Xbrane Biopharma Corporate Presentation April 2019 · Board & Management Team Jointly Involved In...
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1 Xbrane Biopharma Corporate Presentation April 2019
Transcript of Xbrane Biopharma Corporate Presentation April 2019 · Board & Management Team Jointly Involved In...
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Xbrane Biopharma Corporate Presentation April 2019
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Important Information
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Table of Contents
Presenters
Martin ÅmarkCEO
Anders Tullgren
Chairman of the Board
1. Xbrane Biopharma Overview
2. The Biosimilar Market
3. The VGEF Market & The Unmet Medical Need
4. Lead Product Xlucane
5. Summary & Investment Highlights
4
Xbrane - Biosimilar Developer With Patented High Yield Technology
Lead Product Xlucane In Phase III With Commercial Partner STADA. Annual Sales Target Of €350 M. Income Of €100 M For Xbrane After COGS, SG&A And Partner Profit Sharing.
Addressing Attractive Biosimilar Market Opportunity. The Fastest Growing Segment Within Pharma Combined With Low Technical Risk
Patented Innovative High-yield Technology Platform Resulting In Low Production Costs
Strong Product Pipeline Targeting +€ 11 B In Originator Sales. Only Public Biosimilar Developments To Opdivo® And Cimzia®
Listed At Nasdaq First North With € 35 M* Market Cap – Up-Listing To Main Market During 2019
*As of 2019-04-18
5
Portfolio of 5 Biosimilars In Development – Lead Product Xlucane In Phase III
Commercialization Partner
o
Candidate / Product
Originator Product
Indication Development phase Planned launch
Xlucane
Xcimzane
Xoncane
Spherotide
Xdivane
Lucentis®(Roche )
Cimzia®(UCB)
Oncaspar®(Servier)
Decapeptyl®(Debiopharm
/ Ipsen / Ferring)
Age related macular degeneration, Diabetic macular edema, Diabetic related retinopathy
Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis and Crohn's disease
Acute Lymphocytic Leukaemia (ALL)
Prostate cancer, Breast cancer, Endometriosis and Myoma
At patent expiry
Opdivo®(BMS)
Lung, liver, head & neck, kidney, colorectal cancer and melanoma
Primary Patent Expiry
2020 / 2022 (US) / (EU)
2024 (EU/US)
Expired
Expired
Global Annual Sales
€3.5 B
€1.4 B
€0.2 B
€0.4 B
2026-2030 €5.4 B
At patent expiry
At patent expiry
Phase III
Pre-clinical
Pre-clinical
Pre-clinical
Pre-clinical
Total €11 B
Source: Year end reports, IQVIA
6Source: STADA corporate presentation
STADA Experienced in Successfully Launching Biosimilars
Key Strategic Focus on Biosimilars
o STADA Owners Bain Capital and Cinven view Biosimilars as key growth creation driver
o Portfolio of 7 Biosimilars with 2 currently on the market
o Dedicated Biosimilar Team of 200+ Professionals
o EPO (Silapo®/Erypo®) Biosimilar Developed In-House, Annual EU Sales of €200 M
201820172016
€
7
Strategic Partnership With STADA regarding Xlucane’s Sales & Development
Upfront Payment From STADA of €7.5 M
Development Costs Shared Equally
50/50 Commercialization Split
Xbrane Responsible for R&D and Registration
STADA Responsible for Sales & Marketing
Close Collaboration Across All Levels
Biosimilar Leader
8Note: Data provided by S&P CapitalIQ 2019-04-18
Candidate (Target) DeveloperCommercialisation
Partner
Other Biosimilars Under
Development
Market Cap. (SEK in Millions)
Other Partners
Lucentis® Phase III 4 Pre-clinical €35 MCR Pharma
(Distribution in China)
Lucentis® Phase III Formycon AG None 2 Pre-clinical €320 M Bioeq IP
Lucentis® Phase IIISamsung Bioepis
None4 Approved2 in Clinical
N/ABiogenMerck
Overview of phase III Lucentis Biosimilars
Xlucane Only Lucentis® Biosimilar In Phase III With Commercialization Partner
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Patented High Yield Platform Technology Delivers Low Production Costs
Increasing R&D Productivity, Via Regulating Production Intensity
On Off
Xbrane’s platform: Regulating production intensity
Standard systems: On/Off
Production in e.Coli cells
pLemo
pET
0-4,000 µM rhmanose
OHOH
OHOH oCH2
IPTG
SOH o
CH
CH2 OH
Target mRNA
Target-protein
Large amount of sugar added
Optimal sugar concentration
Low amount of sugar added
o
• Source: Schlegel S, Rujas E, Ytterberg AJ, Zubarev RA, Luirink J, de Gier JW. Optimizing heterologous protein production in the periplasm of E. coli by regulating gene expression levels. Microb Cell Fact. 2013 Mar 12;12:24. Wagner S, Klepsch MM, Schlegel S, Appel A, Draheim R, Tarry M, Högbom M, van Wijk KJ, Slotboom DJ, Persson JO, de Gier JW. Tuning Escherichia coli for membrane protein overexpression. Proc Natl Acad Sci U S A. 2008 Sep 23;105(38):14371-6. Löw C1, Jegerschöld C, Kovermann M, Moberg P, Nordlund P. Optimisation of over-expression in E. coli and biophysical characterisation of human membrane protein synaptogyrin 1. PLoS One. 2012;7(6).
Up To 12x Yield Compared To Standard Systems
• A standard system with an ”on/off” switch produces only at an accelerated level, leading to toxic cells causing protein misfoldings, resulting in a sub-optimal yield
• Xbrane’s technology allows for adaptable production intensity (i.e. dimmer-like) for target proteins, with no toxic effects. Academic studies shows that this results in an improved yield of up to 12x vs. a standard system, i.e. more grams of high quality protein per litre of fermentation tank
• As production cost is dictated by the time a production tank is occupied, a higher yield results in a lower production cost per gram of product
Xbrane’s Relative Yield vs. Standard System
0%
20%
40%
60%
80%
100%
Membrane protein Average of16 different proteins
Antibody fragment
Xbrane technology (LEMO) BL21(DE3)Relative expression (%)
12x 5x 3x
10
Jointly involved in development of
over 25 marketed pharmaceuticals
ChaAnders
Tullgren
M.Sc.
Chairman
Saeid
Esmaeilzadeh
Ph.D.
Board Member
Maris Hartmanis
Ph.D.
Board Member
Peter Edman
Ph.D.
Board Member
Karin Wingstrand
M.Sc.
Board Member
Alessandro Sidoli
M.Sc.
Board Member
Giorgio Chirivi
M.Sc.
Board Member
Board & Management Team Jointly Involved In Development Of Over 35 Marketed Pharmaceuticals
Board of Directors Management And Core Development Team
Jointly involved in development of over 10 marketed pharmaceuticals
CEO
Martin Åmark
M.Sc./MBA
Head of Biosimilars
Siavash Bashiri
M.Sc.
CFO
Susanna Helgesen
M.Sc.
Head of Long acting
injectables
Paolo Sarmientos
Ph.D.
CTO
David Vikström
Ph.D.
Head of Clinical Affairs
Dina Jurman
M.Sc.
Head of Regulatory
Maria Edebrink
M.Sc.
Head of Analytics
Per Edebrink
Ph.D
Patrik Samuelsson
Head of Upstream
Ph.D
Nurzian Ismail
Head of Downstream
Ph.D
Anders Wallström
Head of Supply-Chain
M.Sc.
Ilaria Sammartino
Quality Assurance
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Company History
Xbrane BipharmaFounded at Stockholm
University
2008
Acquired Primm Pharma
with the product Spherotide
2015
GMP Approval Xbrane obtains GMP
approval for its facility for the production of Spherotide
2016 2017
Commercialization agreement
for Sphetodite in China signed with the country’s second largest
pharmaceutical distribute CR Pharma
2018
Xbrane partners with STADA for the development and
commercialization of Xlucane
First patient inIn Xlucane phase III trial
2019
CTA Approval from FDA
for initiation of pivotal phase III study with
Xlucane
Xbrane IPO’son Nasdaq First North and raised SEK 100 M
Establishment of biosimilar pilot
facilityin Stockholm
Patent approval of E.coli platform
Xbrane E.coli expression technology patent approved
in Europe
Mammalian cell based platform
establishedand development of
Xdivane (Opdivo) accelerated
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Table of Contents
1. Xbrane Biopharma Overview
2. The Biosimilar Market
3. The VGEF Market & The Unmet Medical Need
4. Lead Product Xlucane
5. Summary & Investment Highlights
Presenters
Martin ÅmarkCEO
Anders Tullgren
Chairman of the Board
13
Biosimilars: Follow-On Biologics Launched When Originator Product Patent Expires
Source: 1FDA; CancerNet Dictionary
Based on living cells, with complex molecular structures requiring high-level development and production yet have the advantages of fewer side effects and enhanced efficacy
Based on chemical substances, made by combining specific chemical ingredients in an ordered process, creating a well-
defined chemical structure. Can usually be analyzed to determine all its various components
GENERICS
• Identical copy of originator active ingredient
• Bioequivalence demonstrated clinically
PHARMACEUTICALS
SMALL MOLECULES BIOLOGICS
BIOSIMILARS
• Highly similar molecule as originator
• Analytical similarity demonstrated with +20 methods
• Equivalent efficacy and safety demonstrated clinically (Phase I and Phase III)
Living cellChemicalsubstance
14Note: Exchange rate EUR/USD = 1.2003 as of December 31 2017. Source: 1) Tufts Center for the Study of Drug Development (CSDD); 2) Informa Pharma’s Biomedtracker database, based on 108 tracked biosimilardevelopment programs and over 10,000 novel product development programs; 3) IQVIA - The impact of biosimilar competition in Europe.
Biosimilars: High Probability of Success with Large Sales & Margin Potential
Development Costs1: €3-4 M €50-100 M + €1 B
Development time: 2-3 years 6-7 years +10 years
Probability of success2: +90%78% (entering phase I)
95% (entering phase III)10% (entering phase I)
50% (entering phase III)
Barriers of entry: LowHigh Technological / scientific know-
howVery high patent protection and
technological / scientific know-how
Price reduction vs. originator3:
90% 20-40% N/A
Way to differentiate: Price
• Price• Low cost position via proprietary
technology• Sales and marketing/ brand
• Clinical/regulatory approach• Sales and marketing/brand• Price
Generics Biosimilars Novel Drugs
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11 of Global Top 15 Drugs Are Biologics
Source: IGEA
Position ProductAnnual Sales 2017
(€ Billion)Category
1 Humira® €16,2 Biologic
2 Revlimid® €7,2 Small Molecule
3 Rituxan® €7,1 Biologic
4 Enbrel® €7,0 Biologic
5 Herceptin® €6,6 Biologic
6 Eliquis® €6,5 Small Molecule
7 Avastin® €6,3 Biologic
8 Remicade® €6,3 Biologic
9 Xarelto® €5,8 Small Molecule
10 Eylea® €5,5 Biologic
11 Januvia® €5,2 Small Molecule
12 Lantus® €5,0 Biologic
13 Prevnar® €4,9 Biologic
14 Opdivo® €4,4 Biologic
15 Neulasta® €4,0 Biologic
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US & EU Biosimilar Market Expected To Grow from €2.6 B to €11.8 B in 2025
Loss of Exclusivity of Originators
+€ 100B additional originator sales to be exposed 2022
Regulatory Clarity
44 biosimilars approved in Europe, 19 in US
Payor, Physician and Patient Adoption
Biosimilar penetration on filgrastim up to 90% in Europe
Source: BCC research. IQVIA; Morgan Stanley
Growth drivers
0,91,7 2,3
3,14,0
6,16,9
7,7
1,7
3,0
3,6
3,7
4,2
4,34,2
4,2
2,6
4,7
5,9
6,9
8,2
10,411,1
11,8
-1,0
1,0
3,0
5,0
7,0
9,0
11,0
13,0
15,0
2018 2019 2020 2021 2022 2023 2024 2025
Biosimilar Market (€ Billion)
US EU
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By Year Three Biosimilars Reached 50-75% Market Share – Faster Uptake In Recent Launches
0%
25%
50%
75%
100%
0 1 2 3 4 5 6 7 8 9
Years After Launch
EPO
GCSF
HGH
Infliximab
Etanercept
Rituximab
Traztuzumab
Adalimumab
Average Biosimilar Volume Market Share vs. Originator In Europe
91%
8 years
51%
3 years
67%
9 years
41%
8 years
60%
1 years
35%
4 months 40%
2 years10%
2 months
Laun
chseq
uen
ce
Source: IQVIA, - The impact of biosimilar competition in Europe, Morgaon Stanley – Biosimilars infancy to Youth
0%
25%
50%
75%
100%
0 1 2 3
Years After Launch
GCSF
InsulinGlargine
Average Biosimilar Volume Market Share Vs. Originator In US
75%
3 years
26%
1,5 years
6%
1 year
Agressiveportfolio rebatedefense by J&J
Laun
chseq
uen
ce
18
Europe Average Molecule Prices 2018 vs. Pre-biosimilar Prices (%)
-50%
-40%
-30%
-20%
-10%
0%
GCSF (2008) EPO (2007) HGH (2006) Anti-TNF (2013)
# biosimilars: 5 3 1 3
-50%
-40%
-30%
-20%
-10%
0%
Infliximab Peg-GCSF Insulin Glargine GCSF
US Biosimilar WAC Discount (%)
Biosimilars On Average Priced 20-40% Below Originator in Both EU & US
2 2 1 1
Source: IQVIA, - The impact of biosimilar competition in Europe, Morgan Stanley – Biosimilars infancy to Youth
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Biosimilars Generated Annual Sales Of €300-600 Million
0
100
200
300
400
500
600
700
Basalgar Inflectra Benepali Truxima Remsima
Annual Sales 2018 Select Biosimilars (€ M)
Europe US
Launch: US 2017EU 2016
US 2016EU 2015
2016 2017 2015
Truxima And Remsima DevelopedBy Celltrion - Generating 65% OfRevenue From Biosimilars With55% Operating Margin In 2018
Source: IQVIA, - The impact of biosimilar competition in Europe, Morgan Stanley – Biosimilars infancy to Youth
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Table of Contents
1. Xbrane Biopharma Overview
2. The Biosimilar Market
3. The VGEF Market & The Unmet Medical Need
4. Lead Product Xlucane
5. Summary & Investment Highlights
Presenters
Martin ÅmarkCEO
Anders Tullgren
Chairman of the Board
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VEGFa Inhibitors Used To Treat Age Related Macular Degeneration
Wet age-related macular degeneration (“wAMD”) and swelling in the retina caused by diabetes (“DME”) or by a blockage in the blood vessels leading to severe deterioration of vision if untreated
Binds to the growth factor VEGFa and thereby inhibits growth of abnormal blood vessels causing the deteriorating vision amongst patients
Disease VEGFa Inhibitor Mode of action
Normal vision Affected vision
Growth ofabnormal
blood vessels
Intravitrealinjection of
VEGFa inhibitor
2222Source: 1) HARBOR, ANCHOR, MARINA, PrONTO trials; 2) VIEW1 and VIEW2 trials; On average treatment initiated at 60 letters baseline, normal vision at about 90 letters 3) CATT trial, Pharmacies; Assuming price discount of 30-40% vs. reference product; Based on real world data from Swedish Macular Registry. Exchange rate EUR/SEK=10.4638 as of June 30 2018.
Avastin®Lucentis®
Lucentis® & Eylea® Only Approved VEGFa Inhibitors For Ophtalmic Use
Treatment
Efficacy(vision improvement after
12 months)
Safety
Average
Cost(Per patient
per year)
US
EU
• 7 – 11 letters (on average 1/3 of vision recovered)1
• Generally well tolerated 1
• Designed to treat macular degenerations
• 7 – 11 letters 1• Non-inferiority to Lucentis
demonstrated 2
• Similar safety profile as Lucentis demonstrated2
• Anti-body used to treat different
types of cancers (off-label)
• Non-inferiority to Lucentis demonstrated 3
• Various safety issues
EUR 9 600
EUR 4 200
EUR 9 760
EUR 4 453
EUR 900
EUR 1 020
Off-label
usage
• Designed to treat macular degenerations
Eylea®
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VEGFa Inhibitor Market Worth €9.4 B Growing With 11% P.A.
3,0 3,1 3,5
4,65,1
5,9
7,68,2
9,4
0
1
2
3
4
5
6
7
8
9
10
2016 2017 2018
Market For VEGFa Inhibitors For Ophthalmic Use (€ Billion)
Annual Growth Rate
13%
8%
11% Market Characteristics
• Double Digit Growth
• Expensive Treatments
• Restrictions In Reimbursement Even In Europe
And US
• Large Untreated Population – Only 1,5 Million
Out Of 18 Treated
• Off-label Usage Of Avastin®
• Stabilized Lucentis® Market Share As Usade At
Same Frequency As Eylea® In Clinic
Source: IQVIA,, Year-end-reports
24Source: Analysis based on prevalence of diseases, sales data from IQVIA on Lucentis and Eylea assuming 6 doses per patient per year and survey data on usage of Avastin
0,8
0,5
0,7
Prevalence Treated
Eylea Lucentis Avastin
Number of Eyes Europe and US (million)
5,2
2
Prevalence Treated
Eylea Lucentis Avastin
12,9
0,5-0,7
+18 Million Eyes Affected Globally – Only 1.5 Million Treated With Approved Biologics
Number of Eyes Rest of World (million)
25
Table of Contents
1. Xbrane Biopharma Overview
2. The Biosimilar Market
3. The VGEF Market & The Unmet Medical Need
4. Lead Product Xlucane
5. Summary & Investment Highlights
Presenters
Martin ÅmarkCEO
Anders TullgrenChairman of the
Board
26
Leading Biosimilar Xlucane (Lucentis® Biosimilar) In Phase III With STADA As Commercial Partner
Ongoing Phase III Study - Launch Expected Q1 2022 As The EU Patent Expires
Historic Probability Of Success 95% For Biosimilars Entering Phase III
Targeting Ophthalmic VEGFa Inhibitor Market Of €9.4 B
STADA As Commercialization Partner – Profit Sharing 50/50
Annual Sales Target Of € 350 M Out Of Which € 100 M In Licensing Income For Xbrane
*As of 2019-04-18
27• Source: Company information.
+/- 3 Standard Deviations of
Originator ProductCommercial Scale Xlucane
BatchesXlucane Batches within +/-3 Standard Deviations of Originator
Batches (Standard Biosimilarity Criteria) ✓
LC-MS
Amino Acid
Sequene
Molecular Mass
Identical
Identical✓
✓
Type Result
Reporter gene assay - VEGF
✓ ✓ ✓ ✓
165 110 189 121Version
Biacore
✓ ✓ ✓ ✓
165 110 189 121Version
HPLC
Version
✓ ✓ ✓ ✓
cIEF SEC RP IEX
✓ ✓ ✓ ✓
Far UV FTIE Near UV DSC
BindingThe Ability of the Protein to Bind to
the Specific Target
PotencyThe Actual Biological Effect on
Human Cells When the Protein
Binds to the Specific Target
Higher Order
StructureThe Way the Amino acid
Sequence Has Folded
PurityThe Percentage of the Actual
Specific Protein Relative to
Potential Impurities
Primary StructureThe Sequence Of Amino Acids
Analytical Similarity of Xlucane Compared To Lucentis® Demonstrated
28
• Two Groups with 8 Rabbits (16 Eyes) In Each Group Recieving Intravitral Injection of Xlucane and Lucentis Respectively
• Serum Concentration of Ranibizumab Analyzed at Hour 4, 8 And 48
• Eye Inflammations Observed Throughout the Duration of The Study
Tolerability1 Pharmacokinetic Profile
Candidate Minimal Mild Moderate Total
Xlucane 1/4 0/4 0/4 1/4
Lucentis 1/4 1/4 1/4 3/4
1
10
100
0 8 16 24 32 40 48
Mea
n (
ng
/mL)
Time (hr)
1 mg/total Lucentis 1 mg/total Xlucane
Study Design
Note: 1) Measured via microscopic evaluation on ocular tissues from animals euthanized on Day 28. Eye inflammation defined as mononuclear cell infiltration in the vitreous body, ciliary body, anterior chamber, optic disc, conjunctiva, retina and/or choroid. Source: A Pharmacokinetics Study of Two Formulations of Ranibizumab following a Single Bilateral Intravitreal Injection in the New Zealand White Rabbit (Study No. 5701026), performed by Charles River Montreal under GLP conditions with Xbrane Biopharma as sponsor.
Equivalent Tolerability and PK Profile of Xlucane Compared To Lucentis® Demonstrated In-Vivo
29
StartRecruitment 9 months Treatment 12 months
Xlucane290 patients
Lucentis®
290 patients
Primary end-point
Change in Visual acuity
(“BCVA”) after 8 weeks
Secondary end-points
after 12 months e.g.
Immunogenicity, BCVA,
Retina thickness
• Multi-regional clinical trial with 150 sites across 16 countries (including EU, US, India)
• Enable Marketing Authorization across key markets globally
• Partnership with highly qualified global CRO
• Clinical trial approval across most countries
• First patient in April 2019 in US
o
Global phase III trial ongoing – all patients to be recruited during 2019
30
EUR 350m
Sales target Total
Xlucane sales target of €350m with significant further upside
Gross margins expected at +90%, profits shared 50/50 with STADA
Taking 25% share ofLucentis in EU/US at price discount of up
to 50%
Taking market share from Eylea
Market expansion through more
patients and doses per patient in
Europe and US
Target untreated patients in rest of
world
Xlucane Sales Target of €350 M Three Years After Launch – With SignificantFurther Upside
31
Xlucane sales
target:
Patients: 120,000*
Doses: 700,000
Sales: € 350 million*
90
55
14
Lucentis
Eylea
Xlucane target*410
190
48
75
90
23
20
25
6
10
25
6
55
50
13
Estimated number of
patients 2018
(thousands)
Xlucane €350 M Sales Target Reached With 120K Patients And 700K Doses
*Target reaching 25% volume market share of current Lucentis® market in each country at 50% price discount to originator
90
45
11
Rest of
Europe
32
European Supply-chain With Capacity For Xlucane Sales Target & Further Upside
• Drug substance manufacturer
• Manufacturing Authorization License issued
by EU EMA (expecting for FDA)
• cGMP compliant analytical development and
testing
• LOI for Xlucane supply capacity signed
• Drug product manufacturer
• Manufacturing Authorization License issued by
Swiss authorities (mutual recognition by EU).
• LOI for Xlucane supply capacity signed
33
Table of Contents
1. Xbrane Biopharma Overview
2. The Biosimilar Market
3. The VGEF Market & The Unmet Medical Need
4. Lead Product Xlucane
5. Summary & Investment Highlights
Presenters
Martin ÅmarkCEO
Anders Tullgren
Chairman of the Board
34
Significant Value Drivers Ahead
Development Timeline
100% Recruited
Phase III/Xplore
Top Line Clinical Data
Approval
Phase III/Xplore
Sales Launch
(Patent Loss)
20222020 2021H1 H22019
First Patient Recruited
Phase III/Xplore
Pre-clinical portfolio:
Xcimzane (Cimzia®)
Xdivane (Opdivo®)
Xoncane (Oncaspar®)
Spherotide (Decapeptyl®)
Partnerships and advancement of development on pre-clinical products
XlucaneOther
Candidates
Pre-Marketing
2023
25/50/75% RecruitedPhase III/Xplore
MAA/BLA Submission
35
Xbrane - Biosimilar Developer With Patented High Yield Technology
Lead Product Xlucane In Phase III With Commercial Partner STADA. Annual Sales Target Of €350 M Out Of Which €100 M In Income For Xbrane
Addressing Attractive Biosimilar Market Opportunity. The Fastest Growing Segment Within Pharma Combined With Low Technical Risk
Patented Innovative High-yield Technology Platform Resulting In Low Production Costs
Strong Product Pipeline Targeting +€ 11 B In Originator Sales. Only Public Biosimilar Developments To Opdivo® And Cimzia®
Listed At Nasdaq First North With €35 M* Market Cap – Up-listing To Main Market During 2019
*As of 2019-04-18
36
Xbrane Biopharma
Banvaktsvägen 22
17148 Solna, Sweden
Thank You
37
No Late Stage Product With Superior Efficacy Nor Safety To Lucentis Or Eylea. Preclinical Pipeline Dry.
Wet-AMD Development Pipeline and Marketed Assets
Marketed
Phase I/II
Legend
Injection Ophthalmic/Drops
Mechanisms/Targets
Route of Administration
SF0166 - SciFluor
Complement factor C3
inhibitor
*Used off-label
Phase III
Lucentis (ranibizumab) -
Novartis
Eylea (aflibercept) -
Regeneron/Bayer/Sanofi
Brolucizumab - Novartis
KH 902 (Conbercept) - Chengdu
Kanghong,
Marketed in China only
Avastin* (bevacizumab) -
Genentech
VEGF-A
Abicipar (Abicipar pegol) -
Allergan/Molecular Partners AG
ranibizumab (Lucentis) biosimilar
- Formycon/Bioeq
VEGFR-2 inhibitor
PAN 90806 - PanOptica
OPT-302 – Opthea
Faricimab – Roche
Zimura (avacincaptad pegol) –
Ophthotech Corporation
Complement factor C5 inhibitor
DE-122 (carotuximab) – Tracon
Pharmaceuticals/Santen
Anti-endoglin MAbChemokine CCL11
inhibitors
PO/Tablet
ALK 4290 – Alkahest
Phase II
ICON-1 - Iconic Therapeutics
Anti-tissue factor MAb factor VII
conjugate
ranibizumab (Lucentis) biosimilar
- Samsung Bioepis Co., Ltd.
Integrin alpha 5 beta 3 inhibitor
Topical Solution
Biosimilar
APL-2 - Apellis
VEGF-C/VEGF-D
GB-102 (sunitinib) - Greybug
Vision
Molecule receptor
tyrosine kinase inhibitor
aflibercept (Eylea) biosimilar –
Mylan/Momenta
Pharmaceuticals
Implant
ranibizumab PDS– Genentech
XLUCANE ranibizumab
(Lucentis) biosimilar – Xbrane
Conbercept – Chengdu KH
Source: Xbrane research
38
Phase III
MAA/BLA
Europe: 44 approvals
US: 19 approvals
Launch
100% (Europe) and
70% (US) launched
upon patent
expiration/readiness
3%EU:1.7% US:3%
Historic Overall Success Rate of Approx. 95% For Biosimilars Entering Phase III
Source: Xbrane research, Informa Biomedtracker
39
Source: Curtis LH, et al. Arch Ophthalmol 2010;128:1273-9, Adjusted outcomes at 1 year for the comparison of ranibizumab (n = 19,026) and bevacizumab (n = 21,815) as first-line therapy
Avastin® Is Attached With Serious Safety Risks
28% significant increased risk with Avastin
16% significant increased risk with Avastin
0.6 0.7 0.8 0.9 1.0 1.1 1.2 1.3
Stroke
Bleeding
Death
More events with LucentisMore events with Avastin
0.78 (0.64-0.96)
1.03 (0.92-1.16)
0.83 (0.64-1.08)
0.86 (0.75-0.98)
Myocardial infarction
40
-1
0
1
2
3
4
5
6
7
8
9
10
11
12
3 4 5 6 7 8 9 10 11 12
Vis
ual
imp
rove
men
t af
ter
12
mo
nth
s (l
ette
rs)
Number of Lucentis® injections in 1st year
Strong Rationale For Market Expansion In Terms Of Doses Per Patient - Currently Sub-Optimal Effect Due To Expensive Treatments
x
Real World Data EU2
Clinical Trials1
Source: 1) HARBOR; ANCHOR; MARINA; PrONTO; VIEW1; VIEW2; CATT; IVAN trials; 2) LUMINOUS trials
41
Source: IQVIA Midas
1,24 1,29 1,59
1,14 1,16
1,25
0,62 0,60
0,64
0
1
2
3
4
2016 2017 2018
US Europe Others
Lucentis® (Ranibizumab) Global Sales (€ Billion)
0,3 0,3 0,4
0,3 0,3 0,3
0,2 0,20,2
0,1 0,10,10,1 0,10,10,2 0,2
0,2
0,0
0,5
1,0
1,5
2,0
2016 2017 2018
France Germany UK Spain Italy Others
Lucentis® (Ranibizumab) Europe Sales (€ Billion)
8% P.A.
5% P.A.
Lucentis (Ranibizumab) Generates Sales of €3.5 B Growing At 8% P.A.
