2017-03-20 Abzena Corporate Presentation 2 · These slides (the "Document") ... The 12 most...
Transcript of 2017-03-20 Abzena Corporate Presentation 2 · These slides (the "Document") ... The 12 most...
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Important notice
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 this presentation 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 you have 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 nor the 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 Company have 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 other jurisdiction 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, the registration requirements of the Securities Act. Neither the United States Securities and Exchange Commission nor any securities regulatory body of any state or other jurisdiction of the 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 the accuracy 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 the Company concerning, among other things, the Company's results of operations, financial condition, liquidity, prospects, growth, resource estimates, strategies and the Company's markets. By their nature, forward-looking statements involve risk and uncertainty because they relate to future events and circumstances. Actual results and developments may and often 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 to risks relating to future events and other risks, uncertainties and assumptions relating to the Company's operations, resource estimates, results of operations, growth strategy and liquidity. Whilst the Directors consider these assumptions to be reasonable based upon information currently available, they may prove to be incorrect, therefore reliance should not be 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 results of 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 or circumstances 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 by any 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 other written 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 its subsidiaries 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.
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Provider of specialist services & technologies to the biopharmaceutical industry
- Operating in the growing multi-billion dollar biopharmaceutical R&D market - Exponential rise in development of biopharmaceutical medicines - Increased outsourcing due to requirement for technical expertise and specialist equipment
- Complementary biology, chemistry and manufacturing services in UK & US - Customers include 18 of top 25 biopharmaceutical companies - >40% business growth rate, with further ability to grow especially through biomanufacturing
investment - Significant cross-selling within and across the group’s service and technology offerings
- ABZENA Inside technology licence portfolio - ABZENA Inside portfolio of licence & licence option agreements for Group’s proprietary
technologies - 12 ABZENA Inside products in clinical development - $0.5bn potential licence fees & milestone payments, plus royalties on products within
ABZENA Inside portfolio
Biopharmaceuticals 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. ADC’s are antibody drug conjugates.
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Lead discovery
Clinical studies In people Phase I, II and III
Regulatory approval
Treating patients
Non-clinical development (not in people)
Lead selection Lead optimization Manufacture
Non GMPGMP Manufacture
for PIII and the marketAntibody discovery
Manufacture GMP for phase I and II
Revenue generating services & technologies across the drug development process
ABZENA InsidePortfolio of agreements with downstream terms including combinations of licence fees, milestone payments, and/or royalties if products progress through development and reach the market.
The 12 most advanced are in clinical development.
Development & manufacturing services (H1 2017 revenue £2.0m up 60%) Cell line development Process development GMP manufacture of antibodies and proteins
Biology research services (H1 2017 revenue £3.2m up 16%) Antibody discovery Immunology
Protein engineering Technology licence
Alliance
Technology licence
Chemistry research services (H1 2017 revenue £3.5m up 66%) Bioconjugation for ADCs Chemistry research
Enabling progression into clinical studies Revenue growth numbers on a proforma aggregated basis for the six months ending 30 September 2016 prepared as if the group had existed for the comparative six-month period
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Abzena – international operations
Global business
Abzena is a global business with customers worldwide. Its headquarters and biology & chemistry research laboratories are in Cambridge (UK), biologic manufacturing and laboratory facilities in San Diego CA (USA) and chemistry research in Bristol, PA (USA).
The US operations were acquired in the second half of 2015. Abzena is quoted on the Alternative Investment Market of the London Stock Exchange.
CHO – Chinese Hamster Ovary cell line NS0 – Mouse myeloma cell line PQA – Product Quality Attributes
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Reported revenue for six months to
30 September 2015
Growth of biology research services Growth of manufacturing services Revenue for six months to 30 September 2016
Biology Chemistry Manufacturing Licence revenue Total
£2.0m £0.3m
TCRS acquisition
PacificGMP acquisition £3.5m
£6.1m
£9.0m
+£0.5m ↑ 16%
+£0.2m ↑ 326%+£0.8m
↑ 60%
+£1.4m ↑ 66%
Strong underlying growth and acquisitions contributing to significantly increased revenue
• 157% increase in reported H1 FY2017 revenue vs H1 FY2016 • 46% underlying revenue growth • 59% of revenue recorded in USD (H1 FY2017)
£3.2m
£3.5m
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Financial review – income statement
Unaudited six months to
30 September 2016
Unaudited six months to
30 September 2015Audited twelve months
to 31 March 2016 £’000 £’000 £’000
Revenue 8,960 3,501 9,854 Cost of sales (5,179) (1,881) (5,319)Gross profit 3,781 1,620 4,535
Other operating income 236 166 367 R&D costs (1,950) (1,857) (4,216)Expenses - Administration (6,385) (3,393) (9,047) - Exceptional items – (500) (2,542)Operating loss (4,318) (3,964) (10,903)Net finance income 46 24 244 Loss before income tax (4,272) (3,940) (10,659)Income tax 242 408 961 Loss for the year (4,030) (3,532) (9,698) Adjusted EBITDA loss (3,004) (2,914) (6,329)
Loss per share (3p) (4p) (9p)
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Financial review – balance sheet
As at 30 Sept 2016
As at 31 March 2016
£’000 £’000 Non–Current Assets Goodwill 17,112 15,060 Other intangible assets 7,939 8,117 Property, plant and equipment 5,033 4,170 Total Non–Current Assets 30,084 27,347
Current Assets Inventories 1,579 1,379 Trade and other receivables 5,758 5,436 Current income tax assets 1,130 1,569 Cash and cash equivalents 9,379 13,724 Total Current Assets 17,846 22,108 Total Assets 47,930 49,455
As at 30 Sept 2016
As at 31 March 2016
£’000 £’000 Equity Issued share capital 274 272 Share premium 41,307 41,263 Retained earnings (5,114) (1,026)Reserves 2,875 547 Total Equity 39,342 41,056 Liabilities Non-Current Liabilities 2,420 2,549 Current Liabilities 6,168 5,850 Total Liabilities 8,588 8,399 Total Equity and Liabilities 47,930 49,455
- All goodwill and intangible assets arise on acquisition of subsidiary companies – no R&D or patent expenditure is capitalised, movement reflects IFRS revaluation of acquisition goodwill
- Non-current liabilities principally relate to a deferred tax liability arising on acquisition accounting, with £0.4m for finance lease liabilities
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ABZENA Inside portfolio – includes 12 products in clinical development
Further pre-clinical licence agreements
- ThioBridge™ADC licences with potential to yield $0.5 billion licence fees and milestone payments plus royalties - Halozyme Therapeutics (Jan 2016) – up to 3 ADC targets - Undisclosed San Diego-based partner (Jan 2017) – up to 10 ADC products - Major pharma company ThioBridge™option agreement for up to 10 ADC products
- Further disclosed research & preclinical Composite Human Antibody™ programs:
- UCL anti-LRG1 antibody - Faron Pharmaceuticals’ Clevegen - Denceptor Therapeutics anti-CD40:HPV16.E6/E7 antibody-antigen fusion - Trieza Therapeutics licence up to $35m milestone payments plus royalties
Company & product candidate Potential indications Phase 1 Phase II Phase IIIGilead Sciences – GS-5745 Gastric cancer, RA, cystic fibrosis Opsona Therapeutics – OPN-305 Myelodysplastic syndrome Vascular Pharmaceuticals – VPI-2690B Diabetic nephropathy Roche – RG6125 Rheumatoid arthritis Undisclosed major US Pharma Neurodegenerative conditions Undisclosed major US Pharma Neurodegenerative conditionsTrue North Therapeutics – TNT009 Cold agglutinin disease & antibody-driven
diseasesNKT Therapeutics – NKTT120 Sickle cell disease Therapure Innovations – TBI 304H Chemotherapy-induced anaemia 3 Undisclosed biotech companies for undisclosed indications
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Summary
- Growing international service and technology group to enable the development of better biopharmaceuticals
- Global customer base, including 18 of the top 25 major biopharmaceutical companies, enabling integrated service and technology provision for drug development from discovery to clinical manufacturing
- Commitment to invest in service innovation, technology development and capacity expansion
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Abzena’s corporate history & major shareholders
- Group created in July 2013 through combination of PolyTherics (London, UK) & Antitope (Cambridge, UK)
- IPO on London Stock Exchange AIM market in July 2014 (ticker: ABZA)
- Acquisitions of PacificGMP (San Diego CA, USA) & The Chemistry Research Solution “TCRS” (Bristol PA, USA) in September & December 2015 respectively
- Major shareholders*: - Invesco Perpetual 26.2% - Woodford Investment Management 23.1% - Touchstone Innovations (formerly Imperial Innovations) 19.7% - Baillie Gifford 3.3% - Directors 2.6%
* As at 01 March 2017
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Leadership with extensive sector and governance experience
Ken Cunningham Chairman
John Burt Chief Executive Officer
Julian Smith Chief Financial Officer
Tony Brampton Partner Longbow Capital
Nigel Pitchford Chief Investment Officer Touchstone Innovations
Peter Grant Chairman designate LiDCO group PLC
Donna Hackett SVP IP, Commercial & Legal Affairs
Non-executive directors
Executive management
Sven Lee Chief Business Officer
Executive directors
John Manzello President, Abzena (US)
Jim Mills SVP Technical Operations
Campbell Bunce SVP Scientific Operations
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Business review – biology research services
- 1H 2017 revenue increased 16% to £3.2 million
- International customer base including 7 of the top 25 major biopharmaceutical companies during the period - 58 immunology projects (37 customers) - 31 protein engineering projects (16 customers)
- Nine ABZENA Inside Composite Human Antibody™ projects ongoing during the period
- Two protein engineering customers continuing programmes through to cell-line development
- Technology development and investment in analytical equipment enhancing immunology service offering
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Immune Profiling of Vaccine and Biologic Products to Improve Clinical Outcome
Protein TherapeuticVaccine
Abzena: • Has robust methods to profile the
immune response • Can inform mode of action and
potential efficacy of test product. • Can inform on potential safety issues • Can design in desirable features • Can design out undesirable features
Desired response good/beneficial
Protective immunity / effective therapeutic outcome
Undesired response bad/detrimental
Drug neutralised / reduced efficacy
Toxicology / safety implications
• Optimise product design • Improve confidence in lead candidate
selection • Reduce risk in committed downstream costs • Help manage clinical risk • Help define regulatory strategy • Maximise success in the clinic
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EpiScreenTM technology detects T cell epitopes in protein therapeutics: Example humanised antibody
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Business review – chemistry research services
- H1 2017 revenue of £3.5m (H1 2016: £0.2m) reflects growth in UK chemistry services and contribution from acquisition of TCRS, December 2015 - Underlying revenue increased 66% (proforma aggregate revenue H1 2016: £2.1m)
- More than half of customers have pursued programmes related to Group’s proprietary technologies
- Continued R&D investment in ADC technology development as well as establishment of GMP linker-payload synthesis capability in Bristol, PA
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ADC development & manufacturing capabilities
Production of ADC candidates for screening
In vitro potency assays
Cellular pharmacodynamic
s
In vivo efficacy studies*
In vivo pharmacokinetics*In vitro safety
studiesFormulation
0 100 200 300 400 500 600 700 800 9000.1
1
10
100
1000
ADC 2
Adcetris
ADC 4
ADC 3ADC 1
Time (h)
mA
b co
ncen
trat
ion
(µg/
mL)
Conc (pM)
Cel
l Via
bilit
y [%
]
100 101 102 103 1040
50
100
MMAEAdcetrisThioBridge™ ADC 1ThioBridge™ ADC 2ThioBridge™ ADC 3ThioBridge™ ADC 4
Apoptosis assay (Caspase-3 and -7 activity) - 48hrs incubationAnti-PSMA Conjugates included in mouse xenograft study 140294
Compound Concentration (nM)
Apop
tosi
s(F
old
over
Unt
reat
ed c
ells
)
0.001 0.01 0.1 1 100
1
2
3
4
5
6
7
8 PT074-BM004PT074-BM005
PT073-MP007PT74-TK002
PT073-MP005PT073-MP006PT074-BM006PT074-TK007PT55-ED006-3
PT55-TK004-2PT55-TK003-1
PT55-ED006-1PT55-ED006-2
Imaging for biodistribution*
Range of reagents with different
payloads
O
OHN
O
O
NH
OO
NH
ONH
O
HN
H2N O
O
O2S
SO2
NH
NHN
ON
O H
O
N
O O
HN
O
OH24
Ex vivo stability studies
0
20
40
60
80
100
120
Bren-B4-vc-PAB-MMAE
Bren-PEG(6u)-vc-PAB-MMAE
Bren-B4-PEG(24u)-vc-PAB-MMAE
Bren-B4-branched-vc-PAB-MMAE
Adcetris
Bren-PA1
0 102030 45 120 240
Time (min)
% re
leas
ed M
MAE
ADC production for preclinical
studies
GMP manufacture of reagents and
antibodies
The process flow demonstrates Abzena’s capabilities for supporting partners at each step of ADC development
*Outsourced by Abzena for partner
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Business review - manufacturing
- H1 2017 revenue increased 60% over proforma aggregated revenue to £2.0m
- San Diego manufacturing business has grown 47% since equivalent period
- Investigating funding options to accelerate further capacity expansion for process development and manufacturing and upgrade of GMP manufacturing platform
- Cell line development revenue more than doubled and has exceeded revenue for FY2016
- Investment in PQA analytical development capabilities has enhanced biosimilar offering
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QC and transfection
Gene amplification Increasing MTX
Pre-adapted suspension/serum-free Composite CHO™
Cloning plus optical imaging
Automated clone selection ClonePix FL screening
Vector construction
pANT-DEx-dhfr09 BssH II
BamH I
Mlu I
Hind III
Selection of lead clones and upstream
optimisation in ambr®15
Lead selection, GMP ready RCB suitable for
MCB generation, process scale up and production
Titre screen in well plates
Bioassay and characterising PQA
Bioassay and PQA protocol development PQA, bioassays
Overall timescale for DNA to RCB: 6-8mo plus stability studies
Bioassay and characterising PQA
Bioassay and characterising PQA
Manufacturing Cell Line Development Process Overview
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Manufacturing Summary
Scale-up and process development
• Route design, optimization and trouble-shooting
• Process optimization (avoidance of chromatography, solvent minimization, impurity profiles, avoidance of potential genotoxic reagents and manufacturability)
Antibody manufacture
• Production and purification of products for use in preclinical, Phase I and II clinical trials
• Mammalian protein expression from 10L to 500L in batch/fed-batch mode and up to 15,000L in perfusion culture
Payload manufacture
• Abzena currently has the capability to scale-up multi-step procedures to multi-gram quantities of target material
Conjugate manufacture
• Non-GMP batches for GLP Toxicology studies
• Tech-transfer for multi-kg GMP scale
• Full batch records for CMC section
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- JV between Baylor Institute of Immunology Research, part of Baylor Scott & White Health, and Abzena; established July 2016
- Denceptor will develop novel dendritic cell (DC) targeting immunotherapies to treat various cancer & autoimmune diseases
- Denceptor will seek third party funding to take its lead immunotherapy product into clinical development and progress other earlier-stage candidates - Lead product is an HPV E6/E7 immunotherapy for head and neck cancer and other HPV-
associated malignancies which is expected to enter the clinic in H1 2017 - Potential value to Abzena
- Progression of royalty-bearing ABZENA Inside antibodies into clinical development - Service revenues: protein engineering, cell line development & GMP manufacturing - Equity participation provides share of the value of the Company’s future potential value
Denceptor Therapeutics: DC targeting vaccines in collaboration with Baylor Institute for Immunology Research* (BIIR)
Antigenic payload
VL
VHCH
CL
CH2
CH3
Ag1
Antibody targeting DC receptors
DC-targeting fusion proteins
Engineering: Humanisation
Manufacturing: Cell Line Development
VL
VHCH
CL
CH2
CH3
Murine antibody targeting human DC
receptors