26
HALF-YEAR RESULTS 2019 ANALYST CALL 8 AUGUST 2019, 2:00 PM CEST PRESENTATION
HALF-YEAR RESULTS 2019
ANALYST CALL
8 AUGUST 2019, 2:00 PM CEST
PRESENTATION
© Vifor Pharma
ETIENNE JORNOD
EXECUTIVE CHAIRMAN
OF THE BOARD OF DIRECTORS
STEFAN SCHULZE
PRESIDENT OF THE EXECUTIVE
COMMITTEE & COO
COLIN BOND
CHIEF FINANCIAL OFFICER
ANALYST CALL
SPEAKERS
8 August 2019 2
© Vifor Pharma
1 Vifor Pharma
2 Business update H1 2019 and outlook 2019
3 Financial performance H1 2019 and guidance 2019
AGENDA
3 8 August 2019
© Vifor Pharma 8 August 2019 4
STRATEGIC OVERVIEW
LOOKING BACK AT THE KEY DRIVERS 1
Galenica
Santé IPO
2000
Venofer® US
FDA approval
Leadership position in i.v. iron
and entering into nephrology
Building i.v. iron portfolio
and international expansion
Leadership position in nephrology
and entering cardio-renal
2010 2015 2020 2008
Creation of
EU affiliates
Ferinject® EU
approval
Acquisition
Aspreva
Injectafer®
FDA approval
2013
Velphoro® EU &
US approval Creation of
VFMCRP
Veltassa® license
ex-US/Japan
Relypsa
acquisition
Vadadustat
in-license
2016 2017
Mircera®
in-license
4 in-licensing
deals
2007 2018
CR845
in-license
2009
Acquisition
OM Pharma
© Vifor Pharma 8 August 2019
1) 2017 EBITDA guidance excluded launch and ramp-up costs of Veltassa® 2) At constant exchange rates
MILESTONE 2020
GUIDANCE ALWAYS ACHIEVED IN THE PAST
1
FY 2018
+22.7%
+39.7%
H1 2019
>15%
Between
25% and 30%
5
+22.2%
+32.6%
FY 20192)
Actual Guidance
FY 2020
More than CHF 2.0bn
In the range of
CHF 700m
FY 2017
+15.0% Net Sales
EBITDA +18.0%1)
© Vifor Pharma 8 August 2019 6
OBJECTIVE 2025
DELIVERING ON OUR THREE GROWTH DRIVERS 1
Drive Veltassa® growth
Generate further evidence in cardiology and raise awareness globally
Maximise Ferinject® potential
Exploit key therapy areas, expand geographically and generate further clinical data
Build optimal
launch capabilities Rayaldee® launch
Avacopan launch
CR845 launch
Vadadustat launch
CCX140 launch
© Vifor Pharma 8 August 2019 7
OBJECTIVE 2025
EXPLOIT OUR COMPETITIVE ADVANTAGES
EXISTING GROWTH DRIVERS
Ferinject® – Exploit the potential
Veltassa® – Build a blockbuster
VFMCRP – Grow and enhance value
• Merger & acquisitions
• Licensing & co-promotion
• Strategic partnerships
INORGANIC GROWTH
• Leverage US commercial infrastructure
• Become EU partner of choice for non-European growth
companies
EXISTING INFRASTRUCTURE
• Exploit data & pay-for-performance (anaemia and
bone-mineral metabolism management, etc.)
• Replicate VFMCRP structure in other therapeutic areas
NEW TECHNOLOGIES AND BUSINESS AREAS
1
© Vifor Pharma
AGENDA
1
8
Vifor Pharma
2 Business update H1 2019 and outlook 2019
8 August 2019
3 Financial performance H1 2019 and guidance 2019
© Vifor Pharma 9
2 H1 2019 HIGHLIGHTS
KEY CORPORATE DEVELOPMENTS
8 August 2019
H1 2019
April
Expansion of the license
agreement with Akebia
Potential reach of up to 60%
of US dialysis patients
May
Veltassa® DIAMOND
study enrolls first patient
First results expected in 2022
June
Positive CR845 KALM-1
study results
Encouraging results in light of
the upcoming KALM-2 results
May
Veltassa® AMBER study
meets primary endpoint
Suggest patients are more likely
to stay on spironolactone therapy
January
Positive results of the
PIVOTAL study on Venofer®
High dosage reduces risk of death
and MCE1) in dialysis patients
1) Major cardiovascular events 2) European Medicines Agency
June
Orphan drug designation
granted to VIT-2763 by
US FDA and EMA2)
© Vifor Pharma
Veltassa® Build a blockbuster
Vifor Fresenius Medical Care Renal Pharma Grow and enhance value
THREE STRATEGIC GROWTH DRIVERS 2
10 8 August 2019
Ferinject® Exploit the potential through market awareness
© Vifor Pharma
REPORTED NET SALES CHF million
115 140 155
43
59
74
19
30
45
177
229
273
H1 2017 H1 2018 H1 2019
8 August 2019 11
1) Net sales restated for IFRS 15 impact
FERINJECT®
STRONG GROWTH CONTINUES 2
+29%
+19%
Europe US RoW
1)
• Reported growth impacted by:
o Exchange rates: -1.5%
o Order phasing: +0.5%
• Growth driven by cardiology, patient blood
management (PBM) and gastroenterology
• Volume growth of +24.4%
• Approved in Japan in H1 2019
© Vifor Pharma
IN-MARKET SALES CHF million
137
219 276
424
578
745
946
MATQ1-2013
MATQ1-2014
MATQ1-2015
MATQ1-2016
MATQ1-2017
MATQ1-2018
MATQ1-2019
MAT1) DATA FROM MARCH 20192)
• Global i.v. iron market size of CHF 1,917
million, +18% versus prior year period
• Ferinject® in-market sales increase of 27%
to CHF 946 million
• Market share of Ferinject® in value of 49%
worldwide (55% in the top 10 markets)
• In-market sales of Injectafer® in the US now
higher than Ferinject® in-market sales in
Europe
8 August 2019
FERINJECT®
A BLOCKBUSTER ALREADY IN 2019 2
Europe US ROW
1) Moving Annual Total 2) Based on quarterly IQVIATM MIDAS® panel, Farma&Cia, GERS, DLI at wholesale acquisition costs. Average 2018 exchange rates have been applied.
CAGR 38%
12
© Vifor Pharma
VELPHORO® NET SALES CHF million
39 36
81
H1 2017 H1 2018 H1 2019
8 August 2019 13
• KDIGO1) guideline updated in 2017 to
recommend the use of non-calcium based
phosphate binders
• Reported net sales increase of 197.8% to
CHF 68.1 million in the US
• Market share of 16.5%2) in the US
VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA
VELPHORO®
1) Kidney Disease Improving Global Outcomes 2) Based on quarterly IQVIATM MIDAS® panel, INSIGHT Health & DN, GERS, DLI, Faminform, MAT Q1-2019. Average 2018 exchange rates have been applied. 3) Net sales restated for IFRS 15 impact
2
-9%
+127%
3)
© Vifor Pharma
ESA PORTFOLIO NET SALES CHF million
155
214
279
H1 2017 H1 2018 H1 2019
8 August 2019 14
VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA
MIRCERA®/RETACRITTM
2
• Increase in reported net sales of 30.4% to
CHF 279.1 million
• Growth mainly driven by Mircera® with further
conversion of existing long-acting ESA
patients
• Conversion primarily within mid-sized and
independent dialysis organisations in the US
+38%
+30%
Mircera® RetacritTM
© Vifor Pharma
• ~10% of total Injectafer® net sales
currently in pre dialysis
• I.v. iron currently first line therapy
in ND-CKD
• No iron sparing evidence for HIFs
• Blood loss not addressed by HIFs
8 August 2019 15
• Vadadustat as complement to an
already diversified portfolio
• Extension agreement with Akebia
Therapeutics signed
VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA
DIVERSIFIED ANAEMIA PORTFOLIO REDUCES RISKS
2
DIALYSIS
PRE
DIALYSIS
I.V. IRON ESA
• Not currently targeted
© Vifor Pharma 8 August 2019 16
VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA
POSITIVE KALM-1 PHASE-III STUDY RESULTS FOR CR845
2
PRIMARY ENDPOINT (% OF SUBJECTS)
>3 POINT IMPROVEMENT IN WI-NRS SCORE
• Primary and all secondary endpoints of KALM-1
phase-III pivotal study met
• CR845 generally well tolerated with a safety profile
consistent with prior studies in this patient population
• Enrolment in the second pivotal phase-III study
(KALM-2) completed with top line data expected
in H2 2019
Estimated percentage & P-value based on a logistic regression model with terms for treatment group, baseline worst itching intensity numeric rating scale (WI-NRS) score, and strata
Missing data imputed using multiple imputation (MI) under missing at random (MAR) assumption
Placebo (N=189) CR845 (N=189)
28%
P=.000019
51%
© Vifor Pharma
VELTASSA® NET SALES CHF million
24
37
63
H1 2017 H1 2018 H1 2019
8 August 2019 17
1) Net sales restated for IFRS 15 impact
VELTASSA®
NET SALES GROWTH OF 69.9% IN H1 2019
2
52%
HIGHLIGHTS
• Growth driven by the US with CHF 59.4m in reported
net sales, a 63.7% increase compared to H1 2018
• Launched in the US, Germany, Denmark, Belgium,
Norway, and Sweden
• Final reimbursement price received in Germany and
Spain in H1 2019
• Positive results of the AMBER study presented in
May 2019
• First patient enrolled in May in the phase-IIIb
DIAMOND study, readout expected in 2022
US Europe
+70%
1)
© Vifor Pharma
FIRST PATIENT ENROLLED
Primary endpoint: time to first occurrence
of CV1) death or CV hospitalisation.
POSITIVE TOPLINE DATA
Significantly higher proportion of patients
remained on spironolactone therapy
DIAMOND AMBER
8 August 2019 18
VELTASSA®
CLINICAL DATA TO UNLOCK THE CARDIOLOGY SPACE
1) Cardiovascular 3) Chronic Kidney Disease 3) Heart failure
2
Update
Patient
population
Size
HF3) patients, with or without CKD CKD2) patient with resistant hypertension
~2’400 patients 290 patients
Objective Raise awareness and inclusion in
treatment guidelines Label change and strengthened treatment
guidelines
© Vifor Pharma
OUTLOOK 2019
CLINICAL TRIALS
MARKET ACCESS
Veltassa®: presentation of the AMBER study results (May 2019)
Veltassa®: initiation of the DIAMOND outcome study for RAASi enabling (May 2019)
Ferroportin inhibitor: initiation of phase-II study (Q4 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, subject to reimbursement
Go-to-market strategy in China for Ferinject®
Partnering the Japanese rights for CCX140
BUSINESS
DEVELOPEMENT At least one additional in-licensing, product acquisition or corporate transaction
8 August 2019 19
2
© Vifor Pharma
1 Vifor Pharma
2 Business update H1 2019 and outlook 2019
3 Financial performance H1 2019 and guidance 2019
AGENDA
20 8 August 2019
© Vifor Pharma
H1
2018
H1
2019
%∆ vs.
H1 2018
Net Sales 747.4 913.3 +22.2%
Other Income 41.0 20.4 -50.3%
Gross Profit 500.2 560.3 +12.0%
EBITDA 192.0 254.6 +32.6%
Depreciation and amortization -76.7 -106.0 -38.1%
EBIT 115.2 148.7 +29.0%
Financial result 41.8 -8.9 NM
Income tax 1.0 -13.8 NM
Net Profit before minorities 158.0 126.0 -20.3%
Net Profit after minorities 118.0 65.2 -44.8%
Core earnings1 per share 2.66 2.11 -20.7%
8 August 2019 21
P&L OVERVIEW (IN CHF MILLION)
NM = not meaningful
3
• Net sales increase of +22.2%
driven by Ferinject®, Mircera®
Velphoro® and Veltassa®
• Proportionately lower gross profit
increase due to lower other income
and higher cost of sales related to
Mircera® commercialisation rights
• EBITDA increase of +32.6% driven
by strong top-line growth and cost
containment
• Growth in net profit after minorities
impacted by a one-off FX gain in
H1 2018 and higher tax expenses
© Vifor Pharma
44.4
5.7
65.1
45.3
25.7
-20.3
165.9
+19.4%
+9.6%
30.4%
+126.6%
+69.9%
-11.8%
+22.2%
8 August 2019 22
NET SALES OVERVIEW (IN CHF MILLION)
SOLID GROWTH IN H1 2019
H1
2018
H1
2019
Ferinject®/Injectafer® 229.0 273.4
Venofer® 59.6 65.4
Mircera®/RetacritTM 214.0 279.1
Velphoro® 35.8 81.1
Veltassa® 36.8 62.6
Others 172.1 151.9
Net sales 747.4 913.3
Growth
in H1 2019
3
© Vifor Pharma
31 Dec
2018
30 Jun
2019
Change vs.
31 Dec 2018
Cash & cash equivalents 400.3 321.5 (78.8)
Trade & other receivables 509.0 522.3 13.4
Inventories 281.7 319.4 37.7
Financial investments & other assets 354.5 329.9 (24.6)
PPE1)
& RoU2)
assets 274.0 341.6 67.6
Intangible assets 2'676.0 2'643.0 (33.0)
Assets 4'495.5 4'477.8 (17.7)
Current financial & lease liabilities 116.2 115.1 (1.1)
Other current liabilities 478.3 466.2 (12.1)
Non-current financial & lease liabilities 492.4 554.0 61.6
Other non-current liabilities 44.1 30.8 (13.3)
Shareholders' equity 3'364.6 3'311.7 (52.9)
Liabilities & shareholders' equity 4'495.5 4'477.8 (17.7)
• Decrease in cash & cash
equivalents mainly driven by
dividend payments
• Increase in inventories to support
the growth of the business
• Increase in PPE1) & RoU2) assets
and non-current financial & lease
liabilities driven by the adoption of
IFRS 16
8 August 2019 23
BALANCE SHEET OVERVIEW (IN CHF MILLION)
STRONG EQUITY RATIO OF 74.0%
1) Property, plant & equipment 2) Right-of-use
3
© Vifor Pharma
2019
Opening cash & cash equivalents, 1 January 400.3
Operating activities 267.7
Net working capital (NWC) (57.5)
Interest, tax & other financial payments (12.3)
Cash flow from operating activities 197.9
Milestones & BD&L1)
investments (58.3)
Capex & others (12.7)
Cash flow from investing activities (71.1)
Dividends paid (174.7)
Financing & others (28.2)
Cash flow from financing activities (202.9)
Exchange rate effects (2.7)
Ending cash & cash equivalents, 30 June 321.5
Interest bearing financial liabilities (excl. leases) (564.4)
Net debt (242.8)
• Strong cash flow from operating
activities, despite the increase in NWC to
support topline growth
• Cash flow from investing activities driven
by the Mircera® commercialisation rights
(CHF 37.7)
• Cash flow from financing activities driven
by dividend payments of CHF 129.7 to
Vifor Pharma shareholders and CHF 45.0
to Fresenius Medical Care
CASH FLOW OVERVIEW (IN CHF MILLION)
NET DEBT OF CHF 242.8 MILLION
24
3
8 August 2019
1) Business development & licensing
© Vifor Pharma
GUIDANCE 2019
3
In 2019 at constant exchange rates, Vifor Pharma net sales are expected to exceed 15%,
reported EBITDA is expected to grow between 25% and 30%.
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.
25 8 August 2019
© 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.
8 August 2019 26
