INVESTOR PRESENTATION - VIFOR PHARMA
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PRESENTATION
VIFOR PHARMA
INVESTOR PRESENTATION
January 2019
VIFOR PHARMA
OUR VISION
Global leader
in iron deficiency, nephrology
and cardio-renal therapies.
© Vifor Pharma January 2019 2
EXPERIENCED LEADERSHIP TEAM
PROVEN TRACK RECORD
ETIENNE JORNOD STEFAN SCHULZE COLIN BOND
EXECUTIVE CHAIRMAN PRESIDENT OF THE EXECUTIVE CHIEF FINANCIAL OFFICER
OF THE BOARD OF DIRECTORS COMMITTEE & COO
© Vifor Pharma January 2019 3
PROVEN TRACK RECORD
CORPORATE TIMELINE AND STRATEGY
2020
2015
2010
2000 BECOMING GLOBAL LEADER
IN NEPHROLOGY AND ENTERING
BECOMING GLOBAL LEADER
CARDIO-RENAL DISEASE AREA
BUILDING IRON PORTFOLIO IN IRON DEFICIENCY AND
AND INTERNATIONAL EXPANSION ENTERING INTO NEPHROLOGY • 2015: Mircera® license
• 2000: Venofer® US FDA approval • 2015: Veltassa® license
• 2010: Creation of VFMCRP • 2016: Four licensing deals
• 2007: Launch of Ferinject®
• 2013: Injectafer® – FDA approval • 2016: Relypsa acquisition
• 2008: Acquisition Aspreva
• 2013: Launch of Velphoro® • 2017: Galenica Santé IPO
• 2008: Creation of EU affiliates
• 2009: Acquisition OM Pharma • 2017: Vadadustat license
• 2017: Veltassa® EU approval
• 2017: Mircera® license expansion
• 2018: CR845 license
© Vifor Pharma January 2019 4
LEADING PORTFOLIO IN TARGET THERAPY AREAS
Iron
Nephrology Cardio-renal
deficiency
Own
products
In-licensed Avacopan1) CCX1401)
1)
products
Vadadustat1) CR8451)
1) Pre-commercial products
© Vifor Pharma January 2019 5THREE 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 January 2019 6FERINJECT®
A BLOCKBUSTER BY 2020
FERINJECT ® IN-MARKET
GLOBAL I.V. IRON Q2 1)2018)
SALES
MARKET (MAT (MCHF)
1) IN-MARKET SALES1)
CHF MILLION
• Market totalled CHF 1’698 million, +15% versus prior year period
• Ferinject® growth represented 88% of the total market growth, with +32% versus prior year period 850-880
• Global market share of Ferinject® in value is 47% (54% in our top 10 markets)
692
535
374
240
123 163
58 81
16 38
2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018E2)
Launch in FAIR-HF FERGI-COR PREFER study FIND-CKD CONFIRM- New EU New ESC Intensifying
CH, UK, study study (fatigue) study (ND- HF study onco guidelines promotional
Spain (cardio) (gastro) CKD) (cardio) guidelines (cardio) effort by
New EU
Daiichi
guidelines: Injectafer® EFFECT-HF
Sankyo
nephro, cardio, approved study
gastro, onco in the USA (cardio)
Europe US ROW
MAT = Moving annual total
1) Based on Quarterly IQVIATM MIDAS® panel, GERS, Insight Health, DLI, historical data at constant exchange rate (average 2017) 2) Estimate based on IQVIATM
© Vifor Pharma January 2019 7FERINJECT®
SIGNIFICANT MARKET OPPORTUNITY REMAINS 1)
Ferinject® in-market volume growth Ferinject® volume per capita2)
Launch Date
5% Switzerland 253 2008
33% Australia 107 2011
47% New Zealand 51 2012
16% Sweden 36 2008
16% Germany 34 2007
39% Spain 29 2009
16% France 22 2011
22% UK 22 2008
53% Italy 22 2012
45% U.S. 12 2013
0% Japan 0 2019
0% China 0 2021
1) Based on Quarterly IQVIATM MIDAS® panel, GERS, Insight Health, Moving Annual Total (MAT) Q2 2017-18
2) 100 mg eq./1’000 population
© Vifor Pharma January 2019 8FERINJECT®
THE BLOCKBUSTER PLAN
Therapeutic • Heart failure Strong • Partnering with leading
areas with high • Patient blood management partnerships companies
unmet need • Gastroenterology
• Nephrology
Geographic • Japan (2019) Life cycle • AFFIRM-AHF
expansion • China (2021) management • HEART-FID1)
• Key pharmerging markets
1) Study conducted by our US partner Daiichi Sankyo
© Vifor Pharma January 2019 9FERINJECT®
EXPLOIT THE POTENTIAL
2019 2020 2021 2022 2023 2024 2025
> CHF 2 billion
Japan launch China launch
in-market sales
H2 2019 2021
potential
AFFIRM-AHF FAIR-HF2 HEART-FID
U.S. label
completion completion1) completion2)
update
Post-approval study Post-approval study U.S. Post-approval study
Focus on cardiology, patient blood management, gastroenterology and nephrology
EU guidelines* U.S. guidelines*
update based on update based on
AFFIRM AHF HEART-FID
*Targeted guidelines:
1) Investigator initiated study, University of Hamburg 2) Study conducted by our US partner Daiichi Sankyo
© Vifor Pharma January 2019 10VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA
THE RATIONALE
55% Stake
STRONG IRON AND PHARMA EXPERTISE
1)
CCX1401)
Avacopan1)
CR8451) Vadadustat1)
GLOBAL LEADER IN DIALYSIS
45% Stake
1) Pre-commercial products
© Vifor Pharma January 2019 11VIFOR 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 clinics1) become SoC2)
45% Stake
1) Fresenius Kidney Care (FKC): Fresenius Medical Care North America dialysis provider organization
2) Standard of care
© Vifor Pharma January 2019 12VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA
CURRENT PORTFOLIO
ANAEMIA MINERAL & BONE KIDNEY CKD-ASSOCIATED CARDIO-RENAL
MANAGEMENT MANAGEMENT PROTECTION COMPLICATIONS MANAGEMENT
Avacopan1) CR8451)
1)
CCX1401)
Vadadustat1)
1) Pre-commercial products
© Vifor Pharma January 2019 13VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA
DELIVERING INNOVATION TO NEPRHOLOGY PATIENTS
2019 2020 2021 2022 2023 2024 2025
Rayaldee® Avacopan Vadadustat > CHF 1bn
launch launch launch reported sales
CCX140 / FSGS CR845 CCX140 Additional launches in
Ph. II trial completion launch launch nephrology
Avacopan / AAV Vadadustat
Ph. III trial Ph. III trials
completion completion
CR845 / Uremic
Avacopan / C3G
Pruritus Ph. II trial completion
Ph. III trial completion
© Vifor Pharma January 2019 14NEPHROLOGY
NUMEROUS OPPORTUNITIES REMAIN
CURRENT INDICATIONS PIPELINE INDICATIONS POTENTIAL INDICATIONS
Hypernatremia
Vascular calcification
FSGS
Iron deficiency Polycystic kidney disease
ANCA associated vasculitis
Anaemia Kidney stones aHUS
Secondary hyperparathyroidism β-Thalassemia renal disease
Hyperphosphatemia
Hyperkalemia Uremic pruritus Metabolic acidosis
Acute kidney injury
C3G
Diabetic nephropathy
Fabry
© Vifor Pharma January 2019 15NEPHROLOGY
LEADERSHIP OF THE WHOLE NEPHROLOGY CHAIN
PRE CLINICAL CLINICAL / PRE-COMMERCIAL
PARTNERSHIP IN-LICENSING DEALS AND PARTNERSHIPS
Avacopan
DATA GENERATION
CCX140
CR845 Vadadustat
COMMERCIAL
PRE DIALYSIS DIALYSIS TRANSPLANTATION
© Vifor Pharma January 2019 16VELTASSA®
OVERVIEW OF KEY FEATURES
Mode of action High safety profile
Calcium-based, non-absorbed Limited undesirable effects
52-weeks data RAASi enabling
AMETHYST-DN study Included in SmPC1) in Europe
Broad use Room temperature storage
Acute & Chronic US: 3 months / EU: 6 months
1) SmPC = summary of product characteristics
© Vifor Pharma January 2019 17VELTASSA® U.S. RAMP-UP
KEY CONSIDERATIONS
U.S. addressable market 3 million hyperkalemia patients
Nephrology: impact analysis ranked #11)
Awareness
Cardiology: Diamond study needed to unlock the cardiology space
Market access Prescribed by 89% of nephrologists2)
Pricing Monthly gross price USD 820
Duration of treatment Currently ~4-5 months
67% Medicare coverage
Payers’ coverage
Median out-of-pocket costs of $6 for all approved claims
1) BrandImpact, Q1’17 2) Relypsa data on file
© Vifor Pharma January 2019 18VELTASSA®
DRIVE TO BLOCKBUSTER STATUS
2019 2020 2021 2022 2023 2024 2025
European rollout Japan launch Blockbuster
Zeria status
AMBER Guideline* DIAMOND Guideline*
completion updates based on completion updates based on
Post-approval study AMBER results Post-approval study DIAMOND results
Label updates based on
DIAMOND results
*Targeted guidelines:
© Vifor Pharma January 2019 19R&D INVESTMENTS
KEY CLINICAL TRIALS ONGOING
PHASE 1 PHASE 2 PHASE 3 LIFE CYCLE MANAGEMENT
Oral ferroportin
Initiation mid-2019 AFFIRM-AHF (Q4 2019)
inhibitor1)
Own
HEART FID (2022)2)
Products
AMBER (H1 2019)
DIAMOND (2022)
Avacopan (Q4 2019)
In-licensed CCX140 (2020)
Products
CR845 (H2 2019)
Vadadustat (2020)
1) Iron overload; leveraging iron metabolism expertise 2) Study conducted by our US partner Daiichi Sankyo
© Vifor Pharma January 2019 20FINANCIAL HIGHLIGHTS 1)
NET SALES EBITDA FERINJECT®/INJECTAFER®
+23.4% +44.5% +29.3%
CORE EPS2) (in CHF) NET DEBT (in million CHF) EQUITY RATIO
2.66 127.5 80.0%
1) Half-year results 2018
2) Reported earnings after minorities adjusted for amortisation of intangible assets to normalise for the significant impact from the acquisition of Relypsa
© Vifor Pharma January 2019 21GUIDANCE 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 2017. From 2020
onwards, the payout ratio is targeted at 35% of net income.
© Vifor Pharma January 2019 22OUTLOOK 2019
Ferinject® launch in Japan (H2 2019)
Rayaldee® filing in Europe (H1 2019)
MARKET ACCESS
Expansion of footprint in China
Partnering the Japanese rights for CCX140
IN-LICENSING Completion of at least one additional bolt-on transaction during the course of 2019
Veltassa®: read-out of the AMBER study (H1 2019)
Veltassa®: initiation of the DIAMOND outcome study for RAASi enabling (Q1 2019)
CLINICAL TRIALS 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 (H2 2019)
© Vifor Pharma January 2019 23CONTACT INFORMATION
Colin Bond – CFO
Phone: +41 58 851 83 53
Email: colin.bond@viforpharma.com
INVESTOR RELATIONS
Julien Vignot – Head of Investor Relations
Phone: +41 58 851 66 90
Email: julien.vignot@viforpharma.com
Laurent de Weck – Investor Relations Manager
Phone: +41 58 851 80 95
Email: laurent.deweck@viforpharma.com
© Vifor Pharma January 2019 24DISCLAIMER 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 January 2019 25
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