PRESENTATION VIFOR PHARMA INVESTOR PRESENTATION. August 2018

Transcription

1 PRESENTATION VIFOR PHARMA INVESTOR PRESENTATION August 2018

2 VIFOR PHARMA VISION Global Leader in Iron Deficiency, Nephrology and Cardio-Renal Therapies. August

3 AGENDA 1 Experienced leadership team 2 3 Proven track record Leading portfolio in target disease areas Three mid-term strategic growth drivers Investments H performance and 2018 outlook August

4 1 EXPERIENCED LEADERSHIP TEAM Etienne Jornod Executive Chairman Stefan Schulze President and COO Colin Bond Chief Financial Officer Christoph Springer Chief Strategy Officer Dario Eklund Chief Commercial Officer Scott Garland President, Relypsa David Bevan CEO, VFMCRP 1) and Chief Marketing Officer Michael Puri Chief Human Resources Officer 1) Vifor Fresenius Medical Care Renal Pharma August

5 2 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 August

6 3 LEADING PORTFOLIO IN TARGET DISEASE AREAS IRON DEFICIENCY NEPHROLOGY CARDIO-RENAL Own Products In-licensed Products 1) Avacopan 1) CCX140 1) Vadadustat 1) CR845 1) 1) Pre-commercial products August

7 4 THREE MID-TERM STRATEGIC GROWTH DRIVERS Ferinject Exploit the Potential through Market Awareness Vifor Fresenius Medical Care Renal Pharma Grow and Enhance Value Veltassa Build a Blockbuster August

8 4 FERINJECT SIGNIFICANT MARKET OPPORTUNITY REMAINS 1) MAT Ferinject In-Market Volume Growth MAT Ferinject Volume Per Capita 2) Launch Date 3% Switzerland % Australia % New Zealand % Sweden % Germany % Turkey % Spain % France % UK % Italy % US ) Based on Quarterly IQVIA MIDAS TM panel, GERS, Insight Health, Q ) 100 mg eq./1 000 population August

9 4 FERINJECT A BLOCKBUSTER BY 2020 FERINJECT IN-MARKET SALES 1) (MCHF) Global i.v. iron market totalled CHF 1,564 million in 2017, growth of 12.7% vs Ferinject responsible for 90.3% of the total value growth of the i.v. iron market in 2017 The market share of Ferinject in value was 50.6% in December 2017 in the top 10 markets Approval in EU / CH First launch in Germany 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 New EU onco guidelines Europe US ROW 1) Based on Quarterly IQVIA MIDAS TM panel, GERS, Insight Health, DLI, data at constant exchange rate (average 2017) August

10 4 FERINJECT THE BLOCKBUSTER PLAN 1 Therapeutic Heart Failure 3 Strong areas with high Gastroenterology partnerships unmet need Nephrology Patient Blood Management Partnering with leading companies in and outside of Europe 2 Geographic Japan (2019) 4 Life Cycle expansion China (2021) Management Key pharmerging markets AFFIRM-AHF HEART-FID August

11 4 VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA THE RATIONALE STRONG IRON AND PHARMA EXPERTISE 55% Stake CR845 1) Avacopan 1) CCX140 1) Vadadustat 1) GLOBAL LEADER IN DIALYSIS 45% Stake 1) Pre-commercial products August

12 4 VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA CURRENT PORTFOLIO ANAEMIA MANAGEMENT MINERAL & BONE MANAGEMENT KIDNEY PROTECTION CKD-ASSOCIATED COMPLICATIONS CARDIO-RENAL MANAGEMENT Avacopan 1) CR845 1) CCX140 1) 1) Vadadustat 1) 1) Pre-commercial products August

13 4 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 1) in Europe Broad use Acute & Chronic Room temperature storage US: 3 months / EU: 6 months 1) SmPC = summary of product characteristics August

14 AMI patients with in-hospital events (%) 4 VELTASSA ADDRESSES LIFE THREATENING UNMET MEDICAL NEED MORTALITY AND CARDIAC ARREST IN IN-HOSPITAL EVENTS VS SERUM K + DISEASE BACKGROUND 60 Hypokalemia Normal Hyperkalemia Prevalent in CKD and CHF patients Death Asymptomatic Inhibits use of renin angiotensin aldosterone inhibitors (RAASi) Post admission serum potassium level (mean, meq/l) Disease awareness is underdeveloped August

15 Demand (boxes) per BD 4 VELTASSA TOTAL US DEMAND PER BUSINESS DAY (BD) Demand growth: +81% year over year Global net sales: CHF 36.8 million (+51.8%) in H % of lives covered, Medicare coverage increased to 64% Amber study expected to be completed in 2018 August

16 5 R&D INVESTMENTS MILESTONE 2020 STRATEGIC PLAN PHASE 1 PHASE 2 PHASE 3 COMMERCIAL PHASE 4 Own Products Ferroportin inhibitor 1) Anti-infectives AFFIRM-AHF Paediatric AMBER DIAMOND In-licensed Products 2019 CCX140 Avacopan Vadadustat 3) CR ) 1) Iron overload; leveraging iron metabolism expertise 2) Earlier launch possible due to EMA conditional marketing approval 3) Filing expected by the end of 2019 August

17 6 P&L OVERVIEW (IN CHF MILLION) STRONG H RESULTS H H % vs. H Net Sales % Other Income % Gross Profit % EBITDA % Depreciation and amortization % EBIT % Financial result N/A Income tax N/A Net Profit before minorities 1, N/A Net Profit after minorities 1, N/A Core earnings 1 per share N/A Net sales increase of +23.4% driven by Ferinject, Veltassa and Mircera EBITDA increase of +44.5% driven by top-line growth Financial result of CHF 41.8 million, driven by FX gains on intercompany loan repayment Cash taxes fully offset by deferred tax asset recognition 1) Reported earnings after minorities adjusted for amortisation of intangible assets and goodwill of CHF 54.5 million August

18 6 NET SALES 1) (IN CHF MILLION) H H Growth in H Ferinject % Venofer % Mircera % Velphoro % -3.5 Veltassa Others % +9.7% Net Sales % 1) H net sales restated in accordance to IFRS 15 August

19 6 BALANCE SHEET OVERVIEW (IN CHF MILLION) STRONG EQUITY RATIO OF 80.0% NET DEBT OF CHF MILLION EQUITY RATIO OF 80.0% 4, , Cash and cash equivalents Receivables and other Inventories Property a equipment 4, , Current financial liabilities Other current liabilities Long-term liabilities 2, ,710.3 Goodwill and intangibles 3, ,312.9 Shareholders equity August

20 6 CASH FLOW OVERVIEW (IN CHF MILLION) NET DEBT OF CHF MILLION 2018 Opening Cash, 1 January Cash flow from operating activities 38.4 Capex Investing activities, in-licensing, milestones Investments in financial assets and others Cash flow from investing activities Dividend 2017 paid in May Dividend to FMC Proceeds from financial liabilities Repayment of financial liabilities and others Cash flow from financing activities Exchange rate effects 0.5 Increase/(decrease) in cash and cash equivalents Ending cash and cash equivalents, 30 June Liquidity as at 30 June 2018: 31 Dec Jun 2018 Cash & cash equivalents Financial liabilities Net Cash / (Net Debt) CHF million private placements repaid in March Dividend payments to public shareholders CHF million and to FMC CHF million CHF million drawn under CHF 300 million credit facility August

21 6 GUIDANCE 2018 NET SALES AND EBITDA GUIDANCE INCREASED In 2018 at constant exchange rates Vifor Pharma net sales are expected to grow by more than 15% and reported EBITDA by more than 25%. In 2020 net sales are expected to exceed CHF 2 billion and EBITDA to reach a high triple-digit level. For 2018 and 2019, the dividend is expected to be at the same level as for From 2020 onwards, the payout ratio is targeted at 35% of net income. August

22 6 OUTLOOK 2018 PRODUCT LAUNCHES Veltassa commercial launch in key European countries Avacopan approval in Europe late 2018/early 2019 PARTNERING Veltassa partnering in Japan Partnering the Japanese rights for CCX 140 IN-LICENSING Completion of one additional in-licensing deal during the course of 2018 CLINICAL Veltassa : completion of the AMBER study for treatment of patients with resistant hypertension Veltassa : initiation of the DIAMOND outcome study for RAASi enabling Ferroportin inhibitor: completion of phase-i study August

23 CONTACT INFORMATION Colin Bond CFO Phone: Investor Relations Julien Vignot Head Investor Relations Phone: August

24 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. August