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HALF-YEAR RESULTS 2020 ANALYST CALL PRESENTATION 6 AUGUST 2020, 2:00 PM CET

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Page 1: PRESENTATION HALF-YEAR RESULTS 2020/media/Files/V/Vifor-Pharma/... · 2020. 8. 6. · February Creation of a joint venture with Fresenius Kabi in China May Vadadustat2 positive INNO

HALF-YEARRESULTS 2020ANALYST CALL

PRESENTATION

6 AUGUST 2020, 2:00 PM CET

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HALF-YEAR RESULTS 2020

6 AUGUST 2020

SPEAKERS

STEFAN SCHULZE

CHIEF EXECUTIVE OFFICER

COLIN BOND

CHIEF FINANCIAL OFFICER

2

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BUSINESS UPDATE AND OUTLOOKSTEFAN SCHULZE, CHIEF EXECUTIVE OFFICER

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H1 2020KEY CORPORATE DEVELOPMENTS

1) Licensed from Cara Therapeutics, Inc. 2) Licensed from Akebia Therapeutics, Inc., subject to certain conditions 3) Licensed from ChemoCentryx, Inc. 4) Licensed from OPKO Health, Inc.

H1 2020

6 AUGUST 2020 4

April

CR8451 positive

KALM-2 phase-III

study results

February

Creation of a joint

venture with Fresenius

Kabi in China

May

Vadadustat2 positive

INNO2VATE phase-III

results

May

CCX1403 LUMINA-1

phase-II study

results

May

Changes to the Board

of Directors and

COO/CEO

March

Second investment

grade rating from

Fitch Ratings (BBB-)

June

Rayaldee®4 central

marketing authorisation

received in Europe

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142158 147

59

7473

28

4242229

273262

H1 2018 H1 2019 H1 2020

FERINJECT®/INJECTAFER®

6 AUGUST 2020 5

COVID-19 IMPACT IN Q2 2020

H1 2020 net sales decrease of 0.1%

at constant exchange rate

Q2 2020 heavily impacted by COVID-

19 driven by patients delaying

appointments

AFFIRM-AHF study on track to

readout before year-end

NET SALESCHF million

Europe US RoW

+19%

-4%

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0

20

40

60

Q1 Average April May June Q2 Average H1 Average

FERINJECT®/INJECTAFER®

6 AUGUST 2020 6

RECOVERY STARTED IN JUNE

Strong growth of 23% in Q1

compared to prior period

COVID-19 impact in April and May

due to incapacity of most patients to

receive infusions

Impact in cardiology and patient blood

management estimated at ~80% in

April and May

Recovery started in June with easing

restrictions

NET SALES EVOLUTIONIn CHF million

+23% -33%-37%

-9%-26%

-4%

2019 2020

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19%

81%

50%50%

FERINJECT®/INJECTAFER®

GLOBAL LEADER IN THE I.V. IRON MARKET

6 AUGUST 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

7

2017

1’437

CHFm

40%

60%

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VIT-2763 (FERROPORTIN INHIBITOR)

6 AUGUST 2020 8

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

6 AUGUST 2020 9

LEADERSHIP OF THE WHOLE NEPHROLOGY CHAIN

1) Licensed from ChemoCentryx, Inc. 2) Licensed from OPKO Health, Inc. 3) Licensed from Cara Therapeutics, Inc. 4) Licensed from Akebia Therapeutics, Inc., subject to certain conditions5) Joint commercialisation agreement with Janssen Pharmaceuticals Inc. 6) Licensed from Pfizer Inc. 7) Licensed from F. Hoffmann-La Roche AG

CLINICAL / PRE-COMMERCIAL

IN-LICENSING DEALS AND PARTNERSHIPS

Avacopan1

Vadadustat4CR8453

PRE-CLINICAL

DA

TA

GE

NE

RA

TIO

N

PARTNERSHIP

TRANSPLANTATION

COMMERCIAL

PRE-DIALYSIS DIALYSIS

NephTheraRayaldee®2

56

7

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60

65

68

H1 2018 H1 2019 H1 2020

214

279 293

H1 2018 H1 2019 H1 2020

VENOFER® NET SALESCHF million

Venofer® net sales increased 8.1% at constant exchange rates

Growth driven by the US and China

ESA PORTFOLIO NET SALESCHF million

ESA portfolio increased 8.2% at constant exchange rate

Growth driven by higher demand for Retacrit®

NEPHROLOGY

6 AUGUST 2020 10

SUSTAINED GROWTH IN ANAEMIA MANAGEMENT

1) Licensed from F. Hoffmann-La Roche AG 2) Licensed from Pfizer Inc.

Mircera®1 Retacrit®2

+30%

+5%

+10%

+5%

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36

8174

H1 2018 H1 2019 H1 2020

NEPHROLOGY

6 AUGUST 2020 11

VELPHORO® IMPACTED BY ORDER PATTERNS

VELPHORO® NET SALESCHF million

Net sales decrease 6.1% at constant exchange

rate, mainly due to shift in order patterns across

periods

Full-year net sales expected to be at the 2019

level

Global leader with 24.3% market share1

Protected by various Orange Book listed patents

expiring between Nov. 2028 and Nov. 2034

1) Monthly IQVIATM MIDAS® panel, INSIGHT Health & DN, GERS, DLI, Farminform, moving annual total April 2020. Average 2019 exchange rates have been applied.

+127%

-9%

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AVACOPAN

6 AUGUST 2020 12

NEW STANDARD OF CARE IN ANCA-AV

ANCA-AV = Anti-neutrophil cytoplasmic antibody-associated vasculitis1) Study 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

6 AUGUST 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

6 AUGUST 2020 14

POTENTIAL NEW ORAL STANDARD OF CARE IN DIALYSIS

ESAs = Erythropoiesis-stimulating agents ND = Non-dialysis dependent DD = Dialysis dependent CKD = Chronic kidney disease1) 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

6 AUGUST 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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VELTASSA®

6 AUGUST 2020 16

GROWTH IMPACTED BY REDUCED PROMOTION

Net sales decreased by 1.7% at constant

exchange rate

COVID-19 impact:

− Patient discontinuation

− Postponed new patient starts

− Suspension of face-to-face promotion

− Delay in DIAMOND study recruitment

Formulary access agreed in the UK in H1 2020

NET SALESCHF million

US Europe

37

6360

H1 2018 H1 2019 H1 2020

+70%

-5%

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45%

13%

43%

VELTASSA®

6 AUGUST 2020 17

ABILITY TO BUILD MARKET AWARENESS

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

20202016

181

CHFm

391

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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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

6 AUGUST 2020 18

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FINANCIAL PERFORMANCE AND GUIDANCE 2020COLIN BOND, CHIEF FINANCIAL OFFICER

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H1 2020 PERFORMANCE

6 AUGUST 2020 20

STABLE NET SALES IN H1 2020

Note: growth at constant exchange rate

Mircera®/Retacrit®

Anti-infectives

Venofer®

Veltassa®

Velphoro®

Ferinject®/Injectafer®

In CHF million -15 -10 -5 0 5 10 15

+8.2%

+8.1%

-1.7%

-6.1%

-0.1%

+8.7%

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H1 2020 PERFORMANCE

6 AUGUST 2020 21

COST CONTAINMENT1) DRIVING EBITDA GROWTH

1) Change vs prior period FTE = Full-time employee

Average number of FTEs

Marketing and advertising

Clinical studies

Travel

+1.7% or 46 FTEs

-19.7% or CHF 12.3 million

-32.8% or CHF 14.4 million

-60.2% or CHF 7.6 million

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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

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)

6 AUGUST 2020 22

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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

6 AUGUST 2020 23

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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

6 AUGUST 2020 24

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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%.

6 AUGUST 2020 25

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DISCLAIMER

6 AUGUST 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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