presentation half-year results 2020/media/files/v/vifor-pharma/... · 2020. 8. 6. · february...
TRANSCRIPT
HALF-YEARRESULTS 2020ANALYST CALL
PRESENTATION
6 AUGUST 2020, 2:00 PM CET
HALF-YEAR RESULTS 2020
6 AUGUST 2020
SPEAKERS
STEFAN SCHULZE
CHIEF EXECUTIVE OFFICER
COLIN BOND
CHIEF FINANCIAL OFFICER
2
BUSINESS UPDATE AND OUTLOOKSTEFAN SCHULZE, CHIEF EXECUTIVE OFFICER
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
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%
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
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%
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
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
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%
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%
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
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
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
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
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%
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
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
FINANCIAL PERFORMANCE AND GUIDANCE 2020COLIN BOND, CHIEF FINANCIAL OFFICER
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%
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
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
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
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
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
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.
26