Allergy Therapeutics Plc · LSE:AGY

Allergy Therapeutics — FY2016 Earnings Presentation

31 slides from Allergy Therapeutics's earnings presentation, Sep 26, 2016

  1. Slide 1: Preliminary results for the year ending 30 June 2016

    Allergy Therapeutics Preliminary results for the year ending 30 June 2016 September 2016 STRICTLY PRIVATE AND CONFIDENTIAL

  2. Slide 2: Financial highlights

    Financial highlights  19% increase in revenue at constant currency to £51.5m (2015: £43.2m)*  12% increase in revenue to £48.5m (£43.2m)  Core business excluding R&D shows 11% increase in Operating Profit to £4.3m (2015: £3.8m)  Ramp up on R&D investment with £16.2m (2015: £3.1m) spent, reflecti

  3. Slide 3: Operational highlights

    Operational highlights  Increased market share in our main European markets to 12% (2015: 10%)  Achieved primary endpoint for PQ Birch Phase II Study in Europe and with dose selected which will be used in Phase III starting in 2017  Inconclusive results of Phase II dosing study in the US for Poll

  4. Slide 4: Competitive landscape

    Competitive landscape Eventful year for the industry:  SLIT competitor manufacturing shutdown  UK Biotech phase III study failure for cat allergen  Key German competitor put up for sale  MSD (Merck) dissolution of partnership in North America with European SLIT manufacturer STRICTLY PRIVATE AND

  5. Slide 5: Strategy

    Strategy September 2016 STRICTLY PRIVATE AND CONFIDENTIAL

  6. Slide 6: Strategy

    Strategy Allergy Therapeutics Group - 60 Gross Revenue £m 50  European business momentum increasing 40 CAGR 9% 30 20  US opportunity opens up a potential $2bn* 10 - SIT market 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Financial Year Ending Gross Reve

  7. Slide 7: European business

    European business  Growth of 19% at constant rate (12% actual) in broadly flat market  Gain of 2% market share to 12% this year  Supply chain integrity and unparalleled customer service  Alerpharma acquisition fully integrated  Eventful year in competitive landscape STRICTLY PRIVATE AND CONFIDE

  8. Slide 8: Sales breakdown

    Sales breakdown Sales by Country Sales by Product¹ Czech + Slovak, 2% Diagnostics, Switzerland, 4% Other, 1% 1% Pollinex, 14% Venomil, 3% Netherlands, 4% Other Third UK Market, 5% Party Products, 10% Austria, 6% Acarovac Plus, 2% TyroMILBE, 5% Spain, 9% Tyrosine S / TU, 4% Italy, 10% Pollinex Oralva

  9. Slide 9: Recent developments in US

    Recent developments in US  Demand for product that improves patient adherence  Regulators clamping down on manufacturing standards in extracts  Allergists coming under regulations of compounding pharmacies (USP797)  Enforcement of 28 day shelf life of mixed extracts  Drive towards single allerg

  10. Slide 10: US PQ product opportunity

    US PQ product opportunity Current US SCIT market Allergy Therapeutics’ entry in the US • Home made preparation • Standardised dose vaccine • Non GMP manufacturing • GMP manufactured • Non registered • FDA submission planned in 2020 • No clinical evidence • Multiple clinical studies • Long courses of

  11. Slide 11: The US opportunity

    The US opportunity  Immunotherapy is expected to grow at a CAGR of 11% to 2020*  Estimated market: cost to payer $2 billion**  Currently no registered injected products  Clinical Development Plan for PQ Grass at dosage stage  Opportunity fully funded to end of Phase III trial based on current a

  12. Slide 12: Phase II Birch dosing study in Europe (B204)

    Phase II Birch dosing study in Europe (B204)  Positive top-line results for Phase II Birch dosing study  Randomised 371 patients into six cumulative dosing regimes plus placebo  Conjunctival provocation test  Primary endpoint to demonstrate a statistically significant dose response for 5,000 to

  13. Slide 13: Phase II Grass dosing study in the US (G204)

    Phase II Grass dosing study in the US (G204)  Exploratory Phase II dose-ranging study for US Grass MATA MPL clinical development program  Results inconclusive and could not determine suitable dose  Investigation of reasons for results underway  Trial used mobile challenge chambers  Further Phas

  14. Slide 14: Acarovac Plus / Acarovac Quattro

    Acarovac Plus / Acarovac Quattro Acarovac Plus– Next Generation Products for Short-Course Dust Mite Immunotherapy  Acarovac Plus has undergone further clinical development, building on success of 2014 publication and is top selling product in Spain this year  A 1-year follow up study reveals a >50

  15. Slide 15: The peanut allergy opportunity

    The peanut allergy opportunity  Allergy acquired the exclusive right in November 2015 to develop Virus Like Particles (VLP) technology for allergy vaccines  Carrier system to present allergens to immune system  First development will be for peanut allergy • Currently no established and safe treat

  16. Slide 16: Other developments

    Other developments  Adjuvant Systems • MCT, MPL & VLP • Researching on MCT mechanism of action • Testing adjuvant systems in several vaccines • Results and publication expected soon  Synbiotics • Synbiotics = prebiotics + probiotics • Synbiotics as modulators of the allergic response • Innovative

  17. Slide 17: Financial Results

    Financial Results September 2016 STRICTLY PRIVATE AND CONFIDENTIAL

  18. Slide 18: P&L – Year to 30 June 2016

    P&L – Year to 30 June 2016  Strong sales performance in all markets despite weaker euro Audited 2016 2015 Variance % £'m £'m £'m  Strong sales drives gross profit growth and gross profit % up on Revenue 48.5 43.2 5.3 12% constant basis Gross profit 34.4 31.1 3.4 11%  Overheads Overheads (30.3) (2

  19. Slide 19: Sales – Year to 30 June 2016

    Sales – Year to 30 June 2016  Significant improvement in sales against flat markets Audited 2016 2015 Variance %  All markets performing well £'m £'m £'m Gross Revenue at Constant Exchange Rate 55.7 46.1 9.6 21%  Strong growth in Pollinex Quattro and Oralvac Rebate at Constant Exchange Rate (4.2)

  20. Slide 20: Balance sheet at 30 June 2016

    Balance sheet at 30 June 2016 • Increase in non current assets driven by currency movements and Audited 2016 2015 Var £'m £'m £'m investment in infrastructure Non-current assets Property, plant and equipment 9.7 8.7 1.0 • Trade debtors higher due to FX and Intangible assets 5.4 5.0 0.4 timing of sig

  21. Slide 21: Funds Flow for Year to 30 June 2016

    Funds Flow for Year to 30 June 2016 Audited 2016 2015  Net use of cash in £'m £'m £'m £'m operations driven by R&D Opening cash balance 1st July 21.2 2.0 investment (Loss)/Profit before tax (12.1) 0.7 Adjustments re operations 0.6 2.9 Net cash (used)/ generated by operations (11.5) 3.6  Fundraisin

  22. Slide 22: Summary

    Summary September 2016 STRICTLY PRIVATE AND CONFIDENTIAL

  23. Slide 23: Summary

    Summary  Strong trading in the 2015/16 financial year: +19% revenue growth at constant currency with gain in market share of competitive markets from 10% to 12%  Moving forward R&D and regulatory maintenance projects  Exciting pipeline progressing  US opportunity delayed about 1 year, all additi

  24. Slide 24: Outlook

    Outlook  We expect to submit BLA for Pollinex Quattro Grass in 2020 with commercial launch in 2020/2021  We expect to be the first to market in the US SCIT segment with a registered product  We aim to be market leaders in the SCIT allergy segment by 2020  Phase III PQ Birch trial for Europe to c

  25. Slide 25: 2016 expected newsflow

    2016 expected newsflow Nov 2016 Capital Markets Day Q4 2016 Europe – clinical trial approval for PQ Birch 301 Q4 2016 CTA approval for Acarovac Quattro Phase I trials Jan 2017 Trading update Mar 2017 Half year results STRICTLY PRIVATE AND CONFIDENTIAL 25

  26. Slide 26: Appendix

    Appendix September 2016 STRICTLY PRIVATE AND CONFIDENTIAL

  27. Slide 27: Global presence

    Global presence  Sales and marketing network comprising c.120 European sales force UK Netherlands & Latvia, Estonia Canada Germany & Lithuania Poland Austria & Czech Switzerland Italy Republic & Slovakia Portugal Greece South Korea Spain Subsidiaries Distributors New Markets Subsidiaries in 7 count

  28. Slide 28: 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 processes enabling defined particle morphology and size optimized for binding to wide variety of antigens. • MCT Process patent extended-UK (2032)/EU f

  29. Slide 29: PQ: An unique Platform Technology in the US

    PQ: An unique Platform Technology in the US Pollinex Quattro: 4 injections in 3 weeks, efficacy in 3 weeks Allergoid • Allergen chemically modified with glutaraldehyde • Reduces IgE reactivity vs. that induced by native allergens used in SIT • Retains IgG-allergen stimulating properties MPL Adjuvant

  30. Slide 30: Keys to Success for PQ in the US

    Keys to Success for PQ in the US  Proprietary Technology  IP Protected  De-risked opportunity • Treated more than 250,000 patients and marketed in 7 countries  Building on Progress to date in the US: • US$ 100 million invested in clinical studies to date • 15 clinical trials completed to date, i

  31. Slide 31: Key investment highlights

    Key investment highlights 1 Lead product Pollinex Quattro, a proven, unique and highly differentiated allergy vaccination 2 Integrated, efficient and scalable platform technology 3 Strong late stage pipeline of aluminium-free allergy products 4 Well established European commercial presence through d

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