Allergy Therapeutics Plc · LSE:AGY
Allergy Therapeutics — FY2021 Earnings Presentation
35 slides from Allergy Therapeutics's earnings presentation, 2021
Slide 1: Delivering on our Strategy
Delivering on our Strategy Preliminary Results for the year ended 30 June 2021 Manuel Llobet – Chief Executive Officer Nick Wykeman – Chief Financial Officer Alan Bullimore – Head of Business Innovation
Slide 2: Disclaimer
Disclaimer The information contained in this presentation (“Presentation”) is being This Presentation includes “forward-looking statements” which include supplied to you solely for your information and may not be copied, reproduced all statements other than statements of historical facts, including,
Slide 3: Contents
Contents 01 2021 Financial and Operating Highlights 02 Business and Strategy 03 Progress on Key Pipeline Products 04 Adopting ESG Framework Financial Results 05 Conclusion 06 Timeline 07 3 Allergy Therapeutics 08 Appendix
Slide 4: 2021 Financial and Operational Highlights
2021 Financial and Operational Highlights VLP Peanut Successful ex vivo study increase in 8% reported revenue to £84.3m (2020 £78.2m) First indications of safety profile Grass MATA MPL Exploratory Field Trial Operating profit pre R&D up 19% treatment phase completed Data expected in late autumn 2021
Slide 5: Business and Strategy
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Slide 6: Three Pillars to Growth: Advancing a Leading Allergy Immunotherapy Company
Three Pillars to Growth: Advancing a Leading Allergy Immunotherapy Company 01 02 03 Expanding in Europe Strong pipeline Preparing for US entry Strongly performing New technologies underpin Significant opportunity profitable business pipeline breadth and depth in largest allergy market Growing market
Slide 7: Expanding in Europe
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Slide 8: Robust European Business
Robust European Business • Continued and strong growth in Germany and Austria while Southern Europe affected 9% CAGR growth by COVID-19 over last 23 years • Successful ImmunoBON launches in Germany and Austria with potential to since formation launch in other major European markets in the next year
Slide 9: Pipeline progress
Pipeline progress Allergy Therapeutics 9
Slide 10: Innovative, Broad Pipeline and Marketed Products
Innovative, Broad Pipeline and Marketed Products Also available as a Pre-clinical Phase I Phase II Phase III Market/Registered Named Patient Product Grass MATA Short-course SCIT Tree MATA Short-course SCIT Ragweed MATA Short-course SCIT Bee Venom SCIT Short-course SCIT Wasp Venom SCIT Short-course S
Slide 11: VLP Peanut: a potential next generation peanut allergy immunotherapy
VLP Peanut: a potential next generation peanut allergy immunotherapy Successful primary IND submission to outcome in Imperial US FDA expected biomarker study late 2021 Study demonstrates VLP Manufacturing batch Peanut's hypoallergenic scale up successfully potential with 24-fold achieved reduction i
Slide 12: Peanut Study Results: evaluating biomarkers from peanut allergic patients
Peanut Study Results: evaluating biomarkers from peanut allergic patients • Ex-vivo study using blood samples from peanut allergic patients • 24-fold reduction in basophil activation and histamine release after VLP Peanut compared to Ara h 2 (the major peanut allergen) • Target was a 10-fold reducti
Slide 13: Grass MATA MPL
Grass MATA MPL Completion of treatment Product is one Phase III phase in exploratory field efficacy trial and completion study (G309) with results of safety database away expected autumn of 2021 from filing in US Key product for US Efficacy field study (G306) introduction – Ragweed and to start H2 2
Slide 14: Preparing for United States
Preparing for United States Allergy Therapeutics 14
Slide 15: Preparing for US entry
Preparing for US entry >100 injections Current treatment: up to 100 $2bn Capturing the injections over 3-5 years*** estimated allergy immunotherapy market** opportunity New USP and FDA regulations 2-3m drive towards pharmaceutical Americans receive allergy grade, centrally manufactured, 16% immunoth
Slide 16: Ensuring Sustainable Long-Term Value
Ensuring Sustainable Long-Term Value
Slide 17: Adopting an ESG Framework
Adopting an ESG Framework Environmental Social Governance • Become a Net Zero Carbon emission • Set gender diversity targets for our Board and • Created a more robust compliance framework Company by 2030 Executive Team - 30% Board and 50% Exec with additional controls relating to ethical Team by 202
Slide 18: Financial Results
Financial Results - Seen
Slide 19: P&L – year ended June 2021
P&L – year ended 30 June 2021 2021 2020 Variance % £’m £’m £’m +8% Revenue 84.3 78.2 6.1 8% Solid reported sales performance Gross profit 62.2 58.0 4.2 7% Overheads (45.9) (44.5) (1.4) 3% +3% R&D - Expenditure (12.9) (9.0) (3.9) Increase in costs due - Settlement 3.2 (3.2) Covid restrictions Other I
Slide 20: Balance sheet at June 2021
Balance sheet at 30 June 2021 2021 2020 Variance £'m £'m £'m Non-current assets £0.7m Property , plant and equipment Intangible assets 19.7 4.7 20.4 4.7 (0.7) 0.0 Increase in inventory due to Investments 5.8 5.9 (0.1) extended Brexit supply chain 30.2 31.0 (0.8) Current assets Inventories 10.8 10.1
Slide 21: Cashflow for the year ended June 2021
Cashflow for the year ended 30 June 2021 2021 2020 £’m £’m £’m £’m Positive net cash pre R&D Opening cash balance 1st July 37.0 27.4 generated by growth in Profit before tax 3.7 8.1 business and low costs Adjustments re operations 4.7 5.3 due to COVID Net cash generated by operations 8.4 13.4 Tax re
Slide 22: Conclusion
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Slide 23: 2022 Year
2022 Year • Upcoming IND Meeting with FDA for VLP Peanut • Initiation of Peanut Phase I trial (PROTECT) • Read out of Grass MATA MPL G309 trial and start of pivotal G306 trial • ImmunoBON additional EU launches and further data generation/indication expansion • Maintaining focus on SCIT and innovati
Slide 24: Key Milestones (Calendar Years)
Key Milestones (Calendar Years) Grass MATA MPL Grass MATA MPL pivotal Phase III VLP Peanut Phase I (P101) exploratory field trial (G306) – – Planned Results study (G309) – Study start Results Grass MATA MPL VLP Peanut Phase I (P101) pivotal Phase III – First in human study start trial (G306) – plann
Slide 25: Q&A
Q&A Preliminary Results for the year ended 30 June 2021
Slide 26: Appendix
Appendix Allergy Therapeutics 26
Slide 27: Allergy Therapeutics
Allergy Therapeutics 9% compound Leading, fully integrated annual revenue biopharmaceutical company based in the UK growth achieved over the last 23 years Provide treatments that Leading provider of have potential to cure subcutaneous aluminium- disease, not just free allergy vaccines symptoms. Focu
Slide 28: Sales breakdown for FY 2021
Sales breakdown for FY 2021 Sales by country Sales of £84.3m by product1* Diagnostics 1% Third Party Products 6% Pollinex 21% 2% 5% Acarovac Plus 3% UK Netherlands Venomil 64% Tyromite 5% 6% Germany 1% Czech republic 5yrosine S/TU 1% Slovakia 6% 7% 4% Austria 1% Switzerland Other Pollinex Quattro Or
Slide 29: Cutting-edge Platform Technologies
Cutting-edge Platform Technologies Modified Microcrystalli Monophospho Virus-Like Native Recombinant Lipocalin Allergen ne Tyrosine ryl Lipid A Particles Allergen Allergen Technology (Allergoid) (MCT) (MPL) (VLP) MATA MATA MPL (PQ) Sublingual Mite SCIT ImmunoBON Venom SCIT Peanut* * Product under pr
Slide 30: Unique depot Microcrystalline tyrosine (MCT) provides aluminium alternative
Unique depot Microcrystalline tyrosine (MCT) provides aluminium alternative as well as adjuvant properties Patent protection for MCT Processing patent covers MCT MCT particles are formulated as sterile in state MCT Process patent of the art processes enabling defined particle extended-UK (2032)/EU m
Slide 31: PQ: Differentiated platform approach enhances compliance
PQ: Differentiated platform approach enhances compliance, leads to higher efficacy and successful outcomes MPL Adjuvant MPL Adjuvant MPL (Monophosphoryl MPL allows Specific Lipid A) is a non-toxic Immunotherapy (SIT) derivative of treatment course to be lipopolysaccharide shortened (big impact on (L
Slide 32: Peanut VLP
Peanut VLP Adjuvant T cell Epitope T cell epitope derived T cell epitope enhances the from tetanus toxin. immune response to the VLP and shortens the duration of treatment Peanut Protein Protein Peanut protein bound Peanut protein introduced to the VLP carrier by VLP allows immune system to become t
Slide 33: The changing US regulatory landscape offers potential for significant commercial growth
The changing US regulatory landscape offers potential for significant commercial growth Current US SCIT market Allergy Therapeutics’ entry in the US • Home made, unlicensed New USP and FDA • Standardised dose vaccine preparation regulations drive towards pharmaceutical • GMP manufactured • Non GMP m
Slide 34: Virus like particle (VLP) platform
Virus like particle (VLP) platform VLP platform has potential in many different allergy areas. Sophisticated technology with potential to treat severe and extreme allergies • Engineered with a T-cell epitope derived from the tetanus toxin • Leads to activation of memory cells • Increased antibody re
Slide 35: Allergy Therapeutics: Company with Solid Sales and Global presence
Allergy Therapeutics: Company with Solid Sales and Global presence Sales and marketing network comprising c.140 European sales force Latvia Estonia Lithuania South Korea Belarus Netherlands Poland UK Germany Czech Rep. Slovakia Austria Switzerland Serbia Italy Spain Albania Subsidiaries in 7 Portuga