Allergy Therapeutics Plc · LSE:AGY
Allergy Therapeutics — H1 2018 Earnings Presentation
36 slides from Allergy Therapeutics's earnings presentation, March 2018
Slide 1: Allergy Therapeutics Interim Results
Allergy Therapeutics Interim results for the six months ending 31 December 2017 Delivering on our strategy – three areas for growth March 2018
Slide 2: Disclaimer
Disclaimer The information contained in this presentation (“Presentation”) is being supplied to you solely for your information and may not be copied, reproduced or further distributed to any person or published, in whole or in part, for any purpose. No reliance may be placed for any purpose whatsoe
Slide 3: Introduction to Allergy Therapeutics
Introduction to Allergy Therapeutics Leading allergy immunotherapy Double digit compound annual company with a portfolio of growth achieved over the past Dedicated to marketed products and strong 18 years allergy treatment development pipeline and prevention Provide treatments that have Robust reven
Slide 4: Financial highlights
Financial highlights ~ Double digit compound annual growth achieved over the past 18 years ~ Solid growth in operating profit pre R&D up 1.3%* increase in revenue at constant currency** to 12% to £12.3m as a result of leveraging sales growth, a stated aim of management £40.9m (H1 2017: £11.1m) (H1 2
Slide 5: Operational highlights
Operational highlights Increased market share in Solid revenue growth across Europe – strong performance from Germany Venomil and Acarovac Plus 14% Completion of recruitment for pivotal Phase III Pollinex Quattro (2017: 13%) Birch trial Completion of recruitment for US Grass Mata MPL Phase II trial
Slide 6: Strategy
ler O98 occ Transforming Allergy Treatment ‘ ‘ March 2018
Slide 7: Delivering our strategy
Delivering our strategy Three pillars to the business Expanding in Europe Strong pipeline Preparing for US entry Strongly performing New technologies Significant opportunity profitable business underpin pipeline breadth and depth in largest allergy market Growing market share Investment strategy Cha
Slide 8: Expanding in Europe
Delivering our strategy EXPANDING IN EUROPE 8
Slide 9: Delivery of European growth strategy
Delivery of European growth strategy Solid sales growth of 1.3%* in H1 2018 and increased German market share to 14% from 13% driven by: Innovative, convenient Increased regulatory Focused investment Strength of broad Scaling-up to drive and patient-friendly requirements to ATL across business portf
Slide 10: Sales breakdown for FY 2017
Sales breakdown for FY 2017 Sales by country Sales by product1 Pollinex, Venomil, 17% 3% Diagnostics, 1% 4% 4% Netherlands Third Party UK Products, 9% 59% Germany 2% Acarovac Plus, Czech republic 2% 2% 7% Slovakia TyroMILBE, 5% 1% 3% Austria Pollinex Quattro, 44% Other Switzerland Tyrosine S / TU, 5
Slide 11: Strong pipeline
Delivering our strategy STRONG PIPELINE 11
Slide 12: TAV (Therapy Allergy Ordinance) process
TAV (Therapy Allergy Ordinance) process Includes all products 40% of all submitted products have now been TAV German process without registration removed from the process and are no longer initiated in 2008 on the market (PEI Seminar, 2017) and driven by the Paul Ehrlich Institute based Germany cont
Slide 13: Broad pipeline
Broad pipeline Also available as a Pre-clinical Phase I Phase II Phase III Market/Registered Named Patient Product Pollinex Grass Short-course SCIT Pollinex Tree Short-course SCIT Pollinex Ragweed Short-course SCIT Venomil Bee Bee venom SCIT Venomil Wasp Wasp venom SCIT Pollinex Quattro Grass * Shor
Slide 14: Pipeline trials
Pipeline trials PQ Birch – Phase III (Germany – TAV process) Positive top-line • Recruitment completed and patients already being treated results for Phase II • Results expected H2 2018 Birch dosing study • If successful, regulatory submission 2019 (B204) using conjunctival provocation test PQ Grass
Slide 15: Polyvac peanut product
Polyvac peanut product Single dose of virus like particle Manufacturing contract for (VLP) combined with recombinant scale-up of Polyvac product Positive results peanut allergen successfully signed with Biomeva achieved protects against anaphylaxis with aim of having first in human from preclinical
Slide 16: Preparing for US entry
Delivering our strategy PREPARING FOR US ENTRY 16
Slide 17: Portfolio of products to capture US opportunity
Portfolio of products to capture US opportunity Pollinex Quattro Grass ✓ Proprietary, IP protected technology ✓ De-risked opportunity Pollinex • Treated more than 250,000 patients and marketed in 7 countries (pollens) Quattro Ragweed ✓ First mover advantage • First to market in the seasonal injected
Slide 18: The evolving US opportunity
The evolving US opportunity $2 billion** estimated allergy immunotherapy market 2-3 Estimated peak grass sales million*** Americans $300-400 receive allergy million** immunotherapy US opportunity Currently no Current treatment: registered up to 100 injected injections over products 3-5 years*** Some
Slide 19: Financial results
Financial results March 2018
Slide 20: P&L – six months ended 31 December 2017
P&L – six months ended 31 December 2017 H1 2018 H1 2017 Variance % £'m £'m £'m Solid sales performance in abnormally weak pollen season Revenue 42.2 40.4 1.8 4% Gross profit 33.5 31.5 2.0 6% Sales drive gross profit growth Overheads (21.4) (20.5) (0.9) (4%) Overheads up R&D (5.9) (3.8) (2.1) due to
Slide 21: Sales – six months ended 31 December 2017
Sales – six months ended 31 December 2017 Strong sales increases in Spain and H1 2018 H1 2017 Variance % £'m £'m £'m Eastern Europe Gross Revenue at Constant Exchange Rate 44.9 44.3 0.6 1% Most markets Rebate at Constant Exchange Rate (4.0) (3.9) (0.1) (3%) performing robustly Net Revenue at Constan
Slide 22: Balance sheet at 31 December 2017
Balance sheet at 31 December 2017 2018 2017 Var £'m £'m £'m Non-current assets Increase in non-current assets Property, plant and equipment 9.8 9.7 0.1 driven by increase in pension investments Intangible assets 5.1 5.4 (0.3) Investments 4.9 4.3 0.6 19.8 19.4 0.4 Inventory higher Current Assets due
Slide 23: Cashflow for the six months ended 31 December 2017
Cashflow for the six months ended 31 December 2017 2018 2017 £'m £'m £'m £'m Opening cash balance 1st July 22.1 23.4 (Loss)/Profit before tax 6.4 7.2 Positive net cash generated by Adjustments re operations (2.1) (1.7) growth in business and foreign Net cash (used)/ generated by operations 4.3 5.5 e
Slide 24: Summary and outlook
Summary and outlook March 2018
Slide 25: Summary and outlook: 2018 set to be a pivotal year
Summary and outlook 2018 set to be a pivotal year Solid trading in H1 2018: Delivering against our strategy: three pillars to growth 1.3*% Robust financials set to continue sales growth at constant currency Clinical trials progressing as planned – broad pipeline underpinned by innovative technologie
Slide 26: 2018 expected key value driving newsflow
2018 expected key value driving newsflow Full year results Early H2 2018 H2 2018 H1 2019 PQ Grass Phase II PQ Birch Phase III Acarovac MPL for US and Europe – for Europe Phase I – results results of conjunctival - results of pivotal for the new dust provocation test field trial for PQ mite technolog
Slide 27: Appendix
OQreray Therapeutics” Appendix e March 2018
Slide 28: Analysis of regulated products
Analysis of regulated products Named patient basis Approved¹ German TAV process US Process Other Clinical trials Vaccines Pollinex X X Pollinex Quattro Grass X X X Pollinex Quattro Birch X X Pollinex Quattro Ragweed X X Pollinex Quattro Trees X X X Pollinex Quattro Grass & Birch X X Pollinex Quattro
Slide 29: Global presence
Global presence Sales and marketing network comprising c.160 European sales force Latvia Estonia Lithuania South Korea Belarus Netherlands Poland UK Germany Czech Rep. Slovakia Austria Switzerland Serbia Italy Albania Spain Canada Portugal Greece Malta Subsidiaries in 7 countries and distribution ag
Slide 30: Changing US landscape to drive market share
Changing US landscape to drive market share Current US SCIT market Allergy Therapeutics’ entry in the US Home made, unlicensed preparation Standardised dose vaccine Non GMP manufacturing New USP and FDA GMP manufactured Non registered regulations drive FDA submission No clinical evidence towards Mul
Slide 31: Microcrystalline tyrosine (MCT)
Microcrystalline tyrosine (MCT) Patent protection for MCT Processing patent covers MCT MCT particles are formulated as sterile in state of the art MCT Process patent processes enabling defined particle morphology and size extended-UK (2032)/EU optimised for binding to wide variety of antigens. filin
Slide 32: PQ: a unique platform technology
PQ: a unique platform technology MPL Adjuvant MPL Adjuvant MPL (Monophosphoryl MPL allows the SIT Regulates expression Acts locally as a Lipid A) is a non-toxic treatment course to be of co-stimulatory TLR4 agonist and derivative of shortened (big impact molecules on antigen- increases IgG lipopolys
Slide 33: Acarovac MPL house dust mite product
Acarovac MPL house dust mite product Phase I first patient treated Results of Phase I Trial in June 2017 as part of 32 expected H1 2019 Short-course patient trial (AM101) product with global potential Acarovac product without Market opportunity of MPL growing well in Spain $3-4bn* worldwide with onl
Slide 34: Bencard Adjuvant Systems division
Bencard Adjuvant Systems division Strategy Studies MCT, MPL & VLP Pre-clinical study using MCT in a Researching on MCT seasonal influenza model – elicited mechanism of action immune response indicative of protection Potential for licencing or Pre-clinical model using MCT and use in development of VL
Slide 35: Platform technologies
Platform technologies Modified Allergen Recombinant Microcrystalline Monophosphoryl Virus-Like Particles Native Allergen (Allergoid) Allergen Tyrosine (MCT) Lipid A (MPL) (VLP) Pollinex ✓ - - ✓ - - Pollinex Quattro ✓ - - ✓ ✓ - Oralvac - ✓ - - - - Acarovac Plus ✓ - - ✓ - - Acarovac MPL ✓ - - ✓ ✓ - Ve
Slide 36: TAV process
TAV process No Can Remove deficiencies be product from rectified? (only market Yes allowed once) No Yes No Carry out trials Does the or provide Does trial Is product Register Submit No Yes CMC file have No data to prove data prove authorised? with TAV? CMC File deficiencies ? efficacy efficacy? Yes