INVESTOR PRESENTATION - VIFOR PHARMA
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PRESENTATION
VIFOR PHARMA
INVESTOR PRESENTATION
March 2019
VIFOR PHARMA
OUR VISION
Global leader
in iron deficiency, nephrology
and cardio-renal therapies.
© Vifor Pharma March 2019 2
EXPERIENCED LEADERSHIP TEAM
PROVEN TRACK RECORD
ETIENNE JORNOD STEFAN SCHULZE COLIN BOND
EXECUTIVE CHAIRMAN PRESIDENT OF THE EXECUTIVE CHIEF FINANCIAL OFFICER
OF THE BOARD OF DIRECTORS COMMITTEE & COO
© Vifor Pharma March 2019 3
PROVEN TRACK RECORD
CORPORATE TIMELINE AND STRATEGY
2020
2015
2010
2000 BECOMING GLOBAL LEADER
IN NEPHROLOGY AND ENTERING
BECOMING GLOBAL LEADER
CARDIO-RENAL DISEASE AREA
BUILDING IRON PORTFOLIO IN IRON DEFICIENCY AND
AND INTERNATIONAL EXPANSION ENTERING INTO NEPHROLOGY • 2015: Mircera® license
• 2000: Venofer® US FDA approval • 2015: Veltassa® license
• 2010: Creation of VFMCRP • 2016: Four licensing deals
• 2007: Launch of Ferinject®
• 2013: Injectafer® – FDA approval • 2016: Relypsa acquisition
• 2008: Acquisition Aspreva
• 2013: Launch of Velphoro® • 2017: Galenica Santé IPO
• 2008: Creation of EU affiliates
• 2009: Acquisition OM Pharma • 2017: Vadadustat license
• 2017: Veltassa® EU approval
• 2017: Mircera® license expansion
• 2018: CR845 license
© Vifor Pharma March 2019 4
LEADING PORTFOLIO IN TARGET THERAPY AREAS
Iron
Nephrology Cardio-renal
deficiency
Own
products
In-licensed Avacopan1) CCX1401)
1)
products
Vadadustat1) CR8451)
1) Pre-commercial products
© Vifor Pharma March 2019 5THREE STRATEGIC GROWTH DRIVERS
Ferinject®
Exploit the potential through market awareness
Vifor Fresenius Medical Care Renal Pharma
Grow and enhance value
Veltassa®
Build a blockbuster
© Vifor Pharma March 2019 6FERINJECT®
A BLOCKBUSTER POTENTIALLY ALREADY IN 2019
GLOBAL I.V. IRON MARKET (MAT Q4 2018)1) IN-MARKET SALES1) 898
CHF MILLION
• Global in-market sales of CHF 1’837 million (+17%)
• Ferinject® in-market sales growth of 29% 698
• Global market share of Ferinject® in value is 49% 540
379
244
191
126
59 83
16 39
2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
Launch in FAIR-HF FERGI-COR PREFER study FIND-CKD CONFIRM- New EU New ESC Intensifying
CH, UK, study study (fatigue) study (ND- HF study onco guidelines promotional
Spain (cardio) (gastro) CKD) (cardio) guidelines (cardio) effort by
New EU
Daiichi
guidelines: Injectafer® EFFECT-HF
Sankyo
nephro, cardio, approved study
gastro, onco in the USA (cardio)
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)
© Vifor Pharma March 2019 7FERINJECT®
SIGNIFICANT MARKET OPPORTUNITY REMAINS 1)
Ferinject® in-market volume growth Ferinject® volume per capita2)
Launch Date
6% Switzerland 251 2008
23% Australia 109 2011
44% New Zealand 56 2012
13% Sweden 38 2008
35% Spain 34 2009
11% Germany 34 2007
48% Italy 27 2012
22% UK 24 2008
11% France 23 2011
39% U.S. 14 2013
0% Japan 0 2019
0% China 0 2021
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
© Vifor Pharma March 2019 8FERINJECT®
THE BLOCKBUSTER PLAN
Therapeutic • Heart failure Strong • Partnering with leading
areas with high • Patient blood management partnerships companies
unmet need • Gastroenterology
• Nephrology
Geographic • Japan (2019) Life cycle • AFFIRM-AHF
expansion • China (2021) management • HEART-FID1)
• Key pharmerging markets
1) Study conducted by our US partner Daiichi Sankyo
© Vifor Pharma March 2019 9FERINJECT®
EXPLOIT THE POTENTIAL
2019 2020 2021 2022 2023 2024 2025
> CHF 2 billion
Japan launch China launch
in-market sales
H2 2019 2021
potential
AFFIRM-AHF FAIR-HF2 HEART-FID
U.S. label
completion completion1) completion2)
update
Post-approval study Post-approval study U.S. Post-approval study
Focus on cardiology, patient blood management, gastroenterology and nephrology
EU guidelines* U.S. guidelines*
update based on update based on
AFFIRM AHF HEART-FID
*Targeted guidelines:
1) Investigator initiated study, University of Hamburg 2) Study conducted by our US partner Daiichi Sankyo
© Vifor Pharma March 2019 10VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA
THE RATIONALE
55% Stake
STRONG IRON AND PHARMA EXPERTISE
1)
CCX1401)
Avacopan1)
CR8451) Vadadustat1)
GLOBAL LEADER IN DIALYSIS
45% Stake
1) Pre-commercial products
© Vifor Pharma March 2019 11VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA
SYNERGISTIC PARTNERSHIP
55% Stake
STRONG IRON AND PHARMA EXPERTISE
Sourcing of innovation
Evaluation of clinical assets
Acceptance of clinical risk
Regulatory and market access expertise Focus on pharma needs of nephrology patients – Global Leader
Access to patient data. Faster clinical trial execution
Faster uptake and utilisation
GLOBAL LEADER IN DIALYSIS Partnership technically controlled by Vifor Pharma
Managed care expertise
Patient access (>300k patients)
Validation of innovation
Medications in FKC clinics1) become SoC2)
45% Stake
1) Fresenius Kidney Care (FKC): Fresenius Medical Care North America dialysis provider organization
2) Standard of care
© Vifor Pharma March 2019 12VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA
CURRENT PORTFOLIO
ANAEMIA MINERAL & BONE KIDNEY CKD-ASSOCIATED CARDIO-RENAL
MANAGEMENT MANAGEMENT PROTECTION COMPLICATIONS MANAGEMENT
Avacopan1) CR8451)
1)
CCX1401)
Vadadustat1)
1) Pre-commercial products
© Vifor Pharma March 2019 13VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA
DELIVERING INNOVATION TO NEPRHOLOGY PATIENTS
2019 2020 2021 2022 2023 2024 2025
Rayaldee® Avacopan Vadadustat > CHF 1bn
launch launch launch reported sales
CCX140 / FSGS CR845 CCX140 Additional launches in
Ph. II trial completion launch launch nephrology
Avacopan / AAV Vadadustat
Ph. III trial Ph. III trials
completion completion
CR845 / Uremic
Avacopan / C3G
Pruritus Ph. II trial completion
Ph. III trial completion
© Vifor Pharma March 2019 14NEPHROLOGY
NUMEROUS OPPORTUNITIES REMAIN
CURRENT INDICATIONS PIPELINE INDICATIONS POTENTIAL INDICATIONS
Hypernatremia
Vascular calcification
FSGS
Iron deficiency Polycystic kidney disease
ANCA associated vasculitis
Anaemia Kidney stones aHUS
Secondary hyperparathyroidism β-Thalassemia renal disease
Hyperphosphatemia
Hyperkalemia Uremic pruritus Metabolic acidosis
Acute kidney injury
C3G
Diabetic nephropathy
Fabry
© Vifor Pharma March 2019 15NEPHROLOGY
LEADERSHIP OF THE WHOLE NEPHROLOGY CHAIN
PRE CLINICAL CLINICAL / PRE-COMMERCIAL
PARTNERSHIP IN-LICENSING DEALS AND PARTNERSHIPS
Avacopan
DATA GENERATION
CCX140
CR845 Vadadustat
COMMERCIAL
PRE DIALYSIS DIALYSIS TRANSPLANTATION
© Vifor Pharma March 2019 16VELTASSA®
OVERVIEW OF KEY FEATURES
Mode of action High safety profile
Calcium-based, non-absorbed Limited undesirable effects
52-weeks data RAASi enabling
AMETHYST-DN study Included in SmPC1) in Europe
Broad use Room temperature storage
Acute & Chronic US: 3 months / EU: 6 months
1) SmPC = summary of product characteristics
© Vifor Pharma March 2019 17VELTASSA®
ASSESSMENT OF LONG TERM POTENTIAL UNCHANGED
US MARKET OPPORTUNITY
3 million x USD 820 x 6 months = > USD 10 billion
Estimated Monthly gross price Targeted duration Potential market size
hyperkalaemia patients of treatment (net sales)
© Vifor Pharma March 2019 18VELTASSA®
TOTAL US DEMAND PER BUSINESS DAY (BD)
900
800
700
Demand (boxes) per BD
600
500
400
300
200
100
0
© Vifor Pharma March 2019 19VELTASSA®
DRIVE TO BLOCKBUSTER STATUS
2019 2020 2021 2022 2023 2024 2025
European rollout Japan launch Blockbuster
Zeria status
AMBER study Guideline* DIAMOND Guideline*
results publication updates based on completion updates based on
Post-approval study AMBER results Post-approval study DIAMOND results
Label updates based on
DIAMOND results
*Targeted guidelines:
© Vifor Pharma March 2019 20R&D INVESTMENTS
FOCUS IS ON KEY PRODUCTS AND CLINICAL PIPELINE
PHASE 1 PHASE 2 PHASE 3 LIFE CYCLE MANAGEMENT
Oral ferroportin
Initiation mid-2019 AFFIRM-AHF (2020)
inhibitor1)
Own
HEART FID (2022)2)
Products
AMBER (May 2019)
DIAMOND (2022)
Avacopan (Q4 2019)
In-licensed CCX140 (2020)
Products
CR845 (H2 2019)
Vadadustat (2020)
1) Iron overload; leveraging iron metabolism expertise 2) Study conducted by our US partner Daiichi Sankyo
© Vifor Pharma March 2019 21P&L OVERVIEW (IN CHF MILLION)
ON TRACK TO ACHIEVE MILESTONE 2020 GUIDANCE
FY FY Change • Net sales increase of 22.7% driven by
20171) 2018 vs. 2017 Ferinject®/Injectafer®, Mircera®,
Net sales 1'291.7 1'584.6 +22.7% Veltassa® and Velphoro®
Other income 91.6 64.6 -29.5%
Cost of sales (517.9) (648.7) +25.3% • EBITDA growth of 39.7%, driven by
Gross profit 865.4 1'000.5 +15.6% strong net sales growth and cost
containment
EBITDA 280.4 391.5 +39.7%
• Core earnings per share of 4.16, driven
Depreciation and amortisation (146.0) (164.1) +12.4%
by strong operating performance and
EBIT 134.3 227.4 +69.3%
financial result
Core earnings 2) per share 2.12 4.16 +95.9%
1) Restated for IFRS 15 impact 2) Profit after minorities adjusted for amortisation of intangible assets (CHF 117.5 million in 2018)
© Vifor Pharma March 2019 22NET SALES OVERVIEW (IN CHF MILLION)
SOLID GROWTH IN 2018
FY FY Growth
1)
2017 2018 in 2018
Ferinject®/Injectafer® 391.8 485.1 93.4 +23.8%
Mircera® 339.9 451.3 111.4 +32.8%
Venofer® 109.6 118.2 8.6 +7.9%
Velphoro® 80.6 95.7 15.1 +18.7%
Veltassa® 51.7 90.5 38.8 +75.1%
RetacritTM 0.0 10.0 10.0 NM2)
Others 318.2 333.8 15.6 +4.9%
Net sales 1'291.7 1'584.6 292.9 +22.7%
1) Restated for IFRS 15 impact 2) Not meaningful
© Vifor Pharma March 2019 23BALANCE SHEET OVERVIEW (IN CHF MILLION)
STRONG EQUITY RATIO OF 74.8%
31 Dec 31 Dec Change
2017 2018 vs. 2017 • Receivables increase driven by
Cash & cash equivalents 425.1 400.3 (24.8) net sales increase
Receivables 407.4 509.0 101.6
• Increase in financial investments
Inventories 232.0 281.7 49.7
& other mainly driven by:
Financial investments & other 147.1 266.1 119.0
Deferred tax assets 17.6 88.4 70.8 o ChemoCentryx: CHF 85.4
Property & equipment 245.6 274.0 28.4 o Cara Therapeutics: CHF 14.6
Goodwill & intangibles 2'651.1 2'676.0 24.9 • Increase in non-current liabilities
Assets 4'125.9 4'495.5 369.6 mainly driven by the bond issue of
Current financial liabilities 139.6 116.2 (23.4) CHF 463.8 (net proceeds),
Other current liabilities 449.3 478.3 29.0 partially offset by the repayment of
Non-current liabilities 204.5 536.4 331.9 the private placement of
Shareholders' equity 3'332.5 3'364.6 32.1 CHF 114.5
Liabilities & shareholders' equity 4'125.9 4'495.5 369.6
© Vifor Pharma March 2019 24CASH FLOW OVERVIEW (IN CHF MILLION)
NET DEBT OF CHF 179.7 MILLION
2018 • Cash flow from investing activities mainly
Opening cash, 1 January 425.1 driven by milestones & BD&L
Operating activities 405.9 investments
Net working capital (133.2) o Avacopan: CHF 49.1
Income tax paid (78.9) o Cara Therapeutics: CHF 70.1
Cash flow from operating activities 193.8
o ChemoCentryx: CHF 85.4
Milestones & BD&L investments (318.0)
Capex & others (58.1) • Cash flow from financing activities mainly
Cash flow from investing activities (376.1) driven by:
Dividends paid (174.6) o Dividend payments of CHF 129.6 to
Financing & others 333.2 Vifor Pharma shareholders and CHF
Cash flow from financing activities 158.6 45.0 to Fresenius Medical Care
Exchange rate effects (1.1) o Bond issue of CHF 463.8 (net
Ending cash and cash equivalents, 31 December 400.3 proceeds), partially offset by the
repayment of the private placement of
Financial liabilities (580.0) CHF 114.5
Net debt (179.7)
© Vifor Pharma March 2019 25GUIDANCE 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.
© Vifor Pharma March 2019 26OUTLOOK 2019
Ferinject® launch in Japan (H2 2019)
MARKET ACCESS Go-to-market strategy in China
Partnering the Japanese rights for CCX140
Veltassa®: results of the AMBER study presented in May 20191)
Veltassa®: initiation of the DIAMOND outcome study for RAASi enabling (H1 2019)
CLINICAL TRIALS 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 (Q1 and H2 2019, respectively)
BUSINESS
Completion of at least one additional in-licensing, product acquisition or corporate transaction
DEVELOPEMENT
1) Presentation on 10 May 2019 at the National Kidney Foundation Spring Clinical Meetings
© Vifor Pharma March 2019 27CONTACT INFORMATION
Colin Bond – CFO
Phone: +41 58 851 83 53
Email: colin.bond@viforpharma.com
INVESTOR RELATIONS
Julien Vignot – Head of Investor Relations
Phone: +41 58 851 66 90
Email: julien.vignot@viforpharma.com
Laurent de Weck – Investor Relations Manager
Phone: +41 58 851 80 95
Email: laurent.deweck@viforpharma.com
© Vifor Pharma March 2019 28DISCLAIMER 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. © Vifor Pharma March 2019 29
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