May 2016
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These slides (the "Document") have been prepared and issued on behalf of Abzena plc (the "Company") and its subsidiaries for information purposes only. By attending thispresentation and/or accepting a copy of this Document, you agree to be bound by the following conditions and will be taken to have represented, warranted and undertaken that youhave agreed to the following conditions.
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Important notice
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• Operating in large biopharmaceutical R&D market with outsourcing increasing
• Licensor of proprietary technologies that provides complementary services
• Current service revenue from range of preclinical and manufacturing services
• Significant future potential income from “ABZENA inside” licence portfolio
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Provider of services and technologies to enable the development and commercialisation of better biopharmaceutical products
1Biopharmaceuticals are protein based drugs and include antibodies, antibody-drug conjugates, therapeutic proteins and peptides.ABZENA inside products are biopharmaceutical products that incorporate one or more of Abzena’s proprietary technologies.
“ABZENA inside” licence portfolio• Partner funded products incorporating Abzena technology in development • 11 products in clinical development for wide range of diseases (Phases I-III)• 3 product companies purchased for US$1.5bn – US$500m upfront in cash• Recent licensing deal for antibody drug conjugate linker technology
(up to $150m milestone payments plus royalties on sales)
Growth opportunities• Broader service offering = multiple revenue streams• Increasing service revenue from manufacturing opportunities• Cross-selling and expansion opportunities• “ABZENA inside” technology licensing delivers milestones & royalties
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Broad range of innovative technologies & services to enable the creation, selection and manufacture of better biopharmaceuticals
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Contract process development and GMP manufacture of antibodies and other proteinsSan Diego, USA
Chemistry services including manufacture of ADCs and GMP manufacture of reagents Philadelphia, USA
Bioconjugation to link drugs to antibodies to create antibody drug conjugates (ADC)Cambridge and Coventry, UK
Immunology services, protein engineering and development of manufacturing cell linesCambridge, UK
Good Manufacturing Practice (GMP) is the standard that must be applied to manufacture drugs to test in peopleAntibody drug conjugates (ADC) are antibodies with toxic drugs attached which target tumours to kill them
Antibody discovery services provided under a strategic marketing alliancePorto, Portugal
~180 employees across the UK & USA
Integrated service and technology offering across sites in UK and USA
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Image of new HQ & labs, Cambridge, UK
ADC = antibody drug conjugates; GMP = Good Manufacturing Practice
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Cambridge, UK &Coventry, UK
San Diego, CA, USA
Bristol, PA USA
Immunology assessmentBioconjugation Cell line
developmentProtein
engineeringGMP protein manufacture
ADC manufactureChemistry
San Diego, CA, USA Bristol, PA, USA
Abzena operates in the large growing biopharmaceuticals market
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• Global revenue for biopharmaceuticals ~$163bn - CAGR 8%
• Biopharmaceutical products make up 7 out of the world’s top
10 drugs (by revenue)
• Outsourced early development and contract manufacturing
services market > $5bn and growing
• Innovation thriving as disease mechanisms are better
understood, eg immuno-oncology products harness the
patient’s immune system to attack the tumour
Examples of some currentlyavailable biopharmaceutical drugs
Proportion of revenue attributed to biopharmaceuticals
3%
13%
17%
21%
23%
23%
23%
29%
34%
52%
53%
79%
Astra ZenecaNovartis
GSKMerck & Co
BMSBayer
Eli LillyPfizer
J&JAbbVie
Sanofi-AventisRoche
Leadership with extensive sector and governance experience
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Ken Cunningham ChairmanAbzena plc
John Burt Chief Executive Officer
Julian Smith Chief Financial Officer
Tony BramptonPartnerLongbow Capital
Nigel PitchfordChief Investment Officer Imperial Innovations
Peter GrantChief Executive OfficerSkyePharma plc
Anker LundemoseChief Executive OfficerMISSION Therapeutics
Matthew BakerChief Scientific Officer
Donna HackettVP IP, Commercial & Legal Affairs
Non-executive directors
Executive management
Sally WatermanSVP Corporate Development
Gary PiercePresident, PacificGMP
Leigh PierceChief Technology Officer (Biomanufacturing)
Executive directors
Naresh JainSVP (ADC Biomanufacturing) & Global Head of Chemistry
Jim MillsVP Technical Operations
Campbell BunceSVP Scientific Operations
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• Admitted to AIM in July 2014 and secondary placing in December 2015• Funds being used to achieve step changes in growth trajectory through:
• R&D - investment in innovating, improving & broadening services and technologies• M&A - two acquisitions in H2’15 to add manufacturing capability to build the offering• Expansion - additional GMP capability and increased capacity to meet demand
Strong support for business strategy from leading investors
Services & technologies provided across the drug development process
Lead discovery
Clinical studiesPhase I, II and III
Regulatory approval
Treating patientsNon-clinical development
ABZENA inside
Research servicesOptimisation & selection of better candidatesRevenue generating• Antibody discovery• Immunology• Protein engineering• Bioconjugation for ADCs• Chemistry
Development & manufacturing servicesEnabling progression into clinical studiesRevenue generating - growth facilitated by capex and cross selling • Cell line development• Process development• GMP manufacture of antibodies and proteins• GMP manufacture of ADCs
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Technology licence
Technology licence
To establish
Lead selection Lead optimization Manufacture
(non-GMP)GMP manufacture for Phase III & the market
Antibody discovery
Manufacture for Phase I & II (GMP)
Complementary services and technologies
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All lines provide service revenue
Huge potential licence income11 products in clinical trials1 in phase III trials
ABZENA inside
Assessing the immunogenicity of biopharmaceuticals and vaccines
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Abzena has• Robust methods to identify response• Ability to reduce unwanted response
by re-engineering the protein
Vaccine
Antibody response
Protective immune response
Therapeutic protein (drug)
Anti-drug antibodies neutralise drug• Drug no longer as effective • Potentially serious adverse reaction
EpiScreen™ immunogenicity assessment correlates with published data for unwanted responses in patients
Mean frequency of anti-drug antibodies observed clinically (source PubMed) correlates with observed immunogenicity (% donor response) in ex vivo
EpiScreen™ T cell assays
Baker and Jones et al. 2008 Curr. Opin. Drug Disc. Dev.Barker. Current Drug Safety. 2010; 5(4): 272-274
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Composite Human Antibodies™ Antibody engineering to specifically reduce drug immunogenicity
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Immunogenic sequences
Mouse antibody Chimeric antibodyMouse/Human
Human/Humanised
Human sequencesComposite Human Antibodies™
• Proprietary patented technology
• Designed to • Reduce unwanted
immunogenicity• Retain biological
function
• Technology licence forABZENA inside product
Contract biopharmaceutical manufacturing for Phase I & II studies –pioneers of single-use technology
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Single use technology throughout the process – very cost effective • Disposable Wave bags• Faster process development• Less time between batches• Fewer system requirements• Flexible batch sizes
Best in class: ThioBridge™ ADCs provide superior targeted chemotherapy
January 2016 licence for ThioBridge™ announced Potential to generate up to $150 million license fees and milestone payments plus royalties on product sales
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ThioBridge™ version of Adcetris (marketed ADC) was more efficacious in an animal model of cancer
Antibody drug conjugate (ADC)AntibodyCytotoxic
drug
ThioBridge™ linker• Proprietary technology • More homogeneous ADCs
• Easier to manufacture• More predictable effect
• More stable ADCs – better efficacy
tumour cell
0 10 20 30 40 50 600
1000
2000
3000
Days post treatment
Tum
ourv
olum
e (m
m3 )
VehicleThioBridgeTM ADC (0.4 mg q4dx4)Adcetris (0.4 mg q4dx4)
vehicle (control)ThioBridgeAdcetris
Improvem
ent
ADCs bind and enter the tumour cell where they release the drug to kill the cell
Linker
NASH = Non-alcoholic steatohepatitis; PSC = primary sclerosing cholangitis
CompanyProduct candidate Potential indications Phase I Phase II Phase III
Gilead SciencesGS-5745
Gastric cancer, ulcerative colitis, Crohn’s disease, rheumatoid arthritis, COPD, cystic fibrosis
Gilead SciencesSimtuzumab
NASH & PSC
Opsona TherapeuticsOPN-305
Delayed graft function,myelodysplastic syndrome
Vascular PharmaceuticalsVPI-2690B
Diabetic nephropathy
Roche (Adheron)SDP051
Rheumatoid arthritis, fibrotic conditions, cancer
NKT TherapeuticsNKTT120
Sickle cell disease
Therapure InnovationsTBI 304H
Chemotherapy-induced anaemia
Major US biopharma company Neurodegenerative conditions
US biotech company Immune system and inflammatory conditions
Major US biopharma company Neurodegenerative condition
US biotech company Cancer
Significant future potential income from products in clinical development
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Three ABZENA inside product companies purchased by major biopharma companies for a total of US$1.5bn & product development ongoing
Named products have potential peak sales in excess of US$10bn p.a. (Edison)
Total portfolio exceeds 40 agreements
COPD = chronic pulmonary disease
Financial highlights for the half-year to 30 Sept 2015
Revenue - £3.5m• Increased 43% from H1 2015 with service revenues up 47%• Small contribution from acquisition of PacificGMP (acquired Sept ‘15)• TCRS revenues will start to impact revenues in period to Mar ‘16
Gross profit - £1.6m• Increased by 31% from H1 2015
R&D investment - £1.9m
Reported loss increased to £3.5m• Reported loss for H1 2015 £2.7m
Cash at £7.4m at 30 September 15• £20m (net of expenses) raised in Dec 15
Abzena plc listed on the AIM segment of the LSE since July 2014 (AIM: ABZA)
Service revenue split
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Immunology (£2.0m)Protein engineering (£0.7m)Bioconjugation (£0.2m)Cell line development (£0.3m)Biomanufacturing (£0.2m)
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