Corporate Presentation January 2016 Proactive Investors 28th January - - PowerPoint PPT Presentation

Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director

Allergy Therapeutics Corporate Presentation

January 2016

Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director

Introduction

• We treat people with Allergic disorders
• Focused on the moderate to severe patients
• Providing treatments that cure the disease,

not just treat symptoms

• Robust revenue growth and successful M&A

delivered

• c.420 employees
• Spun-out from Smith Kline Beecham 1999
• Headquarters and manufacturing base in

Worthing, West Sussex

• AIM listed: ticker AGY

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Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director

Strategy

• Strong European business
• European market share increased from 8.7% to 10.1%
• ver last 2 years
• US opportunity
• Poised to execute a pivotal clinical trial programme to

enable access to US – estimated $2bn market size

• New therapeutic areas
• Strong new product pipeline expanding the addressable

markets:

• Peanut allergy- estimated $8bn market size
• House Dust Mite allergy- estimated $3bn market size

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Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director

Global presence

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Subsidiaries in 9 countries and distribution agreements in additional 10 countries

UK Austria & Switzerland Italy Portugal Spain Argentina Canada Chile Venezuela & Columbia South Korea Greece Poland Czech Republic & Slovakia

Subsidiaries Distributors New Markets

Netherlands & Germany Peru Latvia, Estonia & Lithuania

• Sales and marketing network comprising

c.120 European sales force

Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director

Sales breakdown

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1.Sales breakdown based on gross sales at budget exchange rates (before freight, discounts, rebates and exchange) : £49.3 million. After deducting discounts, rebates, freight charges and foreign exchange adjustments, total sales for FY2015 is £43.2 million

Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director

The Peanut Allergy Opportunity

• November 2015- exclusive right to develop Virus Like Particles

(VLP) technology for allergy vaccines

• Carrier system to present allergens to the immune system
• First development will be for peanut allergy
• Currently no established and safe treatment available
• Commencing an R&D investment programme of c.£3m to

progress the programme through to the start of Phase I trials over a 2-3 year period

• Peanut represents a new opportunity into the $8bn worldwide

food allergy market

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Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director

The US opportunity

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• 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 on track
• Opportunity fully funded
• Estimated launch 2019
• Estimated peak grass sales US$300- US$400

million

*Visiongain, AR forecast 2014 **Piper Jaffray Update on the AR market, Sept. 2008. Datamonitor

Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director

Current US SCIT market

• Home made preparation
• Non GMP manufacturing
• Non registered
• No clinical evidence
• Long courses of treatment:
• 50 to 100 injections
• Slow to act: 6 to 12 months
• Low compliance

PQ product opportunity

Allergy Therapeutics’ entry in the US

• Standardised dose vaccine
• GMP manufactured
• FDA submission planned in 2018
• Multiple clinical studies
• Ultra- short course treatment:
• 4 injections
• Efficacy in 3 weeks
• High compliance

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Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director

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
• 14 clinical trials completed to date, including Phase I, II & III successful studies
• Investigated in over 3,000 patients worldwide, mainly in the US
• Strategic fit for US market*
• Pollinex Quattro is an injected product for an injected market
• First mover advantage
• First to market in the seasonal injected segment
• High entry barriers: regulatory requirements for extensive trials on efficacy and safety

Source: *The Current States of Therapy for Allergic Rhinitis in the United States. Lawrence Du Buske, MD.

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Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director

Competitive Landscape

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Four listed companies compete to lead the market in Europe and the US

• ALK
• Grastek: SLIT-Pill for grass allergy. Launched in the US
• Ragwitek: SLIT-Pill for ragweed allergy. Launched in the US
• Stallergenes
• Oralair: SLIT-Pill for grass allergy. Launched in the US
• Allergy Therapeutics
• Pollinex Quattro: ultra-short SCIT for grass allergy. US launch expected in 2019
• Circassia
• ToleroMune: ultra-short SCIT for cat allergy. In clinical development

Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director

2016 Expected News flow

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Q1 2016 US- PQ Grass 204- recruitment update 8 March Interims Q2 2016 Europe- PQ Birch 204- headline results Q2 2016 US- PQ Grass 204- headline results Q4 2016 US- Initiate G306 study recruitment Q4 2016 Europe- Clinical Trial Approval for PQ Birch 301

Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director

Summary

• Immunotherapy is expected to be the fastest growing segment in the allergic rhinitis

treatment market

• Raised £20m March 2015 (21p) to fund US opportunity for Pollinex Quattro Grass
• Planned launch in 2019
• Raised £11m November 2015 (28p) to
• Accelerate core business growth
• Open peanut allergy opportunity
• Strong trading in the first half of the financial year: +12% growth at constant currency

We are delivering on all aspects of our growth strategy

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