May 2016 - Proactiveinvestors UK · 2018-12-08 · May 2016 1 These slides (the "Document") have...

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May 2016 1

Transcript of May 2016 - Proactiveinvestors UK · 2018-12-08 · May 2016 1 These slides (the "Document") have...

Page 1: May 2016 - Proactiveinvestors UK · 2018-12-08 · May 2016 1 These slides (the "Document") have been prepared and issued on behalf of Abzena plc (the "Company") and its subsidiaries

May 2016

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Page 2: May 2016 - Proactiveinvestors UK · 2018-12-08 · May 2016 1 These slides (the "Document") have been prepared and issued on behalf of Abzena plc (the "Company") and its subsidiaries

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.

This Document is for information purposes only and should not be construed as any offer or invitation to subscribe for any securities in the Company nor should it or any part of it northe fact of its distribution, save as otherwise expressly agreed, form the basis of, or be relied on in connection with, any contract or investment decision in relation thereto.

This Document does not constitute or form a part of any offer or solicitation to purchase or subscribe for securities in the United States of America. The securities of the Companyhave not been, and will not be, registered under the United States Securities Act of 1933, as amended (the "Securities Act"), or qualified for sale under the law of any state or otherjurisdiction of the United States of America and may not be offered or sold in the United States of America except pursuant to an exemption from, or in a transaction not subject to, theregistration requirements of the Securities Act. Neither the United States Securities and Exchange Commission nor any securities regulatory body of any state or other jurisdiction ofthe United States of America, nor any securities regulatory body of any other country or political subdivision thereof, has approved or disapproved of this presentation or passed on theaccuracy or adequacy of the contents of this presentation. Any representation to the contrary is a criminal offence in the United States of America.

This Document and any materials distributed in connection with the Document, include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes", "estimates", "plans", "projects", "anticipates", "expects", "intends","may", "will", or "should" or, in each case, their negative or other variations or comparable terminology. These forward-looking statements include matters that are not historical facts.They appear in a number of places throughout this Document and include statements regarding the current intentions, beliefs or expectations of the directors ("Directors") of theCompany concerning, among other things, the Company's results of operations, financial condition, liquidity, prospects, growth, resource estimates, strategies and the Company'smarkets. By their nature, forward-looking statements involve risk and uncertainty because they relate to future events and circumstances. Actual results and developments may andoften do differ materially from those expressed or implied by the forward-looking statements.

Any forward-looking statements in this Document are based on certain factors and assumptions, including the Directors' current view with respect to future events and are subject torisks relating to future events and other risks, uncertainties and assumptions relating to the Company's operations, resource estimates, results of operations, growth strategy andliquidity. Whilst the Directors consider these assumptions to be reasonable based upon information currently available, they may prove to be incorrect, therefore reliance should notbe placed on these forward looking statements. Save as required by law or by any applicable rules or regulations, the Company undertakes no obligation to publicly release the resultsof any revisions to any forward-looking statements in this Document that may occur due to any change in the Directors' expectations or to reflect future events, new information orcircumstances after the date of this Document.

No representation or warranty, express or implied, is or will be made as to, or in relation to, and no responsibility or liability is or will be accepted by the Company, its subsidiaries or byany of their officers, employees, affiliates or agents as to, or in relation to, the accuracy or completeness of the information, data or opinions contained in this Document or any otherwritten or oral information made available to or publicly available to any interested party or its advisers, and any liability therefore is expressly disclaimed, nor have the Company or itssubsidiaries independently verified such information, and any reliance you place thereon will be at your sole risk. Neither the Company, its subsidiaries or by any of their officers,employees, affiliates or agents shall have any obligation to update this Document or any additional information or to correct any inaccuracies in it which may become apparent.

Important notice

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Page 3: May 2016 - Proactiveinvestors UK · 2018-12-08 · May 2016 1 These slides (the "Document") have been prepared and issued on behalf of Abzena plc (the "Company") and its subsidiaries

• 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)

Page 4: May 2016 - Proactiveinvestors UK · 2018-12-08 · May 2016 1 These slides (the "Document") have been prepared and issued on behalf of Abzena plc (the "Company") and its subsidiaries

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

Page 5: May 2016 - Proactiveinvestors UK · 2018-12-08 · May 2016 1 These slides (the "Document") have been prepared and issued on behalf of Abzena plc (the "Company") and its subsidiaries

~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

Page 6: May 2016 - Proactiveinvestors UK · 2018-12-08 · May 2016 1 These slides (the "Document") have been prepared and issued on behalf of Abzena plc (the "Company") and its subsidiaries

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

Page 7: May 2016 - Proactiveinvestors UK · 2018-12-08 · May 2016 1 These slides (the "Document") have been prepared and issued on behalf of Abzena plc (the "Company") and its subsidiaries

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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Page 8: May 2016 - Proactiveinvestors UK · 2018-12-08 · May 2016 1 These slides (the "Document") have been prepared and issued on behalf of Abzena plc (the "Company") and its subsidiaries

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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

Page 9: May 2016 - Proactiveinvestors UK · 2018-12-08 · May 2016 1 These slides (the "Document") have been prepared and issued on behalf of Abzena plc (the "Company") and its subsidiaries

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)

Page 10: May 2016 - Proactiveinvestors UK · 2018-12-08 · May 2016 1 These slides (the "Document") have been prepared and issued on behalf of Abzena plc (the "Company") and its subsidiaries

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

Page 11: May 2016 - Proactiveinvestors UK · 2018-12-08 · May 2016 1 These slides (the "Document") have been prepared and issued on behalf of Abzena plc (the "Company") and its subsidiaries

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

Page 12: May 2016 - Proactiveinvestors UK · 2018-12-08 · May 2016 1 These slides (the "Document") have been prepared and issued on behalf of Abzena plc (the "Company") and its subsidiaries

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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Page 13: May 2016 - Proactiveinvestors UK · 2018-12-08 · May 2016 1 These slides (the "Document") have been prepared and issued on behalf of Abzena plc (the "Company") and its subsidiaries

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

Page 14: May 2016 - Proactiveinvestors UK · 2018-12-08 · May 2016 1 These slides (the "Document") have been prepared and issued on behalf of Abzena plc (the "Company") and its subsidiaries

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

Page 15: May 2016 - Proactiveinvestors UK · 2018-12-08 · May 2016 1 These slides (the "Document") have been prepared and issued on behalf of Abzena plc (the "Company") and its subsidiaries

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

Page 16: May 2016 - Proactiveinvestors UK · 2018-12-08 · May 2016 1 These slides (the "Document") have been prepared and issued on behalf of Abzena plc (the "Company") and its subsidiaries

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

Page 17: May 2016 - Proactiveinvestors UK · 2018-12-08 · May 2016 1 These slides (the "Document") have been prepared and issued on behalf of Abzena plc (the "Company") and its subsidiaries

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)

Page 18: May 2016 - Proactiveinvestors UK · 2018-12-08 · May 2016 1 These slides (the "Document") have been prepared and issued on behalf of Abzena plc (the "Company") and its subsidiaries

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