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Science for High quality BiosimilarsApril 2020
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IMPORTANT INFORMATIONYou must read the following before continuing. The following applies to this document and the information provided in this presentation by Xbrane Biopharma AB (publ) (the “Company”) or any person on behalf of the Company and any other material distributed or statements made in connection with such presentation (the “Information”), and you are therefore advised to carefully read the statements below before reading, accessing or making any other use of the Information. In accessing the Information, you agree to be bound by the following terms and conditions.
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XBRANE BIOPHARMA – THE ONLY NORDIC BIOSIMILAR DEVELOPER
Low-risk high potential lead
phase III biosimilar
• Xlucane (Lucentis® biosimilar) is a low-risk product partnered in 50/50 profit share deal with STADA addressing a €10.4b market expected to generate +€100m in annual income to Xbrane three years after its launch mid-2022
• Xlucane will deliver near term triggers: • 2020: Licence deals together with STADA (particularly North America)• Q3 2020: Phase III fully recruited• Q1 2021: Phase III top-line data • Q2 2021: MAA/BLA filing • Mid-2022: MAA/BLA approval and launch
• Pipeline biosimilar candidates addressing €8.7b of originator sales based on flexible, patented high-yield platform technology
Near term triggers
Strong pipeline biosimilar candidates
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BIOSIMILARS ARE SIMILAR BUT NOT IDENTICAL TO ORIGINATOR BIOLOGICS
Biological originator drug:
• Gene introduced to cell instructing it to produce a protein
• Separation of the protein as active substance in drug
Biosimilar: • Gene instructing cell to produce identical protein as originator product
• Can be demonstrated as highly similar but not identical to originator product
Gene Living cell Protein
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Xlucane used in treatment of severe eye diseases Xlucane binds to growth factor VEGFa
Binds to growth factor VEGFa and thereby inhibits growth of abnormal blood vessels causing the
deteriorating vision
Growth ofabnormal
blood vessels
Intravitrealinjection of
VEGFainhibitor
Normal visionAffected vision
Leads to deterioration of vision and in worst case blindness
Wet age-related macular degeneration (“wAMD”) and Diabetes related macular edema (“DME”)
XLUCANE IS A BIOSIMILAR TO LUCENTIS® BINDING TO GROWTH FACTOR VEGFaAND THEREBY RESTORES VISION
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1
10
100
0 8 16 24 32 40 48
Mea
n (n
g/m
L)
Time (hr)1 mg/total Lucentis1 mg/total Xlucane
Xlucane demonstrates similar PK pattern in vivo
70%
80%
90%
100%
110%
120%
130%
+/- 3 Standard Deviations of Lucentis®
Commercial Scale Xlucane Batches
Bioactivity VEGFa (Reporter Gene Assay)
Xlucane binds equivalently to VEGFa as Lucentis®
”The preliminary physicochemical and biological similarity assessment, confirms a high degree of biosimilarity. All defined acceptance criteria are met.” – EMA tailored scientific advice
February 2020
Source: Xbrane pre-clinical package
VEGFa 165 VEGFa 110 VEGFa 189 VEGFa 121
XLUCANE BINDS EQUIVALENTLY TO VEGFa AS LUCENTIS®
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XPLORE IS A PIVOTAL PHASE III WITH OBJECTIVE TO DEMONSTRATE EQUIVALENCE OF XLUCANE VS. LUCENTIS®
Equivalence margin agreed with EMA and FDA
MARINA clinical trial (Lucentis® vs. placebo)
PlaceboLucentis® 0.5 mgLucentis® 0.3 mg
Xlucane290 patients
Objective to demonstrate equivalence vs. Lucentis®Xplore is a pivotal phase III equivalence trial
Lucentis®290 patients
Weeek 8Primary end-point
Weeek 52End of treatment
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14%
3%
20%
0
100
200
300
400
500
600
Recruited patients Active clinics
10%
3%42%
Eastern Europe
8%
APRIL 2019 MARCH 2020
AS PER END OF MARCH APPROXIMATELY 355 OF 580 PATIENTS RECRUITED 1.5K INJECTIONS PERFORMED WITH NO SAFETY NOR EFFICACY ABNORMALITY IN BLINDED ASSESSMENTS
% of recruitedpatients
LPI Q2
COVID-19 impact
Pre- COVID
-19
LPI Q3
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Xlucane Pivotal Phase III Trial
Study close down
First patient inApril 2019
Last patient in (LPI)
MAA/BLA
Submission(based on 6 month
data)
Approval
2019 2020 2021
LoE EUJuly 2022
2022
Top-line data
XLUCANE LAUNCH EXPECTED AT LUCENTIS® LOSS OF EXCLUSIVITY MID 2022 –MULTIPLE TRIGGERS EXPECTED BEFORE
Xlucane launchJuly 2022
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XLUCANE ADRESSES A €10.4 B MARKET GROWING AT 10% PER YEAR
VEGFa Inhibitors Ophthalmic Use (€ B)
Source: Novartis, Regeneron and Roche financials
3,0 3,1 3,5 3,6
0,035
4,6 5,15,9
6,8
7,68,2
9,4
10,4
0,0
2,0
4,0
6,0
8,0
10,0
12,0
2016 2017 2018 2019
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5.2
1,1
0.6
0.8
0
1
2
3
4
5
6
Affected TreatedEylea® Lucentis® Avastin®
Number of affected Eyes Europe and US (M)
HUGE GLOBAL UNMET MEDICAL NEED FOR XLUCANE
2.5
12.9
0.10.10.6 0
2
4
6
8
10
12
14
Affected TreatedEylea® Lucentis® Avastin®
Number of affected Eyes Rest of World (M)
approx. 0.5 - 1.0
On-label
On-label
Off-label
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COMMERCIAL PARTNER: STADA – BIOSIMILAR LEADER
STADA – a biosimilar leader Strong partnership
201820172016
€
• Biosimilars key value creation driver for PE ownersBain Capital and Cinven
• Portfolio of 14 Biosimilars – 4 on the market• Dedicated Biosimilar Team of 200+ Professionals• EPO (Silapo®/Erypo®) Biosimilar Developed
In-House, Annual EU Sales of €200m
Xlucane co-development deal – 50/50 development and profit split
€4m equity investment in 2019
Ongoing evaluation of collaboration around Xcimzane and Xdivane (ROFR for Europe granted)
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Sales target Total
Xlucane annual net-sales target of €350m three years after launch with significant further upsideExpected annual income of €100m after cost deduction and profit sharing for Xbrane
€350m
Annualnet-sales
target
Potential upside
Annualnet-sales
target
Market expansion through more patients and doses per patient
in Europe and US
Taking market share from
Eylea
Target untreated
patients in rest of world
Taking 25% share ofLucentis in EU/US at
price discount ofup to 50%
XLUCANE EXPECTED TO GENERATE ANNUAL NET-SALES OF €350 M THREE YEARS AFTER LAUNCH OUT OF WHICH €100M INCOME FOR XBRANE
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0%
25%
50%
75%
100%
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Rituximab (EU)
Infliximab (EU)
Etanercept (EU)
Peg-filgrastim(US)
Trastuzumab(EU)
Year 1 Year 2Time after launch
BIOSIMILARS WITH +€400M IN ANNUAL SALES TWO YEARS AFTER LAUNCH
40%2 years
42%2 years
60%2 years
40%2 years25%
1.5 years
Leading biosimilar Annual sales
€400m (Y2)
€440m (Y2)
€410m (Y3)
€317m (Y1)
Average Biosimilar Volume Market Share vs. Originator
Source: IQVIA, - The impact of biosimilar competition in Europe, Morgan Stanley – Biosimilars infancy to Youth
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LIMITED COMPETITION – ONLY TWO COMPETING BIOSIMILARS
Developer Partner Deal for developer
€7.5m up-front50/50 development cost and profit split
Global excluding China
Single digit €m up-frontMilestones of +€100m
No royaltiesGlobal
USD 310 m license fee Un-disclosed royalty
Europe and USAlso including Eylea biosoimilar
Overview of phase III Lucentis Biosimilar Developers
1) Data as per 2020-[-] (capitaliq.com)
*Global developmentpartner
*US Commercial partner
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ADDITIONAL LICENSE DEALS WITH XLUCANE EXPECTED DURING 2020
€3.3b
€6.2b Ongoing out-licensing to US**
€0.1b Ongoing establishment of distribution partners**
€0.1b Ongoing out-licensing (Xbrane)
€0.7b Discussion with regulatory authority
* Combined annual sales for Eylea and Lucentis** Together with STADA
Market 2019*
Xlucane only remaining
available Lucentis biosimilar in
North America
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OUR PORTFOLIO: TARGET APPROXIMATELY € 12 BILLION IN ORIGINATOR SALES
Commercialization Partner
Candidate / Product
Originator Product Indication Development
PhasePlanned Launch
Xlucane
Xcimzane
Lucentis®(Roche)
Cimzia®(UCB)
Age related macular degeneration, Diabetic
macular edema, Diabetic related retinopathy
Rhematoid arthrisis, psoriatic arthrisis,
ankylosing spondylotis, psoriasis and Crohn’s
disease
At patent expiry
Primary Patent Expiry
2020 / 2022
(US) / (EU)
2025/2024 (EU/USA)
Global Annual Sales
€3.6b
€1.7b At patent expiry
Ongoing Phase III
Pre-clinical
Xoncane Oncaspar®(Servier)
Acute Lymphotic (ALL) Expired €0.2b Pre-clinical
Decapeptyl®(Debiopharm
/ Ipsen / Ferring)
Prostate cancer, Breast cancer, Endometriosis and
MyomaExpired €0.4b Pre-clinical
Total €12.3b
Opdivo®(BMS)
Lung, liver, head & neck, kidney, colorectal cancer
and melanoma2026-2030 €6.4b
At patent expiryPre-clinicalXdivane
Spherotide
Ongoing evaluation by
STADA
Ongoing evaluation by
STADA
Term-sheet with STADA
Pre-clinical trial
Phase completed
Ongoing phase III
Remaining
Source: Year end reports, IQVIA
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EXPERIENCED AND DEDICATED TEAM
Management Board of Directors
Martin ÅmarkCEO
Siavash BashiriCOO
Susanna HelgesenCFO
David VikströmCTO
Anders Tullgren Chairman of the Board
Eva NilsagårdDirector of the Board
Karin WingstrandDirector of the Board
Dina JurmanHead of Clinical
Affairs
Maria EdebrinkHead of Regulatory
Affairs
Anders WallströmHead of
Manufacturing & Supply Chain
Peter EdmanDirector of the Board
Giorgio ChiriviDirector of the Board
Ivan Cohen-TanugiDirector of the Board
Xiaoli HuHead of Business
Development
Maris HartmanisDirector of the Board
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Science for High quality Biosimilars