PRESENTATION VIFOR PHARMA/media/Files/V/Vifor-Pharma/documents/en/investors/ir... · o Dividend payments of CHF 129.6 to Vifor Pharma shareholders and CHF 45.0 to Fresenius Medical

VIFOR PHARMA

INVESTOR PRESENTATION

PRESENTATION

March 2019

© Vifor Pharma March 2019 2

VIFOR PHARMA

OUR VISION

Global leader

in iron deficiency, nephrology

and cardio-renal therapies.

© Vifor Pharma

EXPERIENCED LEADERSHIP TEAM

PROVEN TRACK RECORD

March 2019 3

ETIENNE JORNOD

EXECUTIVE CHAIRMAN

OF THE BOARD OF DIRECTORS

STEFAN SCHULZE

PRESIDENT OF THE EXECUTIVE

COMMITTEE & COO

COLIN BOND

CHIEF FINANCIAL OFFICER

© 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

March 2019 4

© Vifor Pharma

LEADING PORTFOLIO IN TARGET THERAPY AREAS

1) Pre-commercial products

Avacopan1) CCX1401)

1)

Vadadustat1)

March 2019 5

CR8451)

Iron

deficiency Nephrology Cardio-renal

Own

products

In-licensed

products

© 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

March 2019 6

© Vifor Pharma

16 39 59 83 126

191 244

379

540

698

898

March 2019

FERINJECT®

A BLOCKBUSTER POTENTIALLY ALREADY IN 2019

Europe US RoW

MAT = Moving annual total

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

7

GLOBAL I.V. IRON MARKET (MAT Q4 2018)1)

• Global in-market sales of CHF 1’837 million (+17%)

• Ferinject® in-market sales growth of 29%

• Global market share of Ferinject® in value is 49%

IN-MARKET SALES1)

CHF MILLION

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018

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

© Vifor Pharma

Switzerland

Australia

New Zealand

Sweden

Spain

Germany

Italy

UK

France

U.S.

Japan

China

6%

23%

44%

13%

35%

11%

48%

22%

11%

39%

0%

0%

March 2019 8

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

Launch Date

2008

2011

2012

2008

2009

2007

2012

2008

2011

2013

2019

2021

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

251

109

56

38

34

34

27

24

23

14

0

0

© Vifor Pharma March 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)

© Vifor Pharma

2020 2021 2022 2023 2024

March 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

© Vifor Pharma March 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)

© 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

March 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

© Vifor Pharma

VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA

CURRENT PORTFOLIO

March 2019 13

1) Pre-commercial products

CARDIO-RENAL

MANAGEMENT

MINERAL & BONE

MANAGEMENT

ANAEMIA

MANAGEMENT

KIDNEY

PROTECTION

Avacopan1)

1)

Vadadustat1)

CR8451)

CCX1401)

CKD-ASSOCIATED

COMPLICATIONS

© Vifor Pharma

2020 2021 2022 2023 2024

March 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 trials 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

© Vifor Pharma

CURRENT INDICATIONS

March 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

© Vifor Pharma March 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

© Vifor Pharma March 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

© Vifor Pharma

US MARKET OPPORTUNITY

March 2019 18

VELTASSA®

ASSESSMENT OF LONG TERM POTENTIAL UNCHANGED

3 million USD 820

Monthly gross price Estimated

hyperkalaemia patients

6 months

Targeted duration

of treatment

x x > USD 10 billion =

Potential market size

(net sales)

© Vifor Pharma

VELTASSA®

TOTAL US DEMAND PER BUSINESS DAY (BD)

19 March 2019

Dem

an

d (

bo

xes)

per

BD

0

100

200

300

400

500

600

700

800

900

© Vifor Pharma

2020 2021 2022 2023 2024

March 2019 20

VELTASSA®

DRIVE TO BLOCKBUSTER STATUS

2019 2025

DIAMOND

completion Post-approval study

AMBER study

results publication 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

© Vifor Pharma March 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)

AMBER (May 2019)

DIAMOND (2022)

Vadadustat (2020)

21

CR845 (Q2/H2 2019)

Initiation mid-2019

HEART FID (2022)2)

© Vifor Pharma

FY

2017

FY

2018

Change

vs. 2017

Net sales 1'291.7 1'584.6 +22.7%

Other income 91.6 64.6 -29.5%

Cost of sales (517.9) (648.7) +25.3%

Gross profit 865.4 1'000.5 +15.6%

EBITDA 280.4 391.5 +39.7%

Depreciation and amortisation (146.0) (164.1) +12.4%

EBIT 134.3 227.4 +69.3%

Core earnings2)

per share 2.12 4.16 +95.9%

March 2019 22

P&L OVERVIEW (IN CHF MILLION)

ON TRACK TO ACHIEVE MILESTONE 2020 GUIDANCE

1) Restated for IFRS 15 impact 2) Profit after minorities adjusted for amortisation of intangible assets (CHF 117.5 million in 2018)

• Net sales increase of 22.7% driven by

Ferinject®/Injectafer®, Mircera®,

Veltassa® and Velphoro®

• EBITDA growth of 39.7%, driven by

strong net sales growth and cost

containment

• Core earnings per share of 4.16, driven

by strong operating performance and

financial result

1)

© Vifor Pharma

93.4

111.4

8.6

15.1

38.8

10.0

15.6

292.9

+23.8%

+32.8%

NM2)

+7.9%

+18.7%

+75.1%

+4.9%

+22.7%

March 2019 23

NET SALES OVERVIEW (IN CHF MILLION)

SOLID GROWTH IN 2018

FY

2017

FY

2018

Ferinject®/Injectafer® 391.8 485.1

Mircera® 339.9 451.3

Venofer® 109.6 118.2

Velphoro® 80.6 95.7

Veltassa® 51.7 90.5

RetacritTM 0.0 10.0

Others 318.2 333.8

Net sales 1'291.7 1'584.6

Growth

in 2018

1) Restated for IFRS 15 impact 2) Not meaningful

1)

© Vifor Pharma

31 Dec

2017

31 Dec

2018

Change

vs. 2017

Cash & cash equivalents 425.1 400.3 (24.8)

Receivables 407.4 509.0 101.6

Inventories 232.0 281.7 49.7

Financial investments & other 147.1 266.1 119.0

Deferred tax assets 17.6 88.4 70.8

Property & equipment 245.6 274.0 28.4

Goodwill & intangibles 2'651.1 2'676.0 24.9

Assets 4'125.9 4'495.5 369.6

Current financial liabilities 139.6 116.2 (23.4)

Other current liabilities 449.3 478.3 29.0

Non-current liabilities 204.5 536.4 331.9

Shareholders' equity 3'332.5 3'364.6 32.1

Liabilities & shareholders' equity 4'125.9 4'495.5 369.6

• Receivables increase driven by

net sales increase

• Increase in financial investments

& other mainly driven by:

o ChemoCentryx: CHF 85.4

o Cara Therapeutics: CHF 14.6

• Increase in non-current liabilities

mainly driven by the bond issue of

CHF 463.8 (net proceeds),

partially offset by the repayment of

the private placement of

CHF 114.5

March 2019 24

BALANCE SHEET OVERVIEW (IN CHF MILLION)

STRONG EQUITY RATIO OF 74.8%

© Vifor Pharma

2018

Opening cash, 1 January 425.1

Operating activities 405.9

Net working capital (133.2)

Income tax paid (78.9)

Cash flow from operating activities 193.8

Milestones & BD&L investments (318.0)

Capex & others (58.1)

Cash flow from investing activities (376.1)

Dividends paid (174.6)

Financing & others 333.2

Cash flow from financing activities 158.6

Exchange rate effects (1.1)

Ending cash and cash equivalents, 31 December 400.3

Financial liabilities (580.0)

Net debt (179.7)

• Cash flow from investing activities mainly

driven by milestones & BD&L

investments

o Avacopan: CHF 49.1

o Cara Therapeutics: CHF 70.1

o ChemoCentryx: CHF 85.4

• Cash flow from financing activities mainly

driven by:

o Dividend payments of CHF 129.6 to

Vifor Pharma shareholders and CHF

45.0 to Fresenius Medical Care

o Bond issue of CHF 463.8 (net

proceeds), partially offset by the

repayment of the private placement of

CHF 114.5

CASH FLOW OVERVIEW (IN CHF MILLION)

NET DEBT OF CHF 179.7 MILLION

25 March 2019

© Vifor Pharma

GUIDANCE 2019

In 2019 at constant exchange rates Vifor Pharma net sales are expected to grow

between 11% and 13%, reported EBITDA is expected to increase by 25%.

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.

26 March 2019

© Vifor Pharma

OUTLOOK 2019

1) Presentation on 10 May 2019 at the National Kidney Foundation Spring Clinical Meetings

CLINICAL TRIALS

MARKET ACCESS

Veltassa®: results of the AMBER study presented in May 20191)

Veltassa®: initiation of the DIAMOND outcome study for RAASi enabling (H1 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 (Q2 and H2 2019, respectively)

Ferinject® launch in Japan (H2 2019)

Go-to-market strategy in China

Partnering the Japanese rights for CCX140

BUSINESS

DEVELOPEMENT Completion of at least one additional in-licensing, product acquisition or corporate transaction

March 2019 27

© 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]

March 2019 28

© 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.

March 2019 29