VATE studies readout (May 2020)

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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]

May 2020 27

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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.

May 2020 28