PRESENTATION VIFOR PHARMA INVESTOR PRESENTATION. April 2019

Transcription

1 PRESENTATION VIFOR PHARMA INVESTOR PRESENTATION

2 VIFOR PHARMA OUR VISION Global leader in iron deficiency, nephrology and cardio-renal therapies. 2

3 EXPERIENCED LEADERSHIP TEAM PROVEN TRACK RECORD ETIENNE JORNOD EXECUTIVE CHAIRMAN OF THE BOARD OF DIRECTORS STEFAN SCHULZE PRESIDENT OF THE EXECUTIVE COMMITTEE & COO COLIN BOND CHIEF FINANCIAL OFFICER 3

4 PROVEN TRACK RECORD CORPORATE TIMELINE AND STRATEGY 2000 BUILDING IRON PORTFOLIO AND INTERNATIONAL EXPANSION 2000: Venofer US FDA approval 2007: Launch of Ferinject 2008: Acquisition Aspreva 2008: Creation of EU affiliates 2009: Acquisition OM Pharma 2010 BECOMING GLOBAL LEADER IN IRON DEFICIENCY AND ENTERING INTO NEPHROLOGY 2010: Creation of VFMCRP 2013: Injectafer FDA approval 2013: Launch of Velphoro BECOMING GLOBAL LEADER IN NEPHROLOGY AND ENTERING CARDIO-RENAL DISEASE AREA 2015: Mircera license 2015: Veltassa license 2016: Four licensing deals 2016: Relypsa acquisition 2017: Galenica Santé IPO 2017: Vadadustat license 2017: Veltassa EU approval 2017: Mircera license expansion 2018: CR845 license 4

5 LEADING PORTFOLIO IN TARGET THERAPY AREAS Iron deficiency Nephrology Cardio-renal Own products In-licensed products Avacopan CCX140 Vadadustat CR845 Pre-commercial products 5

6 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 6

7 FERINJECT A BLOCKBUSTER POTENTIALLY ALREADY IN 2019 GLOBAL I.V. IRON MARKET (MAT Q4 2018) Global in-market sales of CHF million (+17%) Ferinject in-market sales growth of 29% IN-MARKET SALES CHF MILLION Global market share of Ferinject in value is 49% Launch in CH, UK, Spain FAIR-HF study (cardio) FERGI-COR study (gastro) PREFER study (fatigue) New EU guidelines: nephro, cardio, gastro, onco FIND-CKD study (ND- CKD) Injectafer approved in the USA CONFIRM- HF study (cardio) New EU onco guidelines New ESC guidelines (cardio) EFFECT-HF study (cardio) Intensifying promotional effort by Daiichi Sankyo Europe US RoW MAT = Moving annual total Based on quarterly IQVIA TM MIDAS panel, GERS, Insight Health, DLI, historical data at constant exchange rate (average 2018) 7

8 FERINJECT SIGNIFICANT MARKET OPPORTUNITY REMAINS Ferinject in-market volume growth Ferinject volume per capita 2) Launch Date 6% Switzerland % Australia % New Zealand % Sweden % Spain % Germany % Italy % UK % France % U.S % Japan % China Based on quarterly IQVIA TM MIDAS panel, GERS, Insight Health, moving annual total (MAT) Q , historical data at constant exchange rate (average 2018) 2) 100 mg eq./1 000 population 8

9 FERINJECT THE BLOCKBUSTER PLAN Therapeutic areas with high unmet need Heart failure Patient blood management Gastroenterology Strong partnerships Partnering with leading companies Nephrology Geographic expansion Japan (2019) China (202 Life cycle management AFFIRM-AHF HEART-FID Key pharmerging markets Study conducted by our US partner Daiichi Sankyo 9

10 FERINJECT EXPLOIT THE POTENTIAL Japan launch H China launch 2021 > CHF 2 billion in-market sales potential AFFIRM-AHF completion Post-approval study FAIR-HF2 completion Post-approval study HEART-FID completion 2) U.S. Post-approval study U.S. label update Focus on cardiology, patient blood management, gastroenterology and nephrology EU guidelines* update based on AFFIRM AHF U.S. guidelines* update based on HEART-FID *Targeted guidelines: Investigator initiated study, University of Hamburg 2) Study conducted by our US partner Daiichi Sankyo 10

11 VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA THE RATIONALE STRONG IRON AND PHARMA EXPERTISE 55% Stake CCX140 Avacopan CR845 Vadadustat GLOBAL LEADER IN DIALYSIS 45% Stake Pre-commercial products 11

12 VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA SYNERGISTIC PARTNERSHIP 55% Stake STRONG IRON AND PHARMA EXPERTISE Sourcing of innovation Evaluation of clinical assets Acceptance of clinical risk Regulatory and market access expertise Focus on pharma needs of nephrology patients Global Leader Access to patient data. Faster clinical trial execution Faster uptake and utilisation GLOBAL LEADER IN DIALYSIS Partnership technically controlled by Vifor Pharma Managed care expertise Patient access (>300k patients) Validation of innovation Medications in FKC clinics become SoC 2) Fresenius Kidney Care (FKC): Fresenius Medical Care North America dialysis provider organization 45% Stake 2) Standard of care 12

13 VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA CURRENT PORTFOLIO ANAEMIA MANAGEMENT MINERAL & BONE MANAGEMENT KIDNEY PROTECTION CKD-ASSOCIATED COMPLICATIONS CARDIO-RENAL MANAGEMENT Avacopan CR845 CCX140 Vadadustat Pre-commercial products 13

14 VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA DELIVERING INNOVATION TO NEPRHOLOGY PATIENTS Rayaldee launch Avacopan launch Vadadustat launch > CHF 1bn reported sales CCX140 / FSGS Ph. II trial completion CR845 launch CCX140 launch Additional launches in nephrology Avacopan / AAV Ph. III trial completion CR845 / Uremic Pruritus Ph. III trials completion Vadadustat Ph. III trials completion Avacopan / C3G Ph. II trial completion 14

15 NEPHROLOGY NUMEROUS OPPORTUNITIES REMAIN CURRENT INDICATIONS PIPELINE INDICATIONS POTENTIAL INDICATIONS Iron deficiency Anaemia Hyperphosphatemia Hyperkalemia FSGS ANCA associated vasculitis Secondary hyperparathyroidism Uremic pruritus C3G Hypernatremia Vascular calcification Polycystic kidney disease Kidney stones ahus β-thalassemia renal disease Metabolic acidosis Acute kidney injury Diabetic nephropathy Fabry 15

16 NEPHROLOGY LEADERSHIP OF THE WHOLE NEPHROLOGY CHAIN PRE CLINICAL PARTNERSHIP CLINICAL / PRE-COMMERCIAL IN-LICENSING DEALS AND PARTNERSHIPS PRE DIALYSIS CCX140 CR845 COMMERCIAL DIALYSIS Avacopan Vadadustat TRANSPLANTATION DATA GENERATION 16

17 VELTASSA OVERVIEW OF KEY FEATURES Mode of action Calcium-based, non-absorbed High safety profile Limited undesirable effects 52-weeks data AMETHYST-DN study RAASi enabling Included in SmPC in Europe Broad use Acute & Chronic Room temperature storage US: 3 months / EU: 6 months SmPC = summary of product characteristics 17

18 VELTASSA ASSESSMENT OF LONG TERM POTENTIAL UNCHANGED US MARKET OPPORTUNITY 3 million x USD 820 x 6 months = > USD 10 billion Estimated hyperkalaemia patients Monthly gross price Targeted duration of treatment Potential market size (net sales) 18

19 Demand (boxes) per BD VELTASSA TOTAL US DEMAND PER BUSINESS DAY (BD)

20 VELTASSA DRIVE TO BLOCKBUSTER STATUS European rollout Japan launch Zeria Blockbuster status AMBER study results publication Post-approval study Guideline* updates based on AMBER results DIAMOND completion Post-approval study Guideline* updates based on DIAMOND results Label updates based on DIAMOND results *Targeted guidelines: 20

21 R&D INVESTMENTS FOCUS IS ON KEY PRODUCTS AND CLINICAL PIPELINE PHASE 1 PHASE 2 PHASE 3 LIFE CYCLE MANAGEMENT Own Products Oral ferroportin inhibitor Initiation mid-2019 AFFIRM-AHF (2020) HEART FID (2022) 2) AMBER (May 2019) DIAMOND (2022) Avacopan (Q4 2019) In-licensed Products CCX140 (2020) CR845 (Q2/H2 2019) Vadadustat (2020) Iron overload; leveraging iron metabolism expertise 2) Study conducted by our US partner Daiichi Sankyo 21

22 P&L OVERVIEW (IN CHF MILLION) ON TRACK TO ACHIEVE MILESTONE 2020 GUIDANCE FY 2017 FY 2018 Change vs Net sales 1' ' % Other income % Cost of sales (517.9) (648.7) +25.3% Gross profit ' % EBITDA % Depreciation and amortisation (146.0) ( % EBIT % Net sales increase of 22.7% driven by Ferinject /Injectafer, Mircera, Veltassa and Velphoro EBITDA growth of 39.7%, driven by strong net sales growth and cost containment Core earnings per share of 4.16, driven by strong operating performance and financial result Core earnings 2) per share % Restated for IFRS 15 impact 2) Profit after minorities adjusted for amortisation of intangible assets (CHF million in 2018) 22

23 NET SALES OVERVIEW (IN CHF MILLION) SOLID GROWTH IN 2018 FY 2017 FY 2018 Growth in 2018 Ferinject /Injectafer % Mircera % Venofer Velphoro % +18.7% Veltassa % Retacrit TM Others NM 2) +4.9% Net sales 1' ' % Restated for IFRS 15 impact 2) Not meaningful 23

24 BALANCE SHEET OVERVIEW (IN CHF MILLION) STRONG EQUITY RATIO OF 74.8% 31 Dec Dec 2018 Change vs Cash & cash equivalents (24.8) Receivables Inventories Financial investments & other Deferred tax assets Property & equipment Goodwill & intangibles 2' ' Assets 4' ' Current financial liabilities (23.4) Other current liabilities Non-current liabilities Shareholders' equity 3' ' Liabilities & shareholders' equity 4' ' Receivables increase driven by net sales increase Increase in financial investments & other mainly driven by: o ChemoCentryx: CHF 85.4 o Cara Therapeutics: CHF 14.6 Increase in non-current liabilities mainly driven by the bond issue of CHF (net proceeds), partially offset by the repayment of the private placement of CHF

25 CASH FLOW OVERVIEW (IN CHF MILLION) NET DEBT OF CHF MILLION 2018 Opening cash, 1 January Operating activities Net working capital (133.2) Income tax paid (78.9) Cash flow from operating activities Milestones & BD&L investments (318.0) Capex & others (58. Cash flow from investing activities (376. Dividends paid (174.6) Financing & others Cash flow from financing activities Exchange rate effects (1. Ending cash and cash equivalents, 31 December Financial liabilities (580.0) Net debt (179.7) Cash flow from investing activities mainly driven by milestones & BD&L investments o Avacopan: CHF 49.1 o Cara Therapeutics: CHF 70.1 o ChemoCentryx: CHF 85.4 Cash flow from financing activities mainly driven by: o Dividend payments of CHF to Vifor Pharma shareholders and CHF 45.0 to Fresenius Medical Care o Bond issue of CHF (net proceeds), partially offset by the repayment of the private placement of CHF

26 GUIDANCE 2019 In 2019 at constant exchange rates Vifor Pharma net sales are expected to grow between 11% and 13%, reported EBITDA is expected to increase by 25%. 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. 26

27 OUTLOOK 2019 MARKET ACCESS Ferinject launch in Japan (H2 2019) Go-to-market strategy in China Partnering the Japanese rights for CCX140 CLINICAL TRIALS Veltassa : results of the AMBER study presented in May 2019 Veltassa : initiation of the DIAMOND outcome study for RAASi enabling (H1 2019) Ferroportin inhibitor: initiation of phase-ii study (mid-2019) Avacopan: phase-iii ADVOCATE study readout (Q4 2019) CR845: KALM-1 and KALM-2 study readouts (Q2 and H2 2019, respectively) BUSINESS DEVELOPEMENT Completion of at least one additional in-licensing, product acquisition or corporate transaction Presentation on 10 May 2019 at the National Kidney Foundation Spring Clinical Meetings 27

28 CONTACT INFORMATION Colin Bond CFO Phone: INVESTOR RELATIONS Julien Vignot Head of Investor Relations Phone: Laurent de Weck Investor Relations Manager Phone:

29 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, forwardlooking 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 forwardlooking statements, which speak only as of the date of this presentation. 29