ANALYST CALL HALF-YEAR RESULTS 2019 - 8 AUGUST 2019, 2:00 PM CEST - Vifor Pharma
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PRESENTATION
HALF-YEAR RESULTS 2019
ANALYST CALL
8 AUGUST 2019, 2:00 PM CEST
ANALYST CALL
SPEAKERS
ETIENNE JORNOD STEFAN SCHULZE COLIN BOND
EXECUTIVE CHAIRMAN PRESIDENT OF THE EXECUTIVE CHIEF FINANCIAL OFFICER
OF THE BOARD OF DIRECTORS COMMITTEE & COO
© Vifor Pharma 8 August 2019 2
AGENDA 1 Vifor Pharma 2 Business update H1 2019 and outlook 2019 3 Financial performance H1 2019 and guidance 2019 © Vifor Pharma 8 August 2019 3
1 STRATEGIC OVERVIEW
LOOKING BACK AT THE KEY DRIVERS
Building i.v. iron portfolio Leadership position in i.v. iron Leadership position in nephrology
and international expansion and entering into nephrology and entering cardio-renal
Ferinject® EU Creation of Creation of Velphoro® EU & Mircera® 4 in-licensing Vadadustat CR845
approval EU affiliates VFMCRP US approval in-license deals in-license in-license
2000 2007 2008 2009 2010 2013 2015 2016 2017 2018 2020
Venofer® US Acquisition Acquisition Injectafer® Veltassa® license Relypsa Galenica
FDA approval Aspreva OM Pharma FDA approval ex-US/Japan acquisition Santé IPO
© Vifor Pharma 8 August 2019 41 MILESTONE 2020
GUIDANCE ALWAYS ACHIEVED IN THE PAST
FY 2017 FY 2018 H1 2019 FY 20192) FY 2020
Net Sales +15.0% +22.7% +22.2% >15% More than CHF 2.0bn
Between In the range of
EBITDA +18.0%1) +39.7% +32.6%
25% and 30% CHF 700m
Actual Guidance
1) 2017 EBITDA guidance excluded launch and ramp-up costs of Veltassa® 2) At constant exchange rates
© Vifor Pharma 8 August 2019 51 OBJECTIVE 2025
DELIVERING ON OUR THREE GROWTH DRIVERS
Maximise Ferinject® potential
Exploit key therapy areas, expand geographically and generate further clinical data
Avacopan launch Vadadustat launch
Build optimal
launch capabilities
Rayaldee® launch CR845 launch CCX140 launch
Drive Veltassa® growth
Generate further evidence in cardiology and raise awareness globally
© Vifor Pharma 8 August 2019 61 OBJECTIVE 2025
EXPLOIT OUR COMPETITIVE ADVANTAGES
EXISTING GROWTH DRIVERS EXISTING INFRASTRUCTURE
Ferinject® – Exploit the potential
• Leverage US commercial infrastructure
VFMCRP – Grow and enhance value • Become EU partner of choice for non-European growth
companies
Veltassa® – Build a blockbuster
INORGANIC GROWTH NEW TECHNOLOGIES AND BUSINESS AREAS
• Merger & acquisitions • Exploit data & pay-for-performance (anaemia and
• Licensing & co-promotion bone-mineral metabolism management, etc.)
• Strategic partnerships • Replicate VFMCRP structure in other therapeutic areas
© Vifor Pharma 8 August 2019 7AGENDA 1 Vifor Pharma 2 Business update H1 2019 and outlook 2019 3 Financial performance H1 2019 and guidance 2019 © Vifor Pharma 8 August 2019 8
2 H1 2019 HIGHLIGHTS
KEY CORPORATE DEVELOPMENTS
April May June
Expansion of the license Veltassa® DIAMOND Orphan drug designation
agreement with Akebia study enrolls first patient granted to VIT-2763 by
US FDA and EMA2)
Potential reach of up to 60% First results expected in 2022
of US dialysis patients
H1 2019
January May June
Positive results of the Veltassa® AMBER study Positive CR845 KALM-1
PIVOTAL study on Venofer® meets primary endpoint study results
High dosage reduces risk of death Suggest patients are more likely Encouraging results in light of
and MCE1) in dialysis patients to stay on spironolactone therapy the upcoming KALM-2 results
1) Major cardiovascular events 2) European Medicines Agency
© Vifor Pharma 8 August 2019 92 THREE 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 8 August 2019 102 FERINJECT®
STRONG GROWTH CONTINUES
REPORTED NET SALES • Reported growth impacted by:
CHF million
o Exchange rates: -1.5%
273 o Order phasing: +0.5%
229 +19% 45
• Growth driven by cardiology, patient blood
30 management (PBM) and gastroenterology
177 +29%
74
19 59 • Volume growth of +24.4%
43 • Approved in Japan in H1 2019
140 155
115
1)
H1 2017 H1 2018 H1 2019
Europe US RoW
1) Net sales restated for IFRS 15 impact
© Vifor Pharma 8 August 2019 112 FERINJECT®
A BLOCKBUSTER ALREADY IN 2019
IN-MARKET SALES MAT1) DATA FROM MARCH 20192)
CHF million
946
• Global i.v. iron market size of CHF 1,917
CAGR 38% million, +18% versus prior year period
745
• Ferinject® in-market sales increase of 27%
578 to CHF 946 million
424 • Market share of Ferinject® in value of 49%
worldwide (55% in the top 10 markets)
276
219 • In-market sales of Injectafer® in the US now
137 higher than Ferinject® in-market sales in
Europe
MAT MAT MAT MAT MAT MAT MAT
Q1-2013 Q1-2014 Q1-2015 Q1-2016 Q1-2017 Q1-2018 Q1-2019
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.
© Vifor Pharma 8 August 2019 122 VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA
VELPHORO®
VELPHORO® NET SALES • KDIGO1) guideline updated in 2017 to
CHF million
recommend the use of non-calcium based
81 phosphate binders
• Reported net sales increase of 197.8% to
CHF 68.1 million in the US
+127%
• Market share of 16.5%2) in the US
39
36
-9%
3)
H1 2017 H1 2018 H1 2019
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
© Vifor Pharma 8 August 2019 132 VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA
MIRCERA®/RETACRIT TM
ESA PORTFOLIO NET SALES • Increase in reported net sales of 30.4% to
CHF million
CHF 279.1 million
279
• Growth mainly driven by Mircera® with further
+30%
conversion of existing long-acting ESA
214
patients
155 +38% • Conversion primarily within mid-sized and
independent dialysis organisations in the US
H1 2017 H1 2018 H1 2019
Mircera® RetacritTM
© Vifor Pharma 8 August 2019 142 VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA
DIVERSIFIED ANAEMIA PORTFOLIO REDUCES RISKS
I.V. IRON ESA
• Vadadustat as complement to an
• No iron sparing evidence for HIFs already diversified portfolio
DIALYSIS
• Blood loss not addressed by HIFs • Extension agreement with Akebia
Therapeutics signed
• ~10% of total Injectafer® net sales
PRE currently in pre dialysis
• Not currently targeted
DIALYSIS • I.v. iron currently first line therapy
in ND-CKD
© Vifor Pharma 8 August 2019 152 VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA
POSITIVE KALM-1 PHASE-III STUDY RESULTS FOR CR845
PRIMARY ENDPOINT (% OF SUBJECTS) • Primary and all secondary endpoints of KALM-1
>3 POINT IMPROVEMENT IN WI-NRS SCORE phase-III pivotal study met
P=.000019 • CR845 generally well tolerated with a safety profile
51%
consistent with prior studies in this patient population
• Enrolment in the second pivotal phase-III study
(KALM-2) completed with top line data expected
28% in H2 2019
Placebo (N=189) CR845 (N=189)
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
© Vifor Pharma 8 August 2019 162 VELTASSA®
NET SALES GROWTH OF 69.9% IN H1 2019
VELTASSA® NET SALES HIGHLIGHTS
CHF million
• Growth driven by the US with CHF 59.4m in reported
63 net sales, a 63.7% increase compared to H1 2018
• Launched in the US, Germany, Denmark, Belgium,
+70% Norway, and Sweden
37 • Final reimbursement price received in Germany and
Spain in H1 2019
24 52%
• 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
1)
H1 2017 H1 2018 H1 2019
US Europe
1) Net sales restated for IFRS 15 impact
© Vifor Pharma 8 August 2019 172 VELTASSA®
CLINICAL DATA TO UNLOCK THE CARDIOLOGY SPACE
AMBER DIAMOND
POSITIVE TOPLINE DATA FIRST PATIENT ENROLLED
Update Significantly higher proportion of patients Primary endpoint: time to first occurrence
remained on spironolactone therapy of CV1) death or CV hospitalisation.
Patient
CKD2) patient with resistant hypertension HF3) patients, with or without CKD
population
Size 290 patients ~2’400 patients
Raise awareness and inclusion in Label change and strengthened treatment
Objective
treatment guidelines guidelines
1) Cardiovascular 3) Chronic Kidney Disease 3) Heart failure
© Vifor Pharma 8 August 2019 182 OUTLOOK 2019
Ferinject® launch in Japan, subject to reimbursement
MARKET ACCESS Go-to-market strategy in China for Ferinject®
Partnering the Japanese rights for CCX140
Veltassa®: presentation of the AMBER study results (May 2019)
Veltassa®: initiation of the DIAMOND outcome study for RAASi enabling (May 2019)
CLINICAL TRIALS 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)
BUSINESS
At least one additional in-licensing, product acquisition or corporate transaction
DEVELOPEMENT
© Vifor Pharma 8 August 2019 19AGENDA 1 Vifor Pharma 2 Business update H1 2019 and outlook 2019 3 Financial performance H1 2019 and guidance 2019 © Vifor Pharma 8 August 2019 20
3 P&L OVERVIEW (IN CHF MILLION)
H1 H1 %∆ vs. • Net sales increase of +22.2%
2018 2019 H1 2018 driven by Ferinject®, Mircera®
Net Sales 747.4 913.3 +22.2% Velphoro® and Veltassa®
Other Income 41.0 20.4 -50.3%
• Proportionately lower gross profit
Gross Profit 500.2 560.3 +12.0%
increase due to lower other income
EBITDA 192.0 254.6 +32.6% and higher cost of sales related to
Depreciation and amortization -76.7 -106.0 -38.1% Mircera® commercialisation rights
EBIT 115.2 148.7 +29.0%
Financial result 41.8 -8.9 NM • EBITDA increase of +32.6% driven
Income tax 1.0 -13.8 NM by strong top-line growth and cost
containment
Net Profit before minorities 158.0 126.0 -20.3%
Net Profit after minorities 118.0 65.2 -44.8% • Growth in net profit after minorities
impacted by a one-off FX gain in
Core earnings 1 per share 2.66 2.11 -20.7% H1 2018 and higher tax expenses
NM = not meaningful
© Vifor Pharma 8 August 2019 213 NET SALES OVERVIEW (IN CHF MILLION)
SOLID GROWTH IN H1 2019
H1 H1 Growth
2018 2019 in H1 2019
Ferinject®/Injectafer® 229.0 273.4 44.4 +19.4%
Venofer® 59.6 65.4 5.7 +9.6%
Mircera®/RetacritTM 214.0 279.1 65.1 30.4%
Velphoro® 35.8 81.1 45.3 +126.6%
Veltassa® 36.8 62.6 25.7 +69.9%
Others 172.1 151.9 -11.8% -20.3
Net sales 747.4 913.3 165.9 +22.2%
© Vifor Pharma 8 August 2019 223 BALANCE SHEET OVERVIEW (IN CHF MILLION)
STRONG EQUITY RATIO OF 74.0%
31 Dec 30 Jun Change vs.
2018 2019 31 Dec 2018
Cash & cash equivalents 400.3 321.5 (78.8) • Decrease in cash & cash
Trade & other receivables 509.0 522.3 13.4 equivalents mainly driven by
Inventories 281.7 319.4 37.7 dividend payments
Financial investments & other assets 354.5 329.9 (24.6)
PPE1) & RoU2) assets 274.0 341.6 67.6 • Increase in inventories to support
Intangible assets 2'676.0 2'643.0 (33.0) the growth of the business
Assets 4'495.5 4'477.8 (17.7)
Current financial & lease liabilities 116.2 115.1 (1.1) • Increase in PPE1) & RoU2) assets
Other current liabilities 478.3 466.2 (12.1) and non-current financial & lease
Non-current financial & lease liabilities 492.4 554.0 61.6 liabilities driven by the adoption of
Other non-current liabilities 44.1 30.8 (13.3) IFRS 16
Shareholders' equity 3'364.6 3'311.7 (52.9)
Liabilities & shareholders' equity 4'495.5 4'477.8 (17.7)
1) Property, plant & equipment 2) Right-of-use
© Vifor Pharma 8 August 2019 233 CASH FLOW OVERVIEW (IN CHF MILLION)
NET DEBT OF CHF 242.8 MILLION
2019
Opening cash & cash equivalents, 1 January 400.3
Operating activities 267.7
• Strong cash flow from operating
Net working capital (NWC) (57.5)
activities, despite the increase in NWC to
Interest, tax & other financial payments (12.3)
support topline growth
Cash flow from operating activities 197.9
Milestones & BD&L1) investments (58.3) • Cash flow from investing activities driven
Capex & others (12.7) by the Mircera® commercialisation rights
Cash flow from investing activities (71.1) (CHF 37.7)
Dividends paid (174.7)
• Cash flow from financing activities driven
Financing & others (28.2)
by dividend payments of CHF 129.7 to
Cash flow from financing activities (202.9) Vifor Pharma shareholders and CHF 45.0
Exchange rate effects (2.7) to Fresenius Medical Care
Ending cash & cash equivalents, 30 June 321.5
Interest bearing financial liabilities (excl. leases) (564.4)
Net debt (242.8)
1) Business development & licensing
© Vifor Pharma 8 August 2019 243 GUIDANCE 2019
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.
© Vifor Pharma 8 August 2019 25DISCLAIMER 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 8 August 2019 26
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