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VIFOR PHARMA INVESTOR PRESENTATION November 2019
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Page 1: VIFOR PHARMA/media/Files/V/Vifor-Pharma/... · 2019-11-08 · In 2019 at constant exchange rates, Vifor Pharma net sales are expected to exceed 15%, reported EBITDA is expected to

VIFOR PHARMAINVESTOR PRESENTATION

November 2019

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© Vifor Pharma November 2019

VIFOR PHARMA

OUR VISION

Global leader

in iron deficiency, nephrology

and cardio-renal therapies.

2

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© Vifor Pharma

EXPERIENCED LEADERSHIP TEAM

PROVEN TRACK RECORD

November 2019

ETIENNE JORNOD

EXECUTIVE CHAIRMAN

OF THE BOARD OF DIRECTORS

STEFAN SCHULZE

PRESIDENT OF THE EXECUTIVE

COMMITTEE & COO

COLIN BOND

CHIEF FINANCIAL OFFICER

3

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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

November 2019 4

1) Pre-commercial products

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© Vifor Pharma

LEADING PORTFOLIO IN TARGET THERAPY AREAS

1) Pre-commercial products

Avacopan1) CCX1401)

1)

Vadadustat1)

November 2019

CR8451)

Iron

deficiencyNephrology Cardio-renal

Own

products

In-licensed

products

5

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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

November 2019 6

1) Vifor Fresenius Medical Care Renal Pharma

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© Vifor Pharma

[T

November 2019 7

Source: quarterly IQVIATM MIDAS® panel, GERS, Insight Health, DLI, MAT Q2-2019, historical data at constant exchange rate (average 2018)

FERINJECT®

GLOBAL LEADER IN THE I.V. IRON MARKET

81

CHFm

20191996

1’991

CHFm

23%

50%

28%

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© Vifor Pharma November 2019

FERINJECT®

BLOCKBUSTER STATUS ALREADY REACHED IN 2019

Europe US RoW

1) Based on quarterly IQVIATM MIDAS® panel, GERS, Insight Health, DLI, historical data at constant exchange rate (average 2018)

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

8

2018

16 39 59 83126

191244

379

540

698

898>1’000

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© Vifor Pharma

Switzerland

Australia

Sweden

Spain

Germany

Italy

UK

U.S.

Japan

China

6%

23%

13%

35%

11%

48%

22%

39%

0%

0%

November 2019

FERINJECT®

SIGNIFICANT MARKET OPPORTUNITY REMAINS1)

1) Based on quarterly IQVIATM MIDAS® panel, GERS, Insight Health, moving annual total (MAT) Q4 2017-18, historical data at constant exchange rate (average 2018)2) 100 mg eq./1’000 population 3) Subject to reimbursement

Launch Date

2008

2011

2008

2009

2007

2012

2008

2013

20193)

2021

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

251

109

38

34

34

27

24

14

0

0

9

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© Vifor Pharma

2021 2022 2023 2024

Life cycle

management

Indications

with high

unmet need

November 2019

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

10

Geographic

expansion

AFFIRM-AHF

completion*Post-approval

study

China launch

2021

Japan launch1)

2019

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© Vifor Pharma

NEPHROLOGY

HIGHLY DIVERSIFIED PORTFOLIO

November 2019

1) Pre-commercial products

11

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

November 2019

NEPHROLOGY

DELIVERING INNOVATION TO NEPRHOLOGY PATIENTS

2019 2025

Additional launches in nephrologyVadadustat

launch

CCX140

launch

CR845 / Uremic

PruritusPh. III trials completion

VadadustatPh. III trials

completion

> CHF 1bn

reported sales

Avacopan &

CR845 launch

Avacopan / AAVPh. III trial

completion

CCX140 / FSGS Ph. II trial completion

Rayaldee®

launch

13

Early stage development through the joint venture with Evotec

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© Vifor Pharma

CURRENT INDICATIONS

November 2019

NEPHROLOGY

NUMEROUS OPPORTUNITIES REMAIN

Polycystic kidney disease

Metabolic acidosis

Vascular calcification

Kidney stones

Hypernatremia

Fabry

aHUS

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

14

Diabetic kidney diseaseKidney fibrosis

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© Vifor Pharma November 2019

NEPHROLOGY

LEADERSHIP OF THE WHOLE NEPHROLOGY CHAIN

CLINICAL / PRE-COMMERCIAL

IN-LICENSING DEALS AND PARTNERSHIPS

Avacopan

VadadustatCR845

CCX140

PRE-CLINICAL

DA

TA

GE

NE

RA

TIO

N

PARTNERSHIP

TRANSPLANTATION

COMMERCIAL

PRE-DIALYSIS DIALYSIS

15

Joint venture

with Evotec

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© Vifor Pharma

US nephrologists

November 2019 16

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

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© Vifor Pharma

[]

November 2019 17

NEPHROLOGY

ADDING WORLD CLASS PRE-CLINICAL CAPABILITIES

Joint venture

50%

50%

Pre-clinical candidates

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© Vifor Pharma

[]

November 2019 18

NEPHROLOGY

STAGED, SUCCESS DEPENDENT PARTNERSHIP

Joint venture

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

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© Vifor Pharma

[]

November 2019 19

• 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 2018) 1) SmPC = summary of product characteristics

46%

54%

175

CHFm

295

CHFm

20192015

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© Vifor Pharma

US MARKET OPPORTUNITY

November 2019

VELTASSA®

ASSESSMENT OF LONG TERM POTENTIAL UNCHANGED

3 million USD 820

Monthly gross priceEstimated

hyperkalaemia patients

6 months

Targeted duration

of treatment

x x > USD 10 billion =

Potential market size

(net sales)

20

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© Vifor Pharma

2020 2021 2022 2023 2024

November 2019

VELTASSA®

DRIVE TO BLOCKBUSTER STATUS

2019 2025

DIAMOND

completionPost-approval study

AMBER study

results publishedPost-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

21

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© Vifor Pharma

PRE-CLINICAL

November 2019

R&D INVESTMENTS

FOCUS IS ON KEY PRODUCTS AND CLINICAL PIPELINE

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

(2020)

DIAMOND

(2022)

Vadadustat(Q2 2020)

CR845 (Q2 2020)

Initiation

Q4 2019HEART FID

(2022)2)

22

Joint venture

with Evotec

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© Vifor Pharma

H1

2018

H1

2019

%∆ vs.

H1 2018

Net Sales 747.4 913.3 +22.2%

Other Income 41.0 20.4 -50.3%

Gross Profit 500.2 560.3 +12.0%

EBITDA 192.0 254.6 +32.6%

Depreciation and amortization -76.7 -106.0 -38.1%

EBIT 115.2 148.7 +29.0%

Financial result 41.8 -8.9 NM

Income tax 1.0 -13.8 NM

Net Profit before minorities 158.0 126.0 -20.3%

Net Profit after minorities 118.0 65.2 -44.8%

Core earnings1 per share 2.66 2.11 -20.7%

November 2019 23

P&L OVERVIEW (IN CHF MILLION)

NM = not meaningful

• Net sales increase of +22.2%

driven by Ferinject®, Mircera®

Velphoro® and Veltassa®

• Proportionately lower gross profit

increase due to lower other income

and higher cost of sales related to

Mircera® commercialisation rights

• EBITDA increase of +32.6% driven

by strong top-line growth and cost

containment

• Growth in net profit after minorities

impacted by a one-off FX gain in

H1 2018 and higher tax expenses

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© Vifor Pharma

44.4

5.7

65.1

45.3

25.7

-20.3

165.9

+19.4%

+9.6%

30.4%

+126.6%

+69.9%

-11.8%

+22.2%

November 2019 24

NET SALES OVERVIEW (IN CHF MILLION)

SOLID GROWTH IN H1 2019

H1

2018

H1

2019

Ferinject®/Injectafer® 229.0 273.4

Venofer® 59.6 65.4

Mircera®/RetacritTM 214.0 279.1

Velphoro® 35.8 81.1

Veltassa® 36.8 62.6

Others 172.1 151.9

Net sales 747.4 913.3

Growth

in H1 2019

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© Vifor Pharma

31 Dec

2018

30 Jun

2019

Change vs.

31 Dec 2018

Cash & cash equivalents 400.3 321.5 (78.8)

Trade & other receivables 509.0 522.3 13.4

Inventories 281.7 319.4 37.7

Financial investments & other assets 354.5 329.9 (24.6)

PPE1)

& RoU2)

assets 274.0 341.6 67.6

Intangible assets 2'676.0 2'643.0 (33.0)

Assets 4'495.5 4'477.8 (17.7)

Current financial & lease liabilities 116.2 115.1 (1.1)

Other current liabilities 478.3 466.2 (12.1)

Non-current financial & lease liabilities 492.4 554.0 61.6

Other non-current liabilities 44.1 30.8 (13.3)

Shareholders' equity 3'364.6 3'311.7 (52.9)

Liabilities & shareholders' equity 4'495.5 4'477.8 (17.7)

• Decrease in cash & cash

equivalents mainly driven by

dividend payments

• Increase in inventories to support

the growth of the business

• Increase in PPE1) & RoU2) assets

and non-current financial & lease

liabilities driven by the adoption of

IFRS 16

November 2019 25

BALANCE SHEET OVERVIEW (IN CHF MILLION)

STRONG EQUITY RATIO OF 74.0%

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

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© Vifor Pharma

2019

Opening cash & cash equivalents, 1 January 400.3

Operating activities 267.7

Net working capital (NWC) (57.5)

Interest, tax & other financial payments (12.3)

Cash flow from operating activities 197.9

Milestones & BD&L1)

investments (58.3)

Capex & others (12.7)

Cash flow from investing activities (71.1)

Dividends paid (174.7)

Financing & others (28.2)

Cash flow from financing activities (202.9)

Exchange rate effects (2.7)

Ending cash & cash equivalents, 30 June 321.5

Interest bearing financial liabilities (excl. leases) (564.4)

Net debt (242.8)

• Strong cash flow from operating

activities, despite the increase in NWC to

support topline growth

• Cash flow from investing activities driven

by the Mircera® commercialisation rights

(CHF 37.7)

• Cash flow from financing activities driven

by dividend payments of CHF 129.7 to

Vifor Pharma shareholders and CHF 45.0

to Fresenius Medical Care

CASH FLOW OVERVIEW (IN CHF MILLION)

NET DEBT OF CHF 242.8 MILLION

26November 2019

1) Business development & licensing

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© Vifor Pharma

GUIDANCE 2019

NET SALES AND EBITDA GUIDANCE INCREASED

In 2019 at constant exchange rates, Vifor Pharma net sales are expected to exceed 15%,

reported EBITDA is expected to grow between 25% and 30%.

In 2020 net sales are expected to exceed CHF 2 billion and

EBITDA to be in the range of CHF 700 million.

Going forward the dividend is expected to remain at the current level of CHF 2 per share.

November 2019 27

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© Vifor Pharma

OUTLOOK 2019

CLINICAL TRIALS

MARKET ACCESS

Veltassa®: presentation of the AMBER study results (May 2019)

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

Ferroportin inhibitor: initiation of phase-II study (Q4 2019)

Avacopan: phase-III ADVOCATE study readout (Q4 2019)

CR845: readouts of KALM-1 study (May 2019) and KALM-2 study (shifted to Q2 2020)

Ferinject® launch in Japan, subject to reimbursement

Go-to-market strategy in China for Ferinject®

BUSINESS

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

November 2019 28

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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]

November 2019 29

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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.

November 2019 30


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