FULL-YEAR RESULTS 2020 - ANALYST CALL 3 MARCH 2021, 2:00 PM CET - Vifor Pharma
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
PRESENTATION
FULL-YEAR
RESULTS 2020
ANALYST CALL
3 MARCH 2021, 2:00 PM CET
FULL-YEAR RESULTS 2020
SPEAKERS
STEFAN SCHULZE COLIN BOND
CHIEF EXECUTIVE OFFICER CHIEF FINANCIAL OFFICER
3 MARCH 2021 2BUSINESS UPDATE AND OUTLOOK STEFAN SCHULZE, CHIEF EXECUTIVE OFFICER
2020 HIGHLIGHTS
KEY MILESTONES ACHIEVED ACROSS ALL AREAS
AFFIRM-AHF study of Ferinject® positive readout
KALM-2 phase-III study of KORSUVATM 1 positive readout
CLINICAL TRIALS INNO2VATE phase-III study of vadadustat2 positive readout
ACCOLADE phase-II study of avacopan3 readout
Recruitment in the phase-II study of VIT-2763 in beta-thalassemia started
Ferinject® launched in Japan
China: Ferinject® and Veltassa® partnered & NDA submission accepted for Ferinject®
MARKET ACCESS
Avacopan3 filing accepted for review in Europe
KORSUVATM 1 filed in the US
In-licensing agreement with Cara Therapeutics for KORSUVATM 1 extended
BUSINESS
Worldwide rights4 of ANG-3777 licensed from Angion Biomedica
DEVELOPMENT
Divestment of OM Pharma strengthens focus on key therapeutic areas
1) Licensed from Cara Therapeutics, Inc. 2) Licensed from Akebia Therapeutics, Inc., subject to certain conditions and limited to the US dialysis market
3) Licensed from ChemoCentryx, Inc. 4) Excluding China, Taiwan, Hong Kong and Macau; for all nephrology indications and congestive heart-failure
3 MARCH 2021 42020 HIGHLIGHTS
STRONG FINANCIAL PERFORMANCE DESPITE COVID-19
NET SALES CHF 1’705.6 million, -1.1% or +3.7% at constant exchange rates (CER)
CHF 575.8 million, +18.7% or +29.4% at CER, and +35.7% on a
EBITDA
comparable basis1
CORE EARNINGS PER SHARE CHF 4.99, +28.7% vs. prior year
NET CASH POSITION CHF 190.6 million
EQUITY RATIO 77.1%
1) At CER and excluding the IAS 19 impact
3 MARCH 2021 5STRATEGIC FOCUS
THREE KEY AREAS AS BASIS FOR FUTURE GROWTH
1
Iron Deficiency
2
Nephrology
3
Cardio-Renal
3 MARCH 2021 6IRON DEFICIENCY – MARKET OVERVIEW
DRIVING OVERALL MARKET GROWTH
2014 2017 2020
36%
1’924 2’633 43% 3’392 46%
CHFm 57% CHFm 54% CHFm
64%
Ferinject®/Injectafer®, Venofer® and Maltofer®
Source: quarterly IQVIATM MIDAS® panel, GERS, Insight Health, DLI, moving annual total Q4-2020. Average 2020 exchange rates have been applied
3 MARCH 2021 7FERINJECT®/INJECTAFER®
SIGNIFICANT GROWTH IMPACT BY COVID-19 PANDEMIC
NET SALES
CHF million
561 552 Net sales increased by 3% at constant
-2% exchange rates
90 99
20% growth target missed due to impacts by
151 138
COVID-19 pandemic:
− Reduced physician office visits
− Temporary closure of administration sites
320 315 − Delay of elective surgeries
2019 2020
Europe US RoW
3 MARCH 2021 8FERINJECT®/INJECTAFER®
STRONG REBOUND AFTER DECREASE IN RESTRICTIONS
NET SALES EVOLUTION
In CHF million, % at CER Q1: Growth compared to prior period
180 in line with expectations
-26% -2%
+26% +16% Q2: Heavily impacted by COVID-19
150 measures during first wave
120 Q3: Immediate and strong return to
pre-COVID 19 growth with easing
90 restrictions in most countries
Q4: 2nd wave less impactful with
60
better prepared healthcare system
30 Conclusion:
Ferinject®/Injectafer® expected to
0 be back to pre-COVID-19 growth
Q1 Q2 Q3 Q4 with easing lockdown measures
2019 2020
CER = constant exchange rates
3 MARCH 2021 9STRATEGIC FOCUS
THREE KEY AREAS AS BASIS FOR FUTURE GROWTH
1
Iron Deficiency
2
Nephrology
3
Cardio-Renal
3 MARCH 2021 10NEPHROLOGY
STRONG RESILIENCE IN ANEMIA MANAGEMENT
ESA PORTFOLIO NET SALES VENOFER® NET SALES
CHF million CHF million
540 524
-3%
132 136
+3%
2019 2020 2019 2020
Mircera® 1 Retacrit® 2
ESA portfolio growth of 3% at CER, driven by overall demand Strong growth of +8% at CER
for Retacrit® Net sales growth driven by higher demand in US and China
Mircera® growth impacted by phasing of orders
CER = constant exchange rates 1) Licensed from F. Hoffmann-La Roche AG 2) Licensed from Pfizer Inc.
3 MARCH 2021 11NEPHROLOGY
VELPHORO® IMPACTED BY ORDER PATTERNS
VELPHORO® NET SALES
CHF million
182 178
-2% Net sales increased by 4% at CER
Strong in-market sales growth of 25%
Global leader with in-market sales of CHF 439
million or 29% market share1
Protected by various Orange Book listed patents
expiring between Nov. 2028 and Nov. 2034
2019 2020
CER = constant exchange rates
1) Monthly IQVIATM MIDAS® panel, INSIGHT Health & DN, GERS, DLI, Farminform, moving annual total Q4-2020. Average 2020 exchange rates have been applied.
3 MARCH 2021 12NEPHROLOGY – ANG 3777
EXPANDING THE PIPELINE IN NEPHROLOGY
First small molecule Global rights2
hepatocyte growth factor mimetic in DGF and CSA-AKI
ANG-37771
~110k patients with CSA-AKI ~26k patients with DGF
US, UK and EU4 combined US, UK and EU4 combined
Phase-II study in CSA-AKI Phase-III study in DGF
read out in H2 2021 read out in end of 2021
DGF = Delayed graft function CSA-AKI = Cardiac surgery associated acute kidney injury
1) Licensed from Angion Biomedica Corp. 2) Excluding China, Taiwan, Hong Kong and Macau
3 MARCH 2021 13NEPHROLOGY
LEADERSHIP OF THE WHOLE NEPHROLOGY CHAIN
PRE-CLINICAL CLINICAL / PRE-COMMERCIAL
PARTNERSHIP IN-LICENSING DEALS AND PARTNERSHIPS
Avacopan1 Rayaldee®2
DATA GENERATION
NephThera
CR8453 Vadadustat4
COMMERCIAL
PRE-DIALYSIS DIALYSIS TRANSPLANTATION
7
5 6 ANG-37778
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 conditions and limited to the US dialysis market
5) Joint commercialization agreement with Janssen Pharmaceuticals Inc. 6) Licensed from Pfizer Inc. 7) Licensed from F. Hoffmann-La Roche AG 8) Licensed from Angion Biomedica Corp.; excluding China, Taiwan, Hong Kong and Macau
3 MARCH 2021 14STRATEGIC FOCUS
THREE KEY AREAS AS BASIS FOR FUTURE GROWTH
1
Iron Deficiency
2
Nephrology
3
Cardio-Renal
3 MARCH 2021 15CARDIO-RENAL – FERINJECT®
AFFIRM-AHF STUDY SHOWED STRONG CLINICAL BENEFITS
TOTAL HEART FAILURE HOSPITALISATION
100
Rate ratio (95% CI): 0.74 (0.58–0.94); p=0.013
Mean cumulative events per 100 patients
26% reduction in heart failure
80
re-hospitalization
60
Reduction irrespective of anemia status
Strengthening of ESC guideline expected
40 in 2021
Market opportunity in heart failure of
20
> CHF 500m in Europe and
0
0 4 8 12 16 20 24 28 32 36 40 44 48 52
> CHF 1bn in the US
Time since randomization (weeks)
Ferinject® Placebo
3 MARCH 2021 16CARDIO-RENAL – VELTASSA®
ADDRESS KEY DEMAND DRIVERS TO RESUME GROWTH
NET SALES
CHF million
Demand mainly impacted by reduced nephrology
132 office visits due to COVID-19 restrictions
-11% 118
In 2021, further differentiate the clinical benefits
of Veltassa® and improve formulary coverage
PLATINUM study initiated in 2020 to evaluate
benefit of Veltassa® use in the emergency setting
2019 2020
US Europe
3 MARCH 2021 17CARDIO-RENAL – VELTASSA®
SIGNIFICANT OPPORTUNITY WITH EXISTING PRESCRIBERS
IN-MARKET SALES – WORLDWIDE
KEY CHARACTERISTICS
2015 2020 Calcium-based, non-absorbed
52-weeks data available
Acute & chronic usage
38% 40% KEY FOCUS
172 431
CHFm CHFm Build awareness
Establish clinical differentiation
Improve pull-through
22%
DIAMOND study is significant growth
accelerator and “differentiator”
Veltassa® Sodium zirconium cyclosilicate Other potassium binders
Source: monthly IQVIATM MIDAS® panel, GERS, InsightHealth, DLI, moving annual total Q4-2020. Average 2020 exchange rates have been applied.
3 MARCH 2021 18OUTLOOK 2021
Ferinject® approval in China
KorsuvaTM 1 approval in the US and filing in Europe
MARKET ACCESS 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
VIT-2763 phase-II initiation in sickle cell disease in H1 2021
VIT-2763 phase-II recruitment completion in beta thalassemia in H2 2021
CLINICAL TRIALS
ANG-37774 phase-II readout in CSA-AKI in H2 2021
ANG-37774 phase-III readout in DGF in Q4 2021
BD&L At least two in-licensing deals, product acquisitions or corporate transactions
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 market
4) Licensed from Angion Biomedica Corp.
3 MARCH 2021 19FINANCIAL PERFORMANCE AND GUIDANCE COLIN BOND, CHIEF FINANCIAL OFFICER
2020 PERFORMANCE
OVERALL PORTFOLIO RESILIENT
Net sales growth at constant exchange rates
Venofer® 8.4%
Maltofer® 7.8%
Velphoro® 3.6%
Ferinject®/Injectafer® 3.0%
Mircera®/Retacrit® 2.5%
Veltassa® -5.1%
Net sales 3.7%
-10% -5% 0% 5% 10%
3 MARCH 2021 21P&L OVERVIEW (IN CHF MILLION)
EBITDA GROWTH OF 35.7% ON A COMPARABLE BASIS
FY FY %∆ vs.
2019 1 2020 2019 Other income increase driven by
Net Sales 1’725.0 1’705.6 -1.1% partnering activities for Ferinject®,
Other Income 37.0 96.4 +160.5% Veltassa® and Velphoro® as well as
Gross Profit 1’061.2 1’100.8 +3.7% disposal of non-core products
EBITDA 485.0 575.8 +18.7% EBITDA growth of +35.7% on a
Depreciation and amortization -209.1 -284.4 -36.0% comparable basis driven by cost
EBIT 275.9 291.4 +5.6%
containment measures
Profit from continuing operations 222.8 237.6 6.6%
Profit from discontinued operations 50.9 220.9 334.0% Depreciation and amortization
Net profit before NCI 273.8 458.6 67.5% driven by CCX140 impairment of
Non-controlling interests -114.7 -98.9 13.8% CHF 56.2 million (H1 2020)
Net profit after NCI 159.1 359.6 126.0%
2
Profit from discontinued operations
Core EPS from continuing operations 3.88 4.99 +28.7%
due to disposal of OM Pharma in
September 2020
NCI = non-controlling interests EPS = earnings per share
1) 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)
3 MARCH 2021 22BALANCE SHEET OVERVIEW (IN CHF MILLION)
STRONG EQUITY RATIO OF 77.1%
31 Dec 31 Dec Change vs.
2019 1 2020 2019
Cash & cash equivalents increase
Cash & cash equivalents 544.9 730.0 185.1 driven by OM Pharma divestment,
Trade & other receivables 471.9 487.7 15.8 partly offset by BD&L4 investments
Inventories 348.6 339.8 (8.8) and dividend distributions
Financial investments & other assets 633.5 896.8 263.3
2 3
PPE & RoU assets 351.0 302.8 (48.2) Financial investments increase
Intangible assets 2’584.5 2’454.5 (130.0) mainly driven by gain on
Assets 4’934.4 5’211.7 277.3 ChemoCentryx equity stake
Current financial & lease liabilities 17.8 23.0 5.2 Intangible assets decrease mainly
Other current liabilities 523.6 521.0 (2.6) driven by OM Pharma divestment
Non-current financial & lease liabilities 626.5 608.6 (17.9) and CCX140 impairment, partly
Other non-current liabilities 31.3 41.5 10.2
Shareholders' equity 3’735.3 4’017.6 282.3
offset by purchase of a priority
Liabilities & shareholders' equity 4’934.4 5’211.7 277.3 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
3 MARCH 2021 23CASH FLOW OVERVIEW (IN CHF MILLION)
NET CASH POSITION OF CHF 190.6 MILLION
2020
Opening cash & cash equivalents, 1 January 544.9 Net working capital increase due to phasing
Operating activities 549.1 of payment from major customers and
Net working capital (127.2) planned increase in inventory
Interest, tax & other financial payments (19.3)
Operating cash flow from discontinued operations 21.2 Milestone and BD&L1 investments driven by
Cash flow from operating activities 423.8 extension of the agreement with Cara
Milestones & BD&L1 investments (256.0) Therapeutics, licensing of ANG-3777 and
Capex & others (70.0) acquisition of a priority review voucher
Net proceeds from OM Pharma divestment 378.4
Cash flow from investing activities 52.4 Investments more than offset by net
Dividends paid (219.6) proceeds from the OM Pharma divestment
Financing & others (48.7) of CHF 378.4 million
Cash flow from financing activities (268.4)
Dividend payments of CHF 129.6 million to
Exchange rate effects (22.7)
Vifor Pharma shareholders and CHF 90.0
Ending cash & cash equivalents, 31 December 730.0
million to Fresenius Medical Care
Financial liabilities2 (539.5)
Net debt 190.6
1) Business development and licensing 2) Excluding non-interest bearing financial liabilities and lease liabilities
3 MARCH 2021 24GUIDANCE 20211
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.
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
3 MARCH 2021 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. 3 MARCH 2021 26
You can also read
