Allergy Therapeutics Corporate Presentation - January 2016 - Proactive ...
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Allergy Therapeutics
Corporate Presentation
January 2016
Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance DirectorIntroduction
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
Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director 2Strategy
Strong European business
European market share increased from 8.7% to 10.1%
over 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
Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director 3Global 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
Venezuela &
Columbia
Peru
Subsidiaries
Chile
Argentina Distributors
New Markets
Subsidiaries in 9 countries and distribution agreements in additional 10 countries
Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director 4Sales breakdown 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 5
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
Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director 6The 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 on track
Opportunity fully funded
Estimated launch 2019
Estimated peak grass sales US$300- US$400
million
*Visiongain, AR forecast 2014
**Piper Jaffray Update on the AR market, Sept. 2008. Datamonitor
Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director 7PQ product opportunity
Current US SCIT market Allergy Therapeutics’ entry in the US
• Home made preparation • Standardised dose vaccine
• Non GMP manufacturing • GMP manufactured
• Non registered • FDA submission planned in 2018
• No clinical evidence • Multiple clinical studies
• Long courses of treatment: • Ultra- short course treatment:
• 50 to 100 injections • 4 injections
• Slow to act: 6 to 12 months • Efficacy in 3 weeks
• Low compliance • High compliance
Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director 8Keys to Success for PQ in the US
Proprietary Technology
IP Protected
De-risked opportunity
• Treated more than 250,000 patients and marketed in 7 countries
Building on Progress to date in the US:
• US$ 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.
Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director 9Competitive Landscape
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 102016 Expected News flow
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 11Summary
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
Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director 12You can also read