march 2021 vifor pharma
TRANSCRIPT
VIFOR PHARMA
INVESTOR PRESENTATION
MARCH 2021
LEADING PORTFOLIO IN TARGET THERAPY AREAS
MARCH 2021
1) Restriction of iron availability, i.e. for treating non-transfusion-dependent thalassemia or sickle cell disease 2) Licensed from F. Hoffmann-La Roche AG 3) Licensed from Pfizer Inc. 4) Joint commercialisation agreement with Janssen Pharmaceuticals Inc. 5) Licensed from OPKO Health, Inc. 6) Licensed from ChemoCentryx, Inc. 7) Licensed from Cara Therapeutics, Inc. 8) Licensed from Akebia Therapeutics, Inc., subject to certain conditions and limited to the US dialysis market 9) Licensed from Angion Biomedica Corp.
Iron
deficiencyNephrology Cardio-renal
Commercial
products
Pipeline
products
Avacopan6
Vadadustat8
KorsuvaTM 7
Rayaldee®5
2
ANG-37779
VIT-27631
2
43
Iron Deficiency
Cardio-Renal
3
Nephrology
MARCH 2021
3
1
2
VIFOR PHARMA STRATEGIC FOCUSTHREE AREAS AS BASIS FOR FUTURE GROWTH
Global market leader
High unmet medical need
Ferinject®: defined by manufacturing process
36%
64%
43%
57%
46%
54%
IRON DEFICIENCY – MARKET OVERVIEW
MARCH 2021
DRIVING OVERALL MARKET GROWTH
Source: quarterly IQVIATM MIDAS® panel, GERS, Insight Health, DLI, moving annual total Q4-2020. Average 2020 exchange rates have been applied
20202014
3’392
CHFm
1’924
CHFm
4
2017
2’633
CHFm
Ferinject®/Injectafer®, Venofer® and Maltofer®
0
30
60
90
120
150
180
Q1 Q2 Q3 Q4
IRON DEFICIENCY – FERINJECT®/INJECTAFER®
MARCH 2021 5
STRONG REBOUND AFTER DECREASE IN RESTRICTIONS
Q1: Growth compared to prior period
in line with expectations
Q2: Heavily impacted by COVID-19
measures during first wave
Q3: Immediate and strong return to
pre-COVID 19 growth with easing
restrictions in most countries
Q4: 2nd wave less impactful with
better prepared healthcare system
Conclusion:
Ferinject®/Injectafer® expected to
be back to pre-COVID-19 growth
with easing lockdown measures
NET SALES EVOLUTIONIn CHF million, % at CER
+26%-26%
+16%-2%
2019 2020
CER = constant exchange rates
1) Pre-COVID-19 year-over-year growth rate as per end of Q1 2020Source: quarterly IQVIATM MIDAS® panel, GERS, Insight Health, moving annual total Q3-2020 in 100mg equivalents; EU4: Germany, France, Italy and Spain
MARCH 2021
INDICATIONS SPLIT DRIVEN BY REGIONAL FOCUS
6
Patient blood
management
Heart failure Gastro-
enterology
Oncology /
Hematology
Nephrology OtherWomen’s health
EU4 and the UK US
CAGR
’16-201 40% 40%
Sales
share by
indication
IRON DEFICIENCY – FERINJECT® INDICATIONS
20% 20%16% 15%
12%9% 9%
17%
3%
40%
9%
26%
4%1%
PATIENT DROP-OFF – EU4 AND THE UK
MARCH 2021 7
MAJOR GROWTH OPPORTUNITY
Source: Vifor Pharma analysis, 2019, EU4: Germany, France, Italy and Spain 1) Patient Blood Management 2) Froessler B, et al. Risk Manag Health Policy 2018;11:77–82;
1
Not treatedOther i.v. iron Ferinject®
1’207K
135K
221K
1’933K
With iron deficiency Transfusion
370K PBM strongly supported by
World Health Organization
Estimated savings per patient
of CHF 850 vs usual care2
Additional real world
evidence data expected in
2021
IRON DEFICIENCY – FERINJECT® PBM1 EUROPE
Iron Deficiency
Cardio-Renal
8
Nephrology
MARCH 2021
3
1
2
VIFOR PHARMA STRATEGIC FOCUSTHREE AREAS AS BASIS FOR FUTURE GROWTH
Establish leadership position
Fast growing market
Leverage unique partnership
NEPHROLOGY – PORTFOLIO OVERVIEW
MARCH 2021 9
CONTINUING TO ESTABLISH LEADERSHIP POSITION
1) Sales in chronic kidney disease 2) Pipeline products 3) Licensed from F. Hoffmann-La Roche AG 4) Licensed from Pfizer Inc. 5) Licensed from OPKO Health, Inc. 6) Licensed from ChemoCentryx, Inc. 7) Licensed from Cara Therapeutics, Inc. 8) Licensed from Akebia Therapeutics, Inc., subject to certain conditions and limited to the US dialysis market 9) Licensed from Angion Biomedica Corp.
2010 2015 2020 2025
Nephrology
portfolio
1 1 Avacopan2 6
Vadadustat2 8
KorsuvaTM 2 7
Initial portfolio Portfolio expansion
Exploring BD&L
opportunities
Nephrology
revenue
KorsuvaTM 2 7 expansion
Creation of
VFMCRP
in 2010
ANG-37772 9
launch 2015
launch 2018
Upcoming launches
Rayaldee® 2 5
3
4
NEPHROLOGY OPPORTUNITIES
10
LARGE AND GROWING MARKET WITH HIGH UNMET MEDICAL NEED
COMMERCIAL PIPELINE BD&L OPPORTUNITIES
Hyperphosphatemia
Hyperkalemia
Anaemia
Iron deficiency
Diabetic kidney disease
MARCH 2021
Uremic pruritus
Secondary hyperparathyroidism
ANCA associated vasculitis
Cardiac surgery associated
acute kidney injury
CKD associated complications
CKD progression drivers
Acute kidney injury
Dialysis related complications
TransplantationC3G
Delayed graft function
11
1) Fresenius Medical Care
Global leadership in nephrology through:
Combination of strengths
Optimal sourcing of innovation
Access to patient data & faster clinical trial execution
Improving outcomes via treatment algorithms
Clinical development
Manufacturing, regulatory and market access experiences
Global commercial presence
STRONG IRON AND PHARMA EXPERTISE
GLOBAL LEADER IN DIALYSIS
55%
Stake
45%
Stake
~350’000patients
>52 milliondialysis treatments p.a.
>4’000clinics
NEPHROLOGY – PARTNERSHIP WITH FMC1
UNIQUE EXPERTISE AND PATIENT ACCESS
MARCH 2021
Iron Deficiency
Cardio-Renal
12
Nephrology
MARCH 2021
3
1
2
VIFOR PHARMA STRATEGIC FOCUSTHREE AREAS AS BASIS FOR FUTURE GROWTH
Natural portfolio extension
Strong momentum in Europe
Significant opportunity with Veltassa®
CARDIO-RENAL – PATIENT POPULATION
MARCH 2021 13
NATURAL EXTENSION OF OUR THERAPY AREA FOCUS
NEPHROLOGY
HEART FAILURE
Stage I Stage II Stage III Stage IV Stage V
Stage IStage IIStage IIIStage IV
Reduced kidney
function
associated with
increased risk of
heart impairment
Reduced heart
function
associated with
increased risk of
renal impairment
CARDIO-RENAL PATIENTS
NEPHROLOGISTS AND CARDIOLOGISTS
ALREADY TARGETED TODAY
CARDIO-RENAL – FERINJECT® EUROPE
MARCH 2021 14
AFFIRM-AHF STUDY SHOWED STRONG CLINICAL BENEFITS
26% reduction in heart failure
re-hospitalization
Reduction irrespective of anemia status
Strengthening of ESC guideline expected
in 2021
Market opportunity over CHF 500m in
Europe
TOTAL HEART FAILURE HOSPITALISATION
0
20
40
60
80
100
0 4 8 12 16 20 24 28 32 36 40 44 48 52
Me
an
cu
mu
lative
eve
nts
pe
r 1
00
pa
tie
nts
Time since randomization (weeks)
Rate ratio (95% CI): 0.74 (0.58–0.94); p=0.013
Ferinject® Placebo
CARDIO-RENAL – INJECTAFER® US
MARCH 2021 15
MAJOR UNADDRESSED GROWTH OPPORTUNITY
1) Heart failure with preserved injection fractionSource: interviews with US HF specialists, ZS analysis on claims, ATU research, scientific papers
Injectafer® label extension based on
FAIR-HF & CONFIRM-HF in 2021/22
Further label and guideline
strengthening following HEART-FID
study
US market opportunity over USD 1
billion
HFrEF1 PATIENT DROP-OFF – US
Not treatedOther i.v. iron Ferinject®
500K
21K 17K
948K
With iron deficiency
anaemia (IDA)
Other iron
410K
40%
22%
38%
CARDIO-RENAL – VELTASSA®
MARCH 2021
SIGNIFICANT OPPORTUNITY WITH EXISTING PRESCRIBERS
Source: monthly IQVIATM MIDAS® panel, GERS, InsightHealth, DLI, moving annual total Q4-2020. Average 2020 exchange rates have been applied.
20202015
172
CHFm
431
CHFm
KEY CHARACTERISTICS
Calcium-based, non-absorbed
52-weeks data available
Acute & chronic usage
Veltassa® Sodium zirconium cyclosilicate Other potassium binders
IN-MARKET SALES – WORLDWIDE
16
KEY FOCUS
Build awareness
Establish clinical differentiation
Improve pull-through
DIAMOND study is significant growth
accelerator and “differentiator”
PRE-CLINICAL
PROVEN BD&L CAPABILITIES & STRONG PIPELINE
MARCH 2021 17
KEY UPCOMING LAUNCHES AND DATA READOUTS
BD&L = Business development and licensing DGF = Delayed graft function CSA-AKI = Cardiac surgery associated acute kidney injury1) Licensed from Angion Biomedica Corp. 2) Licensed from OPKO Health, Inc. 3) Licensed from Cara Therapeutics, Inc. 4) Licensed from ChemoCentryx, Inc. 5) Licensed from Akebia Therapeutics, Inc., subject to certain conditions and limited to the US dialysis market 6) Study conducted by our US partner Daiichi Sankyo
PHASE 1 PHASE 2 PHASE 3 LIFE CYCLE MANAGEMENT
DIAMOND
Vadadustat5
KorsuvaTM 3
HEART-FID6
ANG-37771
(CSA-AKI)
PRE-COMMERCIAL
ANG-37771
(DGF)
Avacopan4
Rayaldee® 2
NephThera(Kidney fibrosis) VIT-2763
(Ferroportin inhibitor)
Global rights
excl. US
Potential in further indication
including C3G and HS
Reduce glucocorticoid toxicity
vs. standard of care
Sustain remission
statistically superior at 52 weeks
Approval in Europe and Japan
2021
Orphan and rare renal disease
around 50k patients in Europe
AVACOPAN
MARCH 2021
NEW STANDARD OF CARE IN ANCA-AV
ANCA-AV = Anti-neutrophil cytoplasmic antibody-associated vasculitis C3G = C3 glomerulopathy HS = Hidradenitis suppurativa 1) Licensed from ChemoCentryx, Inc.
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Avacopan1
Global rights
excl. Japan and South Korea
Leverage commercial organisation
established presence in dialysis
~40% of ESRD patients
moderate to severe CKD-aP
Standard of care with poor efficacy
and/or unfavorable safety profile
Launch in the US in end of 2021
followed by Europe in 2022
No approved treatment
in the US and Europe
KORSUVATM (CR845/DIFELIKEFALIN) INJECTION
MARCH 2021
INNOVATION IN CKD-ASSOCIATED PRURITUS
1) Licensed from Cara Therapeutics, Inc.
19
KorsuvaTM 1
~26k patients with DGF
US, UK and EU4 combined
Phase-III study in DGF
read out in end of 2021
Global rights2
in DGF and CSA-AKI
First small molecule
hepatocyte growth factor mimetic
Phase-II study in CSA-AKI
read out in H2 2021
~110k patients with CSA-AKI
US, UK and EU4 combined
ANG-3777
MARCH 2021
EXPANDING LEADERSHIP ON THE NEPHROLOGY CHAIN
DGF = Delayed graft function CSA-AKI = Cardiac surgery associated acute kidney injury1) Licensed from Angion Biomedica Corp. 2) Excluding China, Taiwan, Hong Kong and Macau
20
ANG-37771
MARCH 2021
TARGETING RARE BLOOD DISORDERS
1) US and EU combined estimate
Recruitment completion expected in H2 2021
Approx. 150’000
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
21
VIT-2763 (FERROPORTIN INHIBITOR)
2020 PERFORMANCE
MARCH 2021 22
OVERALL PORTFOLIO RESILIENT
Venofer®
Maltofer®
Velphoro®
Ferinject®/Injectafer®
Mircera®/Retacrit®
Veltassa®
Net sales
Net sales growth at constant exchange rates
8.4%
7.8%
3.6%
3.0%
2.5%
-5.1%
3.7%
-10% -5% 0% 5% 10%
FY
2019
FY
2020
%∆ vs.
2019
Net Sales 1’725.0 1’705.6 -1.1%
Other Income 37.0 96.4 +160.5%
Gross Profit 1’061.2 1’100.8 +3.7%
EBITDA 485.0 575.8 +18.7%
Depreciation and amortization -209.1 -284.4 -36.0%
EBIT 275.9 291.4 +5.6%
Profit from continuing operations 222.8 237.6 6.6%
Profit from discontinued operations 50.9 220.9 334.0%
Net profit before NCI 273.8 458.6 67.5%
Non-controlling interests -114.7 -98.9 13.8%
Net profit after NCI 159.1 359.6 126.0%
Core EPS2 from continuing operations 3.88 4.99 +28.7%
P&L OVERVIEW (IN CHF MILLION)
EBITDA GROWTH OF 35.7% ON A COMPARABLE BASIS
Other income increase driven by
partnering activities for Ferinject®,
Veltassa® and Velphoro® as well as
disposal of non-core products
EBITDA growth of +35.7% on a
comparable basis driven by cost
containment measures
Depreciation and amortization
driven by CCX140 impairment of
CHF 56.2 million (H1 2020)
Profit from discontinued operations
due to disposal of OM Pharma in
September 2020
NCI = non-controlling interests EPS = earnings per share1) Restated 2) Reported earnings after non-controlling interests adjusted for proportionate amortization and impairment of intangible assets of CHF 185.0 million in 2020 (2019: CHF 143.5 million)
MARCH 2021 23
1
31 Dec
2019
31 Dec
2020
Change vs.
2019
Cash & cash equivalents 544.9 730.0 185.1
Trade & other receivables 471.9 487.7 15.8
Inventories 348.6 339.8 (8.8)
Financial investments & other assets 633.5 896.8 263.3
PPE2 & RoU
3 assets 351.0 302.8 (48.2)
Intangible assets 2’584.5 2’454.5 (130.0)
Assets 4’934.4 5’211.7 277.3
Current financial & lease liabilities 17.8 23.0 5.2
Other current liabilities 523.6 521.0 (2.6)
Non-current financial & lease liabilities 626.5 608.6 (17.9)
Other non-current liabilities 31.3 41.5 10.2
Shareholders' equity 3’735.3 4’017.6 282.3
Liabilities & shareholders' equity 4’934.4 5’211.7 277.3
BALANCE SHEET OVERVIEW (IN CHF MILLION)
STRONG EQUITY RATIO OF 77.1%
Cash & cash equivalents increase
driven by OM Pharma divestment,
partly offset by BD&L4 investments
and dividend distributions
Financial investments increase
mainly driven by gain on
ChemoCentryx equity stake
Intangible assets decrease mainly
driven by OM Pharma divestment
and CCX140 impairment, partly
offset by purchase of a priority
review voucher for CHF 107.7
million
1) Balance sheet as of 31 December 2019 not restated 2) Property, plant & equipment 3) Right-of-use 4) Business development and licensing
MARCH 2021 24
1
2020
Opening cash & cash equivalents, 1 January 544.9
Operating activities 549.1
Net working capital (127.2)
Interest, tax & other financial payments (19.3)
Operating cash flow from discontinued operations 21.2
Cash flow from operating activities 423.8
Milestones & BD&L1 investments (256.0)
Capex & others (70.0)
Net proceeds from OM Pharma divestment 378.4
Cash flow from investing activities 52.4
Dividends paid (219.6)
Financing & others (48.7)
Cash flow from financing activities (268.4)
Exchange rate effects (22.7)
Ending cash & cash equivalents, 31 December 730.0
Financial liabilities2 (539.5)
Net debt 190.6
CASH FLOW OVERVIEW (IN CHF MILLION)
NET CASH POSITION OF CHF 190.6 MILLION
Net working capital increase due to phasing
of payment from major customers and
planned increase in inventory
Milestone and BD&L1 investments driven by
extension of the agreement with Cara
Therapeutics, licensing of ANG-3777 and
acquisition of a priority review voucher
Investments more than offset by net
proceeds from the OM Pharma divestment
of CHF 378.4 million
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
MARCH 2021 25
GUIDANCE 20211
MARCH 2021 26
1) The COVID-19 pandemic continues to impact economic conditions and patient access to our treatments; therefore Vifor Pharma’s 2021 guidance assumes a progressive improvement of patients access to the Company’s treatments as of H2 2021
In 2021, at constant exchange rates, net sales are expected
to grow at a low-to-mid single digit rate, and EBITDA to grow
at a high single digit rate.
OUTLOOK 2021
1) Licensed from Cara Therapeutics, Inc. 2) Licensed from ChemoCentryx, Inc. 3) Licensed from Akebia Therapeutics, Inc., subject to certain conditions and limited to the US dialysis market4) Licensed from Angion Biomedica Corp.
CLINICAL TRIALS
MARKET ACCESS
Ferinject® approval in China
KorsuvaTM 1 approval in the US and filing in Europe
Avacopan2 approval in Europe and Japan
Avacopan2 & KorsuvaTM 1 partnering in China
Vadadustat3 filing in the US by our partner Akebia Therapeutics by mid-Q2 2021
BD&L At least two in-licensing deals, product acquisitions or corporate transactions
VIT-2763 phase-II initiation in sickle cell disease in H1 2021
VIT-2763 phase-II recruitment completion in beta thalassemia in H2 2021
ANG-37774 phase-II readout in CSA-AKI in H2 2021
ANG-37774 phase-III readout in DGF in Q4 2021
MARCH 2021 27
CONTACT INFORMATION
MARCH 2021
Colin Bond Chief Financial Officer
Phone: +41 58 851 83 53
Email: [email protected]
Julien Vignot Head of Investor Relations
Phone: +41 58 851 66 90
Email: [email protected]
Laurent de Weck Investor Relations Senior Manager
Phone: +41 58 851 80 95
Email: [email protected]
Investor relations
28
DISCLAIMER
MARCH 2021
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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