12 MARCH 2020 FULL-YEAR RESULTS 2019/media/Files/V/Vifor-Pharma/...OUTLOOK 2020 CLINICAL TRIALS...
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FULL-YEAR RESULTS 2019 ANALYST CALL 12 MARCH 2020 12 MARCH 2020, 2:00 PM CET
Transcript of 12 MARCH 2020 FULL-YEAR RESULTS 2019/media/Files/V/Vifor-Pharma/...OUTLOOK 2020 CLINICAL TRIALS...
FULL-YEAR RESULTS 2019ANALYST CALL
12 MARCH 2020
12 MARCH 2020, 2:00 PM CET
© Vifor Pharma
ETIENNE JORNOD
EXECUTIVE CHAIRMAN
OF THE BOARD OF DIRECTORS
STEFAN SCHULZE
PRESIDENT OF THE EXECUTIVE
COMMITTEE & COO
COLIN BOND
CHIEF FINANCIAL OFFICER
FULL-YEAR RESULTS 2019
SPEAKERS
12 March 2020 2
© Vifor Pharma
AGENDA
1
2
Vifor Pharma
2019 highlights
3 Business update and outlook 2020
12 March 2020
4 Financial performance 2019 and guidance 2020
3
© Vifor Pharma
1) At constant exchange rates
1 GUIDANCE 2019
EXCEEDED OUR RAISED GUIDANCE
12 March 2020
Reported EBITDA growth between 25% and 30% 37.9%
Net sales increase by more than 15% 18.4%1)
4
© Vifor Pharma
EXECUTION
MILESTONE 2020
EXECUTING ON OUR THREE GROWTH DRIVERS
Ferinject®
Exploit the potential through market awareness
Veltassa®
Build a blockbuster
Nephrology (VFMCRP1)) Expand leadership position
12 March 2020 5
1) Vifor Fresenius Medical Care Renal Pharma
1
IPO
METAMORPHOSIS
© Vifor Pharma
16 38 58 81123
163
242
377
538
693
890
1’060
12 March 2020
FERINJECT®
BLOCKBUSTER STATUS ALREADY REACHED IN 2019
Europe US RoW
Source: in-market sales, quarterly IQVIATM MIDAS® panel, GERS, Insight Health, DLI, MAT Q4-2019, historical data at constant exchange rate (average 2019)
2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
6
2019
1
© Vifor Pharma
[ ]
12 March 2020
NEPHROLOGY
CONSOLIDATING OUR LEADERSHIP POSITION1
7
Avacopan
CR845
Vadadustat
IN-LICENSING DEALS
PRE-CLINICAL NephThera
COMMERCIAL
World class pre-clinical capabilities with Evotec
Expansion of the license agreement
Positive phase-III readout in November 2019
Positive KALM-1 phase-III readout in May 2019
Leveraging our own US sales force
© Vifor Pharma
VELTASSA®
BUILDING THE HYPERKALAEMIA MARKET
1. []
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Source: in-market sales, quarterly IQVIATM MIDAS® panel, GERS, Insight Health, DLI, MAT Q4-2019, historical data at constant exchange rate (average 2019)
46%
54%
179
CHFm
340
CHFm
20192015
1
© Vifor Pharma
EBITDA
280.4391.5
540.0
FY 2017 FY 2018 FY 2019 2020E
NET SALES
1’291.7
1’584.6
1’877.2
FY 2017 FY 2018 FY 2019 2020E
12 March 2020
MILESTONE 2020
ON TRACK TO ACHIEVE OUR GUIDANCE
2) Reported EBITDA growth, including OM Pharma1) Growth at constant exchange rate, including OM Pharma
1
+23%
More than
25%2)
+40%
9
In the range
of 10%1)
+18%
+38%
© Vifor Pharma
AGENDA
1
2
Vifor Pharma
2019 highlights
3 Business update and outlook 2020
12 March 2020
4 Financial performance 2019 and guidance 2020
10
© Vifor Pharma
2 HIGHLIGHTS 2019
KEY CORPORATE DEVELOPMENTS
12 March 2020
2019
May
Positive CR-845 KALM-1
study results
November
Phase-III ADVOCATE
study readout
May
Veltassa® AMBER study
meets primary endpoint
November
Collaboration in the
US with Janssen
11
April
Expansion of the license
agreement with Akebia
September
Initiation of S&P credit
rating coverage
November
NephThera joint-
venture with Evotec
May
Initiation of the Veltassa®
DIAMOND study
© Vifor Pharma
1) Profit after minorities adjusted for amortisation of intangible assets
2 HIGHLIGHTS 2019
FINANCIAL OVERVIEW
• FY 2019 net sales of CHF 1’877.2 million, up 18.5%
• FY 2019 EBITDA of CHF 540.0 million, up 37.9%
• Core earnings1) per share of CHF 4.67
• Net cash position of CHF 5.7 million
• Equity ratio of 75.7%
KEY FINANCIAL HIGHLIGHTS
12 March 2020 12
© Vifor Pharma
AGENDA
1
2
Vifor Pharma
2019 highlights
3 Business update and outlook 2020
12 March 2020
4 Financial performance 2019 and guidance 2020
13
© Vifor Pharma
THREE STRATEGIC GROWTH DRIVERS
Ferinject®
Exploit the potential through market awareness
Veltassa®
Build a blockbuster
Nephrology (VFMCRP1)) Expand leadership position
12 March 2020 14
1) Vifor Fresenius Medical Care Renal Pharma
3
© Vifor Pharma
NET SALESCHF million
248286
320
91
127
151
53
73
90
392
485
561
2017 2018 2019
12 March 2020
1) Net sales restated for IFRS 15 impact
FERINJECT®
SUSTAINABLE GROWTH >10 YEARS POST LAUNCH 3
Europe US RoW
1)
15
+24%
+16%
© Vifor Pharma
16 38 58 81123
163
242
377
538
693
890
1’060
12 March 2020
FERINJECT®
BLOCKBUSTER STATUS ACHIEVED ONE YEAR EARLIER3
Europe US RoW
MAT = Moving annual total1) Based on quarterly IQVIATM MIDAS® panel, GERS, Insight Health, DLI, historical data at constant exchange rate (average 2019)
2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
GLOBAL I.V. IRON MARKET (MAT Q4 2019)1)
• Global in-market sales of CHF 2’131 million (+16%)
• Ferinject® in-market sales growth of 19%
• Global market share of Ferinject® in value is 50%
IN-MARKET SALES1)
CHF MILLION
2018
16
2019
© Vifor Pharma 12 March 2020 17
1) Iron deficiency anaemia
FERINJECT® IN CHINA
STRONG PARTNER IN HOSPITAL SETTINGS
55%
45%
• Largest IDA1) population and a huge unmet medical
need due to blood shortages
• Targeting patient blood management, with an
estimated 2.3 million patients
• Over 250 sales representatives covering >2’000
hospitals in China
3
VPFK Joint Company
© Vifor Pharma 12 March 2020
1) Fresenius Kidney Care (FKC): Fresenius Medical Care North America dialysis provider organization 2) Net sales restated for IFRS 15 impact
VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA
ESA PORTFOLIO / VELPHORO® - STRONG GROWTH 3
18
VELPHORO® NET SALESCHF million
8196
182
2017 2018 2019
ESA PORTFOLIO NET SALESCHF million
340
461
540
2017 2018 2019
• >95% penetration of Mircera® in FKC clinics1)
• Continued expansion of Mircera® sales outside of FKC clinics1)
• Continued adoption of updated KDIGO guidelines recommending use of non-calcium based phosphate binders
Mircera® RetacritTM
2)
+36%
+17%
+19%
+90%
© Vifor Pharma 12 March 2020
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
19
NephTheraRayaldee®
3
© Vifor Pharma
US nephrologists
12 March 2020 20
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
3
© Vifor Pharma
[]
12 March 2020 21
NEPHROLOGY
ADDING WORLD CLASS PRE-CLINICAL CAPABILITIES
NephThera
50%
50%
Pre-clinical candidates
3
© Vifor Pharma
[]
12 March 2020 22
NEPHROLOGY
STAGED, SUCCESS DEPENDENT PARTNERSHIP
NephThera
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
3
© Vifor Pharma 12 March 2020 23
1) Birmingham Vasculitis Activity Score
NEPHROLOGY
AVACOPAN POSITIVE PHASE-III TRIAL RESULTS
Reduce glucocorticoid toxicity
Imp
rove r
en
al fu
ncti
on
• Week 26: BVAS1) remission
• Week 52: statistically superior
• Improved quality of life
• Increased risk of mortality
• High risk of infections
• Irreversible kidney damage
Standard of care
Avacopan
3
© Vifor Pharma
VELTASSA® MARKET SHARE1)
CHF million
12 March 2020
1) In-market sales, quarterly IQVIATM MIDAS® panel, GERS, Insight Health, DLI, MAT Q4-2019, historical data at constant exchange rate (average 2019) 2) National Institute for Health and Care Excellence
VELTASSA®
NET SALES GROWTH OF 46% IN 20193
24
179 340
20192015
VELTASSA® NET SALES
CHF million
52
91
132
2017 2018 2019
US
Europe
+75%
+46%
• Reimbursement secured in Germany, Austria, Belgium, Finland, Portugal and Spain
• Positive recommendation received from NICE2) in the UK
• Positive results of the AMBER study and initiation of the DIAMOND study in May 2019
46%
54%
© Vifor Pharma
OUTLOOK 2020
CLINICAL TRIALS
MARKET ACCESS
Ferinject® launch in Japan, subject to reimbursement
Go-to-market strategy and filing in China for Ferinject®
Filing of Avacopan in Europe
BUSINESS
DEVELOPMENT At least one in-licensing, product acquisition or corporate transaction
12 March 2020 25
Ferinject® phase-IV AFFIRM-AHF study readout (H2 2020)
CR-845 phase-III KALM-2 study readout (Q2 2020)
Vadadustat phase-III INNO2VATE studies readout (Q2 2020)
CCX140: LUMINA-1 and LUMINA-2 phase-II studies readout (Q2 and H2 2020)
3
© Vifor Pharma
AGENDA
1
2
Vifor Pharma
2019 highlights
3 Business update and outlook 2020
12 March 2020
4 Financial performance 2019 and guidance 2020
26
© Vifor Pharma
FY
2018
FY
2019
Change
vs. 2018
Net sales 1’584.6 1’877.2 +18.5%
Other income 64.6 38.4 -40.4%
Cost of sales (648.7) (761.5) +17.4%
Gross profit 1’000.5 1’154.2 +15.4%
Marketing and distribution (410.8) (455.3) -10.8%
Research and development (206.4) (228.3) -10.6%
General and administration (155.9) (145.7) +6.5%
EBIT 227.4 325.0 +42.9%
Average number of FTE1) 2’671 2’792 +4.5%
12 March 2020
P&L OVERVIEW (IN CHF MILLION)
1) Full-time employees
4
• Gross profit margin decrease due to
planned reduction in CellCept®
royalties
• Marketing and distribution expenses
higher due to investments in pre-
launch activities of pipeline products
• Research and development increase
due to investment in DIAMOND study
• Low FTE1) increase despite
investments in pipeline and clinical
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© Vifor Pharma
75.9
78.5
86.0
14.2
41.8
7.1
-10.9
292.6
+15.6%
+17.0%
+6.4
+89.9%
+12.0%
+46.2%
-4.9%
+18.5%
12 March 2020
NET SALES OVERVIEW (IN CHF MILLION)
GROWTH EXCEEDING GUIDANCE IN 2019
FY
2018
FY
2019
Ferinject®/Injectafer® 485.1 561.0
Mircera®/RetacritTM 461.3 539.8
Velphoro® 95.7 181.7
Venofer® 118.2 132.4
Veltassa® 90.5 132.3
Anti-infectives 112.1 119.2
Others 221.7 210.8
Net sales 1’584.6 1’877.2
Growth
in 2019
4
28
© Vifor Pharma
FY
2018
FY
2019
Change
vs. 2018
EBITDA 391.5 540.0 +37.9%
Depreciation and amortisation (164.1) (215.0) -31.0%
EBIT 227.4 325.0 +42.9%
Financial result 42.0 (15.4) -136.6%
Taxes (25.0) (35.9) -43.2%
Net profit before minorities 244.4 273.8 +12.0%
Minority interests (92.0) (114.7) -24.6%
Profit after minorities 152.4 159.1 +4.4%
Core earnings1)
per share2) 4.16 4.67 +12.2%
12 March 2020
1) Profit after minorities adjusted for amortisation of intangible assets (CHF 143.9 million in 2019) 2) Share amount of 64.9 million3) Fresenius Kidney Care (FKC): Fresenius Medical Care North America dialysis provider organization
EARNINGS OVERVIEW (IN CHF MILLION)
STRONG UNDERLYING CORE EARNINGS GROWTH
• EBITDA growth exceeding raised
full-year guidance
• Depreciation and amortisation
increase driven by the Mircera®
commercialisation rights extension
outside of FKC3) clinics and the new
leasing standard IFRS 16
• Financial result impacted by an
exceptional FX gain in 2018
• Minority interests increase mainly
driven by the growth of Velphoro®
• Core earnings per share increase by
23.2% when adjusted for FX gain in
2018 and IAS 19 impact in 2019
4
29
© Vifor Pharma
31 Dec
2018
31 Dec
2019
Change
vs. 2018
Cash & cash equivalents 400.3 544.9 144.6
Trade & other receivables 509.0 471.9 (37.0)
Inventories 281.7 348.6 66.9
Financial investments & other assets 354.5 633.4 279.0
PPE1)
& RoU2)
assets 274.0 351.0 77.0
Intangible assets 2’676.0 2’584.5 (91.5)
Assets 4’495.5 4’934.4 438.9
Current financial & lease liabilities 116.2 16.8 (99.3)
Other current liabilities 478.3 524.5 46.3
Non-current financial & lease liabilities 492.4 626.5 134.1
Other non-current liabilities 44.1 31.3 (12.8)
Shareholders' equity 3’364.6 3’735.3 370.7
Liabilities & shareholders' equity 4’495.5 4’934.4 438.9
• Trade & other receivables
reduction despite strong top line
growth
• Financial investments increase
driven by the gain on the 18.3%
equity stake in ChemoCentryx
• Right-of-use assets mostly related
to the adoption of the new leasing
standard IFRS 16
12 March 2020
BALANCE SHEET OVERVIEW (IN CHF MILLION)
STRONG EQUITY RATIO OF 75.7%
1) Property, plant & equipment 2) Right-of-use
4
30
© Vifor Pharma
2019
Opening cash, 1 January 400.3
Operating activities 534.3
Net working capital 18.9
Income tax paid (28.3)
Cash flow from operating activities 524.8
Net investments in milestones & BD&L1) (86.0)
Capex & others (46.5)
Cash flow from investing activities (132.5)
Dividends paid (174.7)
Financing & others (63.7)
Cash flow from financing activities (238.5)
Exchange rate effects (9.3)-
Ending cash and cash equivalents, 31 December 544.9
Financial liabilities2) 539.2
Net cash 5.7
• Milestone and BD&L investments
mainly due to the extension of the
Mircera® commercialisation rights
outside of FKC3) clinics for 2020
• Dividend payments of CHF 129.7
million to Vifor Pharma shareholders
and CHF 45.0 million to Fresenius
Medical Care
• BBB- investment grade rating
assigned by S&P in September 2019
and Fitch Ratings in March 2020
12 March 2020 31
1) Business development & licensing 2) Excluding non-interest bearing financial liabilities and lease liabilities 3) Fresenius Kidney Care (FKC): Fresenius Medical Care North America dialysis provider organization
CASH FLOW OVERVIEW (IN CHF MILLION)
NET CASH POSITION OF CHF 5.7 MILLION4
© Vifor Pharma
GUIDANCE 20201)
1) Including OM Pharma
4
12 March 2020 32
In 2020 at constant exchange rates, Vifor Pharma net sales are expected
to grow in the range of 10%, reported EBITDA is expected to grow by
more than 25%.
© 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.
12 March 2020 33
